October 19, 2017

All Hail Harsanyi

In the extremely unlikely event that I join Brother Keith in boycotting the NFL, it will not be because of pink shoes, or horrible relay decisions, or anthem kneeling. It will be to avoid the teaser commercials for "60 Minutes."

Without football, I can pretent that 60 minutes doesn't exist. I know it does, it's not denial. It's like "The View," or "Judge Judy," or whatever vehicle Dr. Oz is using to spread pseudoscience this week. It's there but it does not affect me.

With football, especially Denver Broncos / AFC football, the story is hyped all through the game. When I heard about the forthcoming exposé on Big Pharma fueling the opioid crisis, I knew <southparkvoice>we were gonna have a bad time.</southparkvoice>

Of course I did not watch. But Reason and now David Harsanyi have filled me in.

A number of reporters in my social media feed were especially enthusiastic about the article. The purity of the drug czar seat had been saved! This, they explained, was why journalism still mattered. One hopes not, considering how the article illustrates that a trumped-up non-story can drive coverage on important issues.

People "curing the opioid epidemic" by denying medication to the people who need it should get their own special place in hell -- I'd free the usurers to make room if needed!

Posted by John Kranz at 2:24 PM | Comments (0)

June 5, 2017

Ms. Rand, Line One...

States have decided that they can properly direct the pharmaceutical industry. They know "what counts as an 'essential' diabetes medicine" (Nevada, vetoed by Republican Governor), as well as what constitutes "an 'unconscionable' price increase."

The WSJ Ed Page is on it.

Yet instead of noticing such disincentives, state governments are now attacking the generic industry. In May, Maryland's Republican Governor Larry Hogan allowed a bill to become law without his signature that would unleash the state Attorney General to investigate any generic drugmaker responsible for an "unconscionable" price increase. Remember that the left defines as unconscionable paying money for any health-care product or service.

I referenced Ayn Rand in the headline -- well, for clickbait, of course, but also -- because these seem to be lifted from Atlas Shrugged. The arrogance of Wesley Mouch, and the real harm to producers and customers.

But, all kinds of great intentions!

Posted by John Kranz at 10:34 AM | Comments (0)

August 25, 2016


Why, it would take the former Secretary 12.5 seconds of speechifyin' to afford one of those! It's outrageous!

But not necessarily capitalism's fault...

Posted by John Kranz at 4:11 PM | Comments (2)
But nanobrewer thinks:

And now it's shown that Mylan was a Clinton Foundation donor.

Posted by: nanobrewer at August 27, 2016 12:15 AM
But johngalt thinks:

This comment could have gone onto the free enterprise vs. socialism "chart" post below, but since it is specifically about Epi-pens.


So why is the government having so much trouble permitting a usable form of a common medication?

There are a lot of different factors, but let me focus on the most annoying one. EpiPen manufacturer Mylan Inc spends about a million dollars on lobbying per year. OpenSecrets.org tells us what bills got all that money. They seem to have given the most to defeat S.214, the "Preserve Access to Affordable Generics Act". The bill would ban pharmaceutical companies from bribing generic companies not to create generic drugs.

Did they win? Yup. In fact, various versions of this bill have apparently failed so many times that FDA Law Blog notes that "insanity is doing the same thing over and over again and expecting different result".

The whole piece is pretty good.

Posted by: johngalt at August 30, 2016 3:31 PM

August 10, 2016

Children Dying to Cover Asses?

I've already posted [1] [2] [3] links about the FDA's insane decision to withhold approval for a promising treatment for Duchenne Muscular Dystrophy.

My fourth link suggests an even more nefarious agenda:

Here is one reason an FDA staffer would file a complaint against eteplirsen: To protect his job after a contentious proceeding noticed by patients, the press and several U.S. Senators. The agency manual says that "all initiators of disputes are protected from any retaliation by their supervisors, peers, leadership and others, related to initiating or engaging in this process."

This could be an insurance policy against getting fired for "scientifically questionable comparisons" and "errors." That's how more than 35 Duchenne experts described one of FDA's eteplirsen review documents in a February letter to neurology division director Billy Dunn.

Researching the links to the previous posts, one cannot help notice jg's prescient comment to the first:
How can this be excused as "for the children?"

It's more like, "for the bureaucracy."

Posted by John Kranz at 11:07 AM | Comments (0)

May 26, 2016

Or maybe it's the FDA...

WSJ Ed Page:

Boys with lethal Duchenne muscular dystrophy have waited years for the Food and Drug Administration to approve a safe and innovative treatment, and they'll have to hold out longer. On Wednesday the FDA delayed a decision on eteplirsen by Sarepta Therapeutics, but the agency can still choose the correct scientific and legal outcome.

Sarepta said FDA had notified the company that a decision would not be issued on Thursday as scheduled. The agency offered no clues beyond promising to finish "internal discussions" and the broader review "in as timely a manner as possible." An FDA advisory panel voted against approval in April, though agency bosses can accept or disregard the input.

It ain't Disney World.

Posted by John Kranz at 1:15 PM | Comments (0)

April 29, 2016

Your FDA at Work

I look forward to the day I can stop posting these stories and stop complaining. But this tale of the FDA blocking treatment for Duchenne Muscular Dystrophy hits too close to home. I saw a video of a mother with two sons. Both had Duchenne. One was in the trial and had to watch his brother deteriorate because he could not get this treatment. You'd think the FDA would at least let Mom decide which kid she wants to let the government kill.

No, measured speech will not be employed in this post. I have been on trials for nine years and have seen how resource-intensive they are. Big Pharma has spent a ton of dough on me: some to develop and test product, but as much or more to satisfy a government which keeps the compound that helps me away from the others in the infusion room. At least they're not my brothers.

A small company like Sarepta can't summon the resources to produce unlimited drug doses at government whim, but set that aside. There aren't enough patients for such a double-blind trial. An estimated 12,000 boys in the U.S. suffer from Duchenne, but only 13% have the mutation amenable to eteplirsen (more iterations are on the way, unless FDA prevails). Many patients have deteriorated too far to be eligible or live too far from a city with a trial.

FDA's demands also violate ethical standards of medicine. Eteplirsen requires a weekly muscle infusion, with biopsies that are exhausting and risky for someone with a degenerative neuromuscular disorder. The agency would ask kids to be lab rats and lose the ability to walk or catch a ball while receiving intensive injections of what might be sugar water.

Well, those 12,000 boys can just wither and die I guess. I'm sure a new study will help the next generation of patients. Oh. Wait.
FDA has suggested no alternative path to approval.

JS Mill weeps. If you cannot read the story, let me know and I will smuggle through the paywall.

UPDATE: Here is the story I mentioned of the mother with two sons.

Posted by John Kranz at 10:30 AM | Comments (4)
But Keith Arnold thinks:

Your words are far less outraged than you would be entitled to use.

Unlike Rick Perry, I would have no problem at all naming three Federal agencies that I would take a chainsaw too, and I wouldn't need to trade any draft choices to make the FDA a first-round pick (hey, by the way, Paxton Lynch? Great choice, especially under the tutelage of the right QB coach.). If we were a free society, this mother - and for that matter, you - would be able to walk into a pharmacy, point, and say "our doctor says we're going to try that one." A willing buyer and a willing seller shouldn't need to deal with a nosy government coming between them.

With respect to your personal stake in this, I will yield the floor to you. Don't apologize for making a full-throated protest at this government's unfitness to deal with the circumstances.

Posted by: Keith Arnold at April 29, 2016 12:47 PM
But johngalt thinks:

Double-blind trials suck. I read an article on cancer immunotherapy studies last week, however, where they give all of the study participants the trial drug. There are no sacrificial placebo patients. I wonder why the double standard?

"I Survived Stage IV Melanoma: How Immunotherapy Saved My Life"
'Health' magazine, May 2016 issue

Posted by: johngalt at April 29, 2016 1:06 PM
But johngalt thinks:

Re: Paxton Lynch - In my circles we're pretty happy with the pick. Brock who? Don't know anyone by that name. ;)

Posted by: johngalt at April 29, 2016 1:54 PM
But jk thinks:

For better or worse, double-blind is the government standard. There are a few oddities. I received routine and expensive MRIs -- but my neurologist was not able to see them. Mmmkay.

When "shopping" for trials, I was very careful to select studies where full placebo was not an option. I was deteriorating quickly and didn't want three years of sugar pills.

My first trial was a combination on two drugs; some got both, some one, some the other. They go through these elaborate double-blinding but both compounds have huge and notable side effects; you knew what you were on in a few weeks, and if you chatted with your Doctor, so did he or she. I gave myself a shot every day for three years that I was 91.753% sure was nothing. Your blog brother is truly dedicated to science.

My second (and successful) one was a Phase II where they were trying different dosages. A bag would show up with my initials on it and they'd insert (IV, not suppository...) it without knowledge of the dose. That probably was a decent variable. [SPOILER ALERT:] That stopped progression of symptoms for all intents and purposes and I am on a continuation trial where I take a known dose and they just make sure I am still alive and have not "grown an extra teat" as my wife tells the story.

Since that time, I have listened to several of Russ Roberts's EconTalk podcasts. If you go by the numbers, the placebo control group in many trials does quite well. That is counter-intuitive and depressing to someone who celebrates innovation as I do. But in many trials it is not a death sentence to draw the sugar card.

I'll call this study different. There is a minimal chance of "just getting better" and I take their point on the stress and potential harm of treatment.

Posted by: jk at April 29, 2016 2:15 PM

January 26, 2016

Yawn! FDA destroys some more families

This time a treatment for Duchenne muscular dystrophy. I saw a video clip of a mother who had two sons with the disease. One was on the trial and doing great -- Mom was unable to get the pencil-pushers at the FDA to allow her to save the life of her other son.

It was tragic and heartbreaking, but I have good news: from now on, neither son will be able to get this treatment and should it happen again, both kids can die. For the FDA has spoken: Biomarin Pharmaceutical's drug Kyndrisa™ has had its application rejected.

Doing so became a true disaster. Under the 1962 law, drug after drug was removed from the market after years of successful use because the FDA decided that well-controlled clinical trials, for all their cost and limitation, were better than the long-term success of various drugs in the marketplace. It is for good reason that children, parents, and physicians are asking a different question from that which the FDA puts to itself: are they better off with the drug than without it? And when there is no alternative remedy, the answer is that they are better off with it.

At this point, the first question has nothing to do with abstract standards of scientific evidence. It has to do with the simple issue of who gets to decide what type of evidence, systematic or anecdotal, is most valid. American law today wrongly vests that power in the FDA on the ground that its expertise is needed on matters of public health. But Duchenne and similar genetic diseases are not communicable, as most public health concerns are. They are individual, not interconnected, tragedies.

I know my FDA tirades become tiresome, but Richard Epstein's "The Other Drug War" is worth a read in full.

Posted by John Kranz at 2:00 PM | Comments (1)
But johngalt thinks:

How can this be excused as "for the children?"

It's more like, "for the bureaucracy."

Posted by: johngalt at January 26, 2016 2:54 PM

April 8, 2015

Left vs. Left - Public Health Mandates and Naturalists

I may not agree with naturalist nut-job RFK Junior that childhood vaccinations constitute a "holocaust" in our country but I defend his right to opt-out of vaccinating his children if he should so choose. Meanwhile, California's legislature is considering SB 277 to eliminate exemptions from vaccination mandates.

If it would save over 100 people in a state of 38+ million people from infection by a largely treatable disease, wouldn't it be worth it to make individual choice illegal?

Posted by JohnGalt at 3:03 PM | Comments (0)

August 20, 2014

Still a piece of health care outside government control?

Mai non!

"A big part of our concern is not just Sovaldi, but all the other specialty drugs," said Mario Molina, the CEO of Molina Healthcare that runs Medicaid and ObamaCare plans in nine states, on a July earnings call. He added: "I think that the government needs to step in here and make sure that the market is rational. If we as a health plan want a rate increase, we have to go to our regulators and get it approved. There's no such thing going on in the pharmaceutical market. Right now, pharmaceutical companies can charge whatever they want, and I think there needs to be a rational basis for all of this."

Oh, dearie me.

For those who have not been watching closely, Sovaldi pretty much cures Hep-C. Not manages its symptoms, not prolongs life, cures.

The WSJ Ed Page points out that the typical complaints of "copycat" and incremental pharmaceuticals do not apply. Sovaldi is a breakthrough. At $89,000 it is pretty pricey. But the alternatives include liver transplants, and constant, intensive, expensive treatments to maintain and mange symptoms. If you'll pardon my "playing the Medical Card," were there an $89K cure for MS I would be both applying for loans and throwing a party.

I guess I can see why Mr. Molina's life sucks. The government sets his prices, offerings, profits and fat content in the cafeteria. How sad it must be to look out the dirty window at freedom. But let us not forget what brought us here.

To the extent drug prices are rising, one reason is because researchers are asking more challenging clinical and biological questions. Only two of every 10 drugs on the market ever earn back enough money to match the cost of R&D and FDA approval before patents expire. Successful drugs thus underwrite the uncertain, failure-prone, time-consuming and often wasteful and even random process of scientific invention.

Yes, Mr. Molina, we could spread dirigisme to the Pharma sector. Might I suggest we try freedom?

Posted by John Kranz at 4:32 PM | Comments (0)

January 17, 2014

Hey hey, FDA, How Many kids you kill today?

It was sickening to watch the FDA deny an obviously effective and important therapy to those afflicted with a terrible disease [Multiple Sclerosis]. For as long as the decision stands, much needless suffering will result (and much needless foreign travel). The agency's action is also a vivid example of the serious problems besetting U.S. drug regulation.
My beloved Facebook friends love to post how GMO Corn or some such thing is banned in 20 countries -- why not here? I'll take the liberty side of that one any day, and frequently annoy a couple of conservative, GOP-votin' folks who consider me something of a fellow traveler but have bought into the GMO and vaccine junk science.

I did plop this on FB. Maybe some of those will join me on the liberty side of this -- why cannot an MS patient and his/her physician choose to try this treatment?

The WSJ Editorial is very good -- let me know if you don't subscribe and would like a copy emailed. The trials it describes are similar to those in which I have participated. And this treatment actually sounds similar to what I am on. I've little doubt it is a related compound.

The primary reason FDA reviewers gave for rejecting Lemtrada was that the studies demonstrating the drug's efficacy did not conform to the agency's standard requirement of double-blind, placebo-controlled drug trials--where some patients, unbeknownst to themselves and their doctors, receive placebo treatments. There are excellent reasons for the standard approach, but only up to a point. Lemtrada and many established MS treatments have immediate side effects, such as nausea and headaches, that are well known to doctors and patients. A double-blind trial would not really be blind. Patients on a placebo would promptly discover that they were the "controls," and many would decline to participate further--scrambling the statistical comparison with patients receiving real treatments.

The Lemtrada investigators therefore designed "active control" trials that matched it against a leading MS therapy (a branded version of beta interferon) that would be its primary clinical alternative. The trials found that Lemtrada patients relapsed into active MS symptoms at rates 50% lower than patients taking the alternative. These results were buttressed by MRI and other objective measures that found, for example, highly significant reductions in brain atrophy and new brain lesions

I've been in the former (of course, the FDA accepts no other) and it is laughable. The first trial I took two treatments and knew that at least one was valid. I could tell in a week that one was placebo as I had no effects and that one was the real deal because I got sick as a dog. For three years, I gave myself a daily shot that I knew with 99% certainty was saline. (Can't you guys give me a gummy bear to chew or something instead?)

As I said on FB, the standard is "compared to leeches" so we have to compare every drug to leeches. I would not participate in -- and find it cruel to demand -- a trial where one could be on no treatment for two or three years. MS is a progressive and debilitating disease. Let the patient get worse and lose good years of life so that some bureaucrat in DC can check a box on a form.

And, if they don't mistreat patients, they cannot sell their wares in the USA.

Posted by John Kranz at 12:41 PM | Comments (1)
But johngalt thinks:

"We're from the government. We're here to help. It's true, because we said so."

Not to mention that there's never any blame to place when "nothing" happens.

Posted by: johngalt at January 20, 2014 2:40 PM

November 20, 2013

Hey, hey, FDA, how many did you kill today...

I've been too kind to the FDA of late. I am clearly losing my edge. Take it away, Mister Gillespie (sans Jacket):

(~8:26): "[If the FDA had continued with the fast track procedures allowed for HIV drugs] we would be a decade or two ahead of where we are today on curing a lot of intractable diseases."

Posted by John Kranz at 1:56 PM | Comments (0)

June 26, 2013

Project for Awesome

Segue machine, Engage! The previous post lamented that cheap money could not "create new technologies. It can't make older people younger."

Project for Awesome, originating in the Colorado Springs area as far as I can tell, shows us what can do - both of those.

P4A 2012 - SENS Foundation

[Wanted to embed but seems to be broken, or disabled.]

Posted by JohnGalt at 3:51 PM | Comments (0)

May 23, 2012

Mister Vice President!

What liberty sounds like:

Posted by John Kranz at 7:43 PM | Comments (3)
But Keith Arnold thinks:

The floor recognizes Senator Hoss of Kentucky...

... and if his amendment had simply ELIMINATED the FDA, I'd seriously consider him as my running mate.

Posted by: Keith Arnold at May 23, 2012 10:31 PM
But jk thinks:

Yes, let's not make the perfect the enemy of the good -- taking their guns away is an awesome first step!

Beyond FDA bashing, which is always in season, I really appreciated his nod to mens rea. Reason and Stossel have made me more aware and concerned of this threat to liberty. The guy who goes to jail for importing lobster in plastic bags.

Posted by: jk at May 24, 2012 9:24 AM
But Perry Eidelbus thinks:

The apple did not fall far from the tree.

"I think we have bigger problems in our country without sending armed FDA agents." End stop.

Posted by: Perry Eidelbus at May 24, 2012 11:24 AM

March 14, 2012

JG agrees with Boulder DA

Like myself, Boulder's [Democrat] District Attorney Stan Garnett doesn't understand why the Obama Justice Department is so tough on the medical marijuana business. After all, aren't Democrats and weed activists fellow travelers? And, perhaps because I had dinner with the man 12 days ago (well, actually, different tables in the same Boulder burger joint) I agree verbatim with General Garnett on this sentence from his letter to United States Attorney John Walsh:

"The people of Boulder County do not need Washington, D.C., or the federal government dictating ..." WAIT! Stop right there.

But he continued, "how far dispensaries should be from schools or other fine points of local land use law," Garnett wrote.

I don't think Garnett helped his effort by suggesting what the US Attorney's priorities should be, but that probably won't be what makes or breaks the G-Men's "prosecutorial discretion."

In the "things that make you say, hmmm" department: The article also says that Boulder has an estimated 12 dispensaries within 1000 feet of a school.

Posted by JohnGalt at 3:11 PM | Comments (2)
But jk thinks:

I think it is part of the First Lady's initiative to make schoolchildren walk more.

Flippancy aside, yaay DA Garnett for asserting our rights -- maybe he'll join The Filburn Society. (Do follow that link if you have not seen it!)

Posted by: jk at March 14, 2012 4:23 PM
But Bryan thinks:

It’s wonderful to see the Boulder DA standing up to the Feds on what really is a 10th Amendment issue.

It’s too bad that he and other Democrats (and some Republicans), don't apply this principal consistently on all of the issues that the Federal Government should not be meddling in.

Posted by: Bryan at March 15, 2012 12:52 PM

October 31, 2011

Russ Roberts, Call your Office!

We've gone whizzing past France and are somewhere between the Soviet Union and Orwell's Oceana. President Obama outlawed shortages today! I wish he'd sign a bill making us all smarter and better looking -- that would not require Congress either.
Until that time, at least we will be safe from drug shortages:

At least 232 shortages have been reported through the end of October, said Erin Fox of the University of Utah, who monitors drug shortages for the American Society of Health-System Pharmacists.

That constitutes a record number that has included crucial drugs needed to care for cancer patients, heart attack victims, accident survivors and a host of other ill people. The shortages include some of the most commonly used drugs used in hospitals, and they have led to a spike in the cost of some medications and delays in treatment.

I hate to make light of a serious health issue, but I cannot let the Administration's response pass without ridicule. How do you fix a shortage? [Da daa duh, da da duh duh dunht. Duh da duh da DUN! da da da da daaa...] Umm, Price Controls? Correct, but you did not phrase your answer in the form of a question -- that's going to cost you $14.5 Trillion.
Obama's executive order instructs the FDA to adopt measures to prevent price-gouging and protect consumers.

Seems like it would have been better if he had simply outlawed Cancer...

Posted by John Kranz at 6:40 PM | Comments (3)
But johngalt thinks:

There you go again, looking for the simple answer!

And that $14.5 Trillion line? A gem. I'm glad I wasn't drinking coffee when I read it.

Posted by: johngalt at October 31, 2011 7:30 PM
But Keith Arnold thinks:

And to think that I said that Nixon's greater sins were legitimizing Red China and the Wage and Price Controls. I never knew before that Congress was optional for legislation; if we'd known we could simply legislate by Executive Order, we could have simply dissolved Congress entirely. Who knew?

Posted by: Keith Arnold at October 31, 2011 8:02 PM
But jk thinks:

You left out the EPA. Thanks, Dick!

Posted by: jk at November 2, 2011 12:11 PM

August 4, 2011

Great Personal News

Fear not, it will not diminish my enthusiasm for fighting the FDA one iota (how may picofarads in an iota?) But I received some very good news.

It seems they have added an open-label extension to the drug trial I was on. This will allow me to get the compound that was pretty effective for me with minimal side effects. They will provide product for a mixture of compassionate use and safety monitoring, likely unit it is approved.


Posted by John Kranz at 1:08 PM | Comments (2)
But Boulder Refugee thinks:

Woo hoo!!

Posted by: Boulder Refugee at August 4, 2011 1:30 PM
But johngalt thinks:

Compassionate use be upon thee.

Posted by: johngalt at August 7, 2011 7:27 PM

July 27, 2011

Half Measures

It's not exactly first principles, and it is a far cry from the real solution of privatizing the FDA, but Michele Boldrin and S. Joshua Swamidass (and you thought you got teased in school) have a better-than-half solution to drug approvals in the WSJ Ed Page today.

Considering that the bulk of FDA approvals are to prove efficacy, Professor Boldrin and Dr. Swamidass suggest that the FDA pare down its mission to safety and trust medical journals and private research to prove efficacy. The present "contract" has become too expensive for innovation:

Every drug approval requires a massive bet--so massive that only very large companies can afford it. Too many drugs become profitable only when the expected payoff is in the billions. As a consequence, competition in the drug-development market shrinks. Only a few large companies can afford the final clinical trials, hence key innovators--small biotechnology companies and academic scientists--can't compete. As Paul Hastings, CEO of OncoMed Pharmaceuticals, testified before the House Subcommittee on Health this month, "When it comes to venture-backed startup biotechnology discovery companies, our industry is facing a crisis."

Perhaps more importantly, in this high-stakes environment it is difficult to justify developing drugs for rare diseases. They simply do not make enough money to pay for their development. A colleague in the pharmaceutical industry shared why his company recently ended a particular drug project. Although the internal consensus was that the drug would work, it would only make $30 million per year--not enough money to justify the cost and risk of clinical trials. (As in most cases, the details are confidential.) How many potentially good drugs are dropped in silence every year?

I still prefer the idea of an Underwriters Laboratories model, but there is a lot to like here. Government's protecting on safety issues may not be an enumerated power per se, but it is far less of an affront to liberty than telling us what medicine we may buy. To use a random MS patient I know as an example (hope he does not object), it would allow him to continue with the effective experimental drug he found in a trial even though that trial is over.

In retrospect, it is better than half. But it seems just as impossible to enact as a perfect solution. The authors point out "Now is the right time for reform, while the House continues hearings on the fourth reauthorization of the Prescription Drug User Fee Act. The law, first enacted in 1992, was originally designed to provide the FDA with enough funding to reduce approval times, but it is also used to adjust the drug approval process itself. "

I'm not certain the FDA will see this as "the right time" to cut its budget, influence, and power.

Posted by John Kranz at 10:34 AM | Comments (0)

July 4, 2011

Dirty Hippies run the FDA

Last week JK wrote about the FDA's anti-prosperity ruling on the clinical use of Avastin to treat breast cancer. Two days later, American Spectator's Robert M. Goldberg wrote in FDA Decision Dooms Cancer Patients some background on the individuals at FDA who were responsible.

Goozner -- who has no medical background -- was appointed to an FDA advisory committee on pharmaceutical science. Two senior Public Citizen operatives, Peter Lurie and Larry Sasich, now set policy for the FDA. Fran Visco, the head of the National Breast Cancer Coalition, applauded the FDA decision after lobbying for it over the past year. Visco, a Democrat, is also on Experts Advisory Panel for the Universal Health Insurance Program at the New America Foundation, a left-wing think tank supporting Obamacare. The NBBC also supported the administration's decision not to cover mammograms for women under 50 though many breast cancers grow faster and earlier in African-American women.

Goldberg goes on to predict that Medicare and some other health plans will try to stop paying for Avastin, but he also makes this prediction:

To these groups, the FDA decision was a triumph. But their effort to manipulate the FDA will backfire. The EMA and every major group of cancer providers support Avastin's use. Cancer patients moblilized spontaneously to keep Avastin's label. They will take on the anti-innovation establishment and the FDA with greater intensity and vigor.

Related: Medicare Won't Drop Avastin for Breast Cancer

Posted by JohnGalt at 11:55 AM | Comments (0)

June 29, 2011

First Principles, Please.

The Gillespie-Welch book "Declaration of Independents" is remarkably uplifting. Yes, government's gone to the crapper, but outside of politics, freedom rocks and rules and expands. It has cheered me up quite a bit.

Meanwhile, there are the Avastin-FDA trials. Two somewhat contradictory articles appear today. The WSJ Ed Page, from whom much of my FDA antipathy was inducted, is aghast:

Genentech clearly has a self-interest in sticking up for a drug that generates $6 billion in annual revenue, about $1 billion of that from breast cancer. But no drug maker, ever, has formally and so publicly challenged the ukase of the FDA--an agency that can make or break companies and is known for punishing those who challenge it.

FDA cancer drugs chief Richard Pazdur has enormous discretion in drug approvals, and he can be especially vindictive. Genentech has more than 20 new drugs in oncology, immunology and neuroscience in its clinical development pipeline, and it is a unit of Roche, the Swiss health-care holding company. The politically easier route would be to avoid Dr. Pazdur's wrath. He and biologics deputy Patricia Keegan are as important to Genentech's future as are its own scientists and researchers.

We'll get back to the arguments. But "wrath?" "vindictive?" Am I the only one who thinks that drug approvals should be formulaic? Allow me to suggest a formula: compound x doesn't present more danger than the disease it treats, go right ahead.

Derek Lowe writes about the trials as well, and I agree with his thesis: Passion should lose. Emotional patients are a poor source of policy You can file that away with all the liberty-sapping regulations named after a dead toddler.

If you disagree with the whole idea of risk/benefit analysis, then. . .well, you'd better have something more useful to offer. And you'd better be sure that it doesn't end with the decisions going to whoever is the most passionate and tearful in making their case. That won't end well.

On the other hand, Doctor Lowe, the patient pathos is in opposition to "vindictive" "wrathful" Federal bureaucrats who would deny a terminal patient's doctor from accessing a powerful compound to combat cancer. Lowe thinks Avastin is on the wrong side of the statistics here and questions its efficacy. A couple of readers have sent me similar stories.

I cannot say whether Avastin is good for breast cancer. I am neither an oncologist nor do I play one on tv. But -- like President Madison -- I cannot lay my finger on that part of the Constitution that empowers the Federal government to make that choice.

Posted by John Kranz at 1:34 PM | Comments (2)
But johngalt thinks:

It's in the same clause that authorizes a Federal health care mandate. FDA autocracy and Obamacare share the clause because they serve each other's purpose: Witholding FDA approval for expensive drugs helps keep the single-payer's costs down; and when government is the only entity paying the bills for medical care there is less scrutiny of the vindictive, wrathful, and (you forgot to mention) punitive discretion of self-important government functionaries.

So Genentech has, for the first time ever, formally and publicly challenged the [had to look it up] edict of the FDA? Good for them! Consider this a positive unintended consequence of Obamacare. After flirting with collusion with these "officials" Big Pharma seems to finally recognize that after patients and doctors, they are next on the collectivism menu.

So what do we call them? Ukased Enough Already Partiers? The Twentieth Century Drug Company? Pharmaceutical Libertarians?

Posted by: johngalt at June 29, 2011 3:02 PM
But jk thinks:

Full disclosure: Genentech/Roche developed the experimental treatment that helped me greatly but that I can, of course, no longer get. Perhaps I should not push them toward enraging the wrathful and vindictive Dr. Pazdur.

Posted by: jk at June 29, 2011 3:20 PM

May 13, 2011

Executive Power on Steroids

Richard Epstein hits one out of the park, intertwining two of my favorite topics: FDA drug approvals and arrogation of power to the Executive Branch. In so doing, he plasters the Obama Administration (okay, so three of my favorite things).

In dealing with the abuse of power, it is important to recall that each branch of government has its own defined responsibilities. On the legislative side, clear statutory commands should give fair notice to individuals, allowing them to conform their conduct to the dictates of the law. In the executive branch, the great challenge is to install managerial safeguards ensuring that the immense reservoir of discretion accorded to public officials is exercised in consistent and determinate ways. On the judicial front, it is critical to develop procedures that provide an individual with sufficient notice of charges, and an opportunity for a hearing before an impartial decision-maker prior to being subject to any criminal or civil sanctions.

One of my constant concerns with the Obama administration is that its vision of executive power means that it has not recognized the need to rein in its discretion. Quite the contrary, in a variety of areas it seems only too eager to use its discretion to maximum advantage, often to support its own political agenda. That is the chief charge against the way Obama's National Labor Relations Board has instituted litigation against The Boeing Company for imagined unfair labor practices when the company decided to open up its new assembly plants in management-friendly South Carolina.

That same tendency toward mischief has been revealed in two of its other recent actions, each of which sheds light on the risks of the abuse of discretion. I speak here of criminal punishment for off-label drug uses and mandatory disclosures of campaign contributions by prospective government contractors.

It's tough but serious -- all the more devastating for its not being a partisan hit piece. A little longer than a Friday blog post, but I highly recommend a read in full.

Posted by John Kranz at 3:09 PM | Comments (0)

March 4, 2011

FDA Hell, Chapter CCXCVI

Because you wouldn't want to let the dying women to whom you're denying the drug have any input at a hearing. The Cruel FDA Rollercoaster

Can it get any worse than this? First you find out you have an incurable disease. Bad news. Then you find out there is a drug that may not cure you but at least keeps you alive. Great news. You take the drug and miraculously your disease is held in check. Miraculous news. Then the FDA tells you that despite your positive results, the drug does not work and they are pulling it off label. Nightmarish news.

However, as the drug is available for other diseases, you can still get the drug off label. Good news. But the drug costs between $56,000 and $96,000 per annum, and Medicare and private insurance companies often deny coverage for off-label prescription. Tough news. Maybe the drug company will make the drug available for free on a compassionate use basis. Hopeful news. But they can't because they are afraid of corporate and personal liability. Sad news.

Then the drug company applies to the FDA for a hearing to review their earlier decision. Positive news. The FDA announces that a hearing will be held June 28-29 in Washington, D.C., at the FDA headquarters. Encouraging news. But no patients will be allowed to speak. Insulting news.

Posted by John Kranz at 10:59 AM | Comments (4)
But johngalt thinks:

"We've repeated your screening test - you don't actually have breast cancer after all Ms. THX1138."

Posted by: johngalt at March 4, 2011 3:22 PM
But jk thinks:

Looks like my "compassionate use" request is going down in flames as well. My latest trial drug held off progression well with minimal side effects. Thankfully, the government will step in to make sure I don't get any more of that!

Posted by: jk at March 4, 2011 4:44 PM
But johngalt thinks:

It is frightening to contemplate that drug research and clinical trials may be ended as we've known them by the actions of President Obama and the 110th Congress. Are there other trials for your affliction on the horizon?

Posted by: johngalt at March 6, 2011 12:00 PM
But jk thinks:

There is a disability scale called the EDSS. Most trials have a range which is acceptable, and I am too high for most of them. I'm just starting my hunt, because I was hoping for either an open-label or compassionate use continuation of the current compound.

Posted by: jk at March 8, 2011 11:15 AM

February 28, 2011

You Guys Think I Make this Stuff Up

Well, maybe not "you guys" but I tell people FDA stories, even about Erbitux, which got a lot of media play thanks to Martha Stewart -- I mean Convict#3847XSZ. They agree my concern is compelling (it's the way I tell it) but even friendly, liberty loving people think "this cannot really be going on in this country, why haven't I heard about it?" less friendly, liberty loving people think "what kind of goof-assed, rightwing nutjob, black-helicopter, crap blogs is jk reading that feeds him this wacko b******t?"

The answer to both is the WSJ Ed Page. Every editor in its illustrious history would proudly proclaim the page's dedication to free people and free markets. It's not a partisan-free, even-handed source. But none can say that it is not a serious enterprise devoted to facts and journalistic standards.

And, it happens, they are the highest visibility source on the beat. Today, they have a lengthy, fact-filled story on the cancer drug pixantrone. Please let me know if you would like me to email it over Rupert's wall. It is worth a complete read.

The FDA is about to withdraw Avastin as a treatment for women with terminal breast cancer, and then there's a drug that most readers probably haven't heard of, called pixantrone. Like Avastin, its story reveals an agency that cares more about its regulatory prerogatives than about the thousands of patients who might benefit and will die waiting.

In May 2010, the FDA rejected pixantrone for treating non-Hodgkin's lymphoma, a blood cancer that kills nearly 12,000 Americans a year. The agency's veto came not because pixantrone failed in a clinical trialin fact, it was a qualified success. Instead, the FDA determined that the trial was not "flawlessly executed," as its regulations demand.

If perfection is the standard for new cancer drugs, then we may as well give up hope of ever getting another one. As destructive, the FDA went out of its way to railroad pixantrone and make an example of the drug's maker, Cell Therapeutics, in order to send another warning to the drug industry to jump through the right bureaucratic hoops.

One can accept that procedures are important and that Pharma companies have learned that managing approvals is as important as managing their labs (typing it, that is perhaps the worst part of the problem). But we have a system in which tinhorn bureaucrats put i-dotting and t-crossing above lives, and the structure of the system and oversight supports it.

No regulator will ever be called in front of Congress to explain why this promising cure was pulled from tens of thousands of dying cancer patients and yet, one 114 year-old has a heart attack on VIOXX®...

Here's a link that should be good for a week.

Posted by John Kranz at 12:21 PM | Comments (2)
But johngalt thinks:

Who can offer proof that these drug license withdrawals have nothing to do it dotted i's and crossed t's, but instead are an embodiment of Walter Russell Mead's "blue state" reaction to a "cost of delivering services" problem? [2 posts down, 3rd comment]

Posted by: johngalt at February 28, 2011 2:54 PM
But johngalt thinks:

Correction: Who can offer proof that the withdrawals aren't an embodiment of Walter Russell Mead's "blue state" reaction to a "cost of delivering services" problem, and the dotted i's and crossed t's are just the means to that end?

Posted by: johngalt at February 28, 2011 3:31 PM

February 9, 2011

Just When You Get to Like the Guy

Michael Milken perhaps wins some award for rags to riches to rags to riches cycles. The poster boy of 80s "greed" rejuvenated himself -- and to some extent greed -- as many Americans realized he was right. The man succeeded in battling Altruism and Cancer, he should be a ThreeSources hero.

Today, he's on the case of Pharma innovation. He sounds like me with a good editor as he decries the abysmal P/E ratios in the sector:

Consider companies that make consumer products--things like soft drinks, detergent, cosmetics and beer. While their price-earnings ratios will vary, in today's market their average will most likely be in the neighborhood of 20. But the average P/E of the largest American pharmaceutical research companies (Abbott Labs, Bristol-Myers Squibb, Johnson & Johnson, Eli Lilly, Merck and Pfizer) was recently near 10. Investors must have concluded that pretzels and eyeliner produce faster profit growth than prescription medicines.

Lower Pharma P/E ratios are a recent phenomenon. A generation ago, drug firms regularly topped magazine lists of the most-admired companies in America, a reputation usually reflected in their stock prices. But facing the specter of regulated returns, enterprise values dropped sharply during debates about proposed health-reform legislation in 1993. When the proposals failed in Congress, valuations eventually recovered. In the last decade, Pharma P/E ratios dropped again.

Contributing to these lower valuations are patent expirations, regulatory complexity, uncertainty about litigation exposure, and high U.S. taxes on repatriated foreign income. These factors undoubtedly influenced the decision by Procter & Gamble to leave the pharmaceutical business entirely in 2009 and concentrate on consumer products.

Procter & Gamble responded rationally to clear market signals that discouraged development of life-saving drugs. But for people whose health, and perhaps survival, will depend on these medicines--that includes you and me--the implications of the disparity in market valuations are ominous.

Pretty good stuff. So what is Milken's answer to "patent expirations, regulatory complexity, uncertainty about litigation exposure, and high U.S. taxes on repatriated foreign income?" Clearly, the answer is more Federal spending and regulation.

Sorry if that last paragraph induced whiplash, but I'm serious. He wants to increase the FDA's budget rather than shrink its mission. He wants to increase NIH spending (whatever, we do much worse things...) Support prevention (I think all that's left are mandatory, random, government colonoscopies). Match other countries' tax breaks (who is this guy?)

He clearly identifies the problem of too much government, enumerates its costs in dollars and life. Then, curiously, calls for more government to fix it.

Maybe Michael Douglas was right.

Posted by John Kranz at 11:41 AM | Comments (0)

February 3, 2011

What Happens When Desert Goes Communist?

First, nothing, then: sand shortage.

And the list of drug shortages keeps on growing

Fear not, the government is poised to help:

In December, US Senator Amy Klobuchar, a Minnesota Democrat, vowed to introduce a bill by last month that would give the FDA new tools for require drugmakers to contact the FDA as soon as they believe a supply problem exists (see the statement). The idea is to give the agency additional time to locate other suppliers, including from outside the US. So far, though, Klobuhar has not introduced a bill.

"New tools to require..." I really like that locution. I'm thinking of the Angel episode where the torture expert solemnly lays out his pliers and saws, prepping just like a dental hygienist for prophylaxis. The problem is not mentioned in the article, but the first commenter nails it. Government has pushed the prices down for generic drugs, more tightly regulated the producers, and it is no longer a profitable industry.

Perhaps Senator Klobuchar could write a bill...

Posted by John Kranz at 11:07 AM | Comments (3)
But johngalt thinks:

I wish Sen. Klobuchar would also write a bill telling me who to notify when the toilet paper roll is close to empty in the Atlantis Farm crapper. (Nothing is too small for a central-planning solution, right?)

Posted by: johngalt at February 3, 2011 2:54 PM
But Boulder Refugee thinks:

I think there is an iPhone app for that.

Posted by: Boulder Refugee at February 4, 2011 10:41 AM
But johngalt thinks:

Ha! But my government issued iPhone hasn't yet arrived in the mail.

Side note: In Ayn Rand's first novel "Anthem" almost all of the characters use words like "we" and "us" but nobody uses the "selfish" term "I." Yet Apple has everyone saying it. Who'd've ever thought that Apple would become a clandestine subversive outfit in the service of selfishness?

Posted by: johngalt at February 4, 2011 3:44 PM

January 24, 2011

Having Killed the Golden Goose...

...the government puts on a goose costume and hopes nobody notices.

Blog friend Sugarchuck sent this link yesterday. Comment seems superfluous (not that that'll stop me.)

The Obama administration has become so concerned about the slowing pace of new drugs coming out of the pharmaceutical industry that officials have decided to start a billion-dollar government drug development center to help create medicines.

The new effort comes as many large drugmakers, unable to find enough new drugs, are paring back research. Promising discoveries in such illnesses as depression and Parkinson's that once would have led to clinical trials are instead going unexplored because companies have neither the will nor the resources to undertake the effort. Drug companies have typically spent twice as much on marketing as on research, a business model that is increasingly suspect.

Six years after the Democratic VP nominee vowed, in his precious North Carolina accent, that he and President Kerry "would fiiiight the drug companies," I think we can say they won.

They may not have won the election but their ilk destroyed one of the most innovative and productive economic sectors of all time. One dedicated to saving, extending and improving life -- all for the crime of profitability. And for anybody who is not paying attention, this is clearly the model for the rest of health care: regulate and tax it to death, then swoop in to save the industry by a Federal takeover. It doesn't hurt when a clever New York Times reporter blames their "increasingly suspect" business models.

With apologies to Mister Eliot, This is the way the free world ends -- not with a bang but a whimper.

Posted by John Kranz at 10:32 AM | Comments (7)
But Keith Arnold thinks:

I don't think government has ever successfully invented anything, besides penumbras and employment figures. Innovation is the realm of private citizens and private industry.

I don't honestly believe that this "billion-dollar government drug development center" would have the ability to come up with a new flavor of toothpaste without cost overruns.

Posted by: Keith Arnold at January 24, 2011 3:32 PM
But jk thinks:

Watch it man. If they start invading the Toothpaste Czar's turf...

Posted by: jk at January 24, 2011 3:56 PM
But johngalt thinks:

Let it not be said that I never gave government the credit it deserves: Government invented the condition in which "gridlock" is a desirable situation.

Posted by: johngalt at January 24, 2011 4:09 PM
But Amy thinks:

I've been waiting for this article ever since the health care bill became an issue. My liberal online acquaintances would always be astonished when they found out that I was both mostly disabled and ferociously against the bill, because it was supposedly FOR people like myself. It was futile trying to explain to them that the bill wouldn't help ANYONE, and would in fact rip down the one remaining area of health care innovation that was left. I told them that eventually, nothing new would be made here, and they told me I was being silly.

The bill isn't even officially ENACTED yet, but insurance companies have been scrambling (I don't know about you guys, but my rates have skyrocketed), costs now have no objective setting, and...now this.

This is what scares me the most, because while people can look at concretes like costs of insurance and figure out how to fix those damages, how long will it take to convince companies that they can innovate again? How long will it take to remind people that it's them and not their country, that should be coming up with new ideas?

Pfizer's introduction of Lyrica allowed me to start working full-time again, it managed my pain so well. I've had more health issues pop up since then, but the medical industry hasn't kept up with me, and now I don't know that it ever will.

Posted by: Amy at January 26, 2011 1:39 PM
But jk thinks:

Welcome to ThreeSources, Amy, and thanks for the thoughtful comments.

I have MS so yeah, all this is for me too. So lucky to have gub'mint looking out for us, huh?

Posted by: jk at January 26, 2011 2:05 PM
But johngalt thinks:

"How long will it take to remind people that it's them and not their country, that should be coming up with new ideas?" Bingo! Right on target Amy.

But last night we saw the president's idea of how to inspire innovation. Borrowing from the fictional prose linked in that article,

"...who then proceed to seize the farmer, to chain him, to deprive him of tools, of seeds, of water, of soil, to push him out on a barren rock and to command: "Now grow a harvest and feed us!"

Posted by: johngalt at January 26, 2011 2:51 PM

December 2, 2010

They've done so well so far

Clearly, we should give the FDA more authority. Let's bring their hyper-regulation and risk aversion to more industries. Hell, they should manage all our food!

The Senate waved through the largest expansion of food regulation since FDR on Tuesday, 73 to 25, and maybe the bill won the votes of 13 Republicans because there was hardly any public controversy. These days, the government needs to take over entire industries to get anyone to notice.

Not that this bill in the name of food safety isn't a down payment. The Food and Drug Administration will gain new powers over the 2.2 million farms and 28,000 food producers in America--including federal standards for agricultural practices and food processing, transportation and storage--as well as the authority to mandate nationwide recalls.

This WSJ Editorial claims that the FDA regulates 25% of the US Economy. My leftist friends will be happy to see Cargill and ADM finally getting government oversight. But, as always:
Not surprisingly, this bill's main critics have been the small farms and local and organic food outfits that don't have the profit margins to comply with new regulatory burdens like the "risk-based preventative controls" that the FDA will soon enforce. The House version applies even to farmers markets and roadside stands. Naturally, agribusiness and the processed food industry (and their legal departments) couldn't be happier, and it's not the first time big business has leveraged government to weigh down smaller competitors.

The big guys can manage and mitigate -- they probably wrote most of the law in the first place. Sad days. Thirteen Republicans.

Posted by John Kranz at 11:53 AM | Comments (0)

August 30, 2010

Quote of the Day

Stage IV metastatic variety of melanoma has a 5 year survival rate below 20% and even lower in some cases. Malignant melanoma diagnosis amounts to a check-out notice from the Life Hotel. Such check-out notices ought to entitle you to a "Get out of the FDA jail card" where you get to try experimental treatments. -- Randall Parker
Parker seems to think we are citizens and not subjects...
Posted by John Kranz at 3:17 PM | Comments (0)

August 20, 2010

More on Broomfield Stem Cell Ban

We had a go round last month. I am quick to oppose the FDA on any issue, any time, any place but was concerned with the language of the opposition.

Ari Armstrong tweets about a Post story and I think that the folks have good point

Dr. Chris Centeno, a pioneer in stem-cell research and co-founder of Regenerative Science's Centeno-Schultz clinic and its Regenexx procedure, said in a statement that the injunction was "litigation posturing."

While Centeno has agreed to the FDA's demand to stop culturing the cell products, his clinic's statement said his team welcomes a chance "to question the FDA's policy that adult stem cells can be classified as drugs when used as part of a medical practice."

Centeno's clinic -- one of the first to move from stem-cell research into practice -- draws stem cells from a patient's bone marrow, grows more in an outside lab and reinjects the tissue-repairing cells back into ailing joints. The company's website says it has treated 416 patients since 2006.

The FDA in 2008 sent Centeno a letter warning that he needed federal approval and licensing for the process. The FDA said it considers the cells drugs that fall under federal regulation.

Centeno argues the stem cells he uses are body parts, akin to fertilized eggs.

"The only difference is that we're using stem cells and fertility clinics use fertilized eggs," said Dr. John Schultz, a co-founder of the Centeno-Schultz clinic, in the company statement.

Posted by John Kranz at 1:24 PM | Comments (0)

August 18, 2010

FDA: A Model for ObamaCare®?

Starting to wonder whether putting the government in charge of health care was a good idea...

The WSJ Ed Page suggests that the FDA is a good model for the politicization of medicine that will spread, pari passu, with Federal influence. Is that what we want?

The Avastin mugging is really an attempt to undermine regulatory modernization like accelerated approval that offends the FDA's institutional culture of control and delay. It is also meant to discourage innovations like Avastin that the political and medical left has decided are too costly, with damaging implications for the next generation of cancer drugs.

The FDA started with a mission of safety. Then it decided it was in charge of efficacy (cf. Erbitux, Sam Waksal, Martha Stewart &c.). Now it has appointed itself the arbiter of cost containment. Sure Avastin suppresses tumor growth in Breast Cancer patients -- but it's awfully expensive.

UPDATE: Ann Althouse and Mickey Kaus and <modesty>me</modesty>are unafraid to call them Death Panels.

Posted by John Kranz at 10:11 AM | Comments (1)
But Boulder Refugee thinks:

Medical decisions will be a private discussion between you, your doctor, your God and your bureaucrat. Of the four, who is most powerful and whose opinion will carry the day?

Posted by: Boulder Refugee at August 18, 2010 12:45 PM

August 10, 2010

Dear Michael J Fox: I told you so! Love, jk

Anybody who's read this blog twice will believe me.

The Democratic Party made a wildly effective campaign of opposition to President Bush's compromise on embryonic stem-cell research. My lowest moment was seeing Michael J. Fox come down from the great north to campaign for Claire McCaskill in Missouri.

Ah yes, a Senator McCaskill will vote for research and the lame will walk.

Instead, of course, the real Senator McCaskill votes for ObamaCare® which will cripple medical innovation both by shrinking its markets and directly taxing its successful producers. Now, Instapundit links to a site that says stem cell research is being shut down by a Democrat-led FDA and an overwhelmingly Democratic 111th Congress.

Today in 2010 two years after Barack Obama promised to open up Stem Cell research, therapy and treatments within the US borders the FDA is overstepping its authority in regulating medicine and attempting to shut down live saving stem cell treatments. The FDA is banning stem cells to be used in the United States while many Americans are having to travel to foreign countries to receive treatment.

If I dare to claim I-told-you-sos, I should provide links:
Michael J Fox Ads
One I Called Right
Free Market Medical Research
The Problem with Government Research

UPDATE: I am a little skeptical about the stem cell link. It is built around a press release of the offended company and does itself no favors by putting "Barack Obama" in a larger type face. Either way, pointy-holdy. Research is a complex topic, and this gimpy boy feels a lot more comfortable trusting those that do not seek to bankrupt the Pharma Companies.

Posted by John Kranz at 10:37 AM | Comments (3)
But Boulder Refugee thinks:

This one might not be worth the $.44. The press release sounds like spin bordering on distortion by the company (right here in Colorado, if you can believe it.) Apparently, the FDA shut them down for mislabeling and failing to "keep the product free of objectionable microorganisms." We can argue about the FDA on many points, but I don't think they've shut down stem cell research in any manner.

Here's the link: http://www.courthousenews.com/2010/08/10/29439.htm

Posted by: Boulder Refugee at August 10, 2010 12:04 PM
But johngalt thinks:

I'm not ready to dismiss the company. This sounds like legitimate medical innovation colliding with the federal medical bureaucracy. When you add in the potential threat to the revenue stream of established joint replacement manufacturers (Stryker Medical, as in Colorado Democrat Pat Stryker, for example) then the patronage picture comes into focus.

As JK so ably documented, the Dems made a big deal of supporting stem cell medical RESEARCH. But in fairness they never claimed they'd ever let anyone receive TREATMENT.

Posted by: johngalt at August 10, 2010 2:43 PM
But Boulder Refugee thinks:

Not saying that the innovation is not worthwhile nor that the FDA is not acting capriciously - I dont' know either way, based on this information. However, the company's assertion that Obama has ended domestic stem cell research seems to be completely specious. A quick Google search will reveal several instance just this month in which the FDA approved other stem cell therapies and further research.

Posted by: Boulder Refugee at August 10, 2010 6:12 PM

July 16, 2010

Clause of the Day

"...and for many patients and their physicians the benefits of controlling blood sugar levels outweigh the risks. "
The Wall Street Journal Editorial Page has long been a beacon for responsible access to pharmaceuticals. If you want to read or share just one editorial that captures the problems of political control over medicines, I recommend today's on Avandia.

Sorry Rupert, I respect your property rights but I am going to steal the whole text after the jump. The FDA was a bad idea when President Franklin Roosevelt foisted it upon us, but it is far worse today as pharmaceuticals become more individualized.

Critics of the pharmaceutical industry were frustrated this week as an FDA review panel voted to allow Avandia to remain on the U.S. market, despite concerns that the diabetes drug may increase heart attacks. Those who thought Avandia should remain a patient-doctor option were frustrated too, as the panel also voted for severe new restrictions. And for once, both groups may have a point.

GlaxoSmithKline's Avandiaonce among the world's best-selling medicineshas been chased by claims that it increases cardiovascular risks and that the drug maker concealed clinical evidence from the Food and Drug Administration. Yet nearly 9% of the U.S. population suffers from Type 2 diabetes, and for many patients and their physicians the benefits of controlling blood sugar levels outweigh the risks.

With a final regulatory decision imminent, the episode is a useful lesson in the complexities and uncertainties of modern medicine. Not to mention, ahem, the inability of the political class to behave responsibly when it is looking for corporate villains.

The 33-member advisory committee delivered a more nuanced verdict. In a contentious sequence of votes over two days, a 20-12 majority recommended that Avandia remain available, albeit with new restrictions beyond the stringent "black box" warning that the drug already carries. At the same time, a majority also decided that Avandia increases the risk of heart attacks and strokes (but not the risk of death), with 12 members voting to pull it from the market altogether.

Such ambiguities have rarely been conceded in the political fracas, with its relentless prosecutorial tone. The Cleveland Clinic cardiologist and pharma scourge Steven Nissen fired the starting pistol in 2007 with a "meta analysis" that showed cardiac risks that weren't reflected in any of the many data from separate clinical trials he analyzed.

Hoping for a replay of the Vioxx panic that Dr. Nissen also helped to touch off, Avandia's opponents came to include the New England Journal of Medicine, the Journal of the American Medical Association and the Senate Finance Committee with Chuck Grassley at the prow.

The reporters transcribing the Iowa Republican's charges were aided by internal Glaxo documents allegedly showing that adverse data had been concealed from regulators and by the accusations of an FDA drug investigator who believed his superiors had papered over safety concerns.

It would be an obvious problem if Glaxo really did manipulate the evidence, though the company claims that the leaks are a misleading selection of the 14 million pages of documents it has turned over to plaintiffs lawyers in multiple liability suits. This would not be the first time reporters took selective dictation from the lawsuit industry.

The larger Avandia debate is really over statistical techniques and the design of randomized clinical trials, like so many other FDA debates. Meta analyses like Dr. Nissen's are themselves often unreliable or misleading because they merge into one data set many different studies with different levels of quality and size and which are meant to measure different outcomes.

The large average probabilities captured by such analysis also don't allow for the possibility that some drugs work best for some patients but not for others. Health care has advanced far beyond definitive answers that must apply everywhere and always to everyone, even if ObamaCare will turn U.S. policy toward standardized medicine and fewer individual choices.

In any case, the FDA is now under intense political pressure to withdraw Avandia amid the panel's public feud and its mixed finding. We hear FDA Commissioner Peggy Hamburg's chief deputy Josh Sharfstein, a former Henry Waxman aide, is lobbying intensely for that outcome, and we hope Ms. Hamburg shows better judgment in preserving patient access to Avandia, even if as a second-line treatment.

Yes, banning Avandia would give Washington another political scalp. It would also send a terrible signal about drug approvals, while depriving the two million Americans who continued to take Avandia last year despite the risks of a drug that meets their needs.

Posted by John Kranz at 11:19 AM | Comments (1)
But Perry Eidelbus thinks:

Schumer is about as execrable as a politician can get. I call him two things: "Chuck the Schmuck" and another one very similar.

Posted by: Perry Eidelbus at July 16, 2010 2:26 PM

May 20, 2010

Another Word the Administration Doesn't Understand

I suggested to Regulator Czar (do not hold your head higher than the Regulatory Czar's!) Cass Sustein that "voluntary" was not as complicated a term as he thought. In my indefatigable effort to augment the Administration's vocabulary, I suggest the word of the Day be "Innovative."

When property rights are protected, companies will find innovative (Inn-oh-vay-tiv) solutions. Case in point, an American Pharma firm "licensing" counterfeiters in India:

Nonetheless, Gilead, a pharmaceutical company based in Foster City, California, continued in its efforts to make money as well as increase access to medicines. Even without an Indian patent, it negotiated with 13 Indian companies to make its anti-HIV drug, TDF. This way, Gilead retains its innovator patent rights in rich countries, but helps Indian companies make TDF to sell in the poorest countries. Today, Gileads most successful Indian partner is Matrix Laboratories. In 2009, Matrix sold more TDF than Gilead, producing treatments for more than 420,000 patients in the developing world. Matrixs production costs are about half those of Gilead, allowing the company to make a profit at a far lower pricearound $8 per month per patient versus Gileads $17.

This Administration reflexively goes for the top-down bureaucratic solution. I know I'm preaching to the choir here, but look what can happen when you let innovation flourish.

Posted by John Kranz at 6:06 PM | Comments (0)

May 7, 2010

I Think it is the Same Thing

I applaud the ThreeSources commentariat for the thoughtful and intelligent discussion on drug laws. Even though you don't agree with me and are clearly a bunch of snarky, redneck authoritarians, I have enjoyed hearing your views.

Here is my problem. It's not about weed for me, it is about the FDA. It is that the government has set itself as the arbiter of what we may and may not buy, sell, and ingest. As Governor Palin might say, "How's that [...] workin' out for ya?"

In May of 2007 two unique cancer therapies for the treatment of prostate cancer and osteosarcoma (a type of bone cancer) came under review at the FDA on the same day. Both the new agent for prostate cancer, Provenge, and the new agent for osteosarcoma, Mepact, had shown the ability to prolong lives to a significant degree. And both drugs were summarily rejected. Provenge and Mepact were tossed back to the companies developing them with the directive to do more clinical studies.

This was easy enough for Provenge, due to the return on the risk of investment possible with a new prostate cancer drug and the large number of men with the disease available for another clinical trial. The Dendreon company, makers of Provenge, worked as quickly as possible to redo their already successful trial. The results of the new trial turned out the same as the original, and the drug was finally approved by the FDA last week.

In the three years that it took to duplicate what was already known, upwards of 80,000 men lost their lives to prostate cancer. This is equal to the number of men killed in combat in the Korean, Vietnam and Iraq wars combined.

The rest of the guest editorial points out that while the one compound eventually was approved (let that word sink in, liberty lovers) the other one could not find enough trial patients to repeat the trial. So the 900 patients with osteosarcoma can simply die rather than take a drug that the government has not "approved."

Citizens or subjects? If I have to ask Mom before I eat anything, I'm not an adult.

Posted by John Kranz at 12:51 PM | Comments (1)
But johngalt thinks:

I don't think so. Experimental pharmaceuticals and illicit narcotics are both "drugs" and the FDA, DEA and FBI are all federal government agencies but the similarities end there. We're all likely to agree that a private "Good Housekeeping Seal" is as much or more efficacious than the federal drug safety bureaucracy but the 28 comments on our little blog are proof of serious disagreement over the "it's just my body" argument regarding "recreational" use of psychoactive substances. In fact, there's an entire wikipedia entry about it (consciously risking another 20-plus comment thread) here.

Posted by: johngalt at May 9, 2010 11:29 AM

November 16, 2009

Billions, Trillions, and a cure for frigidity

I was drawn to this story on a legal settlement with state governments over supposedly misleading advertising by Vonage, the internet phone provider. Not because I'm a Vonage customer, but because the supposed settlement fine was 3 billion dollars. Hmm, thought I. What's their market cap anyway? Oops - Reuters got it wrong. Was supposed to be million. I guess all those stories about government spending have got the Reuters newsroom desensitized to the size of a BILLION DOLLARS.

But the foray onto the Reuters site wasn't completely without reward. I happened across this anti-frigidity pill developed in Germany and on track for the U.S. market in three years or so.

"By modulating the neurotransmitter system, flibanserin may help to restore a balance between inhibitory and excitatory factors leading to a healthy sexual response," said Elaine Jolly, a Canadian gynaecologist and medical researcher who helped oversee the trials.


During the half-year course of once-daily flibanserin in the trials, the number of satisfying sexual events -- which did not necessarily involve orgasm -- rose to an average 4.5 per month from 2.8 in the North American arm of the trial, the study shows.

In the control group on placebo the rate rose to 3.7.

Women on the drug also reported a higher level of sexual desire and less distress from sexual dysfunction than those on placebo.

The drug's side effects were described as mild to moderate and included dizziness, nausea, sleepiness and insomnia.

So it makes women more interested in having sex and falling asleep afterwards. Men of the world rejoice!

(And before anyone slams me for calling it "frigidity" I'll link to the clinical description.)

Posted by JohnGalt at 3:51 PM | Comments (3)
But jk thinks:

Maybe it's my background, but I was trying to imagine the clinical trials...

Posted by: jk at November 16, 2009 4:06 PM
But Boulder Refugee thinks:

...and how does one sign up?

Posted by: Boulder Refugee at November 16, 2009 9:31 PM
But johngalt thinks:

Doesn't it bode well for all of us that we've not had occasion to learn about the clinical trials?

Posted by: johngalt at November 17, 2009 2:18 PM

April 21, 2009

Citizens or Subjects II

A great friend whom I had better not identify does cancer research and sent along some comments on my post about Provenge approval. When I said that only me and the Wall Street Journal Ed Page cared, I think I left a few folks out. There are a lot of caring MDs and technicians who work on these trials.

> I read your Three Sources post regarding the FDA denial of approval
> for Provenge with great interest. A few years back I conducted a few
> trials with Dendreon's vaccine against multiple myeloma.

> Getting FDA approval was an
> expensive and cumbersome process and, as a small biotech start-up,
> Dendreon desperately needed to get something to market.
> Unfortunately, due to economic pressures
> Dendreon eventually made a business decision to
> abandon their myeloma program. The prostate cancer vaccine program
> was farther along and frankly would have a much bigger market, so they
> put their eggs in that basket. A few months ago, I decided to
> re-look at our data. We compared all the patients enrolled in our
> trial to all the patients with myeloma who were not enrolled in the
> trial and had a stem cell transplant during the same time interval.

> Patients in the vaccine trial have lived an average 2 years longer
> than the patients who did not get the vaccines.
> Alas, because the FDA made the approval process so
> cumbersome, the vaccines are no longer available. So we cannot do the
> larger confirmatory trials to see if the vaccine really works.

> Feel free to excerpt anonymously as an example
> of how FDA policy costs lives. Multiple myeloma is a fatal cancer
> with life expectancy of 3-5 years. If our findings hold up, two years
> is a huge advance.

Beyond the Martha Stewarts and Sam Waksals, it has been my main point that the FDA scares capital out of the pharmaceutical sector. Here, its sluggishness and capriciousness cause a firm to abandon a promising treatment.

Posted by John Kranz at 7:24 PM | Comments (1)
But johngalt thinks:

Indeed. We look at President Historical and Speaker Business Jet's promises to nationalize healthcare and wonder where Canadians will then go when they really need a critical medical procedure. Free-market medicine is more advanced, medically and scientifically, than that in a controlled market. But since the U.S. economy is mixed there are doubtless many potential advances that never occurred, even here, as a result.

Posted by: johngalt at April 23, 2009 12:29 PM

April 20, 2009

Citizen or Subject?

One of my favorite parts of Amity Shlaes's The Forgotten Man is when the publisher of Good Housekeeping is at the White House (for dinner as I recall) and is told about the new FDA that will replace her cherished "Good Housekeeping Seal of Approval."

I have tiresomely suggested a privatized FDA based on the Underwriter's Laboratory/CSA model, but I think I'd take about anything over what we have now. While 30,000 die each year of prostrate cancer, the FDA is empowered (again) to keep its most promising new drug off the market for a couple of years so that the developer can complete some more t-dotting and i-crossing. And only the WSJ Ed Page and I seem to care.

Provenge is an advanced cancer "vaccine," which stimulates the body's immune system to attack tumor cells and thereby fight off cancer on its own, instead of using chemotherapy or surgery. In an earlier placebo-controlled Phase III trial (the most rigorous kind), men with late-stage cancer who received Provenge lived a median of 25.9 months, compared with 21.4 months otherwise. After three years, 34% were alive, compared to only 11% for the control group. In March 2007, an FDA advisory panel voted 13 to 4 that there was "substantial evidence" the drug worked, and 17-0 that it was safe.

But later that year, the FDA delayed approval, ruling that the trial did not meet its criteria for statistical significance and that the patient sample was too small. So Dendreon agreed to complete another double-blind trial to FDA specifications, and Dendreon officials say the results have now met those benchmarks. The detailed results will be presented later this month.

The larger question is why Provenge wasn't made available sooner to the 30,000 American men who die each year from prostate cancer. The FDA regularly -- and pointlessly -- slow-walks potentially revolutionary therapies, relying on overly simplistic and unscientific statistical models that don't take into account the fact that some drugs may work better in certain subgroups than in others. Its regulatory blockade is especially cruel to terminally ill patients for whom drugs like Provenge may mean extra months or years of life.

And the even larger question is are we citizens or subjects? Must we go quietly die in the corner while we wait for our goverment to "approve" a treatment that was voted 17-0 for safety?

Posted by John Kranz at 12:38 PM | Comments (12)
But Keith thinks:

jg: I confess I don't recognize that one, and it would be cheating to google it, so either it's an original jg epigram, or you're going to have to edumacate me. BUT - and this is a critical but - if, as you assert, "there are no great men," then Howard Roark's statement that great men can't be ruled becomes moot.

There's a syllogism in there, and one worthy of Shaw.

I'll confess the quotation is in response to jk's chosen title for this post, "Citizen or Subject?" and the question of whether we are free citizens, or vassals of a state bent on commanding us.

"I am not a number! I am a free man!" Anyone want to take a stab at that one?

Posted by: Keith at April 21, 2009 5:56 PM
But Keith thinks:

As for "There are no great men only great ideas and the men who promulgate them," I would propose that great ideas require great men to originate them, wise men to recognize them, and good men to support them.

No offense intended to any ladies among the readership...

Posted by: Keith at April 21, 2009 5:59 PM
But Perry Eidelbus thinks:

"we have so willingly ceded to the government the right to protect our life. Though it came in with FDR nobody I know (except ThreeSourcers) can even imagine a world without the FDA."

You may have ceded that to government, and I did once upon a time, but I have taken back what I mistakenly gave away. Let me put it this way. If there's a certain medicine I want, I'm going to get and use it, and there's not a damn thing the government can do to stop me. But I guess I'm just a "radical" like Jefferson when it comes to freedom.

I can most certainly imagine a world without the FDA. It existed only a matter of several decades ago. Our foods and preparation methods are far superior than ever, but that isn't because of the FDA or health departments. It's because of technology.

Posted by: Perry Eidelbus at April 22, 2009 12:03 PM
But johngalt thinks:

You're right Keith, it's an original, and loosely based on Admiral Bull Halsey's "There are no great men. Just great challenges that ordinary men, out of necessity, are force by circumstance to meet."

My contention was that the greatness of one's ideas is what makes him great, but this leaves out his actions. Not very profound after all.

Posted by: johngalt at April 22, 2009 3:42 PM
But johngalt thinks:

RE: "I am not a number! I am a free man!"

dagny's guess is 'Les Miserables'

jg's guess is 'THX-1138' (For which, incidentally, jg thinks Lucas "borrowed" the theme from Rand's "Anthem."

Posted by: johngalt at April 23, 2009 12:17 PM
But Keith thinks:

jg and dagny: both fine guesses, but not quite. I should pay tribute here to Mr. Beck, my seventh-grade science teacher, who, once a week, would read to his science class a section of Anthem (and when that book was finished, Animal Farm). I couldn't wait for the next week to come, and after Anthem, I couldn't get enough of Ayn Rand. Hard to believe I can thank a California public schoolteacher for planting the first seeds of my Weltanschauung.

No, "I am not a number! I am a free man!" comes from a British television series about government and individualism: The Prisoner (1967 - before your time, young'uns):


Posted by: Keith at April 23, 2009 1:35 PM

February 22, 2008

Hooray for the FDA!

There's a headline you were not expecting in ThreeSources. Certainly not from me.

But they passed -- mirabile dictu -- the moral test I linked to the other day.

Going against the recommendation of its advisory panel, the Food and Drug Administration cleared Genentech's Avastin, which is already approved for treating lung and colon cancer, based on findings that it slowed tumor growth.

The agency has traditionally approved drugs for late-stage cancer if they extended, or improved the quality of, patients' lives. Avastin showed neither, according to Genentech's application.

This is excellent news. Too bad all three major candidates still in the running consider the biotech and pharma sectors to be evil.

I beat up on the FDA enough, however, I owe them some public approbation when they get one right. Well done, gang.

Posted by John Kranz at 4:41 PM

February 21, 2008

Forty Thousand Deaths a Year

Some 40,000 women died from breast cancer in 2007. Almost unbelievably, the federal government may block one of the disease's more promising therapies for no other reason than the Food and Drug Administration's obsolete, even antimodern, regulations and approval models.
You can -- and I do -- complain about marginal tax rates, tariffs, free trade, and civil liberties. But at the end of the day, no intrusion on our freedoms matches that of the FDA. Locke and Jefferson both put life first when enumerating our birthright liberties.

These 40,000 might have wanted to try Avastin. Certainly the people at Genentech would have loved to sell it to them. Yet our government, with the thinnest Constitutional purview, forbids the sale of lifesaving drugs. The Wall Street Journal Editorial Page calls it "A Moral Test for the FDA"

In February, Genentech also released the preliminary findings of a more rigorous follow-up study, including the FDA's "gold standard" of randomized and placebo-controlled clinical trials. It again confirmed that Avastin improves progression-free survival, though the full results have not yet been made public.

In other words, dying patients live nearly twice as long on average before their disease gets worse, and maybe longer. It translates into an improvement in quality of life by delaying the onset of symptoms. But only in a few isolated contemporary cases has the FDA deemed progression-free survival as a relevant "end point" for approval. There's no reason besides the FDA's complacency and archaic procedures; a recent review by the agency's own Science Board concluded that "evaluation methods have remained largely unchanged over the last half-century."

Extending life is the FDA's acid test for any anticancer agent, but studies designed to prove it take years and thousands of patients to get large average effects. In the Avastin study, women lived slightly longer, a median of 26.5 months compared with 24.8 with Taxol alone. But those results weren't proved statistically significant to FDA satisfaction.

It works. It helps. It just doesn't work they way we like it to work well enough. So we will proscribe its sale. Next year's 40,000? Drop dead.

Posted by John Kranz at 1:06 PM

November 27, 2007

Pharma Sector Bad, Journalists Good.

"If you can't get a drug on the market with that kind of data, we should stop developing drugs."
So says a Duke University Cardiologist about Eli Lilly's TRITON trial. He is quoted in a guest editorial in the WSJ from Eli Lilly CEO Sidney Taurel. I have suggested that people who choose to invest in or directly try to the improve human life through technology face opposition from politicians, trial lawyers, luddites, and a burdensome government approvals process.

Taurel adds journalists to that list. When Lilly stopped a trial to ensure patient safety, the press smelled blood in the water:

When it comes to describing the benefits and risks of prescription drugs, the hyper-competitive, around-the-clock media is rarely at its best. Call the following a case study in the challenge of doing right by doctors and patients -- in spite of the need to feed the media beast with copy.

It's a sad story that follows. Six billion in market capitalization (That equals six million little plastic bracelets, folks).and loss of investor confidence in a promising new compound.

Posted by John Kranz at 7:12 PM | Comments (1)
But TrekMedic251 thinks:

My friend's wife is a doctor who works for a big Pharma. As we watch the Eagles flail helplessly across the field, she spends time reading the reports that come back from clinical trials (she's involved in patient safety). For people with MDs and PhDs, they can sometimes be as dumb as dirt when it comes to writing a detailed report.

It amazes me how much time and energy is wasted having to ask over and again for clarification about one paragraph in a 10-page report!

Posted by: TrekMedic251 at November 27, 2007 10:37 PM

September 11, 2007

Thank You, Martha Stewart

Not only for the paint color "sea foam," though we have used it extensively in our house and love it. The walls take on the weather outside -- when it is stormy, they are grey, when it is bright, they are bright.

Actually, I wanted to thank you for your investment in Dr. Sam Waksal's ImClone. Thanks to you and other investors, Dr. Waksal was able to develop an impressive treatment for cancer, Erbitux. The WSJ reports (paid link) that it has now shown efficacy in a certain type of lung cancer.

In a statement, the companies said that a Phase III clinical trial showed that patients with advanced lung cancer taking Erbitux in combination with the chemotherapy regimen cisplatin and vinorelbine had a higher overall survival rate than those taking just chemotherapy alone. The companies did not immediately say how much longer the patients lived.

ImClone and Bristol-Myers are testing Erbitux for the treatment of non-small cell lung cancer, the most common type of the deadly disease. Erbitux is already approved to treat colorectal, head and neck cancers.

The companies said they plan to present more detailed results of the clinical trial, which was run by partner Merck KGaA at a future medical conference.

Oh, and Ms. Stewart, I'm very sorry that my government prosecuted you and Dr. Waksal for developing this life saving compound and participating in an efficient capital market. Please know that that was not my idea.

I'm also sorry for the tens of thousands who have died in the last two years from cancers that might have been ameliorated with Erbitux. The same government decided that the "arrogant" Dr. Waksal needed to jump through some extra hoops and be taken down a peg. That was not my idea either.

Posted by John Kranz at 11:13 AM

August 23, 2007

A Friendly Voice in the Crowd

The Glenn and Helen Show today interviews Law Professor Richard Epstein, about his new book Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation.

It's a 35:16 podcast on my favorite topic. It gives me hope that this issue is starting to get a little traction outside of the WSJ Ed Page. There's a long way to go but I look forward to the book.

Posted by John Kranz at 4:13 PM

August 10, 2007

That right to life thing again

Under a Constitution that expressly protects the right to life, how did we get to where government can effectively restrict the right, and the courts will do nothing?
Blogging on Steroids® makes me a more loquacious blogger. Sorry for the post lengths. This was to be included in my earlier post. They are separate but related ideas. And I thought folks might need a breather.

After my rant on the roadblocks to self directed health care and rent seeking mechanism that the pharmacy laws represent, Cato's Roger Pilon writes a guest editorial in the Wall Street Journal (free link on Cato site). He touches on the pharmacy regulations as a side effect of my other favorite topic: the FDA's clearly unconstitutional restrictions of our right to life. A D.C. Circuit decision has not gone my way, but Pilon shares a striking dissent, written by Judge Judith Rogers and joined by Chief Judge Douglas Ginsburg.

Citing the Fifth Amendment's right to life, the Ninth Amendment's assurance to the Constitution's ratifiers that the rights retained by the people far exceed those named in the document, and the Supreme Court's "fundamental rights" jurisprudence, Judge Rogers argued that the right to life, the right to self-preservation, and the right against interference with those rights which the FDA is guilty of are of one piece. They are deeply rooted in common law and the nation's history and traditions, implicit in the concept of ordered liberty, and thus "fundamental."

Indeed, it is startling, she noted, that the rights "to marry, to fornicate, to have children, to control the education and upbringing of children, to perform varied sexual acts in private, and to control one's own body have all been deemed fundamental, but the right to try to save one's life is left out in the cold despite its textual anchor in the right to life." Because the rights at issue here are "fundamental," she concluded, the court must apply, in judicial parlance, "strict scrutiny." The burden is on the FDA to show why its interference is justified to show that its regulatory interests are compelling and its means narrowly tailored to serve those interests.

Read this brilliant piece coast to coast, even if you don't then have time to read my whiny personal post below.

Posted by John Kranz at 12:59 PM

Blogging on Steroids®

I am going to have to join the libertarians. I never use that appellation on myself except when stealing Milton Friedman's line about a little-l libertarian and a big-r Republican. Yet I have allowed my National Review subscription to expire and find myself very excited when a new Reason shows up. I called myself a libertarian a few weeks ago for the first time.

Pardon the navel-gazing but I am "Blogging On Steroids®" this weekend. My last batch cost me $400 for the meds and $350 for home nursing services. Colorado suffered from extreme blizzards that week and, as I was experienced doing my own infusions, I told the nurses not to brave the elements. (UPDATE: Needless to say, they did not respond with "Okay, keep your $350.")

Thinking I am a pro now, I investigated a self-directed plan for this dose. The nurse I see for my clinical trial agreed to put the IV in. I had a few needle/catheters and supplies from the last batch. I still have a stand, and a couple of tubes, &c. Walgreens pharmacy said they could hook me up with the drugs for $269 (something about a Barry Bonds Special, I didnt catch all the details...)

After every dose, you wash the line with a saline syringe and shoot in some Heparin, to keep your line smooth, clean and free of gunky deposits. I asked the Walgreen's Pharmacist about getting these and he could not without a separate prescription. I have a prescription for home care or ER for the application. Either would supply me a gob of these (35 ml in a gob).

But Mr. Pharmacist would not. "Federal Regulations" he tells me. I decide now is not the time for a Ninth Amendment discussion.

I call around and look around, but there seems to be no choice. I go to the Urgent care clinic. They are swell folks and check me into a room, offer me juice and take superb care of me. As they will on the next nine visits. The care is superb, but I will pay $500 bucks in copays and I-don't-even-wanna-know how much for hospital prices on the prescription. It is probably going to cost me $750 because the Pharmacist is proscribed from selling me an IV supply with an IV prescription. Madness!

I get my first dose last night. At the end she flushes with saline and I ask "Aren't you going to use Heparin?"

"No," she says. "We don't do that anymore."

Posted by John Kranz at 12:02 PM | Comments (4)
But mdmhvonpa thinks:

Prednisone? Ghaa ... hate the stuff. And that damn 'cyborg' catheter in the vein. You just cannot do anything without it snagging on something.

Posted by: mdmhvonpa at August 10, 2007 3:08 PM
But jk thinks:

Solumedrol (is that a Prednisone derivative?) Other than a horrid last-night's-stout-and-cigars taste in the back of my mouth, I don't have any real problems. Last time I got some very good results from it. They did not last long, but it was a welcome vacation from the worst bits of MS.

Posted by: jk at August 10, 2007 3:42 PM
But Terri thinks:


Madness is right!

Posted by: Terri at August 10, 2007 6:59 PM
But jk thinks:

An update: I think my point still holds, but before you all start crying on my behalf, I will point out that things are going well.

It turns out that the copay, like ice skating at the Y, is an all-day pass, so I can do two sessions on one. Had I known, I wouldn't have started at night, but...

The care has truly been stellar. These people are friendly and professional and I would be foolish not to put value on having professional care nearby in case of problems, expert opinions on the condition of the injection site, and new bandages and packing with each infusion.

I would still like the choice, and I think our health care system needs to move to be friendlier to self-directed care. But this is working out okay for me. Y'all can stop mailing the 10s and 20s...

Posted by: jk at August 12, 2007 1:27 PM

August 1, 2007

Government to Kill More People

I do go on about the FDA. But, freedom lovers, let me remind you that John Locke and Thomas Jefferson claimed life to be the first birthright: life, liberty, estate/pursuit of happiness.

A guest editorial in the WSJ today (right next to Greta's column on a missing college student), tells of five promising Cancer drugs that have been pulled because the manufacturer felt they could not get FDA approval -- even after successful trials. Dr. Richard Miller, president and CEO of Pharmacyclics, and adjunct professor of oncology at Stanford University Medical Center, is concerned that "the fight against tumors is regressing."

This is not the way the regulatory system is supposed to work for patients with life-threatening diseases such as AIDS, cancer and Alzheimer's. Thanks in large part to AIDS activism, Congress passed legislation that in 1992 resulted in new regulations that streamlined the approval process for drugs intended to treat life-threatening diseases. One such regulation, accelerated approval, gave desperately needy patients faster access to new drugs. It allows for conditional approval based on data "reasonably likely" to predict clinical benefit while more definitive trials are being conducted.

The idea worked: 26 new cancer drugs for 30 different clinical indications were approved between 1995 and 2005 under the accelerated approval regulation. Important drugs such as Camptosar, Eloxitan, Gleevec, Temodar and others were made available to patients more quickly than under the standard approval procedures. Thousands of patients benefited from faster access, and these drugs went on to find vital and expanded roles for the treatment of many types of cancer.

There appears to be no evidence that any harm was done by accelerating the approval process for these products. Indirectly, the streamlined review and approval process has also stimulated the pharmaceutical industry to invest in the development of new drugs for these diseases.

In recent years, the FDA has effectively regressed to a pre-AIDS mindset. The accelerated approval requirements have stiffened and the real benefits of the process for patients have been whittled away. Since 2005, only one drug has achieved accelerated approval and this year none have been able to break through the FDA's iron gate.

I feel a little lonely in this fight some days. It seems that only me and the WSJ Ed Page care (and the Ed Page was just sold). But I read an article in last month's Reason that is now available online..

Kerry Howley shares my concern and makes a point I had not contemplated. The current system for approvals cannot allow dying patients access to lifesaving drugs because it requires a continuing stream of desperate, dying patients who are desperate enough to sign up for a placebo trial for a terminal illness. I'm paraphrase sensationally, but read the whole thing. I'm paraphrasing accurately.

Since the 1960s, when randomized, double-blind clinical trials became a standard requirement for bringing new drugs to market, clinical researchers have confronted the chaos of disease with the trappings of a regimented, uncompromising order. Drug trials are rooted in centralized authority: trial slots are numbered, subjects handpicked, control groups maintained, patients monitored. Maintaining this level of precision requires not only the cooperation of willing test subjects, but the coercion of the general population. To preserve pristine testing conditions, the federal government curtails our freedom of exchange and our right to take risks. Ailing individuals and drug companies are prohibited from trading in unapproved drugs, and terminal patients forbidden to experiment outside a clinician's watch.

This approach to drug testing is rife with serious ethical problems, but the preconditions for meaningful change are mind-boggling. The current clinical trial regime is cemented in place by legal restrictions that prevent patients from waiving their rights to sue and a regulatory regime that resists even incremental change. Alternatives to the standard placebo-controlled, closed clinical trials exist, but guarantees that such trials will lead to a drug's approval do not. A system meant to facilitate innovation in drug development is itself resistant to change.

It is a serious and heartbreaking story. Government bureaucracy is stifling innovation, chasing capital out of the pharmaceutical and biotech sectors, and killing tens of thousands of Americans every year.

I can blame my buddy FDR. There is a great story in "The Forgotten Man" where the publisher of Good Housekeeping gives one of Roosevelt's cabinet an earful because the government is taking over the "Good Housekeeping Seal of Approval." Drug testing is a private function in Europe and should still be here.

Posted by John Kranz at 11:21 AM

July 24, 2007

Bush's Health Care Plan

I guess I don't make enough enemies around here with my GOPragmatism®, I had to go out looking for trouble on other blogs.

Josh Hendrickson at The Everyday Economist is unimpressed with the President's Health Care plan, as expressed today in a WSJ editorial by L. Ron. Allan Hubbard. Hubbard makes a great case for the importance of keeping what's good about American care while trying to repair what is bad.

The problem is straightforward: Under today's tax code, people who are fortunate enough to get health insurance through their jobs get a big tax break -- but those who have to buy coverage on their own get no tax break at all. That is not fair, and it is not wise. It makes it impossible for millions of Americans who work for small businesses or who are self-employed to afford health insurance. And it drives up the cost of coverage for us all.

So President Bush has proposed to level the playing field for health insurance. Under his plan, every family with private health coverage would receive a standard tax deduction of $15,000 -- no matter where they get their health insurance. This deduction would encourage more people to buy their own health insurance, just like the mortgage interest deduction encourages more people to buy their own homes. Some have suggested that a flat tax credit could also achieve the president's goal of leveling the playing field, and he has signaled that he would be open to that option.

I like this plan as a bold step to break the country's dependence on employer-provided care. If that can be broken, a lot of other reforms are enabled. People will demand interstate insurance and other innovations.

Hendrickson provides a generous excerpt, salutes the good parts, then questions both the ability of helping those too poor to buy insurance with a 15,000 deduction, and:

We need to eliminate all tax deductions and credits (whether personal or corporate) and move toward an insurance policy that is much more similar to auto insurance than modern health insurance. Such a plan would bring price back into the equation and limit the administrative costs of HMOs and other managed care organizations. The plan proposed by Hubbard essentially tries rather unsuccessfully to give everyone the incentive to over-insure.

I think the President is tilting at windmills here, but I would like to see the GOP take this up as a realistic alternative to HillaryCare. Providing tax-neutrality between employer funded and self funded insurance would be huge. That is the stumbling block that prevents the innovations from auto insurance from arriving in health insurance.

As I commented there, I'd be all for the government getting entirely out of the equation. But this would be an improvement very much worth fighting for.

Posted by John Kranz at 2:04 PM

July 12, 2007

Joining the Club

The good folks at Cato are promoting an "Anti-Universal Coverage Club." Sign me up.

Here are the guiding principles of the Anti-Universal Coverage Club:
  • Health policy should focus on making health care of ever-increasing quality available to an ever-increasing number of people.
  • To achieve universal coverage would require either having the government provide health insurance to everyone or forcing everyone to buy it. Government provision is undesirable, because government does a poor job of improving quality or efficiency. Forcing people to get insurance would lead to a worse health-care system for everyone, because it would necessitate so much more government intervention.
  • In a free country, people should have the right to refuse health insurance.
  • If governments must subsidize those who cannot afford medical care, they should be free to experiment with different types of subsidies (cash, vouchers, insurance, public clinics & hospitals, uncompensated care payments, etc.) and tax exemptions, rather than be forced by a policy of universal coverage to subsidize people via insurance.
Hat-tip: The Everyday Economist
Posted by John Kranz at 12:15 PM | Comments (5)
But Charlie on the PA Tpk thinks:

I've heard that the biggest insurance industry in France is Supplemental Health Care, with 80% of the population paying for it; I'll search for that link because that dismisses how supposedly great Universal Care is where it is practised.

Posted by: Charlie on the PA Tpk at July 13, 2007 7:45 AM
But jk thinks:

I'd love to see that. I didn't know France allowed that. The UK and Republic of Ireland have that and you end up with a stratified system that would be unpalatable here.

In Sweden (and Hillary Clinton's 1993 plan) it's illegal to buy private care.

Posted by: jk at July 13, 2007 10:28 AM
But Perry Eidelbus thinks:

Government has no business making a health care policy, energy policy, etc. Government's only responsibilities there is to punish people who interfere with my right to voluntary commerce with those who would sell me health care, energy, etc. Now, government is the chief criminal when it comes to that interference.

"Government provision is undesirable"

This is the problem with Cato. The word is not "undesirable," but "unacceptable."

Posted by: Perry Eidelbus at July 13, 2007 3:24 PM
But jk thinks:

Yeah, those left-wing, socialist, pinko commies at Cato!

Once again, Perry, I'm going to call "exigencies!" You are right, but the unfortunate reality is that Government is completely entangled with every aspect of health care. If you're going to pick a fight with Cato over just how bad government interference is, you're going to have a lot more.

Posted by: jk at July 13, 2007 3:45 PM
But Perry Eidelbus thinks:

I'm pretty sure you know I don't believe Cato's people are really left-wing. Not at all. I just think they're too willing to compromise.

HB had a good quote above, which I hadn't heard before. However, it wasn't hard to realize that compromise only leads to bigger and bigger government. There comes a time when we need to stop accepting certain "unfortunate realities" and instead fight for what's right.

Posted by: Perry Eidelbus at July 13, 2007 4:20 PM

July 6, 2007

Jihadi Doctors

To be honest, I think most of the suggested ties between Britain's National Health Service and the al-Qaeda connected doctors has been pretty specious, even when humorous.

Hugh Hewitt makes an interesting point today, namely that the UK would not need so many foreign doctors if it provided some opportunities for its homegrown ones. He shares a letter from a friend:

Why is the UK importing all these foreign doctors?

One answer is because many of the good ones left when the powers that be decided that nationalized government-run medical care was the way to go.

Ill give you 2 examples from one specialty, ophthalmology:

S___ was the son and grandson of family physicians in the north of England. When the UK opted for socialized medicine, Stuart decided it was a bad move, so he moved, eventually winding up in Orange County, CA. S____ is the inventor of [a key advance in eye care] and co-founder of [a major company]. The device that allows the recipient thereof to see objects at far, intermediate and near distances. It is under the control of the ciliary muscle in the eye, and mimics the function of the natural lens before birthdays get a hold of it and the arms become too short. Its a remarkable lens, manufactured right there in Aliso Viejo.

But do you think a Brit can get one of these intraocular marvels? Not likely. He can come here to receive it and pay cash, but if he wants surgery done in the UK, he must sign up, wait for a very long time, then have a German ophthalmic surgeon who flies into England do his surgery since theres such a shortage of English ophthalmologist. This situation is dripping with irony!.

I cannot complain about not hiring foreign programmers in the US and hiring too many foreign doctors in the UK, but it does seem significant that they are chasing out their best and the brightest.

Of course, that will not happen here under HillaryCare. There will be no good places left for brilliant Doctors to emigrate.

Posted by John Kranz at 1:29 PM

July 2, 2007


Blog friend Perry Eidlebus got an ear infection (hope you're better!) and hit on a government-control topic that predated my political interest in health care: prescription control of compounds that have a low opportunity for abuse.

The doctor prescribed 800 mg doses of Motrin, Amoxycillin tablets, and Neomycin/Polymyxin B drops. Now, in a true free market system, I could have bought the stronger painkillers and antibiotics myself -- on Friday, which would have killed the infection early on and saved me unnecessary pain last night. Taking antibiotics early would have also saved the health care system the hundreds of dollars that my ER visit cost.

My wife used to teach day care and get routine bronchial infections. She knew when she got them and knew what worked. I was always astonished that an MD had to sign off. I know that some will claim the existence of superbugs if antibiotics are overused. Perry makes a good point about those who deny us choices because we're not smart enough to handle risk.

Even if you had to keep antibiotics as prescription. I'm calling a Doctor today to get a Potassium supplement renewed for somebody. I had a hassle when I was fitted for an Ankle Foot Orthotic I wear (A giant ugly, uncomfortable plastic brace from under my knee to my toes). I said "what -- are all the high school kids going to be getting these?"

I can see them in their black T-Shirts and baggy trousers: chugging Amoxycillin, snorting Potassium tablets and skateboarding in their Orthotics. Good thing the government is there to protect us.

Posted by John Kranz at 11:06 AM | Comments (1)
But Perry Eidelbus thinks:

Strange as it sounds, economic interventionists should want government policies that encourage "superbugs." Why? Because of the old Keynesian mantra: "It creates employment."

The more superbugs, the more the pharmaceutical companies will have to create new drugs, and the more jobs (at the plants and at government bureaus) will result. Bastiat had his "Broken window fallacy" and "Candlestick makers' petition." Extending them to modern times, we have the "Runny nose fallacy," since if we were all constantly sick, it would create jobs for doctors, nurses, orderlies, drug makers, government bureaucrats, and all the people who must make goods and provide services for them. Right?

Antibiotic-resistant strains are a growing problem, but if there were ever one thing to learn about the several thousand years of human civilization, it's that we tend to find ways to innovate. We find a wider river, we build a longer bridge. We find a deeper-hiding terrorist, we create a bigger Daisy Cutter. We find a new bug, we make a new drug.

Besides, breeding new resistant strains doesn't come solely from "overuse." The patient likely won't see a doctor until it gets bad enough to warrant a visit, perhaps days after the infection first begins. A broad-spectrum treatment, sufficiently early, could well kill off the bacteria before it has time to mutate in a human host and produce descendants with resistance. And if the bacteria already had genes giving it resistance, then the drug wouldn't have mattered anyway. That's why there would have been no harm done in the end had I taken antibiotics myself on Friday. If it didn't help, then I'd try something else, or go see a doctor.

Besides, I thought economic interventionists believed in pragmatism, in trying something new when the previous method failed?

Posted by: Perry Eidelbus at July 2, 2007 4:27 PM

June 24, 2007

The Reality is More Complex

Everyday Economist links to Michal Moynihans review of Michael Moore's Sicko in Reason Magazine. (I could do four prepositional phrases in a sentence, but it's Sunday.) "Watching 'Sicko' so you don't have to."

I may have to. It's my issue, so to speak, and I want to credibly rebut it. I also just learned that a freind-of-a-freind's parents are the objects of the opening segment. Pardon my name dropping. It is so crazy a premise, however, it seems an unfair world that would actually call one to reasonably rebut.

Viewers are taken to London's Hammersmith Hospital, held up as a shining example of socialized care, where doctors are well-paid and patients well looked after. Moore ambles through the corridors interviewing patients that acclaim the NHS's free care,' and express horror at the barbarism of the American system. Indeed, the facility's "cashier" exists to give money to patientsfor travel reimbursementsrather than taking it from them. But as is often the case with Moore's films, the reality is more complex.

In 2005, London's Evening Standard reported that Hammersmith Hospital would slash hundreds of jobs; the hospital, the most debt-ridden in Britain, was hemorrhaging money and desperately needed to cut costs. And while the hospital was "downsizing", Hammersmith's CEOyes, even the NHS has an executive classcollected a year-end bonus of close to $20,000. Small beer by American standards, but enough to provoke tabloid headlines in Britain.

At least Britain and Ireland allow private care. This provides much more of a two-tiered system than Americans would tolerate. Part of me likes the Irish model: government provides a base level to all citizens but any sane human purchases private insurance to get better care. Not sure you could sell that to either side around here.

Worse is the Swedish system, which provides good care but proscribes purchasing better care. Which glass would you rather drink from?

But Dillner's truculent insurance provider was not Aetna or Kaiser, but the notoriously generous Swedish welfare state, where health care is "free." And because there is no private clinic in Sweden that could perform the operation, Elias will sit in a queue, hoping, in lieu of privatization, for prioritization. Swedish legislator Robert Uitto said that the Dillner case was unfortunate, but "People shouldn't, on principle, be allowed to purchase care in the public system."

Sicko also introduces us to Diane, whose brain tumor operation was initially denied by Horizon BlueCross because it didn't consider her condition "life threatening." She eventually received treatment, but "not without battling the insurance companies," Moore says.

Jack Szmyt found himself in a similar situation. After waiting two months for his initial diagnosishe too had a brain tumorSzmyt was told that it would be another month until doctors could start the necessary treatment. Rather than wait in a queue, he borrowed $30,000 from a friend, and flew to a private clinic in Germany. Had he not sought private treatment abroad, his German doctor said, he would likely have died. When contacted by the media, his insurer, again the Swedish government, said it didn't consider the assigned waiting period "unreasonable."

This is where HillaryCare really blew up, if I remember correctly. Somebody found $1,000 fines and jail time on repeat offenses for Doctors who took money to work outside the system. People -- rightly -- recoiled at that. It will be interesting to see the Democratic proposals and measure them on this yardstick: will they allow better care for the rich ("The Rich would live and the poor would die" I can hear Peter, Paul & Mary singing...), or would they forbid private care which is quickly shown as both un-American and something most people would not want to face if their child were sick.

From the review and Moore's history, I think it's safe to say that level of nuance is not explored. Maybe if Arnold Kling made a film version of "Crisis of Abundance..."

Posted by John Kranz at 2:03 PM

June 19, 2007

The Problem with Govt. Research

Suppose President Hillary Clinton and the Democratic 111th Congress get their wish. Much of health care is nationalized, price controls are placed on drugs, and the private pharmaceutical sector is severely reduced in capitalization.

I'm assured by my lefty friends that government research will take up the slack as it has in Europe. While we may have led the way, we cannot deny that some important discoveries have come from such systems.

I'll rebut this without naming an Austrian economist (though the fingers are itching). Even if the same magnitude of money could be directed, I do not trust the decisions that government would make. Research in a powerful Senator's state would receive better funding and the disease of a popular movie star or media figure would be addressed over other choices.

Worse still, the decisions would be made politically -- is that really what anybody wants? I suggest the finest proof for my critique is found in the battle over embryonic stem cell research. Michael Cook has a TCSDaily column today that documents opposition to promising new research that I find to be nakedly political.

Stem cell research has been a great issue for the Democrats. Michael J. Fox asked voters in 2006 to elect Claire McCaskill and Sherrod Brown to the US Senate, where they could overturn those troglodyte right to lifers who would rather see Michael J. Fox suffer than use a clump of cells that will be destroyed anyway. (I paraphrase only a little).

Now that there seems to be a breakthrough:

Only a few days ago an article in the leading journal Nature brought amazing news. A Japanese team at Kyoto University has discovered how to reprogram skin cells so that they "dedifferentiate" into the equivalent of an embryonic stem cell. From this they can be morphed, theoretically, into any cell in the body, a property called pluripotency. It could be the Holy Grail of stem cell science: a technique that is both feasible and unambiguously ethical.

Some scientists are opposed which strikes me as fair. Hay--I mean most people would admit innovation is best served when many people pursue their own beliefs, and if they think that embryonic research is farther along, or shows more promise, have at it.

What concerns me is the opposition from Rep Rahm Emmanuel the famed molecular biologist Democratic Congressional Caucus Chairman. Emmanuel said "It is ironic that every time we vote on this legislation, all of a sudden there is a major scientific discovery that basically says, 'You don't have to do [embryonic] stem cell research.' " .

The Democrats are locked into supporting a line of research for the simple reason that President Bush doesn't like it. This does not strike me as an efficient decision mechanism. And it will only get worse when they control even more of the purse strings.

Posted by John Kranz at 1:16 PM | Comments (1)
But Everyday Economist thinks:

I was opposed to the stem cell research bill because I did not believe that such research needed federal funding.

Why doesn't Rep. Emmanuel have the same skeptical belief regarding global warming?

The simple fact is that federal spending can be pointed to by those in elected office as evidence of what they did to help. However, if the results of the spending prove dubious, there is little discussion of the spending at all. However, it is much harder for politicians who opposed federal spending on something that turned out to be ineffective from saying, "look what I protected you, the taxpayer, from funding."

Posted by: Everyday Economist at June 19, 2007 3:08 PM

June 18, 2007

Democrats Seek Bill to Kill American Poor

A guest Editorial in the WSJ uses the less provocative headline "Uncle Sam, M.D." (Paid link)

But never, never forget that increased government in the regulation of pharmaceuticals costs lives. Dr. Scott Gottlieb opens his article with an important story of expanding the use of a compound outside of its approval aegis.

Almost 13 years after the drug Bexxar was first used in cancer patients, the Food and Drug Administration cleared it for marketing in June 2003 to treat a particularly deadly form of non-Hodgkin's lymphoma. Bexxar represents a leading edge of cancer innovation, attaching a radioactive payload to a protein that is designed to hone in on cancer cells and unload its toxic cargo. The drug isn't a certain cure but has clearly prolonged many lives in its four years on the market, and might have already benefited twice as many patients if it didn't spend an equal number of years awaiting FDA approval.

The same thing happened to Erbitux. While Dr. Waksal and Martha Stewart were in court, prison, or house arrest, and imClone was performing two years additional testing for a use the company did not recommend, people were dying of colon cancer at the rate of 15,000 per year.

After it was approved, it was found effective in treating other forms of cancer -- upping the death toll from keeping it off the market for two years and stifling innovation.

No bad deed goes unrewarded in government. A new, Democratic led 110th Congress is seeking broader powers for the FDA:

The new drug safety legislation, which is attached to a larger bill that renews the FDA's principal funding stream called the Prescription Drug User Fee Act, will change the way drugs are used by patients through provisions that give the FDA more control of medicines after they are approved. One central measure would put the FDA squarely in the role of regulating medical decisions in order to "manage" drug risks -- by giving the agency unprecedented new authority to control the way drugs are distributed by pharmacies and prescribed by physicians. It's a watershed measure, one that will grant the FDA some of the same responsibility for regulating medical practice that has been traditionally left to the states and professional medical bodies.

Please call your representatives. Tell them not to allow the Democrats to keep new drug innovations away from our nation's poor. It's just not right.

Posted by John Kranz at 9:54 AM | Comments (2)
But TrekMedic251 thinks:

Why would Dumb-o-crats want to kill America's poor. That's most of their electoral base, right?

FWIW, as a member of the medical field, sometimes its the old "money talks, BS walks" principle with pharmaceuticals. Too many drugs get green-lighted without the proper testing and many target-specific drugs, like Bexxar, get delayed because there's no profit in them.

My $0.02

Posted by: TrekMedic251 at June 18, 2007 8:38 PM
But jk thinks:

You're taking me down a more partisan road than I like to travel, trek, but trust me: their policies can create plenty more poor people. No need to worry about attrition when we have price-gouging and minimum wage laws with a huge marginal rate on the nation's producers.

I'm not sure I buy your assessment of pharmaceutical approval. I hate to do it by anecdote but several potential blockbuster compounds have been ground down by the FDA. On the other side, I'd ask you to name one drug that was approved in the last decade with inadequate testing.

Frankly, I wish I believed you; a more bribable FDA would be a great boon to innovation. I'm afraid we're stuck with our petty bureaucrats.

Posted by: jk at June 19, 2007 10:42 AM

Democrats Seek Bill to Kill American Poor

A guest Editorial in the WSJ uses the less provocative headline "Uncle Sam, M.D." (Paid link)

But never, never forget that increased government in the regulation of pharmaceuticals costs lives. Dr. Scott Gottlieb opens his article with an important story of expanding the use of a compound outside of its approval aegis.

Almost 13 years after the drug Bexxar was first used in cancer patients, the Food and Drug Administration cleared it for marketing in June 2003 to treat a particularly deadly form of non-Hodgkin's lymphoma. Bexxar represents a leading edge of cancer innovation, attaching a radioactive payload to a protein that is designed to hone in on cancer cells and unload its toxic cargo. The drug isn't a certain cure but has clearly prolonged many lives in its four years on the market, and might have already benefited twice as many patients if it didn't spend an equal number of years awaiting FDA approval.

The same thing happened to Erbitux. While Dr. Waksal and Martha Stewart were in court, prison, or house arrest, and imClone was performing two years additional testing for a use the company did not recommend, people were dying of colon cancer at the rate of 15,000 per year.

After it was approved, it was found effective in treating other forms of cancer -- upping the death toll from keeping it off the market for two years and stifling innovation.

No bad deed goes unrewarded in government. A new, Democratic led 110th Congress is seeking broader powers for the FDA:

The new drug safety legislation, which is attached to a larger bill that renews the FDA's principal funding stream called the Prescription Drug User Fee Act, will change the way drugs are used by patients through provisions that give the FDA more control of medicines after they are approved. One central measure would put the FDA squarely in the role of regulating medical decisions in order to "manage" drug risks -- by giving the agency unprecedented new authority to control the way drugs are distributed by pharmacies and prescribed by physicians. It's a watershed measure, one that will grant the FDA some of the same responsibility for regulating medical practice that has been traditionally left to the states and professional medical bodies.

Please call your representatives. Tell them not to allow the Democrats to keep new drug innovations away from our nation's poor. It's just not right.

Posted by John Kranz at 9:54 AM | Comments (2)
But TrekMedic251 thinks:

Why would Dumb-o-crats want to kill America's poor. That's most of their electoral base, right?

FWIW, as a member of the medical field, sometimes its the old "money talks, BS walks" principle with pharmaceuticals. Too many drugs get green-lighted without the proper testing and many target-specific drugs, like Bexxar, get delayed because there's no profit in them.

My $0.02

Posted by: TrekMedic251 at June 18, 2007 8:38 PM
But jk thinks:

You're taking me down a more partisan road than I like to travel, trek, but trust me: their policies can create plenty more poor people. No need to worry about attrition when we have price-gouging and minimum wage laws with a huge marginal rate on the nation's producers.

I'm not sure I buy your assessment of pharmaceutical approval. I hate to do it by anecdote but several potential blockbuster compounds have been ground down by the FDA. On the other side, I'd ask you to name one drug that was approved in the last decade with inadequate testing.

Frankly, I wish I believed you; a more bribable FDA would be a great boon to innovation. I'm afraid we're stuck with our petty bureaucrats.

Posted by: jk at June 19, 2007 10:42 AM

May 14, 2007

FDA: Black Wednesday

Brother Johngalt and I explore some unexpected internecine disagreement in the "Pharmaceuticals" topic. I tried to explain in an answering comment that I'd like to see the FDA focus on safety and let the medical community -- a Hayekian collection of doctors, patients and researchers -- explore efficacy and benefits.

In addition to that response, I'd like to hide behind another WSJ editorial (another paid link). Dr. Mark Thornton, "a former medical officer in the FDA Office of Oncology Products, [who] volunteers as president of the Sarcoma Foundation of America" shares my disappointment.

May 9, 2007, should be cited in the annals of cancer immunotherapy as Black Wednesday. Within an eight-hour period that day, the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient's immune system against cancer. The FDA's hubris will affect the lives and possibly the life spans of cancer patients from nearly every demographic, from elderly men with prostate cancer to young children with the rarest of bone cancers.

I invoked Hayek because the problem here is a command and control structure. One drug is disallowed because it displays a 94% efficacy rate instead of 95%. One oncologist who votes in a minority on the first panel "launched an unprecedented PR campaign" against those who voted to approve and ultimately prevailed. It disturbs me that one doctor, who may be right or wrong, is enabled by our government to keep other Doctors from trying the treatment.

Though the author is a doctor, he knows that this ruling might cause the company or its investors to drop the product entirely, further driving up the risk premium for the pharmaceutical sector. Better to invest in something safe, like soap or cigarettes.

Both the Provenge and Junovan clinical trials provided evidence that patients lived longer compared to control groups. But according to the FDA, these "survival advantages" that statisticians talk about had "issues." When the issues were discussed in the Provenge public meeting the majority of the committee (in a 13-4 vote) thought the issues, while relevant and important, were superseded by the solid immunology science behind the product.

Posted by John Kranz at 11:58 AM

May 10, 2007

FDA To Allow More Americans to Die

I said I wouldn't -- but how do I know you read the TCS piece...

Dr. Richard Miller, an oncologist at Stanford writes in today's WSJ Ed Page:

Cancer patients suffered a serious setback yesterday. The Food and Drug Administration sent back Dendreon's Provenge, a development-stage drug for prostate cancer, requesting additional clinical data. The FDA rejected the drug despite an outside advisory panel's overwhelming recommendation to approve it.

Provenge's fate has wider implications. It is the first of a growing number of therapeutic cancer vaccines to go up for approval, and is emblematic of the gap between medicine and statistics that paralyzes the FDA approval process and keeps vital treatments from reaching critically ill patients. The FDA bases its approvals -- for everything from medications for minor ailments to new cancer treatments -- on the rigid application of the same outdated statistical standards. Any new drug or other form of treatment, whether it's a therapeutic treatment for infected hangnails or a cancer vaccine, must meet the FDA's standard of 95% certainty that any positive results claimed for its use are not due to chance.

While hangnail sufferers may be in a position to (uncomfortably) wait for such levels to be achieved, it is difficult to argue that terminally ill patients with only months to live should have to do so -- especially when more than 1,500 Americans die of some form of cancer every day.
Millions of healthy Americans willingly face the roughly one-in-a-million chance that they will die from their annual flu shots, because they (rightly) judge that the potential benefits outweigh the potential risks. This risk-benefit analysis changes sharply when you are terminally ill. Shouldn't we give those patients at least a voice in deciding what risks they are willing to take when it comes to treatment options?

If, based on extensive review of all available data, the FDA has determined that a drug is safe and able to benefit some individuals, then patients and their doctors should be given the choice to use it. That will only happen if the FDA changes its one-size-fits-all method and uses a context-based approach to approving new drugs.

They took Erbitux of the market for two years, during which time 30,000 people died of colon cancer, for which Erbitux has been shown to be a helpful treatment. (Sam Waksal and Martha Stewart went to jail -- teach then to try to cure Cancer, the bastards!) Here, friends, we go again.

It's bad when the government takes your house or scrutinizes your library book list. Mr. Jefferson (and Mr. Locke, I believe) put "Life" even before liberty or happiness. That the government tells you and your doctor that it is illegal to buy treatment that might spare your life is the worst thing -- of many bad things -- that the government does.

Posted by John Kranz at 11:34 AM | Comments (2)
But johngalt thinks:

JK knows I'm of a like mind regarding government over-regulation, but I'm not so sure this Provenge decision is an example of that. Dr. Miller complains of the "95% certainty" requirement but in the case of Provenge, the only statistically significant trial data showed that, in a population of 127 men, the drug extended median survival by 4.5 months versus placebo.

Provenge is the first of many, many potential vaccine formulations for various cancers. This is an area of great promise, but the Provenge data shows limited efficacy compared to what is promised by the clinical approach: Activating the body's natural immune system to destroy cancer cells throughout the body. There is great hope in cancer research circles that we're on the trail of a cancer "cure" with these treatments.

With the dozens of vaccines under development there are many, many opportunities for current patients to participate in clinical trials of these compounds. The chief effect of the FDA witholding approval is that the pharmaceutical companies must pay for the drugs instead of patients and their insurance companies. This is a huge incentive for the developers to carefully select where they make their investments and will shorten the time to better drugs. Meanwhile, today's patients have reasonable access to the best contemporary treatments and contribute greatly to progress of the science.

Posted by: johngalt at May 13, 2007 11:12 AM
But jk thinks:

I most heartily disagree.

Patients can determine whether the efficacy of the drug warrants its selection for treatment. Four and a half months might sound inviting to a patient who is having a difficult time with other treatments.

When treatments are available, combinations of treatments or differences in dosage frequently augment their efficacy. Many -- like Erbitux -- are found to be effective for other conditions. The government is terminating this opportunity by proscribing it.

In my view, the government should not disallow any medication unless it is shown to be unsafe. Efficacy and suitability should be left to doctors and patients.

I also take exception (respectfully, of course) with your assertion that it is somehow available through clinical trial even though the FDA has disallowed its sale. A patient who meets certain, exacting criteria, can with some luck, get accepted into a trial where he or she might be receiving a placebo for a terminal disease.

It is not about who pays for the study or the drugs. It is our government telling a doctor or patient that it is illegal to try a new compound to treat a terminal illness. I cannot condone that.

Posted by: jk at May 13, 2007 5:49 PM

May 9, 2007

Hear him tell it

I know, my rants on pharmaceuticals are probably getting to the level of Andrew Sullivan on torture or Professor Reynolds on non-stick cookware. It's my passion, and it is under more extreme pressure from a Democratic 110th Congress.

Ignore me. Listen to this guy. Charles Hooper is a consultant to drug companies, with the unfortunately necessary job of telling them to pull the plug on development.

Don't be misled into believing that Arcoxia, which has been tested in over 34,000 patients, is a wildly dangerous drug. According to Merck, "there is more long-term safety data from controlled clinical trials, in terms of patient-years on treatment, for Arcoxia than for any other NSAID, including traditional NSAIDs and Cox-2 selective inhibitors." Do the English or Germans seem careless or inept? Those countries already allow patients to use Arcoxia, as do 61 other countries in Asia, Latin America and Europe. It's as if the FDA is our parent and, after a long drive to the beach, is telling us not to swim in the water because he/she isn't convinced the water is warm enough. We nod agreement and then look out to see 63 other kids happily swimming. Hmmm. Maybe we're old enough to decide for ourselves.

At the end of the day, it will be my company that kills a new drug. So, yes, I'm a drug killer. But the FDA is the true drug killer. I'm merely acting out the FDA's script.

If you'll read the whole thing, I'll shut up about the topic for at least 30 days -- deal?

Posted by John Kranz at 12:44 PM

April 20, 2007

Thanks, Dr, McClellan

Kim Strassel of the WSJ Ed Page pens a nice piece lauding Dr. Mark McClellan:

Republicans won a big victory this week, shooting down a Democratic plan for more government-run health care. The GOP victors, and free-marketers, might send their thank-you notes to Dr. Mark McClellan.

Dr. McClellan is the 43-year-old internist who, until recently, held the thankless job of running Medicare. He was handed the further thankless task of designing and implementing Congress's tepid 2003 Medicare reform. And he's the big brain who then wrung every last ounce out of that authority to create a striking new model for Medicare competition that is today not only performing beyond expectations, but is changing the political health-care debate.

She goes on to credit him with a great part of the success of the Medicare Part D, and much of the parts that free market lovers actually like about it.
Dr. McClellan's solution was a program that gave companies maximum freedom to design plans, bundle drugs and turn a profit. He was a salesman, talking up the opportunities and even traveling to New York to reassure Wall Street. It worked, and by the first days of business most seniors were being courted by anywhere from 11 to 23 plan sponsors. Those numbers have only grown, creating so much competition that sponsors are eliminating deductibles, lowering premiums, offering more drugs. It's also led to smart cost-cutting and efficiencies; an estimated 60% of Medicare prescriptions are now for generics.

She titles the piece "The Competence Man." When some of the Presidents picks have seemed not to be the best and brightest, Dr. Mac was an exception (his brother did okay at press secretary, but was no Tony Snow).

I wrote about Dr, McClellan in May of 2003 in an essay called "The Best and the Brightest."

Last night, I saw Dr. McClellan. The dude is an M.D. and has a PhD. in Economics. He has taken on one of the most stifling, sclerotic, anti-competitive bureaucracies and is leading it the right way. His fast tracking of Cancer drugs will save tens of thousands of lives. His less-adversarial demeanor will bring back capital to the pharmaceutical sector, which will save millions. The Wall Street Journal has relentlessly attacked the FDA before his tenure, doing their best work around the Erbitux-ImClone-Waksal-and-Martha-Stewart imbroglio. But theres a new sheriff in town.

McClellan was starting to reform my bete noire, the FDA. I was saddened when he was moved out of that post to Medicare but it seems that move might have saved this nation Billions of dollars.

Thanks, Doc.

Posted by John Kranz at 5:49 PM

April 18, 2007

Hayek vs. Marx

The World's Greatest Deliberative Body will vote today on one of the worst of the six in '06 initiatives that the Democrats campaigned on: allowing the government to negotiate drug prices for Medicare Part D.

I was on board with the President when Part D was enacted. Many thoughtful libertarians and small government types decried it as a new entitlement. It's a valid point, but if the government is going to pay for heart surgery, it seems that buying a bottle of Plavix(r) might be cost-effective. I also appreciated that there were free market mechanisms built in.

The WSJ Ed Page point out that this part of the program has mitigated their opposition.

We opposed the prescription drug bill as a vast new entitlement, but there's no denying the program's innovation of using private-sector competition has worked far better than critics predicted. In the first year alone, the cost of Medicare Part D came in 30% below projections. The Congressional Budget Office calculates the 10-year cost of Medicare Part D will be a whopping $265 billion below original estimates.

Seniors are also saving money under this private competition model. Premiums for the drug benefit were expected to average $37 a month. Instead, premiums this year are averaging $22 a month -- a more than 40% saving. Democrats don't like to be reminded that many of them wanted to lock in premiums at $35 a month back in 2003. No wonder recent polls find that about 80% of seniors say they're satisfied with their new Medicare drug benefits.

Now, the Democrats are in charge and the one good part of the bill in danger. (To be fair, this vote alone is an "I told you so" against my initial support.) We can't let people choose and companies compete and innovate -- it would be better if the government did all that! Like they do for the Veteran's Health Administration.

That's a good comparison. The VHA offers only one in five of new drugs released since 2000. Of the 300 drugs most commonly prescribed for seniors. a study found that one in three -- including such popular medicines as Lipitor, Crestor, Nexium and Celebrex -- are not covered under VHA, while 94% are available under Part D. The best comparison between VHA and Part D?

Statistics released March 22 by the VHA and Department of Health and Human Services show that 1.16 million seniors who are already enrolled in the VHA drug program have nonetheless signed up for Medicare Part D. That's about one-third of the entire VHA case load. Why? Because these seniors have figured out that Medicare Part D offers more convenience, often lower prices, and better insurance coverage for their prescription drugs. In short, seniors are voting with their feet against the very price control system that Democratic leaders Harry Reid and Nancy Pelosi want to push them into.

Where the market works, government will work much better. Just like when the government does...uuh...

Posted by John Kranz at 10:31 AM

March 22, 2007


Cancer is in the news again today. "Democratic presidential hopeful Sen. John Edwards, D-N.C., announced today that his wife's cancer has returned, but that his presidential campaign will go on." Mrs. Edwards' cancer is apparently a metastasis of her breast cancer, thought effectively treated in 2004 with radiation and chemotherapy. And the metastasis site is now within bone, which makes it difficult to treat: The bone is one of the most common places where breast cancer spreads, and once it does so it is not considered curable.

When it comes to cancer, the present day "standard of care" as it's called - radiation treatments and chemotherapy - is brutal on the body and bleak in long-term prognosis. Cancers are very rarely referred to "cured" but instead are said to be in remission. The good news is that the scope and quality of cancer fighting research is truly impressive in this nascent age of genetic science.

The bad news is that no new treatments have thus far been approved by regulatory bodies which do much more than to extend a patient's life by a few months or years. What's more, the cutting edge pharmaceuticals being developed are monstrously expensive - on the order of $10,000 per week with treatments required for life in some cases.

But in February 2007 something different came to light. A biomedical researcher at the University of Alberta, Canada, Dr. Evangelos Michelakis, published a research paper in the journal 'Cancer Cell' that showed "Cancer Mitochondria Are Hyperpolarized and Have Suppressed Oxidative Metabolism, Both of which Are Reversed by DCA."

"DCA" or dichloroacetate, is a simple compound that has apparently been approved for treatment of certain rare metabolic disorders in children. It is also a long-standing compound and can't be patented. Nonetheless, unless Dr. Michelakis' team's discovery is another cold fusion debacle, it could be a safe and powerful new treatment for this devastating disease. If true, this could also be an incredible threat to the big business of cancer cures.

But the more pressing concern is what is happening with DCA today among current cancer patients, some of whom are considered "terminal." They are treating themselves - illegally - with this unproven compound.

Desperate cancer patients are self-medicating with a cheap compound that has yet to be tested in humans, despite dire warnings of potential toxic poisonings.

Predictably, the medical establishment and government regulatory bodies reactions range from extreme caution to total fear of the unknown. But for someone with no hope left, what's to lose?

Dr. Evangelos Michelakis, the cardiologist whose academic paper sparked the worldwide fervour, said people shouldn't take DCA until clinical trials prove it is safe on humans and actually shrinks tumours as it did in rats.

In clinical trials to see how DCA works in metabolic disorders, children took the drug and showed no signs of toxic poisoning. But when similar trials were done on adults, most had to discontinue using it, since they developed severe peripheral neuropathy, Michelakis said.

The damage to the peripheral nerves caused imbalance and finger numbness. Michelakis said if people take DCA along with other cancer treatments, the consequences could be lethal.

Even for those who say they have only six months to live and nothing to lose, Michelakis said it's not worth it. "You can die earlier and in much worse shape," he said.

Jim Tassano, a biologist in Sonora, Calif., and a University of California chemist have begun making DCA and selling it over the Internet. "Are there side effects?" Tassano said. "Absolutely, but compare that to radiation."

This is a complicated moral situation, one on which I've had difficulty forming an opinion. I think though my attitude is best expressed by an opinion on "thedcasite.com" which asks, "Is DCA worth trying?"

We absolutely think so..

The risks of a DCA-based therapy are trivial compared to those of accepted cancer therapy. Isn't radiation bad for you? Doesn't radiation cause cancer? What does a man feel like after he loses sexual function when a doctor cuts the nerve near his prostate gland? How does a women feel after having her breasts removed? Have you ever seen someone after a chemo treatment so sick they cannot get out of bed for days? What is like to be told that there is nothing that can be done for you, to just go home and die? Why is all that okay? Why would anyone opt for the cutting, burning and poisoning of their bodies when they could drink a tiny amount of sodium dichloroacetate every day for a few months, live a totally normal life and pay only a few hundred dollars? What is there to lose? A reversible neropathy? A risk of cancer that is probably vastly less than the risk radiation therapy places upon you?

That is the allure, the great hope that DCA gives us.

There is a problem, and it is not DCA.

Posted by JohnGalt at 2:53 PM | Comments (3)
But jk thinks:

I post in "Philosophy" so you just have to post in "Pharmaceuticals." Coincidence?

I think it is criminal for the government to disallow terminal cancer patients the right to try any therapy they would like. I was surprised that you called it a "complicated moral situation," jg. It seems pretty easy to me. Angel Raich should be allowed to use marijuana to ease her pain and Elizabeth Edwards, should she so choose, should be allowed to try DCP.

I can see no legitimate reason for the government to prohibit either one of these women from directing their own treatment.

Posted by: jk at March 22, 2007 6:11 PM
But johngalt thinks:

No, there is nothing complicated about government coercion. It is bad. What's complicated is... a few things:

Medical professionals, including the researcher who discovered the effect, strongly discourage human use. Is this because they really believe there's a safety concern, because they're fearful of government or industry retribution or, in the case of the discoverer, because he has a patent that he'd like to see commercialized?

Drug companies spend millions to explore complicated compounds with novel mechanisms but [apparently] aren't interested in a potentially simple cure. Is this because they don't believe in its potential or because there's more profit potential in the alternatives?

Given the uncertainties listed, what decision does a desperate patient make? This is where it gets complicated. In addition to not prohibiting access to a treatment, government also should not have a knee-jerk cautionary reaction to it.

Posted by: johngalt at March 23, 2007 3:38 PM
But jk thinks:

I guess we're in complete agreement (as usual -- right!) There are some very difficult decisions to be made. I just don't want governmnet to make them.

Posted by: jk at March 24, 2007 1:45 PM

March 7, 2007

Scandal or SOP?

Standard Operating Procedure for government work.

Ronald Bailey on Reason Magazines Hit & Run blog hits a theme I also heard from Fred Barnes on FOXNews last night. The "scandalous" treatment of wounded soldiers at Walter Reed is indeed an outrage, but it is also how the government does business and what we should expect when we create our own American version of the UK's NHS:

Well, look no further than the scandalous mess at Walter Reed Army Hospital. Crappy hospitals, endless waits, mountains of paperwork and, at the end of the day, no real accountability from the people who run the joint. Folks, if the government can't or won't take good care of our injured soldiers, what makes you think that it will take good care of little Sally or Uncle Bill?

Health care in the United States is screwed up. This is largely due to bad government policies, e.g., third party payment encouraged through the tax code and multiplying state insurance mandates that unnecessarily boost costs. As the example of Walter Reed is warning us, putting total control of all health care in the hands of those who wrecked it in first place--Congress, states and federal agencies--is the wrong way to go.

Hat-tip: Everyday Economist

Posted by John Kranz at 12:50 PM

February 2, 2007

The Wrong DIrection for the FDA

I am frequently and consistently disappointed by Republicans. They forget their principles routinely. When their hearts and mind are in the right place, they seem ineffective and pusillanimous compared to the folks across the aisle.

Yet I can never credibly threaten to abandon them (though I stand by my pledge) because the Democrats are effective, just at moving the wrong way. Yes, the Democrats won the 110th fair and square. Yes, I knew there would be legislative consequences. Yes I knew my beloved pharmaceutical sector would be severely threatened.

But right out of the chute, I see Senator Kennedy on the front page of the Wall Street Journal in Drug Industry Faces Bitter Pill. (Paid link, sorry!) Keep in mind that this is the fairly liberal news division, not my right wing wackos on the Editorial Page.

Congress is kicking off efforts to pass big reforms of the Food and Drug Administration, and that could produce some bitter pills for the pharmaceutical industry: potentially, tougher safety rules and provisions to reduce the cost of medicines.

Proposals to beef up regulation have stalled before, often due to skepticism from Republican allies of the industry. This year is likely to be different. Democrats aren't reluctant to give expanded authority to federal regulators and see the drug industry as a tempting target because of its tenuous popularity with consumers and its traditional ties to Republicans. And they're getting support from some Republicans upset by a series of high-profile drug-safety problems, including the 2004 withdrawal of the painkiller Vioxx.

Also, lawmakers have a ready-made vehicle for the changes: legislation that must be approved this year to renew the deal under which the industry pays fees to fund much of the FDA's drug-review process. The current user-fee agreement expires later this year.

"It's pretty clear we have drug-safety problems, and it's clear we need to address those matters," says Rep. John Dingell (D., Mich.), chairman of the House Energy and Commerce Committee, which has jurisdiction over the FDA. Several lawmakers say the agency's latest drug-safety initiatives, announced Tuesday, need to be bolstered with new legislation.

"Pretty clear we have a safety problem is Rep. Dingell-speak for "It's pretty clear my committee needs to take over this sector of the economy."

So we will cut their profits with price controls, scare off their investors with endless Congressional hearings, then regulate the crap out of what's left. But we're going to raise subsidies for stem-cell research, as long as the researcher can categorically prove that it will disturb the President.

Posted by John Kranz at 6:25 PM

Does NHS pay?

Twiglet, a 12-year-old grey tabby (yes, "grey" she lives in old Blighty) has become the first cat in Britain on Prozac

A ginger tom had chased her and even jumped through the cat flap to attack her in her own kitchen.
"When I took her to the vet I was told she had anxiety issues and depression brought on by the stress of being bullied by other cats," said Miss Martin.

Twiglet was prescribed the Prozac-like drug amitriptyline, to be taken once a day. The vet also put her on a strict diet and Miss Martin sent a note to her neighbours asking them not to feed her pet.

Happy endings ensue -- better living through chemistry. My 12-year old pooch has been on Rimadyl for a few years. Her boyfriend across the street may go on Vicodin (any "House" fans?).

Seriously, after the FDA shuts down all research in the US (paid link, sorry), maybe research for pet medications will be modified for use with homo sapiens.

Hat-tip: Mickey Kaus who also wonders why Senator Clinton has not gotten "nearly enough grief for declaring, of the Iraq War: 'The President has said this is going to be left to his successor. I think it's the height of irresponsibility, and I really resent it'" Good point.

Posted by John Kranz at 12:22 PM

January 31, 2007

Where's my Fake ID?

I reuse a stupid joke. I tell my friends that I am looking for my old fake IDs I used to use to buy beer -- because now I'll get the Senior Discount at Denny's. (It's much better when I tell it...)

I think I might be in the market for a fake ID, if a great idea by Economist James D. Miller could catch hold. Miller writes in TCS Daily that it's time to "Free the Elderly."

Consider a 90-year-old man suffering from severe kidney disease. He would like to take an experimental drug, but his doctor can't get him in on the clinical trials. As a result, the man must wait nine more years until the drug is approved by the FDA. Unfortunately, this man's advanced age means he has only a slight chance of living another nine years.

On average around 12-15 years elapse between the discovery of a medicinally useful chemical compound and that compound's approval by the FDA. This is an intolerable delay to impose on the elderly who often have life expectancies of less than 12-15 years.

He links to an article by Gary Becker (where have I heard that name around ThreeSources?) that suggests weakening FDA restrictions as the answer to rising pharmaceutical prices. Becker suggest that the FDA should test for basic safety and let the medical community sort out efficacy concerns. This would bring drugs to market quicker and more cheaply, giving the developer a revenue stream and additional testing.

I'm not elderly nor terminal but if MS is cured tomorrow, it's pretty unlikely that I would get the treatment before I die. Our government does a lot of stupid things, but making it illegal for a drug company to sell medicine to a dying person rises to the top of the list for me.

Posted by John Kranz at 1:58 PM

January 16, 2007


Two articles in the Wall Street Journal today combine to give me a sinking feeling.

The good news is an H-P breakthrough, using nanotechnology to build faster computers. I do like faster computers.

The bad news concerns Pfizer's reorganization and cost containment strategies expected from its new CEO.

As new Pfizer Inc. chief Jeffrey B. Kindler prepares to give the first details on his strategic vision for the company, his plan is likely to involve shedding more jobs and rethinking the way the drug giant develops, makes and markets medicines.

Employees at the world's largest drug maker are bracing for deep cutbacks when Mr. Kindler presents analysts with some specifics on his plan to overhaul Pfizer on Monday, say people close to the situation. The job cuts could involve several thousand positions, these people say, including some in the European sales force. Mr. Kindler recently reshuffled some senior managers for the second time since taking the top job in July.
"I'd most like to see new drugs, but if he's able to revive the pipeline and R&D productivity, it'll take years. I'm sure he'll talk about it, but it's not much more than a promise," said Michael Krensavage, an analyst at Raymond James. "He's handcuffed to cutting costs. It'll be very difficult to change the direction of the iceberg with one meeting."

I don't think this is a Schumpeterian reorg, this is recognizing the exigencies of trying to develop innovative cures in an industry that will be more regulated.

H-P can raise capital and spend it on R&D in a free market, realizing that it might recoup those expenses many times over should it bring a valuable product to market. Of course, both H-P and Pfizer could lay a billion dollar egg, that's the marketplace.

But even if Pfizer develops something the public wants, its profit will be proportional to what Senator Schumer and Rep Franks think is fair compensation. Not surprisingly, investors are not lining up for that. The 110th Congress has not had a bill signed into law, but they have already changed the face of an important industry.

That's okay guys, I'm not sick or anything...

Posted by John Kranz at 10:23 AM

January 5, 2007

And The FDA Tests It

Andrew Roth suggests three important viewpoints on the new diet medication for dogs.

  • As a testament to our country's unrivaled prosperity, there is actually a market for this drug.

  • Pfizer, a leading drug company for humans, recognized this market and created the drug to meet the demand.

  • When should we expect the new Democratic Congress to propose a new Medicare Prescription Drug Benefit for Dogs bill (Medicare Part E?).

I'd have to add #4:
  • We need to have a Federal Agency regulate and approve these compounds.

Celebrate our economy, but fear for the Republic.

Posted by John Kranz at 4:46 PM

January 4, 2007

Haste Makes Waste

Opinion Journal looks at the Democrats rush to get things done in the first 100 hours and their motivations for doing so.

Namely, their ideas won't stand up to scrutiny.

    The need for scrutiny is even more compelling on price controls for Medicare prescription drugs. Under the Medicare Part D benefit that took effect last year, private companies negotiate prices. Democrats want to allow the government to deal directly with drug companies. They argue that this would lead to lower prices for medicines, but the more likely outcome is fewer drug choices and price controls.

    Democrats point to the Department of Veteran Affairs as a model, but we doubt seniors will like that story when they learn about it. The government already negotiates drug prices directly with the VA. But as Robert Goldberg wrote last month in The Weekly Standard, "Far from negotiating prices, the VA imposes them. Federal law requires companies to sell to the VA at 24% below wholesale price. If they won't, they are banned from selling medicines to Medicaid, Medicare and the public health service."

    The VA has created a list of approved drugs for its patients. Companies that don't pay the VA price don't make the list, and a slew of drugs fall into that category. They include Azilect and Tysabri, two of the newest therapies for Parkinson's and multiple sclerosis, respectively. That's what happens when keeping prices down takes priority over getting the best available medicines to patients. Both drugs are available through Medicare Part D, by the way. Maybe Congress ought to debate this.

Posted by AlexC at 2:01 PM

December 21, 2006

Patents Are Killing You

So say the would-be thieves.

    A report by the General Accounting Office concludes that current patent law discourages drug companies from developing new drugs by allowing them to make excessive profits through minor changes to existing pharmaceuticals. While pharmaceutical research and development expenses have increased by 147% since 1993, applications for approval of "new molecular entity" (NME) drugs, or drugs which differ significantly from others already on the market, have risen only 7%. According to the report, the majority of newly developed medicines are so-called "me-too" drugs, which are substantially similar to existing drugs, are less risky than NMEs drugs to develop, and which "offer little in the way of therapeutic breakthroughs."

Posted by AlexC at 4:38 PM | Comments (1)
But jk thinks:

I have read very intelligent commentary on both sides of this issue and I am torn. I've long railed on these pages to allow pharmaceutical firms to make profits. Yet a compelling and nuanced case can be made that Patents ultimately hamper discovery.

Of course, you'll hear no such nuance from Senator Dick Durban, who cannot wait to wave his new gavel at drug companies:

"Commenting on the report, Senator Dick Durbin (D-IL) said that existing patent law allows drug companies to drive up their profits at the expense of patients needing innovative treatments. 'The findings in this new GAO report,' said Senator Durbin, 'raise serious questions about the pharmaceutical industry claims that there is a connection between new drug development and the soaring price of drugs already on the market. Most troubling is the notion that pharmaceutical industry profits are coming at the expense of consumers in the form of higher prices and fewer new drugs.'"

I fear for the Republic and its inhabitants...

Posted by: jk at December 21, 2006 5:36 PM

December 11, 2006

Can We Reimport These?

Hyper-regulatory Europe speeds in front of the United States again. Dr. Gilbert Ross writes in TCS Daily.

There are two new COX-2 inhibitors on the market in Europe and many other regions, offering possible help against both arthritis and cancer but not in the United States: Novartis' Prexige and Merck's Arcoxia. Will our drug agency fairly evaluate them on the standard benefits and risks scale?

Not only can a firm open its shares to public purchase without premeasuring its officers for prison garb, but a person with arthritis can fill a prescription for the newest COX2 inhibitors.
Now Merck is testing the COX-2 waters again. Its Arcoxia has been available worldwide for some time, but the application it first submitted to the FDA in 2003 has been on hold ever since. A newly released study shows that the drug is relatively safe for the stomach and has no excess cardiovascular risk. These data came from a study involving over 34,000 patients and were reported by researchers from the Harvard Medical School. Merck expects the FDA to have its re-evaluation completed by April 2007.

The Swiss company Novartis recently received EU approval to market Prexige. A new study showed that this drug was associated with far fewer gastrointestinal side effects than two older NSAIDs, ibuprofen and naproxen. And, as with Arcoxia, there was no increase in cardiovascular adverse effects. The FDA will also get to consider Prexige early in 2007, according to Novartis.

Doctors and patients will be keeping close track of the FDA deliberations on these drugs. Will the new members of the suspect COX-2 class get a fair hearing from the chronically risk-averse FDA? Experience has shown that the FDA is not immune to unscientific pressures. In the case of the COX-2 drugs, trying to avoid all risk is, in fact, a bigger risk than allowing them on the market. The newer COX-2's have been shown to be as effective as, and safer than, the older arthritis drugs. The scientists at the FDA know that all drugs have risks. As a former practicing rheumatologist, I can bear witness to the suffering caused by arthritis, and I hope the regulators see fit to allow patients access to new treatment options and do not hesitate because of baggage from "the Vioxx taint."

Too much government power has been given to the FDA. People and their doctors should be able to choose these medicines where they're appropriate.

Posted by John Kranz at 7:26 PM

December 4, 2006

Great Days For Senator Edwards

Eighty two people have died in a Pfizer drug trial. Not only will that provide 82 clients for Edwards's supporters in the trial bar, but it has caused Pfizer to suspend development of a promising new blockbuster drug for cholesterol management.

The announcement raises new questions about one of the pharmaceutical industry's most anticipated new ideas. Several companies have made investments in this area in the hunt for badly needed sales and profit growth.

Just two days earlier, in an upbeat presentation to analysts, Pfizer research chief John LaMattina reiterated the company's backing for the compound. "We believe this is the most important new development in cardiovascular medicine in years," he said.

Senator Edwards swore in 2004 that he would "fight the drug companies." He must be happy to see one of the sector's leaders imperiled. The WSJ News page (paid link sorry) says:
[CEO Jeffrey] Kindler, a lawyer whose nearly five years at Pfizer account for his entire rsum in the pharmaceutical industry, now faces a daunting challenge. He was tapped only this past July over two longtime Pfizer executives to become chief executive officer of the languishing giant. He will have to move even more aggressively to cut costs and restock the company's medicine chest, possibly through acquisitions.

Building the pipeline through M&A instead of R&D is a good move but it will save far fewer lives.

There is no government angle here, I'm not castigating the FDA. I'm just reminding the Pharma-haters of the biggest natural predator to pharmaceutical development: plain old experimental failure. Two days takes a pipeline drug from rescuing your company to a tax write off.

To continue with research we will need to continue to reward those who are successful. Another CEO, Eli Lilly's Sidney Taurel, is interviewed by Rob Pollack of the WSJ Ed Page. His editorial was promoted to the free site yesterday. He says in a single column what I have been beating the drum about since I started blogging: research's access to capital is severely threatened by government policy.

"I've seen the bad effects that government policies of price controls and overregulation can have," Mr. Taurel tells me. "When you look at Europe 30 years ago, that was where most of the innovation in pharmaceuticals used to take place. When I joined the industry, the No. 1 was Roche, and then it was Hoechst and Bayer and all these companies, which today are not as big. What 30 years of price controls have done is more and more of the research has come here. I think only about 25% of the total research in the whole industry is done in Europe."

But this is no reason for complacency, Mr. Taurel stresses. We are at a "crossroads" in the U.S., he says, "between people who want a government-run system and those of who want a free market" in health care.

Read that one coast to coast. Please.

UPDATE: Fixed the first link (ThreeSources apologizes for any inconvenience). Here is a (free) link to a CNBC video.

Posted by John Kranz at 10:40 AM | Comments (3)
But AlexC thinks:

An amazing figure from this story. The development of this drug cost $800 million dollars.

This drug, which won't make it to market, is an $800 million dollar loss for the company.

Posted by: AlexC at December 4, 2006 11:04 AM
But jk thinks:

It's okay because that $800,000,000 came from stockholders and capital markets. As we know, real medical research is funded by bake sales, pledge walks, Federal programs and colored bracelets.

Posted by: jk at December 4, 2006 11:46 AM
But Everyday Economist thinks:

This is a prime example of how R&D costs increase the price of drugs. Those who favor negotiated prices often claim that pharma firms are price gouging. They claim that these firms shouldn't be able to charge high prices for pills that cost the company very little to produce. While it is true that the second pill may cost very little to produce, that first pill cost millions.

Where would you like me to set the brownies?

Posted by: Everyday Economist at December 4, 2006 11:56 AM

November 27, 2006

Socialized Health Care


    A Canadian man who could not figure out how to deal with his girlfriend's feverish 10-month-old daughter put the baby into a freezer to cool her down, a local newspaper reported on Friday.

    Derrick Hardy faces charges of criminal negligence and assaulting the infant, who was rescued when her mother came home, the Charlottetown Guardian said.

    The Canadian Broadcasting Corp. said the mother found the girl crammed into the freezer alongside ice cubes and hamburger meat. Hardy said he had left the door ajar but the mother said it had been closed when she returned.

    He told a court in the eastern province of Prince Edward Island on Thursday the child had only been in the freezer for about 40 seconds.

Surely he should have known that he could go to his friendly local health clinic (free you know), and they would have dealt with the child promptly and efficiently.

(tip to Ace)

Posted by AlexC at 8:26 PM | Comments (2)
But mdmhvonpa thinks:

Hey, it's Canada ... just open the friggen window!

Posted by: mdmhvonpa at November 28, 2006 12:20 PM
But jk thinks:

Socialism, Schmocialism, he speaks the truth (LOL).

Posted by: jk at November 28, 2006 5:38 PM

November 25, 2006

Free Market Medical Research

Glenn Reynolds links to an interesting article on stem cell research. It interested the writer from the Globe and Mail because some plucky Canadian scientists have bested their better funded peers below the border. It interested Professor Reynolds because a better understanding of the cells that can produce and sustain tumors augurs well for innovation in treatment and prevention.

It interested me because it speaks of a Hayekian mechanism that works in so many arenas as being important in scientific research. The so called "bad news" of this recent discovery is that it discredits the foundation of the most popular research of the last decade.

The implications are staggering. Billions of dollars and decades of research may have targeted the wrong cells to cure the disease. No current treatment has been designed to kill them and they appear to be naturally resistant to the gold-standard therapies.

The work has whipped new optimism into cancer research, but Dr. Dick is loath to take too much credit. It's rare in science you find something that is completely novel, said Dr. Dick, who holds the Canada Research Chair in Stem Cell Biology. Science is like laying a brick wall, one piece is laid over another.

Science, like any other human endeavour, can be a slave to fashion. From 1975 to 1995, the research world was captivated by the wonder of genes and molecular biology, Dr. Dick said. Cell biology had fallen by the wayside, and stem-cell research was carried on by a fairly small club of people.

This is exactly how the market works. Let the herd chase the conventional and the fad while a small group rewrite the rules and leap to the top in a redefined game.

The Hayekian mechanism is allowing a large group to pursue a large number of ideas and using market forces to pick a winner. The antithesis is the top down, command and control method where experts choose the fields of study.

I posit that Billions of government jack's being "invested" in stem cells short circuits this process. We have allowed Christopher Reeve and Michael J. Fox to select the most promising areas of research, now politicians are mad to shovel more and more money into it.

Private research, or smaller scale academic projects have a better chance of finding the most effective areas of study over the most popular. Pharmaceutical companies are paying taxes they could be using for R&D to chase technology that has been selected by Senators and actors.

I have no objection to stem-cell research based on the destruction of embryos, (though I can respect the position of those who do. I do object to this herd mentality of allowing people to pick winners instead of allowing science to pick winners.

Posted by John Kranz at 2:04 PM | Comments (1)
But mdmhvonpa thinks:

Sorry, your consideration is not to be included in the 10 year economic plan for scientific advancement. Check back next decade and we will see if the soviet board will consider your application. Provided there is not an islamic coup by then.

Posted by: mdmhvonpa at November 25, 2006 11:11 PM

November 20, 2006

More Breast Banter

Must be my week for promotion and publicity at ThreeSources, I've hit breast implants twice in as many days.

The Wall Street Journal Ed Page hails the FDA for finally putting science over politics and lifting the 14 year ban on silicone implants.

The news is good for freedom lovers, but the editorial warns that the forces of darkness are still arrayed:

One of the ugliest aspects of the breast-implant controversy has been the irresponsibility of the feminist movement, whose championship of a woman's right to "choose" doesn't extend to breast implants. It's all the more outrageous given the tens of thousands of breast-cancer victims seeking reconstructive surgery each year. Silicone-gel implants tend to feel and look more natural than the saline alternative.

It would be nice to think that the FDA's move closes the chapter on this nasty episode, but given the anti-implant crowd's reaction to Friday's announcement, that's probably too much to hope for. Kim Gandy, president of the National Organization for Women, called it a "reckless decision" and promises to seek reversal "when the new Congress takes office." Sidney Wolfe, head of Public Citizen's Health Research Group -- the Naderite outlet that spearheaded the campaign against silicone in the 1980s and is a front for the trial bar -- called breast implants "the most defective medical device ever approved by the FDA." He also vowed to seek Congressional action.

While we're glad the FDA has overturned 14 years of politicized medicine by approving silicone breast implants, it's worth remembering the enormous price that has been paid: to the credibility of the legal system, in jobs lost, and in public health. And it's worth asking what is more toxic: the silicone implants preferred by thousands of women, or the trial bar that purports to "protect" them.

In case you missed my post yesterday, I'd call your attention to a piece by Lance at A Second Hand Conjecture. This is one of the great blog essays I have ever encountered. He ties in freedom, innovation and choice.

UPDATE: Welcome to the Blogroll: A Second Hand Conjecture

Posted by John Kranz at 11:29 AM

November 19, 2006

Let's tralk about breasts.

I've been whining about the FDA' s supra constitutional intrusion into our lives for many years. I hear you tuning out already. Were I discussing women's breasts, you'd stick around, right?

Lance, at A Second Hand Conjecture looks at the FDA's role regarding Dow Corning's silicone implants. Not just the FDA, but also the whole gamut of elite opinion makers and organizations bent on taking care of us by removing our birthright liberty.

Okay, so the breast discussion is strangely un-titillating. But he looks at the issue in light of Virginia Postrel's "The Future and its Enemies:"

Technocracy is by nature hostile to diversity and freedom. Its goal is controla uniform future shaped by experts. It recognizes only one best way. So it overrides the judgments and desires of individuals, curbing choice, experimentation, and learning in the name of scientific wisdom. Now, however, our technocrats arent keeping their side of the bargain. Theyre destroying not only choice but progress, attacking not only liberty but truth. They have joined forces with those who seek to quash technology, innovation, and unnatural inventionsto create a static society by defamation and decree. By attacking the innocent and emboldening the malevolent, spreading rumors and defying their own experts, they have betrayed the public trust.

He contextualizes it in reference to the drug war and do-gooder feminists, everybody who wants to make our decisions for us. Comparing it to the drug war, he finds that black market implants go for $1800 a pair (that would be $900 apiece) and tells the story of an unfortunate man busted --and jailed -- for smuggling. (Anything to declare?)

It's a long piece and sadly there are no pictures. But he does keep his composure better than I. My friend Sugarchuck does a great riff on the Supreme Court using Major League Baseball's antitrust exemption. This is the strongest freedom in medicine piece I have read and I collect them.

The implications however go further still. In previous essays I have argued that the recent outrage about our civil liberties being eroded are misplaced. I do not mean to imply that issues such as the warrantless wiretapping are unimportant, or worthy of serious debate. I do mean to say that they are not the largest or most prevalent threat to us as a free people. It is the very size and reach of the government. The story of how bogus science, zealous litigators and activist groups acting on our behalf limited our freedom, destroyed careers and fortunes is alarming, but it is part and parcel of the technocratic regulatory vision which animates the drug war, invades our privacy, and the privacy of how we chose to live our lives.

Hat-tip: Instapundit and I'll steal his line: Read The Whole Thing.

Posted by John Kranz at 1:00 PM | Comments (2)
But johngalt thinks:

I was most interested in this passage from Lance's piece:

"We have to give a good reason for our choices. For those of us concerned about the ongoing drug war, such as the recently deceased Milton Friedman, this is a key point. I have a close friend who often used to justify (despite ample evidence) his vote for Democrats on the Republican drug war. I argued that neither party was serious about doing anything about it, and that the most vocal opponents of it were certain Republicans and libertarians."

Voting for Democrats will give no more satisfactory resolution to the "war on drugs" than it will to the "culture of corruption" in government. Sadly, voting for Republicans is rarely better, but only the best of two bad alternatives.

Posted by: johngalt at November 20, 2006 5:22 PM
But jk thinks:

Amen. I would even ask gay marriage supporters if the Democrats' tepid non-opposition is worth their vote.

The heart of this piece is its assurance that we quibble about crumbs of liberty on the edges while ceding swaths of control without a quibble. (Sorry about the high metaphor density of that last paragraph). Have hearings on terrorist surveillance -- but allow the FDA to deny 30,000 terminal colon cancer patients access to Erbitux.

Posted by: jk at November 20, 2006 5:36 PM

November 10, 2006

One I Called Right

My electoral predictions, errr, sucked.

My prescient warnings of electoral failure on the immigration issue are disputed by many at ThreeSources

The Broncos did not get blown out in Indianapolis

But, Michael J Fox notwithstanding, the election of Democrats will have an adverse effect on medical innovation by chasing capital out of the pharmaceutical sector.

Greg Mankiw

Yesterday, as the market was processing all the political news, the stock market was up slightly ( 0.2%), but pharmaceutical companies took a hit.

My interpretation: The Dems will likely give us lower drug prices and less research into new drugs. Good news if you plan to be sick soon. Bad news if you plan to be sick in the more distant future.

Told you so. People who'll cheer a bake sale for MDA or go nuts over an AIDS walk don't see this chart as denoting the real funding prospects for research.

Hat-tip: Josh at Everyday Economist

Posted by John Kranz at 2:25 PM

November 9, 2006

FDA: One Step Forward?

Some good news in the Wall Street Journal today: "Election a bad dream, GOP keeps both houses." Well, no. The actual headline was FDA May Broaden Access To Experimental Drugs. Life and political battles go on. And the story starts out promising.

The Food and Drug Administration is moving to broaden access to experimental drugs for people with serious illnesses, with efforts that would represent a middle ground in the emotional debate over when unproven treatments should be available to patients with no other options.

Great news: some people will be allowed to buy drugs that will help them. If, they can prove that they will die. And there's nothing else. And they fill out the right form. And if their form is approved.

Two sides to a controversy, and the article points out the other side.

The FDA is preparing a proposal that would clarify how doctors and drug companies can make certain drugs, not yet FDA-approved, available to small groups and individual patients with dangerous diseases and no other treatment options, according to people with knowledge of the matter. Agency officials have also drafted a proposal that would lay out more situations in which companies could charge patients for access to experimental drugs, though not for a profit, these people said.

Both proposals are subject to approval by the White House's Office of Management and Budget and could change before they are released.

The FDA proposals, which wouldn't represent a major revamping of the current system, don't go as far as the most aggressive patient activists wish. On the other side, some doctors warn that the agency needs to make sure there is reason to believe a drug could work before patients start taking something that may not help.

With apologies to James Taranto, "what would we do without 'some doctors?'" Where in the Constitution is government given the right to prevent the sale of treatment? People are suffering. If they know the risks, the government should not have the right to preclude access to treatment.

Better to let 99 snake oil shysters bilk some unfortunate people out of money for ineffective treatment than to let one person die because some bureaucrat thought the form was filled out incorrectly. 30,000 people died of colon cancer while Erbitux was forced to perform 24 more months of trials. Many though it was because Dr. Sam Waksal was "arrogant."

Im happy for the small step, but still reject Government's having any authority in this ambit. Free markets could do better.

Posted by John Kranz at 12:43 PM

November 3, 2006

GOP Health Care

I've been the lone voice in the wilderness the last couple years: a sure sign of individual vision and perspective, or complete madness.

I think that the GOP should celebrate its record of protection of quality health care. The Democrats claim education and health care as their issues, when many of their policy ideas would weaken the system.

Some guy named AlexC at SantorumBlog prints a letter of support for Senator Santorum signed by more than 50 MDs and several more health care professionals.

As a leader in the Senate, Rick Santorum has been a champion for safety, quality, research, and access to care for every Pennsylvanian and every American. Sen. Santorum has earned the respect of health care professionals throughout the nation, and for good reason.

In addition to the health care leaders listed at the end of this letter, Rick Santorum has been endorsed by the Pennsylvania Medical Society Political Action Committee (PAC), Ob/Gyns for Womens Health PAC, Pennsylvania Orthopaedic PAC and the Pennsylvania Physicians for the Protection of Specialty Care (3PSC). And because he wants to ensure that patients continue to have timely access to quality health care, Rick Santorum is also supported by The American Association of Neurological Surgeons PAC. His opponent has received little or no support from the medical community, also for good reason.

I think you can make a good case for protecting that which works in our system. Americans rejected HillaryCare pretty soundly.

Posted by John Kranz at 4:47 PM

October 29, 2006

Michael J Fox Ads

Instapundit linked to this ad where Michael Steele fights back.

He is using the victim of a terrible disease to frighten people, all for his own political gain.

I was pretty disappointed with the Michael J Fox ads supporting Ben Cardin and Claire McCaskill. C'est la guerre, I suppose, but like so many celebrity activists, Fox has fastened onto a single issue with partisan effects.

Where the hell are these people when a Democratic VP candidate swears "they will fight the drug companies" and where are they when price controls, additional regulation, drug importing, and a non-friendly-to-Pharma FDA are discussed?

As an MS patient, embryonic stem cells might offer some hope (not that the FDA would let me have a cure were it discovered tomorrow) and, like many on this blog, I would not have a huge problem allowing Federal funding of research.

As all the lefties of the world line up to support something just because President Bush has set boundaries for it, all promising research in the world is put at risk by rapacious tort lawyers and a sclerotic FDA bureaucracy. Yet I am not expecting to see Ed Asner and Rob Reiner sing "We are the Pharma" even though that's where the real hope lies.

Count two MS patients for Steele!.

UPDATE: Deja vu all over again. On October 6, 2004 I made Taranto's Best Of The Web with a post that included Michael J Fox, politics, pharmaceutical companies, Sen. Edwards's vow to "fight the drug companies," and even the word hell.

Posted by John Kranz at 12:59 PM | Comments (5)
But johngalt thinks:

Federal funding of research? What about dem dere "market forces?"

Posted by: johngalt at October 30, 2006 3:24 PM
But jk thinks:

I might oppose it as Federal Funding qua Federal Funding. I was conceding that I am not morally opposed to ESC research.

Didn't we just do this with me on the other side? Who are you and what have you done with JohnGalt?

Posted by: jk at October 30, 2006 4:35 PM
But johngalt thinks:

Has johngalt ever endorsed federal funding of anything other than national defense, or ever opposed any free scientific inquiry? Point me to the instance and I'll correct it!

Posted by: johngalt at October 31, 2006 2:51 PM
But jk thinks:

Not exactly. But on July 19, we did seem to be in different corners: http://www.threesources.com/archives/003126.html

jk: Unclench your jaw my friend. This issue is complex. I am guessing that we are on the same side in a way. Using a pro-life argument to block scientific research rubs me the wrong way, and I'm guessing that is what disturbs you.

On the other hand, kimosabe, we are talking about Federal funding of research. Private companies can do what they want. Applying limits to Federal Funding seems very legitimate even if don't happen to agree with the reason. I'll allow you to make the case for Federal funding.

jg: Well done on the Federal funding angle, but even an Objectivist (notice the absence of the curious term "Randian") must be practical. Unlike the president, when I take it upon myself to dismantle the present practice of Federal funding of research I will not start with the branch of human biotechnology that holds the greatest promise for the future of humanity since penicillin.

jk: So's your old man...

Posted by: jk at October 31, 2006 4:28 PM
But jk thinks:

Randian was used in Whittaker Chamberss 1957 review of Atlas Shrugged in National Review (He didnt like it). http://www.nationalreview.com/flashback/flashback200501050715.asp

Jonah Goldberg has kept it in currency. I, for one, would call myself a Randian but not an Objectivist.

Posted by: jk at October 31, 2006 4:33 PM

October 24, 2006

Gene Pool

I don't see this as a problem.

    Men who use mobile phones could be risking their fertility, warn researchers.

    A new study shows a worrying link between poor sperm and the number of hours a day that a man uses his mobile phone.

    Those who made calls on a mobile phone for more than four hours a day had the worst sperm counts and the poorest quality sperm, according to results released yest at the American Society for Reproductive Medicine annual meeting in New Orleans.

    Doctors believe the damage could be caused by the electromagnetic radiation emitted by handsets or the heat they generate.

There are too many morons out there abusing cell phones.

The last thing we need are for them to breed.

Don't get me started on the bluetooth earpieces. "No. You cannot pretend that you're Lt Uhura."

Posted by AlexC at 1:37 AM

October 13, 2006

Make the FDA Worse

Now that I have said not-unkind things about the FDA, the WSJ Ed Page points out that it could get a lot worse under a Democratic Congress. Democrats, for some reason I don't completely grasp, like to "FIGHT!" the pharmaceutical companies that are trying to improve our lives. It seems the evil drug firms want to make money or pay bills or return capital to shareholders or something unseemly like that. I won't know until the big Michael Moore documentary comes out.

The WSJEdPage reports that a 1992 law that allowed companies to pay the FDA for faster reviews will itself be reviewed, sadly by a Congress that may want to prove how tough it is on Big Pharma.

So allow us to draw attention to an important and undernoticed study, "Assessing the Safety and Efficacy of the FDA," published by the National Bureau of Economic Research. Its surprising conclusion is that the FDA does a pretty good job managing "the central speed-safety trade-off" involved in drug approvals -- and might even do well to move faster.

The authors looked at 662 drugs approved between 1979 and 2002, a period that included the passage of the Prescription Drug User Fee Act that allowed drug companies to help fund the FDA budget in exchange for faster reviews. They found that the resulting modest gains in drug review times have produced unambiguous public benefits.

Not that Democrats are needed to make things worse. If Senators Grassley and Dodd are teaming up, you can bet it ain't gwine be pretty. Even a competing and unflattering study thinks they go too far.
We've looked at the IOM report in detail, and it's hardly as damning of the FDA as media reports suggest. For example, the report explicitly rejects the idea that high-profile drug withdrawals -- such as Vioxx -- "represent de facto failures of the drug safety regulatory system. . . This is not so." The IOM also rejects the basic idea behind legislation sponsored by Senators Chuck Grassley and Chris Dodd that the FDA should have a drug safety office separate from the office that approves drugs in the first place: "Risk and benefit cannot be considered in isolation from one another."

Amen. The FDA sees too much risk and not enough benefit.

Posted by John Kranz at 11:17 AM | Comments (2)
But mdmhvonpa thinks:

In this day and age, aspirin would have never been put on the market, OTC or otherwise.

Posted by: mdmhvonpa at October 13, 2006 11:44 AM
But jk thinks:

That evil Bayer Company is only in it for the money! Selling their damn snake oil! Where's John Edwards when you need him?

Posted by: jk at October 13, 2006 11:47 AM

October 8, 2006

Research for the World

I have been pretty hard on the FDA since I began blogging. I don't know all its responsibilities, but have always felt that the pharmaceutical approval process could best be replaced with private testing on the model of UL, CSA and DE.

A favorite cuz of mine works for the FDA. At his house last month, enjoying his hospitality and drinking a perfectly hopped porter he had made, I broached the topic gently. He appreciated my concerns but made the great point that our system with all its flaws is the best in the world. (Kind of sounded like me arguing against socialized medicine...)

Panama has pulled the blood pressure medication Lisinopril from its shelves after 19 mysterious deaths in 7,000 people taking it. When they saw problems, did they call Europe? Cuba?, Hugo Chavez?

Switching to the FDA: When this first started Panama turned to the Centers for Disease Control in Atlanta because they thought they had an unidentified virus or bacteria on their hands. Now that it's starting to look like a case of bad meds, they are starting to work more closely with the Food and Drug Administration from the United States. Government health officials have sent samples of tissues, blood, and other bodily fluids from the patients to the CDC labs in the United States for testing. The samples were flown back in a "special plane" that is designed for this task.

This brought me back to my post on the NYTimes article which explains that our health care expenditures benefit the whole world.

Sweeping the scientific Nobel prizes this year made WSJ Ed Page's Dan Henninger chant "U-S-A! U-S-A!" on the "Journal Editorial Report" on FOXNews. I think we can alternate between pride of accomplishment and despair at the number of free-riders.

Posted by John Kranz at 11:53 AM

October 6, 2006

American Health Care

We spend so much on health care, yet don't outlive our socialist allies -- what gives?

I think it's a specious comparison. Not every dollar is spent to stave off the reaper, much is spent on quality of life. Plus there are innumerable other variables in life expectancy. Still, it is a favorite of the crowd that calls for medical collectivism. Josh at Everyday Economist links to an excellent story in the New York Times.

This innovation-rich environment stems from the money spent on American health care and also from the richer and more competitive American universities. The American government could use its size, or use the law, to bargain down health care prices, as many European governments have done. In the short run, this would save money but in the longer run it would cost lives.

Medical innovations improve health and life expectancy in all wealthy countries, not just in the United States. That is one reason American citizens do not live longer. Furthermore, the lucrative United States health care market enhances research and development abroad and not just at home.

The gains from medical innovations are high. For instance, increases in life expectancy resulting from better treatment of cardiovascular disease from 1970 to 1990 have been conservatively estimated as bringing benefits worth more than $500 billion a year. And that is just for the United States.

The author, an economics professor at George Mason University, admits the system's flaws but, like me, doesn't want to kill the engine of innovation and discovery.
Most fundamentally, the lack of good measures of health care quality makes it hard to identify and eliminate waste.

These problems should be addressed, but it would be hasty to conclude that the United States should move closer to European health care institutions. The American health care system, high expenditures and all, is driving innovation for the entire world.

Posted by John Kranz at 5:38 PM

October 4, 2006


I guess the Senate will be decided on who may have used a racial pejorative in school and the House will be decided on which party is demonstrably more suspicious of gays (with Nancy Pelosi's Democrats taking a commanding early lead).

If anybody's left who enjoys actual politics and policy, there's an interesting editorial in the WSJ today (Paid site, sorry!)

While they are not ready to recant in their opposition to the new Medicare drug plan, Gigot & Co. are pretty pleased with the way the market-driven elements of the plan have performed.

The early returns are encouraging, on both price and choice. Over the weekend insurers began marketing their 2007 Medicare drug plans, and all states except Hawaii and Alaska have more than 50 private options available -- up from an average of about 40 in 2006. Seventeen insurers are selling nationwide plans, up from nine this year. That compares with the one or two that critics of including private plans predicted would be available in many markets.

The average monthly premium that seniors pay is again $24, far lower than the $37 originally estimated by government actuaries. And while Democrats have hammered away at the idea that having seniors choose among competing drug plans is too "confusing," recent polls show satisfaction with the benefit in the 80% range.

I've mentioned before, my biggest problem with the plan is that, with no means testing, it is welfare for the masses, getting the government involved in everyone's plan. Yet it has been pretty mercilessly criticized by the Right. Ryan Sager considers it Exhibit A in an indictment of Bush's failures to promote conservative principles.

It is worth celebrating the market forces that were included in this plan's structure. And it is worth remembering what the plan would look like if the other guys drew it:

All of this would also seem to rebut the current Democratic campaign theme that having drug prices "negotiated" -- i.e., dictated -- by government is an urgent priority. Democrats point to the drug coverage provided by the Veteran's Administration as a model. But the VA usually keeps costs down by refusing to pay for newer, more effective medicines. The VA drug formulary includes only 19% of the medicines approved by the FDA since 2000.

One of our fears about the drug program is that it will devolve into price controls, thus destroying incentives for research and development as European governments have done. It would be a cruel irony if the Medicare drug benefit were to have the effect of delaying the cure for, say, Alzheimer's. Yet this is where Democrats seem to want to go..

Lastly, Vive la Difference!
Mark McClellan, the Bush appointee who has done so well in supervising the Medicare drug launch, is about to step down, so the choice of his successor will be crucial to keeping this market momentum. All the more so if Democrats take the House or Senate, where Henry Waxman, Pete Stark and others wait to do whatever it takes to show that the free market can't work in health care.

We'd have thought Republicans would be trumpeting the success of market competition in producing more choices and lower prices in Medicare, but instead most of them are merely advertising the new entitlement. Even they seem not to understand the stakes in making competition in Medicare work.

Posted by John Kranz at 4:46 PM

October 3, 2006

Socialized Medicine, Part CMXIV

Philip Chaston of Samizdata reports on an interesting side effect of the US-UK alliance:

Soldiers on operations say they would rather receive a more serious injury and go to the top American military hospital in Ramstein, Germany, than end up in a NHS hospital.

They now half jokingly refer to getting "a Boche rather than a Blighty" in reference to the wounds that would send them home. Ramstein has an outstanding unit for brain surgery, and neurological intensive care beds in Britain are in short supply. "The blokes see it that if you are unlucky you get wounded and go to the UK at the mercy of the NHS, but if you get a head wound you get sent to Ramstein in Germany where the US has an outstanding medical facility," said an officer serving in Afghanistan.

"It also does not do morale much good knowing that within 18 hours of being wounded you could wake up in a NHS hospital with a mental health patient on one side and an incontinent geriatric on the other."

The post points out that -- in addition to the wonders of socialized medicine -- the British soldiers are threatened by British Muslims near the hospital.

Posted by John Kranz at 7:19 PM

September 21, 2006

This Free Market Thing

What to do about runaway drug costs? That's the intractable problem that has animated the Democratic Party for years and forced the GOP to enact the first new entitlement since LBJ lived at 1600 Pennsylvania.

I'm not saying that this is a panacea, but Wal*Mart is testing a new program to offer $4 generic drugs (my co-pay is six). The Wall Street Journal reports (paid link) that the evil giant will use its fearful monopsony powers to, umm, provide inexpensive drugs to people.

Retail giant Wal-Mart Stores Inc., eyeing a long list of brand-name pharmaceuticals about to lose patent protection, announced plans to test a low-price strategy for generic drugs sold at its pharmacies.

The Bentonville, Ark., company said it will cut the price of nearly 300 generic drugs sold at Wal-Mart store pharmacies in Florida's Tampa Bay area to $4. The company plans to expand the program to all Florida stores in January 2007, and in other states next year.

Wal-Mart said the program will be available to customers with insurance as well as the uninsured. It will include medications to treat allergies, cholesterol, high blood pressure and diabetes. The discount giant said some antibiotics, antidepressants, antipsychotics and prescription vitamins will also be included.

Again, I don't claim that the problem is somehow solved, but this shows the power of a free market solution.

Posted by John Kranz at 10:35 AM

September 13, 2006



    For three years, Riaan Bolton has lain motionless, his eyes open but unseeing. After a devastating car crash doctors said he would never again see or speak or hear. Now his mother, Johanna, dissolves a pill in a little water on a teaspoon and forces it gently into his mouth. Within half an hour, as if a switch has been flicked in his brain, Riaan looks around his home in the South African town of Kimberley and says, "Hello." Shortly after his accident, Johanna had turned down the option of letting him die.

    Three hundred miles away, Louis Viljoen, a young man who had once been cruelly described by a doctor as "a cabbage", greets me with a mischievous smile and a streetwise four-move handshake. Until he took the pill, he too was supposed to be in what doctors call a persistent vegetative state.
    Across the Atlantic in the United States, George Melendez, who is also brain-damaged, has lain twitching and moaning as if in agony for years, causing his parents unbearable grief. He, too, is given this little tablet and again, it's as if a light comes on. His father asks him if he is, indeed, in pain. "No," George smiles, and his family burst into tears.

Amazing. Read it all.

Posted by AlexC at 12:01 PM | Comments (3)
But jk thinks:

Interesting. I say we halt all sales of this product until the FDA can do an exhaustive 20 year study, allowing thousands to die on placebos. It's really the only safe way to proceed.

While these are always interesting, there is always a "cold fusion" element to these. Like reading Drudge, you read a hundred of them and occasionally one comes true.

Posted by: jk at September 13, 2006 2:31 PM
But johngalt thinks:

Unlike "cold fusion" however, something like this is actually more likely than unlikely to one day come to pass. Keep on truckin' private pharmaceutical researchers.

Posted by: johngalt at September 13, 2006 5:26 PM
But jk thinks:

Nobody holds "big pharma" in higher esteem than me, but I get a few emails a month with somebody who's curing MS in Landgmapalaaka with Diet Coke and Tiddlywinks. One's grain of salt quotient gets pretty high.

Though if The Guardian must be right about something, this would be my choice...

Posted by: jk at September 13, 2006 6:43 PM

August 23, 2006

Rudderless FDA

Y'all think I make this stuff up. Our government is endangering lives by bureaucratically keeping pharmaceutical innovation down. Dr. Henry Miller, a physician and former FDA official, points out in TCS today that the agency has had a confirmed commissioner for only 20 months of the Bush presidency ( I gave kudos to Dr. McClellan in May of 2003).

The acting head is facing a tough challenge in Senate hearings because all of government is really about abortion, and two Democratic Senators have a hold on his nomination. Even if Emily's list is placated, Miller is not excited that nominee Andrew von Eschenbach will champion the necessary reforms.

The lack of leadership makes the agency more risk averse than usual. And Miller reports that the innovation-suppressing is taking its toll.

In spite of increasingly more powerful and precise technologies for drug discovery, purification and production, during the past twenty years development costs have skyrocketed, with direct and indirect expenses now exceeding $800 million to bring an average drug to market. And the trends are ominous: the length of clinical testing for the average drug is increasing, fewer drugs are being approved, and the number of applications to FDA by industry for marketing approval has been decreasing for a decade.

FDA is largely responsible for these worrisome trends. Regulators keep raising the bar for approval, especially for innovative, high-tech products. Human gene therapy and other treatments tailored to individual patients have been hit especially hard, and the agency has made it more difficult for badly needed new antibiotics to be licensed. FDA's demands for post-marketing clinical trials have proliferated wildly, and "risk management" plans for newly approved drugs have been punitive and designed more to protect regulators' derrieres than patients.

Nope. Nobody sick out here and in need of new medications. Take your time.

The country -- and ThreeSources -- has focused much attention on whether or not the Federal government should subsidize Embryonic Stem Cell (ESC) research, and it is a valid, political question. At the same time, I wish that half of the effort directed at promoting more Federal $$ to ESC could be directed at the things which truly prevent miracle drugs: FDA bureaucracy and a rapacious tort bar.

Read the whole thing. It seems Europe has a largely private sector system for drug and device approvals. Oh well, they always lead the way in freedom...

Posted by John Kranz at 12:30 PM

August 7, 2006

Socialized Medicine

Saw this over at Club for Growth's Blog.

UK Telegraph

    After years of Government targets pushing them to cut waiting lists, staff are now being warned against "over-performing" by treating patients too quickly. The Sunday Telegraph has learned that at least six trusts have imposed the minimum times.

    In March, Patricia Hewitt, the Secretary of State for Health, offered her apparent blessing for the minimum waiting times by announcing they would be "appropriate" in some cases. Amid fears about 1.27 billion of NHS debts, she expressed concern that some hospitals were so productive "they actually got ahead of what the NHS could afford".

The lesson here? In the United Kingdom, if you do your job quickly, seeing more patients, you're going to be kneecapped.

Nice. Let's take two helpings of that here.

UPDATE: jk busting in on another's post, here. I wanted to give a link to a thoughful post on this topic from Perry at Eidelblog.

Posted by AlexC at 1:49 PM

August 3, 2006

jk 5, Erin Brokovitch 3

I appreciate the sagacious counsel I have received on the Vioxx matter. But I can still root for Merck. And the Wall Street Journal reports:

A California jury cleared Merck & Co. of responsibility for the heart attack of Stewart Grossberg, a 71-year-old retired construction manager who took the painkiller Vioxx for about two years.

The 12-person jury deliberated for 4 hours before finding Merck wasn't negligent. The jury said Vioxx did have risks that were knowable but that the risks didn't present a substantial danger to users.

The verdict, in Los Angeles Superior Court, widens Merck's slight edge on the Vioxx trial score card, with the drug maker winning five trials and losing three. The Whitehouse Station, N.J., drug maker faces some 14,200 suits over Vioxx, roughly 490 of which have been filed in California. "Today's outcome demonstrates, again, why we will defend these cases on a case-by-case basis," Kenneth Frazier, Merck's general counsel, said in a statement.

Posted by John Kranz at 1:28 PM

June 14, 2006

Coffee for Cirrhosis

The other day I blogged about a new study that said 17 beers in one day (everyday) would be good for your prostate.

The obvious downside is liver damage.

But wait!

    Drinking coffee may shield the liver from the worst ravages of alcohol, a study of more than 125,000 people suggests. The risk of developing alcoholic cirrhosis of the liver dropped with each cup of coffee they drank per day.

    "Consuming coffee seems to have some protective benefits against alcoholic cirrhosis, and the more coffee a person consumes the less risk they seem to have of being hospitalised or dying of alcoholic cirrhosis," says Arthur Klatsky at Kaiser Permanente Medical Care Programme in Oakland, California, US, who led the study.

So.... if you drink 17 Bailey Irish Creme's and coffee, you'll be in tip top shape!

Drink up my friends.

Posted by AlexC at 2:44 AM | Comments (1)
But jk thinks:

Perry at Eidelblog links as well, and seperately offers this Thought for the Day:

"Keep your libraries, keep your penal institutions, keep your insane asylums... give me beer. You think man needs rule, he needs beer. The world does not need morals, it needs beer. It does not need your lectures and charity. The souls of men have been fed with indigestibles, but the soul could make use of beer." - Henry Miller, "Make Beer For Man" (1925)


Posted by: jk at June 14, 2006 2:20 PM

June 12, 2006

Beer for Your Prostate

Drink up folks.

    Researchers at Oregon State University say that the compound xanthohumol, found in hops, inhibits a protein in the cells along the surface of the prostate gland. The protein acts like a switch that turns on a variety cancers, including prostate cancer.

    Dr. Richard N. Atkins, CEO of the National Prostate Cancer Coalition, said the experiments are encouraging and "perhaps men could take it in pill form someday."

The catch?

17 beers at a sitting.

I couldn't drink that much water, milk, soda!

Posted by AlexC at 10:40 PM | Comments (3)
But jk thinks:

If I HAVE to...

Posted by: jk at June 13, 2006 9:49 AM
But johngalt thinks:

The science behind this discovery must still be a bit tangential. I'm curious about what the original premise was and how closely observations matched expectations.

That said, I have long maintained that beer is a health food. Unless you drink 17 of them a day, that is. The MSM just can't figure out how to dig deeper than the pat sound bites in stories like this.

So it's gotta be 17 beers, huh? Every report on the story has the same number: 17 beers. Sixteen would have no benefit (from the xanthohumol, that is) right? Wouldn't eight and a half beers have half the effect? Wouldn't one beer have one seventeenth? Please.

And what exactly do they mean by "beer?" Samuel Adams Premium Lager easily has 17 times the hop content as Budweiser. And forget about "lite" beers. American brewers' idea of hops in lite beer is to bottle the stuff in the adjacent room to where hops are stored for use in ACTUAL beer.

But the news is still good. Better than what's being reported, in fact - analogous to Iraq war reporting.

Drink with pleasure my brothers. As the good brothers of Andechs Monastery call it, beer is "Pleasure for body and soul!"

Posted by: johngalt at June 13, 2006 2:45 PM
But silence dogood thinks:

Can I get a prescription for that?

How about highly hopped "Medicinal Beer" as a new marketing trend?

Beer, it makes men stronger and women more beautiful, how can it not be considered a wonder drug?

Posted by: silence dogood at June 13, 2006 3:17 PM

June 9, 2006

Tysabri Price Premium

"We're from the Government, and we're here to help!"

The Wall Street Journal news page reports that Tysabri will be released at a 20% premium to its debut price.

According to a posting on Elan's Web site, Tysabri will cost $2184.62 a vial, or about $28,000 a year, compared with a price of about $22,000 a year when the drug was launched in 2004.

According to Christopher Raymond, an analyst with Robert W. Baird & Co. the increase "is not a shock" given that the drug, which will come back with restrictions, will become more of a niche product. Mr. Raymond also said the increase is reasonable considering that Biogen and Elan will have to spend resources tracking every patient that takes the drug, as the FDA has required.

The drug will become available to patients on a roll out basis by July this year.

So, they yanked it for 16 months and told the patients who were finding relief with it to just suffer. Now, the price has gone up 20%, ostensibly to cover regulations. One wonders if there isn't a bit of a legal slush fund in the new rate.

Privatize the FDA!

Posted by John Kranz at 11:31 AM

June 8, 2006

Good News on Drugs

The FDA will allow MS patients to try Tysabri after a 16 month hiatus.

The Wall Street Journal Editorial Page suggests Now Bring Back Vioxx

Better late than never, we guess. And as long as the FDA is considering drug comebacks, what about the unfairly maligned painkiller Vioxx? There's new evidence suggesting it's no more dangerous to the cardiovascular system than other commonly used painkillers.

The new study, published in the British Medical Journal, is a so-called "meta" analysis of data from 138 separate drug trials involving about 140,000 patients. It found that high doses of ibuprofen -- commonly sold over the counter as Advil and Motrin -- and of the prescription pain reliever diclofenac raised the risk of adverse cardiovascular events by roughly as much as such COX-2 drugs as Vioxx and Celebrex.

We thought Merck made a mistake in withdrawing Vioxx from the market in late 2004. It's pretty clear now that Merck could have done better by patients -- and avoided feeding the tort lawyer frenzy that now threatens to destroy it -- by merely slapping a stronger warning label on Vioxx.

The lesson in both these cases is that all drugs have risks as well as benefits. The FDA now recognizes the right of MS patients to take the small risks associated with Tysabri in order to slow the progression of their disabling disease. Those suffering from debilitating pain should also have a right to take Vioxx, or ibuprofen, if they so choose.

For more than a year, patients who were seeing relief could not get Tysabri. But the FDA "has a public to protect!" How many dollars were chased out of the sector while the FDA was setting up a strict risk management program?

Posted by John Kranz at 11:42 AM | Comments (2)
But mdmhvonpa thinks:

I'm not entirely enthused.

Posted by: mdmhvonpa at June 9, 2006 11:35 AM
But jk thinks:

Don't know you well enough to read that, mdmh.

Tysabri is a lot more severe than anything I am looking at, I just want the government to get the hell out of the way for people who are developing new things.

Plus, Avonex + Copaxone don't seem to be doing much; I might be in the market for something more intense when the clinical trial I am in ends in a couple years.

Posted by: jk at June 9, 2006 12:56 PM

May 31, 2006

Bad News for Merck

I recently had the opportunity to discuss the Vioxx trials with two M.D.s who are both active in research. Both concluded that Merck had shaded results and had not been forthcoming. While one initially supported Merck, neither was very sympathetic when we spoke.

My hunch is that this disclosure will not bolster my side of the argument:

Merck has contended that the study shows an increased risk of heart attacks and strokes only for patients taking Vioxx for 18 months or longer, and made that contention a foundation of its legal strategy. The company said in a statement yesterday that the correction doesn't change the study's results.

But, using the method that the study's guidelines recommended, Vioxx's risks don't appear to change over time, compared with the risks to patients taking a placebo, in a statistically significant way. The changes could be due to chance.

Plaintiffs' attorneys, who have been sparring with Merck in courtrooms across the country for months, seized on the error. "This latest revelation confirms that Merck's 18-month argument is scientifically meritless," said David Buchanan, an attorney with Seeger Weiss LLP. "For that reason, it has no place in any courtroom."

Longtime readers know I am completely in the bag for "Big Pharma." I see their being constantly attacked from the FDA, trial bar, and demagogic politicians (cf. Sen. John Edwards).

I'll admit this looks bad, but I will ask what I asked the physicians: mistakes in Judgment were made, does this mean that a great American pharmaceutical firm should be shut down? Should they lose their company over this?

With 11,500 lawsuits outstanding, and the firm's principal defense seemingly removed, not much math is required. If every patient who took Vioxx and has heart disease is entitled to tens of millions, its $72 Billion market cap could be swallowed up quickly.

Heart disease is common, and probably very common in the demographic most likely to take a Cox-2 (my doctor pals didn't like that assertion but I contend it holds some intuitive value. The actors on the commercials for herpes treatment seem considerable younger than the Vioxx/Celebrex crowd).

Farewell Merck! Sorry we'll never see al the wonder drugs you would have created. But at least some lawyers' kids will be buying some nice cars.

Posted by John Kranz at 10:22 AM | Comments (13)
But sugarchuck thinks:

The Dow Corning comparison is invalid, as Dow Corning's product worked as they said it should, and was safe, as their research and later research at the Mayo Clinic showed. Dow Corning was the victim of junk science and juries that didn't understand the evidence they were presented with, not dishonest research or unethical leadership. Merck screwed the pooch and got caught. Given the litigious climate we live in, and the enormous expense and difficulty of bringing a drug to the market, how can any stockholder condone falsifying and witholding data when it's inevitable discovery will lead to the ruin of the business. Frankly I am shocked that the science guys on Three Scources and the rule of law guys on Three Scources are so situational in what they will and will not condemn.

Posted by: sugarchuck at June 1, 2006 5:55 PM
But jk thinks:

I'm a big fan of tort reform. Put me down for both "loser pays" and severe restriction or elimination of punitive damages or "pain and suffering" damages.

In fact, however, lawsuits are completely compatible with free markets. Individual juries in individual districts will hear individual cases and each will make its own decision. The sum of this is the pain to be inflicted on Merck.

Posted by: jk at June 1, 2006 6:55 PM
But jk thinks:

SC, I liken this to GAAP accounting and assume there is a large discretional area when to recognize revenue and when to use logrithmic time. If they purposefully and willfully falsified research, by all means cry havoc and let loose the dogs of the tort bar.

But if a great American Pharma concern behaved -- as the WSJ Ed Page suggested -- and made a judgement call, I am willing to give them some benefit of the doubt. To be fair, my physician frinds are closer and strongly disagree.

Posted by: jk at June 1, 2006 7:01 PM
But jk thinks:

-- and I am not situational. The less attractive truth is that I am myopically and reflexively pro-business. Without clear (obvious) malfeasance, I will root for the evil corporation against the brave litigant every time.

That will not go over well at my Senate confirmation hearing, will it?

Posted by: jk at June 1, 2006 7:49 PM
But johngalt thinks:

I'll take your point a step further Sugarchuck: Given the litigious climate we live in, and the enormous expense and difficulty of bringing a drug to the market, how can any stockholder condone {bringing a drug to the market when a single error on a single drug may} lead to the ruin of the business?

This is the essence of my earlier point, and not that Merck should be forgiven if they pulled a "Pinto Gambit." I don't know enough about the regulatory process and the specifics of how Merck complied with it to say that they "screwed the pooch" here. I suspect even JK's doctor friends don't know the entire story, though I'm prepared to be proven wrong.

Posted by: johngalt at June 2, 2006 3:05 PM
But sugarchuck thinks:

I like the reference to the Pinto. Very good point! And now a thought on some collateral damage done by Merck. The next time someone introduces legislation providing some relief from the trial lawyers, the liberal du jour will jump up and say we can't loosen these laws; if anything our experience with Merck shows they should be tighter still.
This situation further strained the relationship between physicians and drug companies/drug reps. There are a great many doctors who gladly accept huge salaries for treating patients, yet expect drug companies to provide drugs on a non-profit basis. The drug companies are thus forced, unfairly, to operate under a cloud of suspicion. The cloud, post-Merck, just got bigger and darker, proving that people motivated by profit are unethical and corrupt. Maybe the best remedy for this is to buy your MD a Thomas Sowel book.

Posted by: sugarchuck at June 2, 2006 4:12 PM

May 3, 2006

Mexican Drug Policy

Amsterdam? Why bother?

How about Mexico?

    Mexican President Vicente Fox will sign a bill that would legalize the use of nearly every drug and narcotic sold by the same Mexican cartels he's vowed to fight during his five years in office, a spokesman said Tuesday.

    The list of illegal drugs approved for personal consumption by Mexico's Congress last week is enough to make one dizzy or worse.

    Cocaine. Heroin. LSD. Marijuana. PCP. Opium. Synthetic opiates. Mescaline. Peyote. Psilocybin mushrooms. Amphetamines. Methamphetamines.

I propose a trade.

Your workers for our junkies. That might put an end to all this immigration talk.

Posted by AlexC at 12:15 PM | Comments (2)
But jk thinks:

I had seen a small story on this, thanks for the link.

I have to applaud Mexico for this. This country has a lot more severe problems than personal drug use by its citizenry. I think that makes the US (puritans!) the only place in North America where one can be jailed for small amounts of marijuana.

I would not punish anyone for possession, but I would prosecute fiercely for legal infractions or driving while impaired.

A Samizdata commenter last year moved to Mexico (from the UK), calling it one of the last free places on earth. I ain't moving there, but it i8s emerging as a libertarian oasis of sorts. If they could just control corruption, we'd be swimming the Rio Grande southward.

Posted by: jk at May 3, 2006 3:25 PM
But johngalt thinks:

What do you mean "they?" Don't you know that "Republicans are controlled by a culture of corruption?"

Posted by: johngalt at May 4, 2006 2:38 PM

April 11, 2006

Don't Get Sick

Don't invest in Pharmaceutical stocks, don't go into research, and for NED's sake, don't come down with a chronic disease!

WSJ.com - Vioxx Jury Adds $9 Million To Damages Merck Must Pay

In an unexpected verdict, Merck & Co. will have to pay $9 million in punitive damages to a man who had a heart attack while taking Vioxx. The verdict came after a jury here concluded that the drug maker knowingly misled regulators about its troubled painkiller.
Last Wednesday, in the first phase of the trial, the jury awarded John McDarby, 77 years old, and his wife $4.5 million in compensatory damages for his heart attack, which the jury determined was caused by Vioxx. In this second phase, the jury was asked to determine what punitive damages, if any, Merck should pay Mr. McDarby.

Tysabri, a godsend to some advanced MS patients was pulled from clinical trials last year. The FDA has now given the green light, but nobody will protect the manufacturer from one of these ambulance chasers. A potential but rare side effect is a fatal brain infection -- that'll play well to the jury! Best to just let patients suffer.

I rail against the FDA as a murderous bureaucracy, but at least it exists under elected, executive branch authority. The tort bar is not elected -- I'm not talking about John Edwards. These people are effectively setting policy for trials and treatments.

The medications I take are decades old, but when I need something "stronger" or a new treatment, it is unlikely I will be given the chance, or that enough dollars will be invested in the sector to fund research. Screw the fund raising walks, we'd be better off marching on Washington for FDA rand tort reform.

Sorry if I'm grouchy. And I apologize to people who need COX-2 inhibitors for their quality of life but are not allowed to make their own decisions in the land of the free and the home of the brave.

Posted by John Kranz at 11:16 AM | Comments (3)
But johngalt thinks:

A contraire, mon ami. Your grouchiness is rational and well placed. The FDA is, as you contend, a murderous bureaucracy. They effectively kill individuals in the most advanced society on earth by forcibly denying them access to the most advanced pharmaceutical products. They do this in the name of "safety" but the safety they try to gerrymander is a collective safety. Why? Because, in the words of former FDA commissioner David Kessler, "To argue that people ought to be able to choose their own risks is to impose an unrealistic burden on people."

The next step is for government to ban skydiving, crossing the street, and joining the navy.

For more on this see Alex Epstein's essay at: http://www.aynrand.org/site/News2?page=NewsArticle&id=10859

Posted by: johngalt at April 11, 2006 3:19 PM
But mdmhvonpa thinks:

JK, you have come to a conclusion that folks like you and I are essentially doomed. No new vaccines, no new cures, just dumb-ass studies that tell us George Bush causes cancer in rats due to global warming. I'm going to start a class action suit against the UN, US, DuPont and all Auto Makers because they did not tell me about the hazards that chewing on my steering wheel. Then I'm going after the lawyers for failing to sue before I got sick. Then I'm going to sue myself (someone has already done this) for pain and suffering by getting sick.

Posted by: mdmhvonpa at April 11, 2006 3:50 PM
But jk thinks:

No. mdmhvonpa, I don't know what's worse, giving up or really believing that constant links on this site to WSJ Editorials will do any good, but I'm in the latter, delusional camp.

Three thousand innocent Americans were killed on Sept 11, 2001 and it "changed everything." Ten times that number could have been saved from colon cancer if not for the FDA's two year delay of Erbitux. Sam Waksal and Martha Stewart went to jail, imClone imPloded, and 30,000 innocent Americans died of colon cancer.

Sorry to anyone bothered by the comparison. In a way it is grossly unfair. But the numbers make one stop and think...

Posted by: jk at April 11, 2006 4:07 PM

March 14, 2006


New Scientist

    Long-term users of marijuana gradually become worse at learning and remembering things, a new study suggests.

    “It definitely fogs your brain,” says Lambros Messinis, who led the study at the University Hospital of Patras in Greece.

    Messinis and colleagues tested the mental abilities of 20 long-term users who had taken marijuana heavily – smoking at least four joints a week – for an average of 15 years. Their brains were rustier than those of 20 short-term users – who had averaged seven years of use – and 24 controls who had used the drug sporadically or not at all.

    Long-term users performed worse in tests to measure memory, learning ability and the capacity to recall information. Asked to recall lists of 15 words that they had seen earlier, for example, the long-term users averaged seven, compared with nine recalled by short-term users and 12 by controls.

Well, at least it wasn't American money being spent to study the obvious.

Posted by AlexC at 11:56 AM

March 6, 2006

Call John Edwards!

Senator Edwards proclaimed he was "gonna fight!" the drug companies. That topped the list of reasons I would not support his candidacy -- it's hard to think of a reason I would.

Sorry if I'm a broken record, but the impediments to medical research are sometimes beyond belief. The WSJ Ed Page brings two pieces of good news today. Erbitux is effective in treating cancerous head and neck tumors, as Dr. Waksel (I mean #8790-562) predicted it would in 2000 -- don't you wish you had snapped up Martha Stewart's ImClone stock?

In short, Erbitux is a perfect example of why it's important to get active drugs with reasonable safety profiles out before all the efficacy data is refined to the 10th decimal place, as the FDA always tries to insist. Such data are never going to be complete anyway. Think of all the new benefits that still keep being discovered for humble aspirin.

The second story is even closer to home. A promising Multiple Sclerosis treatment will be back on the market as well.
The second good-news story last week concerns Tysabri, the multiple sclerosis treatment that was voluntarily withdrawn last year (read: lawsuit panic) after three patients on the drug developed a rare neurological infection. This possible side effect wasn't entirely surprising, given that MS is a degenerative neurological disorder caused by immune system dysfunction and Tysabri works by depressing parts of the immune system. But it was also clear, as we editorialized at the time, that the patients in question had been treated with other immuno-suppressive drugs too, and that the risks of untreated or poorly treated MS probably outweighed the risks of taking Tysabri.

Looking at this from the dark side...neck cancer patients have lost six years of data on Erbitux's efficacy, and the trial lawyers have delayed a promising MS treatment by one year.

How many folks died? How many conditions got far more severe because this essential freedom has been stripped away by the Executive (FDA) and by unelected maggots (the Tort Bar). People who have serious medical conditions should be allowed to pursue any treatment if they know the risk. It is criminal to prevent that.

Posted by John Kranz at 8:44 PM | Comments (1)
But AlexC thinks:

John who? A Senator? Surely you jest.

Posted by: AlexC at March 7, 2006 12:14 AM

February 27, 2006

Socialized Medicine III

It has been a tough week for government run health care on ThreeSources. Today, Cafe Hayek reports on The Death of the Canadian Model

We pointed out things were bad at the NHS. Our neighbors to the north allowed the crack in the dam when its supreme court ruled that private medical purchases could not be outlawed. Freedom is now rushing in. The NYTimes reports:

The country's publicly financed health insurance system — frequently described as the third rail of its political system and a core value of its national identity — is gradually breaking down. Private clinics are opening around the country by an estimated one a week, and private insurance companies are about to find a gold mine.

I flog this deceased equine because many people still want to bring this model here.

Posted by John Kranz at 1:08 PM

February 26, 2006

Socialized Medicine II

A couple days ago JK made a post comparing the survival rates of cancer patients between socialized medicine nations and the United States.

Unsurprisingly, Americans have a higher survival rate.

I commented somewhat sarcastically...

    Yet another unsurprising factoid from the ills of socialized medicine.
    I can't wait until euthanasia becomes prescribed by the health systems of those countries.
    It's the most cost-effective, after all.
    Then we're one step closer to Logan's Run. ;)

Well, here's a case, where I'd rather be wrong.

    The parents of Charlotte Wyatt have been told that doctors are to be allowed to let their profoundly ill baby daughter die if they feel it is in her best interests.

    A High Court judge yesterday lifted a previous ruling that she should always be resuscitated, on the grounds that the two-year-old was now on a "downward rather than an upward trend".

    Mr Justice Hedley heard an emergency application from doctors treating her that she had developed an aggressive chest infection and was unlikely to survive any moves to keep her alive.

    "Medical evidence speaks with one voice, that ventilation simply will not achieve the end for which no doubt the parents would wish," he said.

It's not quite a prescription for death by bureaocracy.... but it's awfully close.

Posted by AlexC at 12:46 PM | Comments (1)
But jk thinks:

Very sad. The mother believes "that if her daughter were ventilated she would recover," but the UK's NHS doesn't think her chances are worth the investmnet.

It amazes me how many people think it's okay to give government control over life and death.

Posted by: jk at February 26, 2006 2:08 PM

February 23, 2006

Socialized Medicine

In The Big Idea, AlexC asks what the Left stands for. If we had more progressives running around here (for better or worse), I've no doubt we would hear something about healthcare and some very large number n of uninsured Americans. If they have an idea, it includes greater government involvement in health care

They have an idea, and it's bad -- check out these statistics from a WSJ ed, Cancer Prognosis (paid again, sorry!) about how Cancer rates are dropping in the US.

Both are the result of medical innovation funded by government, private donations, and profit-making bio-medical and pharmaceutical companies. Colonoscopies, mammograms and other tests are more widely publicized and utilized. And new drug therapies, less punishing and invasive than surgery or chemotherapy, have been developed thanks to the incentives of a private medical marketplace.

This is in marked contrast to the anti-cancer record of government-run health systems elsewhere in the world. As Michael Tanner, health-care expert at the Cato Institute, notes: "Because cancer is a slow moving and expensive disease to treat, it is not cost-effective under socialized medicine to treat the disease too aggressively. This saves governments money but at a high human cost."

The statistics bear out Mr. Tanner's point. Only about one in five men with prostate cancer in the U.S. will die from it. But, according to a study by the Commonwealth Fund, about 57% of British men, and nearly half of French and German men, will do so. In Britain only 40% of cancer patients are even permitted to see an oncologist to treat the disease. Two-thirds of Canadian provinces report sending their colon cancer patients to the U.S. for treatment. Government-run medical systems can be as cruel to cancer patients as the cancer itself.

Twenty percent vs. 57%? Yeah, let's bring that great idea to this country!

Posted by John Kranz at 5:11 PM | Comments (1)
But AlexC thinks:

Yet another unsurprising factoid from the ills of socialized medicine.

I can't wait until euthanasia becomes prescribed by the health systems of those countries.

It's the most cost-effective, after all.

Then we're one step closer to Logan's Run. ;)

Posted by: AlexC at February 23, 2006 7:29 PM

February 21, 2006

Free Market Health Care

Not as fun as a hunting accident, but the President's health care ideas are getting high marks. The WSJ says (paid site, sorry!):

Washington denizens who say the Bush Administration is out of domestic ideas haven't been paying attention. The more we look at the fine print in the health-care reforms President Bush is now stumping for, the more we see the potential for the most sweeping and beneficial changes in half a century.

One way to think about the Bush reforms is as HillaryCare in reverse. The former first lady sought to mandate employer-based coverage and then hold down costs by brute government force ("managed care"). Mr. Bush is instead attempting to revitalize the private market for individual health insurance, so employees are ultimately less dependent on their bosses' coverage and can ultimately buy the kind of insurance that makes better sense for them. Along the way, Americans would also become wiser consumers of health-care services.

When you start to think that the Democrats and Republicans are all alike -- which they too often are -- contrast command-and-control-HillartyCare to Hayekian-free-market-HSAs and walk proudly, Republicans!

Posted by John Kranz at 9:27 AM

January 26, 2006

Not Just for SPAM anymore

Virginia Postrel and I know Bayesian filters for their implementations in SPAM avoidance. She links to an article that discusses its promise in clinical trials.

Not many ideas of 18th-century Presbyterian ministers attract the interest of the pharmaceutical industry. But the works of Rev. Thomas Bayes have improved greatly with age. The paper that made his name was published in 1763 (two years after his death), where he proposed a method to decide the likelihood of an event while taking into account one's prior knowledge of what might occur. This idea bounced around through the mathematical literature for the next century or two, but it fell out of favor in the 1930s with the advent of the statistical methods that have been used ever since. For decades, no one heard very much about Bayesian statistics at all. One reason for this was they're much more computationally demanding, which was a real handicap until fairly recently.

I'm a math guy but not a stats guy ay all. I will try to find some rudimentary documentation on this as it has really caught my eye. The current methods in trials are broken, and cannot keep up with subtle interactions. Placebo trials are flat out irresponsible in chronic or terminal illnesses, yet the FDA still demand them.

Hat-tip: Dont call her Ginny

Posted by John Kranz at 3:27 PM

January 4, 2006

Privatize the FDA

I think new media may be the answer to the FDA. I don't know whether overblown rhetoric will help or hurt but I contend that they kill a lot more people than hurricanes, wildfires and mudslides put together.

Instapundit links to "Fckng Ralph Nader, fckng Public Citizen" on the Making Light Blog. How's this for a Christmas Present from Ralph Nader and the FDA:

Cylert (generic name pemoline) has been the most effective treatment for Teresas narcolepsy in 24 years since she was first diagnosed. Shes been taking it for most of that time. Now its gone.

We discovered this when we tried to refill her standard prescription, just before Christmas, and the pharmacy didnt have anyand, after some confusion, reported back that the wholesaler didnt have any either, because (surprise!) its no longer being made.

Cylert has been implicated in some peoples liver problems. Teresa is regularly tested and her liver is fine. Evidently Abbott, makers of brand-name Cylert, discontinued it in Marchbut Sandoz intended to keep making the generic version, until the FDA, pressured by Naders group, weighed in to discontinue it entirelydespite a last-minute appeal from the Narcolepsy Network. Thank you, Public Citizen, for completely shafting my wife.

I am stunned to read about people traveling to the Pacific Rim to get procedures not allowed here. Take a minute and read some of the comments (there are a lot!). This seems common on this site and some of the MS blogs I get on.

Abolish the FDA. Privatization is the best option. Hands off our bodies! How's that for a motto?

UPDATE: I should have mentioned that I hijacked the discussion from blaming Mr. Nader to blaming the FDA. The delightfully subtitled "Armed and Dangerous" blog challenges her on this exact point.

Teresa, even as I feel your pain, Im wondering if youre going to learn the right lesson. The Cylert ban isnt an accidental failure of the system, its an essential one. It wasnt perpetrated by villains, but by well-intentioned people working the levers of a system designed to elevate public safety above individual choice. That system functioned as designed; its the design thats broken.

Posted by John Kranz at 11:13 AM | Comments (1)
But johngalt thinks:

Government types just don't think the same way as normal people, JK. To them, failure of government is NEVER cause for privatization, merely more "reform." The greater the failure, the more "reform" they'll reach for (at a million dollars of OPM per unit.)

Posted by: johngalt at January 4, 2006 3:20 PM

December 23, 2005

Good News for Kianna

The WSJ Ed Page reports progress in the FDA:

Cancer victims got some holiday cheer Tuesday when the Food and Drug Administration approved Bayer's Nexavar for the treatment of advanced kidney cancer. Nexavar is the first new treatment for this particularly deadly cancer to be approved in more than a decade. And it's an easily administered pill that produces minimal side effects compared with chemotherapy.

Nexavar also happens to be one of the two promising developmental drugs we highlighted earlier this year in editorials on the plight of Kianna Karnes, who died in March, unable to obtain either of them for treatment. Tuesday's approval by no means makes full amends for that scandal. But it does show that the FDA is finally taking seriously complaints about tardiness, and at least acknowledging the ethical issues involved in giving people placebos (i.e., sugar pills) when testing drugs for terminal disease.

On the rapidity front, the important news is that the Nexavar approval was granted based on a new way of measuring the effectiveness of cancer therapies. Until now, believe it or not, the FDA's cancer division has usually focused on crude mortality statistics when approving new drugs and scoffed at other possible metrics such as tumor shrinkage and improved quality of life. But in conjunction with the American Society of Clinical Oncologists, the FDA has recently decided to recognize "progression-free survival" -- no tumor growth or metastasis, and no death -- as a sufficient clinical benefit.

To put it plainly, the FDA is no longer insisting that we wait around for people to die to get statistics when a drug is obviously working. This should enable faster approval of other drugs in the future. Nexavar, by the way, doubles the length of progression-free survival in advanced kidney cancer.

I blogged about Kianna's Law last March, and Senator Brownback from Kansas is still pursuing it. Miles to go, but much good news for the season.


Posted by John Kranz at 1:12 PM

October 20, 2005

If Cut Do I Not Bleed?

I know I look foolish defending Goliath drug companies, but it is insane to think that their investors can take continual abuse. The abuse comes from lawsuits, regulation, bureaucratic approval processes, political admonishments, threats to absolve property (patent) rights, and knowledge that they are the target for the next Michael Moore movie (I can hardly wait).

I'd like them working on more amazing wonder drugs (you know, an MS cure wouldn't be so bad).

But Merck is under incredible lawsuit pressure and Pfizer gives weak guidance today:

Pfizer Inc. reported a 52% drop in third-quarter profit amid slowing sales and cut its full-year earnings forecast.

The New York-based drug giant also pulled its outlooks for 2006 and 2007, citing lower prescription growth and increased competition in key markets. The company said those factors will "temper" fourth-quarter sales.
The pharmaceutical company noted an "unexpectedly rapid slowdown" in new cholesterol-drug prescriptions written in the U.S., as well as the loss of patent protection for certain major drugs.

Its shares were down $1.50, or 6%, to $22.47 in early trading on the New York Stock Exchange.

I'm sure John Edwards and Michael Moore are happy. Everyone who might know somebody who might get sick someday should be a little down.

Posted by John Kranz at 11:56 AM

September 20, 2005

Go Big Pharma!

I haven't linked to Andrew Sullivan in many moons. To be honest, I stopped reading him after the elections in '04. He really has descended into Daily Kos territory, throwing away all of his conservative principles because he disagrees with the President on gay marriage. Sad to lose a great writer, but I couldn't possibly take any more.

One thing we do agree on, is the life giving and enhancing work of the drug companies and astonishmentat the antipathy they engender (maybe I'll get a "Poseur award" for that last sentence). Happily, Sully has been helped by new HIV drugs:

BACK FROM THE DOC: Just an HIV update. I've been on the new meds for a couple of months now and after a week or so of torpor, have no side-effects that I can speak of. My viral load - i.e. the amount of virus in my bloodstream - went from 141,000 particles per cubic mililiter of blood in late May to 1500 after ten days on June 2 and has now come down to a grand total of 121. Still not good enough. We're hoping for under 50 at the next count. My CD4 cell count - a sign of the strength of your immune system - has gone back into its normal range. Thank God for the evil pharmaceutical companies. One day, when the history of this period is written, I have a feeling we will look back with astonishment as we recognize that advances in medical science, particularly pharmaceuticals, were arguably one of the most significant developments of this era. And yet the people who pioneered these breakthroughs were ... demonized and attacked. Baffling and bizarre. I'm merely grateful the attacks haven't stopped the research progress. They've merely slowed it.

The problem, brother 'drew, is that you don't know how much they have been slowed by the lack of capital. Would you invest in a firm that a VP candidate "swears he is going to fight" A sector that the tot bar has its eyes on?

The P/E multiple in this sector is waaaay lower than it should be. With more money, they could discover more amazing drugs.

Hat-tip: Instapundit.

Posted by John Kranz at 3:38 PM | Comments (2)
But Silence Dogood thinks:

I wonder if Big Pharma's marketing isn't working against it. The endless TV commercials - "ask your doctor about..." I don't even know what half of these maladies are except that they can keep you from running through a field of flowers with your dog and a beautiful woman. (Do those come with the prescription or does the drug attract them?) My family practice office even has a room set up specifically for the pharma reps, last time I was there I saw 3 reps come through in 30 minutes. These are the folks taking the docs out for dinner and golf and spreading product imprinted tissue boxes, magazine holders and prescription pads around. I had to laugh when the 3rd rep had to move a product imprinted Kleenex box over on the table to fit hers in when that competing one had been placed there not 5 minutes before. This is what consumers see before being hit with the $5 per pill price. Hey, I have been in and out of product development for almost 20 years so I am usually the first to stand up and defend the cost of drugs based on what it costs to research and develop them, but those huge sales forces with their endless perks and prime time TV spots don't come cheap either. Not that they shouldn't be allowed to advertise their products and I am sure they do get people to "ask their doctor about.." but I wonder if it doesn't tarnish their image.

Posted by: Silence Dogood at September 21, 2005 4:43 PM
But jk thinks:

I have heard a LOT of criticism about pharmaceutical marketing. I am of a different mind here.

I see it as empowered medical consumers. Did you know there was a pill to kill toenail fungus? Are there not people who have tried to control cholesterol through diet but have failed and might need medication?

For me, it is part of a grand movement from the experts in government, medicine, and academia, to the people. You bet I am tired of Cialis commercials, but I think it is a step in a free market, Hayekian distributed knowledge medical environment.

Posted by: jk at September 22, 2005 11:29 AM

August 22, 2005

The Vioxx Verdict, II

When I calmly think a situation over and refrain from making a rash decision, as I did in my first posting on the $229 Million Texas Vioxx Verdict, I reserve the right to change my mind.

Like Trivial Pursuit, sometimes your first answer is the best. And my first answer is that Merck in no way deserves this company-threatening decision. Two columns in today's Wall Street Journal have put me back on-track.

Both detail facts I did not know when I let the silver tongued lawyer calm me and Larry Kudlow on CNBC's "Kudlow & Company." Although some data exist showing accelerated heart risk, there is actually little chance and no evidence that Vioxx contributed to this death at all. The widow's husband had 70% blockage of his arteries, did not suffer a heart-attack according to the death certificate, and had only taken Vioxx for eight months (elevated risk usually shows up after 18).

First is a Wall Street Journal editorial that questions Merck's viability "if you multiply the number of suits by only the $25 million in economic losses imposed by the Texas jury you have a company that could soon be turning over most or all of its earnings to the trial bar."

The verdict is also more bad news for the millions of Americans who suffer from the kind of chronic pain for which stomach-friendly Cox-2 inhibitors like Vioxx provide welcome relief. Before Vioxx, Celebrex and other Cox-2 inhibitors, patients relied on pain medications like aspirin and ibuprofen, which are harder for some to tolerate. There are 15,000-plus deaths a year from gastrointestinal bleeding in people who develop full-blown stomach ulcers on this older class of drugs.

The cardiovascular risk that led Merck to withdraw Vioxx appears only in patients who have taken the drug for more than 18 months. The husband of the plaintiff only took it for eight. Merck had kept the Food and Drug Administration fully aware of its clinical results showing the relatively small heart-attack risks.

Like all drugs, Vioxx has risks and side-effects but was hardly an "unsafe" drug. Earlier this year, an FDA advisory panel recommended that the drug go back on the market, with appropriate re-labeling. But after Friday, and given the brutal vagaries of the American tort system, the question is less about Vioxx's survival than Merck's.

The second is a guest editorial by Richard Epstein, Ambush in Angleton, which questions the size of the award and the effect on the whole pharmaceutical sector.
Forget the jury's whopping quarter-billion-dollar verdict in Ernst v. Merck, because it's cut 90% by the caps that Texas law places on punitive damages. Still, where do $25 million in actual damages come from? Robert Ernst died in his sleep, without pain and without medical bills. His lost income as a Wal-Mart employee was small. But the $24 million price tag for anguish and loss of companionship to his widow Carol is off the charts.

It seems the doctors were arrogant and the jurors wanted to send a message.
So, in return, I would like to send my message to Mr. Lanier and those indignant jurors. It's not from an irate tort professor, but from a scared citizen who is steamed that those "good people" have imperiled his own health and that of his family and friends. None of you have ever done a single blessed thing to help relieve anybody's pain and suffering. Just do the math to grasp the harm that you've done.
Ah, you will say, but we're only after Vioxx, and not those good drugs. Sorry, the investment community won't take you at your word. It realizes that any new drug which treats common chronic conditions can generate the same ruinous financial losses as Vioxx, because the flimsy evidence on causation and malice you cobbled together in the Ernst case can be ginned up in any other. Clever lawyers like Mr. Lanier will be able to ambush enough large corporations in small, dusty towns where they will stand the same chance of survival that Custer had at Little Big Horn. Investors can multiply: They won't bet hundreds of millions of dollars in new therapies on the off-chance of being proved wrong. They know they'll go broke if they win 90% of the time.

Mr. Epstein contends that "Much as I disapprove of how the FDA does business, we must enact this hard-edged no-nonsense legal rule: no drug that makes it through the FDA gauntlet can be attacked for bad warnings or deficient design."

Its hard to pick a villain between the tort bar and the FDA. I would not choose to further empower the Government as an absolute arbiter of safety and efficacy, because I wish to reduce the FDAs role. But we have to do something. I need new drugs today, we will all need them, someday.

Posted by John Kranz at 4:31 PM | Comments (2)
But johngalt thinks:

The problem here is that the current system is not a compromise between these two villains, but the WORST of both! If drug companies are not protected from predatory lawyers by the FDA seal of approval, what good is it? If companies submit to the FDA's labyrinthian trial and approval process, intended to uncover every possible flaw in the drug or its application, how can they be judged "incompetent" or "negligent" thereafter?

Government's ox is not gored, nor is the trial bar's, but the businessman - he gets the royal treatment. Why? Because, just like Dillinger said about banks... "That's where the money is!"

Posted by: johngalt at August 25, 2005 4:05 PM
But jk thinks:

Agreed. BUT if we make the FDA responsible for protection from redress, than they will want to be more cautious, which will fit their bureaucratic desires as well.

Tempting to say "make it good for something," but I fear it's counter-productive.

Posted by: jk at August 25, 2005 4:35 PM

August 19, 2005

The Vioxx Verdict

Sounds like a Ludlum book...

I went to write a knee-jerk, pro-Merck, "are you joking?" post about the award of more than a quarter billion dollars to the widow of a 59-year old Wal*Mart manager.

I own the high horse of "chasing capital out of the pharmaceutical sector," and my Multiple Sclerosis gives me what Maureen Dowd would call "absolute moral authority."

But I counted to ten and watched Larry Kudlow's show, and I am having second thoughts. The widow's attorneys were on and made a compelling case to Larry, who is at least as tough on tort reform and crazy awards as I am. One said that the juries were conservative, many Republican; most favored tort reform and the forewoman said during jury selection that she thought Merck was a great company.

The guy watches Kudlow & Co., and said "Larry, that's how strong the evidence was -- you'd've voted for this settlement."

Kudlow was surprised and so was I. Color me suspicious still, but perhaps there is real evidence of malfeasance, in which case I will not blindly back the corporation.

Hinderacker at Power Line notes that the settlement will get a serious haircut in the appellate process, which is good. The amount was outrageous.

The problem is that this was the first of several thousand Vioxx cases to go to trial. It isn't feasible to try them all, so the first few verdicts will tend to set the ground rules for future settlements. Even though the plaintiff will never collect the bulk of this particular verdict, it likely will cost Merck more than $250 million in the years to come. The company's stock lost more than $5 billion in value today.

No word on whether John Hinderacker saw Kudlow & Co. today.

UPDATE: I have had a change of heart.

Posted by John Kranz at 8:16 PM

August 18, 2005

Canadian Health Care

Captain Ed looks at health care from the North and comes to the same conclusion as Silence and I did this week.

The Captain complains that "While Americans tend to think of the Canadian health-care system as a model of nationalized medicine, many Canadians have to travel to the US in order to get timely treatment. " I fear he is right, many Americans do think highly of the Canadian system. I will have to continue blogging until that notion is disabused!

What Canadians have discovered is that government-rationed health care provides slow and limited options for patients, just like everywhere else it has been tried. The American healthcare system, in comparison, uses the market to ration care and results in much more responsive providers. It also provides higher degrees of innovation and gives doctors incentives to specialize. In Britain, for example, hospitals discarded viable transplantable organs due to a lack of trained physicians to perform the operations -- a shortage caused by the lack of compensation for transplant surgeons despite the increased cost of certification for the procedure.

Market-based rationing may have its flaws, especially in a litigation-heavy arena like health care. However, those rarely get solved by government-based rationing, which not only make the same flaws worse but compound them with a raft of other destructive practices. The CMA should be congratulated for starting to comprehend this pattern. Their patients have already made their diagnosis.

Posted by John Kranz at 6:20 PM

August 16, 2005

Free Market Health Care

Just got back from the new Boulder Community Foothills Hospital, where I had some MRIs done on their new "open" MRI machine. A couple of observations on health care and health care finance seem germane.

1) Supremacy of US Health Care.
There is much anecdotal evidence to the superiority of out health care system. One of the quantitative facts I look to is the availability of MRI imaging equipment and the public access to it. MRIs are important diagnostic tools, yet they are expensive to purchase and operate. Socialized systems such as Canada and the UK have to severely restrict access to the few machines they have available. In Canada, there is a $1000 fine for veterinary hospitals which use Phideaux's machine to view a tumor on Phideaux's owner. (The latest Canadian Supreme court ruling allowing private medicine might alleviate this.)

I called to schedule my MRI last Wednesday, and was given a choice of three machines, from one hospital network. There are certainly more available from the other hospital chains. But BCH has one in its main hospital, one in Lafayette where I live, and the new open machine in the new hospital. I opted for the open. My waiting time -- non-emergency -- was five days.

2) Role of the free market in health care.
Our hybrid private-public-insurance fiasco of a financing system is indeed weak. But the cure is more private funding, not more socialism: more distributed market forces and less centralization.

As proof I offer the new hospital. It's primary function is childbirth. Expectant parents, like patients for vision corrective surgery, have a choice of facilities. Insurance may pay but there is a whiff of choice. The result of this is that new hospitals are spring up and they are designed to close the sale.

The new hospital was described to me by a friend "It's like the Marriott!" Seeing it this morning, I will say it is like a brand new Marriott in a high-rent location. Virginia Postrel call your office! The waiting areas are very Marriott-esque, with four soft chairs around a small table. This morning's New York Times, Boulder Daily Camera and a few Wall Street Journals are available.

Coming out, the nurse told me to drink lots of liquids to flush the dye out of my veins. So I got a cappuccino. The barista asked me in a European accent, "Do you want a real cappuccino, or do you want it wet?" "Real, please; I like mine dry."

The other area that has seen market forces is vision-correction. Insurance plans will generally not cover this, so people shop. People shop and the prices have plummeted; people shop and the systems have improved; people shop and the warranties have been extended.

Health Savings Accounts would throw a lot of market forces at health care. We could serve the indigent with subsidies to shut up some of the lefty chorus, but real market forces are the solution to our problems.

Posted by John Kranz at 1:09 PM | Comments (2)
But Silence Dogood thinks:

I agree JK. (Hey, I have to chime in and agree sometimes too!) I don't think that Canada's( or Sweden's) medical care is better or cheaper really than ours. At the end of the day medical care is expensive and socialized systems end up having to effectively ration it to pay for everyone. There is probably a valid argument that basic care is more available in a socialized system and some savings does result from catching maladies early when treatment is less expensive and shorter rather than have an uninsured group that must wait till they need to avail themselves of emergency care. On the flip side however is that beyond basic care are many diagnostics such as MRI's that have to be rationed due to cost. I believe the real savings in a socialized system is reduced paperwork via the single payer system. I really see no reason why the overhead part of medicine could not be made more efficient even in a multi-payer system, in fact competition in this arena might take you even further. Part of this problem is insurance companies who seem to count on getting out of honoring claims by tying them up in paperwork. It almost seems as if this is part of the business plan. Again, choice is the answer, if I had a choice of group coverage plans and had trouble with company "A" then I could switch to company "B" or "C" until I was satisfied. Enough people doing this and the system would change to be more attractive to consumers, much like the new Boulder hospital.

Posted by: Silence Dogood at August 18, 2005 3:24 PM
But jk thinks:

I remember at lunch once your suggesting that a universal form and transfer capacity among the different insurance carriers would save buckets of time and money.

Just having dealt with so much of this, I wonder -- can we write it and sell it to the providers. Perhaps the insurance folks really do see themselves' benefiting from tie-ups (I doubt it but have no proof). The Hospitals and care providers, however, have every incentive to pursue efficiency.

Posted by: jk at August 18, 2005 4:00 PM

July 22, 2005

Pot Theft

From 6ABC

    Donald Nord won't be getting his pot back. Federal agents seized his stash and took some pipes, too.

    The Hayden, Colorado, man has a state-issued medical-use permit for his weed. No federal charges were filed against Nord, so he asked a county court to order the pot's return.

    The Drug Enforcement Administration agents refused and Nord sought a contempt citation. Now, a federal judge has ruled a local court doesn't have the power to hold the D-E-A agents in contempt.

If the feds have a law prohibiting marijuana, then they should charge him. If they haven't charged him, what right to they have to retain his property?

This guy's getting screwed.

Posted by AlexC at 4:00 PM | Comments (2)
But jk thinks:


Who cares about Roe? I want to see Judge Roberts's stand on Raich.

Posted by: jk at July 22, 2005 4:55 PM
But johngalt thinks:

I heard that Roberts holds a narrow view on the Interstate Commerce Clause and Affirmative Action.

Posted by: johngalt at July 24, 2005 12:12 PM

July 6, 2005

So, Ten Percent Can Die

I blogged in May that the FDA was considering pulling a Cancer drug because only ten percent benefit from it.

Well politics and personal ambition has prevailed over the minutia of saving lives, and the FDA has decided to re-label Iressa, preventing its use for new patients outside of clinical trials. Even though a gene test can now determine the exact 10% who can be helped by the drug. It seems that a company made a bureaucrat mad, so thousands of Cancer patients will have to die. The WSJ Ed Page comments:

What has changed is the politics. For starters, Dr. Pazdur no longer labors under the reform-minded former FDA Commissioner Mark McClellan. Dr. Pazdur has also since stacked ODAC with people who share his anti-industry views. Most importantly, the unrelated panic over painkiller safety last fall has created the political cover for Dr. Pazdur to punish AstraZeneca for disobeying his wishes.

Some readers may find it hard to believe that life and death decisions about drug approvals and withdrawals would be made for political reasons. So it's worth pointing out that Dr. Pazdur has admitted doing so before. In 2002, the FDA rejected Erbitux, with Dr. Pazdur admitting it was a "good drug" but that it had a "bad development plan." Erbitux later became a clinical success against colon cancer.

But later that same year when the FDA approved a colon cancer chemotherapy called Eloxatin, Dr. Pazdur approvingly remarked "we want to send a message" about "the value in doing randomized trials." In other words, the less revolutionary drug (Eloxatin) got approved first because its makers had jumped through the right bureaucratic hoops.

The Iressa move is Dr. Pazdur's way of sending another "message" about the necessity of doing things his way. It isn't so much a withdrawal as a relabeling of the product. Patients currently on the drug will be able to continue with it. But come September no new patients will be able to start on it outside FDA-approved clinical trials. In other words, the option to use Iressa freely as a front-line cancer treatment will disappear.

That prospect doesn't sit well with patients like Sandy Britt, who believes Iressa saved her life after she was diagnosed with metastatic, stage 4 lung cancer late last year. "The first doctor gave me a death sentence," the 46-year Alameda, California, resident tells us. "She wasn't even going to treat me." But another doctor administered a genetic test that indicated she would be one of the 10% who respond to Iressa. "I've had an amazing response to it. They predicted I'd be dead now. Instead, I just got back from three weeks in Italy." As for Dr. Pazdur's decision, Ms. Britt asks a common-sense question: "This is a drug that works amazingly well for some people, so why take it off the market?"
Dr. Pazdur and his allies like to suggest that accelerated-approval advocates risk throwing science out the window. But in truth, there's no scientific reason to believe that large placebo-controlled trials -- in which treatments are tested against nothing, i.e., the proverbial sugar pill -- should be considered the "gold standard," as Dr. Pazdur believes. Withholding treatment is unethical in terminal diseases, and we have enough historical data about how cancer patients fare to judge new treatments without the need for placebo control groups.

This was the philosophy that the practicing doctors of ODAC implicitly endorsed when they approved Iressa; it was the philosophy promoted by former Commissioner McClellan; and it is the philosophy that Dr. Pazdur and his fellow FDA bureaucrats are challenging by pulling Iressa now that there is a politically opportune moment for them to do so. Never since the creation of the accelerated approval process in 1992 have the regulatory barriers to cancer research looked so oppressive.

Your tax dollars at work, folks. I am going to posit that the FDA has killed quite a few more people this decade than have the Army, Navy, Air Force and Marines.

Posted by John Kranz at 11:57 AM

June 10, 2005

Liberals & the Drug War

Dan Henninger provides yet another insightful Wonder Land column today. Writing on Raich, he offers this brief summation:

Liberalism to cancer patients: Drop dead.

Henninger suggests that the liberal wing of SCOTUS can be blamed for this (this would hold more weight had Scalia not voted with the majority).

Again, it's a good article and I enjoy seeing the Deputy Editor of my favorite Ed Page show a little softness on the War on Drugs -- it is about the only issue on which I typically disagree with them.

But his conclusion disturbs me. Yes, it will be illegal, but it won't be enforced.

Studies of physician fear of prosecution have been done, which conclude that prosecutions of honest doctors prescribing such pain-killers are rare.
Once-in-a-lifetime users of medical marijuana are also collateral damage in the war on drugs. Writing for the majority, Justice Stevens said, with approval: "Congress was particularly concerned [in 1970] with the need to prevent the diversion of drugs from legitimate to illicit channels." Some argue, including proponents of drug legalization, that a Supreme Court imprimatur for medical marijuana would have no relevance to campaigns to legalize recreational use of this and other drugs. I don't believe that. There isn't much self-restraint in our activist politics.

What now? My guess is 99.99% of medical marijuana users won't get prosecuted. Society's disapproval of marijuana stays in place, but patients get their drug. Live and let live. Benevolent hypocrisy comes in handy in a free country when public politics, as now, often makes sensible solutions impossible.

Frederic Bastiat said that just law had to be understandable and avoidable to prevent capricious enforcement. That is exactly what we will have. Prosecutors can move on cancer patients for all the wrong reasons, and laws will not be fixed because most patients slip through.

I think I might make a ThreeSources.com T-Shirt that says "The Last Federalist." I'll send an XL to Justice Thomas.

Posted by John Kranz at 12:19 PM

June 8, 2005

A Break Is Given!

My favorite TeeVee news personality is on my favorite soapbox.

John Stossel blasts the FDA in a second column in two weeks, hitting a personal favorite, private competition to the FDA

Why must we give big government so much power? Couldn't FDA scrutiny be voluntary and advisory? Companies that want government blessing would go through the whole process and, after 10 or 15 years, get the FDA's seal of approval. Those of us who are cautious would take only FDA-approved drugs.

But if you had a terminal illness, you could try something that might save your life. You could try it without having to wait 15 years without having to break your country's laws to import it illegally from Europe without sneaking into Mexico to experiment in some dubious clinic. If I'm dying, shouldn't my government allow me the right to try whatever I want?

If FDA scrutiny were voluntary, the government agency would soon have competition. Private groups like Consumer Reports and Underwriters Laboratories (UL) might step in to compete with the FDA. The UL symbol is already on thousands of products. No government force was required. Yet even though UL certification is voluntary, its safety standards are so commonly accepted that most stores won't carry products without the UL symbol.

With such competition, the FDA might devise a ratings system ("general use," "medical guidance suggested," "patients strongly cautioned," or something like that), and drug packages would carry that information. We'd know that the government was evaluating new drugs, but government wouldn't stand between lifesaving treatments and us. Most of us, most of the time, would take the government's advice, but because it would be our choice, we could try new or risky drugs when nothing government-approved was available.

I had suggested privatization before, but I like the idea of a voluntary FDA. As long as they are no longer empowered to remove compounds from the market, I'd even fund them.

ADDITIONAL NOTE: Stossel's book is very good. It's a ot more accessible than Hayek or Mises, yet it gives a pretty good overview of most of my basic beliefs. Billy-Jo-JK-Bob gives it Five stars!

Posted by John Kranz at 11:46 AM | Comments (1)
But johngalt thinks:

Go John go. But, a clarification: UL certification IS voluntary, but many products are effectively unmarketable without the "voluntary" seal of approval. National Building Codes, for example, prohibit the use of any electrical device or component that lacks the UL mark. Consequently, the customer service from this private organization declined while its prices rose. Enter - competition. ETL is a welcome alternative that will force UL to improve or perish. http://www.intertek-etlsemko.com/portal/page?_pageid=34,86852&_dad=cust_portal&_schema=CUST_PORTAL

Posted by: johngalt at June 8, 2005 3:11 PM

June 6, 2005

Justice Thomas

Senator Reid may find him lacking, but Radley Balko says "He's easily the most principled and consistent defender of federalism on the court."

Sadly, that's becoming a lower bar all the time. Balko quotes his dissent on TheAgitator.com:

If Congress can regulate this under the Commerce Clause, then it can regulate virtually anything--and the Federal Government is no longer one of limited and enumerated powers.
Certainly no evidence from the founding suggests that "commerce" included the mere possession of a good or some purely personal activity that did not involve trade or exchange for value. In the early days of the Republic, it would have been unthinkable that Congress could prohibit the local cultivation, possession, and consumption of marijuana.

Props to O'Connor for dissenting -- and what's up with Nino?
Congress may regulate even noneconomic local activity if that regulation is a necessary part of a more general regulation of interstate commerce . . .The relevant question is simply whether the means chosen are "reasonably adapted" to the attainment of a legitimate end under the commerce power.

Hat-tip: AlexC's buddy, Instapundit, who sez "The 9th Circuit asked the Supreme Court how serious it was about enumerated powers, and the answer, apparently was not so much. "

Posted by John Kranz at 3:51 PM

May 19, 2005

Only Ten Percent?

The WSJ Ed Page is on my favorite soapbox again today: The FDA vs. Cancer Patients. The piece ends with "Who would have thought that, five years into a Republican Administration, the FDA would be staffed by people who regard industry as an adversary, not a partner, in the anti-cancer fight."

It seems that the gains made by Dr. McClellan that I supported are being undone by anti-business bureaucrats.

The next thing to watch for is the fate of AstraZeneca's lung-cancer drug Iressa, which Dr. Pazdur is signaling he may actually pull from the market as one of those "low efficacy" drugs. True, Iressa helps only about 10% of patients. But those who respond to it respond massively. "I've had patients who have gone from being on oxygen to skiing at altitude," says one doctor of the drug. Genetic tests are being developed to better predict who will respond to Iressa. Yet Dr. Pazdur seems to regard the FDA's Iressa approval in 2003 as an instance of the drug industry getting away with one. Incredible.
Imagine that -- it only helps 10% of cancer patients and our government still allows it to be sold!

Maybe I am too close to this. I know there's a war on and I know we have justices to confirm. But how long can we allow our government to kill innocent citizens and chase capital out of the pharmaceutical sector?

Posted by John Kranz at 1:22 PM

May 13, 2005

Comparative Advantage

I love TechCentralStation.com. You get an adult daily dose of economics, market news, and junk-science-debunking from a libertarian perspective.

The last couple of days have included a few good health care pieces. One discusses European drug manufacturers' choice to focus on generics. This will help them with the bottom line in price-controlled, socialist markets. But this will not provide capital for R&D, so we should not look to the EU nations for any more medical innovation.

Another discusses "Activist Medicine." Unlike Activist judges, activist medicine is not necessarily a pejorative, just a reference to using all resources to diagnose and treat every illness. My wife's life was saved six weeks ago by activist medicine but I still see Kling's point: Can we afford to throw everything at every case?

But the one that gets excerpted is A Passage to Indian Health Care which describes the advantages of traveling to India for inexpensive, high quality health care.

Medical tourism to India started fairly recently when NRIs (non-resident Indians -- those living and working in the West) began to go "home" to India seeking not just their roots, but root canals. They returned with killer smiles and tales of the staggering savings in costs -- even factoring in airfares -- and excellence of treatment. NRIs, aware from their families of India's state-of-the-art technology and the level of surgical skill, also head off "home" for more critical treatment, like kidney transplants, hip replacements and open heart surgery. Indeed, India's 20 million diaspora returning to the US and Britain after successful treatment are India's best ambassadors.

Britons plagued by their socialist and inefficient National Health Service waiting lists (people diagnosed with cancer or degenerative heart disease can wait for an operation for a year or even more) and Americans who didn't keep up their health insurance after retiring -- or never had any -- are now choosing their hospitals and surgeons on the internet and booking their flights to India. And to make it even easier, there are medical tourism companies in India who will take care of all these details for them.

Now, some enterprising hospitals offer greet-and-treat services with an all-inclusive health-tourist package, including the desired medical procedure, hotel, air travel, bookings and admissions to popular tourist attractions. And India has the overwhelming advantage being Anglophone.

Comparative advantage. Free movement of labor and capital. Let India perform non-emergency health care, EU nations manufacture generic drugs and we will have the money to develop new treatments and perform cutting edge emergency medicine at home.

Posted by John Kranz at 6:38 AM | Comments (2)
But Silence Dogood thinks:

Now if we could just fix the legal system that installs so many roadblocks in the development and use of new treatments. This is one area where the EU has an advantage over us. They may not get the profit from their drugs, but they don't have as high malpractice costs either. Perhaps the major pharmaceutical companies will develop here, test in Europe and end up selling in India.

Posted by: Silence Dogood at May 13, 2005 12:19 PM
But jk thinks:

Actually, India has been utilized as well in the testing arena -- specifically for the reasons you cite. But I would love to test some products on the French and Belgians...

Posted by: jk at May 13, 2005 12:31 PM

April 26, 2005

Pharma Culture

Were one sufficiently starved for entertainment to read my entire Pharmaceuticals category on this blog, and then go back to my writings on Berkeley Square Blog, you'd find a tireless and pedantic advocate of the pharmaceutical companies. I defend them and smite their opponents, be they politicians, lawyers, or journalists.

Give me my cred -- if I got money, you'd say I was in their pockets. Yet even I am disturbed at the prevalence of chemical solutions to life's vicissitudes (did somebody say "pedantic?") I don't doubt ADD is real but suspect it is highly over-diagnosed and over-prescribed.

My wife is in rehab for a stroke, and all the nurses are amazed that she is not on any regular medication. They think we're lying. "Every woman your age in here is at least on anti-depressants," we were told.

Last weekend's on call doc is a bright and professional woman who is very easy to talk to and very compassionate. But I have to relate two stories about her. She casually prescribed anti-depressants for my wife, based on "situational depression." The nurse described them to us as the doctor didn't even think it was important enough to discuss. These were non-narcotic, non-addictive, and they're not happy pills. You'd probably get off them in six months.

Wow. "Do you want those?" I ask. "No, I am pretty scared of that," she says. We decide to pass but know that these are on her chart and she can request them at any time.

The second story happened earlier, but I have withheld it for dramatic effect. This same doctor had a fit that my wife was drinking a smoothie I had brought in. "What's in this? Do the nurses know you brought this?" "I really suggest you stick to the dietician's plan! (of a lot of stuff she won't eat)."

So fruit juice is the devil's weed and should be considered seriously, but a half a year's anti-depressants are prescribed without patient input, request, or the suggestion of medical staff who have worked with her longer.

I guess I am naive. Am I nuts?

Posted by John Kranz at 9:51 PM | Comments (3)
But AlexC thinks:

No, you're nuts. ;)

You see, there wasn't anyone from Orange Julius buying your doctor dinner or taking her out for a round of golf.

I have no problem with a company advertising their products, but a lot of pharma-reps are little more than bribers, and some Doctors are willing to be shills for a perk or two.

Power and all that, ya know.

I don't go to doctors, except for extremis (or regular visits to pediatrician), and yet when I'm there, inevitably there's some jack-off (male or female) peddling their wares, aggressively.

Standing their like a pinhead for what could be hours waiting to "talk."

Some doctors even have weekly scheduled "take me out to dinner sessions".

Makes used car salesmen and lawyers look upstanding.

But maybe I'm just embittered!

Posted by: AlexC at April 26, 2005 11:14 PM
But jk thinks:

Don't ice it, man, tell us how you feel.

I cringe a little, because the evil Pharma reps you describe are employed in selling a legal product. If it works, doctors should know about it. In short, it's part of the ugly rough-and-tumble of the free market, is it not?

If you are going to have competition in the sector -- an unadulterated good -- you will have to make room for some Willy Lomans to distribute it.

Posted by: jk at April 27, 2005 11:44 AM
But johngalt thinks:

I think what you experienced is a more general trend toward the "black box" treatment, or "experts know best." Contemporary consumers have little or no interest in the how, what, and why of the services they receive, be it medical care or an oil change. Hell, I even ASK repair shops to keep the old parts for me and they pitch them anyway. It's just not conceivable to them that someone would want to know what they did or why.

Why is this? I haven't pondered it deeply but in general I can say that knowledge is power. Insecure people don't go around sharing either of them without putting up a fight.

This must not be Riza's regular doctor. If so, it's time to get a new regular doctor - one who knows her patient at least tangentially.

Posted by: johngalt at April 27, 2005 3:37 PM

April 14, 2005


You didn't expect me to keep quiet about Bextra, did you?

The FDA have pulled this compound because of a one in a million risk of severe toxicity. Dr. Gilbert Ross has an National Review Online piece. recounting those who lose in the regulation:

So Bextra is gone, joining Vioxx on the pharmaceutical museum shelf. Of course, there is a theoretical possibility that one or both of these drugs, and the unique benefits they hold for many, may someday return. Meanwhile, what about the many thousands of patients who got relief of pain and no untoward effects? Too bad they have been regulated out of the picture. Bextras only a me-too drug, after all, and one person in a million may get a skin condition, so out it goes. Activists have advocated, regulators have regulated, and patients will now pay the price. The choice to use this drug in appropriate populations in bygone days, a choice made between doctor and patient is no longer to be an option. Someday, regulators and consumers will learn that nothing is risk-free.

Of course another loss is $1.3 Billion in revenue for Pfizer, plus countless resources for compliance, and extreme exposure to lawsuits.

Wouldn't this money be better spent, say finding a cure for MS? Or better recovery from stroke?

Posted by John Kranz at 1:38 PM

March 29, 2005

Kianna's Law

Instead of a wave of Terri's Laws that will introduce government intrusion into private family decisions, The Wall Street Journal suggests Kianna's Law, for Kianna Karnes, who died at the age of 44 from kidney cancer. She was denied any chance at clinical trials because our beloved FDA has a public to protect.

After her write-up in the Journal, the drug manufacturers and the FDA called to help. But...

But isn't it a national scandal that cancer sufferers should have to be written about in The Wall Street Journal to be offered legal access to emerging therapies once they've run out of other options?

The FDA's oncology division has proven to be essentially incorrigible on this point in recent years, so it's time for Congressional action mandating that the agency use 21st-century science and statistical methods to get these therapies to patients sooner. More specifically, drug approvals could be based on large trials open to all comers and analyzed with so-called Bayesian statistics, as already happens in the FDA's medical device division. (Yes, the agency at least recognizes that studies involving, say, "placebo" defibrillators would be beyond the pale.)

Mrs. Karnes's father John Rowe -- himself a leukemia survivor -- plans intense Congressional lobbying in the coming weeks, and he's had some interest from Congressman Dan Burton's (R., Indiana) office in the possibility of sponsoring a "Kianna's Law." No doubt there will be others willing to sign on.

Terri Schiavo was well served by the law. She got multiple chances for redress, and in the end got what her husband said she wanted. Kianna Karnes received no chances at what she clearly wanted -- to purchase drugs that might save her life.

Posted by John Kranz at 5:24 PM | Comments (5)
But Silence Dogood thinks:

Yes, interesting that we can allow (in some states) access to marijuana for medical purposes but not unapproved drug therapies. To my knowledge marijuana has never passed any FDA approval testing.

Posted by: Silence Dogood at March 30, 2005 10:37 AM
But jk thinks:

You'll get me started on another rant if you're not careful. Although 11 states have passed Medical Marijuana statutes, the feds will still not allow it. In California, they throw terminal cancer patients in jail for using the only thing that brings them relief.

Posted by: jk at March 30, 2005 10:59 AM
But johngalt thinks:

I don't believe the government has any business restricting marijuana use any more than it does alcohol, which is to say - apply the current alcohol laws, don't abolish them all for both substances.

However, I sympathize with the conviction that so-called "medical marijuana" is a canard to get the drug legalized by deadbeat low-lifes.

I'd support this compromise: Marijuana can be legally sold at regulated stores (like liquor stores) but only to people over 21 AND ... clean shaven with a neat haircut, no odious personal odors and closed shoes of some kind. And any straight-laced proxy buyers caught aiding the sandal wearers would be prosecuted for felony mischief.

Posted by: johngalt at March 30, 2005 3:12 PM
But jk thinks:

Okay, I'll contravene my libertarian ideals to go with your dress code requirements.

I am in favor of BOTH legalization and medical, although I don't think of one as a loss-leader.

I am gonna try to convert you, though, jg. Even if you do not believe in the efficacy of doobage for pain management, do you really approve of the gub'mint telling an MS or terminal cancer patient that they cannot even try it?

I have read of terminal cancer patients thrown in jail, because that is all that works for them (this is in National Review, not Rolling Stone or High Times). And, in the MS world, it is very popular. If 11 states' voters say they think people should get this chance, why is it the Fed's job to meddle? Tenth Amendment anybody? Federalism? If you can't allow Interstate Commerce, I suppose they can grow it locally.

Posted by: jk at March 30, 2005 5:54 PM
But johngalt thinks:

No, I'm honestly with ya on this JK. Ward Churchill's just got my dander up at the moment.

The drinking age should be abolished as well.

Posted by: johngalt at March 31, 2005 2:37 PM

March 2, 2005

Post-Vioxx Twilight Zone

Apologies to Dow Jones, but I must post (steal is such a charged word) a Wall Street Journal Editorial in its entirety today. Subscribers who want to read it legally may click here

Still don't think political frenzies have consequences? Consider the weird and troubling inversion this week regarding the promising new treatment for multiple sclerosis, Tysabri.

The biotech partners Biogen and Elan pulled their drug from the U.S. market following just two reports (including one fatality) of serious complications possibly linked to the compound. Meanwhile, officials at the FDA went out of their way to defend Tysabri. Steve Galson of the agency's Center for Drug Evaluation and Research said the FDA "continues to believe Tysabri offers great hope to MS patients." Added drug evaluator Douglas Throckmorton, "It makes meaningful differences in people's lives."

Welcome to the twilight zone of pharmaceutical development post-Vioxx, in which the natural hyper-caution of regulators is exceeded only by the hyper-caution of terrified drug makers. Perhaps Biogen and Elan possess some information that the rest of us don't. But on the face of it the Tysabri withdrawal appears to be an overreaction that will harm MS patients in the near term, and all of us who depend on a healthy drug-development culture over the long run.

Tysabri had received accelerated approval from the FDA just three months ago because clinical trials had shown it to be twice as effective as alternative therapies in preventing flare-ups of MS, which is a degenerative and eventually fatal disease. Tysabri is also easier to take than alternative treatments, and tolerated by a subset of MS patients who can't take the others at all.

But for the indefinite future everyone will have to do without because two of the thousands of patients who've received Tysabri developed a rare neurological disorder. Those two patients happened to also be on another immuno-suppressive MS treatment called Avonex. There is no reason to believe that Tysabri has caused this disorder when used alone.

There's plenty of blame to go around here, starting with the trial lawyers and their climate of fear. Congressmen who demagogue about non-existent FDA safety "lapses" aren't much better. But we're also disappointed with CEOs who imagine they're doing patients and shareholders a favor with such rash decisions. In retrospect, Merck CEO Ray Gilmartin only strengthened the hand of the lawyers by withdrawing Vioxx when the FDA would have been content with relabeling.

Biogen and Elan seem not to have learned Merck's lesson and paid for it by having $17 billion wiped off their market caps on Monday. Litigation is in fact less of a risk in the smaller MS market than it was to Merck. But there's also political risk, and the last thing Biogen and Elan probably wanted was to have their names dragged before Capitol Hill cameras by Ted Kennedy or Chuck Grassley. On the other hand, withdrawal only attracts more media attention than the more sensible move of product relabeling.

Whatever the corporate motivations, it's obvious that no one benefits from this climate of drug-development fear. Just about everyone agrees that Tysabri will return to the market at some point, to be taken by many patients whose MS will have progressed further than it would have otherwise. Meantime, another bad business precedent has been set. Sick patients everywhere should stand up and cheer for the next CEO who keeps a beneficial product on the market, despite news of a troubling side effect.

L'audace! guys, l'audace! Timidity will not help your shareholders, will not score points with regulators -- and it woun't do a lot of good for us MS patients, either!

(For those keeping score, I am taking no medication at present. My neurologist suggests that steroid treatments might help but I am overdue for a return visit.)

Posted by John Kranz at 10:57 AM

March 1, 2005

Evil Drug Firms

Not all of the bad luck that can befall a drug firm comes at the hand of government. Yesterday, an MS treatment was voluntarily withdrawn from the market, following a death and a serious complication.

I mention it because I want to beat that lifeless equine: low multiples in the pharma sector. The cost for this voluntary yanking was $17 Billion in market capitalization for the two firms involved. The Wall Street Journal sez

Biogen and Elan characterized the withdrawal as a "voluntary suspension" and said the product may find its way back to the marketplace at a later date. The Food and Drug Administration offered some encouragement, saying in a statement that the agency "continues to believe Tysabri offers great hope to MS patients."

Shares of Elan declined $18.90 to $8 as of 4 p.m. in New York Stock Exchange trading. Biogen Idec shares were down $28.63, to $38.65, as of 4 p.m. in Nasdaq stock-market trading.

The decision to halt sales of Tysabri comes amid wider controversy about the safety of other drugs approved by the FDA, particularly whether regulators have been correctly balancing the risks of new drugs with their benefits. The FDA has come under scrutiny in recent months over the safety of widely used painkillers, following the voluntary decision by Merck & Co. to pull its best-selling painkiller Vioxx last September after a trial tied it to higher rates of heart attacks and strokes.

Now the regulators are ready to roll back the gains of the FDA Early Approval Process. But in spite of regulation, the point is the vicissitudes of the industry. The good folks at Biogen and Elan are trying to develop compounds to cure my MS, and they just lost 17 billion dollars. John Edwards may be happy, but these guys are not evil when they make money, they use it to make our lives better.

Posted by John Kranz at 11:51 AM | Comments (2)
But johngalt thinks:

Expect the share prices of Biogen and Elan to recover in less than six months when the drugs are re-released, a la Vioxx. And expect Elliot Spitzer to go after them for artificial manipulation of their valuations.

Posted by: johngalt at March 1, 2005 2:55 PM
But jk thinks:

Even if recovers, it has added to a beta (risk factor) that will continue to depress valuations in the sector. The higher cost of capital means less money to fund research.

Nothing nefarious here, the market is doing its job -- funnel capital toward things perceived as more successful. My point was just leveled in opposition to those who demonize the drug companies -- they have their share of problems, too.

Posted by: jk at March 1, 2005 4:19 PM

February 22, 2005

Hey The FDA Did Something Good!

This would be the second time I have written something good about the FDA. I wrote favorably about Dr. Mark McClellan's appointment to be Food and Drug Administration commissioner. Dr. McClellan tried his best with the giant bureaucracy and I was sad to see him leave.

Yet, there is a bright moment at the FDA under acting FDA Commissioner Lester Crawford. The WSJ Ed page points out (paid site) that at a three day hearing, those who would keep a drug off the market for fear of whom it would harm were forced to account for those whom it could help.

Particular credit here goes to acting FDA Commissioner (now the official nominee for the job) Lester Crawford, for convening an unprecedented three days of open hearings on the issue. Cox-2 critics -- including the FDA's own David Graham, who has been feted as heroic in the press -- were given a fair hearing. But in front of the panel of distinguished outside statisticians and clinicians (read: doctors who actually treat patients), he came off as less than fully scientific and, well, a bit uncaring.

Dr. Graham's case against the acceptability of any increased cardiovascular risk for Cox-2s rests on the relatively small percentage of patients who develop full-blown stomach ulcers from older pain medicines like naproxen and ibuprofen. But that small percentage still means a high absolute number (15,000-plus) of deaths annually from gastrointestinal bleeding. And it utterly misses the point that most vulnerable patients never develop ulcers because stomach discomfort causes them to drop their medications long beforehand. Dr. Graham's implicit advice to the pain patients who can't tolerate those drugs: Grin and bear it.

Grin and bear it. Unless you died of colon cancer while the FDA was dreaming up more hurdles for Erbitux. The drug was finally approved, but 15,000 people died and Sam Waksal and Martha Stewart went to prison. Another day's work for the FDA.

Posted by John Kranz at 11:11 AM

February 17, 2005

Those Bastards!

It seems a drug company improved their product to help patients but -- they did it for money!

The Wall Street Journal broke this story (I remember reading it and thinking about the disparity between the News and Editorial staffs). But it took the New Yorker's anti-capitalist condescension to do it justice.

A friend sent me a link to the Critic At Large column, remarking "I am astonished at the level of bitterness towards drug companies, given that the people I know involved in drug research and development are so committed to improving the lives of patients."

Well, yeah, if they gave it away...

In short, AstraZeneca, launched an internal project to patent an improvement to its Prilosec so that the firm could continue to profit when the patent expired. They modified its structure to seek improvements.

Here's Malcolm Gladwell's take on this nefarious scheme:

AstraZeneca then had to prove that the single-isomer version of the drug was better than regular Prilosec. It chose as its target something called erosive esophagitis, a condition in which stomach acid begins to bubble up and harm the lining of the esophagus. In one study, half the patients took Prilosec, and half took Son of Prilosec. After one month, the two drugs were dead even. But after two months, to the delight of the Shark Fin team, the single-isomer version edged aheadwith a ninety-per-cent healing rate versus Prilosecs eighty-seven per cent. The new drug was called Nexium. A patent was filed, the F.D.A. gave its blessing, and, in March of 2001, Nexium hit the pharmacy shelves priced at a hundred and twenty dollars for a months worth of pills. To keep cheaper generics at bay, and persuade patients and doctors to think of Nexium as state of the art, AstraZeneca spent half a billion dollars in marketing and advertising in the year following the launch. It is now one of the half-dozen top-selling drugs in America.

Oddly enough, the article eventually comes around to defending some pharmaceutical firms, pointing out that doctors or insurance companies could use the generic Prilosec.

Mr. Gladwell may not need Nexium (I could use a hit, reading his column) and feels that isomer selection doesn't rise to his high standards of chemical discovery, but the product was improved. It took scientists and lab techs and time and electricity and lawyers. Shouldn't he be glad it's there if he needs it?

He also hits the "cox-2 inhibitors are no better than Advil unless you have stomach ulcers" meme. Once again, these bastards are just trying to sell us $5 aspirin! I dare say if you have thin blood, ulcers, and are in extreme pain, it is might handy to have it around.

Yes, they're oversubscribed, yes a less expensive alternative probably works 90% of the time. But what if it's for your spouse and the Insurance company says use the cheap one. What are you going to say? What's your attorney going to say?

Posted by John Kranz at 12:15 PM

February 15, 2005

For This We Elect Republicans?

Sensing that the government was not doing enough to hamper innovation and destroy valuations in the pharmaceutical sector, Congress has sprung into life:

Yahoo! News - New Board to Check Drugs After Approval

WASHINGTON - The government is setting up a monitoring board to keep checking on medicines once they're on the market and to update doctors and patients on risks and benefits.

I guess I'll just short Pfizer and learn to live with Multiple Sclerosis -- they got a public to protect!!!

Posted by John Kranz at 4:39 PM