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.
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.
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.
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 PMSeptember 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.
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.
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.
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 didn’t 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."
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 PMSolumedrol (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 PMAn 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...
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.
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.
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:Hat-tip: The Everyday Economist
- 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.”
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 AMI'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 AMGovernment 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 PMYeah, 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.
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 PMJuly 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.
I’ll 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. It’s 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 there’s 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.
July 2, 2007
Rx
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.
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 PMJune 24, 2007
The Reality is More Complex
Everyday Economist links to Michal Moynihan’s 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 patients—for travel reimbursements—rather 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 CEO—yes, even the NHS has an executive class—collected 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 diagnosis—he too had a brain tumor—Szmyt 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..."
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.
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 PMJune 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.
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 PMYou'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 AMDemocrats 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.
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 PMYou'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 AMMay 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.
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.
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 AMI 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.
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?
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 President’s 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 there’s 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.
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...
March 22, 2007
Efficacy
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.
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.
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 PMI 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 PMMarch 7, 2007
Scandal or SOP?
Standard Operating Procedure for government work.
Ronald Bailey on Reason Magazine’s 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
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.
Uh-oh,
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.
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.
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.
January 16, 2007
Exigencies
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...
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.
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.
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."
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...
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.
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 résumé 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.
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 AMIt'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 AMThis 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 AMNovember 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)
Hey, it's Canada ... just open the friggen window!
Posted by: mdmhvonpa at November 28, 2006 12:20 PMSocialism, Schmocialism, he speaks the truth (LOL).
Posted by: jk at November 28, 2006 5:38 PMNovember 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.
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 PMNovember 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
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 control–a 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 aren’t keeping their side of the bargain. They’re 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” inventions–to 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.
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 PMAmen. 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.
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 MankiwYesterday, 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
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."
I’m happy for the small step, but still reject Government's having any authority in this ambit. Free markets could do better.
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 Women’s 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.