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-- for everything from medications for minor ailments to new cancer treatments -- on the rigid application of the same outdated statistical standards.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.
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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.
Posted by: jk at May 13, 2007 5:49 PM | What do you think? [2]