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medpundit |
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Sunday, September 15, 2002Many people would be willing to accept a slightly higher risk of death in exchange for a large improvement in their quality of life. Many surgeries are performed to treat conditions that aren't life-threatening, yet surgery itself increases the risk of death--do you think these surgeries should be banned too? Do you think patients who have their wisdom teeth removed should be prohibited by the federal government from receiving anesthesia? What do you think the optimal speed limit on federal highways is? 65 mph? 55 mph? Why not 5 mph--sure this would be inconveient, but fewer people would die in traffic fatalities. I am taking the argument to the extreme, I know, but I think the extreme examples illustrate the fact that people trade off mortality risk for quality of life all the time. There is nothing wrong with that. Since different people value mortality risk and quality of life differently, I think these tradeoffs should generally be made on a decentralized basis by doctors and their patients, not by the FDA. I would make an exception to this rule for drugs for which no reasonable person could think that the health benefits exceed the mortality risk (like thalidomide in pregnant women), but I think those should be exceptions not the rule. For some cases, that’s true, but the issue here is whether or not the drug is as safe as the company is making it sound. I didn’t quote the entire BMJ article in the last post, but it also pointed out that the main bone of contention between the FDA advisors who are speaking up now and the FDA adminstrators was the actual incidence of potentially fatal side effects. The advisors estimate that the incidence could be as high as 1 in 200 users. That’s much higher than the risk for elective surgeries. The company disputes that, but hasn’t given enough concrete evidence to be convincing. The advisory panel was willing to allow compassionate use within clinical trials while the review continued, but the drug company refused. They had brought the drug to market with the intention that this would be a “blockbuster” for them, and restricting its use would foil their profit plans. They also got the FDA to forgo strict rules about who could prescribe the drug. The advisory panel recommended that it be issued only by doctors who were certified to use it, but in the final re-approval it can be given by anyone who thinks they know enough about it to give it. That means that I could prescribe it after reading the package insert if I thought that was sufficent knowledge. The other disturbing aspect of the article was this revelation: The International Foundation for Functional Gastrointestinal Disorders, which did have funding from GlaxoWellcome, also pushed for the drug's return. Its president, Ms Nancy Norton, testified at all three advisory committee meetings without revealing her organisation's link to the manufacturer. Asked why not, she says she was not specifically asked, and that the link appears on her foundation's website. (The website buries that information in a link that appears under the subheading “I am a - choose one: patient, health professional, donor. You would only stumble upon their drug company ties if you hit donor, which few people would do.) There are now so many ways for drug companies to use their financial clout to influence regulatory decisions it’s impossible to keep track of them. Between their contributions to politicians, the FDA, and the disease activist groups that lobby them, they’ve got all the bases covered. It should come as no surprise that they were able to quash the evidence the advisory committee was gathering on the drug's risks. posted by Sydney on 9/15/2002 08:19:00 AM 0 comments 0 Comments: |
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