Two other factors are at work in the widespread rejection of Kirsch's (and, now, other scientists') findings about antidepressants. First, defenders of the drugs scoff at the idea that the FDA would have approved ineffective drugs. (Simple explanation: the FDA requires two well-designed clinical trials showing a drug is more effective than a placebo. That's two, period—even if many more studies show no such effectiveness. And the size of the "more effective" doesn't much matter, as long as it is statistically significant.)
Libertarian critics of the FDA often claim that the FDA is risk-averse when permitting potentially beneficial remedies and procedures, because the political cost to the regulators of unsuccessful applications of a remedy or procedure outweighs the political benefit to regulators of successful applications of the remedy or procedure. One death caused by a drug ignites a political firestorm, even if the the drug has saved hundreds or thousands.
Why, then, did the FDA give a pass to antidepressants in the absence of evidence of effectiveness? Perhaps the FDA does not have as much an incentive to care about effectiveness as about risk. If the FDA has no reason to suspect politically dangerous amounts of ill effects from a remedy, perhaps they will permit it even if there is insufficient evidence that it is effective. In both cases, though, the FDA does not seem to function the way in which its supporters claim.
6 comments:
It's hard to say why they failed in this case without learning more details about the FDA process in this case. Was it failure to change outdated rules? A manpower shortage(which has made them impotent in the area of food inspections)? Industry infiltration into the agency (like the USDA)? Tell us more FDA. Also, placebos are threatening the pharmaceutical industry. Read all about it here!
http://www.wired.com/medtech/drugs/magazine/17-09/ff_placebo_effect?
More approval = more money, faster approval = more money. I wonder, now that it is so easy to advertise pharmaceutical drugs, how many advertising campaigns are prepared before official approval.http://www.jabfm.org/cgi/content/full/17/2/142
My impression is they would rather take the money and approve a drug with the moral mantras of potential good to the many; with out acknowledging the lack of certainty which reveals equally the potential harm.
Yeah the FDA, and all medical treatment is frustrating.
This morning I watched Titicut Follies by Frederick Wiseman, a horrifying documentary in a mental hospital, if you might be interested int that.
The self-diagnosing commercials on television are the most annoying. "If you've ever felt sad before... Try this pill."
Yeah the placebo affect is interesting. And that the FDA is more interested in producing non-fatal drugs than it is producing accurate and helpful drugs is just lame. I think Merck is more like a make-up company, just masking problems.
I read once about a pill in Canada called 714-X that sounded almost like a placebo that cures cancer. I wonder if there have been placebo studies on cancer patients. The people that I've heard of curing cancer include a very high morale in the patient.
Well, in all candor, it would be overly hasty to conclude that the FDA failed in this case. If the issue is whether antidepressants should be legally permissible, I think the answers is yes (even if they are ineffective), therefore in that sense the FDA did not err.
But there is still the puzzle about the FDA's low standard for showing effectiveness. I submit that if what the article said was true, we don't need to know more about the FDA's process to make a judgment here. It is enough to know that they only require two studies showing effectiveness--regardless of how may studies might fail to show effectiveness. This is an inherently flawed methodology for assessing effectiveness.
It may be true that the more drugs that are approved, the more money drug companies can make, but this does not explain why the FDA is slow to approve procedures that are already approved in Europe (for example). I attempted to give a sketch of a public choice argument, considering the incentives facing FDA regulators: it looks very bad if they approve a drug which causes someone to die (even if the chance of death is statisically very small), but it does not look so bad if they approve a drug which doesn't work if it is not likely to cause any deaths (or not likely to be able to be proven to have resulted in a death).
And for the record, slimy libertarian (of sorts) that I am, I do not dispute the need for an agency that monitors the effectiveness and/or the riskiness of drugs or medical procedures. I am just not sure that (1) the agency should be a governmental one and (the quite independent point) that (2) the FDA is doing as good a job as we would like to think it does.
Aaron: Re. "Titicut Follies," I actually saw that film on PBS in 1993. I was oddly enough just thinking about it the other day. The film is a horror-fest, but on the other hand I believe that the mental health profession has advanced considerably since the bad old days of the 1960s.
My father told me that he had a friend who considering going into psychology in the 1960s, but actually changed his mind after visiting a mental hospital while he was a student. Apparently, he thought they were over-using electroconvulsive therapy, even using it as a sort of punishment, among other things.
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