http://brodyhooked.blogspot.com/2007/12/off-label-what-are-issues.html
So that must mean that I am OK with the FDA's proposed rules change...
http://www.nytimes.com/2008/02/16/business/16drug.html?scp=4&sq=gardiner+harris+f.d.a.+&st=nyt
...that would allow companies to start marketing drugs off label if they:
- Distribute to physicians only peer reviewed medical journal articles describing the proposed off label use
- Accompany any such article with a clear statement that the use described is not FDA approved
Right? Well, not exactly.
The point I tried to make in my earlier post is that even though many off label uses of drugs are quite defensible and are in the patient's interest, we need to be very wary of any specific rules change in the companies' favor, given their past ability to drive huge trucks through even the tiniest regulatory cracks.
The defenses for the new FDA policy, as summarized by Gardiner Harris in the NY Times, basically all amount to the same thing-- if there's scientific evidence that a drug works even off label, isn't it a good thing that docs see this scientific evidence as soon as possible? The answer is NO, not this way at least, for a bunch of reasons.
- The most basic reason--if docs are too busy and harried to read the journals assiduously, why should they, as professionals, turn to a for-profit industry to help them? Why not develop a more professionally responsible and less commercially biased way to disseminate information quickly? (As in fact is now happening more widely.)
- Why worry about for-profit bias? Often a single study will tell only a small piece of the story. For every study that shows a good outcome there might be one showing a bad outcome. How much can we rely on the industry to circulate both sorts of studies equally? Fat chance.
- Now, the more subtle concern. We have seen mountains of evidence (HOOKED could have been twice as long had I included more of it) of companies fudging research results in more ways than you could name, to make a study come out as if the drug performed well and was safe, when the real data would show quite the opposite. The industry claims: we would never do that; we are scientific drug firms; we live or die on our spotless reputations; it is contrary to our commercial interests to put our names on garbage research. These claims have now been proven many times over to be bull. The companies can get away with garbage research because they know that the same busy docs that are too busy to read the journals carefully, are also too busy to read the entire article; they will be lucky to read the abstract. Spin the abstract so that the drug looks good, and you can have table after table of damning data in plain sight in the rest of the article, and most docs won't notice. Now, if the company knows that a research paper is going to be published in an obscure journal, where hardly any doc is going to see it, there is a certain amount of incentive both to fund the research in the first place, and to spin it in the second place. But if the company knows that its detail reps have free rein to push this article about off-label use under every doctor's nose, then the incentive to fund garbage research, and to spin it further, goes way up.
The new FDA rule proposal, therefore, is not a tiny crack through which the clever industry can drive the proverbial Mack truck. The opening is Mack-truck-sized from the get go.
Harris G. F.D.A. seeks to broaden range of use for drugs. New York Times, Feb. 16, 2008.
