Conspiracy mongering among CAM advocates


Anyone who pokes around this blog for only a few minutes knows I’m generally sympathetic to CAM practitioners and advocates. However, sometimes I just have to shake my head when I hear an CAM advocate argue his case. For example, a recent “article”:http://www.newstarget.com/019309.html on “NewsTarget”:http://www.newstarget.com/ (a CAM news and commentary site) has the following:

bq. How much of a better deal does Taurel want than today’s industry-friendly FDA, anyway? It’s hard to get any more lenient on drug companies than the FDA is right now. That’s why some people call the FDA the, “Federal Drug Advocates.”

This sort of conspiracy-mongering damages the credibility of the CAM advocate because it conveys a lack of understanding of the drug development and approval process. The FDA gets harsher by the year. For example, in recent years a couple out of the many approved drugs were found to cause an increased risk of QT elongation (i.e. increases the time it takes for the heart’s ventricles to lose and then regain their charge) and even “torsade de points”:http://www.emedicine.com/emerg/topic596.htm (which, as you can see from the “sudden death” in the synonyms section of the link, is a very dangerous condition).

The FDA’s response? Every new drug must include electrocardiography, and especially QT monitoring, in its development plan. Ideally, there would be a separate QT study.

Another example, Pfizer in 2004 got “spanked”:http://www.fda.gov/cder/warn/2004/12726.pdf over this “ad”:http://www.fda.gov/cder/warn/2004/12726ad.pdf. The reason is that the ad could have been inferred to say that Viagra™ could restore sexual function to an earlier state (“He’s back!”), rather than the “true indication”:http://pfizer.com/pfizer/download/uspi_viagra.pdf which is to treat erectile dysfunction.

Said the FDA:

bq. FDA is not aware of substantial evidence or substantial clinical experience demonstrating this benefit for patients who take Viagra. If you have data substantiating this claim, please submit them to FDA for review.

Whether or not the FDA acted appropriately in this case, this doesn’t sound like “Federal Drug Advocates” to me.

Of course, it’s probable that the FDA fell down on the job in particular instances. The Merck case is opening the FDA up to further scrutiny, and we expect the FDA to refine its procedures to exert better quality assurance during the review process.

*Update*

Pat Sullivan “notes another example”:http://www.patsullivan.com/blog/2006/03/the_fda.html of some people within the FDA acting questionably in a situation of “it’s who you know.” Note the first few sentences. For most people, it’s a long and arduous process to get something approved. (Mr. Sullivan and I probably disagree on exactly what the balance of science and politics is at the FDA, and that’s ok. I recommend you read through some of the links he provided and some of the warning letters on the FDA site, which you can find “here”:http://www.fda.gov/cder/warn/. And before claiming impropriety in any particular case, do the research and get the facts.)

I hope that CAM advocates study the rules a little closer. Arguing from reality rather than a constructed image is going to earn them more leverage to be more effective in the future.

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