Thursday, April 07, 2005

Current events -- again!

**The FDA has asked Pfizer to pull Bextra off the market. Bextra is a COX-2 inhibitor, like Vioxx (remember Vioxx?). The problem, according to the FDA, is that Bextra has a raft of serious side effects (like Vioxx), including cardiovascular problems, stroke, and "a potentially life-threatening skin condition called Stevens-Johnson syndrome, an allergic reaction that usually begins as a blistering of the mouth and lips and can spread to the rest of the body." And, for all the risks, it has no added advantages as a painkiller.

I don't know for sure that the research that brought Bextra to market tested it against a placebo instead of against other well-characterized painkillers ... but it wouldn't surprise me.

**Stephen Johnson, President Bush's choice to head the EPA may have his nomination blocked owing to ethical concerns about an EPA study he oversaw about children and pesticides. While the study has been suspended, it has not been cancelled. The idea of the study was to identify families who used pesticides and monitor the children of these families to see if the family pesticide use was having any effects on the kids. The problem? In recruiting families for the study -- mostly low-income families -- the EPA did not make it sufficiently clear that they were only looking to study families already using pesticides in the home. Plus, they offered about $900 and a free camcorder for participation. ("Hey honey, if we spray for roaches we can get some cash!") And, in recruiting families with babies as young as 3 months, it's not clear that the researchers provided potential participants with the information that is known about potential effects of pesticide exposure in babies and children.

Free and fully informed consent, anyone?

Oh, and it happens that the American Chemistry Council (an industry group) provided funding for the study in question. Not that that necessarily means there would be a conflict of interest ... but it could color the kind of information about pesticides being offered to potential participants in the study.

And speaking of conflicts of interest ...

**Due at least in part to the threatened departure of some prominent scientists, the NIH may relax its rules on conflicts of interest. The current rules prevent NIH administrators and scientists from holding lucrative consulting contracts with drug companies. They also require that NIH administrators and scientists divest themselves of stocks in biomedical companies and put real restrictions on consulting and other "work for hire" that academic scientists frequently do for extra income. But concerns have been raised over whether these strict rules will make it difficult to attract and retain talented researchers at the NIH. Further, the argument has been advanced that these protections against outside influence are more important for administrators than for research scientists. (Research scientists are pure of heart, after all.)

Now, I'm the last person who's going to tell you that researchers working for the government (or for public universities) are well-compensated. And the government does not have the buckets of money sitting around that is did in rosier economic times. But might there not still be reason to believe that consulting contracts with, or stock holdings in, private drug companies could have some influence on what the scientists see in their data?

Stay tuned for more updates from the world out there ...


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