Saturday, February 21, 2009

Lilly Says Jump, FDA Says How High--More on "Intellectual Bias"

The main story appears on the "Heartwire" (theheart.org) site (and thanks to colleagues at Healthy Skepticism for the tip)--

http://www.theheart.org/article/943511.do

The story has several themes--most notably 1) the debate over "intellectual bias" or sometimes "intellectual conflict of interest"; and 2) the FDA's excessive willingness to do the bidding of industry and to neglect its duties to protect public safety.

The basic facts: The drug plasugrel, an anti-clotting drug supposedly of value in heart attack and stroke, is currently under review by an FDA scientific advisory committee. Dr. Sanjay Kaul, of Cedars-Sinai Medical Center in Los Angeles, had been invited to be a member of the advisory committee, but he was then asked by FDA staff not to make the trip to Bethesda. It was then revealed that Eli Lilly, the drug's manufacturer, had contacted the FDA just before the decision was made, to protest Dr. Kaul's earlier skeptical publications about the drug and his purported "intellectual bias." The FDA has now admitted error in this process.

Taking the latter theme first, there have been a number of instances in which physician-scientists who were known to be critical of a drug were excluded from an FDA advisory committee, even as scientists who had stark financial conflicts of interest with the manufacturer were allowed to sit on the panel through routine waivers of FDA rules. This, to the best of my recollection (which is exceedingly shaky these days), is the first time that there has been such a direct link made between a contact to the FDA by the company, and the decision to exclude the scientist. (Wouldn't want to keep the busy folks at Lilly waiting, after all.)

Now for the first theme. I have previously posted about this nonsense of "intellectual bias," which is not really so bad when called by that name, but does nefarious work when relabeled as "intellectual conflict of interest." See for instance http://brodyhooked.blogspot.com/2008/03/more-on-intellectual-conflict-of.html for a great expose of the flawed reasoning. The basic idea: Everyone agrees that scientists are subject to intellectual bias. They tend to believe that their own pet theories are right and the opposing theories are wrong. Apologists for industry then proceed to relabel this bias as "intellectual conflict of interest." They then proceed to argue that we should simply ignore financial conflicts of interest as unimportant. After all, they then argue, if COI is all over the place, we can hardly get too excited about any one manifestation of it; intellectual COI is all over the place; therefore we should not get excited about COI; therefore financial COI is not anything to worry about either. In other words, by this sleight of hand, we go from humans are human and have biases, to it is all right for scientists to pocket huge sums from manufacturers and then sit on FDA advisory committees judging that manufacturers' drug.

The FDA has, in recent years, promised to start to become tighter about enforcing their rules and not issuing blanket waivers like they used to. I am not sure how well they have made this switch in policy (anyone else know the recent track record?). What they clearly have done, however, is to be much stricter about letting the supposedly anti-drug folks sit on committees, even those who have no financial conflicts whatever and simply doubt the quality or validity of the drug industry's so-called evidence.

We can be hopeful that the Obama folks, when they finally come in and take over the FDA, may reverse these unfortunate trends, but we can also be sure that the industry is exerting its utmost behind the scenes to make sure that the harshest critics of industry do not make the final cut for high-level appointments in the Obama FDA.

1 comment:

Marilyn Mann said...

Thanks for posting on this. I also wrote about it on Gooznews.