Family Member

Is bias about a pharmaceutical company’s products limited only to direct financial benefits (as U.S. Senator Charles Grassley has so adeptly shown)? Or can a conflict of interest exist where no money changes hands, but a person has other reasons to either promote or speak out against a company and its products?

This is a loaded question, obviously, because the answer is, of course conflicts of interest can go above and beyond any direct monetary reinforcement. What if your own child was harmed, in your opinion, by one of the drugs you are then asked to judge?

If this were a court trial, such a juror would never be seated on the jury. Lawyers are keenly aware of these kinds of human influence biases, and ask questions to try and feel out whether such biases exist in potential jurors. Both sides disqualify obviously biased jurors, such as in a product liability case where a juror’s family member has been ill affected by the product in question.

So it came as some surprise to see that while the U.S. Food and Drug Administration has been cleaning its house of researchers and professionals with potential conflicts of interests on its advisory panels, it seems to have failed to do so when it comes to its consumer members and other kinds of conflicts of interest, as Merrill Goozner recounts:

I was rather shocked as the patient representative — Margy Lawrence of Potomac, Md. — on the panel announced her vote against approving the drug. ‘My son died of sudden cardiac arrest,’ she said. ‘Seroquel was part of his cocktail.’

Margy Lawrence sat on the advisory committee panel that recommended against granting Seroquel approval for additional uses (except one, as a second-line treatment for major depression when other treatments have failed). How can a process be thought to be fair and unbiased with such a representative? If this were a jury trial, Ms. Lawrence would’ve never sat on the jury to begin with. Shouldn’t all government processes seek to uphold the same sense of fairness and balance, no matter whether they’re a jury trial or a government advisory panel making influential recommendations?

Philip over at Furious Seasons suggests, “It would be virtually impossible to have patient and consumer reps on FDA advisory panels who do not have some kind of experience or exposure (through themselves, family members or friends) to the very meds they are being asked to review.” I suppose that’s true. But couldn’t we ask that anyone who attributes a direct family member’s death to the drug under review to recuse themselves from such a panel? I mean, we’re kidding ourselves if we believe such a member could be objective in their criticism (just as we were kidding ourselves about those researchers).

I’m glad the FDA has scrubbed its panels of direct pharmaceutical influence. But let’s not swing the scale in the other direction and put people on these panels who have an equally direct negative bias against a company’s product for very good personal reasons. As Goozner notes, if that happens, the process itself could be at risk of being discredited, hopelessly unable to assemble an unbiased, objective and independent panel.

Hat tip: Furious Seasons