PhilStatLaw: Bad-Faith Assertions of Conflicts of Interest?*

In response to an indication that the FDA might need to loosen conflict-of-interest (COI) rules to get sufficient experts to serve on their advisory panels, a list has been proferred of “industry-free” experts capable of serving with “clean hands”  (See Oct 10 post: Junk Science ) But why not also seek “litigation-free” experts, asks lawyer, Nathan Schachtman on his interesting blog (Dec. 28) The Continuing Saga of Bad-Faith Assertions of Conflicts of Interest:
Conflicts of interest (COI), real or potential, have become a weapon used to silence the manufacturing industry in various scientific debates and discussions.  Other equally “interested” parties, labor unions, advocacy groups, and consultants to the other industry – the litigation industry – have used conflicts and ethical claims to silence the manufacturing industry and to engage in unfettered false scientific speech. The public, unwilling and untrained to look at evidence on the merits, is conditioned to accepting an allegation of COI as the end of the discussion on scientific issues.
Recently, journalist Shannon Brownlee … “Is There an Independent Unbiased Expert in the House” (Aug. 3, 2011)…sent FDA Commissioner Margaret Hamburg a list of allegedly neutral experts who could advise the agency.  Brownlee gave everyone on her list a clean bill of ethical health, and has published the list on multiple occasions, …. What the gullible may not appreciate is that the list fallaciously is based upon only one exclusionary criterion:  having consulted for the pharmaceutical industry.  The list omits other important COI exclusionary criteria, such as having consulted for the litigation industry, or having taken erroneous, unwarranted, and ideologically driven positions on scientific issues.
What litigation industry?  Brownlee may have missed the fact that plaintiffs’ lawyers represent a huge financial interest in obtaining compensation for others, with 40 percent of the proceeds going to themselves.  This litigation industry thrives, even with Dickie Scruggs in prison, and Stanley Chesley in disrepute.
In today’s litigation environment, with aggregation of claims in federal multi-district cases, plaintiffs’ counsel stand to profit in the billions from scientific positions espoused by their expert witnesses.
…..Now some people may claim that the litigation industry consultants, and the anti-industry zealots, take their positions not to please their sponsors, or to pursue lucrative opportunity, but because they fervently believe the positions that they take. But then why not give the pharmaceutical industry consultants the same benefit of the doubt?  Indeed, why not move beyond COI allegations to creating lists of scientists and physicians who have demonstrated proficiency in advancing evidence-based judgments that have withstood the test of time? This anti-industry hypocrisy manifests not only in assertions of conflicts of interest, but also in calls for industry to disclose all underlying data from industry-funded or sponsored studies, while taking a protectionist stance on all other underlying data.
For his full article see his Dec 28 post.
There is indeed a tendency to regard suspicions of industry consultants as altogether justified while downplaying or ignoring possible biases of “anti-industry zealots”.  Schachtman regards this as unfair “anti-industry hypocrisy”, and he may well be correct.  Thoughts? 


*BLOG-CROSSING!  I just noticed Schachtman discusses some earlier posts of my blog on his blog today with a post called, “The Will to Ummph“!
Categories: Statistics | Tags: , , , | 5 Comments

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5 thoughts on “PhilStatLaw: Bad-Faith Assertions of Conflicts of Interest?*

  1. Corey

    Schachtman’s post is meretricious garbage. He wrote all of that and never got around to explaining how it would redound to the benefit of an expert associated with the “litigation industry” to give anything but his or her honest assessment to the FDA. (Indeed, it’s in the financial interest of such advisors to be lax in order to enable the (possible) malfeasance of the pharmaceutical industry and thereby get paid for testifying as experts at subsequent lawsuits.)
    I don’t deny that the assessments of such experts, while honest, might be skewed by past associations, but that is a question of cognitive bias, not conflict of interest. So by all means, let us make having a demonstrated proficiency in advancing evidence-based judgments that have withstood the test of time be a *necessary* condition for serving as a scientific advisor to the FDA. But don’t try to pretend that pharma-associated experts and “litigation industry” associated experts interests’ are equal and opposite when it comes to regulating drugs.

    • I take his point to be that some of the litigation lawyers have made large profits, and he mentions a couple who are in jail. It would be a conflict, would it not, if they gave biased interpretations of data so as to win the case and reap profits? Wouldn’t that be more than cognitive bias? Advising the FDA might be different, as you say, but entanglements on both sides are not unknown. Thanks for the comment.

  2. NathanSchachtman

    Well, some may think my post was garbage, but it was certainly not
    meretricious. Maybe gratuitous would be a better adjective because it describes the compensation that I received from writing it.

    Associations with the litigation industry are not merely a possible source of cognitive bias. In the vast literature on conflicts of interest, non-financial conflicts are recognized as potent, whether they be friendship, familial relationship, or what lawyers refer to as “positional” conflicts. Working as an expert witness for either side is remunerative, with fees often approach $1,000/hr.

    Human motivations are often mixed and complex. Scientists with pharma industry “ties” may be just as interested in public health goals as those with litigation industry ties. My point is that they both may have COI. Indeed, my post was directed at the fact that several of the supposed neutral experts had testified for the litigation industry, and they had been compensated by those litigation entrepreneurs. Those COIs are on the same footing in my view as the experts paid for consultation with pharmaceutical companies, except of course pharmaceutical companies sometimes do really make lifesaving drugs, whereas plaintiffs’ lawyers not so much. This is a reality, not a pretend exercise.

    The scenario described for the motivation of the putative expert, with litigation industry ties, who sits on an FDA Advisory Committee panel, assumes that the panel is advising on the initial licensing of the medication. Just as likely is that the AdCom member is voting on a recommendation to withdraw the medication or to change its labeling or indication. One thing that is clear beyond cavil: When an AdCom votes on such a recommendation, regardless whether the FDA follows the recommendation, plaintiffs’ lawyers will file lawsuits.

    NAS

    • Corey


      One thing that is clear beyond cavil: When an AdCom votes on such a recommendation, regardless whether the FDA follows the recommendation, plaintiffs’ lawyers will file lawsuits.”

      I am justly rebutted and withdraw my argument.
      Like Reply

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