Friday, April 10, 2009

Who Is Now Scolding the "Pharmascolds?"

Ah, there they go again. This week, the Wall Street Journal published an op-ed by David A Shaywitz and Dr Thomas P Stossel whose title says it all, "It's Time to Fight the 'Pharmascolds.'"
On the Hooked: Ethics, Medicine and Pharma Blog, Dr Howard Brody provided a pithy point by point response to Shaywitz and Stossel, which is very much worth reading. But given the sweeping nature of Shaywitz and Stossel's arguments, and the prominent forum in which they appeared, I thought I could add to the discussion.

Shaywitz and Stossel's main point was that "relationships between university researchers and medical product companies are under relentless attack by critics who portray these associations as a morality play in which noble academics struggle to resist the dark, corrupting influence of industry." They castigated

the disproportionate influence of a coterie of prominent critics we have previously dubbed 'pharmascolds,' who routinely vilify the medical products industry and portray academics working with it as traitors and sellouts. These critics are pious academics, self-righteous medical journal editors, and opportunistic politicians and journalists. Their condemnation of anyone's legitimate profit -- it's all 'corruption' in their book -- has in fact materially enhanced their own careers. They extrapolate from occasional behavioral lapses in industry -- which is equally, if not more prevalent, in universities -- to demonize the market and portray scientific medicine as an ascetic religion, which it is not.

I can't claim to be "prominent," and my career has certainly not been "materially enhanced" so far by my writing on Health Care Renewal, but I am sure some of what my colleagues and I have written puts us at least in the company of more prominent "pharmascolds," in Shaywitz and Stossel's book.

However, their arguments seem to be based on a slippery slope, or, on over-generalization of criticism of certain kinds of relationships among certain people and organizations under certain circumstances.

In particular, I see nothing wrong, in general, with "relationships" among academics and industry. However, there are specific kinds of conflicts of interest in academic medicine that ought to cause concern. So let me take this opportunity to first postulate a simple definition of conflict of interest in this context, and provide specific examples of the sorts of conflicts that ought to be troubling.

Definition: An individual conflict of interest occurs when a person with entrusted responsibility has another interest that may conflict with the proper exercise of that responsibility.

Examples of conflicts of interest relevant to academic medicine include:

- A physician entrusted to take the best possible care of individual patients receives payments from a drug manufacturer which might bias his or her decisions to use that company's drugs even for patients for whom these drugs would not be the best possible treatment.
- A clinical teacher entrusted to honestly impart information, skills, and judgment receives payments from a drug manufacturer which might bias his or her teaching in favor of that company's products
- A clinical researcher entrusted to discover and disseminate the truth based on research on human beings receives payments from a drug manufacturer which might bias the design, implementation, analysis or dissemination of studies on humans in favor of that manufacturer's products, or against its competitor's products
- An administrator entrusted to uphold the mission of the academic institution receives payments from a drug manufacturer that might bias his or her management decisions in favor of that company's interests, but against the institution's mission
- An academic entrusted to provide honest, clear health policy advice receives payments from a drug manufacturer that might bias his or her advice in favor of that company's interests

On the other hand, I do not have a problem with true collaboration among academics and industry that does not involve industry paying the academics money, or paying the academics' institutions money for which the individuals receive credit. One can envision all sorts of collaborations that do not involve one party paying the other.

Furthermore, I do not necessarily have a problem with industry paying an academic in the course of the conduct of basic science, that is in this case, science that does not involve research done on humans. Shaywitz and Stossel seem most concerned with the damage "pharmascolds" might do to basic and translational research. They warned of dire results from barriers that might mainly be designed to discourage the sorts of conflicts of interest listed above, but would damage the progress of basic science and translational research. For example, they warn

each new barrier -- such as the National Institutes of Health's ban on paid consulting for industry -- erected between publicly funded researchers and companies, especially cash-strapped start-ups where many of the breakthroughs occur, slows the progress of potential treatments.

There is the germ of an important idea in there. In fact, many medical academics simultaneously wear many hats. So someone who sees patients in practice, and teaches students about clinical medicine may also do bench research in the laboratory. Banning such an individual from receiving consulting payments from drug, biotechnology, device and other companies to prevent bias in his or her patient care or teaching might conceivably adversely affect his or her biomedical research. How to handle such trade-offs has not been widely discussed, but needs to be.

But the notion that all relationships among medical academics and industry are meant to promote science and find new cures for disease, but not to market products or influence policy in favor or industry, is at best naive.

So Shaywitz and Stossel's dire warnings that seemed based on this notion seem as naive as the notion they attribute to their opponents, that all relationships among academics and industry are evil.

Finally, Shaywitz and Stossel did some scolding of their own, addressed to medical academics who do not stand up for their relationships with industry

When challenged by reporters, most academic consultants to industry refuse to comment or offer a meek explanation, instead of retorting that industry pays them because they add critically important value. This evasion has only emboldened industry critics, disheartened company employees, and caused even allies to wonder if there really is something to hide.

They concluded with plea that academics with industry relationships stand up for these relationships, to wit,

For the sake of the many patients whose diseases require innovative treatments -- and for the medical philanthropists determined to make it happen -- it's time for the leaders of the medical products industry to take pride in their purpose and start fighting back.

They are entitled to their opinion, of course. However, there is just a whiff of hypocrisy emanating from this.

Just below it, Dr Stossel identifies himself as "a professor of medicine at Harvard and a fellow at the Manhattan Institute," which is surely true.

But it is also surely incomplete. As we have posted before, Dr Stossel himself has multiple relationships with industry, some of which he has revealed in other venues.

As we wrote in 2007, in a commentary in the New England Journal(1) in which Stossel attacked the rigorous conflicts of interest rules that were once again imposed on the US National Institutes of Health (NIH), Stossel disclosed

having received consulting fees from ZymeQuest, owning stock options in ZymeQuest and Biogen, and having pending and issued patents, owned by Brigham and Women's Hospital, some of which are licensed to ZymeQuest.

In another paean to a laissez-faire approach to conflicts of interest in Perspectives in Biology and Medicine(2), Stossel also disclosed that he

is a member of the Board of Directors of Zymequest Inc, and the Scientific Leadership Advisory Board of Merck & Co. The author is a founding scientist of Critical Biologics Corporation and a consultant to Boston Scientific, Inc., and Gerson-Lehrman, Inc.

In a commentary in the British Medical Journal(3) arguing once again that concerns with conflicts of interest have gone too far, he disclosed, he

is on the boards of directors and owns stock options in ZymeQuest and Critical Biologics Corporations, and his employer has licensed intellectual property to these companies, which may result in his receiving milestone payments, royalties and in the stock options having financial value. He receives fees for speaking to corporations and other organisations on the topic of conflict of interest. He has served on scientific advisory boards for Biogen, Dyax, and Merck.

So maybe Dr Stossel should take his own advice, and proudly declare his complex relationships with industry in the course of yet another of his arguments that any criticism of any relationships among medical academics and industry under any circumstances will deprive humanity of future cures of dread diseases. As long as medical academics with relationships to industry, of all kinds and in all contexts, fail to disclose such relationships when they might be germane to the topic at hand, others will continue to wonder if they indeed do have something to hide.


1. Stossel TP. Regulating academic-industrial research relationships - solving problems or stifling progress? N Engl J Med 2005; 353: 1060-1065. Link
2. Stossel TP. Regulation of financial conflicts of interest in medical practice and medical research. Perspect Biol Med 2007; 50: 54-71. Link
3. Stossel TP. Has the hunt for conflicts of interst gone too far? - Yes. Brit Med J 2008; 336: 476. Link

1 comment:

Anonymous said...

This ordeal only became precipitious due to exposure of wrongdoing. Had this not occured, neither would any precipite.

Conflicts of interests corrupt or alter the duties of others who are are obligated to perform.

The conflict can either be actual or potential. In this particular case, the corruption from the conflict of interest atrophies the reliability of clinical researchers, and perhaps IRBs, annotators, and so forth.

This happens because there are no clear guidelines between the pharma industry and elements of clinical research.

Other professions are different regarding conflicts of interests.

With lawyers, if a conflict of interest exists or is discovered, the lawyer involved with performing duties related to their profession withdrawls and new counsel is engaged as a result.

This is due to the Model Rules Of Professional Conduct. Perhaps the pharma industry needs a similiar Model Rules maxim.