healthy4u: Thomas Stossel

Using Logical Fallacies to Scold "Pharmascolds"

I first became dimly aware of how dysfunctional health care had become in the US after seeing, up close and personal, a case of attempted suppression of medical research because its content offended vested interests.  (See "Academic Freedom and the Corporate University" by Jennifer Washburn <a href="http://www.aaup.org/AAUP/pubsres/academe/2011/JF/Feat/wash.htm">here</a>.)  We have since blogged frequently about <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of research</a>, other threats to <a href="http://hcrenewal.blogspot.com/search/label/free%20speech">free speech</a> and <a href="http://hcrenewal.blogspot.com/search/label/academic%20freedom">academic freedom</a> in health care, and the larger <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, which undermines discussion of many of the threats to core values in health care. A Case Illustrating "How Academic Orthodoxy is Enforced?" Thus, I am always on the lookout for new cases which illuminate these issues.  So a recent <a href="http://www.forbes.com/sites/davidshaywitz/2011/09/18/how-academic-orthodoxy-is-enforced/">post</a> on the well-known Forbes blog site by David Shaywitz, identified only as a "contributor," caught my attention: <blockquote>an elite coterie of self-righteous academics seek not to level the playing field but to dominate it, imposing their particular world view on everyone else. Of course, conservatives, among others, have long alleged this is the true nature of American colleges– where tolerance and open-mindedness is said extend from the left all the way to … the far left. But we now have the opportunity to see this play out at the professional level as well.</blockquote> This sounds somewhat familiar. The FIRE (Foundation for Individual Rights in Education) <a href="http://www.thefire.org/">web-site</a> boasts a huge case file of attacks on free speech in academia. Most of them did not involve professional schools, or academic medicine in particular. Note, however, that FIRE is avowedly non-partisan, and while many attacks they deplore seemed to be on the free speech of those on the right, quite a few were also on those on the left. So what was the nature of this illuminating case? <blockquote>Those who wonder how academic orthodoxy is enforced in practice need look no further than the response to a recent lecture given at Case Western University by Dr. Tom Stossel, the American Cancer Society Professor of Medicine at Harvard, and Director of the Translational Medicine Division of the Brigham and Women’s Hospital, where he is also an attending physician. (Disclosure: Stossel was an academic colleague of mine back when I was in Boston, and we have co-written a number of commentaries over the years; we also coined the term, Pharmascolds.) Stossel’s lecture, from what I’ve heard, was well-attended — so good for him. But the real news was the three sentence email received by members of the Case Western faculty prior to Stossel’s lecture — a nastygram sent by a colleague at the neighboring Cleveland Clinic. Subject line: 'Re: Medicine Grand Rounds — Tuesday September 13th' (i.e. Stossel’s talk). Body of the email (in full): 'This guy is an embarrassment to the medical profession. Can’t believe you would have him provide Grand Rounds. Your trainees deserve better.'</blockquote> Enforcement or Just Argument? Unless there is more too it, however, this case would not seem to fit in the category of attempts at suppression of free speech or academic freedom. After all, the folks from FIRE often note that the best response to speech or writing with which one disagrees is more speech or writing. The case above seems to involve two people who disagree, Dr Stossel, and whoever wrote the email. Disagreement is what free speech is all about. Per the FIRE web-site <a href="http://thefire.org/cases/freespeech/">section</a> on free speech: <blockquote>Freedom of speech is a fundamental American freedom, and nowhere should it be more valued and protected than at America's colleges and universities. The 'marketplace of ideas' upon which a university depends for its intellectual vitality cannot flourish when students or faculty members must fear punishment for expressing views that might be unpopular with the public at large or disfavored by university administrators. </blockquote> For this case to be an example of someone trying to "enforce academic orthodoxy," there needs to be an action, or at least threat of an action to silence one of these two people, or to punish one of them for what he or she already said. So I looked for the next part of this case. But there appears to be a problem. There is no more to the case than what appears above: <blockquote>And there you have it — watch and learn kids! - here’s how A-list academics do it, in three steps and three sentences.</blockquote> So Mr Shaywitz appeared to be arguing that somehow the email sent about Dr Stossel is a threat to free speech. However, unless the email came from some academic official who could punish Dr Stossel or his audience at Case Western University, the threat to free speech is not apparent. So we need to find out who wrote the three-sentence email, and whether he or she had the power to enforce his or her opinions as orthodoxy.  Who wrote the email? <blockquote>The author of this email? Dr. Steven Nissen, perhaps America’s most quoted Pharmascold.</blockquote> Dr Nissen is <a href="http://my.clevelandclinic.org/staff_directory/staff_display.aspx?doctorid=1185">Chief</a> of Cardiovascular Medicine at the Cleveland Clinic. Although he appears to have an appointment at the Case Western Reserve Medical School, the chair of <a href="http://www.cwrumedicine.org/divisions/cardiovascular-medicine">cardiovascular medicine </a>there is Dr Dan Simon. Maybe Dr Nissen did not agree with Dr Stossel, but there is no obvious way he could "enforce" his dislike, or otherwise turn it into "orthodoxy." Dr Stossel's speech may be obnoxious to Dr Nissen. And Dr Nissen's written email may be obnoxious to Dr Stossel, and to Mr Shaywitz. However, neither side has enforced its orthodoxy on, or suppressed the speech of the other. Logical Fallacies Relativist Fallacy If Dr Nissen could enforce orthodoxy by merely writing an email, then Dr Stossel presumably could do so by giving his talk, and Mr Shaywitz could also do so by publishing his post. Implying that only Dr Nissen, with whom Mr Shaywitz disagreed, enforced orthodoxy appears to be an example of the <a href="http://www.nizkor.org/features/fallacies/relativist-fallacy.html">relativist fallacy</a>, the fallacy that a claim may be true for others, but not for the person making it. Thus the central premise of the blog post appeared to be based on a logical fallacy.  This suggests one should be highly skeptical that the goal of the published work was really the defense of free speech.  Straw Man Fallacy It did begin with a paean to free speech that even FIRE staff might like, but then posed an interesting contrast: <blockquote>When you think about the arguments raised by the Pharmascolds, critics who worry about university/industry interactions, constriction of academic freedom is typically cited as a key concern. To the Pharmascolds, industry represents an inherently corruptive influence on students and trainees, and threatens to impose a restrictive and biased world view upon them. While this 'Pharmascolds as defenders of academic freedom' narrative has certainly enjoyed considerable traction (likely related to the enabling role of journalists in this dynamic), there’s another competing narrative to consider.</blockquote> It appears that Mr Shaywitz really does not agree with the "Pharmascolds," a group in which he believes Dr Nissen fits.  Mr Shaywitz did not explain who the Pharmascolds other than Dr Nissen are. He did not provide evidence in support of his summary of their views.  So, at least in this blog post, the Pharmascolds appear to be straw men, and Mr Shaywitz thus appeared to be using the <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw man fallacy</a> to support his argument. A Second Relativist Fallacy Moreover, Mr Shaywitz did not try to challenge the truth of the "Pharmascolds'" supposed views. Rather, he offered a "competing narrative." That is a surprising form of argumentation for someone who seemed to be appealing to conservatives. The notion that there is no truth, only competing narratives, is straight out of post-modernism, a school of thought with which conservatives rarely identify. Mr Shaywitz's casting of his argument as a better, but still "competing narrative," thus appears to be another use of the <a href="http://www.nizkor.org/features/fallacies/relativist-fallacy.html">relativist fallacy</a>. So this extraordinary blog post in Forbes appears to be less a reasoned defense of free speech and academic freedom and more an attempt to once again discredit the "Pharmascolds," and hence to discredit anyone who is skeptical of the influence of pharmaceutical companies and other commercial vested interests on academic medicine. But like the <a href="http://hcrenewal.blogspot.com/2009/04/who-is-now-scolding-pharmascolds.html">last attempt </a>to mock the "Pharmascolds," this one was based on primarily on logical fallacies. Summary We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples <a href="http://hcrenewal.blogspot.com/2011/03/once-more-with-feeling-another-defense.html">here</a>, <a href="http://hcrenewal.blogspot.com/2010/11/there-you-go-again-richard-epstein-says.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2009/09/latest-version-of-argument-that-we-are.html">here</a>.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests. I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts.  While David Shaywtiz was identified only as a "contributor" on his Forbes post, and as an "adjunct scholar" on the <a href="http://www.aei.org/article/104155">version</a> on the American Enterprise Institute site, his <a href="http://blogs.forbes.com/people/davidshaywitz/">profile</a> on the Forbes site notes that he really is Dr David Shaywitz, trained as a "physician-scientist," who now "works at a biopharmaceutical company in San Francisco." His <a href="http://davidshaywitz.wordpress.com/">own blog</a> identifies him as "currently Director of Strategic and Commercial Planning at Theravance, a publicly-held drug development company in South San Francisco."  So perhaps Dr Shaywitz disagrees with the "Pharmascolds" because their skepticism may be perceived as threatening the vested interests of Dr Shaywitz's company? Perhaps the campaign against the "Pharmascolds" is yet another example of stealth health policy advocacy by those with vested interests that might be threatened by skepticism about ties among physicians, academic medicine, and industry? Physicians and the public need to stay extremely skeptical about much of published health policy advocacy, particularly when the arguments appear illogical, or the interests of the advocates are not clear.

Using Logical Fallacies to Scold "Pharmascolds"

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26 Sep 2011

BLOGSCAN - Reports from the ACRE Meeting

The proceedings at the first meeting of the benignly titled Association of Clinical Researchers and Educators (ACRE) was chronicled on the Carlat Psychiatry Blog <a href="http://carlatpsychiatry.blogspot.com/2009/07/acre-meeting-welcome-to-anger-village.html">here</a>, and on Postscript, the Prescription Project blog <a href="http://blog.prescriptionproject.org/?p=733">here</a>. ACRE, <a href="http://hcrenewal.blogspot.com/2009/07/stossel-and-acre-wheres-beef.html">founded by Dr Thomas Stossel </a>(see relevant post <a href="http://hcrenewal.blogspot.com/2007/04/can-people-with-conflicts-of-interest.html">here</a> on the sorts of arguments Dr Stossel has made), was founded to defend academics who are paid on the side by drug, biotechnology, and device companies from the complaints of the "pharmascolds." What I found most troubling was that the conference was officially opened by Dr Jeffrey Flier, the Dean of the Harvard medical school, implying a medical school endorsement of this group, and featured presentations by the presidents of the American Association of Clinical Endocrinologists, and the American Society of Hypertension, implying endorsement by these medical societies. But also see<a href="http://brodyhooked.blogspot.com/2009/07/carlats-take-on-acre-some-ruminations.html"> the comments </a>by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog that there may be a silver lining to this cloud.

BLOGSCAN - Reports from the ACRE Meeting

The proceedings at the first meeting of the benignly titled Association of Clinical Researchers and Educators (ACRE) was chronicled on the Carlat Psychiatry Blog here, and on Postscript, the Prescript…

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25 Jul 2009

STOSSEL and ACRE: WHERE'S the BEEF?

STOSSEL and ACRE – WHERE’S the BEEF? Thomas Stossel from Harvard is at it again. As Daniel Carlat has humorously <a href="http://carlatpsychiatry.blogspot.com/2009/07/acre-academics-craving-reimbursement.html">described</a>, Stossel is planning the inaugural meeting next week of a group to counter those he calls pharmascolds. The group is named ACRE – Association of Clinical Researchers and Educators. Here is its website: <a href="http://www.acreonline.org/">http://www.acreonline.org/</a> For months, Stossel has been warning of the dire negative consequences that will result from tightened conflict of interest policies, but he has not presented any persuasive examples of damage to “productive relationships between industry and physicians involved in clinical research and educational outreach.” At the same time, Dr. Stossel has conveniently overlooked the shenanigans of the bad actors whom Senator Grassley exposed. Dr. Stossel is a blowhard, as I have described here <a href="http://hcrenewal.blogspot.com/2008/02/dr-stossel-sounds-off.html">before</a>. But wait! ACRE has found something! A News item in the July 2009 issue of Nature Medicine (“Conflict of interest rules seen by some as too stringent”) quoted one of the participants in the upcoming ACRE conference. Avi Markowitz, chief of oncology at UT Medical Branch, Galveston, came up with this example: Patients taking a Sanofi Aventis chemotherapy product may experience peripheral neuropathy, which can cause unpleasant sensations in the hands and feet. ‘Sanofi Aventis had been providing Markowitz and his UTMB colleagues with free blankets and gloves for those patients. Last fall, however, the university adopted stricter rules banning industry freebies. Now, Markowitz can’t even accept the unbranded blankets and gloves that Sanofi Aventis has offered to provide.’ Reading between the lines, it is a good bet that these items originally were branded. Whatever. And never mind that the patients receiving chemotherapy at UTMB are doubtless billed a hefty facility fee that must include comfort items like blankets and gloves. Since when does a chief of oncology need to beg for these basic patient care provisions from drug companies? Is this all that ACRE can come up with? The ACRE homepage warned sternly of “restrictive conflict of interest policies that often sever productive relationships between industry and physicians involved in clinical research and educational outreach.” Does Thomas Stossel’s whining and catastrophizing through ACRE come down to piffling items like blankets and gloves for chemotherapy patients? That’s it? Where’s the beef? At least ACRE has the good sense not to include on its program the smooth operators whom Senator Grassley outed – like Nemeroff at Emory, Schatzberg at Stanford, Kuklo at Walter Reed, Keller at Brown, Biederman at Harvard. Not even Stossel has been brazen enough to try to defend them. The Nature Medicine News item does close on a helpful note: 'Stossel would like to see abuses involving financial conflicts of interest treated more like cases of scientific misconduct. Rather than forcing everyone to abide by prohibitive rules, he says administrators should focus on weeding out those who misbehave.' I say Amen to that, even if it is a day late and a dollar short. We have arrived at our present state of discomfiture because the leaders of academic institutions and professional societies looked the other way for too long. They failed to do their job of reining in the ethical outliers. Grassley had to do it for them. As a result, the rest of us will be burdened with new regulations for years to come. Those who did speak up years ago were ignored or demonized. As the saying goes, every group gets the leadership it deserves. Those in academic medicine had better not count on Stossel and ACRE to lead them out of the wilderness. Bernard Carroll.

STOSSEL and ACRE: WHERE'S the BEEF?

STOSSEL and ACRE – WHERE’S the BEEF?Thomas Stossel from Harvard is at it again. As Daniel Carlat has humorously described, Stossel is planning the inaugural meeting next week of a group to counter tho…

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18 Jul 2009

Who Is Now Scolding the "Pharmascolds?"

Ah, there they go again. This week, the Wall Street Journal published an <a href="http://online.wsj.com/article/SB123914780537299005.html">op-ed </a>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 <a href="http://brodyhooked.blogspot.com/2009/04/pharmascolds-strike-back-latest-from.html">provided</a> 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 <blockquote> 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. </blockquote> 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 <blockquote>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. </blockquote> 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 <blockquote>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. </blockquote>They concluded with plea that academics with industry relationships stand up for these relationships, to wit, <blockquote> 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. </blockquote> 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 <a href="http://hcrenewal.blogspot.com/2007/04/can-people-with-conflicts-of-interest.html">wrote in 2007</a>, in a <a href="http://content.nejm.org/cgi/reprint/353/10/1060.pdf">commentary</a> 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 <blockquote>having received consulting fees from <a href="http://zymequest.com/">ZymeQuest</a>, 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. </blockquote> In another paean to a laissez-faire approach to conflicts of interest in Perspectives in Biology and Medicine(2), Stossel also disclosed that he <blockquote> 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. </blockquote> 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 <blockquote> 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. </blockquote> 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. References 1. Stossel TP. Regulating academic-industrial research relationships - solving problems or stifling progress? N Engl J Med 2005; 353: 1060-1065. Link <a href="http://content.nejm.org/cgi/content/full/353/10/1060">here</a>. 2. Stossel TP. Regulation of financial conflicts of interest in medical practice and medical research. Perspect Biol Med 2007; 50: 54-71. Link <a href="http://muse.jhu.edu/journals/perspectives_in_biology_and_medicine/v050/50.1stossel.html">here</a>. 3. Stossel TP. Has the hunt for conflicts of interst gone too far? - Yes. Brit Med J 2008; 336: 476. Link <a href="http://www.bmj.com/cgi/content/full/336/7642/476">here</a>.

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 Hooke…

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10 Apr 2009

End of the Anechoic Effect: Editorial Reaction to the New NIH Rules

The announcement of the <a href="http://hcrenewal.blogspot.com/2005/02/nih-seeks-higher-standard-better-late.html">change in NIH conflict of interest rules </a>has created quite a bit of press, maybe finally signaling the end of the <a href="http://hcrenewal.blogspot.com/2004/12/anechoic-effect-and-conflicts-of.html">"anechoic effect"</a> for this particular story. Oddly enough, the old way of doing business at the NIH has found a few prominent apologists, echoing the troubling reaction by NIH staff <a href="http://hcrenewal.blogspot.com/2005/02/pogo-at-nih.html">I discussed yesterday. </a> For example, see the <a href="http://www.washingtonpost.com/wp-dyn/articles/A62214-2005Feb3.html">commentary by Steven Pearlstein in the Washington Post</a>. Here are a few quotes with my comments. "A Massachusetts politician once told me, over lunch at Boston's Locke-Ober cafe, that most systems work best when lubricated with a bit of moral ambiguity." As a Rhode Island resident, I didn't think this was a promising start for a discussion of ethics and research. The moral ambiguity of many politicians has fueled considerable cynicism about politics in general. "I'm not sure I see the wisdom of drawing a 'bright line,' ... between NIH scientistis doing basic research and commercial enterprises that build upon that research. " This is a false dichotomy, but seems to be a prevalent argument against the new standards. The false dichotomy is between major financial entanglements with pharma and biotechnology firms and no contact at all with such firms. NIH staff don't need to be paid huge consulting fees over and above their full-time salaries, or hold stock or collect stock options in pharmaceutical and biotech companies to work collaboratively with industry. "What purpose is served by preventing them (NIH staff) from making a buck by sharing that informal knowledge with profit-making companies?" The purpose is not having them feel beholden to the profit-making companies for all those bucks they make on the side. But again, why should people who work full-time for the NIH, and get six-figure salaries from the government, need to also "make a buck" from these companies? "A surprising number of people violated those [existing] rules [requiring disclosing conflicts of interest]. But rather than coping with that by dealing harshly and publicly with a few of the worse offenders, the NIH brass have now caved in to pressure from Capitol Hill to prohibit drug and biotech-related investments and commercial entanglements by their researchers." It is true that no one has yet dealt harshly with the NIH leaders who made the most money from consulting fees and stock options while supposedly working full time for Uncle Sam. Actually it is not true that the rules prohibit biotech-related investments by NIH staff, since they can still invest indirectly through, for example, mutual funds. Why is it bad in this case to listen to the opinion of Congress? "But the right question is not whether we should stomp out every last bit of such 'corruption,' but whether the price is worth it. Having a fuzzy line, and giving administrators some flexibility in enforcing it, was probably better for medicine, better for the biotech industry, and certainly better for the Washington economy." There has been very little research on the effects of conflicts of interest and corruption affecting the leaders of health care organizations, so there is no good data about what might be good for "medicine" or the public. However, it seems reasonable to hypothesize that commerical entanglements are bad because they may sway such NIH leaders, who have considerable power over what science gets done and how it is reported, in favor of their outside benefactors, leading to biased science, biased interpretation of science, and biased science policy. Furthermore, the knowledge that some NIH leaders may be beholden to commercial vested interests outside of the NIH threatens the credibility of all NIH sponsored research, the credibility of the NIH research priorities, and the credibility of NIH efforts to translate and disseminate research results. Finally, knowing that some NIH leaders are financially benefiting from conflicts of interest may clearly demoralize NIH staff, NIH-supported scientists, and researchers seeking NIH support who do not have such conflicts. Similar was <a href="http://www.forbes.com/columnists/free_forbes/2005/0214/040.html">the commentary in Forbes by Thomas P. Stossel MD</a>. "In the real world, these restrictions (on conflicts of interest) address nearly nonexistent scientific corruption and ultimately impede medical progress by depriving pharmaceutical companies of access to biomedical scholars." See my comments above. Since there have been few relevant studies, it's not clear how much corruption there is. Again, biomedical companies can easily get access to and collaborate with scholars without paying them personally for consulting or handing them stock options. "How did financial conflicts-of-interest rules get to be such a big deal? One reason is that the gatekeepers of the medical literature believe it is. Editors of high-profile medical journals vilify the pharmaceutical industry..." Funny, I have seen criticism that medical journals have been too cozy with that industry. Note that for Stossel the bogey-man seems to be journal editors, while for Pearlstein it was "Capitol Hill." "The public wants trustworthy science, and it can get that without new ethical rules. Even more, it wants results - lives saved - and it can't get those if commercial sponsorship of research is made difficult, if not impossible." Again, why should the public will find research more trustworthy if the researcher is getting paid on the side by industry? Again, note the false dichotomy. Industry can certainly sponsor research done at academic organizations by research grants without paying researchers consulting fees in addition to their full-time salaries. For contrast, see <a href="http://www.philly.com/mld/inquirer/10811695.htm">the editorial in the Philadelphia Inquirer</a>. My favorite quotes were: "The NIH staffers' outside work involved paid consulting, teaching, speaking or writing for private health-care firms - with drugmakes bankrolling many of the deals. Financial arrangements like these, allowed since, 1995, pose a huge conflict for all the 6,000-plus NIH scientists. How so? Because NIH officials' day jobs position them to promote or aid these firms through grants, contracts, and approvals." "As a group, NIH scientists pulled in millions of dollars in consulting and other fees. With that kind of money at stake, to whose interests were they most attuned - the publics', or their second employers'? "Institutes' officials must monitor whether an exodus of talent occurs. If so, the correct remedy is better pay - not watering down ethical core standards." 'Nuff said.

End of the Anechoic Effect: Editorial Reaction to the New NIH Rules

The announcement of the change in NIH conflict of interest rules has created quite a bit of press, maybe finally signaling the end of the "anechoic effect" for this particular story. Oddly enough, the…

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04 Feb 2005

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