healthy4u: Cox-2 inhibitors

The latest version of the argument that we are all getting too worked up over conflicts of interest in health care has appeared, this time in a scholarly, peer-reviewed journal. (Hirsch LJ. Conflicts of interest, authorship, and disclosures in industry-related scientific publishing: the tort bar and editorial oversight in medical journals. Mayo Clinic Proc 2009; 84: 811-821. Link <a href="http://www.mayoclinicproceedings.com/content/84/9/811.full?etoc">here</a>.) The major point of the paper seems to be that payments to physicians, particularly academic physicians by pharmaceutical, biotechnology, and device companies are necessary for medical progress, so instead of perseverating about them, we all should pay far more attention to the evil of payments made for expert testimony by physicians who serve as expert witnesses in litigation against such companies. In the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2009/09/fairness-in-enforcing-coi-regs-by.html">addressed</a> this main argument, while dismissing the bulk of the article as merely "illogic and innuendo." I think that Dr Brody failed to grasp the educational opportunities that the Hirsch article presented. It offers a true cornucopia of logical fallacies, making it ideal teaching material for the sort of course in logic and evidence that should be taught in all our medical schools, but is not. So let me use this "teachable moment" to address just some of the many logical fallacies that Dr Hirsch so enthusiastically employed, in order of their first appearance in his article. Appeal to Ridicule <blockquote> There is a politically correct herd mentality that ascribes to the concept that objectivity is forsaken by medical companies that seek profit (and by their employees) because of 'conflict of interest.' </blockquote> Also, <blockquote> These overt restrictions on researcher communications in today’s climate of political correctness on COI are causing more than policy debates among various stakeholders.... </blockquote> In both these examples, concerns about conflicts of interest are deemed mere "political correctness." Thus, this is an <a href="http://www.nizkor.org/features/fallacies/appeal-to-ridicule.html">appeal to ridicule</a>. <blockquote> Yet today there is a McCarthyesque reaction to the term, conflict of interest, with an unstated presumption of guilt until proven innocent. </blockquote> Here instead the term of ridicule is "McCarthyesque." Straw Man Fallacy <blockquote> There is a politically correct herd mentality that ascribes to the concept that objectivity is forsaken by medical companies that seek profit (and by their employees) because of 'conflict of interest.' </blockquote> This single sentence employed two fallacies for the price of one. I would challenge Dr Hirsch to provide a credible example that any thoughtful figure in the conflict of interest discussion has dismissed the objectivity of all for profit health care corporations, and all of their employees. He apparently has constructed a <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw man </a>argument which he has attributed to his opponents, one that is either to strike down than their real arguments. Appeal to Authority <blockquote> Previously, the president of the Association of American Medical Colleges emphasized that the term indicates a state of affairs and not a behavior, that COIs are ubiquitous, and that despite their inaccurate portrayal by the media, COIs do not indicate the occurrence of any improper behavior, much less scientific misconduct, analogous to a state of potential energy </blockquote> If he said it, was he right? Is he still right today? Obviously, because someone with a distinguished title expresses an opinion does not mean it is true. Thus, this is an <a href="http://www.nizkor.org/features/fallacies/appeal-to-authority.html">appeal to authority</a>. (Note: since the reference appended to this sentence appears to have nothing to do with the content of the sentence, it is not even clear that the authority in question made such a statement. Link <a href="http://jama.ama-assn.org/cgi/content/full/286/10/1232">here</a>.) Appeal to Common Practice <blockquote> Publication bias (preferential publication of studies with positive outcomes vs trials with negative, neutral, or ambiguous outcomes) has been reported for more than 2 decades,.... Publication bias clearly extends to government- and nonprofit-funded research.... </blockquote> The thrust here was clearly that publication bias is common and has been around for a long time, so why worry? This is an <a href="http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html">appeal to common practice</a>, which equates a statement that a pheonomenon is common with the assertion that it is reasonable, justified, ethical, optimal, etc. Special Pleading <blockquote> For the 2008 article that was critical of Merck’s authorship practices by Ross, Hill, Egilman and Krumholz, the entire disclosure statement was, 'All of the authors have been compensated for their work as consultants at the request of plaintiffs in litigation against Merck & Co, Inc, related to rofecoxib.' Only in the middle of the Comment (Discussion) portion of the article was it mentioned that the authors had served as paid expert witnesses for plaintiffs’ attorneys in rofecoxib litigation. The terse disclosure statement seems at odds with JAMA’s stated policy in its Instructions for Authors that financial COI disclosure must be complete. Regardless, the information provided hardly conveyed that, as of January 2007, Krumholz had received more than $300,000 for his consulting from plaintiffs’ attorney Mark Lanier (no relationship to Mayo Clinic Proceedings Editor-in-Chief William L. Lanier, MD), which only became public in a letter to the editor of BMJ that responded to a previous article critical of Merck by Krumholz et al. Krumholz’ remuneration seems substantial until it is compared to that of another coauthor of the JAMA authorship report,16 David Egilman. Egilman has testified for Mr Lanier and other attorneys in more than 100 tort cases (nearly always for plaintiffs) for approximately 2 decades and, by his own estimate, has earned $20 to $25 million for such testimony. </blockquote> [Note: this discussion appeared in the midst of a long tirade against the editorial policies and practices of JAMA, especially in relation to controversy about the drug rofecoxib (Vioxx), the now withdrawn Merck Cox-2 inhibitor. Dr Hirsch apparently was responsible for Merck's publication policies about this drug. Further note that there are major questions about whether the figures supplied by Dr Hirsch are correct. Appended to the post in Dr Brody's blog <a href="http://brodyhooked.blogspot.com/2009/09/fairness-in-enforcing-coi-regs-by.html">post</a> is a categorical denial by Dr Krumholz that he was paid, as asserted by Dr Hirsch, over $300,000, and evidence against the assertions by Dr Hirsch about Dr Egilman's pay.] While Dr Hirsch alleged that the disclosures by the authors of this article were incomplete, he did not compare them to the disclosures made by authors of other articles in JAMA. In fact, I have never seen an article in JAMA which included disclsoure of dollar amounts, and could not find any such disclosure in spot checks of the latest issue. On the other hand, here is the disclosure Dr Hirsch made in his own article: <blockquote> Dr Hirsch was an employee at Merck & Co from 1988-2006 and managed the Medical Communications Department for clinical research publications from late 2001 to mid-2006. He currently is employed at a medical device and technology company that has no financial interest in any matters related to rofecoxib or the resulting tort litigation involving Merck & Co. Dr Hirsch owns mutual funds with stock from a variety of pharmaceutical and device companies, including Merck, and some shares of Merck and other medical product companies. </blockquote> He did not disclose dollar amounts connected with any of these activities. He would not name his current employer on the grounds that it has no interest in rofecoxib and related litigation. However, his article is ostensibly about the broader issues of conflict of interest, authorship, etc which may relate to the interests of Becton Dickinson, which currently employs Dr Hirsch in the capacity of <a href="http://www.bd.com/us/diabetes/page.aspx?cat=7001&id=19101&CMP=OTC-RSS_Diabetes">Worldwide Vice President of Medical Affairs, BD Diabetes Care</a>. He did not name the "medical product companies" whose shares he owns. Thus, Dr Hirsch argued that Dr Krumholz and Dr Egilman were wrong not to disclose the details of their financial arrangements with plaintiffs' attorneys (setting aside the likely inaccuracy of Dr Hirsch's contentions about the specifics of these arrangements), even though the detail they provided in their disclosures was similar to that provided by other JAMA authors, and even though Dr Hirsch did not find it necessary to himself disclose in such detail. Thus, Dr Hirsch was advocating a double standard, and in this case, his argument amounts to a <a href="http://www.nizkor.org/features/fallacies/special-pleading.html">special pleading</a>, since the standard he advocated for others was not the same he felt obliged to uphold. Appeal to Fear <blockquote> [standards regarding COI] are beginning to affect the willingness of prominent researchers to interact with industry in any manner that involves even minimal compensation for their time and efforts. </blockquote> Also, <blockquote> There are serious negative implications for the future of medical product development if top academic researchers are shamed into ceasing any type of compensated interactions with industry. </blockquote> Dr Hirsch implied that medical progress would be greatly endangered if industry no longer paid practicing physicians and full-time academics to work on the side, and that such payments would no longer be possible were COI disclosure requirements to be made more strict. Such dire warnings, without evidence to support them, amount to <a href="http://www.nizkor.org/features/fallacies/appeal-to-fear.html">appeals to fear</a>. Summary So Dr Hirsch has provided yet another example of an apologia for conflicted physicians and academics based on a panoply of logical fallacies. We have offered several other examples of fallacious defenses of conflicts of interest, compiled<a href="http://hcrenewal.blogspot.com/search/label/logical%20fallacies"> here</a>. It is sad to see logical fallacies so cavalierly employed. There frequent, sometimes strident use in current health policy suggest the need to better train health care professionals in logic and the use of evidence. I am still awaiting a defense of the sorts of conflicts of interest that we frequently discuss on Health Care Renewal that is based on logic and evidence, but it may be that no one can produce such a defense. Meanwhile, we continue to recommend that at the very least, medical academics, medical academic institutions, and other health care not-for-profits or NGOs should reveal in detail what payments they get from companies selling health care products or services, and how these payments could relate to the companies' marketing or lobbying efforts. In the US, some such disclosure would be mandated by the proposed "Sunshine" legislation now being considered by the US Congress. (By the way, note that this problem is hardly confined to the US, and needs global, not just American attention.) However, physicians (at least physicians in full-time private practice, academic positions, and employed by mission-oriented not for profit organizations) should go further, and consider whether receiving industry money is worth the ongoing damage it does to our professionalism and our professional reputations. Medical schools, universities, health care foundations, disease advocacy groups, and other health care not-for-profits and NGOs should also go further, and consider whether receiving industry money is worth the ongoing damage it does to their missions, and their institutional reputations.

Again, Defending Conflicts of Interest with Logical Fallacies

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Re the $2.3 billion dollar Pfizer settlement, in the headlines today... <a href="http://hcrenewal.blogspot.com/">Health Care Renewal </a>readers learned about it in February, <a href="http://hcrenewal.blogspot.com/2009/02/pfizer-settles-for-mere-2300000000.html">here</a>. At the time, we mentioned how little coverage the news had received, a manifestation of the <a href="http://hcrenewal.blogspot.com/2007/08/bling-bling-poltical-correctness-and.html">anechoic effect</a>. We said this about it then: <blockquote> We have posted about numerous settlements of charges of misbehavior by drug, device, insurance and other health care organizations. Stacking them all up suggests the magnitude of bad behavior by the leaders of health care organizations. Yet it's not clear that all these monetary penalties are discouraging bad behavior. In almost all cases, the monetary penalties accrue to the organization as a whole, not to the individuals whose behavior incited the settlement. And I have not so far ever heard of a case in which the organization which has to pay a settlement turns around and enforces a penalty upon the responsible leaders. Thus, the deterrent effect, even of large penalties, is thus diffuse. An executive, knowing that bad behavior may increase short term profits, and hence may markedly increase his or her compensation in the short run, may be undeterred by the threat of a future settlement that he or she does not have to pay. Instead, the settlement may come out of the pockets of stock-holders, employees as a whole, customers, clients, or patients, or the public. If we want to prevent health care leaders from continuing "childish" behaviors, allowing health care to "spin out of control," (as per President Obama' inaugural address, see post <a href="http://hcrenewal.blogspot.com/2009/01/inaugural-moment-to-improve-health-care.html">here</a>), we must do a better job of enforcing negative consequences, as the mother of any five-year old will tell us. </blockquote> Rest assured we will have more to say about this topic, now that it is in the headlines.

Pfizer's $2,300,000,000 Settlement No Longer Anechoic

Re the $2.3 billion dollar Pfizer settlement, in the headlines today...Health Care Renewal readers learned about it in February, here.At the time, we mentioned how little coverage the news had receive…

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Again, Defending Conflicts of Interest with Logical Fallacies

Pfizer's $2,300,000,000 Settlement No Longer Anechoic

Another Cox-2 Takes a Fall