healthy4u: gsk

Defending Academic Whistleblowers: Call Out the Marines?

At "<a href="http://hcrenewal.blogspot.com/2011/09/academic-medicine-deploys-logical.html">Academic Medicine Deploys a Logical Fallacy to Avoid Disclosing Inconvenient Truths</a>" Roy Poses wrote about the illogic employed by academia to weaken draft rules for researchers to disclose conflicts of interest. Another major component of research in academia might be termed "gangster tactics against whistleblowers on wrongdoing." In the following <a href="http://www.pogo.org/resources/public-health/amsterdam-complaint-to-gutmann-re-evans-et-al-misconduct-20110708.html">July 8, 2011 letter</a> to Dr. Amy Guttmann, President of the University of Pennsylvania (courtesy the Project on Government Oversight or POGO), a Penn psychiatry researcher, Dr. Jay Amsterdam, has retained a law firm to represent him in alleged research misconduct by others at Penn, specifically Dwight Evans, the Chair of the Department, and an Associate Professor Dr. Laszlo Gyulai (note: I have never met and do not know any of the people involved): <blockquote>"Dear Dr. Guttmann, On behalf of my client, Dr. Jay Amsterdam, Professor of Psychiatry at the University of Pennsylvania, I would like to inform you that we have filed a charge of research misconduct with the Office of Research Integrity (OR!) against Dr. Dwight L. Evans, Professor of Psychiatry and Chairman of the Department of Psychiatry at the University of Pennsylvania, and Dr. Laszlo Gyulai, Associate Professor of Psychiatry at the University of Pennsylvania. I have enclosed a copy of the complaint and referenced documents for your reference. As chairwoman of President Barack Obama's Presidential Commission for the Study of Bioethical Issues, I feel certain you will deal with this matter in a just and sincere fashion. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgFgtT962Efu8-gpfcRYG7kk8975vsX86dRBFgGFGOIuhWHAVS_vmgK4BDh-U3-t6QFUUjmEEoGlZbwQY-S8LpeJ0B5P6HKSQ9t8X2sFehndKgXueq84E53D7guaE8dn_beFFhbVaOspYgb/s1600/guttman.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5652590687739063698" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgFgtT962Efu8-gpfcRYG7kk8975vsX86dRBFgGFGOIuhWHAVS_vmgK4BDh-U3-t6QFUUjmEEoGlZbwQY-S8LpeJ0B5P6HKSQ9t8X2sFehndKgXueq84E53D7guaE8dn_beFFhbVaOspYgb/s320/guttman.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 255px; height: 320px;" /></a>Letter, page 1 (click to enlarge) </div><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg1aOv-Vr6o3qy1-iOMV9mh4lSLef5PjGr0sBsNzs7JTKsg92sZAiEiawooTx2fvXV79VTQQTog74xOMnwIG9syuihF_J6gkSNi_4QE6TBtaHJ5TFUDGaB7jDmayO4lJI2eK6m6ztwafotq/s1600/guttman.jpg"> </a> <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEie1LrZfOQ_TDSIWFhlGVmINoBbW-bcNkaRe4yWU2JcCrayjDrQN_4czphOnxjnEX81Tpse6FZCRDyn-ryGY7bMd4RDjTHCKOiNM6FM8sUAKMY9J3HXF742VQqbsbsjOgfXYhacTtLMLbuW/s1600/guttmannp2.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5652591223811191458" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEie1LrZfOQ_TDSIWFhlGVmINoBbW-bcNkaRe4yWU2JcCrayjDrQN_4czphOnxjnEX81Tpse6FZCRDyn-ryGY7bMd4RDjTHCKOiNM6FM8sUAKMY9J3HXF742VQqbsbsjOgfXYhacTtLMLbuW/s320/guttmannp2.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 249px; height: 320px;" /></a>Letter, page 2 (click to enlarge) </div></blockquote> The allegations are not in themselves surprising (at least to me). The complaint is that the defendants misappropriated data from a study conducted by the plaintiff, manipulated the data, and used it in a ghostwritten article by a major journal, the American Journal of Psychiatry, in a concealed marketing effort to increase sales of Paxil by GSK. We have documented many examples of this type of behavior in medical research at this blog. (By way of my not being surprised by such allegations, I personally have been involved as junior Yale faulty in that research university's professors' attempts to misappropriate my IP, a computer program I wrote for a Yale collaboration on birth defects in the Arab world, for their own use. My internal complaints were followed by severe retaliation, up to the level of blacklisting and extortion. Those attempts were aided by, of all things, an Associate General Counsel who was not authorized to practice law in the state, apparently not having taken the Law Boards. I put an end to that effort through legal means. This was followed a number of years later by attempted misappropriation of the same property by a Johns Hopkins-affiliated professor with his own software company in a DoD proposal. I also put an end to the latter effort, which involved informing the DoD.) However, my purpose here is not to comment on the allegations of research misconduct. It is to comment on a subject that occupies three of the four paragraphs in the above letter - protection from retaliation: <blockquote>... By filing this complaint, I expect my client to receive full and complete protection from retaliation and/ or defamation by either the University of Pennsylvania and/ or any other parties involved in publishing the referenced study. [E.g., GSK - ed.] It is my client's belief that the data from his study was effectively stolen from him, manipulated and used in a ghostwritten article published in the American Journal of Psychiatry in order to advance a marketing scheme by GlaxoSmithKline to increase sales of Paxil. If any acts of retaliation and/or defamation are taken against my client, I will immediately inform ORI and the Health and Human Services Office of the Inspector General. Furthermore, it is my understanding that several congressional committees have expressed an interest in investigating the problem of research misconduct and ghostwriting in academia and, thus, I intend to allow my client to fully cooperate with any investigation and will inform Congress of any retaliation against him for such cooperation. To ensure this complaint is taken seriously, and to alert interested parties, I am providing copies of this correspondence to Senator Charles Grassley, Senator Herb Kohl, and the Chairman and Ranking members of the House Energy and Commerce, and the House Committee on Oversight and Government Reform. </blockquote>About the only resources left out of the list of protectors of the plaintiff from abuse are the Marines ... and perhaps a threat of "Frontier Justice." That a law firm must include explicit threats to expose retaliation against whistleblowers to high-ranking members of Congress suggests Research universities and their corporate allies have become more like the Mafia than centers of novel scientific discovery. This all reminds me of my Jan. 13, 1999 letter to the editor in the Journal of the American Medical Association (JAMA) entitled "<a href="http://jama.ama-assn.org/content/281/2/135.2.extract">Academic and Legal Aspects of Authorship Disputes</a>." As a result of my Yale experience (which, incidentally, also probably damaged nascent cross-cultural progress due to the unusual aspect of my work in facilitating improved care of children with birth defects in a Middle Eastern oil-producing Kingdom), I wrote a response to a July 1998 JAMA article on growing authorship disputes and abuses at Harvard Medical School ("<a href="http://jama.ama-assn.org/content/280/3/216.abstract">Authorship: The Coin of the Realm, The Source of Complaints</a>" by then-Ombud Linda J. Wilcox). I wrote: <blockquote> Jan. 13, 1999 To the editor: I was alarmed by the statement in the article on authorship by Ms Wilcox [1] saying, "It is unreasonable for institutions to promise that they can protect individuals from retaliation for coming forward to complain through formal grievance procedures." Most organizations have policies on retaliation, especially with regard to grievances. If enforced, these policies can discourage such behavior and ensure the victim of redress. In addition, retaliation such as that mentioned in the public and federal sectors is downright illegal, and university employees fall under Department of Labor workplace standards and laws for their respective states. Universities have serious ethical and credibility problems if they have such poor control over their employees that they cannot promise to protect individuals from actions contrary to their own grievance policies and that are probably illegal.</blockquote> I continued on with the argument that lawlessness in universities was counterproductive and needed to be halted, but Ms. Wilcox' reply was more platitudinous than substantive about the 'helplessness' of universities in protecting their own from retaliation. It seems little has changed. To expect the best research from such an environment is like expecting silk purses to be manufactured by pork producers. -- SS

Defending Academic Whistleblowers: Call Out the Marines?

At " Academic Medicine Deploys a Logical Fallacy to Avoid Disclosing Inconvenient Truths " Roy Poses wrote about the illogic emplo...

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Study: Researchers with Glaxo ties favored Avandia

As mentioned in my previous post on the MIT controversy surrounding an economist's testifying to Congress on healthcare policy without revealing possible economic conflicts of interest that could affect his views, frequently expressed on this blog are concerns about undisclosed conflicts of interest and their corrosive effects upon healthcare (<a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">query link</a>). One major question that arises is the degree to which conflicts of interest can affect the integrity of the scientific literature. Answering this question is more a matter of social science research rather than biomedical inquiry. One internal medicine resident at the Mayo Clinic took on this challenge and published such a study, a systematic review, in the British Medical Journal. It is entitled "<a style="font-weight: bold;" href="http://www.bmj.com/cgi/content/full/340/mar18_1/c1344">Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review</a>" (BMJ 2010;340:c1344). Mayo Clinical researchers led by the resident, Amy Wang, examined more than 200 articles that appeared after an analysis in the NEJM linked Avandia to a 43 percent increased risk of heart attacks, and a subsequent clinical trial found no greater danger of heart disease. The results are fascinating. From a summary in the <a href="http://www.philly.com/inquirer/business/homepage/20100320_Study__Researchers_with_Glaxo_ties_favored_Avandia.html">Philadelphia Inquirer</a>:<blockquote> "We aimed to determine whether financial conflicts of interest with pharmaceutical manufacturers could be fueling this fire," wrote the researchers, led by Amy Wang, a resident in internal medicine at the Mayo Clinic in Rochester, Minn. "From our findings, it appears that the answer is yes.</blockquote> From the BMJ article itself, free full text available as of this writing at link above: <blockquote>For each article, we sought information about the authors’ financial conflicts of interest in the report itself and elsewhere (that is, in all publications within two years of the original publication and online). Two reviewers blinded to the authors’ financial relationships independently classified each article as presenting a favourable (that is, rosiglitazone does not increase the risk of myocardial infarction), neutral, or unfavourable view on the risk of myocardial infarction with rosiglitazone and on recommendations on the use of the drug.</blockquote> The "and elsewhere" can be a valuable addition to the capabilities of today's researchers, often enabled via the internet (e.g., non-literature based resources such as conference brochures, personal web pages, corporate and other financial disclosures. etc.) when articles themselves prove unrevealing. Overall, this is a straightforward methodology, and while potentially subject to bias and expertise issues, nonetheless seems an excellent new contribution to the needed social research on undisclosed COI's. As to results (see the full article for statistical details I am omitting here): <blockquote> Of the 202 included articles, 108 (53%) had a conflict of interest statement. Ninety authors (45%) had financial conflicts of interest. Authors who had a favourable view of the risk of myocardial infarction with rosiglitazone were more likely to have financial conflicts of interest with manufacturers of antihyperglycaemic agents in general, and with rosiglitazone manufacturers in particular, than authors who had an unfavourable view. There was likewise a strong association between favourable recommendations on the use of rosiglitazone and financial conflicts of interest. These links persisted when articles rather than authors were used as the unit of analysis, when the analysis was restricted to opinion articles or to articles in which the rosiglitazone controversy was the main focus, and both in articles published before and after the Food and Drug Administration issued a safety warning for rosiglitazone.</blockquote> While causality is not proven, these results are still stunning. Per the Inquirer's summary: <blockquote>... Almost 90 percent of scientists who wrote positive articles, reviews, or commentaries about Avandia had financial ties to London-based Glaxo, the study published in the British Medical Journal found. Almost three of every four authors who expressed negative views of the drug had no financial ties to manufacturers of diabetes medicines, while just 6 percent of those with positive opinions of the drug received no funding or fees from industry.</blockquote> The authors cite prior literature also demonstrating an associations of COI with pro-industry views (references 2-6; #2 is regarding the mid 1990's calcium channel blocker controversy). The authors observe that: <blockquote>In the past decade, research and policy has focused on this association [between COI and pro-industry views - ed.], leading to important progress in policies to manage and encourage disclosure of such financial conflicts of interest. </blockquote> Their findings about the effects of this "progress" was particularly disappointing, that only about half of the articles carried conflict-of-interest statements: <blockquote> Of the 202 eligible studies (10 reported original research, 91 were letters, editorials, or commentaries, and 101 were reviews, meta-analyses, or guidelines), 108 articles (53%) included a conflict of interest statement. [The other 47% did not - ed.] </blockquote>One wonders about the publishers of the articles themselves omitting COI statements, either acknowledging possible COI's or confirming that no COI's exist. <blockquote>... A total of 90 (45%) of the 202 articles were authored by individuals who had financial conflicts of interest. Of the 90 studies with conflicts of interest, 69 (77%) had a statement disclosing the conflict of interest in the article itself. The other 21 studies with financial conflicts of interest (23%) did not disclose these relationships, which were discovered through searching other publications by the same author or the internet. Three (14%) of these 21 studies published a statement declaring no conflicts of interest. [Oops - ed.]</blockquote> So, almost one quarter of articles with author COI did not disclose that fact, and several misrepresented the issue. Finally, the pharmaceutical company's view, also published in the Inquirer article cited above: <blockquote>A Glaxo spokeswoman said the company posted information and results from all its clinical trials on its Web site. "It's vital that people have trust in the way we do research and the way it's made public," Jo Revill, Glaxo spokeswoman, said yesterday. "Part of that is sharing data. What we have done is develop policies that will have disclosure and encourage disclosure." </blockquote> "Encouraging" disclosure of COI's is far too weak a stand for a pharmaceutical company to take on such a critical issue, in my view. The Mayo researchers wisely conclude: <blockquote> Disclosure rates for financial conflicts of interest were unexpectedly low, and there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies. Although these findings do not necessarily indicate a causal link between the position taken on the cardiac risk of rosiglitazone in patients with diabetes and the authors’ financial conflicts of interest, they underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted.</blockquote> Finally, I add that these findings are not too surprising. It's human nature not to bite the hand that feeds you. Money is also a powerful stimulant to the brain's rationalization (as opposed to rational) centers. We as a culture do truly need to understand the potential corrosive effects on the scientific literature of dysfunctions such as ghostwriting, financial and other conflicts of interest, publish-or-perish pressures of academia, and other such social issues. These practices also simply need to be abolished, for as I have written before on these pages ("<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2009/08/has-ghostwriting-infected-experts-with.html">Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?</a>"), once a "critical mass" of faux knowledge is put into circulation via the scientific literature, even the ostensibly impartial experts' views can become tainted, dependent as they are on that very same scientific literature. Even worse, we don't know what that critical mass is - or whether we've reached it already. -- SS

Study: Researchers with Glaxo ties favored Avandia

As mentioned in my previous post on the MIT controversy surrounding an economist's testifying to Congress on healthcare policy without r...

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