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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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Academic Medicine Deploys a Logical Fallacy to Avoid Disclosing Inconvenient Truths

We recently <a href="http://hcrenewal.blogspot.com/2011/08/retreat-back-to-regulatory-capture-us.html">discussed</a> a simultaneous retreat from aggressive regulation and enforcement applied to big health care corporations by US government agencies.  Now a story published by Bloomberg (currently available without a subscription <a href="http://pharmagossip.blogspot.com/2011/09/universities-lobby-pushed-obama-to-keep.html">here</a> on PharmaGossip) showed that the push for less disclosure of relationships with industry that generated conflicts of interest for academic medicine came not from industry, but from ... academic medicine: <blockquote>The lobby for Harvard University and other research institutions drove the Obama administration to weaken draft rules for scientists to disclose potential conflicts of interest, according to U.S. records and watchdog groups.</blockquote> In particular, <blockquote>Universities objected to draft rules in a letter to NIH and in meetings with officials at the White House Office of Management and Budget, approver of the final version, said Carrie Wolinetz, associate vice president for federal relations at the Association of American Universities that represents 61 research universities.</blockquote> Also, <blockquote>The letter was co-signed with the Association of American Medical Colleges, American Council on Education and Association of Public and Land-Grant Universities. </blockquote> The one example of the universities' reasoning to justify their objections to greater disclosure of conflicts of interest was striking. <blockquote>Wolinetz’s organization wrote in the letter that 'there is a paucity of evidence that the disclosure and management of financial conflicts of interest affect objectivity and integrity.'</blockquote> Recall that the disclosure to which they objected would be by federally funded researchers, and of financial relationships with organizations that had vested interests related to the particular research projects. The Institute of Medicine's landmark <a href="http://www.iom.edu/~/media/Files/Report%20Files/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice/COI%20report%20brief%20for%20web.pdf">report</a>, "Conflict of Interest in Medical Research, Education and Practice,"  stated: <blockquote>Disclosure of financial relationships with industry is an essential, though limited, first step in identifying and responding to conflicts of interest.</blockquote> One could also argue, as did Senator Grassley, (see <a href="http://hcrenewal.blogspot.com/2011/08/retreat-back-to-regulatory-capture-us.html">here</a>) that disclosure is owed to the tax-payers who support the research. On the other hand, I do not think anyone would argue that disclosure and the ill-defined "management" proposed by the NIH would be sufficient to guarantee "objectivity and integrity" of the research. In fact, the IOM report called for going far beyond disclosure.  Specifically, it called for banning most conflicts affecting most clinical research: <blockquote>researchers should not conduct research involving human participants if they have a financial interest in the outcome of the research</blockquote> This goes far beyond what the original NIH revision of its conflict of interest rules mandated. However, I am sure that banning such relationships was the last thing that the AAU and AAMC wanted. So the academic institutions' argument seems to be a variant on the<a href="http://www.nizkor.org/features/fallacies/false-dilemma.html"> false dilemma logical fallacy</a>. If the only alternative to doing nothing about conflicts of interest is disclosure, and if disclosure is really a poor solution to the problem, than perhaps doing nothing makes sense. However, if disclosure is just a necessary first step, as the IOM asserted, then it is a first step that should be taken in preparation for other steps to come. Note that the academic institutions' argument also seems to be a version of what has been called the <a href="http://www.ozarkia.net/bill/anarchism/Fallacies.html#Nirvana">Nirvana fallacy</a>, or the perfect is the enemy of the good fallacy. That is, if what one can do does not result in Nirvana, then one should do nothing. Finally, in this case the academic medical institutions' argument seemed too extreme even for their pharmaceutical industry supporters. As the Bloomberg article reported, <blockquote>Researchers have been lax making financial disclosures and there’s been an absence of oversight, said Peter Pitts, president of the Center for Medicine in the Public Interest, a nonprofit research institute in New York. 'When you don’t properly disclose, you give the impression that you’re trying to hide something.' Institutes should instead disclose all financial interests without trying to judge whether they are conflicts, Pitts said.</blockquote> As we have <a href="http://hcrenewal.blogspot.com/2008/01/logical-fallacies-and-discussion-of.html">discussed previously</a>, Peter Pitts' main occupation has been as a leader in public relations for the pharmaceutical industry. He is currently a senior partner, director, global regulatory & health policy <a href="http://www.porternovelli.com/news-room/forcing-the-hand-facebooks-policy-change-and-the-future-of-pharmaceuticals/">for Porter Novelli</a>. Even though we have previously criticized Pitts for deploying logical fallacies in support of industry positions, in this case the academic medical institutions' argument was too much for him to support. So we have come this far. Universities are ostensibly about finding and disseminating the truth. Yet universities' academic medical subsidiaries now deploy illogic to avoid revealing particular truths that they find uncomfortable, and which might raise questions about relationships with industry that are increasingly lucrative. Universities seem now willing to jettison their mission to make more money. True health care reform would require academic medicine to put its mission ahead of its revenues.

Academic Medicine Deploys a Logical Fallacy to Avoid Disclosing Inconvenient Truths

We recently discussed a simultaneous retreat from aggressive regulation and enforcement applied to big health care corporations by US gover...

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Bioethics panel blasts late U. Pittsburgh professor's 1940s tests in Guatemala

I have only two comments about this horrendous story (read the entire story at the link): <div style="border: medium none; text-align: left; background-color: transparent; color: rgb(0, 0, 0); overflow: hidden; text-decoration: none;"> <div class="story_headline" _counted="undefined"><a href="http://www.post-gazette.com/pg/11257/1174449-84-3.stm"></a></div><blockquote><div class="story_headline" _counted="undefined"><a href="http://www.post-gazette.com/pg/11257/1174449-84.stm">Bioethics panel blasts late Pitt professor's 1940s tests in Guatemala</a></div> <div class="story_lastupdate">Wednesday, September 14, 2011</div> <div class="story_byline">By Torsten Ove, Pittsburgh Post-Gazette In February 1948, John C. Cutler injected a Guatemalan mental patient named Berta with syphilis. A month later, she developed scabies, a skin disease, and a few weeks later Dr. Cutler noticed that she had lesions on her arms and legs and that her skin was wasting away. He finally treated her for syphilis, but on Aug. 23 wrote that she appeared to be dying. He wasn't sure what was killing her, yet on that same day he placed gonorrheal pus from a male subject into her eyes, her urethra and her rectum. A few days later her eyes had filled with pus and she was bleeding from her urethra. She died on Aug. 27. Berta was one of 83 subjects who died during the course of experiments and diagnostic testing conducted by Dr. Cutler and his U.S. Public Health Service colleagues on more than 5,000 subjects in Guatemala from 1946 to 1948. Her story was among several included in a report released Tuesday by an ethics panel that has been examining Dr. Cutler's research at the direction of President Barack Obama. The Presidential Commission for the Study of Bioethical Issues concluded that Dr. Cutler, an assistant U.S. surgeon general and later a professor at the University of Pittsburgh, engaged in "egregious moral wrongs" in intentionally infecting about 1,300 Guatemalans with syphilis. The report also concluded that his supervisors, including Surgeon General Thomas Parran, founder of Pitt's Graduate School of Public Health in 1948, approved of what Dr. Cutler was doing in the name of what he called "pure science." "Rather than a faulty chain of command," the report says, "there was a failure of both professional and institutional leadership in disregarding the excesses of the Guatemala experiments." ... After reviewing more than 125,000 pages of documents detailing events from 1935 to 1956 and also traveling to Guatemala, a team of full-time researchers found that Dr. Cutler's experiments involved a total of 5,500 Guatemalans. He drew blood from and conducted spinal taps on many of them, including orphans and school children, and deliberately infected 1,308 inmates, mental patients, soldiers and prostitutes with syphilis to see if penicillin would cure it. About half of those subjects were never treated. Researchers found that 83 of the 5,500 total died during the two years of the study, but they aren't sure what killed them.</div></blockquote> My comments are these: 1. If someone can explain to me how this "research" for "pure science" differed from the <a href="http://en.wikipedia.org/wiki/Nazi_human_experimentation">medical "research" conducted by the Nazis</a>, I'd like to hear it. 2. Are there "research projects" in this country or others ongoing presently that have been shaped by the same ethical mold? I.e., the experts know best, informed consent is optional or unnecessary, and keeping track of known injuries and deaths is rarely done? -- SS <div style="border: medium none; text-align: left; background-color: transparent; color: rgb(0, 0, 0); overflow: hidden; text-decoration: none;"><a style="color: rgb(0, 51, 153);" href="http://www.post-gazette.com/pg/11257/1174449-84-2.stm#ixzz1XwYqh0UQ"></a></div><a style="color: rgb(0, 51, 153);" href="http://www.post-gazette.com/pg/11257/1174449-84.stm#ixzz1XwYhYDwm"></a></div>

Bioethics panel blasts late U. Pittsburgh professor's 1940s tests in Guatemala

I have only two comments about this horrendous story (read the entire story at the link): Bioethics panel blasts late Pitt professor's...

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Guest Blog: Mediator, symptom of a broken French system

Elena Pasca blogs at PharmaCritique, and is a member of the <a href="http://sciencescitoyennes.org/">Fondation Sciences Citoyennes</a>.  She discusses the pharmaceutical industry in France, and relationships among that industry and physicians and the government.  She demonstrates that the issues we discuss on Health Care Renewal are global. Introduction A few weeks ago, the French health minister proposed a new law to improve pharmacovigilance, drug evaluation and transparency issues. It will be discussed in September by the Parliament. Let’s see what the actual situation is in France. The Médiator (benfluorex) scandal raises not only pharmacovigilance issues. The first question that comes to one’s mind is how could the drugmaker Servier, who knew about its dangers, keep Médiator on the market for 30 years, despite the repeated alerts and the withdrawal of other amphetamines from the same drug class? The answer goes far behind pharmacovigilance dysfunction. Médiator is not an isolated case, but an epiphenomenon of structural failures on every organisational level of the French health care, drug evaluation and health information system. The entire system is broken, and there still are dozens of defective and too risky drugs on the French market. Most relevant for US readers is not to list all the alerts starting in the seventies with the fenfluramines. It’s to understand that the entire system was organised in order to be as industry friendly as possible. And the announced measures aren’t going far enough to change this fact. Private profits before public health In July 2009, president Nicolas Sarkozy decorated Jacques Servier with the Légion d’honneur and criticised again what he considered to be a huge amount of administrative regulations in the pharmaceutical branch. For him as the former business attorney of Servier, whose electoral program stipulated “cleaning business law”, too much regulation means less business, less competitive French drugmakers. President Sarkozy’s health policy clearly favours the pharmaceutical industry, especially Sanofi-Aventis. His choice of Alzheimer disease as the first public health issue is not naïve. Sarkozy’s brothers have multiple conflicts of interests and ties with Sanofi-Aventis, the insurance industry and the organisations and institutions involved in the health care of the elderly, as I <a href="http://pharmacritique.20minutes-blogs.fr/archive/2009/03/05/alzheimer-nouvelle-fondation-de-cooperation-scientifique-mai.html">pointed out</a> in an investigation published on Pharmacritique. And Sanofi hasn’t yet any me-too from the anticholinesterase drug class largely prescribed to Alzheimer patients, despite repeated proof of their ineffectiveness and of their side effects. As a direct result of Sarkozy’s policy, publicly funded research will be exploited through public-private partnerships to produce immediate results – and neglecting fundamental research bringing new knowledge and thus real therapeutic progress. The intellectual property policy clearly favours private profits. The European research policy has the same aims: the Innovative Medicines Initiative is clearly oriented toward “innovation” meant as competitive advantage for the pharmaceutical industry, not as an improvement in disease understanding and treatment. The exploitation of public research for private corporate profits has been <a href="http://www.helmholtz.de/fileadmin/user_upload/helmholtz_international/br%C3%BCssel/IMI_Policy_Document_Comparison_HGF.PDF">criticised </a>by the Helmholtz Gemeinschat (union of the German public research centres). A few weeks ago, 98 European NGOs and organisations wrote an <a href="http://sciencescitoyennes.org/open-letter-eu-research/">open letter</a> criticising the Common Strategic Framework for EU Research and Innovation Funding and asking for a responsible European research policy: “Public Research should benefit Society, not Big Business”. Conflicts of interests are everywhere, corrupting the entire health care system In France, except for two journals (Prescrire and Pratiques), the entire medical press is completely dependent on drugmakers and their advertising. Especially family physicians receive such journals for free. They include no disclosures, so there’s no possibility to sort out advertising from information. Most of those journals are owned by a trust whose leader is Gérard Kouchner, brother of the former health minister Dr. Bernard Kouchner. (See <a href="http://pharmacritique.20minutes-blogs.fr/archive/2008/10/06/presse-medicale-nos-generalistes-sont-en-bonnes-mains-pour-l.html">this post</a> on PharmaCritique.) To this misinformation by the sponsored press has to be added another source of bias: continuing medical education [CME] is funded up to 98% by the pharmaceutical industry. And up to 97% of self-employed physicians still receive drug reps and consider them to be a comfortable, if not reliable, information source. As long as I can go back, all health ministers have had conflicts of interest. In a hearing by the Parliament’s committee on Médiator, Gérard Kouchner was questioned about his journals’ silence about the risks of this drug and about the book written by the whistleblower Dr. Irène Frachon. He answered those journals are serious, no odd news, no sensationalism… As if informing physicians about severe side effects of a drug and experts’ conflicts of interests and drugmaker influence wouldn’t be serious enough… The state can’t control conflicts of interest and implement oversight because the medical corporation is well organised (trade unions…) and opposes every reform or measure restricting its freedom. And the medical lobby knows how to use its political influence. Commercial interests, entrepreneurship, industrial funding (research, travel, professional activities, CME…) are organised and encouraged by the Order of Physicians. Despite of the 1994 law prohibiting gifts, dining, wining and lodging continues. Daily corruption is widely accepted, since it is approved by the Order of Physicians… Organised medicine’s unusually strong influence over France’s health care system is well described by Marc Rodwin in his book “Conflicts of Interest and the Future of Medicine. The United States, France, and Japan” (Oxford University Press 2011). The French FDA – AFSSAPS - is financed up to 80% by the pharmaceutical industry, via taxes. Up to 70% of the AFSSAPS experts have conflicts of interest. But the real percentage must be higher, because the recently introduced disclosures aren’t verified, and omissions or false declarations aren’t prosecuted. In a 2007 report, AFSSAPS officials had to acknowledge their strategy of “managing” conflicts of interests wasn’t a success... The more drugs the agency approves, the more money it gets. Drugmakers exploit competition existing among European agencies to earn more money, and they also know which country will easily approve their drugs, opening the door for a homologation by the EMA (European Medicines Agency). When a drugmaker knows this or that drug is defective, approval is not even attempted in the US, but only in certain European countries. Why risk a defeat that could damage its image? For example, during the swine flu epidemics, some vaccine makers haven’t asked for approval in the USA, because their vaccines contain new technologies (MDCK cells, adjuvants such as squalen) they wanted to “test” on European people first, before submitting them to the FDA. The German independent journal <a href="http://www.arznei-telegramm.de/">Arznei-Telegramm</a> revealed the existence of a market analysis counselling this strategy (2009; 40: 85-7). None of the swine flu vaccines commercialised in Europe were approved in the US. The same laboratories produced different vaccines, and new technologies were used instead of the classical ones, in the name of the… emergency. Since then, hundreds of cases of narcolepsy were reported, especially among children and teen-agers, as a side effect of GSK’s Pandemrix (containing squalen).  (See <a href="http://pharmacritique.20minutes-blogs.fr/archive/2011/03/31/la-suede-suspend-le-pandemrix-a-cause-de-la-narcolepsie-mich.html">this post</a> on PharmaCritique.) Complete lack of information about drugs and their adverse reactions Pharmacovigilance in France is rather pharmacosomnolence: the AFSSAPS reacts late after others western countries when it comes to puttin a defective drug off the market. On the opposite, it easily accepts homologation demands. If you compare the drugs available in France and the USA, you’ll find lots of drugs rapidly withdrawn or rejected by the FDA, or even unknown in the US: etoricoxib (Arcoxia), nimesulid, rimonabant (Acomplia), lots of progestagens, veraliprid (Agréal)… After the FDA decision, it took 11 years to take Distilbene (DES) off the French market. Vioxx continued for years on the French market after its withdrawal in the US. Mediator was withdrawn 1997 in the US, 2010 in France. And so on. In a 2008 article, Donald Light highlighted “Europeans are kept in ignorance about dangerous drugs” (Rev Prescrire 2008;28(297):553). He gave several examples of drugs such as aprotinin, olanzapine, etoricoxib, sleeping drugs… where safety alerts have been made public by the FDA and relayed by the US media, and compared this information with the silence in France. Before the Médiator scandal, the French media weren’t interested in drug safety, conflicts of interest, corruption, bias in the medical research… But it’s even worse. The public has no access to the official prescribing information, reserved to physicians paying for the Vidal (equivalent of the Physicians’ Desk Reference), edited by a private company… I compared the prescribing information of lots for drugs available in the US and in France, produced by the same drug companies, approved in the same indications. The information is so different, as if they weren’t the same drugs… France has few relevant regulations and laws, so the country is a paradise for the pharmaceutical industry, and for industries, lobbies and business in general. There’s no FOIA, no way for watchdogs – even for official watchdog agencies – to get real information. In a 2007 report, the IGAS (General Inspection of Social Affairs, France’s OIG) only could give estimations, based on extrapolations, about lobbying and marketing expenses of the pharmaceutical industry. Consumers International published the results of a 2008 conducted inquiry about drugmakers’ legal obligations in the US compared to Europe. 12 drugmakers answered and all agreed the requirements aren’t at all the same, in regard of transparency and disclosures, in regard of complete information about drugs, and so on. So why would drugmakers give an information no one requires and no one wants? Pharmacovigilance is subordinated to drug approval, and until recently, patients couldn’t report side effects. A pharmacovigilance official told me that even now, adverse reaction reports without documentation and follow-up aren’t always counted. The regional pharmacovigilance centres don’t forward them to the AFSSAPS. There’s no transparency about the specific phases of the drug evaluation system, in terms of risk/benefits, and there’s no evaluation at all in terms of cost/effectiveness and economic efficiency. The Haute Autorité de Santé was created for this kind of quality and economic efficiency evaluation, like the German IQWIG and the British NICE. But everything it does is officialise drugmaker marketing claims and “assess” the improvement in the actual benefit. But it’s only a formal assessment, and I don’t remember of a drug dismissed by this agency because of insufficient improvement… In January 2011, president Sarkozy appointed Pr. Jean-Luc Harousseau as the head of the Haute Autorité de Santé, despite all the recent promises to reform the system and fight against the conflicts of interest of experts and officials. Pr. Harousseau is the perfect example of French opinion leaders with political and industrial interests that become experts and leaders of national institutions: he was politically involved in Sarkozy’s party (UMP); he and his research teams earned more than 200.000 euros in the 3 years before his nomination.  (See <a href="http://pharmacritique.20minutes-blogs.fr/archive/2011/03/13/has-presidence-de-l-ump-jean-luc-harousseau-qui-a-percu-205.html">this post</a> on PharmaCritique.) Philippe Lamoureux, the former head of INPES (National Institute for Prevention and Health Education) went over to the LEEM (French PhRMA), without any “cooling off” period. (See<a href="http://pharmacritique.20minutes-blogs.fr/archive/2008/09/20/conflits-d-interets-public-prive-au-plus-haut-niveau-de-l-et.html"> this post</a> on PharmCritique.) The revolving doors turn very easily in France, as well as in Europe. ALTER-EU (Alliance for Lobbying Transparency and Ethics Regulation) reported about EMA’s former director, Thomas Löngrenn, who took a job as a lobbyist for the pharmaceutical industry, just like other European commissioners. And Guido Rasi, the next EMA director, <a href="http://www.alter-eu.org/fr/press-releases/2011/02/25/conflict-of-interest-case-involving-ex-ema-director">said</a> at a colloquium in Bologna that an expert without conflicts of interest is not interesting, because drug companies only work with the best… Some other points in brief: - there’s no Sunshine Act or any similar obligation in France; - the 2002 law requiring a disclosure for health professionals talking publicly about a drug is not applied; - no whistleblower protection (so that libel law is used all the time against them in SLAPP’s: strategic lawsuits against public participation); - there are no specific laws (like the US False Claims Act or RICO) allowing trials for defective drugs or other abuses; no possibility for a qui tam lawsuit; - no law to prosecute corruption and its consequences (like the US Federal Anti Kickback Statute); - no law enabling class actions; - no specific qualifications for victims of defective drugs (“injury”, “aggravated deception” are those used by Médiator victims and their families…); - taxpayers pay for the victims (if ever they can get recognition and damages); - no physician liability for prescriptions and their consequences, or for conflicts of interest and corruption; - no FOIA; a minimalist law called CADA (« accès aux documents administratifs ») preserves secrecy of data and of conflicts of interests in the name of industrial property and private life protection); - no corporate integrity agreement; - no attorney general asset redistribution programs (well, without trials, there’s no need for such frameworks…); - no disclosure in scientific publications. Direct-to-consumer advertising is prohibited by law. A good point. But this prohibition is by-passed all the time. Pharmaceutical firms sponsor “health education campaigns” organised together with public institutions, medical societies and/or patient associations tied to drugmakers. For example, a public campaign whose official goal is to raise awareness about the “dangers” of cholesterol is meant to transform a risk factor in a disease, medicalise more and more people who will look for the statins commercialised by the sponsor Pfizer. Not to speak about the repeated attempts of the European Commission to impose the “pharmaceutical package” wanted by EFPIA (European Federation of Pharmaceutical Industry Associations), i.e. enable drugmakers to have a direct access to patients and provide “information”, and weaken pharmacovigilance through several regulations exposed in <a href="http://english.prescrire.org/en/79/207/46302/362/355/SubReportDetails.aspx">this text</a> by Prescrire International. Worst of both socialised medicine and market logic The French system allies the worst side of socialised medicine and of the market and competition-based system. Co-payments were introduced a few years ago, but cost reimbursement is still good. Everyone has a public insurance (“régime général”) that covers about 65% of the costs, for a quite large list of drugs and procedures. For the remaining 35%, each individual has to pay for a private insurance. There is a public “universal” insurance for people earning less than 650 euros a month. Nevertheless, about 23% give up health care, because of the costs, and especially because of excessive charges exceeding the statutory fees. This rate is much higher in dental and optical care, where public coverage is almost inexistent. So what’s the problem, compared with countries without universal health insurance? The problem is lack of organisation, poor economic efficiency and quality, in regard of the high costs. Primary care isn’t organised as it should be in a socialised system. Most of it consists of self-employed physicians working alone, and the same applies for self-employed specialists outside hospitals. They work without coordination and oversight. More and more for-profit hospitals are founded, to treat lucrative, acute diseases, leaving the chronic ones and all complications to public hospitals that still do a good job, but are chronically deficient, because of inappropriate activity-based payment model and budget distribution, and because of budgetary restrictions as a result of an irrational policy of economic management and accountable cost containment. This lack of organisation originates in organised medicine’s resistance to any restriction and oversight. It hinders every evaluation in terms of quality and leads to specific forms of conflicts of interest and global poor quality. The recent introduction of some pay-for-performance measures worsens the problem; incentives are paid by the social security for objectives that aren’t subjected to any evaluation. Family physicians get up to 9.000 euros extra a year if they obtain the wanted percentages of regular breast screening, influenza vaccines in elderly, and so on. It’s not prevention, but overmedicalisation and aggressive preventive medicine as described by David Sackett. Organised medicine dominates and shapes France’s medical economy and health care organisation. It also blocks the development of not-for-profit hospitals, created by mutual insurers, as well as any form of medical centres employing physicians. Every attempt to regulate charges exceeding the statutory fees is blocked. The Order of Physicians is the only “judge” in cases of misconduct, and it rarely forwards the proof to the public watchdogs or to prosecutors. Self-regulation through voluntary codes of conduct is the rule, for the medical corporation as well as for the pharmaceutical industry. This can’t be called “socialised medicine” and contradicts the republican principles originating in the French revolution, fought to put a stop to corporations and their influence on public decision, on politics and on economy. Medical consumerism and physician financial interests complete themselves, and “socialised medicine” isn’t appropriate anymore to describe the French system. The dangers for public health care and coverage were pointed out in a paper written by the former medical director of social security, Pr. Claude Béraud.  (See <a href="http://pharmacritique.20minutes-blogs.fr/archive/2011/07/08/menaces-sur-l-assurance-maladie-entre-fictions-et-realites.html">this post</a> on PharmaCritique.) Of course, such a system isn’t affordable in the long term. And this is exactly what ultra-capitalists and right-wing politicians want, in order to demolish socialised medicine and public health care and promote private health maintenance organisations and insurances. Passivity, no awareness, no criticism Another consequence of a deformed conception of socialised medicine is patients’ lack of health education, of healthy skepticism, of criticism and of action. Before the Médiator scandal, patients were too confident in what they thought to be state protection on every level : an approved drug was thought to be sure and useful, an opinion leader’s discourse promoting some new drug was thought to express the highest technical standards, and so on. There was no awareness at all about conflicts of interest. Physicians’ awareness wasn’t much better. For example, Arnold Relman wrote his paper about “The new medical-industrial complex” in 1980. In France, it took 25 years until Jean-Claude Salomon wrote “The medical-financial complex”… The only resistance comes from a few organisations, such as the independent medical journal Prescrire and the grassroots NGO Fondation Sciences Citoyennes, and from a few personalities such as senator François Autain, Pr. Claude Béraud and a few others, mentioned by Marc Rodwin in his book “Conflicts of Interest and the Future of Medicine. The United States, France, and Japan”. The <a href="http://sciencescitoyennes.org/projet-de-loi-lanceurs-d%E2%80%99alerte/">Fondation Sciences Citoyennes</a> and the <a href="http://www.alter-eu.org/fr">European Alliance for Lobbying Transparency and Ethic Regulation</a> regularly protest and start actions and proposals about revolving doors, lobbying, conflicts of interests and corruption in all areas, as well as law proposals about expertise deontology and whistleblower protection. Lots of reports without consequences The left-wing representatives in the two parliament chambers have put in place hearings about the Mediator scandal, but no enquiry that could enable them to investigate the structural causes of repeated drug and conflicts of interest problems and take concrete measures. Some of the representatives are members of the “Club Hippocrate”, sponsored by Glaxo Smith Kline… The congressman Bernard Debré and the former medicine professor Philippe Even, known for his longstanding criticism, have written a vehement report about the drug evaluation system. Without consequences. The Inspector General for Social Affairs (IGAS) has published a report on Médiator that clearly points out the responsibilities: every single institution has failed, from the drug agency to the political instances and the medical organisations. The <a href="http://www.ladocumentationfrancaise.fr/rapports-publics/114000331/index.shtml">last report</a> of the same IGAS, published in June, contains concrete and pragmatic proposals on how to deeply reform the entire pharmacovigilance and drug evaluation system. The assessment process initiated by the health minister Xavier Bertrand – Assises du Médicament – has nothing to do with a trial assessing facts (“assises” means a trial with jurors). The working groups were clearly dominated by LEEM (the French PhRMA) representatives and by opinion leaders tied to drugmakers. Most of the independent organisations and critiques were not allowed to participate, “in order to respect a balance” between different interests. Fondation Sciences Citoyennes was <a href="http://sciencescitoyennes.org/construisons-un-front-commun-pour-des-contre-assises-du-medicament-independantes/">excluded</a> and described the situation in this detailed press release, asking independent NGOs to organise counter-Assises.  The law proposal presented on the 1st August by Xavier Bertrand contains some long due measures, but no real progress. The pharmaceutical industry’s interests won’t be endangered by any measures and laws arising from the Médiator scandal. Elena Pasca Pharmacritique, Fondation Sciences Citoyennes ADDENDUM - Elena Pasca asked me to insert her thanks that we published her guest post.  But we owe her considerable thanks for her efforts to explain the French situation, and show how the issues we discuss on Health Care Renewal are truly global.

Guest Blog: Mediator, symptom of a broken French system

Elena Pasca blogs at PharmaCritique, and is a member of the Fondation Sciences Citoyennes . She discusses the pharmaceutical industry in Fr...

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Once Again, on IBM Watson, Cybernetic Miracles and Reductionist Views of Medicine

The cybernetic miracle shamans are at it again: <blockquote><a href="http://www.engadget.com/2011/09/12/ibms-watson-set-to-tackle-health-insurance-takes-diagnosis-fo/">IBM's Watson set to tackle health insurance, takes 'Diagnosis for $1,000'</a> via Engadget by Billy Steele on 9/12/11 After tackling your tech support woes, the famed Watson is moving on to mop up the health insurance industry. That's right, the IBM showstopper we all know and love for trouncing trivia kings on Jeopardy has been hired by one of the largest health insurance company's in the US. WellPoint Inc. [yes - <a href="http://hcrenewal.blogspot.com/search/label/WellPoint">this</a> WellPoint, a company that HC Renewal has referenced not just a few times - ed.] will make use of the system's breakneck speed and healthcare database alongside patient records -- allowing the supercomputer to guide treatment options and prescribe medicines. [Med Mal plaintiff's attorneys: take note - ed.] Once implemented, data will be combined from three sources in a matter of seconds: a patient's chart / records from a doctor, the insurance company's patient history and the medical knowledge that Watson already possesses. A pilot program will roll out next year to a number of cancer facilities, academic medical centers and oncology practices. No word yet on when The Watson School of Medicine will start accepting applications.</blockquote> I wrote on these issues quite seriously back in January 2011 at this post: "<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/01/ibms-watson-jeopardy-and-revolutioning.html">IBM's Watson, Jeopardy, and Revolutionizing Medicine</a>." I wrote on a somewhat sarcastic note at this March 2011 post: "<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/03/quick-thought-on-cybernetic-medicine.html">Here Comes the Judge! A Quick Thought on Cybernetic Medicine: Why Can't Computers Also Do Law?</a>" My views are unchanged since then. Roy Poses adds a good point: <ul><li>Where are the clinical trials? There is nothing here about actually doing clinical trials to test if Watson is accurate enough to do more good than harm before rolling this out. [As Scot has said a zillion times] This is an experimental technology akin to a new medical device that should be tested as rigorously as any new device or drug should be tested before it is used on patients. </li></ul>To which I further add: <ul><li>Where is the patient informed consent? </li></ul>-- SS Addendum: Perhaps Watson should better replace our "they're all the best and brightest" hospital CEO's and managers.

Once Again, on IBM Watson, Cybernetic Miracles and Reductionist Views of Medicine

The cybernetic miracle shamans are at it again: IBM's Watson set to tackle health insurance, takes 'Diagnosis for $1,000' via En...

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Director of Bristol-Myers-Squibb to Run Weill Cornell Medical School

How the New York Times reported on a change in leadership at one New York medical school has made one issue of interest to Health Care Renewal a bit less <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>. Here is the beginning of the <a href="http://www.nytimes.com/2011/09/08/nyregion/laurie-h-glimcher-named-dean-of-weill-cornell-medical-college.html">story</a>: <blockquote>A Harvard University researcher and professor with strong ties to the pharmaceutical industry has been selected as the new dean of Weill Cornell Medical College in Manhattan, as Cornell University seeks to greatly expand its research programs and obtain more federal and private financing, college officials said Wednesday. The new dean, Dr. Laurie H. Glimcher, 60, who has ties to the pharmaceutical giants Merck and Bristol-Myers Squibb as well as to scientific and biotechnology companies, said she wanted to use her experience to forge partnerships with both the public and private sectors. </blockquote> Dr Glimcher's "ties" to Bristol-Myers-Squibb are particularly striking: <blockquote>Bristol-Myers Squibb, where she has been on the board since 1997, paid her $244,500 in compensation in 2010, including fees and stock awards, according to its 2011 proxy statement. She received $1.4 million in deferred share units, by far the most of any director. </blockquote>A "New Species" of Conflicts of Interest A long time ago, in 2006, we first blogged about a "<a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">new species of conflict of interest</a>" which we thought might prove to be even more important than other conflicts of interest afflicting health care that were then starting to be discussed.  This new species  involved health care organizational leaders who were simultaneously members of the boards of directors of for-profit health care corporations.  We posited these conflicts would be particularly important because being on the board of directors entails not just a financial incentive.  It ostensibly requires board members to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. <a href="http://www.amazon.com/Corporate-Governance-Robert-G-Monks/dp/1405116986">Corporate Governance</a>, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]   Thus, for example, the conflict posed by the president of a university, to whom a medical school and academic medical center report, who also is the director of a pharmaceutical company, would be extreme. In 2006, these apparently major conflicts of interest were highly anechoic, and generally otherwise not considered to be newsworthy or fit for discussion in the medical and health care literature.  This, however, is starting to change.  By 2010, the New York Times published a report, albeit in one of their blogs, on a controversy at the Unviersity of Michigan about whether its president's position on the Johnson and Johnson board had influenced her backing of anti-smoking measures, given that Johnson and Johnson makes smoking cessation products (see post <a href="http://hcrenewal.blogspot.com/2010/07/new-york-times-reports-university.html">here</a>). Now, mention of this sort of particularly intense conflict of interest went into the lead paragraph of a story in one of the world's most respected newspapers. A Conflict Cutting Both Ways: The Bristol-Myers-Squibb Settlement In addition, the Times story connected another dot: <blockquote>While she has been on the board, the company has paid hundreds of millions of dollars to settle federal and shareholder complaints that it had inflated sales figures, although Dr. Glimcher herself was not found liable. </blockquote> That underlines the point that people who simultaneously are leaders of both non-profit health care institutions (like medical schools and hospitals) and for-profit health care corporations ought to simultaneously be held accountable for the actions of both, which may put them in uncomfortable positions. Actually, the Times article seemed to soft-pedal what the 2007 Bristol-Myers-Squibb settlement was actually about. As we discussed in <a href="http://hcrenewal.blogspot.com/2007/10/bristol-myers-squibb-settles-enters.html">this post</a>, the settlement was actually in the amount of $515 million, and the government allegations that lead to the settlement were actually about more than inflated sales figures. From the 2007 Department of Justice <a href="http://www.justice.gov/opa/pr/2007/September/07_civ_782.html">news release</a>: <blockquote>First, the Government alleged that, from approximately 2000 through mid-2003, BMS knowingly and willfully paid illegal remuneration to physicians and other health care providers to induce them to purchase BMS drugs.</blockquote><blockquote>Second, the Government alleged that, from 2002 through the end of 2005, BMS knowingly promoted the sale and use of Abilify, an atypical antipsychotic drug, for pediatric use and to treat dementia-related psychosis, both 'off-label' uses. The Food and Drug Administration has approved Abilify to treat adult schizophrenia and bi-polar disorder, but has not approved the use of Abilify for children and adolescents or for geriatric patients suffering from dementia-related psychosis. Indeed, the FDA has mandated that the package for Abilify carry a 'black box' warning concerning its use in the treatment of dementia-related psychosis.</blockquote><blockquote>Third, the Government alleged that both BMS and Apothecon set and maintained fraudulent and inflated prices for a wide assortment of oncology and generic drug products with the knowledge that federal health care programs established reimbursement rates based on those prices. By reporting false and fraudulent prices that were substantially higher than commonly and widely available prices in the marketplace, BMS and Apothecon created a 'spread' between the reimbursement rates for federal health care providers and the actual prices for the drugs charged to its customers. The larger the spread on a drug, the larger the profit or return on investment for the provider. Because reimbursement from federal programs was based on the fraudulent, inflated prices, the United States alleged that BMS and Apothecon caused false and fraudulent claims to be submitted to federal health care programs.</blockquote><blockquote>Finally, the Government alleged that BMS knowingly misreported its best price for the anti-depression drug, Serzone.  </blockquote> Dr Glimcher has been on the BMS board since 1997, so the actions that lead to these allegations and then the settlement clearly occurred on her watch. Nonetheless, the Times noted: <blockquote>Dr. Glimcher, an immunologist with a strong interest in osteoporosis, defended her outside interests, saying they presented no conflict as long as they were transparent. She said she wanted to 'leverage the strengths of everyone,' whether scientists, pharmaceutical companies or biotechnology companies. 'There should be no silos between all of these different strengths,' she said. </blockquote> How simple transparency would remove a conflict created by a fiduciary duty to the Bristol-Myers-Squibb stockholders, and reinforced by a yearly pay-check of $244,500, she did not say.  Neither did she say how transparency about her service on the board would eliminate her responsibility for actions taken by the BMS management that occurred on her watch. Dubious Enthusiasm from the Former Chairman of Bailed-Out Citigroup The conflict did not seemingly dim the enthusiasm of the Weill Cornell board for her candidacy. As the Times reported: <blockquote>Sanford I. Weill, the former chairman of Citigroup who with his wife was the benefactor for whom the college was named in 1998, said Wednesday that Dr. Glimcher had come to his attention through a good friend, Jim Robinson, a co-founder of the technology venture-capital firm RRE Ventures and a former chairman of Bristol-Myers Squibb and chairman and chief executive of American Express. 'He recommended that I meet Laurie Glimcher when he heard we were going to look for a new dean,' Mr. Weill said.</blockquote> That would be the Sanford Weill who built up Citigroup into a bank that was too large to fail, and which was prevented from failing by a huge government bailout (see this post). In his epic, <a href="http://www.harpercollins.com/books/9780061892486/The_Sellout/index.aspx">The Sellout</a>, about the global financial collapse, this is how Charles Gasparino described Weill (p. 144): <blockquote>But in reality, Will never really ran anything. He was a visionary, to be sure, but one whose vision was so myopically focused on building the empire had lusted for for so long and on its share price that he ignored just about everything else.</blockquote>Weill's record would suggest that his judgment about Dr Glimcher may be open to question. Even More Conflicts of Interest To add a bit more icing to the conflict of interest cake, Dr Glimcher has other financial relationships to which the Times vaguely alluded. The latest (2011) Bristol-Myers-Squibb <a href="http://services.corporate-ir.net/SEC/Document.Service?id=P3VybD1odHRwOi8vaXIuaW50Lndlc3RsYXdidXNpbmVzcy5jb20vZG9jdW1lbnQvdjEvMDAwMTE5MzEyNS0xMS0wNzI0NTcvZG9jL0JyaXN0b2xNeWVyc1NxdWliYl9ERUYxNEFfMjAxMTAzMjEucGRmJnR5cGU9MiZmbj1CcmlzdG9sTXllcnNTcXVpYmJfREVGMTRBXzIwMTEwMzIxLnBkZg==">proxy statement</a> listed the following: - scientific advisory board memberships: <a href="http://www.hcven.com/">Health Care Ventures</a>, Inc, (which invests in new pharmaceutical and biotechnology companies) <a href="http://www.nodality.com/">Nodality Inc</a>, (which develops diagnostics and pharmaceuticals), <a href="http://www.abpro-labs.com/">Abpro Inc</a> (which makes antibodies and proteins), and <a href="http://theraclone-sciences.com/home.php">Theraclone Sciences Inc</a>, (which also is developing antibodies for therapeutic purposes) - board of directors membership: <a href="http://www.waters.com/waters/home.htm?locale=en_US">Waters Corporation </a>(maker of laboratory equipment used in life sciences and pharmaceutical discovery, research and development, and commercialization.) One hardly knows how she would find the time to do anything besides fulfill these responsibilities. No wonder that the Times article said: <blockquote>Cornell University’s president, Dr. David J. Skorton, said he believed Dr. Glimcher had the skills to carry out the medical school’s plan to double its research capacity and to help the university compete to develop a new high-tech campus proposed by the Bloomberg administration. </blockquote> Dr Glimcher certainly seems as tied into the world of commercial pharmaceuticals and biotechnology as much as any ostensible academic might be. Indeed, as posted <a href="http://hcrenewal.blogspot.com/2009/03/harvard-medical-students-against.html">here</a>, Dr Glimcher was quoted in a defense of the then current policy and conflicts of interest at Harvard: <blockquote>Dr. Glimcher says industry money is not only appropriate but necessary. 'Without the support of the private sector, we would not have been able to develop what I call our ‘bone team’ in our lab,' she said at a recent student and faculty forum to discuss industry relationships. Merck is counting on her team to help come up with a successor to Fosamax, the formerly $3 billion-a-year bone drug that went generic last year.</blockquote>So at that time Dr Glimcher thought it was perfectly proper and appropriate for her to be paid by Merck to develop new drugs for that company while she was ostensibly a full-time faculty member at the Harvard Medical School (not to mention a full-time board member of one of Merck's competitors.) Summary and Some Questions So to summarize, Cornell Weill Medical School just named a new dean who has been a leader (as member of the board of directors) of Bristol-Myers-Squib for 14 years, on whose watch there the company paid a huge settlement and entered a corporate integrity agreement for allegations of kickbacks and fraud, and who has also been a leader of a biotechnology company, and advisor to a biotechnology and pharmaceutical venture capital fund and to three other biotechnology companies.  She declared she has no conflicts because she has revealed these relationships, and seemingly has been hired mainly to raise money from the pharmaceutical and biotechnology industry. So maybe some intrepid journalist and/or student will ask her: - Given that they now will be reporting to a member of the board of Bristol-Myers-Squibb, should Cornell students and faculty favor its products or policies that it supports?  Should they worry if they do not?  Should they worry about saying or writing anything that might not be seen as supportive of it?  Should they consider themselves to be now in the Bristol-Myers-Squibb medical school? On the other hand, - Does Dr Glimcher feel responsible for the actions of BMS management that lead to its settlement and corporate integrity agreement?  If not, how can she have a fiduciary responsibility to its stockholders? But I will not hold my breath waiting for answers. At least one hopes that putting these issues in the New York Times will provoke some discussion about whether academic institutions should knowingly seek leaders who must serve so many masters.  Maybe they would do better if they sought leaders who would be notable for their whole-hearted devotion to patient's interests and to the integrity of teaching and research rather than for their cozy ties to other top health care leaders.

Director of Bristol-Myers-Squibb to Run Weill Cornell Medical School

How the New York Times reported on a change in leadership at one New York medical school has made one issue of interest to Health Care Renew...

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Talking Points, Sans Original Thought, to Justify Million Dollar Hospital CEO Compensation

Generous pay given to health care leaders has become an area of interest in the media.  Some recent regional stories had a certain dreary sameness, however.  It seems that nearly everywhere in the US, million dollar CEOs have become commonplace at non-profit hospitals and health care systems.  Atlanta, Georgia Region In July, the Atlanta Journal Constitution <a href="http://www.ajc.com/news/atlanta/hospital-ceo-pay-has-997155.html">reported</a> on the compensation given to some regional hospital leaders.  It included the usual gaggle of million dollar CEOs: <blockquote>Edward Bonn of Southern Regional Health System, which operates Southern Regional Medical Center and two affiliated facilities, made $2,610,175 in fiscal 2009. Bonn left the system that year and received his pay of $421,822 plus $2.2 million from a retirement plan. Hospital CEOs commonly receive extra pay from retirement plans when they leave.</blockquote>and <blockquote>In fiscal 2009, John Fox of Emory Healthcare made $1,671,999 to manage Emory University Hospital and five associated institutions. Tim Stack of Piedmont Healthcare, who manages Piedmont Hospital and three others, made $1,340,974 the same year</blockquote> There were two other million dollar CEOs that the article did not name. The State of Georgia Last month, Georgia Health News published a <a href="http://www.georgiahealthnews.com/2011/08/high-ceo-pay-common-hospitals-statewide">story</a> on other highly paid hospital leaders. In general, <blockquote>Georgia Health News has found that executives at nine other Georgia nonprofit hospitals or health systems outside metro Atlanta received at least $1 million in total compensation during their organizations’ most recent fiscal year</blockquote> Some specifics: <blockquote>Ken Beverly, former CEO and president of Archbold Medical Center, a four-hospital system based in Thomasville, who received $6.2 million in fiscal 2009. The health system told Atlanta Unfiltered that most of that compensation related to Beverly’s retirement benefits, accumulated over many years of service.</blockquote>Also, <blockquote>The Gainesville [Northeast Georgia Health] system, which has 5,000 employees, paid CEO James Gardner $1.4 million in total compensation in fiscal 2009.</blockquote>Furthermore, <blockquote>** The Medical Center of Central Georgia paid Donald Faulk, its CEO, $1,003,412 in fiscal 2009. Faulk has been CEO of the Macon hospital since 1995, and has been employed there for 37 years.</blockquote><blockquote>** Larry Sanders, CEO of Columbus Regional Healthcare System, received compensation of $2.2 million in fiscal 2010, with $1 million of it a payout of a supplemental retirement benefit called a split-dollar life insurance policy. Sanders has worked in that system, which includes the Medical Center in Columbus, for 30 years. ** Jack Drew, with 29 years of service at Athens Regional Medical Center, received $1,185,902 in fiscal 2009.</blockquote><blockquote>** University Health in Augusta paid CEO Larry Read $3.5 million in fiscal 2009, with the majority coming as payment of his retirement benefit. Read retired last year. ** Joel Wernick, longtime CEO at Phoebe Putney in Albany, received $1.3 million, with part of it a one-time deferred compensation payment, in fiscal 2010. ** Kurt Stuenkel, CEO of Floyd Medical Center in Rome, received $1.35 million in compensation in fiscal 2010. ** At St. Joseph’s/Candler in Savannah, Paul Hinchey received $1,053,390 in total compensation in fiscal 2010.</blockquote> Madison, Wisconsin Region Madison.com <a href="http://host.madison.com/wsj/news/local/health_med_fit/article_c9e10fae-d174-11e0-93ad-001cc4c002e0.html">discussed</a> the area's highest paid hospital CEOs. They included: <blockquote>Javon Bea, CEO of Janesville-based Mercy Health System, made $3.6 million in total compensation in 2009 and $4.5 million the year before. The system has hospitals in Janesville, Lake Geneva and Harvard, Ill.</blockquote> Columbus, Ohio Region Columbus Business First <a href="http://www.bizjournals.com/columbus/blog/2011/08/hospital-ceo-pay-shows-wide-disparity.html">noted</a> compensation of regional hospital systems, including: <blockquote>By far the highest paid was Dave Blom, CEO of Columbus-based OhioHealth Corp ., at $1.8 million. About $675,000 of that total is deferred compensation. Among chiefs, he’s followed by Dr. Steve Allen of Nationwide Children’s Hospital at $1.2 million,...</blockquote> Furthermore, the justifications for these pay packages uncovered by reporters in different parts of the country also had a certain sameness.  They were actually so similar as to suggest they came from a common set of talking points generated by a common public relations effort.  We Pay What Everyone Else Pays In Atlanta, in general: <blockquote>Atlanta hospital boards have compensation committees of community leaders to ensure executive salaries meet Internal Revenue Service guidelines and are competitive with salaries offered by other medical facilities.</blockquote> Also, <blockquote>All of the tax exempt hospitals in the area issued statements asserting their CEO’s compensation is vetted by their boards and in line with industry standards....</blockquote> In Georgia <blockquote>Hospital boards 'have to pay market rates in order to attract talent,' said Glenn Pearson, Georgia Hospital Association executive vice president. CEO salaries in Georgia 'appear to be very much in line with national trends,' he said.</blockquote> In Columbus, Ohio <blockquote>Hospital trustees set compensation after studying comparable positions in both the nonprofit and for-profit sectors.</blockquote> CEOs Work Hard and are Brilliant, so They Deserve High Pay In Atlanta, in general: <blockquote>Industry representatives say these pay packages ensure communities get the best possible care by attracting the few people capable of administering these complex organizations.</blockquote> Also, <blockquote>Pay in excess of $1 million a year may seem high for an organization subsidized by taxpayers, but hospital executives and industry representatives said the public should think of these hospitals not as charities, but as complex, billion-dollar organizations. Georgia hospitals report to 27 state and federal agencies and engage in multimillion-dollar building projects. The larger hospital systems have billions in revenue and are among the largest employers in their communities. Many also operate for-profit subsidiaries. 'You can’t lose sight of the fact that it’s not an ice cream shop on the side of the street,' said Joseph Parker, president of the Georgia Hospital Association.</blockquote> In Georgia as a whole, <blockquote>GHA added that hospitals are accountable to 27 state and federal agencies, while dealing with tight Medicaid reimbursement and an increasing number of uninsured people.</blockquote> In Madison, Wisconsin, <blockquote>health care has become much more complicated than when Catholic nuns ran many nonprofit hospitals while taking vows of poverty, said [Integrated Healthcare Strategies vice president David] Bjork, the health care consultant. He said today's hospital executives struggle to keep their complex enterprises afloat, dealing with independent doctors who make many of the key financial decisions while being largely unable to predict when patients need services.</blockquote> High Pay is Needed to Attract and Retain Competent, If Not Brilliant People In Atlanta, <blockquote>The number of people who can manage these facilities is limited and recruitment is competitive, Parker said. Qualified leaders will gravitate to other fields over time if compensation for nonprofit CEOs is decreased, [Mercer Inc pay consultant Jose] Pagoaga said. The 'substandard leadership' that replaces them will degrade the quality of medical care for the community.</blockquote> In Georgia, <blockquote>The pay decision is made by community leaders who serve on hospital boards, Pearson said. Those board leaders want to make sure they 'have the person of the highest quality,' given the challenging financial times that hospitals face, he said.</blockquote>Furthermore, <blockquote>It’s a competitive market nationally for the top people, said Kevin Talbot, a vice president of the [Integrated Healthcare Strategies consulting] firm.</blockquote>Also, <blockquote>Boards of Georgia nonprofit health systems responded to GHN that the compensation is needed to attract and retain talented executives. </blockquote>In particular, <blockquote>'Establishing and maintaining competitive executive compensation is critical to our ability to ensure that we have a highly competent and effective leader at the helm, and it is a responsibility that our board does not take lightly,' said Mary Lynn Coyle, chairman of the board of Northeast Georgia Health System.</blockquote>Finally, <blockquote>'This is a field where there's a great demand for talent,' said Nancy Anderson, chairman of the board of the Medical Center of Central Georgia.</blockquote> In Madison, Wisconsin, <blockquote>But large hospitals such as those in Madison have to pay top dollar to attract people with the skills to manage them, said David Bjork, senior vice president of the Minneapolis-based consulting firm Integrated Healthcare Strategies. 'Running a hospital is probably the toughest management job that exists,' Bjork said.</blockquote> In Columbus, Ohio, <blockquote>'People who are running hospitals and hospital systems are running businesses that are literally saving people’s lives, so it’s really important to have a quality leader,' said Tiffany Himmelreich, spokeswoman for the Ohio Hospital Association</blockquote>And, <blockquote>'People with these types of leadership abilities could easily be snatched up by for-profit businesses,' she said.</blockquote>There was also a certain sameness in what the the reports did not say. Things Unsaid, and Questions Begged None of the news reports contained a response from a million dollar CEO.  Justifications of CEO pay came from hospital trustees, hospital spokespeople, or compensation consultants. None of the news reports explained why a particular CEO should be considered above average, much less brilliant.  None explained why a particular group of comparator hospitals were appropriate for a particular hospital and its CEO.  As we have discussed before, all CEOs cannot be above average, some CEOs must be below average.  Yet while the reports mentioned CEOs who made less than $1 million, none would dare characterize them as below average.  Some news reports noted reasons that particular hospitals or CEOs or CEOs ought not to be compared so favorably to their peers.  For example, Edward Bonn's Southern Regional Health System in the Atlanta area lost $12 million in 2009, Tim Stack's Piedmont Health "will cut 464 jobs," and Ken Beverly, of Archbold Medical Center, "was found guilty on six counts in a health care fraud case." (See <a href="http://hcrenewal.blogspot.com/2011/01/executive-compensation-at-non-profit.html">this post</a> on the latter.)However, nobody in the news reports dared to suggest that these CEOs might be below average in some sense, and hence might not be entitled to such high pay.    The report from Atlanta noted, "hospital executives and industry experts consider the examination of salaries a titillating issue for the public, but a subject lacking in substance."   However, they failed to explain why the incentives created by large salaries may not generate concerns of substance, or address the concern that "the 'rarified existence' of some nonprofit hospital CEOs may warp their financial decisions and blunt the charitable mission." Finally, if CEOs, most of whom are not health care professionals, are credited with "literally saving people's lives," why are the health care professionals who actually do save people's live not credited even more? Summary The extreme consistency of justifications for generous compensation given to hospital and health system CEOs, (and as <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">we have seen</a>, for such compensation given to other health care leaders) suggests that these justifications are talking points being generated by the leaders public relations flacks.  They may be using talking points because they know the real reason for the high pay is that the CEOs have become unaccountable, and able to set their own pay.  If the CEOs and their friendly boards cannot refute this contention, the latter do not deserve their pay, and the former do not deserve their positions of stewardship. Over and over, I say... Health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

Talking Points, Sans Original Thought, to Justify Million Dollar Hospital CEO Compensation

Generous pay given to health care leaders has become an area of interest in the media. Some recent regional stories had a certain dreary sa...

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