healthy4u

Another Episode of "But Don't Worry, Your Records are Safe..."

Oops! <a href="http://www.independent.co.uk/life-style/health-and-families/health-news/nhs-trust-sends-data-cd-to-landfill-2355834.html"></a><blockquote><a href="http://www.independent.co.uk/life-style/health-and-families/health-news/nhs-trust-sends-data-cd-to-landfill-2355834.html">NHS trust sends data CD to landfill</a> By Wesley Johnson Friday, 16 September 2011The personal information of 1.6 million people has been put at risk after a CD was sent to a landfill site by an NHS trust by mistake, a watchdog said. The Eastern and Coastal Kent Primary Care Trust put the CD, which contained the name, address, date of birth, NHS number and GP of about 1.6 million people, in a filing cabinet during an office move. But no one told staff who sent the cabinet to the landfill site and it has not been recovered, the Information Commissioner's Office said. ... An undertaking signed by the trust's chief executive Ann Sutton read: "The Information Commissioner was provided with a report by the data controller informing that a filing cabinet containing personal data had been sent to landfill during a move of office premises. "The filing cabinet contained a CD holding the address, date of birth, NHS number and GP practice code of approximately 1.6 million individuals. </blockquote> Read the whole article. They promise to be more careful - next time. <blockquote> The trust said it would now take action to bring in clear policies and procedures for when moving office, improve staff training and boost security against unauthorised and unlawful processing, accidental loss, destruction and damage of personal records.</blockquote> That is reassuring - I guess. -- SS

Another Episode of "But Don't Worry, Your Records are Safe..."

Oops! NHS trust sends data CD to landfill By Wesley Johnson Friday, 16 September 2011 The personal information of 1.6 million people has b...

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Does "Highly wired" Correspond to "Diligence in Following Guidelines" for Care?

One might think the hospitals that have spent tens or hundreds of millions of dollars on healthcare IT would fare the best in performance measures, i.e., adherence to guidelines (irrespective of whether those measures reflect better outcomes, a topic for another time). Yet, once again that does not appear to be the case. This might seem paradoxical at first glance. However, as I tell my students, there are no paradoxes - only false assumptions: <blockquote style="font-family:arial;"> <a href="http://www.nytimes.com/2011/09/15/us/hospital-performance-improved-report-finds.html?_r=1">Report Finds Improved Performance by Hospitals</a> New York Times By KEVIN SACK Published: September 14, 2011 In the latest advance for health care accountability, the country’s leading hospital accreditation board, the Joint Commission, released a <a href="http://www.jointcommission.org/assets/1/18/Top_Performers_2010_list_9_13_11.pdf" title="Link to Joint Commission list of top performers.">list</a> on Tuesday of 405 medical centers that have been the most diligent in following protocols to treat conditions like <a class="meta-classifier" href="http://health.nytimes.com/health/guides/disease/heart-attack/overview.html?inline=nyt-classifier" title="In-depth reference and news articles about Heart attack.">heart attack</a> and <a class="meta-classifier" href="http://health.nytimes.com/health/guides/disease/pneumonia/overview.html?inline=nyt-classifier" title="In-depth reference and news articles about Pneumonia.">pneumonia</a>. Almost without exception, most highly regarded hospitals in the United States, from Johns Hopkins in Baltimore to the Mayo Clinic in Rochester, Minn., did not make the list. </blockquote> The "most highly regarded" hospitals tend to also be "the most wired." One would think that all that hardware would improve "diligence in following protocols" compared to paper-based hospitals. But this is apparently not the case. <blockquote style="font-family:arial;">... “Reputation and performance on important measures of quality do not always correlate,” said Dr. Mark R. Chassin, the Joint Commission’s president. As an example, none of the 17 medical centers listed by U.S. News & World Report on its “<a href="http://health.usnews.com/health-news/best-hospitals/articles/2011/07/18/best-hospitals-2011-12-the-honor-roll" title="Link to US News & World Report hospital honor roll.">Best Hospitals Honor Roll</a>” this year are on the Joint Commission’s list of 405 hospitals that received at least a 95 percent composite score for compliance with treatment standards. About one-third of a hospital’s score in the U.S. News methodology is based on its reputation as gauged by a survey of physicians. </blockquote>These results are not inconsistent with reports such as: <ul type="disc" style="font-family:arial;"><li class="MsoNormal" style="">The 2009 <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">National Research Council report on Health IT</a>, that found that IT even at some of the "best" computerized centers "did not support physicians' cognitive needs";</li></ul><ul><li><a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387">The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview</a>. Black AD, Car J, Pagliari C, Anandan C, Cresswell K, et al. PLoS Medicine 8(1): e1000387 (Jan. 18, 2011). doi:10.1371/journal.pmed.1000387, that found that "There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers and “techno-enthusiasts” as if this was a given";</li></ul> <ul><li><a href="http://www.amjmed.com/article/S0002-9343%2809%2900816-X/abstract">Hospital Computing and the Costs and Quality of Care: A National Study</a>. Himmelstein. Wright, Woolhandler. The American Journal of Medicine, Volume 123, Issue 1 , Pages 40-46, January 2010, that found "Hospitals on the “Most Wired” list performed no better than others on quality, costs, or administrative costs";</li></ul>  <ul face="arial" type="disc"><li class="MsoNormal" style=""><a href="http://archinte.ama-assn.org/cgi/content/full/archinternmed.2010.527">Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality</a>. Max J. Romano, BA; Randall S. Stafford, MD, PhD, Arch Intern Med. Published online Jan. 24, 2011. doi:10.1001/archinternmed.2010.527, that found that there was "no consistent association between EHRs and CDS and better quality. These results raise concerns about the ability of health information technology to fundamentally alter outpatient care quality";</li></ul><ul face="arial" type="disc"><li class="MsoNormal" style=""><a href="http://archinte.ama-assn.org/cgi/content/short/167/13/1400" target="_parent">Electronic Health Record Use and the Quality of Ambulatory Care in the United States</a>. Linder, Ma, Bates et al. Arch Intern Med. 2007;167:1400-1405, that found that "as implemented, EHRs were not associated with better quality ambulatory care";</li></ul><ul face="arial" type="disc"><li class="MsoNormal" style="">Other articles compiled at my post "An updated reading list on heath IT" <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">at this link</a>. </li></ul> In fact, it is my belief further investigation is needed to measure the distracting effects of information technology on the delivery of healthcare. <blockquote style="font-family:arial;">... The Joint Commission list, at <a href="http://www.jointcommission.org/" target="_">www.jointcommission.org</a>, omitted the Cleveland Clinic; Massachusetts General Hospital in Boston; Duke University Medical Center in Durham, N.C.; Ronald Reagan U.C.L.A. Medical Center; and the University of California San Francisco Medical Center, among others. It did not include a single hospital in New York City, or the most prominent centers in Chicago and Houston. “It’s pretty glaring that they’re not there,” said Dr. Peter J. Pronovost, the senior vice president for patient safety and quality for Johns Hopkins Medicine.Rather, the Joint Commission list of top performers included a disproportionate share of small and rural hospitals, as well as 20 Veterans Affairs medical centers. About 14 percent of roughly 3,000 eligible hospitals made the cut. </blockquote>Small and rural hospitals may have clinicians who are able to remain focused on the business of healthcare - patient care - rather than the business of bureaucracy - notably, performing the task of data entry clerks for payers, and being subject to the whims of the mission hostile user experience (<a href="http://www.tinyurl.com/hostileuserexper">link</a>) of commercial health IT that can cause injury (<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">link</a>) and even kill (<a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">link</a>).In my own personal experience, the care provided to my mother in her final months of life by a small local hospital in my area - using paper - was superior in terms of ensuring basics of good care were followed, to that of the highly computerized behemoth that maimed my mother. The smaller hospital provided more individualized care and attention, because the clinicians were not distracted by balky technology and the "legible gibberish" output by these systems. Unfortunately, the small hospital was then acquired by the behemoth. I was there during the rollout of the EHR from the parent. It was not pretty, and I soon found the small hospital's nurses and physicians as distracted as those at the large center, for example in dealing with risky informational abominations such as grossly defective allergy lists (<a href="http://hcrenewal.blogspot.com/2011/03/ehr-legible-gibberish-another-example.html">link</a>).Perhaps the toxic effects of today's commercial health IT need to be taken into account in the Joint Commission's future studies. -- SS

Does "Highly wired" Correspond to "Diligence in Following Guidelines" for Care?

One might think the hospitals that have spent tens or hundreds of millions of dollars on healthcare IT would fare the best in performance ...

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Highly Paid "Skilled Executives and Visionary Leaders" Sue a Whistleblower

In May, we <a href="http://hcrenewal.blogspot.com/2011/05/million-dollar-plus-hospital-ceo.html">wondered</a> what some hospital executives did to justify their munificent compensation.  Now we have found out a little more. Specifically, we noted that at Wake Forest Baptist Medical Center, the CEO got $1.68 million in fiscal 2009-2010.  The President got $859,521. The CFO got $734,282.  A hospital statement at the time called them "skilled executives and visionary leaders," but provided no evidence to support this claim. Audit Showed the Hospital was Overpaid Now recent news stories show just how skilled and visionary these leaders are.  The Winston-Salem Journal <a href="http://www2.journalnow.com/news/2011/sep/07/1/baptist-hospital-received-134-million-in-overpayme-ar-1365985/">reported</a> how a state health insurance plan had overpaid the hospital, and the hospital had refused to give the money back.  <blockquote>N.C. Baptist Hospital is keeping about $1.34 million in reimbursement rate overpayments from the State Health Plan. The figure was revealed Wednesday in a State Auditor's Office report on the contract between the two groups. Baptist disputes the description of the amount as an overpayment. Plan officials said they will not attempt to recoup the money, which Baptist has declined to repay because it said it complied with the terms of the contract. 'The plan views this as a legal matter, and Baptist Hospital is under no legal/contractual obligation to pay back the overpayments,' said Beth Horner, spokeswoman for the plan.</blockquote> The state auditor was none too pleased: <blockquote>However, Beth Wood, the state's auditor, said she believes Baptist has an ethical obligation to pay some, if not all, of the overpayment it received from 2003 to 2008.</blockquote> A local health care expert also had a dim view of the medical center's actions: <blockquote>Adam Linker, a health-care analyst for the N.C. Justice Center, said the plan 'had the right to ask for more discounts with the Baptist rate increase and failed to do so because it had written a sloppy contract and poorly monitored it.' 'But Baptist failed to notify the plan in a direct manner of the rate increase. It clearly had the obligation as a good partner with the state to give the discount in the spirit of the contract, and not take advantage of a sloppily written, poorly monitored contract.'</blockquote>The leadership at Wake Forest Baptist apparently were not interested in these ethical distinctions.  The Hospital Sued the Whistle Blower Instead, they decided to attack the messenger, or sue the whistle blower in this case.  The Winston-Salem Journal's next relevant <a href="http://www2.journalnow.com/news/2011/sep/11/wsmain01-nc-baptist-suing-former-employee-turned-w-ar-1377598/">story</a> stated: <blockquote>A former N.C. Baptist Hospital employee has spent thousands of dollars defending himself in a lawsuit by the hospital accusing him of 'unjustified, vindictive, malicious and gratuitous actions' for alerting state officials that the State Health Plan was overpaying Baptist. The case of Joseph Vincoli, a former administrative director at the hospital who was terminated, is an example of how little, if any, legal protection a private employee may have when filing a whistle-blower complaint that could affect a state agency and taxpayer money. A state auditor's report released Wednesday appears to confirm that Vincoli's complaints had validity. He alerted state officials in January 2009 that Baptist was collecting more than it would have been entitled to if the State Health Plan had known about hospital rate increases and had insisted on getting rate discounts it was eligible for.</blockquote> In addition, <blockquote>Vincoli, who lives in Clemmons, declined to be interviewed by the Winston-Salem Journal, because he is under legal threat, but Phil Michael, an attorney representing Vincoli, said the state audit report was 'a bittersweet resolution' to the overpayments dispute. 'Joe encountered a situation where the hospital received money he believed it wasn't entitled to, and he did what he believed was his duty by reporting it to the state,' Michael said. The Baptist lawsuit, filed Jan. 26, accuses Vincoli of breaching their confidential settlement by contacting the plan and other state agencies about his concerns and 'providing disparaging and/or confidential information.' Vincoli worked at Baptist as its managed-care director from July 2006 to October 2007, when his employment was terminated by the hospital. The Baptist lawsuit said Vincoli's actions have caused the hospital 'to suffer embarrassment, negative false publicity, loss of goodwill with the state of N.C. and the communities the hospital serves, and financial loss including, but not limited to, attorneys fees.' 'Vincoli had no legitimate reason to involve himself in the SHP contract issue' as a private citizen and later as an employee of two state agencies, the hospital said. Vincoli now works for the N.C. Department of Corrections.</blockquote> Didn't they used to teach in citizenship classes that us ordinary civilians are supposed to notify legal authorities when we see something suspicious? That does not appear to be how the august leaders of Wake Forest Baptist see it. In my humble opinion, but based on the auditor's findings, it was the hospital leadership that caused the institution "to suffer embarrassment, negative false publicity, loss of goodwill with the state of N.C. and the communities the hospital serves...." As a Winston-Salem Journal <a href="http://www2.journalnow.com/news/opinion/2011/sep/15/wsopin01-hospital-made-corporate-case-on-whistlebl-ar-1391660/">editorial</a> put it: <blockquote>The nonprofit hospital has built a good corporate legal defense. Meanwhile a good citizen, a whistle-blower, lost his job and will pay thousands to defend himself for doing what most people should view as the right thing. We commend him. The hospital will likely prevail on the legal issues. As a corporation, it has a duty to do so. But on the moral scorecard, it loses.</blockquote>Summary So now we see just how "visionary" the executives of Wake Forest Baptist are. They seem to have visions about bullying whistle blowers who dare poke their noses into the hospital's dubious financial schemes operated at the expense of local tax-payers. Suing Mr Vincoli would be a low tactic for garbage hauling company to use, but it is incomprehensible how a hospital system could employ it. The "skilled executives" made a mockery of the institution's lofty <a href="http://www.wakehealth.edu/Mission-Statement.htm">vision statement</a>, which included: <blockquote>Compassion - responsive to the physical, emotional, spiritual and intellectual needs of all </blockquote>and <blockquote>Integrity - demonstrate fairness, honesty, sincerity and accountability </blockquote>It looks like protecting revenue and denying that the visionary leaders could make an error trump compassion and integrity. So perhaps the recent high pay of top hospital executives was a terrible error. Maybe the board had no idea what sort of ruthless people it had hired. Or maybe they had a perfect idea, it was no error, and the board wanted to encourage the most ruthless leadership it could, as long as it made money. Perhaps the executives and board members will yet explain why they went after Mr Vincoli. Meanwhile, this case is the latest example of why we need much better legal protections for whistle blowers in health care. So, I turn blue in the face repeating.... 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.

Highly Paid "Skilled Executives and Visionary Leaders" Sue a Whistleblower

In May, we wondered what some hospital executives did to justify their munificent compensation. Now we have found out a little more. Speci...

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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

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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 href="http://www.post-gazette.com/pg/11257/1174449-84-2.stm#ixzz1XwYqh0UQ" style="color: rgb(0, 51, 153);"></a></div><a href="http://www.post-gazette.com/pg/11257/1174449-84.stm#ixzz1XwYhYDwm" style="color: rgb(0, 51, 153);"></a></div>

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

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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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