No Dogs to Bark - Failure to Connect the Events Foreshadowing the Fall of the Upstate President

In <a href="http://en.wikipedia.org/wiki/Silver_Blaze">Silver Blaze</a>, Sherlock Holmes noted the important clue of the watchdog that did not bark.  In health care, nowadays watchdogs are absent, so who is expected to bark?  So, when cases of failed leadership of health care organizations appear, in retrospect they often appear to have been foreshadowed by various events which caused no reaction..  <br /><br />Last week we <a href="http://hcrenewal.blogspot.com/2013/11/engaging-excellence-while-engaging.html">posted</a> about the president of the State University of New York (SUNY) - Upstate Medical University who resigned his job after revelations that he was receiving hundreds of thousands of dollars in income from outside organizations which he had not properly disclosed, and which could have constituted conflicts of interest.  <br /><br />Only days later, on November 20, 2013, James T Mulder, the Syracuse Post-Standard journalist who had done much of the relevant reporting, published an <a href="http://www.syracuse.com/news/index.ssf/2013/11/post_933.html">article</a> summarizing previous events that in retrospect should have suggested that there were serious ongoing problems within SUNY - Upstate leadership.  <br /><br /><b>Claims that the University Fired Physician Whistle-blowers - the Case of Dr Stewart</b><br /><br />According to the summary article,<br /><br /><blockquote class="tr_bq">Critics of [SUNYH - Upstate Medical University President Dr David R] Smith ... [said]  he <i>ruled with an iron first and did not tolerate opposing views.</i><br /><br />'It became clear <i>once he knew who dissenters were, things would happen</i>,' said Dr. James Holsapple, a former Upstate neurosurgeon who now practices and teaches in Boston, Mass.'<i>Dissidents would not be tolerated.</i>'<br /><br />Holsapple cited the case of Dr. William Stewart, a <a href="http://www.syracuse.com/news/index.ssf/2011/04/upstate_fires_whistleblower_do.html">neurosurgeon fired by Upstate </a>in 2011. Stewart contends he was fired because he filed a complaint with the state Health Department, alleging misconduct by two other Upstate doctors. That complaint led to an investigation by the state which issued a report critical of Upstate.<br /><br />Upstate contends Stewart was let go because he refused to cooperate with an investigation into a breach of confidential information, including patient records.<br /><br />Holsapple calls the incident a ' ... clear example of <i>Smith taking out a critic</i>.'<br /><br />In a pending lawsuit in federal court, Holsapple has accused Upstate of retaliating against him for speaking out against what he calls dangerous medical practices and other unethical activities at the Syracuse teaching hospital. Upstate has denied his accusations and called them 'baseless.'</blockquote><br />In fact, Mr Mulder's <a href="http://www.syracuse.com/news/index.ssf/2011/04/upstate_fires_whistleblower_do.html">article</a> from April, 2011 about Dr Stewart's case noted that Dr Stewart<br /><br /><blockquote class="tr_bq">said his complaint ' ... made me an <i>enemy of the regime</i>.'</blockquote><br />Although Upstate accused Dr Stewart,<br /><br /><blockquote class="tr_bq"> ... because he refused Upstate’s request that he cooperate in an investigation into an intentional breach of confidential information, including private patient care records.</blockquote><br />Dr Stewart contended that he knew how to handle confidential information,<br /><br /><br /><blockquote class="tr_bq">Stewart served 20 years as a <i>member of the state Board for Professional Medical Conduct,</i> which takes disciplinary action — including license revocation and suspension — against doctors. <i>He chaired that board for three years</i> in the late 1980s.<br /><br />Stewart said he never disclosed any private patient information. 'I took the Hippocratic oath when I graduated from medical school,' he said.<br /><br />Stewart said <i>physicians are required by state law to report suspected cases of medical misconduct. Failure to do so is considered misconduct under the law.</i><br /><br />Stewart said <i>that’s why he filed a complaint with the Health Department</i>, alleging that a resident neurosurgeon training at Upstate was allowed to perform complex spine surgery without proper supervision because the neurosurgeon who was supposed to be doing the operation was in another operating room with a different patient.</blockquote><br /><br />Furthermore, Dr Stewart alleged that Upstate sought to intimidate him,<br /><br /><blockquote class="tr_bq">Stewart said <i>two private investigators hired by Upstate visited his office</i> in December, but he refused to talk to them.</blockquote><br /><br /><b>Claims that the University Fired Physician Whistle-blowers - the Case of Dr Holsapple</b><br /><br /><br />The case that caused Dr Holsapple to file a lawsuit against Upstate had some interesting similarities, but also some uniquely colorful aspects, as documented in an <a href="http://www.syracuse.com/news/index.ssf/2011/02/doctors_lawsuit_says_upstate_f.html">article</a> from February, 2011, by Mr Mulder.  Dr Holsapple also alleged a major quality of care problem at Upstate,<br /><br /><blockquote class="tr_bq"> The suit charges Holsapple’s problems began in 2007 when he <i>objected to a plan to have a single neurosurgeon supervise two spine surgeries in separate operating rooms at the same time. Holsapple thought the plan was risky for patients</i>. At the time death rates following spine surgery at Upstate were five times higher than normal, the suit said.<br /> <br />The suit contends Dr. Ross Moquin, a neurosurgeon no longer at Upstate, was overseeing the two surgeries, according to the suit. While Moquin was with one patient, <i>Dr. Walter Hall, then chair of the department of neurosurgery, and a resident doctor in training, began surgery on the second patient, the suit says. Neither Hall nor the resident were qualified to finish the operation, but Hall told the resident to complete the surgery because Moquin was busy with the other patient,</i> according to the suit. Holsapple’s suit <i>contends the patient suffered complications.</i> It also accused the hospital of creating fraudulent documentation about the operation and billing fraud. </blockquote><br />Some of these charges appear to have been independently corroborated, at least, <br /><br /><blockquote class="tr_bq"><i>That same two-room spine surgery case was cited in a recent state Health Department <a href="http://www.health.state.ny.us/"></a>investigation. </i>In a 68-page report issued in August, the Health Department said Upstate did not provide surgical services in a way 'that assures protection of the health, safety and rights of patients ... .'</blockquote><br />Nonetheless, Dr Holsapple argued that the hospital punished him for his whistleblowing,<br /><br /><blockquote class="tr_bq">The suit says <i>Hall stripped Holsapple of his job as residency coordinator in 2007 without any explanation, cutting his annual pay by $82,500. Hall also removed Holsapple as the department’s quality officer</i>, according to the suit.</blockquote><br />Dr Holsapple also contended that the hospital attempted to harass him after he left, and did so, as Dr Stewart also argued, using private investigators,<br /><br /><blockquote class="tr_bq">Holsapple contends Upstate continued the retaliation after he left. He said <i>Upstate sent two investigators to his home in South Boston in November to intimidate and harass him and his wife.</i></blockquote><br /><br />The lawsuit suggested that Dr Holsapple was qualified to complain about quality issues,<br /><br /><blockquote class="tr_bq">Upstate hired Holsapple as an assistant professor of neurosurgery in 1994 after he completed his residency training there. In his suit he says he <i>served as the quality improvement officer for the neurosurgery department, on the SUNY faculty senate and on the hospital’s medical executive committee</i> alongside top Upstate executives, department chairs and other officials.</blockquote><br />It also suggested that perhaps Dr Hall, the chairman of neurosurgery whose conduct figured in Dr Holsapple's complaint, was not so qualified to sit in judgment of Dr Holsapple,<br /><br /><br /><blockquote class="tr_bq">The following year nursing staff <i>discovered images of Nazi artifacts within the computerized medical records of Hall’s patients, </i>the suit says.<br /> <br />Holsapple said in an interview the images were photographs of tank medals and other <i>Nazi paraphernalia</i> displaying the swastika.<br /> <br />The suit says a <i>hospital investigation confirmed the Nazi images belonged to Hall and he was forced to resign as chair of the neurosurgery department.</i><br /> <br />Holsapple said in an interview Hall told hospital officials he bought and sold the Nazi memorabilia and stored the images on his computer. 'Some of the Jewish faculty were disturbed these icons were finding their way into the computer system,' Holsapple said.</blockquote><br /><br /><b>A Cheating Scandal and Probation by an Accrediting Agency</b><br /><br />Mr Mulder' November 10, 2013, summary article also reported,<br /><br /><br /><blockquote class="tr_bq">The medical school was embroiled in a cheating scandal in 2011. An Upstate investigation found more than <i>100 fourth-year medical students cheated on quizzes </i>in a medical literature course.<br /> <br />Last year the medical school was <i>placed on probation by the Liaison Committee on Medical Education</i>, an accrediting group. That group criticized the school for having an erratic learning environment. It also said the medical school's curriculum was out of sync, student complaints were being ignored and the dean was ineffective. Upstate fixed the problems and was taken off probation earlier this year.</blockquote><br />Mr Mulder's article jogged by hazy memory into the recollection that I had seen several other examples of problems at SUNY - Upstate, but since the articles that illustrated them seemed to appear in isolation, I had just dumped them into the pile of  documents to be filed. A hurried search then revealed articles on the two whistle-blowers, and the cheating and probation issues above, and...<br /><br /><b>A Costly Merger?</b><br /><br />I found a <a href="http://www.syracuse.com/news/index.ssf/2011/02/will_proposed_merge_between_up.html">story</a> from February 21, 2011, also authored by Mr Mulder, that suggested a merger proposed for Upstate University Hospital would lead to a big increase in health care prices,<br /><br /><blockquote class="tr_bq"> The cost to replace a hip, treat a heart attack and provide many other routine hospital services covered by Medicare is about 46 percent higher at Upstate University Hospital than at Community General Hospital.<br /> <br />Some experts fear a proposal to merge Upstate and Community into one hospital with one payment rate will raise Community’s prices to Upstate’s level and increase overall health care costs in Central New York. </blockquote><br />So,<br /><br /><blockquote class="tr_bq">MVP Healthcare, a health insurer, is worried about potential price increases at Community.<br /> <br />'We need to know if the charges for services provided by Community General Hospital would increase as a result of the merger,' said Gary Hughes, a spokesman for the insurer. 'If the rates increase, we would be concerned how the merger would affect health care costs in the region, how that would affect the business community and individuals.'<br /> <br />At a recent public forum on the proposed acquisition, Dr. Douglas Tucker, of MVP, said blending Upstate’s high rates with Community’s could be 'catastrophic,' especially for patients with high-deductible plans who have to pay big upfront costs before their insurance coverage kicks in.<br /> <br />SEIU Local 1199, the union representing Community General workers, shares that concern. The union wants Community General to remain as a lower cost, private sector community hospital. The union also wants to remain at Community to preserve its members pensions and benefits. It does not want to see Community workers become state employees, who are represented by different unions.</blockquote><br /> <br />Note that although the merger did occur in 2011, I could not find any documentation about its effects on costs since.<br /><br /> <br /><b>Summary</b><br /><br /> <br />In the last two years, SUNY - Upstate Medical University has been accused of seeking a merger mainly to drive up its prices, and of independently driving out and attempting to intimidate two separate physicians for blowing the whistle about health care quality concerns.  The department chairman whose work was criticized by one of the physicians, and who subsequently drove him to leave was himself forced out of his leadership position over allegations of Nazi photographs found within his computerized patient files.  University students were involved in a big cheating scandal, and the university was placed on probation by its accrediting agency.  These stories generated lots of concerned and sarcastic comments online.  However, I could find nothing to suggest that they lead to any official investigations by SUNY leadership, state government, accrediting agencies (other than as listed above), Medicare, medical societies, etc  I could find nothing to suggest that any actions were taken by students or faculty at the school, or by independent watchdogs or other members of civil society. <br /><br /> <br />Yet in retrospect the sequence of events suggested major problems with the leadership of SUNY - Upstate Medical University.  The existence of these problems seems to have been confirmed by the revelations that the university president was accepting hundreds of thousands of dollars of outside income which he failed to properly disclose to the university, and which could have constituted major conflicts of interest.  The seriousness of the leadership problems was just underscored by the recent decision of the state Comptroller to audit the institution's contracts (look <a href="http://www.sfgate.com/news/article/NY-to-audit-hospital-where-president-is-quitting-4968340.php">here</a> for AP story), and the sudden resignation of the university senior vice president for administration and finance who apparently was receiving pay, admittedly which he had disclosed, from the same organizations who were paying the president (see story by Mr Mulder <a href="http://www.syracuse.com/news/index.ssf/2013/11/another_top_upstate_medical_administrator_steps_down_amid_pay_investigation.html">here</a>.) <br /> <br /><br /> One obvious conclusion is that bad leadership leads to lots of bad consequences.<br /><br />Another is that here in these United States we lack any effective watchdogs who can spot major leadership problems at important health care organizations before they lead to bad outcomes.  <br /><br />  In particular, our the leadership of our academic medical organizations do not seem to get any organized scrutiny from student, faculty or alumni groups, from government agencies, from accrediting organizations, from medical societies, or from community based civil society organizations  or health care watchdog groups.  Hoping that overworked local reporters or volunteer bloggers will not only be able to spot evidence of trouble in a timely way, and then make it visible enough to generate action is whistling past the cemetery.  <br /><br /><br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj3FJQhVA_VvgKlI6r4vWn-rEAr0R_KgWXO4Z1Wcnfc7m0e1Su8SeV2CghNSraFdQ0mtzwkO4f95rm8aKkzQkQwr_SQMPTK6IVqxAcjR-6Wid-vW-3G3RK2MErMyrVNE5hfTQFGFif3NpFO/s1600/Ahnold.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj3FJQhVA_VvgKlI6r4vWn-rEAr0R_KgWXO4Z1Wcnfc7m0e1Su8SeV2CghNSraFdQ0mtzwkO4f95rm8aKkzQkQwr_SQMPTK6IVqxAcjR-6Wid-vW-3G3RK2MErMyrVNE5hfTQFGFif3NpFO/s1600/Ahnold.jpg" /></a></div><br />  <br /> IMHO, concerned citizens, hopefully including those in and in training for the health professions, need to set up organized civil society watchdog groups to hold health care leadership accountable, and to push for involvement by government, accrediting organizations, medical societies, etc.  <br />

No Dogs to Bark - Failure to Connect the Events Foreshadowing the Fall of the Upstate President

In Silver Blaze , Sherlock Holmes noted the important clue of the watchdog that did not bark.  In health care, nowadays watchdogs are absent...

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Words that Work: Singing Only Positive - And Often Unsubstantiated - EHR Praise As "Advised" At The University Of Arizona Health Network

When clinicians are told to promote a technology in no uncertain terms, that puts a chilling effect on critical thinking and discourse.  In effect, when under orders to only speak positively about a hospital or its technology, saying anything bad could very likely get clinicians labeled as 'troublemakers' or 'disruptive clinicians.'  Sometimes - in a sadly real example at Affinity Health - it may even get threats of having complaints plastered to one's forehead (see <a href="http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html">http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html</a>), a threat answered to by a judge.<br /><br />The 'disruptive' label usually does not have a good effect on one's evaluations and job (or, for doctors, even career) longevity.  See, for example, the resources at <a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/</a> on <b>sham peer review.</b><br /><br />At <a href="http://www.uahealth.com/">University of Arizona Health Network (UAHN)</a>, clinicians are being told to promote the EPIC EHR.<br /><br />The campaign is under the aegis of executives who know, should know, or should have made it their business to know the mayhem caused at other medical centers by EPIC and other major clinical IT systems (see for example query links <a href="http://hcrenewal.blogspot.com/search/label/EPIC">http://hcrenewal.blogspot.com/search/label/EPIC</a> and <a href="http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20difficulties">http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20difficulties</a>).<br /><br />Here's what clinicians are bring told in the Oct. 3, 2013 "Weekly update for UAHN employees":<br /><blockquote class="tr_bq"><br /><h1 style="color: #606060 !important; display: block; font-family: Helvetica; font-size: 40px; font-style: normal; font-weight: bold; letter-spacing: -1px; line-height: 125%; margin: 0; text-align: left;"> <span style="font-size: 18px;"><span style="color: #1c3e71; font-family: verdana, 'helvetica neue', helvetica, sans-serif; line-height: 18px;">Words that Work </span></span></h1><div style="color: #505050; line-height: 13px;"><br />Talking positively to our patients about our new Electronic Health Record system is important! Here are some key words and phrases you can use to emphasize the many benefits of the new system:</div><ul><li style="color: #505050; line-height: 13px;"> Electronic health record (not ‘Epic’ or ‘EHR’)</li><li style="color: #505050; line-height: 13px;"> One comprehensive record</li><li style="color: #505050; line-height: 13px;"> Coordinated care</li><li style="color: #505050; line-height: 13px;"> Improves patient safety & quality</li><li style="color: #505050; line-height: 13px;"> Convenient, easy patient portal </li><li style="color: #505050; line-height: 13px;"> Private and secure</li></ul><div style="color: #505050; line-height: 13px;"><a href="https://www.uahealth.com/pdf/Epic_Words_That_Work.pdf" style="color: #1c3e71; font-weight: normal; text-decoration: underline; word-wrap: break-word !important;" target="_self"><b>Click here</b></a> for more words and behaviors to inspire confidence in our patients (and ourselves) as we transition to this new system.</div></blockquote><br />The link to "more words" produced this PDF:<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj_OOVivF_6D2GEFgUm6ujfKdJjMf4UMwoxX7ZECU7351gCph46CpKY7tryUY2qq63Q7Snl9fy1SNKk9QOxUyXfhgON7lm2W2MO_Sgin5pPxl4Rf6OR78MIdzjuQrxPDCBQ4ri6BeN3YxKn/s1600/words+that+work.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj_OOVivF_6D2GEFgUm6ujfKdJjMf4UMwoxX7ZECU7351gCph46CpKY7tryUY2qq63Q7Snl9fy1SNKk9QOxUyXfhgON7lm2W2MO_Sgin5pPxl4Rf6OR78MIdzjuQrxPDCBQ4ri6BeN3YxKn/s400/words+that+work.jpg" width="311" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><b>"Words that Work"</b> - If I worked there, I would be concerned that that using "words that don't work" about a project that probably cost hundreds of millions of dollars would likely injure my career. <b> Click to enlarge.</b></td></tr></tbody></table><br />This is shameless.  Many of these claims are unsubstantiated or in significant doubt in the literature.<br /><br />First:<br /><br />They left out issues such as these:<br /><br /><blockquote class="tr_bq">• The software is tested and validated for safety by nobody, including traditional medical device safety testers.<br /><br />• No postmarket surveillance for problems, either.<br /><br />• Transparency about problems that can cause patient harm is severely impeded by systematic impediments to information flow (as per <b>IOM's 2012 study of health IT safety</b> at <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html</a>, <b>FDA via their leaked Internal Memo</b> on HIT safety as at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a>, the <b>Joint Commission in their Sentinel Events Alert on Health IT </b>as at <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html">http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html</a>, and others.)<br /><br />• Problems known are only the <b>"tip of the iceberg"</b> (FDA, ECRI Institute), as at <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html</a> and <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a> </blockquote><blockquote class="tr_bq"><b>(Mar. 2014 addendum:</b> add to that list the revelations of med mal insurer CRICO, that EHR technology has contributed to a substantial fraction of the medical malpractice suits in Massachusetts: <a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a>)</blockquote><br />Of the claims they do make:<br /><br /><blockquote class="tr_bq">• <span style="color: red;"><b><i>Efficient</i></b></span> - see aforementioned links as well as "Common Examples of Healthcare IT Difficulties" at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a><br /><br />• <span style="color: red;"><b><i>Convenient</i></b></span> - as above.  According to whom?  Compared to what?  Pen and paper?<br /><br />• <span style="color: red;"><b><i>Improves patient safety and quality</i></b></span> - see IOM report post at <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a> .  We as a nation <b>are only now studying safety of this technology</b>, and the results are not looking entirely convincing, e.g.<b> ECRI Deep Dive Study</b> of health IT safety at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>.  171 health IT mishaps in 36 hospitals, voluntarily reported over 9 weeks, with 8 reported injuries and 3 reported possible deaths is not what I would call something that "improves patient safety and quality" without qualifications.<br /><br />• <i><span style="color: red;"><b>The Cadillac of its kind</b></span></i> - according to whom?<br /><br />• <i><span style="color: red;"><b>Patients at hospitals using this system love it</b></span> </i>-  Do most patients even know what it, or any EHR, looks like?  Have they provided informed consent to its use?<br /><br />• <span style="color: red;"><i><b>Exciting </b></i></span>- clinician surveys such as by physicians at <a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html</a> and by nurses at <a href="http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html">http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html</a> shed doubt on that assertion.  </blockquote><blockquote class="tr_bq">(<b>Addendum:</b> also see what nurses think about these systems at "<b>Another 'Survey' on EHRs - Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications Only a Matter of Time in Open Letter</b>", <a href="http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html">http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html</a>)<br /><br />• <span style="color: red;"><i><b>The best thing for our patients</b></i></span> - again, according to whom?<br /><br />• <b><span style="color: red;"><i>Sophisticated new system</i></span></b> - "New"?  Not so much, just new for U. Arizona Health.  "Sophisticated", as if that's a virtue?  Too much "sophistication" is in part what causes clinician stress and burnout, raising risk; see this summary of a new, not-free JAMIA article "<b>Electronic medical records and physician stress in primary care: results from the MEMO Study</b>", J Am Med Inform Assoc amiajnl-2013-001875 at <a href="http://www.beckershospitalreview.com/healthcare-information-technology/the-relationship-between-emrs-and-physician-stress.html">http://www.beckershospitalreview.com/healthcare-information-technology/the-relationship-between-emrs-and-physician-stress.html</a>.   From that summary:<br /><br /><blockquote class="tr_bq">... Compared with physicians at clinics with low-function EMRs,<b> physicians at clinics with moderate-function EMRs experienced significantly more stress and had a higher rate of burnout. </b>Additionally, physicians at clinics with moderate- or high-function EMRs felt less satisfied with their current position overall. </blockquote>and:<br /><blockquote class="tr_bq">... Results also showed a significant relationship between time pressure and physician stress in the cohort with high-function EMRs, and only in this cohort, <b>suggesting physicians at these clinics may be particularly pressured for time during patient encounters in the face of a large number of EMR functions</b>. "This 'made sense' to us in thinking about the possibility that those in the high-use group had more to do in the EMR" [say the authors].<b> </b></blockquote><br />• <span style="color: red;"><b><i>Smartest program out there</i></b></span> - "Smartest" meaning what, exactly?  According to whom?  Who performed the comparison?<br /><br />• <i><b><span style="color: red;">Streamlined</span></b> </i>- compared to what?<br /><br />• <b><span style="color: red;"><i>Thank you for your patience</i></span></b> - even if the effects on clinicians gets you or your loved ones maimed or killed?<br /><br />• <span style="color: red;"><b><i>Safe and secure network</i></b></span> - really?  No break ins, ever, considering multiple breach stories like those at <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a>?<br /><br />• <span style="color: red;"><b><i>Keeping you informed is our priority</i></b></span> - informed of what?<br /><br />• <span style="color: red;"><b><i>Specially trained staff</i></b></span> - like these:  <a href="http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html">http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html</a>?</blockquote><br />and this:<br /><br /><blockquote class="tr_bq">• <span style="color: red;"><i><b>Take Responsibility</b></i></span> - I ask, should clinicians "take responsibility" for IT-related disruptions that impair care such as "use error" (as opposed to user error), i.e., what the National Institute of Standards and Technology has called operator error due to poor usability and other features of bad health IT?  (See "<b>NIST on the EHR Mission Hostile User Experience</b>" at <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html</a>.)  What about <b>"glitches"</b> and bugs that corrupt or lose data?  Should clinicians also 'take responsibility' for those?  (See for example the posts on the wild things that happen when IT malpractice leads to clinical mayhem at <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>.)</blockquote><br />It appears to me that this vendor is using its client hospitals' management to enforce an "acceptable point of view" clinicians must proffer to patients about EHRs (which they must call "health" records), despite well-known contradictory findings.  This is, in effect, forced marketing of a device.<br /><br />Trying that for a drug or a conventional medical device (e.g., a particular stent) would be on its face unethical and likely illegal.<br /><br />Finally, critical thinking is what keeps patients alive and safe.  Marketing measures like this (some might call it "propaganda"), espousing and enforcing 'EHR exceptionalism', in my opinion, damage critical thinking and expression, and are thus unacceptable to push on clinicians and on patients.<br /><br />I add that requiring clinicians to promote deceptive propaganda the clinicians themselves know is untrue, from painful experience, is degrading, intimidating and destroys morale.  It is axiomatic that clinicians (or anyone) operating under such conditions cannot perform at their best.<br /><br />Thus the management geniuses who came up with these instructions (if not outright vendor-ghostwritten as at the Aug. 2012 "<b>Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists</b>", <a href="http://www.tinyurl.com/epic-stealth">http://www.tinyurl.com/epic-stealth</a>) are by their actions increasing risk of patient harm. <br /><br />The nurses' unions at at <a href="http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html">http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html</a> have it right, in my view:  complain about the disruptions this technology causes, and complain loudly, if at the very least to make sure the problems are out in the open.<br /><br />-- SS<br /><br /><b>Note: </b>also see the followup Nov. 2013 post "<b>We’ve resolved 6,036 issues and have 3,517 open issues: extolling EPIC EHR virtues at University of Arizona Health System</b>" at <a href="http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html">http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html</a><br /><br />

Words that Work: Singing Only Positive - And Often Unsubstantiated - EHR Praise As "Advised" At The University Of Arizona Health Network

When clinicians are told to promote a technology in no uncertain terms, that puts a chilling effect on critical thinking and discourse.  In ...

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BLOGSCAN - Television Advertising Revenue and the Anechoic Effect

<span style="color: #38761d;">We have often discussed the </span><a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect"><span style="color: #38761d;">anechoic effect</span></a><span style="color: #38761d;">, how cases involving or discussions of the topics we address on </span><a href="http://hcrenewal.blogspot.com/"><span style="color: #38761d;">Health Care Renewal</span></a><span style="color: #38761d;">, the concentration and abuse of power in health care, fail to produce any responses, or echoes.  Two recent blog posts discussed one way in whicht the anechoic effect might be generated.</span><br /><br /><span style="color: #38761d;">A </span><a href="http://currentmedicine.tv/2012/specialties/psychiatry/youre-telling-me-this-now-why-the-news-is-suddenly-critical-of-statins-and-antidepressants"><span style="color: #38761d;">post</span></a><span style="color: #38761d;"> by Dr Steven Greer on CurrentMedicine.TV, </span><a href="http://alison-bass.com/blog/2012/02/why-60-minutes-suddenly-discovered-the-placebo-effect-in-treating-depression"><span style="color: #38761d;">enlarged upon</span></a><span style="color: #38761d;"> by Alison Bass on the Alison Bass blog, discussed a segment on 60 Minutes yesterday that dealt with the evidence that anti-depressant drugs may not be efficacious for mild to moderate depression.  Since this evidence is about four years old, the question is why it has only made it to the main-stream media now?  Both Dr Greer and Ms Bass think it may be because the patents on most of the newer, mainly selective serotonin reuptake inhibitor (SSRI) type anti-depressants have run out.  Therefore, their manufacturers may no longer be interested in using the clout they derive from paying millions for television advertising to keep programs critical of these drugs off the air.  The implication is that large health care organizations may often use threats to withdraw advertising to forestall criticisms of their products or their agendas in the media, hence increasing the anechoic effect.</span><br /><br /><span style="color: #38761d;">ADDENDUM (27 February, 2012) See also <a href="http://1boringoldman.com/index.php/2012/02/24/the-neurotic-covenants">comments</a> on the 1BoringOldMan blog.</span> 

BLOGSCAN - Television Advertising Revenue and the Anechoic Effect

We have often discussed the anechoic effect , how cases involving or discussions of the topics we address on Health Care Renewal , the conce...

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The Texas TMAP Trial as Illustration of a Systematic Stealth Marketing Campaign

Before it was abruptly ended by a sudden settlement for $158 million, the trial in Texas of a suit alleging unethical marketing of the drug Respirdal (risperidone) by the Janssen subsidiary of Johnson and Johnson opened yet another window on organized stealth marketing campaigns in health care. (Note that we first discussed this case <a href="http://hcrenewal.blogspot.com/2006/12/guidelines-in-whose-interest.html">here </a>in 2006, and that this trial and the case was ably covered in detail on the <a href="http://1boringoldman.com/">1BoringOldMan blog</a>.)  <br /><br />Even so, given all the recent attempts to dismiss critics of the pharmaceutical industry as "pharmascolds," (e.g., <a href="http://hcrenewal.blogspot.com/2011/09/using-logical-fallacies-to-scold.html">here</a>), and to otherwise uphold the current status quo in our dysfunctional health care system, I thought it would be useful to rediscuss this case to show how systematic stealth marketing threatens the ideals of rational, evidence-based health care. <br /><br /><a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">Evidence-based medicine</a> may simply be viewed as medicine based on evidence and logic tempered with humanity. A slightly longer definition is practice based on the best evidence from clinical research derived from systematic searches, critically reviewed, used to maximize individual patients' benefits and minimize their harms according to their values.<br /><br />In contrast, brief summaries of sworn testimony during the trial, and of a key report by an expert witness suggested how a commercial health care organization, in this case, the Jennssen subsidiary of Johnson and Johnson, could organize a stealth marketing campaign to promote practice based on deception and falsehoods, entangled in illogic and emotional and psychological manipulation. This was all done to market a product which could not so easily be supported by evidence and logic. <br /><br /><strong>Deception and Falsehoods: Suppression of Medical Research</strong><br /><br />A Bloomberg <a href="http://www.businessweek.com/news/2012-02-01/j-j-hid-3-risperdal-diabetes-studies-from-fda-texas-jury-told.html">report</a> of the last day of the trial showed how the Respirdal stealth marketing campaign used the now classic mechanism of suppression of medical research:<br /><blockquote><em>Johnson & Johnson officials hid three studies showing some patients using Risperdal developed diabetes while claiming the antipsychotic drug didn’t cause the disease</em>, a witness testified.<br /><br />As early as 1999, Johnson & Johnson’s Janssen unit had researchers’ <em>findings that about half the patients taking Risperdal in a study comparing its risks to those of Eli Lilly & Co.’s Zyprexa antipsychotic drug developed diabetes after a year on the medication</em>, Joseph Glenmullen, a psychiatrist and Harvard Medical School instructor, told a Texas jury yesterday.<br /><br />That study concluded Risperdal <em>caused 'medically serious weight gain' that led study subjects to develop diabetes, </em>Glenmullen testified in the trial of the state of Texas’s lawsuit over Janssen’s marketing of the drug. <em>At the same time, Janssen salespeople were telling doctors that researchers concluded the drug didn’t cause the disease</em>, Glenmullen added.</blockquote><br />In particular,<br /><blockquote>Glenmullen, testifying as an expert for the state, told jurors <em>Janssen officials didn’t turn over Study 113, which found Risperdal posed a higher diabetes risk than Zyprexa, to the U.S. Food and Drug Administration </em>when regulators began probing links between anti-psychotic medications and the disease in 2000.<br /><br />The drugmaker also <em>didn’t turn over the results of two other later studies that found Risperdal and Zyprexa posed comparable diabetes risks to the FDA.</em></blockquote>Suppression of research is a severe threat to evidence-based medicine because it can severely bias the clinical evidence base on which it depends.<br /><strong>Deception and Falsehood: Ghostwriting</strong><br /><br />A summary of the 86 page report by Professor David Rothman commissioned by the Texas Attorney General <a href="http://www.houstonpress.com/2011-12-15/news/down-the-hatch-the-rothman-report/">published in the Houston Press</a> provided this example of ghostwriting:<br /><blockquote>A member of J&J's Speakers Bureau, [University of Texas Professor of Psychiatry Dr Alexander] Miller collected at least $82,000 from Janssen and its contractors. He declined to comment for this story, saying he may be called as a witness in the lawsuit.<br /><br /><em>Miller was a 'guest author' for one of Janssen's ghostwritten articles</em>. Upon receiving the manuscript, Miller wrote, 'Yes, I am happy to be included as a co-author. <em>I made a few minor edits and comments in the manuscript.'</em></blockquote>In addition, another <a href="http://www.houstonpress.com/2011-12-15/news/down-the-hatch/">article</a> in the Houston Press summarizing the issues before the trial provided this overview of the ghostwriting process:<br /><blockquote>As described in the AG's expert witness report, <em>a company called Excerpta Medica was hired to draft some of Janssen's Risperdal articles.</em><br /><br />In 2003, according to Rothman, Excerpta Medica issued 'Risperidone Publication Program Status Reports,' indicating that <em>30 of the 145 articles to be published had authors listed as 'to be determined.'</em><br /><br />Rothman also examined what he considered <em>a signature ghostwritten piece meant to boost Risperdal's pediatric profile;</em> the study is included in the 2010 parameters.<br /><br />Rothman cited a barrage of e-mails between Excerpta Medica and J&J in crafting the article. At one point, an Excerpta Medica employee wrote, 'It would be very helpful to receive some guidance in relation to the flow, format and subject in this paper and whether you think this is too marketing oriented or not, in order to prepare a next draft. Besides that we would like [to] have some suggestions for external authors on this paper. Maybe [a] U.S. and a European KOL? Your input will be much appreciated.''<br /><br />The article eventually appeared in a 2007 volume of the European Journal of Child and Adolescent Psychiatry. <em>For a lead author, J&J scored a heavy hitter: Dr. Peter Jensen,</em> former associate director of child and adolescent research at the National Institute of Mental Health, and the founding director of the Center for the Advancement of Children's Mental Health at Columbia University. Now with the Mayo Clinic, Jensen declined to comment for this story.</blockquote><br />This indicates the scope of this particular ghostwriting initiative: 145 articles were planned.  Thus, ghostwritten articles could comprise a major proportion of the apparently scholarly literature relevant to Risperdal.  Ghostwriting is fundamentally deceptive because it allows marketing to appear in the guise of scholarly work.  Ghostwritten reviews can deceptively shift the focus from the questions that need to be addressed by the evidence-based process to benefit patients to those whose answers would benefit marketers.<br /><br /><br /><strong>Deception and Falsehoods: Key Opinion Leaders</strong><br /><strong>Emotional and Psychological Manipulation: Creation of Conflicts of Interest </strong><br /><br />An important element of most stealth marketing campaigns is the creation of <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders</a>.  These are academics or professionals who can promote products in the guise of unbiased expertise.  <br /><br />A summary of the 86 page report by Professor David Rothman commissioned by the Texas Attorney General <a href="http://www.houstonpress.com/2011-12-15/news/down-the-hatch-the-rothman-report/">published in the Houston Press</a> provided the example of Dr Steven Shon:<br /><blockquote>As the head of the state's mental health agency, <em>Shon was perhaps Janssen's most crucial key opinion leader; his influence in <strong>pushing ­Risperdal</strong> was invaluable</em>.<br /><br />He accepted at least $47,000 from Janssen and its medical ghostwriter, Excerpta Medica, and signed an agreement to be a member of Johnson & Johnson's Speakers Bureau. Rothman writes, <em>'The medical director of the state's mental health agency should not be serving as an official spokesperson for a pharmaceutical company</em> whose product state agencies are purchasing.'<br /><br /><em>The company paid for his trips across the country, and even overseas, to promote ­Risperdal as a safe and effective medication</em>. (But the romance between Janssen and Shon was not without its bumps; Shon would get 'upset' if the checks he accepted from Janssen were made out to the MHMRA instead of directly to him. Apparently, those were more difficult to funnel into his personal account.)<br /><br />Shon retired in 2005, allowing him to collect his taxpayer-funded pension. He moved to Las Vegas, where he's the director of psychiatry for a mental health and substance abuse clinic called Harmony Healthcare.<br /><br />Shon was so influential that Janssen grew paranoid and possessive when it learned that other companies sought his partnership as well. When J&J employee Yolanda Roman heard that Eli Lilly had flown him to their headquarters on a private jet, she wrote, "Steve I suppose is enjoying the vast attention and response he can command from Industry...Obviously, Steve has the right to be served by all Industry, let's hope he remains fair [and] balanced and remembers who PLACED HIM ON THE 'TMAP' MAP."<br /><br />Meanwhile, another employee busted out the caps-lock to warn that "WE WILL NOT LET LILLY OR PFIZER PREVAIL WITH <em>OUR MOST IMPORTANT PUBLIC SECTOR THOUGHT LEADER</em>."</blockquote><br />Similarly, a Bloomberg <a href="http://www.bloomberg.com/news/2012-01-11/johnson-johnson-paid-texas-official-to-speak-around-the-u-s-jury-told.html">report</a> of Dr Shon's trial testimony included:<br /><blockquote>Johnson & Johnson’s Janssen unit paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to medicines like the company’s Risperdal, the official said.<br /><br />Steven Shon accepted honorariums to fly to Arizona, Florida and New Jersey to discuss Texas guidelines developed in 1999 advising doctors that a newer class of drugs like Risperdal were a “first choice or option” for schizophrenia, he testified today in state court in Austin.</blockquote><br />Also,<br /><blockquote>Attorneys for Jones questioned Shon, who served as medical director of the Texas Department of Mental Health and Mental Retardation until he involuntarily retired in 2006.<br /><br />Shon testified that he served on Janssen advisory boards, was a board member of a Janssen publication called 'Mental Health Issues Today' and was a continuing medical education speaker in programs sponsored by the company.<br /><br />Shon was asked about six trips in which he got honorariums of $3,000 from Janssen to discuss the TMAP project. In several cases, he kept those payments, he said.<br /><br />In testimony yesterday, a Texas Medicaid investigator said Shon signed several consulting agreements with Janssen, and the company paid him $47,587 over several years. </blockquote><br />Dr Shon's value to Janssen derived from his position as the respected leader of the state's mental health agency. While he was apparently paid by Janssen marketers who saw him as an ally, his marketing was all the more effective because it seemed to come from an unbiased expert. As such it was deceptive. <br /><br />The <a href="http://iom.edu/Activities/Workforce/ConflictOfInterest.aspx">Institute of Medicine report on conflicts of interest</a> defined them as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest." The report, and indeed much of the discussion of conflicts of interest in health care assumes that most secondary interests are "-within limits - legitimate and even desirable goals." For example, an academic physician who also was a basic scientist could be paid by a pharmaceutical company to do a specific assay on samples used in research. In that case, the payments could conceivably create a risk that the academic's professional judgment in a clinical setting would be unduly favorable to the products of the company. However, the relationship hardly seems intended to cause such a bias. Notions that conflicts of interest are "inevitable" but "manageable" may stem from consideration of conflicts of interest like this.<br /><br />However, conflicts of interest deliberately created as perverse incentives may be much more consequential, and as this example shows, perhaps not rare. It appears that Janssen paid Dr Shon not to do some task that was unrelated to how he fulfilled his primary entrusted responsibilities as director of mental health, but in order to influence how he fulfilled them. We have noted previous examples in which corporate marketers consider paid key opinion leaders as sales people (see posts <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>). Such conflicts are deliberately created so that the recipient of payments uses his or her entrusted responsibilities to serve the vested interests of the payer may be deceptive, as noted above.  Furthermore, by being intended to induce changes in how the payee performs his or her primary responsibilities, these conflicts are particularly likely to lead to abuse of these entrusted responsibilities. Given that the <a href="http://www.transparency.org/news_room/faq/corruption_faq">Transparency International definition of corruption</a> is abuse of entrusted power for private gain, we need a new and more incisive term to described this variety of conflicts of interest. <br /><br />The motivation of key opinion leaders by created conflicts of interest can result in powerful manipulation of the key opinion leaders, but more importantly of their audience.  <br /><br /><strong>Emotional and Psychological Manipulation: Intimidation</strong><br /><br />Another Bloomberg <a href="http://www.bloomberg.com/news/2012-01-12/j-j-whistle-blower-recounts-firing-after-finding-payments.html">report</a> included testimony about how someone who attempted to blow the whistle about the Respirdal stealth marketing campaign was intimidated:<br /><blockquote>Allen Jones testified yesterday in state court in Austin, Texas, that he was an investigator in the Pennsylvania Office of Inspector General in 2002 when he looked into an unregistered bank account run by Steven Fiorello, the pharmacist. <em>Fiorello was on a Pennsylvania committee weighing whether to require doctors to give priority to newer, more expensive drugs like Risperdal in state-funded treatment of mental-health patients</em>, Jones said.<br /><br />Jones, 57, said he found <em>a $4,000 check from J&J’s Janssen unit to Harrisburg State Hospital that was sent “\'to the attention of' Fiorello. The check covered a Fiorello trip to New Orleans to discuss Pennsylvania’s drug guidelines. Another check for $1,766 to the hospital account was sent 'in care of' of Fiorello</em>, Jones said. Fiorello controlled the account and didn’t register it with the state, Jones said.<br /><br />'The account was used to deposit money from drug companies,' Jones said yesterday in the trial’s third day of testimony. 'There were real problems here. On many levels, the account was improper.'<br /><br /><em>Janssen also paid $2,000 directly to Fiorello as an honorarium for his speaking at a company-sponsored event</em> in 2002, Jones said. Jones said he followed the money trail and explored efforts by Janssen to promote, on a state-by-state basis, Texas guidelines favoring drugs like Risperdal. The funds sent to the hospital account helped pay travel expenses for programs related to setting up the Texas guidelines in Pennsylvania, he said. <br /><br />The state adopted the guidelines that favored Risperdal in 2003, Jones said. </blockquote><br />Note that this testimony appears to be about yet another KOL paid to promote guidelines that would in turn promote the marketing of Respirdal. So this is yet another case of a conflict of interest apparently deliberately created to influence the individual's primary responsibility.<br /><br />However, then<br /><blockquote>Jones said his boss told him to ease off his probe. He said he was told, <em>'Stay away from the drug companies. This is a personnel issue. Stay away from the drug companies, stay away from TMAP.</em><br /><em><br /></em><br /><em>Jones said his boss said, 'Drug companies write checks to both sides of the aisle. Stay away from it.' His boss told him that 'morally and ethically I was correct, but politically, this was dead.'</em><br /><br /><em>Jones said that later he was removed as the lead investigator from the case, and he was 'marginalized completely</em>.' He continued to pursue the case on his own time, and spoke to the New York Times for a story that ran Feb. 1, 2004. <em>He said he was fired for talking to the newspaper. </em></blockquote><br />So Jones was intimidated to the extent that he lost his job. Note further that the implication is that this intimidation stemmed from yet more conflicts of interest created by Janssen, payments to politicians. This underlines how stealth marketing campaigns become complex systems.<br /><br />Note further that in retrospect, Jones' complaints were deemed true by a court of law and a state commission:<br /><blockquote>Fiorello, once the chief pharmacist for Pennsylvania’s public welfare department, was convicted in December 2008 of felony conflict-of-interest charges for taking payments from drug companies, including Janssen and Pfizer Inc. He was sentenced to 18 months of probation and fined $3,000. He also paid more than $27,000 in civil fines after the Pennsylvania Ethics Commission cited him. </blockquote>In a sense, intimidation and created conflicts of interest are two sides of the same coin.  Both involve the deliberate imposition of incentives, either positive or negative.  These incentives are designed to further marketing aims and organizational interests, not to improve patient care or public health, or advance science.  Thus they are powerful tools of emotional and psychological manipulation. <br /><strong>Summary</strong><br /><br />Note that even the brief summaries of trial evidence suggested how systematic the campaign was, and how within it, the elements of deception and falsehoods (instead of evidence), and emotional and psychological manipulation (instead of logic and humanity) were predominant. This should be added to previous discussion of <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing">stealth marketing campaigns</a>, including such examples as that of Neurontin <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a>). <br /><br />Stealth marketing campaigns are complex examples of how behavior meant to further vested interests may directly threaten evidence-based practice, physicians' professionalism, and ultimately patients' and the public's health.<br /><br />There have been many calls (e.g., see recent posts <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/11/if-medical-school-is-just-part-of.html">here</a>) for increased "collaboration" among health professionals and academics and industry.  Often they are justified by the need for "innovation," while resulting conflicts of interest are deemed "manageable."  The current examples show how the vested interests of health care organizations operating within a laissez faire, anything goes environment may make such collaboration poisonous.

The Texas TMAP Trial as Illustration of a Systematic Stealth Marketing Campaign

Before it was abruptly ended by a sudden settlement for $158 million, the trial in Texas of a suit alleging unethical marketing of the drug ...

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The UC-Davis Pepper-Spray Case as Illustrative of Problems with the Leadership of Health Care

The aggressive actions by University of California-Davis police against unarmed, peaceful student protesters turn out to be the latest illustration of the problems with leadership and governance we discuss on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>.  <br /><br /><strong>The University of California - Davis Pepper Spray Incident</strong><br /><br />To summarize the current episode, I start with quotes about its background <a href="http://www.reuters.com/article/2011/11/19/us-protests-davis-pepperspray-idUSTRE7AI0ZA20111119">from Reuters</a>,<br /><blockquote>Student protesters at Davis had <em>set up an encampment in the university's quad area earlier this month as part of the nationwide Occupy movement against economic inequality and excesses of the financial system.</em><br /><br />Their demonstrations, which had been <em>endorsed by a faculty association</em>, included <em>protests against tuition increases and what they viewed as police brutality on University of California campuses in response to recent protests.</em><br /><br />The students had set up roughly 25 tents in a quad area, but <em>they had been asked not to stay overnight and were told they would not be able to stay during the weekend, due to a lack of university resources, [university Chancellor Linda] Katehi said</em>.<br /><br />Some protesters took their tents down voluntarily while others stayed.</blockquote><br />Then,<br /><blockquote>The pepper spray incident appeared to take place on Friday afternoon, when <em>campus police moved in to forcibly evict the protesters.</em></blockquote><br />Then, as <a href="http://www.independent.co.uk/news/world/americas/outcry-over-chilling-campus-pepper-spray-use-6265203.html">per the (London, UK) Independent</a>,<br /><blockquote><em>A police officer saunters up to a group of young protestors who are sat in a line on the ground, with their arms linked. Then he removes a canister of pepper spray from his belt, with a flourish, before casually proceeding to unload its contents into their faces</em>.<br /><br /><em>The demonstrators remain silent and motionless</em>, with their heads bowed. So the policeman carries on, methodically covering them, from point blank range. By the time he’s finished, their heads and faces are covered in a thick layer of the toxic red liquid.</blockquote><br />The actual video is below:<br /><iframe allowfullscreen="" frameborder="0" height="315" src="http://www.youtube.com/embed/WmJmmnMkuEM" width="560"></iframe><br /><br /><strong>The UC-Davis Chancellor's Defense of the Police Actions</strong><br /><br />The Independent's coverage emphasized that initially the leadership of the campus police defended the use of pepper spray on apparently unarmed, peaceful students:<br /><blockquote>Annette Spicuzza, the head of the UC Davis Campus Police, who were responsible for Friday’s incident .... told reporters that <em>her officers had been 'forced' to use the pepper spray, after demonstrators surrounded them.</em> Lt Pike gave his victims sufficient warning of the impending attack, she added, and emptied the canister with a sweeping motion, in keeping with official procedures.<br /><br />'When you are encircled by 200 individuals, I don’t know if I want to say ‘afraid,’ but I think they <em>were quite concerned about their safety</em>,' she said, regarding the circumstances her officers faced. 'There was no way out of that circle... It's a very volatile situation.'</blockquote><br />That coverage also made clear that the directive to clear the demonstrators came from the top:<br /><blockquote>Linda Katehi, the Chancellor of UC Davis ... had <em><strong>asked the police to clear demonstrators from her campus</strong></em>, a couple of hours north of San Francisco. In the aftermath of the incident, <em>she had initially joined Spicuzza in defending the force's methods, saying that they had 'no option' but to adopt a hard line</em>.</blockquote><br />Ms Katehi later backed off, but only after her first response<br /><blockquote>sparked immediate outrage, and within hours, the university’s Faculty Association, representing Ms Katehi’s employees, issued a statement <em>called for her resignation, saying that her authorisation of 'excessive' force had amounted to a 'gross failure of leadership</em>.'<br /><br />Nathan Brown, an assistant English professor who witnessed the incident, wrote in an open letter: 'Several of these students were hospitalized. Others are seriously injured. One of them, forty-five minutes after being pepper-sprayed down his throat, was still coughing up blood... You are responsible.'</blockquote><br />Other comments likened the police actions to something "coming from some riot-control unit in China, or in Syria," [<a href="http://www.theatlantic.com/national/archive/2011/11/pepper-spray-brutality-at-uc-davis/248764/">James Fallows in the Atlantic</a>] called them indicative of "a police state in its pure form," [<a href="http://www.salon.com/2011/11/20/the_roots_of_the_uc_davis_pepper_spraying/">Glenn Greenwald in Salon</a>], or otherwise denounced them as "outrageous" or "awful." (Clark McPhail, professor emeritus of sociology at the University of Illinois, and Greg Lukianoff, President of the Foundation for Individual Rights in Education, respectively, <a href="http://www.insidehighered.com/news/2011/11/21/experts-and-activists-question-use-pepper-spray-davis">via Inside Higher Ed</a>.)<br /><br />This aggressive, violent response to peaceful protest seems to be the latest example of the arrogance of some current leaders of our important organizations. <br /><br /><strong>Our Previous Discussion of the Chancellor in Health Care Renewal</strong><br /><br />This case appears directly related to the problems in leadership and governance we discuss on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal </a>Ms Katehi has the distinction of having been already written up twice on Health Care Renewal for questions about her leadership.<br /><br />On her arrival at UC-Davis in 2009, she promised to "help UC Davis to become more aggressive in taking new biotechnology and agriculture products to market." This indicates at best ignorance of, at worst hostility to the fundamental university mission, which is hardly developing and particularly marketing products, but discovering and disseminating knowledge (see <a href="http://hcrenewal.blogspot.com/2009/08/university-leaders-goal-taking-new.html">this post</a>).<br /><br />At that time, I called this an example of "how the leaders of academic institutions seem to be forgetting or radically deconstructing their academic missions."<br /><br />In 2011, Ms Katehi defended the payment to the medical center CEO, whom she called a "great CEO,' of nearly a million dollars yearly in compensation. However, that CEO was part of a group of top university leaders demanding large increases in their pensions at a time when the university was under great financial distress. For that, some called them not great leaders, but greedy and "despicable." Thus, Ms Katehi seemed to stand up for top leaders' privilege and exceptionalism, including their entitlement to huge compensation whatever the circumstance, even in a time of financial travail (see <a href="http://hcrenewal.blogspot.com/2011/09/more-repeats-of-talking-points.html">this post</a>).<br /><br />I could not have predicted that Chancellor Katehi would preside over the pepper spraying unarmed students for peaceful, legitimate protest. However, it is not surprising that a leader who does not understand the fundamental academic mission and who supports executive privilege and exceptionalism would foster an authoritarian climate in which such an incident could happen. <br /><br />This example clearly illustrates the issues we have been discussing on Health Care Renewal for a long time. In particular, leaders who are more dedicated to their own and their fellow executives' privilege and exceptionalism than their organizations' missions are likely to end up promoting actions that threaten those  missions. <br /><br /><strong>The Moral of the Story </strong><br /><br />Instead, as we have been preaching endlessly,... 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.<br /><br />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. <br /><br />You heard it here first on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal </a>.<br /><br />Keep your eye on Health Care Renewal for continued discussion of parallels between problems in health care and in the larger political economy.

The UC-Davis Pepper-Spray Case as Illustrative of Problems with the Leadership of Health Care

The aggressive actions by University of California-Davis police against unarmed, peaceful student protesters turn out to be the latest illus...

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Abbott Laboratories and Pig Roasts, the "Philly Mob," and Legal Settlements

Help.... The health care muck is now being raked so fast I can't keep up.<br /><br /><strong>Abbott Laboratories, Prolific Stenters, Pig Barbecues, Etc</strong><br /><br />In the last week, multiple media outlets picked up the story of the cozy relationship between Abbott Laboratories and a doctor now accused of implanting too many cardiac stents for too much money.  The essentials were, as summarized from <a href="http://www.nytimes.com/2010/12/06/health/06stent.html">New York Times</a>, <a href="http://online.wsj.com/article/SB10001424052748704493004576001582557244592.html">Wall Street Journal</a>, and <a href="http://www.baltimoresun.com/health/bs-bz-hancock-stents-abbott-20101206,0,5226901.column">Baltimore Sun</a> articles -<br /><br />Dr Mark Midei was a prolific user of cardiac stents for patient with coronary artery disease (blocked cardiac arteries)<br /><blockquote>In the June deposition, Dr. Midei estimated that in 2005 — before research revealed that many stents were unnecessary — he performed about 800 stent procedures. Instead of dropping in subsequent years, however, the number of stents Dr. Midei inserted rose to as many as 1,200 annually, he estimated. In a 2007 internal document, Abbott Laboratories <em>ranked Dr. Midei’s use of stents behind only five other cardiologists in the Northeast, including those at hospitals four and five times St. Joseph’s size</em>. [NYT] </blockquote><br />Therefore, hospitals sought him out<br /><blockquote>He had been one of the <em>most sought-after clinicians in his region</em>. Trained at Johns Hopkins University, he was a co-founder of MidAtlantic, a practice with dozens of cardiologists that controlled much of the cardiac business in Baltimore’s private hospitals. Dr. Midei was one of the practice’s stars. When MidAtlantic negotiated a $25 million merger with Union Hospital in 2007, the deal was contingent on his continued employment. <br /><br />St. Joseph was so concerned about losing Dr. Midei’s business that <em>the hospital offered a $1.2 million salary</em> if he would leave MidAtlantic and join the hospital’s staff. [NYT]</blockquote><br />However, it appeared he performed the procedures on patients who would not benefit from them.<br /><blockquote>The hospital engaged a panel of experts who reviewed 1,878 cases from January 2007 to May 2009 and found that <em>585 patients might have received unnecessary stents</em>. <br /><br />When asked to review the cases himself, Dr. Midei found far less blockage than he had initially, according to the Maryland Board of Physicians. The hospital <em>suspended his privileges and eventually sent letters to all 585 patients. Hundreds of lawsuits against Dr. Midei and St. Joseph followed,</em> including from patients treated well before January 2007. [NYT]</blockquote><br />Nonetheless, Abbott Laboratories had been rewarding him for frequent use of their products<br /><blockquote>Word quickly reached top executives at Abbott Laboratories that a Baltimore cardiologist, Dr. Mark Midei, had inserted 30 of the company’s cardiac stents in a single day in August 2008, 'which is the biggest day I remember hearing about,' an executive wrote in a celebratory e-mail. <br /><br />Two days later, an Abbott sales representative <em>spent $2,159 to buy a whole, slow-smoked pig, peach cobbler and other fixings for a barbecue dinner at Dr. Midei’s home</em>, according to a report being released Monday by the Senate. The dinner was just a small part of the <em>millions in salary and perks showered on Dr. Midei for putting more stents in more patients than almost any other cardiologist in Baltimore.</em> [NYT]</blockquote><br />When his over-use was alleged, Abbott continued to use him as a key opinion leader.<br /><blockquote>Abbott <em>responded to the controversy by hiring Dr. Midei as a consultant. 'It’s the right thing to do because he helped us so many times over the years,'</em> an Abbott executive wrote in a January e-mail cited in the Senate report. [NYT]</blockquote><br />Also,<br /><blockquote>After St. Joseph barred Dr. Midei from practicing there in May 2009, Abbott arranged consultant work for him, according to emails released by the Senate committee.<br /><br />In December 2009, an Abbott senior vice president wrote in an email that he was 'very open' to having Dr. Midei do consulting 'to see how it might go—either <em>getting the word out in China/Japan, medical or safety work.'</em><br /><br />The following month, the Sun reported on the allegations against Dr. Midei and St. Joseph. According to the Senate report, an Abbott executive subsequently said in an internal company email, 'We recommend that we not use Dr. Midei in the U.S. at this time (the press is just too hot).'<br /><br />Charles Simonton, the medical director of Abbott's vascular division, said in another email cited by the report that Dr. Midei should 'clearly avoid' the Baltimore area, but Dr. Simonton encouraged colleagues to 'please <em>find key physicians or cath labs you'd like him to get in front of with our data.' Abbott wanted to hire Dr. Midei 'because he helped us so many times over the years,'</em> yet another Abbott executive said in an email. <br /><br />Dr. Simonton didn't return phone calls seeking comment. <br /><br />Abbott sent Dr. Midei to Japan to promote the Xience stent, but bad publicity caused that trip to be cut short in late January, the report says. In total, Abbott paid the doctor $30,623 to help market the Xience, the Senate investigators found. [WSJ]</blockquote><br />When the relationship was criticized, Abbott executives responded with threats, or were they jokes?<br /><blockquote>I called David Pacitti, vice president of global marketing for Abbott Laboratories' cardiac-plumbing division, to ask why he seems to want goons to beat me up in the newspaper parking lot.<br /><br />'Don't you have connections in Baltimore?????' Pacitti e-mailed a subordinate regarding a January column I wrote on heart-artery stents.<em><strong> 'Someone needs to take this writer outside and kick his ass! Do I need to send in the Philly mob?'</strong></em><br /><br />Pacitti and other Abbott execs apparently don't care for suggestions that their expensive vascular devices often do patients little good and that a star Baltimore doctor took their encouragement to be 'truly outstanding' a bit too much to heart. [Sun]</blockquote>Furthermore,<br /><blockquote>Pacitti didn't return my phone calls, but an Abbott flack got in touch on Monday.<br /><br />'We sincerely apologize if this caused you any concern or distress,' the company spokesman said. Pacitti's comment, he said, 'wasn't meant to be taken seriously.'<br /><br />Yeah, that's what King Henry II said after they whacked Thomas Becket. [Sun]</blockquote>So here is a particularly vivid case showing how big health care corporations make <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">"key opinion leaders"</a> out of doctors apparently just because they use or prescribe a lot of the company's products, regardless of the doctors' expertise, or ethics.  As we noted before, "key opinion leaders" are seen by corporate marketing executives as fellow travelers or useful idiots (see posts <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a>). It again appears is that all that health care corporate marketers care about is selling product. Whether their pitches are honest or ethical is besides the point. Those who get in their way are treated with contempt, and maybe, just maybe are threatened with violence<br /><br />The physicians who are flattered at being called "key opinion leaders," or "thought leaders" have got to realize that the marketers think they are chumps. If they think they are providing honest information, or education, they are deluded.<br /><br />This case has already been widely discussed in the blogsphere.  See, in particular, posts by Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2010/12/embarrassing-light-on-unnecessary.html">on the Hooked: Ethics, Medicine and Pharma blog</a>, and Larry Husten <a href="http://cardiobrief.org/2010/12/06/senate-report-on-mark-midei-and-abbott-30-stents-in-1-day-pig-roasts-and-more/">on the CardioBrief blog</a>. <br /><br />But if that were not enough, on the heels of this story came several more about Abbott Laboratories<br /><br /><strong>Abbott Laboratories Settles, Twice</strong><br /><br />As <a href="http://www.latimes.com/news/nationworld/nation/wire/sc-dc-1208-drug-promotions-20101207,0,1770487.story">reported</a> by the Los Angeles Times, while Abbott was trying to hide Dr Midei overseas, it was also busily negotiating settlements of completely separate charges:<br /><blockquote><em>Abbott Laboratories and two other pharmaceutical firms agreed to pay more than $421 million to settle claims of defrauding Medicare and Medicaid</em> in the latest in a string of nine- and ten-figure health care fraud settlements announced by the Justice Department.<br /><br /><em>The drug companies charged one set of prices to doctors and pharmacies but reported another set of inflated figures that were used as benchmarks by government insurers reimbursing health care providers</em>. The spread, or difference, amounted to kickbacks to the companies' customers, according to Tony West, assistant attorney general for the Justice Department's civil division, who announced the settlements on Tuesday.</blockquote><br />In particular,<br /><blockquote><em>Abbott, of North Chicago, Ill, agreed to pay $126.5 million to settle accusations that it charged the government inflated prices for products ranging from sterile water and saline solution to vancomycin, an antibiotic.</em><br /><br />An Abbott spokesman said the company believes 'that we have complied with all laws and regulations' and settled the case to avoid 'the uncertainty associated with continued litigation.'</blockquote><br />At least he did not threaten the Department of Justice officials with an attack by the "Philly mob."<br /><br />But that is not all. The Wall Street Journal <a href="http://online.wsj.com/article/SB10001424052748703296604576005674095414668.html">reported</a> that Abbott had to make a second, unrelated settlement:<br /><blockquote>Separately on Tuesday, the Justice Department announced <em>an unrelated $41 million settlement with Abbott subsidiary Kos Pharmaceuticals Inc. on charges that it paid kickbacks to doctors and other health professionals to encourage them to prescribe or recommend the cholesterol drugs Advicor and Niaspan.</em><br /><br />As part of that settlement, <em>Kos entered into an agreement that will allow it to avoid prosecution on criminal charges</em>. 'These actions occurred prior to Abbott's acquisition of Kos in 2006 and Abbott has not been accused of any wrongdoing,' an Abbott spokesman said.</blockquote><br />However, Abbott chose to acquire a company that allegedly chose to pay kickbacks of this sort. The apparent resemblance to Abbott's payments to Dr Midei in the case above are striking.<br /><br />By the way, the Los Angeles Times article also noted previous black marks on Abbott's record:<br /><blockquote><em>Abbott also paid $614 million in civil and criminal penalties in 2003 to end a federal investigation of the company's marketing practices and Medicaid and Medicare reimbursements.</em><br /><br /><em>In 2001, TAP Pharmaceutical Products Inc., of Lake Forest, Ill., an Abbott joint venture, agreed to pay $875 million and plead guilty to a criminal charge of conspiring with doctors to overbill Medicare.</em><br /><br />At the time, the TAP penalty was the largest health care fraud settlement in U.S. history, but it has since been eclipsed by at least two others.</blockquote><br />So we once again illustrate how punishing wrong doing by fining large corporations, when the fines are just seen as a cost of doing business, in the absence ofany negative consequences on the real people who authorized, directed, or implemented the bad behavior fails to deter future bad behavior.<br /><br />This remarkable confluence of cases suggest how rotten are the ethical foundations of even large and previously respected health care organizations. I imagine, though, that as long as these corporations richly reward their executives regardless of the ethics of their actions, and regardless of the long term effects on the organizations' reputations, and as long as their are no externally imposed negative consequences on these leaders, the practices will continue, and will get worse.<br /><br />Health care costs keep rising, access keeps declining, quality gets worse. We moan and wring our hands, but as long as we allow the rot to worsen, and the muck to grow, expect these trends to continue until the whole smelly mess collapses of its own weight (with all those rich executives escaping to their mansions.)<br /><br />If we really want high quality accessible, reasonably priced health care, we need true health care reform that reduces concentration of power in large organizations, and makes health care organizations' leadership accountable, ethical, and transparent. That will not be easy.<br /><br />ADDENDUM (8 December, 2010) - See also comments by Maggie Mahar <a href="http://www.healthbeatblog.com/2010/12/stent-scandal-a-shocking-story-but-not-news-.html#more">on the HealthBeat blog</a>, David Williams <a href="http://www.healthbusinessblog.com/?p=4072">on the Health Business Blog</a>, and Paul Thacker <a href="http://pogoblog.typepad.com/pogo/2010/12/digging-for-gold-a-nugget-from-senate-report-on-baltimore-cardiologist.html#more">on the Project on Government Oversight blog</a>.

Abbott Laboratories and Pig Roasts, the "Philly Mob," and Legal Settlements

Help.... The health care muck is now being raked so fast I can't keep up. Abbott Laboratories, Prolific Stenters, Pig Barbecues, Etc In ...

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Bring Back the DSI*? - the Avandia Case as Spy Novel

Starting in 2007, we posted quite a bit about the "Avandia case," which centered on whether Avandia (rosiglitazone, by GlaxoSmithKline), a glucose lowering drug for type 2 diabetes, presented excess cardiovascular risks, and how evidence about these risks was handled.  <br /><br /><strong>Summary</strong><br /><br />The Nissen and Wolski meta-analysis [Nissen SE, Wolski K. Effects of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356, online <a href="http://content.nejm.org/cgi/content/full/NEJMoa072761">here</a>] was to be the first published article to combine data from all relevant clinical trials of rosiglitazone then available.  Although two major trials of Avandia had been published, its manufacturer, GlaxoSmithKline, had performed many other smaller trials of the drug which remained unpublished.  These results eventually appeared on a <a href="http://www.gsk-clinicalstudyregister.com/">web-site run by GSK</a>. However, this web-site was relatively obscure.  It had not been created voluntarily, but in response to a settlement of legal action that alleged GSK had suppressed clinical research about its antidepresant paroxetine (Paxil). (See Steinbrook R. Registration of clinical trials - voluntary of mandatory. N Engl J Med 2004; 351: 1820-1822, link <a href="http://content.nejm.org/cgi/content/full/351/18/1820">here</a> and our post <a href="http://hcrenewal.blogspot.com/2007/01/not-something-we-want-to-publicise-spin.html">here</a>).<br /><br />Nissen and Wolski found the site, compiled the results of trials on Avandia it contained, and combined their results with those of the few published trials in their meta-analysis. It is to the credit of Nissen and Wolski that they were able to figure out how to do this. It is not to the credit of GSK that they sat on the data from these trials, only put it on this web-site when compelled to do so, did not make any effort to publicize the web-site, and did not publish a meta-analysis done by company scientists that showed qualitatively similar results to that eventually done by Nissen and Wolski (see post <a href="http://hcrenewal.blogspot.com/2007/05/dream-turns-to-nightmare-avandia-and.html">here</a>). <br />  <br />I originally <a href="http://hcrenewal.blogspot.com/2007/06/avandia-spin-cycle-continues.html">thought</a> the case raised two questions:  1 - what are the benefits and harms of rosiglitazone as a treatment of Type 2 diabetes, and therefore for which patients under what circumstances should this drug be used?  2 - what barriers have prevented physicians and patients from getting the best possible answer to the first question, and what can be done about them? <br />  <br />But the immediate response to the Nissen and Wolski meta-analysis was a spin cycle that seemed to obfuscate these questions, and the answers to him (see posts <a href="http://hcrenewal.blogspot.com/2007/06/more-on-avandia-why-we-need-to-call-off.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/06/wall-street-journal-gives-avandia-whirl.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/06/avandia-spin-cycle-continues.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2007/11/silencing-avandia-whistle-blower.html">here</a>) <br />  <br /><strong>A Reconsideration</strong> <br />  <br />In the last few weeks, several articles about Avandia have appeared in the media, and in medical journals, that reconsider the issues, and in particular, the "Avandia Spin Cycle."  First was a commentary in the European Heart Journal by Dr Steven E Nissen, the first author of the meta-analysis [Nissen SE. The rise and fall of rosiglitazone. Eur Heart J 2010: published online <a href="http://eurheartj.oxfordjournals.org/content/early/2010/02/11/eurheartj.ehq016.long">here</a>.]  Dr Nissen provided a narrative history of the Avandia case from his viewpoint, and summarized it thus:<br /><blockquote>What were the key mistakes and lessons learned from the rosiglitazone affair?<br /><br />1. The FDA rushed to approve rosiglitazone because of hepatotoxicity concerns about troglitazone, resulting in failure to consider the ‘signals’ suggesting cardiovascular toxicity.<br />2. An <em>early critic of rosiglitazone was intimidated by company representatives and effectively silenced, a process antithetical to the principals of open scientific discourse</em>.<br />3. Although early warnings were issued for the risk of heart failure, these warnings went largely unheeded in the face of <em>aggressive marketing and promotion suggesting cardiovascular benefits</em>.<br />4. No well-designed cardiovascular outcome trials were ever conducted for rosiglitazone, despite evidence suggesting increased cardiovascular risks. The only cardiovascular outcome trial was an open label study driven by a soft endpoint (hospitalization) with low adherence to randomized medications, seriously underpowered, and not completed until 10 years following launch.<br />5. <em>Although both the FDA and the company were aware of evidence of an increased risk of adverse cardiovascular outcomes, certainly by 2005, neither warned physicians nor the public</em>.<br />6. When a meta-analysis of rosiglitazone was eventually submitted for publication,<em> the company subverted the editorial review process by stealing a copy of the manuscript and used this advance knowledge inappropriately to unblind an ongoing randomized trial</em>.<br />7. Approval of diabetes drugs based exclusively upon their glycaemic effects has been short-sighted and scientifically unwise. Drugs that lower blood sugar may have other adverse effects that overcome any inherent benefits.<br />8. The failure of  50 other PPARs, many for adverse cardiovascular effects, went<em> largely unreported because of negative publication bias</em>. Such knowledge might have warned the medical community about the potential risk of these agents.</blockquote><br />Meanwhile, the <a href="http://www.nytimes.com/2010/02/20/health/policy/20avandia.html">New York Times published </a>conclusions of some internal US Food and Drug Administration (FDA) reports, and of an investigation by the US Senate Finance Committee. FDA safety officials suggested that Avandia should be taken off the market. Some key points from the Senate investigation were:<br /><blockquote>The bipartisan multiyear Senate investigation — whose results are expected to be released publicly on Monday but which were also obtained by The Times — sharply criticizes GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly. <br /><br />'Instead, <em>G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,</em>' ....</blockquote>In combination, the Nissen commentary, and the Senate report nicely summarized what I called the "Avandia spin cycle" above.  It appears that research was suppressed, marketing was deceptive, and critics and whistleblowers were intimidated.  <br /><br />Finally, Dr Harlan Krumholz published a commentary about the thiazolidinedione drugs (a group that includes rosiglirazone) in Circulation Cardiovascular Quality and Outcomes [Krumholz HM. A perspective on the American Heart Association Presidential Commission Advisory on thiazolidenedione drugs. Circ Cardiovasc Qual Outcomes 2010; 3 available online, link <a href="http://circoutcomes.ahajournals.org/cgi/rapidpdf/CIRCOUTCOMES.110.936070v1.pdf">here</a>], and <a href="http://www.forbes.com/2010/02/24/diabetes-glaxosmithkline-avandia-business-healthcare-heart-attack.html">an op-ed in Forbes</a>. The latter sums it all up nicely:<br /><blockquote>I want to believe in America's pharmaceutical companies. I want to believe that people in these companies believe that the best strategy for success is to do what is best for patients. I want to believe that they are interested in scientific truth and eager to know of any safety issues and ready to share that information with the public.<br /><br />This week I was disappointed again.<br /><br />Over the years GlaxoSmithKline ( GSK - news - people ) has <em>repeatedly reassured the public about the safety of its blockbuster diabetes drug Avandia.</em> But this weekend the Senate Finance Committee released a report revealing that inside the company <em>Glaxo's own experts and advisors were raising concerns about whether the drug could cause heart problems all along.</em><br /><br />The report, based on more than 250,000 internal documents, provides a rare and unsettling glimpse into the <em>decision by company executives to deflect safety issues</em>--even as their own experts agreed with conclusions of outside researchers who were warning the public about possible harms.<br /><br />The documents reveal that company researchers were deeply concerned about the cardiovascular safety of the drug as far back as 2003. <em><strong>The pages of the Senate report read like a spy novel</strong>: Glaxo receiving confidential documents leaked by a sympathetic academic who consulted for the company; the company embarking on a campaign to intimidate critics who warned about potential safety issues with the drug; and executives pulling strings to release data early from a scientific study that was supposedly controlled by an 'independent' committee of researchers.</em></blockquote><br />So,<br /><blockquote>The story here is less about the drug--the Senate report breaks no new ground about Avandia's safety issues (even among experts there remains some controversy)--and <em>more about the ethical behavior of a company. What is clear: Glaxo failed to disclose its own concerns even as it sought to discredit outside researchers who were raising questions about the drug.</em><br /><em><br /></em><br /><em>This type of behavior is eroding the public trust in the pharmaceutical industry.</em></blockquote><strong>Policy Implications</strong><br /><br />Finally, Dr Krumholz concludes with some solutions with which I heartily agree:<br /><blockquote>The fix is simple: <em>Once a drug is approved, all data relevant to drug safety should be placed in the public domain</em> and independent investigators across the country should be able to use it. There should be <em>big financial penalties for withholding relevant information</em>. <em>Drug studies sponsored by industry must be truly independent--outside of company control. Companies should give outside investigators independence over every aspect of the study.</em> There are too many examples of companies wresting control of clinical studies from their consultant investigators for reasons that seem more related to product promotion than clinical science.<br /><br />And on all sides there should be a <em>commitment to protect against the intimidation of academics who are willing to raise questions about the safety and effectiveness of company products</em>. The free flow of information about the effects of drugs and medical devices will best serve the public's interest.</blockquote>Here in the US, the debate over health care reform has reached a new phase. Today the President is hosting an attempt to get bipartisan discussion of reform going again. Now that there is a new opportunity for discussion, I submit that would be health care reformers ought to think about the underlying causes of our continuing problems with rising costs, declining access, stagnant quality, and demoralized health care professionals. <br /><br />One set of causes that is rarely discussed has to do with the distortion of clinical research by commercial research sponsors with vested interests in the results turning out in favor of their products, and the further distortion of clinical discourse and decision making by the deceptive marketing practices of these same organizations. If we started introducing steps like those suggested by Dr Krumholz into health care reform, maybe we really could decrease costs, increase access, improve quality, and renew professionalism. <br /><br /><strong>*Bring Back the DSI?</strong><br />To lighten things up a bit, and to explain the title...<br /><br />When I was in school in the 1960s, I first became a fan of the <a href="http://hardyboys.bobfinnan.com/">Hardy Boys</a> mysteries, then the slightly more mature <a href="http://www.aandc.org/research/biblio_pease_h.htm">Tod Moran series</a>.  While on the <a href="http://www.oceanlinermuseum.co.uk/nieuw_amsterdam.htm">Neiuw Amsterdam</a> (the 1938 version) one day out of Kingston, Jamaica, I viewed <a href="http://www.imdb.com/title/tt0055928/">Dr No</a>, the first James Bond movie, a sophisticated spy thriller, not a spoof like some later entries in the series.  I later read all the classics, like those by <a href="http://www.agathachristie.com/">Agatha Christie</a>, <a href="http://en.wikipedia.org/wiki/Erle_Stanley_Gardner">Earl Stanely Gardner</a>, <a href="http://www.nerowolfe.org/">Rex Stout</a>, <a href="http://en.wikipedia.org/wiki/Ellery_Queen">Ellery Queen</a>, etc.  So it should be no surprise that I, like many other schoolboys and girls, collaborated to form an amateur detective and intelligence agency.  But this was the sophisticated 1960s, so we called it the Department of Scientific Investigation (DSI).  We skulked around New York City and its suburbs looking for spies, saboteurs, and common criminals.  Luckily, we never really found any.  As more realities intruded, I gave up any ideas about becoming an investigator or intelligence agent (although I still read mysteries, spy novels, and thrillers to this day, but mainly on airplanes.)  Once I became a physicians, those days in the DSI seemed very remote (although the title does now seem like it ought to be part of the NIH ;-) ).<br /><br />However, after reading Dr Krumholz's article above, maybe we need to resurrect the DSI.  At least, maybe we health professionals ought to consider how we can become better and more organized watchdogs for the kind of problems revealed in the Avandia case, and in many other cases discussed on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>.<br /><br />But if any of my old DSI colleagues want to set up a reunion, it would be fine with me. <br /><br />ADDENDUM (25 February, 2010) - see also comments by Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2010/02/avandia-story-failures-of-regulation.html">on the Hooked: Ethics, Medicine and Pharma blog</a>.

Bring Back the DSI*? - the Avandia Case as Spy Novel

Starting in 2007, we posted quite a bit about the "Avandia case," which centered on whether Avandia (rosiglitazone, by GlaxoSmithK...

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Merck Settles Another Vioxx Case

All the shenanigans that went on in the course of Merck's marketing of the now withdrawn Cox-2 inhibitor non-steroidal anti-inflammatory drug Vioxx have provided grist for the <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> mill since 2005.  For example, see these posts:<br /><br />- <a href="http://hcrenewal.blogspot.com/2005/04/more-evidence-of-ghostwriting.html">here</a> about <em>ghost-writing</em> of a Vioxx research publication; <br />- <a href="http://hcrenewal.blogspot.com/2005/06/allegations-that-merck-threatened.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2005/12/more-allegations-that-merck-executives.html">here</a> about allegations that Merck executives tried to <em>intimidate</em> Vioxx critics; <br />- <a href="http://hcrenewal.blogspot.com/2007/03/drug-crazy.html">here </a>about how advocates of an extreme laissez faire approach to regulation of health care corporations used illogical arguments about the Vioxx case; <br />- <a href="http://hcrenewal.blogspot.com/2008/08/article-in-annals-of-internal-medicine.html">here</a> about how an apparently major clinical trial of Vioxx turned out to be a "<em>seeding trial</em>," that is, a study really meant to recruit supposed physician-researchers as prescribers; and <br />- <a href="http://hcrenewal.blogspot.com/2010/01/physician-pleads-guilty-to-fraud-for.html">here</a> about how one once prominent Vioxx researcher pleaded guilty to <em>fraud</em> in connection with his research on other drugs.  <br /><br />Thus, the Vioxx case provides a good lesson about some of the tactics used to deceptively and unethically promote health care products (pharmaceuticals in this case).<br /><br />Merck just announced just the latest settlement of Vioxx related legal actions, as <a href="http://www.businessweek.com/news/2010-02-10/merck-changes-safety-procedures-pays-in-vioxx-suits-update1-.html">reported by Business Week</a>:<br /><blockquote>Merck & Co. agreed to settle shareholder lawsuits over the withdrawn Vioxx painkiller by strengthening its drug-safety procedures, appointing a new chief medical officer and paying $12.2 million in legal fees.<br /><br />Merck would <em>appoint one committee to address risks that require immediate action and another to monitor the safety of drugs,</em> the company said in a regulatory filing. Merck would also <em>amend its code of conduct to <strong>promote scientific and academic integrity</strong> as well <strong>'honest communication' with doctors</strong></em><strong>.</strong><br /><br />'In all research endeavors that are sponsored by Merck, we <em><strong>will refrain from attempting to influence inappropriately the results and conclusions of such research</strong></em>,' according to the amended code. 'We strive for all <em><strong>communications with the medical community to be accurate, truthful </strong></em>and consistent with labeling.'</blockquote><br />Also, <br /><blockquote>The company will be required to make corporate governance changes and “supplement existing policies and procedures,” ... [a Merck spokesperson] said.</blockquote><blockquote>Merck would <em>submit results of clinical trials to a public registry</em>, with its compliance overseen by an independent third party.<br /><br />The chief medical officer will have an 'executive voice' on product safety issues independent of Merck Research Laboratories. </blockquote>Note that this settlement is only of one type of lawsuit, as described in <a href="http://online.wsj.com/article/SB10001424052748704140104575057231552987908.html">a Wall Street Journal article</a>,<br /><blockquote>The pact, which is pending final court approval, would resolve state and federal shareholder 'derivative' complaints (which are brought by shareholders on behalf of a company) alleging that current and former Merck officers and directors breached their fiduciary duties in handling Vioxx. </blockquote>Merck had already settled thousands of lawsuits,<br /><blockquote>Since the Vioxx controversy erupted, about 27,000 personal-injury lawsuits have been filed, the company says. Merck has been challenging all of the cases and settled many of them. Most notably, it agreed to a pay $4.85 billion to settle personal-injury claims of more than 40,000 people. In another settlement, the company will pay $80 million to resolve 190 claims filed by drug-benefit plans seeking to recover costs of paying for Vioxx use.</blockquote>Merck has lots of other legal actions to go through,<br /><blockquote>The Vioxx litigation remains far from over. The U.S. Supreme Court is weighing a separate shareholder case, seeking billions of dollars in damages from the company. Merck disclosed last year the U.S. Attorney's office in Boston was conducting a grand-jury investigation of Merck's handling of Vioxx. The claims of some 310 plaintiff groups are outstanding in courts in the U.S., according to the securities filing. There are also cases overseas, including Australia and Turkey.</blockquote>So the parade of legal actions and settlements thereof continues.  We believe that the scope of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">this parade</a> provides some sort of index of bad behavior by the health care organizations needing to make such settlements.  Most of these legal results are reported on in the business media, and rarely appear in any medical, health care research, or health policy journals.  I submit that were health care professionals, health care researchers, and health policy makers more systematically aware of these cases, they might realize that unethical and sometimes illegal behavior, often generated by bad leadership unrestrained by poor organizational governance, is a major cause of the current, seemingly intractable health care crisis.<br /><br />One notable attribute of the current Vioxx settlement is that it does mandate some changes in Merck's governance and leadership meant to prevent future cases similar to this one.  These include developing leadership structures and changing the company's code of conduct to emphasize the need for "truthful" communication, and the need to refrain from "inappropriately" influencing research.  <br /><br />On <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> we have discussed numerous examples of deceptive practices by health care organizations, often affecting marketing, and of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> of research.  It is a small step forward for one company to commit to honest communications and to not manipulate research.  A better code of conduct may at least be a start towards an <a href="http://hcrenewal.blogspot.com/2009/10/organisational-ethics-policies-primer.html">organizational ethics policy</a>, which in turn may have the potential to actually improve behavior.  <br /><br />On the other hand, typical settlements that involve only monetary damages paid by the organization seem to have little deterrent effect on future bad behavior. Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts suffers any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior. Until the people who approve, direct, and perform unethical or illegal acts pay some penalties, expect such acts to continue, at best deterred only slightly by written policies that condemn them. I again suggest that to truly reform health care, we need rigorous regulation of health care organizations that has the power to deter unethical behavior that may risk patients' health

Merck Settles Another Vioxx Case

All the shenanigans that went on in the course of Merck's marketing of the now withdrawn Cox-2 inhibitor non-steroidal anti-inflammatory...

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