What Does the Blumsohn - Procter and Gamble -Sheffield University Affair Say About the Fitness of the Latest VA Secretary Candidate?

<b>Introduction - New Leadership for the US Department of Veterans Affairs </b><br /><br />After reports of problems with access, manipulation of data about waiting times, and most recently "a corrosive culture," the US Department of Veterans Affairs, the country's large government run health system, has had a massive leadership overhaul.  President Obama's nominee to head the agency is now Robert A McDonald, former CEO of Procter and Gamble.<br /><br />The choice of a former CEO or a large corporation was called "unorthodox" <a href="http://www.bostonglobe.com/news/nation/2014/06/29/bob-mcdonald-former-chief-obama-nominee-lead-veterans-affairs/zVA9EH7PlMNWaTU7Yyp8NP/story.html">by the Boston Globe</a>, but many saw merit in a business leader running the VA.  As reported by the Globe, House Speaker John Boehner said that as a "private sector" leader,  Mr McDonald is the "kind of person who is capable of implementing the kind of dramatic systemic change that is badly needed and long overdue at the VA."  The Chairman of Boeing, also a member of the P&G board, hailed Mr McDonald as the person who "navigated Procter & Gamble through the difficult post-financial-crisis years, where he expanded business in developing markets and made substantial progress improving the efficiency of the company’s internal operations...."<br /><br />On the other hand, a <a href="http://www.washingtonpost.com/politics/federal_government/obamas-choice-for-va-will-find-fixing-it-is-harder-than-selling-soap/2014/07/01/84cf28d6-0139-11e4-b8ff-89afd3fad6bd_story.html">column in the Washington Post</a> suggested that expertise in "selling Tide and Pantene" might not be relevant to fixing the VA. Yet aside from a <a href="http://ringoffireradio.com/2014/07/obama-nominates-former-corporate-exec-as-veteran-affairs-secretary-2/">single article</a> on the Ring of Fire web site, all news coverage and discussion so far has ignored Mr McDonald previous experience in health care leadership, but also that his relevant track record ought to raise questions about his fitness for the VA position.<br /><br /><b>Procter and Gamble and Health Care</b><br /><br />According to Mr McDonald's <a href="http://www.pg.com/en_US/downloads/company/executive_team/bios/pg_executive_bio_bob_mcdonald.pdf">official P&G biograpy</a>, after various roles in various countries, before becoming CEO,  <br /><br /><blockquote class="tr_bq">Bob returned to the U.S. as the <i>Vice Chairman of Global Operations</i> (2004 to 2007) and later P&G’s <i>Chief Operating Officer</i> (2007 to 2009).</blockquote><br /><br />Although not widely known as a pharmaceutical company, P&G actually had a subsidiary that made prescription drugs, which Mr McDonald sold off in 2009 (see this <a href="http://online.wsj.com/news/articles/SB125111032092353427">Wall Street Journal report</a>.)  As we noted <a href="http://hcrenewal.blogspot.com/2014/05/abort-retry-fail-lancet-avoided-much.html">here</a>, its products still include over the counter pharmaceuticals (e.g., Pepto-Bismal, Metamucil, Prilosec OTC).  Also, while Procter & Gamble does not make it very obvious, it has owned MDVIP, a company that employs physicians to provide concierge medical services, since 2010, although as Cincinnati.com just <a href="http://www.cincinnati.com/story/money/business/2014/05/02/pg-sells-concierge-medicine-unit/8622903/">reported</a>, it will soon sell this unit to private equity.  So during Mr McDonald's tenure, his company was to some extent a pharmaceutical company, and a health care provider.<br /><br /><b>The Blumsohn - Procter and Gamble - Sheffield University Case</b><br /><br />Furthermore, on Mr McDonald's watch as Vice Chairman of Global operations and Chief Operating Officer, there was a case involving Procter and Gamble that raised multiple concerns about the ethics of its pharmaceuticals operations.  We first posted about the case in 2005 (<a href="http://hcrenewal.blogspot.com/2005/12/another-challenge-to-integrity-of.html">here</a>).  For all relevant posts, look <a href="http://hcrenewal.blogspot.com/search/label/Actonel">here</a>. In 2009 we <a href="http://hcrenewal.blogspot.com/2009/12/british-medical-journal-interviews-dr.html">described the case</a> thus,<br /><br /><blockquote class="tr_bq">The case involved <i>suppression and manipulation of research</i>, <i>ghost-writing</i>, <i>institutional conflicts of interest, and attempts to silence a whistle blower. </i>It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research.</blockquote><br />We previously <a href="http://hcrenewal.blogspot.com/2009/09/reappearance-of-ghost-of-seasons-past.html">summarized</a> the case's events<br /><br /><blockquote><ul><li>Dr Aubrey Blumsohn, a senior lecturer at Sheffield University, and Professor Richard Eastell performed a research project on the effects of the drug risedronate (<a href="http://www.actonel.com/index.jsp">Actonel</a>, made by Procter & Gamble Pharmaceuticals [P&G]) under a <a href="http://www.fraudinscience.org/PG/contract.pdf">contract</a> between P&G and the University.</li><li>Although the research contract designated Blumsohn and Eastell as "Investigators" under whose direction the project would be carried out, Blumsohn was not given access to the original data collected by the project.</li><li>Despite numerous requests, (like <a href="http://www.fraudinscience.org/PG/20050525mckay.pdf">this one</a>), P&G <a href="http://www.fraudinscience.org/PG/20030619email.htm">refused access </a>to this data <a href="http://www.fraudinscience.org/PG/attorneyreq.pdf">repeatedly</a>.<br />Blumsohn was concerned that he and Eastell could be accused of scientific fraud if they continued to make presentations and write articles and abstracts without access to the data which they were supposedly writing about.</li><li>Blumsohn became suspicious that some of the analyses done by P&G could be misleading, especially <a href="http://www.fraudinscience.org/PG/20030909audio.htm">related to a graph shown to him that omitted 40% of patient data</a>.</li><li>Blumsohn objected to <a href="http://www.fraudinscience.org/PG/20030424email.htm">P&G arranging for papers and abstracts to be written by a professional writer</a>, but with Blumsohn listed as first author. Blumsohn was concerned that such ghost-written documents were mainly meant to convey "key messages" in support of P&G's commercial interests.</li><li><a href="http://www.fraudinscience.org/PG/20030910audio.htm">Eastell warned Blumsohn </a>not to aggravate P&G, because the company was providing a grant to the University which "is a good source of income."</li><li>After repeated failed attempt to get the data, Blumsohn complained to numerous officials at Sheffield University, including <a href="http://www.fraudinscience.org/PG/20040526eastell.pdf">Eastell</a>, medical school Dean <a href="http://www.fraudinscience.org/PG/20050708weetman.pdf">Tony Weetman</a>, University Vice-Chancellor <a href="http://www.fraudinscience.org/PG/20050814bouche.pdf">Robert Boucher</a>, and the Head of the University's Department of Human Resources, <a href="http://www.fraudinscience.org/PG/20050627boucha.pdf">Ms R Valerio</a>.</li><li>Still unable to get the data, he spoke with news reporters about his case. At this point, Sheffield suspended him, but then <a href="http://www.fraudinscience.org/PG/gag.doc">offered him a severance agreement </a>if he signed a contract binding him not to make any detrimental or derogatory statements about the University and its leaders.</li></ul></blockquote><blockquote>So the case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research.</blockquote><br />Although this case occurred in the UK, it involved actions by the US based Procter and Gamble.  While many of the events in the case occurred before 2004, from 2004 to 2009 it became clear that Procter and Gamble was not going to go easy on Dr Blumsohn.  For example, <a href="http://scientific-misconduct.blogspot.com/2007/03/advice-to-p-pharmaceuticals-how-not-to.html">according to Dr Blumsohn</a>, in 2006, P&G released some scientific data relevant to the case, but not complete enough data to be meaningful.  In 2007, there was still shady business going on involving scientific abstract submissions apparently made in Dr Blumsohn's name by P&G operatives.<br /><br />Since Procter and Gamble never made any known attempt to apologize, explain its conduct, or ameliorate Dr Blumsohn's plight during 2004 - 2009, as one of the most senior leaders of Procter and Gamble, seemingly with direct authority over its pharmaceutical operations in the UK during that time period, Mr McDonald ought to be held accountable for the company's misbehavior described above.  To my knowledge, though, no one at P&G, including Mr McDonald, has ever admitted responsibility or been made accountable in any way.   <br /><br /><b>Summary</b><br /><br />Since Mr McDonald recently was an executive of a company that sold prescription and non-prescription pharmaceuticals, and provided direct health care, confirmation as Veterans Affairs secretary could be regarded as a transit through the revolving door, and hence open to question.  Since Mr McDonald got <b><i>$15,928,015</i></b> in total compensation during his last year as CEO (2012-13) (see the company's 2013 proxy statement), and had accumulated 2,247,593 shares of stock or equivalent by 2013, worth approximately <b><i>$179 million</i></b> at today's price of $79.67, his ability to understand the needs of the often poor veterans whom the VA serves is also open to question.  <br /><br />More importantly, while Mr McDonald held high executive positions at Procter and Gamble, the company was involved in a dodgy affair involving conflicts of interest, manipulation of research, and attempted silencing of whistle blowers.  In my humble opinion, given that these events occurred directly on his watch, his fitness to run a huge health care system ought to be in question unless his responsibility for these events is disproved.<br /><br />The widespread huzzahs for Mr McDonald as potential VA leader based mainly on his exalted status as CEO of a big corporation show that many in the US still see corporate CEOs as aristocracy.  True health care reform would hold health care leaders accountable, particularly for upholding the health care mission and putting patients' and the public's health ahead of revenue generation and especially personal profit.<br /><br />ADDENDUM (7 July, 2014) - Link to McDonald's official P&G biography fixed. <br /><br />ADDENDUM (8 July, 2014) - This post has been re-posted <a href="http://www.nakedcapitalism.com/2014/07/obama-va-robert-macdonald-procter-gamble-scandal.html">on Naked Capitalism</a>, and <a href="http://www.openhealthnews.com/story/2014-07-07/robert-mcdonald-fit-be-va-secretary">on Open Health News</a>. 

What Does the Blumsohn - Procter and Gamble -Sheffield University Affair Say About the Fitness of the Latest VA Secretary Candidate?

Introduction - New Leadership for the US Department of Veterans Affairs After reports of problems with access, manipulation of data about waiting times, and most recently "a corrosive culture," the US…

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CA Supreme Court upholds "whistleblower" protection for Modesto physician - and on replacing the abuser-favoring connotations of "whistleblower" with "Corporate Integrity Advocate"

"Whistleblower" is a term commonly used to refer to insiders in an organization who do not "go along to get along" or look the other way with regard to corruption and malfeasance.<br /><br />The connotation, of course, is that these individuals are "snitches" and "non-team players", in other words, the "bad guys."  They are then punished for their good deeds.<br /><br />(More on the term "whistleblower" below.)<br /><br />Here's one "whistleblower" who punished back:<br /><br /><blockquote class="tr_bq"><b>California Supreme Court upholds whistleblower protection for Modesto physician</b><br /><br />By Ken Carlson<br />February 20, 2014 <br /><a href="http://www.modbee.com/2014/02/20/3201156/california-supreme-court-upholds.html">http://www.modbee.com/2014/02/20/3201156/california-supreme-court-upholds.html</a><br /><br />The California Supreme Court ruled Thursday that a Modesto physician who challenged the termination of his hospital privileges has whistleblower protections.<br /><br />Dr. Mark Fahlen, a kidney specialist, filed a March 2011 whistleblower lawsuit in Stanislaus County Superior Court after Sacramento-based Sutter Health <b>canceled his privileges to care for patients at Memorial Medical Center.</b><br /><br />Fahlen’s lawsuit claims that Sutter Central Valley Hospitals and Steve Mitchell, then the chief operating officer of Memorial, persuaded the Sutter Gould medical group to fire him and terminated his hospital privileges <b>because of his complaints about insubordination and substandard care by hospital nurses.</b></blockquote><br />At least they didn't threaten to plaster his complaints to his forehead as occurred in Ohio (<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>).<br /><br /><blockquote class="tr_bq">His attorney said the court decision guarantees that physicians have the same protections as hospital employees if they report problems that threaten to harm patients.</blockquote><br />That "<b>guarantees protections</b>" and "<b>report problems that threaten to harm patients</b>" have to appear in the same sentence at all is symptomatic of the most severe form of patient-be-damned dysfunction in this industry. <br /><br /><blockquote class="tr_bq">It’s “the biggest victory for patient rights since California’s health care whistleblower law was adopted in 1999,” said attorney Stephen Schear of Oakland. “In a hospital environment dominated by corporate giants too often more focused on protecting their marketing and brand name than patient health, <b>today’s ruling will finally unshackle doctors from fear of retribution so they can protect patients.”</b></blockquote><br />Ditto my prior comment.<br /><br /><blockquote class="tr_bq">In a case closely watched by the hospital industry, the American Medical Association supported Fahlen with a “friend of the court” brief. <b>The California Hospital Association and groups such as Kaiser Foundation Hospitals, Scripps Health and Dignity Health filed briefs on behalf of the defendants.</b></blockquote><br />That is rather indicative of the mindsets of those who filed briefs on behalf of the defendants.<br /><br /><blockquote class="tr_bq">... After he was given staff privileges at Memorial in 2004, Fahlen complained to administrators that nurses refused or failed to follow his patient care instructions. According to facts in the case, Fahlen had six clashes with nurses about patient care from August 2007 to April 2008. He told supervisors and administrators that nurses were insubordinate and that their care was substandard.<br /><br />One complaint was regarding <b>a nurse’s refusal to transfer a patient to intensive care, delaying for five hours the appropriate level of care for the patient,</b> the doctor said.</blockquote><br />What if the patient had died, I ask?<br /><br /><blockquote class="tr_bq">Mitchell, the chief operating officer, <b>blamed Fahlen for his conflicts with nursing staff</b> and contacted Sutter Gould’s medical director about Fahlen’s conduct. Sutter Gould cut ties with Fahlen in May 2008, causing his malpractice insurance to be canceled. Fahlen decided to start his own practice and arranged a meeting with Mitchell to talk about his hospital privileges.<br /><br />Mitchell wrote in an email to Memorial’s chief executive officer that <b>Fahlen “does not get it,” </b>meaning that he was going to lose his privileges. The CEO replied that it “looks like we need to have the medical staff take some action on his MedQuals!!! (or medical qualifications). Soon!”<br /><br />According to the lawsuit, Mitchell told Fahlen at the meeting t<b>hat he should resign and leave town, or the hospital would report him to the Medical Board of California</b>. Fahlen charged that a subsequent in-house investigation, and an executive committee decision not to renew his privileges, occurred in retaliation for his complaints about patient care.</blockquote><br />In other words, the doctor was a "disruptive physician" - a bad schoolboy who needed to be spanked - which was, of course, more important to the executives than maimed or dead patients.<br /><br /><blockquote class="tr_bq">Fahlen asked for a hearing, resulting in an October 2009 to May 2010 review by a six-physician committee at Memorial. The panel concluded that the evidence did not show he was incompetent or that his behavior had endangered patients. [But] <b>Memorial’s board of trustees overruled the panel in early 2011.  <span style="color: red;"><i>[It's not hard to imagine that few if any on that board were themselves medical professionals - ed.]</i></span></b></blockquote><br />It's more likely in my view that this physician was ultra-competent.<br /><blockquote class="tr_bq"><br />Sutter attorneys argued that the doctor first needed to exhaust other legal remedies before bringing the whistleblower lawsuit. <b>The Supreme Court dismissed a previous expectation that doctors exhaust other remedies before filing suit with claims of retaliation. </b>Such conditions would “<b>seriously undermine the Legislature’s purpose to afford a whistleblower on a hospital medical staff the right to sue</b>,” the Supreme Court’s opinion said.</blockquote><br />Next, a typical circular argument:<br /><blockquote class="tr_bq"><br />Attorney Lowell Brown, who handles physician disciplinary cases for hospitals, said Thursday’s ruling will “change the rules of the game,” though additional court decisions will be needed to clarify issues. He predicted doctors will be reluctant to serve on hospital panels that review the competency or behavior of physicians.<br /><br />“The doctor can claim the action is being taken because he or she is whistleblowing,” Brown said. “<b>No one ever produces evidence that a sham peer review has taken place. </b>What we will see is sham whistleblower complaints about peer reviews.”</blockquote><br />Since <b>sham peer review</b> (see more at <a href="http://hcrenewal.blogspot.com/2009/10/sham-peer-review-could-this-bad-faith.html">http://hcrenewal.blogspot.com/2009/10/sham-peer-review-could-this-bad-faith.html</a>) is done secretly and behind closed doors, with protections, it's pretty hard to produce "evidence" of the type required in court.<br /><br /><blockquote class="tr_bq">... Fahlen said the ruling means that “<b>doctors no longer have to choose between speaking out for their patients or continuing with their careers</b>.”</blockquote><br />Again, this is an absolutely perverse choice foisted upon clinicians by corporatized, financialized medicine and its leadership.<br /><br />------------ <br /><br />More on the term "whistleblower" itself.<br /><br />My attitude about that term is clear - the people who use it are attempting an ad hominem attack in one word.  It is a bad term, with bad connotations, and does not actually describe what the individual is attempting to accomplish.<br /><br />AHIMA's  Kim Baldwin Stried-Reich has a similar view, and a suggestion for replacement of that term with a more descriptive and non-abusable term:<br /><br /><blockquote class="tr_bq"><b>"Changing Perception of ‘Whistleblowers’"</b></blockquote><blockquote>From  <a href="http://journal.ahima.org/2014/03/01/hipaa-whistleblower-protections-promote-information-governance/">http://journal.ahima.org/2014/03/01/hipaa-whistleblower-protections-promote-information-governance/</a><br /><br />... According to <b>Kim Baldwin Stried-Reich</b>, the former Speaker of the AHIMA House of Delegates, the new amendment to the HITECH-HIPAA Omnibus rule demonstrates both the increasing importance and value HIM professionals have today in ensuring both integrity and compliance with rules, regulations, and laws governing access and disclosure of health information within their organizations. Baldwin Stried-Reich is a privacy and compliance officer with the Lake County Physicians Association, in Waukegan, IL.<br /><br />She notes that while the new provision provides specific protections against disclosures reported to an oversight agency by whistleblowers and workforce members who are victims of a crime, <b>she’s not so sure this new rule will encourage individuals, such as HIM professionals to speak-up and speak-out when or if they see evidence of systematic and ongoing non-compliance with federal mandates.</b><br /><br />One reason for this is the widespread use of the word “whistleblower,”<b> which often carries negative connotations. </b>She prefers the term <b>“corporate integrity advocate.”</b></blockquote><br /><b>"Corporate Integrity Advocate"</b> clearly and unequivocally describes what the individuals - including those who write for blogs such as this one - are trying to accomplish.<br /><br />It is also a term that is rather hard for malfeasance-doers to use as ad hominem..<br /><br /><blockquote class="tr_bq">“Perhaps if Health and Human Services had utilized another term, such as ‘corporate integrity advocate’ more individuals would understand what the intent of this new law is and that it is meant as <b>an avenue individuals can choose to pursue if their professional integrity and ethics are not in alignment with the corporation’s</b> any longer,” Baldwin Stried-Reich says.</blockquote><br /><br />"Not in alignment with the <i>lack</i> of the corporation's integrity and ethics" is a more direct, and likely more accurate, way to put it.<br /><br /><blockquote class="tr_bq">A relevant example of this is evident in the settlement that Shasta Regional Medical Center (SRMC) entered into with the Department of Health and Human Services (HHS) following an investigation concerning the breach of PHI after senior-level executives intentionally disclosed protected information to the media on at least three separate occasions.<br /><br />The Shasta case demonstrates how and why corporate integrity advocates or whistleblowers are needed to facilitate change within their organizations when it is warranted, Baldwin Stried-Reich explains.</blockquote><br />That example is but the tip of the iceberg.  There are many posts on this blog alone dealing with the issues of <s><span style="mso-bidi-font-weight: bold;">whistleblowers</span></s><span style="mso-bidi-font-weight: bold;"> Corporate Integrity Advocates</span> (see the query link <a href="http://hcrenewal.blogspot.com/search/label/whistle-blowers">http://hcrenewal.blogspot.com/search/label/whistle-blowers</a>).<!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument></xml><![endif]--><br /><br />The term "whistleblower" needs to be retired ASAP.<br /><br />-- SS

CA Supreme Court upholds "whistleblower" protection for Modesto physician - and on replacing the abuser-favoring connotations of "whistleblower" with "Corporate Integrity Advocate"

"Whistleblower" is a term commonly used to refer to insiders in an organization who do not "go along to get along" or look the other way with regard to corruption and malfeasance.The connotation, of c…

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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, so who is expected to bark?  So, when cases of failed leade…

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The Mystery of the Northwestern Settlement - the Plot Thickens

A few weeks ago, we wrote about this curious case.<br /><br /><b>How the Case Stood </b><br /><br />Northwester University, a prominent research university, settled charges it had mismanaged US government grant funds.  While it did not admit guilt, and specifically exonerated the faculty leader on whose watch the mismanagement allegedly occurred, the settlement and most of its coverage strongly suggested wrongdoing by the faculty member in charge of the scientific conduct of the grants, Professor Charles L Bennett.  While the alleged financial mismanagement was of funds in the mere millions, a relatively small amount as federal fraud cases go, and there were no allegations of anything harmful to patients, or of any research misconduct, the investigation involved multiple federal agencies, including the Federal Bureau of Investigation.  The settlement of charges of financial mismanagement, not research misconduct,  included unfavorable references to Dr Bennett, who as Principal Investigator should have been in charge of the scientific conduct of the grants, but not of their financial management.  Much bigger cases of alleged fraud, involving hundreds of millions of dollars, and potentially harm to patients due to overuse of dangerous drugs or devices, have not involved the FBI, and not included any disparagement of individuals who could have authorized, directed, or implemented the alleged misbehavior.<br /><br />None of the initial press coverage noted the peculiarity of these aspects of the case, nor provided any explanations for them.       <br /><br />Days later, the Cancer Letter published a long article in this case, which is now <a href="http://www.cancerletter.com/articles/20130809">available without a subscription</a>.  This article includes even more curiosities that raise even more questions.<br /><br /><b>Dr Bennett Found Irregularities, Sangoleye Pleaded Guilty, Nobody Noticed </b><br /><br />In the original media coverage, Dr Bennett was accused based on complaints by a whistle blower.  For example, in an <a href="http://www.suntimes.com/news/21623742-418/northwestern-to-pay-nearly-3-million-to-settle-cancer-research-fraud-suit.html">article</a> in the Chicago Sun-Times,<br /><br /><blockquote class="tr_bq"> A <i>whistleblower suit filed under seal in 2009 by former Lurie Cancer Center worker Melissa Theis </i>first alleged the wrongdoing by Bennett. </blockquote><br /><br />However, the story in the Cancer Letter suggests Dr Bennett had tried to blow the whistle himself.  First,<br /><br /><blockquote class="tr_bq">Bennett said the allegations that he spent NCI money on dinners and vacations were inaccurate. He said he had encountered administrative irregularities at Northwestern and <i>reported them to compliance officials.</i></blockquote><br />In addition,<br /><br />'I <i>reported administrative issues by Northwestern University with my grants to the university compliance officer</i> in 2006, just prior to my long-term bout with cancer that was diagnosed there,' Bennett said to The Cancer Letter. 'I have never had a single administrative discussion about the matter with anyone.'<br /><br />Specifically,<br /><br /><blockquote class="tr_bq">Bennett’s statement about lax administration of grants at Northwestern appears to be bolstered by <i>an aspect of the scandal that has escaped media attention </i>even as multiple news stories in Chicago and national outlets focused on the settlement.<br /><br />The Cancer Letter has learned that <b><i>days before the settlement with Northwestern was announced, a former research administrator at the Division of Hematology and Oncology at the university’s medical school pled guilty to felony charges stemming from administration of Bennett’s NCI grants.</i></b><br /><br />According to documents filed in the U.S. District Court for the Northern District of Illinois, <i>Feyifunmi Sangoleye, the rogue administrator, set up an elaborate scheme to divert $86,000 to her personal accounts.</i>The proceeds financed a wedding and a honeymoon in Europe, court documents say.</blockquote><br />The article later included more detail,<br /><br /><blockquote class="tr_bq">Bennett said that he <i>saw irregularities in the actions of the research administrator </i>who handled his Research for Adverse Drug Events and Reports and that he has <i>alerted the administration of the Division of Hematology and Oncology.</i><br /><br /><b><i>That same administrator, Sangoleye, pled guilty to larceny and theft, admitting to having embezzled NCI funds from Bennett’s program</i></b> into a checking account created in the name of a fictitious contractor.<br /><br />According to court documents, <i>Sangoleye created a vendor code for a fictitious entity she called ATSDATA.</i><br /><br />Then she <i>created 10 false invoices</i> from that entity and <i>paid them with Northwestern’s checks.</i><br /><br />The checks were <i>sent to the ATSDATA post office box, which Sangoleye had rented, and placed into a bank account she created.</i><br /><br />Between June 29, 2007, and July 29, 2008, ATSDATA received eight Northwestern checks that added up to $86,000. '<i>Sangoleye converted the proceeds of the ATSDATA checks to her own use and to the use of another' individual,</i> the plea agreement states.<br /><br />'I knew nothing about ATSDATA,' Bennett said in response to questions from The Cancer Letter. '<i>The administrator told me that ATSDATA was the billing address for the University of Illinois Survey Research Laboratory</i>, a formal subcontractor. I did not know that the Survey Research Lab had any particular billing name.<i> I have documented this to Jonathan Licht [chief of Northwestern’s Division of Hematology/Oncology] in 2008.</i>'</blockquote>So in summary, Dr Bennett, who was responsible for the scientific integrity but not the financial management of his grants, reported financial irregularities to Northwestern managers.  These reports lead to a guilty plea by a former Northwestern manager who admitted embezzling money.  However, this guilty plea was anechoic.  It did not appear in any media accounts.  The settlement negotiated between Northwestern University and the government did not acknowledge it.    <br /><br /><br />According to the Cancer Letter, Northwestern managers did not want to discuss the crimes of Sangoleye when the Cancer Letter brought it up,<br /><br /><blockquote class="tr_bq"><i> Northwestern officials declined to discuss Sangoleye, </i>saying only that she had been employed by the university as a research administrator from February 2006 through August 2009.</blockquote><br />The Cancer Letter suggested why the university might have had an interest in keeping the Sangoleye crimes and its settlement of the allegations about Dr Bennett apart.<br /><br /><blockquote class="tr_bq">Legal experts say that <i>the final plea agreement between Sangoleye and the government would have weakened Northwestern’s position in negotiating the settlement</i>. The final version of the plea agreement with Sangoleye was filed on July 25, just five days prior to the announcement of the government’s $3 million settlement with Northwestern.</blockquote>Northwestern University might have had an interest in keeping the Sangoleye criminal case and its civil case separate.  However, the government did not obviously have such an interest.<br /><br /><b><i>Why did the government not address Sangoleye's crimes in the settlement it made with Northwestern University?</i></b><br /><br /><b>The Ambiguities of the Named Whistle Blower's Work</b><br /><br />As we noted in our <a href="http://hcrenewal.blogspot.com/2013/08/the-mystery-of-northwestern-settlement.html">earlier post</a> on this case, the role of the named whistle blower, Melissa Theis, was unclear, especially vis a vis Dr Bennett.  Although Dr Bennett as Principal Investigator of some of the grants involved ought not to have had any direct control of the financial management of the grants, Ms Theis apparently worked in some financial management capacity.  Yet Ms Theis apparently blew the whistle on the university, and on Dr Bennett for alleged financial, not research mismanagement. <br /><br />The Cancer Letter raised new doubts about Ms Theis' role,<br /><br /><blockquote class="tr_bq">Several observers were <i>surprised to see that the relator, Theis, was never employed by the cancer center</i>.<br /><br />According to her 2009 suit, Theis came to Northwestern as a temp two years earlier, in 2007, serving as a <i>purchasing coordinator for the Division of Hematology and Oncology. The division, which is separate from the cancer center, administered all but one of the grants in question, the NIH database shows.</i><br /><br />After a year, in 2008, Theis was <i>hired as a fulltime employee of the Northwestern Medical Faculty Foundation. The foundation, which runs the medical practice, is also separate from the cancer center.</i> She left Northwestern in October 2008.<br /><br />'Theis specifically noted that <i>invoices were submitted for consultants and services that were never included in the initial grant budget,</i>' the complaint states. 'Invoices were submitted for consultants and services that were significantly in excess of the amount budgeted for the grant, and many of the consultants and vendors failed to provide detailed information about the actual services rendered.'</blockquote><br />Again, in the usual practice, such invoices might have been requested by a grant investigator, but the requests would have to have been vetted and then the invoices would have to have been generated by managers, not scientists or physicians.  <br /><br /><b><i>Who really administered these grants, and why did the settlement minimize the responsibility of university managers while apparently blaming scientists for bad financial management?</i></b><br /><br /><b>Dr Bennett's Supporters and Enemies</b><br /><br />In our <a href="http://hcrenewal.blogspot.com/2013/08/the-mystery-of-northwestern-settlement.html">first post</a> on this case, we had contrasted how the settlement and media coverage of it appeared to heap blame upon Dr Bennett alone, while not attaching any responsibility to his academic supervisor on one hand, or any university managers on the other.  We noted that Dr Bennett, after having been a consultant for Amgen,  had become known as a "pharmascold," a skeptic of pharmaceutical industry practices, and the author of research that suggested one Amgen product was more hazardous than had been previously thought.  His supervisor, on the other hand, had multiple ongoing financial ties to the pharmaceutical industry.<br /><br />The Cancer Letter suggested others were trying to connect related dots. First, in general,<br /><br /><blockquote class="tr_bq">Making enemies is an exhaustively studied side effect of probing the safety of cancer drugs, and during much of the period in question, <i>Bennett was producing more than his standard quota of foes.</i></blockquote><br />In particular,<br /><br /><blockquote class="tr_bq">Now, researchers who worked with Bennett on the ESA issues are puzzled by his legal problems. <br /><br />'<i>Charlie has been an important voice in raising concerns regarding the use of erythropoietin in patients with cancer,'</i> said Anthony Blau, co-director, Institute for Stem Cell and Regenerative Medicine at the University of Washington. 'In particular, his 2008 metaanalysis, published in JAMA, heightened awareness of the issue and helped to reduce the indiscriminate use of erythropoietin in cancer patients.'<br /><br />Blau is a co-author on the <a href="http://jama.jamanetwork.com/article.aspx?articleid=181533">JAMA paper</a> [as noted in our <a href="http://hcrenewal.blogspot.com/2013/08/the-mystery-of-northwestern-settlement.html">previous post</a>.] <br /><br />'<i>This doesn’t really fit in his picture,</i>' said Michael Henke, a radiation oncologist in Freiburg, Germany, who was the first to stumble across potential problems stemming from overuse of ESAs.<br /><br />'You might recall, we got in contact in 2003 when our group communicated potential dismal effects of erythropoietin on cancer patients—a story not really appreciated these days because of economic interests,'  Henke said referring to the pioneering paper in The Lancet. Henke was the senior author on the JAMA paper.<br /><br />'However, Dr. Bennett and we consistently gathered additional data that were finally reported as a meta-analysis in 2008. Consequently, erythropoietin prescriptions dramatically decreased, eventually prolonging or even saving lives of cancer patients.'<br /><br />'While collaborating, I did learn him <i>as extraordinarily active, alert-eyed colleague who strictly adhered to serious scientific conduct and to the wellbeing of patients</i>.'<br /><br />Henke confesses to <i>wondering whether the many powerful enemies Bennett made in the pharmaceutical and biotechnology industries have struck back.</i><br /><br />'We shouldn’t feed paranoia,' Henke said.  'However, given the exclusively positive experience when collaborating with his group, makes me <i>wonder whether this litigation might follow some very particular other issues</i>.'</blockquote><br /><b><i>Did Dr Bennett's transformation from a consultant to to a fierce scientific skeptic of the pharmaceutical industry influence the handling of this case, and its media coverage?</i></b><br /><br /><b>Summary</b><br /><br />The coverage by the Cancer Letter underscores our previous concerns, so I will simply repeat the summary from my last post.<br /><br />The settlement by Northwestern University, which was mainly about allegations made against Dr Charles L Bennett, who was not a party to the settlement, was very different that the vast majority of the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> whose continuation we have frequently discussed.<br /><br />The settlement and its media coverage raised important questions whose answers would be important to the assessment of  our current regulatory and legal response to misbehavior by and within large health care organizations.  Health Care Renewal is about raising such issues by commenting on public information, media reports, and research.  I hope those with capacity to investigate will consider these questions.  Inquiring minds want to know.<br /><br /><div class="separator" style="clear: both; text-align: center;"></div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhTN3CIxmIM6GicEB51I-Ob3VrzUm8FD4oH4c689NVpFCg9z4d7CjFHCs-xail6Kkz-rNhZ1TwUo05OfwWOZClh2E-YeFEGZin13pIgwRIAyHLGtb2uOYm3pXbLJoImDMJf99kwTf2E3Rn7/s1600/SherlockHolmes(RMP082013).jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="196" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhTN3CIxmIM6GicEB51I-Ob3VrzUm8FD4oH4c689NVpFCg9z4d7CjFHCs-xail6Kkz-rNhZ1TwUo05OfwWOZClh2E-YeFEGZin13pIgwRIAyHLGtb2uOYm3pXbLJoImDMJf99kwTf2E3Rn7/s200/SherlockHolmes(RMP082013).jpg" width="200" /></a></div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiaaBoxJHP1a-4vKQJ-K2QCLeGONuSncMwrZHXm7QlxGpToMSQWfUA8Ynap9x8URrARsYJvEwIE4wUL38ETuPSGQAODJIraz8M9hHw7lu_7KrAzT5KfEXQDC6dkNt7kKVIZcW3iFPoSAwIc/s1600/SherlockHolmes(RMP082013).jpg" imageanchor="1"><br /></a></div>ADDENDUM (27 August, 2013) - See also <a href="http://brodyhooked.blogspot.com/2013/08/the-fate-of-scientist-who-reveals-drug.html">comments</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog. <br /><br /><br />Roy M. Poses MD in Health Care Renewal  <br /><br />

The Mystery of the Northwestern Settlement - the Plot Thickens

A few weeks ago, we wrote about this curious case.How the Case Stood Northwester University, a prominent research university, settled charges it had mismanaged US government grant funds.  While it did…

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The Mystery of the Northwestern Settlement

Watson, quick, the game's afoot.  We have discussed a large number of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> by large health care organizations that serve as markers of misbehavior and often lack of leaderships' responsibility for same.  These settlements often follow a common pattern.  Yet this week a settlement appeared that was quite different, and hence raised some important questions.<br /><br /><b>The Basics of the Settlement</b><br /><br />I will summarize the settlement as <a href="http://online.wsj.com/article/SB10001424127887324170004578638351789022658.html">described</a> by the Wall Street Journal.  The basic points were:<br /><br /><blockquote class="tr_bq">Northwestern University agreed to pay nearly $3 million to settle claims that a former cancer researcher fraudulently used federal grant money for personal expenses, including food, hotels and airfare for family trips between 2003 and 2010.<br /><br />The settlement in the civil suit was unsealed Tuesday by the U.S. Attorney for the Northern District of Illinois, which investigated claims brought by a whistle blower under the False Claims Act.</blockquote><br />The settlement seemed to be more about the researcher, Dr Charles L Bennett, than Northwestern,<br /><br /><br /><blockquote class="tr_bq">At the time of the alleged fraud, Dr. Bennett was the principal investigator on research funded by the National Institutes of Health, studying adverse drug events, multiple myeloma, a blood disorder known as thrombotic thrombocytopenic purpura, and quality of care for cancer patients.<br /><a href="http://www.blogger.com/null" name="U902207295947GR"></a><br />According to the settlement agreement, <i>he allegedly billed federal grants for family trips, meals and hotels for himself and friends, and for 'consulting fees' for unqualified friends and family. Northwestern also allegedly improperly subcontracted, at Dr. Bennett's request, with various universities </i>for services that were paid for by the NIH grants.<br /><a href="http://www.blogger.com/null" name="U902207295947OO"></a><br />'Allowing <i>researchers to use federal grant money to pay for personal travel, hotels, and meals and to hire unqualified friends and relatives as 'consultants' violates the public trust and federal law</i>,' U.S. Attorney Gary S. Shapiro said in a statement.</blockquote><br />Meanwhile,<br /><br /><blockquote class="tr_bq"> Northwestern, which is in Evanston, Ill., cooperated with the investigators and <i>didn't admit to any wrongdoing</i>, according to a statement by the university.</blockquote><br />The settlement was the result of the actions of a purported whistle-blower,<br /><br /><br /><blockquote class="tr_bq">The whistleblower, Melissa Theis, worked as a <i>purchasing coordinator in the Feinberg school's department of hematology and oncology, processing invoices</i> when she 'noticed some red flags,' according to her attorney, Linda Wyetzner, of the Evanston firm Behn & Wyetzner Chartered.<br /><br /><a href="http://www.blogger.com/null" name="U902207295947A3G"></a>The federal False Claims Act allows private citizens who allege government programs are being defrauded to file actions on behalf of the government and receive a portion, usually 15% to 30%, of any recovered damages. Ms. Theis will get $498,100 in settlement proceeds, according to the agreement.</blockquote><br />The settlement resulted from the efforts of multiple federal agencies,<br /><br /><blockquote class="tr_bq"> <i>The allegations were investigated by the NIH, Federal Bureau of Investigation, U.S. Department of Health and Human Services Office of Inspector General and the U.S. attorney's office.</i></blockquote><br /><b>Curious Aspects and the Questions They Raise</b><br /><br />So here is yet another settlement by a large health care organization, in this case, the prestigious academic medical center of a well known university.  This one, however, does not follow the usual pattern, and includes some quite curious aspects. <br /><br /><u>Media Attention vs Severity</u><br /><br />The settlement so far has generated articles in the WSJ (above), the Chicago Tribune, the Chicago Sun-Times, Crains Chicago Business, Medscape, Modern Healthcare, UPI, Bloomberg, other local Chicago and university publications, and local outlets in South Carolina, the state in which Dr Bennett currently works.<br />  <br />The amount of the grants that Dr Bennett allegedly misused was $8 million, according to the University Herald.<br /><br />There are no allegations that any activities of Dr Bennett or the university affected the quality of clinical research, clinical teaching, or patient care.<br /><br />Contrast that substantial media attention to that generated by another recent settlement we just discussed, that of Pfizer misbranding of Rapamune (look <a href="http://hcrenewal.blogspot.com/2013/07/pfizers-umpteenth-settlement-for-491.html">here</a>.)  This involved the excess promotion of a relatively dangerous drug that likely resulted in harm to many patients.  The over-promotion may have caused up to 90% of the drug's $200 million yearly sales.  The settlement itself was for $491 million.  Yet while it got more coverage, mainly from local media outlets which covered it because the settlement will result in payments to individual states, only four big national outlets have covered it so far, again the Wall Street Journal, and  the New York Times, Reuters and Businessweek. <br /><br /><b><i>Why did a relatively small settlement of alleged financial misbehavior without clinical implications get nearly as much attention as a settlement fifty times bigger that involved actions that likely harmed patients?</i></b><br /><br /><u>Intensity of the Government Response</u><br /><br />Dr Bennett's alleged misuse of grant funds required investigation by four different federal agencies, including the FBI.  Pfizer's misbranding of a dangerous drug seemingly was handled only by one, and the FBI was not obviously involved.  In fact, the FBI rarely has rarely been mentioned in the media coverage of most of the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> we have discussed.<br /><br /><b><i>Why did again a case of relatively small alleged financial misbehavior require such massive federal resources when much bigger cases which had implications for clinical care, policy, or research seemed to command lesser resources?</i></b><br /><br /><u>Naming and Shaming</u><br /><br />The settlement did not involve any admission of any wrongdoing by Northwestern. <br /><br />In contrast, nearly all the news coverage of this settlement emphasized the role of Dr Charles L Bennett.  The coverage seemed to be following the lead of the Department of Justice <a href="http://www.justice.gov/usao/iln/pr/chicago/2013/pr0730_01.html">press release</a>, which included,<br /><br /><blockquote class="tr_bq"> Northwestern allegedly allowed one of its researchers, <i>Dr. Charles L. Bennett, to submit false claims</i> under research grants from the National Institutes of Health. The settlement covers <i>improper claims that Dr. Bennett submitted for reimbursement from the federal grants for professional and consulting services, subcontracts, food, hotels, travel and other expenses that benefited Dr. Bennett, his friends, and family</i> from Jan. 1, 2003, through Aug. 31, 2010.</blockquote><br />Yet Dr Bennett appeared not to be a party in this settlement, and it was unclear whether he had a direct opportunity to respond to it.  The Wall Street Journal did note that after it was announced,<br /><br /><blockquote class="tr_bq"> James M. Becker, an attorney for Dr. Bennett, said, 'We deny the allegations.…We are actively engaged in discussions to resolve the allegations.'</blockquote><br />We have discussed numerous <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> by large health care organizations, often involving hundreds of millions or even billions of dollars, sometimes involving guilty pleas by the companies involved or their subsidiaries.  Almost never do these settlements name or involve in any way persons who authorized, directed, or implemented the misbehavior.  In fact, we have commented again and again about the <a href="http://hcrenewal.blogspot.com/search/label/impunity">impunity</a> of health care organizational managers and executives.  For example, the recent $491 million Pfizer settlement did not name or punish any individuals.  Furthermore, Pfizer's $2.3 billion settlement for deceptive marketing of a drug later pulled from the market (Bextra) did not name much less penalize any responsible individuals (look <a href="http://hcrenewal.blogspot.com/2009/09/pfour-legal-settlements-for-pfizer-why.html">here</a>.)  Also, GlaxoSmithKline's $3 billion settlement of numerous unethical practices did not name much less penalize any responsible individuals (look <a href="http://hcrenewal.blogspot.com/2012/07/giant-gsk-settlement-provides-reminder.html">here</a>).<br /><br /><b><i>So why was naming and shaming Dr Charles L Bennett such an important part of the relatively small Northwestern settlement, when much larger settlements, many involving unethical behavior that could have harmed patients or distorted medical research, and some of which involved corporate guilty pleas to criminal charges did not involve naming and shaming any responsible person?</i></b>     <br />  <br /><u>How Accountable was Dr Bennett?</u><br /><br />As in the Wall Street Journal version, the settlement implies that Dr Bennett was the person most responsible.  The Chicago Sun-Times <a href="http://www.suntimes.com/news/21623742-418/northwestern-to-pay-nearly-3-million-to-settle-cancer-research-fraud-suit.html">put it</a> this way,<br /><br /><blockquote class="tr_bq"> <i>Dr. Charles L. Bennett allegedly took his wife on personal trips, then illegally billed the flights, hotels and meals to the National Institutes of Health, claiming it was part of his cancer-fighting work. And he allegedly submitted phony bills for his work </i>over a seven-year period beginning in 2003.</blockquote><br />Here I will have to interject a bit of information about how federal grants work.  As I learned when I was a young faculty member, and as I confirmed with several other experienced researchers who have run and reviewed federal grants, these grants are made to institutions.  In the current case, the grant apparently went to Northwestern University.  The institution that receives the grant is responsible for making all payments and disbursements related to that grant.  The grant's Principal Investigator is responsible for the scientific conduct of the grant, but NOT payments, disbursements, business management or accounting.  The Principal Investigator can request that payments be made for various things, including travel expenses and consulting work.  But the Principal Investigator cannot directly authorize or make these payments.  They are authorized, signed, and made by institutional administrators, usually in grants and contracts offices or the equivalent, and usually only after copious paperwork to justify the payments.<br /><br />So Dr Bennett may have requested reimbursement for travel expenses, or requested the university to hire a consultant.  But university managers must have made those payments, unless the university's grants administration mechanism had completely broken down.  Note that given the usual ways grants are administered, it would appear that Ms Theis, the ostensible whistle-blower, who will receive nearly one half of a million dollars from this settlement, actually may have had more direct responsibility for making the payments in question than did Dr Bennett. <br /><br />Presumably, that is why the settlement was made by Northwestern.<br /><br /><b><i>Why then did the settlement, the DOJ press release, and the media coverage so emphasize Dr Bennett's responsibility, and so minimize the role of the university? </i></b>  <br /><br /><u>Was Anyone Else Accountable?</u><br /><br />The DOJ press release, and all the media articles on the case,  save one, mention only Dr Bennett as the person at fault.  Crain's Chicago Healthcare Daily, however, <a href="http://www.chicagobusiness.com/article/20130801/NEWS03/130809990/northwestern-fraud-settlement-includes-key-researcher">suggested</a> someone else was responsible,<br /><br /><br /><blockquote class="tr_bq">Northwestern University's nearly $3 million settlement of fraud claims by the federal government <i>protects the director of the school's cancer center, who allegedly failed to supervise a researcher</i> who used grant money to cover personal expenses over a seven-year period.<br /><br /><i>Dr. Steven Rosen, director of the <a href="http://cancer.northwestern.edu/home/index.cfm" target="new"">Robert H. Lurie Comprehensive Center for Cancer,</a> and Dr. Charles L. Bennett</i>, a researcher who is no longer with the center, <i>were both named in a whistleblower complaint</i> unsealed on Tuesday, <a href="http://www.chicagobusiness.com/article/20130730/NEWS03/130739982/northwestern-to-pay-u-s-3-million-to-settle-fraud-claims">when the settlement was announced.</a> <br /><br />Dr. Bennett used federal grant money for family trips and fraudulent consulting fees for his brother and cousin from 2003-10, the government alleges.<br /><br /><i>Dr. Rosen 'failed to exercise appropriate responsibility,' Randall Samborn, a spokesman for the U.S. Attorney's office said. 'It was a supervisory function that he didn't adequately fulfill.'</i><br /><br />When the settlement was announced, Mr. Samborn said the agreement did not cover either doctor. On Wednesday, he corrected himself, saying that <i>settlement covered Dr. Rosen, but not Dr. Bennett.</i></blockquote><br />As I noted above, the way federal grants work, it was the university, and its managers and leaders, who were responsible for making all payments on this and other federal grants.<br /><br /><b><i>Why did the government press release and the media coverage emphasize Dr Bennett's alleged role, while ignoring any possible responsibility of anyone else, especially his supervisor?</i></b><br /><br /><br /><u>Backgrounds of the Principles</u><br /><br />Dr Bennett and Dr Rosen, who seemingly were treated so differently in this settlement, travel in very different circles. <br /><br />Most media articles described Dr Bennett as a prolific researcher and medical academic.  Although some described his areas of interest in hematology and oncology, only Medscape <a href="http://www.medscape.com/viewarticle/808784">described</a> one particular project of his.   <br /><br /><blockquote class="tr_bq">Dr. Bennett's research efforts included a 2008 study on which he was the first author (<i>JAMA</i>. <a href="http://jama.jamanetwork.com/article.aspx?articleid=181533" target="_blank">2008;299:914-924</a>). The study was the first meta-analysis to identify an increased mortality risk in cancer patients associated with erythropoiesis-stimulating agents.(1)</blockquote><br />In fact, as we discussed <a href="http://hcrenewal.blogspot.com/2012/12/amgen-settles-pleads-guilty-to.html">here,</a>  Dr Bennett was the first author of a meta-analysis that was the first to show that epoetins increased the rates of adverse effects and death for cancer patients.  This evidence lead to reduced use of some very expensive drugs made by Johnson and Johnson and Amgen, and hence reduced revenues for both companies.<br /><br />The JAMA article noted that at the time he wrote it, Dr Bennett had financial relationships with Amgen.  He and a coauthor "reported serving as consultants to AMGEN and Dr Bennett reported he has received grant support from AMGEN previously."<br /><br />Note that Amgen pleaded guilty to misbranding its epoetin, Aranesp, and therefore paid fine and a civil settlement totaling $762 million.  Given the data on this drug class' adverse events, as shown by Dr Bennett and others, it is likely that the misbranding lead to patients being harmed by the drug without receiving any benefits (look <a href="http://hcrenewal.blogspot.com/2012/12/amgen-settles-pleads-guilty-to.html">here</a>.)  <br /><br />After writing that article, Dr Bennett became known as a strong skeptic of the pharmaceutical industry.  Just before the JAMA article was published, he coauthored an editorial which wondered if conflicts of interest would ever prove to be acceptable once sufficient research was done.(2)  In that article, he disclosed consulting for, and receiving honoraria and research grants from Amgen.  In 2010, he published research showing the effects of conflicts of interest on reporting of possible adverse effects based on basic science research about epoetins.(3)  By then he apparently no longer had financial relationships with Amgen.  In 2011, he reported a survey of major cases of pharmaceutical fraud resulting in legal actions.(4)<br /><br />Dr Bennett became known for skepticism about the practices of pharmaceutical companies, and for publishing about the harms of specific drugs, despite his previous financial relationships with Amgen. <br /><br />However, Dr Rosen apparently has continued to work closely with industry.  His <a href="http://fsmweb.northwestern.edu/faculty/disclosure_profile_display.cfm?xid=15275">faculty disclosure page</a> revealed  the following industry relationships<br /><br /><blockquote class="tr_bq">Consulting / Related Activities<br />Faculty member engaged in activities such as speaking, advising, consulting, or providing educational programs for the following companies or other for-profit entities:<br /><ul><li>Allos Therapeutics, Inc. </li><li>Carden Jennings Publishing Co., Ltd. </li><li>Cerner Corporation </li><li>Dava Oncology, LP </li><li>Elorac, Inc. </li><li>Envision Communications </li><li>Health Practices Consulting - unverified entity </li><li>Plexus Communications </li><li>Prostrakan, Inc. </li><li>Seattle Genetics, Inc. </li><li>Studio ER Congressi (Triumph Group, Inc.) </li><li>The Medal Group Corp. </li></ul>In addition, faculty member received compensation for medical record consultation and/or expert witness testimony.<br /><br />Ownership or Investment Interests<br />Faculty member had an ownership or investment interest in the following companies:<br /><ul><li>AuraSense, LLC </li><li>Nanosphere, Inc. </li></ul>Royalty Payments and Inventor Share<br />Faculty member has the right to receive payments or may receive future financial benefits for inventions or discoveries related to the following companies or other entities:</blockquote><blockquote></blockquote><ul><li><blockquote>Nanosphere, Inc. </blockquote></li></ul>We have seen various important effects of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">individual</a> and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional</a> conflicts of interest in health care.  We have seen <a href="http://hcrenewal.blogspot.com/search/label/corporatism">corporatism</a> and <a href="http://hcrenewal.blogspot.com/search/label/regulatory%20capture">regulatory capture</a> affecting government and its dealings in health care.   <br /><br /><b><i>Did Dr Bennett's break with a powerful industry make it easier to set him up as the villain in this story? </i></b><br /><br /><b>Summary</b>    <br /><br />The settlement by Northwestern University, which was mainly about allegations made against Dr Charles L Bennett, who was not a party to the settlement, was very different that the vast majority of the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> whose continuation we have frequently discussed.<br /><br />The settlement and its media coverage raised important questions whose answers would be important to the assessment of  our current regulatory and legal response to misbehavior by and within large health care organizations.  Health Care Renewal is about raising such issues by commenting on public information, media reports, and research.  I hope those with capacity to investigate will consider these questions.  Inquiring minds want to know.<br /><br />Roy M. Poses MD in Health Care Renewal  <br /><br /><span style="font-size: x-small;"><b>References</b></span><br /><span style="font-size: x-small;"><br /></span><span style="font-size: x-small;">1.  Bennett CI, Silver SM, Djulbegovic B et al.  Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin adminstration for the treatment of cancer-associated anemia.  JAMA 2008; 299: 914-924.</span><br /><span style="font-size: x-small;">2.  Djulbegovic B, Angolotta C, Knox KE, Bennett CI. The sound and the fury: financial conflicts of interest in oncology.  J Clin Oncol 2007; 25:3567-3568.  Link <a href="http://jco.ascopubs.org/content/25/24/3567.full7">here</a> </span><br /><span style="font-size: x-small;">3.  Bennett CI, Lai SY, Henke M et al.  Association between pharmaceutical support and basic science research on erythropoiesis-stimulating agents.  Arch Intern Med 2010; 170: 1490-1498.  Link <a href="http://archinte.jamanetwork.com/article.aspx?articleid=225937">here</a>. </span><br /><span style="font-size: x-small;">4.  Qureshi Z, Sartor O, Xirasagar S, Liu Y, Bennett CI.  Pharmaceutical fraud and abuse in the United States, 1996-2010.  Arch Intern Med 2011; 171: 1503-1506.  Link <a href="http://archinte.jamanetwork.com/article.aspx?articleid=1105899">here</a>. </span>

The Mystery of the Northwestern Settlement

Watson, quick, the game's afoot.  We have discussed a large number of legal settlements by large health care organizations that serve as markers of misbehavior and often lack of leaderships' responsib…

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Pfizer's Umpteenth Settlement (for $491 Million Plus a Guilty Plea), but No Person Held Responsible

The world's largest research based pharmaceutical company was in court again, as <a href="http://www.nytimes.com/2013/07/31/business/pfizer-settles-a-drug-marketing-case-for-491-million.html">reported</a> by the New York Times,<br /><br /><blockquote class="tr_bq"> The drug maker Pfizer<a class="meta-org" href="http://topics.nytimes.com/top/news/business/companies/pfizer_inc/index.html?inline=nyt-org" title="More information about Pfizer Inc"></a><i> agreed to pay $491 million to settle criminal and civil charges over the illegal marketing of the kidney-transplant drug Rapamune,</i> the Justice Department <a href="http://www.justice.gov/opa/pr/2013/July/13-civ-860.html" title="The announcement.">announced on Tuesday</a>. </blockquote><br />In particular,<br /><br /><blockquote class="tr_bq"> The recent case centers on the practices of Wyeth Pharmaceuticals, which Pfizer acquired in 2009.<br /><br /><div itemprop="articleBody">Rapamune, which prevents the body’s immune system from rejecting a transplanted organ, was approved by the Food and Drug Administration in 1999 for use in patients receiving a kidney transplant. However, federal officials said <i>Wyeth aggressively promoted the drug for use in patients receiving other organ transplants, even offering financial incentives to its sales force to do so</i>. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Accusations of Wyeth’s practices became public in 2010 after <i>a whistle-blower lawsuit</i> filed by two former employees was unsealed. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">After lawmakers <a href="http://democrats.oversight.house.gov/index.php?option=com_content&task=view&id=4973&Itemid=49" title="A press release about the inquiry.">announced a Congressional inquiry</a>, the Justice Department <a href="http://www.nytimes.com/2010/09/22/business/22drug.html" title="From the archives.">opted to join the lawsuit</a>. The settlement announced Tuesday, which also resolves a second, similar whistle-blower suit, includes a criminal fine and forfeiture of $233.5 million, and a civil settlement of $257.4 million with the federal government, all 50 states and the District of Columbia. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">The case did not get much media coverage.  So far, the only other somewhat detailed <a href="http://www.bloomberg.com/news/2013-07-30/pfizer-unit-pleads-guilty-pays-491-million-over-drug.html">article</a> on it was put out by Bloomberg.   In fact, the lawyer for two of the whistle-blowers who alerted federal authorities to what Wyeth was doing had to say</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody">the spate of pharmaceutical settlements in recent years had <i>blunted reaction to what he said were shameful practices.</i> 'Everybody’s been asking me why this case is different than any other,' he said. <i>'We used to trust these companies. You can’t trust these companies anymore.'</i></div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">However, we should not be too blase.  This case was not only about money.  The over-promotion of a potentially dangerous drug likely lead to patients being harmed in the absence of any benefits.  Rapamune suppresses the immune system and increases risks of serious infections and malignancy.  Specific serious adverse events have been reported when it is used in transplants of organs other than the kidney (e.g., lung and liver transplants).  (See full prescribing information <a href="http://labeling.pfizer.com/showlabeling.aspx?id=139">here</a>.)  Bloomberg reported that 90% of Wyeth's revenues from Rapamune came from off-label uses, suggesting that quite a few people may have been adversely affected by its excess use.  </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">As in most other members of the march of legal settlements by big health care organizations, this case involved no negative consequences for anybody who authorized, directed, or implemented the improper marketing practices.  While such people must have existed, they were not even named in the press coverage.  At least this settlement involved a guilty plea to a crime, albeit a misdemeanor (misbranding as reported by Bloomberg), so the company did have to admit some wrongdoing.  </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">A Pfizer manager, however, tried to disavow responsibility, as noted by Bloomberg,</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody">'Pfizer was not a subject or target of this matter, and cooperated fully with the government from the time it learned of this investigation in October 2009,' Chris Loder, a Pfizer spokesman,...</div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">But Pfizer had purchased Wyeth, and in doing so got not only assets and profits, but responsibility for actions.</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Also, neither the settlement nor the criminal plea seemed to take into account Pfizer's amazingly sorry recent track record.  I am losing count of all of Pfizer's settlements and/or guilty plea or convictions since 2000.  (The updated list of previous legal results is in the Appendix.)  </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">People found guilty of small-time Medicaid or Medicare fraud often forfeit all their assets and go to jail.  Yet actions by large pharmaceutical companies that may harm patients and cost many millions of dollars almost never result in any individual facing any negative consequences, or even being named and shamed.  Meanwhile, the managers of these companies may make gargantuan amounts of money partially rationalized by the revenues produced by such recurrent misbehavior.  In 2012, according to the company's 2013 proxy filing, Pfizer CEO Ian Reed's total compensation was  <b><i>$25,634,136</i></b>, and the four next most highly paid executives all made more than <b><i>$5,000,000</i></b>.  </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">So the Kabuki play that is regulation of and law enforcement for large health care organizations goes on.  As our society is being increasingly divided into a huge majority in increasingly difficult economic circumstances and a small and  increasingly rich minority, it also seems to be increasingly divided into little people who may be ruined by lawsuits, and imprisoned for even minor infractions, and big people who have impunity.  </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">True health care reform would need to start by making leaders of big health care organizations accountable for their organizations' misbehavior.  </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b>APPENDIX - Pfizer's Settlements</b><br /><br /></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><span style="background-color: #fff2cc;">In the beginning of the 21st century, <a href="http://articles.philly.com/2009-09-03/business/25267571_1_pfizer-employee-pfizer-sales-representatives-zyvox">according to the Philadelphia Inquirer</a>, Pfizer made three major settlements,</span> <br /><blockquote><span style="background-color: #fff2cc;">October 2002: Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.</span></blockquote><blockquote><span style="background-color: #fff2cc;">May 2004: Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.</span> </blockquote><blockquote><span style="background-color: #fff2cc;">April 2007: Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.</span></blockquote><span style="background-color: #fff2cc;"><br />Thereafter, Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post <a href="http://hcrenewal.blogspot.com/2009/09/pfour-legal-settlements-for-pfizer-why.html">here</a>). </span></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><span style="background-color: #fff2cc;"> Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post <a href="http://hcrenewal.blogspot.com/2010/03/settlement-and-conviction-round-up.html">here</a>).  </span></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><span style="background-color: #fff2cc;">The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post <a href="http://hcrenewal.blogspot.com/2010/12/drug-companies-are-now-no-1-when-it.html">here</a>).  </span></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><span style="background-color: #fff2cc;">Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post <a href="http://hcrenewal.blogspot.com/2011/02/pharmacia-or-maybe-pfizer-settles-only.html">here</a>).   </span></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><span style="background-color: #fff2cc;">In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see <a href="http://www.bloomberg.com/news/2011-03-22/pfizer-reaches-asbestos-settlement-that-may-end-quigley-unit-s-bankruptcy.html">this story</a> in Bloomberg).  </span></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><span style="background-color: #fff2cc;">In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this <a href="http://hcrenewal.blogspot.com/2011/10/what-pfizer-v-few-consequences-for-long.html">post</a>). </span></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><span style="background-color: #fff2cc;">In August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this <a href="http://hcrenewal.blogspot.com/2012/08/pfizers-pforeign-pfiasco.html">post</a>).</span></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><span style="background-color: #fff2cc;">In December, 2012, Pfizer settled federal charges that its Wyeth subsidiary deceptively marketed the proton pump inhibitor drug Protonix, using systematic efforts to deceive approved by top management, and settled charges by multiple states' Attorneys' General that it deceptively marketed Zyvox and Lyrica (see this <a href="http://hcrenewal.blogspot.com/2012/12/pfizers-13th-legal-settlement-will-it.html">post</a>).  </span></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><span style="background-color: #fff2cc;"> In January, 2013, Pfizer settled Texas charges that it had misreported information to and over-billed Medicaid (see this <a href="http://hcrenewal.blogspot.com/2013/01/pfizers-pfourteenth-settlement-small.html">post</a>).  </span></div><div itemprop="articleBody"><br /></div><br />

Pfizer's Umpteenth Settlement (for $491 Million Plus a Guilty Plea), but No Person Held Responsible

The world's largest research based pharmaceutical company was in court again, as reported by the New York Times, The drug maker Pfizer agreed to pay $491 million to settle criminal and civil charges o…

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Shut Up and Sell - the Corporate Physician's New Motto?

Evidence has been seeping into public view about the extent physicians who sign up to <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">take care of patients as corporate employees</a> give up their professionalism.<br /><br /><b>Shut Up...</b><br /><br />In April, 2013, Medscape published an <a href="http://www.medscape.com/viewarticle/781964">article</a> whose striking title was "<i>Can You Speak Out Without Getting Fired or Being Labeled a Troublemaker?</i>"  The answer was basically "no."<br /><br /><blockquote class="tr_bq">Physicians often see problems at their workplaces relating to patient quality of care, financial practices, mistreatment of staff, and other issues. But <i>as more doctors take jobs as employees of hospitals, medical groups, and other large organizations, they increasingly face the same dilemmas as millions of other working stiffs. When they come across actions or policies that they don't think are right, they have to decide whether it's worth it to speak out and get labeled as a troublemaker -- or perhaps even get fired.</i><br /><br /> Across the country, a growing number of physicians are indeed losing their jobs -- and often their hospital staff privileges -- after protesting employment conditions. Such complaints may involve patient quality-of-care problems, short staffing, misallocation of funds, improper financial incentives, fraud and abuse, discrimination, overuse or withholding of medical services, or other misconduct, say organized medical groups, employment attorneys, and physician recruiters.</blockquote><br />Of course, physicians swear oaths to put the needs of their individual patients first, and doing so within a large organization might well involve protesting conditions and practices that may affect the quality of care or even endanger patients.  But woe unto physicians who try to fulfill their professional responsibility when doing so goes up against the top executives to whom the physicians must now report.<br /><br /><blockquote class="tr_bq">'We were naive when we went into this,' says Maria Rivero, MD, who with her professional colleague and significant other Derek Kerr, MD, filed administrative complaints against their long-time hospital employer in 2010. 'We thought if we just brought it to people's attention, they would fix the problem and leave us alone. <i>But if you blow the whistle on high-level executives, you need to prepare to be harassed and lose your job</i>.'</blockquote><br />Even working within the system to fix problems can lead to big trouble,<br /><br /><br /><blockquote class="tr_bq">Still, the formal professional approach doesn't always work either. Cloyd Gatrell, MD, an emergency physician who was employed by EmCare, says that he and his wife Kathryn, a nurse, voiced concerns and presented data to executives at Carlisle Regional Medical Center in Pennsylvania in 2008 and 2009 on <i>what they saw as inadequate nurse staffing levels that endangered patients.</i><br /><br />After getting no results, Dr. Gatrell contacted the state health department, prompting a state inspection that found insufficient staffing. In 2010, he was <i>fired by EmCare at the request of the hospital,</i> according to his 2011 lawsuit against the hospital and EmCare claiming violation of whistleblower protection laws. <i>His wife was fired earlier, and she sued separately.</i> The hospital issued a statement declining comment on the litigation.<br /><br />'We're supposed to be advocates for patients, but <i>being employed puts us in a precarious position in taking a position on patient interests that's against what the hospital administration favors,</i>' says Dr. Gatrell, whose suit is in the discovery stage. 'I think a physician still has that responsibility.'</blockquote><br />Physicians who sign contracts with corporate employers, perhaps thinking that they will have less bureaucracy with which to contend and a more certain salary than they did in private practice, seem blissfully, or willfully unaware that those contracts may take away their ability to control their practices and stand up for their patients. <br /><br /><br /><blockquote class="tr_bq">Still, federal and state whistleblower laws only provide protection from retaliation for physicians in certain situations, such as those employed by public entities or those who complain about civil rights violations or Medicare and Medicaid fraud and abuse. Otherwise <i>doctors may have to rely on contract provisions or on state employment law, which may not offer much protection.</i><br /><br />[An anesthesiologist on the AMA Board of Trustees and his hospital system's board,] Dr. Annis says that the AMA's new statement of principles for physician employment -- which asserts that physicians should not be retaliated against by their employers for speaking out on patient care issues -- <i>provides support for doctors when they raise legitimate professional concerns with their employers.</i> He says it's best for physicians to work through their medical staff organization.<br /><br />But Dr. Gatrell points out that <i>the AMA statement explicitly accepts that physician employment contracts may allow hospitals to strip doctors of their medical staff membership and clinical privileges at the same time they are terminated,</i> known as a 'clean sweep' clause. 'If that's accepted by the AMA, the rest of the principles protecting physicians are meaningless," he argues. "<i>If physicians can be fired without cause and then automatically lose their medical staff membership and its due process protection, how many will dare be a patient advocate?</i>'<br /><br />Some experts <i>advise physicians not to sign employment agreements with such onerous provisions</i>. But others say that physicians often have little leverage to remove them. 'It's not an equal negotiating table,' says Dr. Gatrell, who's now working for a small urgent care practice.</blockquote><br />A May, 2013 <a href="http://www.medscape.com/viewarticle/782136">article</a> again in Medscape about the "4 Top Complaints of Employed Doctors," explained why physicians often see a lot they could or should protest to assure the quality of their patients' care,<br /><br /><blockquote class="tr_bq"> Some doctors report that hospital administrators treat them with a lack of respect. One female doctor said, also on condition of anonymity, that her biggest challenge on her job was '<i>how to handle nonphysician high school grads bossing you around when they function as your 'superiors' in your employer's organization. They manage their insecurities by bullying physicians and through passive aggressiveness, but always seem to gain the upper hand with those at the top</i>.'</blockquote><br />These are the sorts of brilliant administrators often hired by brilliant top executives, maybe at a cheap price to keep the bottom line and <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive compensation</a> healthy..  Furthermore, given that as we have discussed, "<a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a>" of hospital management often puts a bigger priority on short-term revenue than on quality care, as per one senior physician,<br /><br /><br /><blockquote class="tr_bq"> 'physicians are being increasingly targeted when they get in the way' of hospitals' agendas</blockquote><br />To make more money faster, many hospital systems now seem to want physicians to only make referrals for lucrative tests and treatments within the system, even if some patients might be better served elsewhere,<br /><br /><br /><blockquote class="tr_bq"><i>The AMA recently issued guidelines for physician employment stating that 'a physician's paramount responsibility is to his or her patients.'</i> Employers should not retaliate against physicians for asserting their patients' interests, according to these guidelines. <i>'In any situation where the economic or other interests of the employer are in conflict with patient welfare, patient welfare must take priority,'</i> the AMA says.<br /><br />The guidelines also <i>call for employers and employed physicians to disclose to patients any agreements or understandings they have that restrict, discourage, or encourage particular treatment or referral options.</i><br /><br />Nevertheless, <i>employed physicians are often expected to refer patients within their own groups and send tests to a hospital laboratory or imaging center</i>. Hospitals may tell employed surgeons which kinds of joint implants to use, and according to a New York Times article even whether to implant defibrillators in Medicaid patients. It's unclear how often any of this is disclosed to patients.<br /><br />'What we doctors say is that we're ethically bound to our patients because we took an oath, and that's what our license is based on,' says Linda Brodsky. 'But many hospitals say, '<i>No, you're employed here, and what we say goes.</i>'</blockquote><br />Note that so far there seems to be little evidence that the AMA guidelines about physician employment are being honored other than in the breach.  It is also disappointing that the leadership of the medical society that represents internists seems so unworried,<br /><br /><blockquote class="tr_bq"> <i>David L. Bronson, MD, President of the American College of Physicians, disputes Brodsky's assertion that hospitals tend to squelch doctors who criticize leadership for policies that they believe harm patient care. In fact, he says, healthcare organizations may identify outspoken physicians as potential leaders,</i> 'as long as they're collaborative and trying to solve problems, and not just be a thorn in the side of everyone they know. Organizations are looking for physician leaders, and physicians who can collaborate and not just be adversarial can go far inside organizations.'</blockquote><br />I would guess, having seen so many examples of <a href="http://hcrenewal.blogspot.com/search/label/generic%20management">generic management</a>, <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">mission-hostile management</a>, management that seems more <a href="http://hcrenewal.blogspot.com/search/label/financialization">focused on the money than patient care,</a> and management that seems to be able to <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">make itself rich</a> without evidence that it has done anything noteworthy to uphold hospitals' clinical missions, that hospital systems that promote physicians who are willing to speak out against hired executives are vanishingly rare.<br /><br /><b>And Sell</b><br /><br />In June, 2013, Beckers Hospital Review published an <a href="http://beckershospitalreview.com/hospital-physician-relationships/teaching-doctors-how-to-sell.html">article</a> suggesting that now hospitals are going beyond just pressuring employed physicians to refer potentially profitable patients within the system, and now are pressuring physicians to act as salespeople to their colleagues,<br /><br /><blockquote class="tr_bq"> A few hospitals are beginning to train their employed physicians to "sell" the hospital, which involves asking referring doctors in the community to send patients their way....  <i>the pressure to bring doctors into sales is mounting.</i></blockquote><br />The author, the former publisher of Modern Healthcare, made a remarkable argument based on a definition that seems wildly optimistic,<br /><br /><blockquote class="tr_bq"> Customer service lies at the core of salesmanship. The Business Dictionary defines salesmanship as satisfying customer needs through a sincere and mutually beneficial process aimed at a long-term relationship.</blockquote><br />Of course, skeptical physicians used to exposure to the sales tactics pharmaceutical and device companies use (look <a href="http://hcrenewal.blogspot.com/2007/05/fool-me-once-shame-on-you-fool-me-twice.html">here</a>, <a href="http://hcrenewal.blogspot.com/2008/03/what-drug-reps-really-care-about.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2008/04/more-about-cynical-world-of-drug-reps.html">here</a>,  for example) might wonder why the author did not discuss such marketing tactics as the employment of half-truths and biased information, and the use of emotional appeals to trump reason and logic. <br /><br />That the author was serious was shown by his list of seven pointers for hospitals seeking to transform its employed physicians into marketers.<br /><br />Of course, physicians who are already "key opinion leaders" employed by drug and device companies, whose marketing executives may think. that "key opinion leaders were sales people for us," (see <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">this post</a>), might not be fazed by now being asked to market their own hospital.  Never mind about Principle II of the <a href="http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/principles-medical-ethics.page?">AMA Code of Ethics</a><br /><br /><blockquote class="tr_bq">II. A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities.</blockquote><br /><br /><b>The Moral of the Story</b><br /><br />We have previously discussed various aspects of the travails of the brave new world of the <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">corporate physician</a>.  Physicians and other health professionals who sign on as full-time employees of large corporate entities have to realize that they are now beholden to managers and executives who may be <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">hostile to their professional values</a>, and who are subject to <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a> that support such hostility, including the potential for huge <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive compensation</a>.  Physicians seem to be willing to sign <a href="http://hcrenewal.blogspot.com/search/label/contracts">contracts </a>that underline their new subservience to their corporate overlords, and likely trap them within <a href="http://hcrenewal.blogspot.com/search/label/confidentiality%20clause">confidentiality clauses</a> that make blowing the whistle likely to lead to extreme unpleasantness. <br /><br />It is disappointing that even medical societies that ostensibly support physicians' professional values have been afraid to warn against such employment, or do much to help physicians trapped within it.<br /><br />Physicians who go to work for big corporations have to realize that they may be forced to put corporate executives' vested interests ahead of their patients.  Patients whose physicians work for big corporations must realize that their health care will now be corporate, with all that entails. <br /><br />  As I have said before, we need to challenge the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care. <br /><br /><br />

Shut Up and Sell - the Corporate Physician's New Motto?

Evidence has been seeping into public view about the extent physicians who sign up to take care of patients as corporate employees give up their professionalism.Shut Up...In April, 2013, Medscape publ…

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