Abort, Retry, Fail? - Lancet Avoided Much Recent Unpleasantness in Reporting on New Gates Foundation CEO (Including Her Defense of $55,000 a Year for Bevacizumab)

The April 26, 2014 issue of the prestigious journal Lancet used two full pages and two separate articles by the same author to discuss the ascension of the Gates Foundation new CEO, Dr Susan Desmond-Hellmann.(1-2)<br /><br /><b>Two Somewhat Redundant Lancet Articles </b><br /><br />Dr Desmond-Hellmann trained as an oncologist, spent time working on AIDS and Kaposi's Sarcoma in Uganda, but then spent much of her career as a pharmaceutical/ biotechnology executive, as described in the first article,(1)<br /><br /><blockquote class="tr_bq">After returning from Uganda, Desmond-Hellmann <i>joined the nascent Taxol development programme at Bristol-Myers Squibb</i>, before being poached by Arthur Levinson, the then Head of Research and Development at Genentech. Levinson was convinced Genentech had a strong pipeline of anticancer therapies, and brought Desmond-Hellmann on board to help guide them through to approval. The <i>pipeline went stratospheric</i>, and <i>took Desmond-Hellmann with it</i>. By 2009 she had been <i>promoted to President of Product Development</i>, having overseen the introduction of two of the first gene-targeted therapies for cancer, bevacizumab and trastuzumab.</blockquote><br />After Genentech was bought out by Roche, Dr Desmond-Hellmann became Chancellor of the University of California, San Francisco,<br /><br /><blockquote class="tr_bq">Over the next 5 years, Desmond-Hellmann <i>instituted wide-ranging reforms</i> at UCSF, including aggressively cutting administrative waste and putting a greater emphasis on partnerships with the biotech and pharmaceutical sectors, coming in for some criticism in the process. 'Some of the press suggested one of Sue's goals was to take UCSF out of the public system', says [current UCSF interim Chancellor Sam] Hawgood. 'Nothing could be further form the truth. She was very proud of the public mission of UCSF, and had no intent to alter that.' Mindful of how damaging perceived conflicts of interest could have been to her credibility during her time at UCSF, Desmond-Hellmann says she '<i>specifically avoided being on pharma and biotech boards'</i>.</blockquote><br />The article suggested we should expect nothing but great things from Dr Desmond-Hellmann at the Gates Foundation,<br /><br /><blockquote class="tr_bq">it is Desmond-Hellmann's ability to forge partnerships and her wide network of contacts, rather than her knack for cutting administrative overheads, that will have seemed most attractive to the Gates Foundation as it looks to speed up the process of translating research into results.</blockquote><br />The second article used remarkably similar wording(2), e.g., regarding her career in the pharmaceutical business,<br /><br /><blockquote class="tr_bq">Soon after joining the Taxol team, Desmond-Hellmann was leading it; the kind of progress that was bound to catch the eye of Genentech's then Head of Research and Development Arthur Levinson. What happened next is <i>part of pharmaceutical folklore</i>, as Desmond-Hellmann helped to mastermind<i> one of the most profitable drug-development pipelines in history</i>, including the approval of two of the first targeted cancer therapies, for Genentech.</blockquote><br />Also, regarding her career at UCSF,(2)<br /><br /><blockquote class="tr_bq"> Desmond-Hellmann from embarking on a <i>programme of structural reforms</i> to cut administrative inefficiency and forge closer links with private industry, something that still stirs up controversy. 'There definitely were concerns, and there remain<i> concerns in academia, about conflicts of interest, privatisation</i>. I think what helped most was that I was clear in my actions that I did and do value that UCSF is a public institution, and I think my actions spoke and speak for themselves', she says. But Desmond-Hellmann is robust in her defence of the <i>importance of public—private partnerships</i> for driving innovations that ultimately benefit society.</blockquote><br />Finally, regarding expectations for her performance in the future,<br /><br /><blockquote class="tr_bq">'There are a lot of people who are looking to the foundation, and in the world of philanthropy there's a lot of visibility to the Bill & Melinda Gates Foundation, so I certainly feel accountable and responsible for doing a good job.' But, she asserts, 'I'm up for it'. With a track record that ranges from clinical research, global health, and the sharp end of commercial drug development, <i>she seems to be made for it.</i></blockquote><br />So Lancet, a very well known journal which normally is very parsimonious about its use of the printed page, used two full pages for two very similar articles about the new Gates Foundation CEO.  Both articles made the same points,<br />-  Dr Desmond-Hellmann had a brilliant career in the pharmaceutical/ biotechnology business, and was responsible for the development of several important cancer drugs<br />-  Dr Desmond-Hellmann made major reforms at UCSF, including pushing for some sort of privatization, and for public-private partnerships, while dismissing concerns about any resulting conflicts of interest<br /> -  Dr Desmond-Hellmann is likely to be very successful as Gates Foundation CEO.<br /><br /><b>What the Articles Did Not Say</b><br /><br />When Dr Desmond-Hellmann's appointment as Chancellor of UCSF was announced in 2009, I <a href="http://hcrenewal.blogspot.com/2009/05/bio-tech-u.html">suggested</a> that she was a very unusual choice because of aspects of her track record in the pharmaceutical/ biotechnology business.  Yet the Lancet's two articles on her prospects as new Gates Foundation CEO ignored these considerations, and ignored or downplayed aspects of her track record as UCSF Chancellor.  In particular,<br /><br /><u>Defending $55,000/ Year Bevacizumab</u><br /><br />As I noted in 2009, Dr Desmond-Hellmann's defense as a Genentech executive of the sky high prices the company was charging for its new drugs was well documented in an article in the Journal of the National Cancer Institute)(3)<br /><br /><blockquote class="tr_bq"><i><b>And cancer biologics, though among the most costly drugs, are still only a tiny fraction of total GDP, said Genentech's Susan Desmond-Hellmann, president for product development,</b></i> at AACR.<br /><br /><i><b>Hellmann and others argue that with these drugs’ potential to alleviate the huge societal burden of cancer, biologics are worth the cost</b></i>.<br /><br />The industry has responded to concerns about costs by putting more resources into patient assistance programs. When Genentech received U.S. Food and Drug Administration approval for bevacizumab in lung cancer last October, it also announced a cap on expenditures for the drug for patients with family incomes less than $100,000 a year. In 2005, the median household income was $46,326.<br /><br /><i>Originally announced as $55,000, the cap actually doesn't kick in until after a patient has received 10,000 mg. At the wholesale acquisition cost, 10,000 mg is about $55,000, </i>said Genentech spokesperson Edward Lang.<br /><br /><i>What the companies have not done so far is reduce prices. The reason, industry representatives say, is the need to recoup massive research and development costs, including high manufacturing costs for biologics. <b>These costs have long kept biotech companies from making much of a profit overall, Hellmann said. She noted that profit levels of publicly held biotech firms have 'hovered close to zero' throughout the life of the industry.</b></i></blockquote><br />Whatever the company's nominal profit levels, its executives, including Dr Desmond-Hellmann, have made extremely good money.   According to <a href="http://www.sec.gov/Archives/edgar/data/318771/000095013408004633/0000950134-08-004633-index.htm">Genentech's 2008 proxy statement</a>, (the last available, since the company has been bought out by Roche), Dr Desmond-Hellmann's <i><b>total compensation was $8,361,348 in 2007 and $7,820,142 in 2006</b></i>. In 2007, her <i><b>total compensation was equal to 0.3% of the firm's total net income</b></i>.<br /><br />Of course, since 2007, and especially since 2009, the problem of hugely expensive pharmaceuticals as a driver of health care costs, especially in the US, has become all too apparent.  The Lancet articles were completely silent about this aspect of Dr Desmond-Hellmann's track record, and what implications it might have for her new role of a foundation that spends $3 billion a year, mainly ostensibly to improve the health of poor people. <br /><br />Since she began as Chancellor of UCSF in 2009, other aspects of Dr Desmond-Hellmann's track record came to light that might have a bearing on how she will conduct herself as Gates Foundation CEO.  <br /><br /><u>Investments in Tobacco Stocks</u><br /><br />As I <a href="http://hcrenewal.blogspot.com/2010/06/smoke-detector-medical-center-leader.html">posted</a> in 2010, then NY Times reporter Duff Wilson discovered that Dr Desmond-Hellmann and her husband (also a physician), had stock holdings in Altria, the parent company of tobacco company Phillip Morris USA, worth between $100,000 and $1,000,000.  When this made public, they abruptly sold the stock.  The head of the UCSF tobacco control center then said,  “I do find that <i>kind of shocking</i>, but at least she got rid of it,...”<br /><br />The goals of tobacco companies seem completely antithetical to those of a medical school, especially one with a tobacco control center, and incidentally seem antithetical to those of the Gates Foundation, which has a <a href="http://www.gatesfoundation.org/What-We-Do/Global-Policy/Tobacco-Control">tobacco control initiative</a>, with a stated goal:<br /><br /><blockquote class="tr_bq">to reduce tobacco-related death and disease in developing countries by preventing the initiation of new smokers, decreasing overall tobacco use, and reducing exposure to secondhand smoke. </blockquote><br />The Lancet articles were silent on this issue.   <br /><br /><u>Questions Whether Industry Partnerships Threaten the University Mission</u><br /><br />In 2011, I <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">posted</a> about Dr Desmond-Hellmann's vigorous push to create public-private partnerships, which seemed meant to turn UCSF into a de facto drug company research and development contract shop.  At the time, I noted that many of her arguments seemed to be based on logical fallacies, and that she never provided any good evidence for her claims of marvelous new "innovations" that would result from such supposed partnerships.  The Lancet articles did not mention any substantive concerns about this issue.<br /><br /><u>Dismissing Concerns about Conflicts of Interest</u><br /><br />In 2012, I <a href="http://hcrenewal.blogspot.com/2012/02/logical-fallacies-in-defense-of.html">posted</a> about how Dr Desmond-Hellmann also dismissed concerns that public-private partnerships could lead to damaging conflicts of interest, again employing several logical fallacies.  In particular, she implied that medical academics should no longer just do research to advance knowledge, but had become responsible for getting their "discoveries to society," and therefore would have to "<i>start a company or work with a company to commercialize a product."  </i>She did not seem to acknowledge the possibility that academics could make discoveries, but perhaps other people would be better at turning these discoveries into useful products.  The Lancet articles were silent on these issues.<br /><br /><u>Minimizing Concerns about Conflicts of Interest due to Membership on the Board of Corporations with Health Care Agendas</u><br /><br />As noted above, Dr Desmond-Hellmann stated that she demonstrated her sensitivity to the issue of conflicts of interest affecting academic health care by avoiding membership on boards of directors of "pharma or biotech" companies.  These, of course are not the only sorts of for-profit corporations who have health care agendas.  This statement appears to have been carefully worded to avoid dealing with Dr Desmond-Hellmann's membership since 2010 on the board of directors of Procter & Gamble (see the company's <a href="http://www.pginvestor.com/file.aspx?IID=4004124&FID=19227491&O=3&OSID=9">2013 proxy statement</a>.)   While Procter & Gamble is no longer a major pharmaceutical company, it has a <a href="http://www.pg.com/en_US/brands/global_health_grooming/index.shtml">Global Health and Grooming unit</a>, whose products include over the counter pharmaceuticals (e.g., Pepto-Bismal, Metamucil, Prilosec OTC).  Also, while Procter & Gamble does not make it very obvious, it has also 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 while perhaps Dr Desmond-Hellmann could claim that while she was UCSF Chancellor she was not on the board of directors of any pure pharmaceutical or biotechnology company, she was certainly on the board of a major international company that sells pharmaceuticals and other health care related products, and employs physicians to provide direct patient care.  (Presumably, she will be staying on the P&G board while she is Gates Foundation CEO.)  The Lancet did not mention this issue.  <br /><br /><u>Privatizing UCSF</u><br /><br />Also, the Lancet articles seemed to contradict other reports that Dr Desmond-Hellmann made a serious attempt to privatize at least some aspects of UCSF, but that this effort failed. (Note that quote by Dr Hawgood from the first article above.)     <br /><br />However, in 2012, I posted about a prevalent conspiracy theory that University of California managers were trying to take the university private.  However, it seemed to be more of a theory, because at least one news report included statements that Dr Desmond-Hellmann wanted to take UCSF out of the state university system.  This week, an <a href="http://www.bizjournals.com/sanfrancisco/blog/2014/04/university-of-california-uc-ucsf-janet-napolitano.html">article</a> in the San Francisco Business Times suggested that this was a serious plan, in that Dr Desmond-Hellmann<br /><br /><blockquote class="tr_bq">ran into opposition when she  <a href="http://pubads.g.doubleclick.net/pagead/adview?ai=B46LUcTVlU4KNFIrUkwT0tYG4DYnY2pwFAAAAEAEgADgAWJmX6YiuAWDJvriM1KSoEIIBF2NhLXB1Yi05NzM2MDkyNjA0Njc3NTE2sgETd3d3LmJpempvdXJuYWxzLmNvbboBCWdmcF9pbWFnZcgBCdoBa2h0dHA6Ly93d3cuYml6am91cm5hbHMuY29tL3NhbmZyYW5jaXNjby9ibG9nLzIwMTQvMDQvdW5pdmVyc2l0eS1vZi1jYWxpZm9ybmlhLXVjLXVjc2YtamFuZXQtbmFwb2xpdGFuby5odG1smALohAHAAgLgAgDqAiI0NjM1L2J6ai5zYW5mcmFuY2lzY28vYXJ0aWNsZV9wYWdl-AL00R6QA-ADmAPgA6gDAeAEAZIFCwgHEAEYByDp888YoAYg&sigh=t4VXjjLVbHw&adurl=http://pagead2.googlesyndication.com/pagead/imgad?id=CICAgKCNn-yIxgEQARgBMggPKtH7CIiUnA%26t%3D10%26cT%3Dhttp%253A//bizjournals.com%26l%3Dhttp%253A//www.bizjournals.com/sanfrancisco/blog/2012/01/susan-desmond-hellmann-ucsf-uc.html">proposed in early 2012 that some of UCSF's functions be separated from the rest of the UC system</a>.<br /><br />The<i> autonomy coming from the separation, Desmond-Hellmann argued at the time,</i> would have meant that the sole graduate-level-only campus in the 10-campus UC system would no longer subsidize UC undergrad programs. It also would have translated into UCSF having more control over the money it generates from its medical center and other operations.</blockquote><br />However, the same article noted that the current University of California President,<br /><br /><blockquote class="tr_bq">dismissed as 'loose talk' <i>a more than two-year-old plan for UCSF to weaken its ties to the larger UC system</i>. 'UCSF is firmly part of the system and will remain so,...' </blockquote>The current president seemed to thus acknowledge that this plan existed, however "loose" it may have been.  Clearly, the Lancet articles suggested rather that Dr Desmond-Hellmann did not have any privatization plans, whatever the criticisms people could have made of them.   <br /><br /><b>Summary</b><br /><br />We have often discussed the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, how it seems taboo to discuss certain unpleasant facts and issues relevant to the health care system, especially those that might lead to questions about the abilities of the current leadership of large health care organizations.  This taboo seems to particularly affect public discourse within the health care system, such as is found in medical and other scholarly health care journals.<br /><br />The Lancet is one of the largest circulation and most prestigious medical journals.  The Gates Foundation is one of the biggest foundations working in the health care sphere.  In their <a href="http://www.gatesfoundation.org/Who-We-Are/General-Information/Letter-from-Bill-and-Melinda-Gates">latest letter</a>, Bill and Melinda Gates stated,<br /><br /><blockquote class="tr_bq">Our foundation is teaming up with partners around the world to take on some tough challenges: extreme poverty and <i>poor health in developing countries</i>, and the failures of America’s education system.</blockquote><br />Yet when the Lancet devoted two full pages to often repetitive discussion of the new leader of the Gates Foundation, it avoided discussion of several issues that might have lead to questions about whether her future leadership would really be about challenging "poor health in developing countries," rather than promoting the interests of large pharmaceutical/ biotechnology and other health care related companies, as she had apparently tried to do before.  That such an important medical journal would publish such incomplete health news reporting suggests the operation of the anechoic effect. <br /><br />I hope the questions that ought to be raised about Dr Desmond-Hellmann's priorities as CEO of the Gates Foundation will eventually be put to rest.  It would be more reassuring, however, if they could be confronted directly rather than obfuscated.  As long as big health care journals remain so deferential to big health care leaders, concerns we have raised before about whether health care is now primarily lead by a small in-group of executives and managers who may put private interests ahead of entrusted responsibilities remain acute.<br /><br />As we have said many, many times, true health care reform would ensure that leaders of big health care organizations really put patients' and the public's health ahead of private interests.  <br /><br /><br /><b>References</b><br /><br />1.  Holmes D. New CEO takes the reins at the Gates Foundation.  Lancet 2014; 383: 1440.  Link <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2960702-9/fulltext">here</a>. <br />2.  Holmes D. Susan Desmond-Hellmann taking charge at the Gates Foundation.  Lancet 2014; 383: 1455.  Link<a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2960706-6/fulltext"> here</a>.<br />3.  McNeil C. Sticker shock sharpens focus on biologics.  J Nat Cancer Instit 2007; 99: 910-914.  Link <a href="http://jnci.oxfordjournals.org/content/99/12/910.extract">here</a>.<br /><br />ADDENDUM - Material about MDVIP as subsidiary of Procter & Gamble added 5 May, 2014 PM. 

Abort, Retry, Fail? - Lancet Avoided Much Recent Unpleasantness in Reporting on New Gates Foundation CEO (Including Her Defense of $55,000 a Year for Bevacizumab)

The April 26, 2014 issue of the prestigious journal Lancet used two full pages and two separate articles by the same author to discuss the ascension of the Gates Foundation new CEO, Dr Susan Desmond-H…

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Planned Obsolescence Disguised as Innovation, Oligopoly Disguised as a Free Market, and the Enrichment of Oligarchs

The New York Times published another<a href="http://www.nytimes.com/2014/04/06/health/even-small-medical-advances-can-mean-big-jumps-in-bills.html"> article</a> in its series on the high cost of US health care.  This one, focused on the care of type 1 diabetes mellitus and other chronic diseases, shines some light on the business management practices that now determine how our health care system functions, or not, and implies who benefits the most from them.<br /><br /><b>Planned Obsolescence Disguised as Innovation</b><br /><br />The article first discussed the brave new world of type 1 diabetes treatment.  The introductory theme was:<br /><br /><blockquote class="tr_bq">Today, the routine care costs of many chronic illnesses eclipse that of acute care because <i>new treatments that keep patients well have become a multibillion-dollar business opportunity</i> for device and drug makers and medical providers.</blockquote><br />Much of modern diabetes treatment seems to depend on medical devices and disposable medical supplies:<br /><br /><blockquote class="tr_bq">That captive audience of Type 1 diabetics has spawned lines of high-priced gadgets and disposable accouterments,<i> borrowing business models from technology companies like Apple: Each pump and monitor requires the separate purchase of an array of items that are often brand and model specific</i>.<br /><br />A steady stream of<i> new models and updates often offer dubious improvement</i>: colored pumps; talking, bilingual meters; sensors reporting minute-by-minute sugar readouts. [Diabetes patient] Ms. Hayley’s new pump will cost $7,350 (she will pay $2,500 under the terms of her insurance). But she will also need to pay her part for supplies, including $100 monitor probes that must be replaced every week, disposable tubing that she must change every three days and 10 or so test strips every day.</blockquote><br />Of course, the device and supply manufacturers claim that the high prices reflect the value of the wondrous new innovations:<br /><br /><blockquote class="tr_bq">Companies that produce the treatments say the higher costs reflect medical advances and the need to recoup money spent on research.</blockquote><br />Yet now the Times reporter was able to find physicians who claim the "innovations" are really just the latest version of planned obsolescence:<br /><br /><blockquote class="tr_bq">Diabetes experts say<b><i> a good part of what companies label as innovation amounts to planned obsolescence</i></b>. Just as Apple customers can no longer buy an iPhone 3 even if they were content with it, diabetics are nudged to keep up with the latest model.</blockquote>For example,<br /><br /><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="410" data-total-count="4006" id="story-continues-3" itemprop="articleBody">Those companies spend millions of dollars recruiting patients at health fairs, through physicians’ offices and with aggressive advertising — often urging them to get devices and treatments that are not necessary, doctors say. 'They may be better in some abstract sense, but the clinical relevance is minor,' said Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center.</div><div class="story-body-text story-content" data-para-count="410" data-total-count="4006" id="story-continues-3" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="109" data-total-count="4115" itemprop="articleBody">'<i>People don’t need a meter that talks to them</i>,' he added. 'There’s an incredible waste of money.'</div></blockquote><br /><br />Pharmaceutical companies have also discovered this model.<br /><br /><blockquote class="tr_bq">insulin ... has been produced with genetic engineering and protected by patents, so that a medicine that cost a few dollars when Ms. Hayley was a child now often sells for more than $200 a vial, meaning some patients must pay more than $4,000 a year.</blockquote><br />In particular,<br /><br /><blockquote class="tr_bq">Synthetic human insulin is safer for patients, who sometimes developed reactions to animal insulin. But it is <i>made by only three companies: Eli Lilly, Sanofi and Novo Nordisk</i>. Manufactured in microbes, each one’s product has minor dissimilarities that reflect the type of cell in which it was made. Since the companies owned the cell lines, it is nearly impossible for other companies to make exact copies or even similar versions that would be cheaper, even once the patents expire. And the pharmaceutical companies defend the patents ferociously.<br /><br /><div class="story-body-text story-content" data-para-count="270" data-total-count="12681" itemprop="articleBody">What’s more, the three companies continued to refine their product, adding chemical groups that made the insulin absorb somewhat more quickly or evenly, for example. They are called insulin analogues, and their benefits are promoted tirelessly to doctors and patients.</div></blockquote><br /><br />Of course, the pharmaceutical companies also claim that it's all about innnovation,<br /><br /><blockquote class="tr_bq">Dr. Todd Hobbs, chief medical officer of Novo Nordisk, defended the rising prices of insulin, linking them to medical benefits. 'The cost to develop these new insulin products has been enormous, and the cost of the insulin to the consumer in developed countries has risen to enable these and future advancements to occur,' he wrote in an email.</blockquote> Not everyone is convinced,<br /><br /><blockquote class="tr_bq">'The insulins are tweaked for minor benefits that may help a small number of patients with difficult-to-control diabetes, and result in major price increases for all,' [Kings College, London, UK Professor] Dr. Pickup said. Because of analogues, he added, Britain’s National Health Service has had to spend 130 percent more on insulin in the past five years. <br /><br />In the United States, said Dr. Zonszein at Montefiore, the price of Humalog, Lilly’s analogue insulin, was typically two to four times that of its older human insulin line, called Humulin. 'There is not a lot of difference between Humulin and analogues,' he said, but he noted that Humulin was getting 'hard to find.' Sanofi Aventis has stopped selling its older product in the United States, and Mr. Kliff, the financial analyst, said other companies were likely to follow suit, effectively forcing patients to use the costlier versions.</blockquote><br /><br />The arguments about valuable innovation also do not explain why the prognosis of diabetes in the US does not seem to reflect all the money we spend on the disease,<br /><br /><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="306" data-total-count="4993" itemprop="articleBody">Complication rates from diabetes in the United States are generally higher than in other developed countries. That is true even though the United States <a href="http://www.cdc.gov/diabetes/statistics/complications_national.htm">spends more</a> per patient and per capita treating diabetes than elsewhere, said Ping Zhang, an economist at the Centers for Disease Control and Prevention.</div><div class="story-body-text story-content" data-para-count="306" data-total-count="4993" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="280" data-total-count="5273" itemprop="articleBody">The high costs are taking their toll on public coffers, since 62 percent of that treatment money comes from government insurers. The cumulative outlays for treating Type 1 and Type 2 diabetes <a href="http://www.diabetes.org/advocacy/news-events/cost-of-diabetes.html">reached nearly $200 billion</a> in 2012, or about 7 percent of America’s health care bill.</div></blockquote><br />So to summarize, there is considerable evidence that companies that make drugs and devices to manage type 1 diabetes constantly provide "innovations," yet most are minor changes that encourage obsolescence of previous products, but do not provide important increases in benefits or reductions in harm for patients.  <br /><br /><br /><b>Oligopoly Disguised as a Free Market</b><br /><br />Many in the US sing the praises of our supposed free-market health care system.  As noted above however, the insulin market is an oligopoly, dominated by three companies.  The diabetes device market is also dominated by a few companies, and in particular, the insulin pump market is dominated by a single company,<br /><br /><blockquote class="tr_bq"><a href="http://www.medtronic.com/">Medtronic</a> is the dominant insulin pump manufacturer,<i> serving 65 percent of American patients and the majority of those worldwide.</i> <i>Though smaller companies sell cheaper pumps, it is hard to make inroads</i>: Once familiar with the Medtronic system and its extensive support network for troubleshooting problems, patients are reluctant to switch. Doctors are leery of prescribing equipment from a new company that may be out of business in a year; their office computer may not sync with the new software anyway.</blockquote><br />Of course, Medtronic public relations will justify it all again based on innovation,<br /><br /><blockquote class="tr_bq">Medtronic declined to talk about specific prices, but said a core tenet was to make only 'a fair profit.' Amanda Sheldon, a spokeswoman, added: 'We are committed to reinvesting in research and development of new technologies to improve the lives of people with diabetes, and our current pricing structure ensures that we can bring new products to market.' </blockquote><br />The article also discussed the prices of treating chronic diseases other than diabetes.  For example, see how a nominally non-profit hospital priced treatments for chronic diseases,<br /><br /><blockquote class="tr_bq">Dr. Kivi was on high doses of steroids for debilitating joint pain that left him unable to walk at times.<br /><br />But when his last<i> three-hour infusion at NYU Langone Medical Center’s outpatient clinic generated a bill of $133,000</i> — and his insurer paid $99,593 — Dr. Kivi was so outraged that he decided to risk switching to another drug that he could inject by himself at home. </blockquote><br />However,  this pricing appears to have been facilitated by the hospital's increasing market domination generated by its purchase of physician practices, <br /><br /><blockquote class="tr_bq">He had moved his care to NYU Langone to follow his longtime doctor, who had <i>moved her practice from a nearby hospital where the same infusion had been billed at $19,000. The average price that hospitals paid for Dr. Kivi’s dose of Remicade late last year was about $1,200,</i> according to Medicare data.</blockquote><br />So in summary, a few companies now dominate the production of drugs and devices for the management of diabetes, and a few large hospitals may increasingly dominate the treatment of particular chronic diseases.  Such oligopolists are able to increase prices without improving treatment to or outcomes of patients.<br /><br /><b>Enrichment of the Oligarchs</b><br /><br />This example shows how the current US health care system is dominated by huge organizations, mostly for-profit corporations but including some nominally non-profit corporations that act similarly.  They loudly proclaim innovation, but much of that innovation seems to provide few benefits to patients, and actually appears to be planned obsolescence.  The result is high and ever-rising prices. So if patients do not benefit from this, who does?<br /><br />It does not appear to be the health care professionals,<br /><br /><blockquote class="tr_bq">Meanwhile, as the price of supplies rises,<i> endocrinologists remain among the lowest-paid specialists in American medicine,</i> meaning severe physician shortages in many areas and long waits to see a doctor.</blockquote><br />We  have seen other examples of how leaders of the big health care organizations have become as<a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation"> rich as royalty</a>.  Therefore, let us consider the pay of the leaders of the organizations mentioned above.  I will focus on the two US based corporations, Eli Lilly and Medtronic, and the New York hospital, NYU Langone Medical Center.<br /><br /><u>Eli Lilly</u><br /><br />According to the company's <a href="http://investor.lilly.com/secfiling.cfm?filingID=59478-14-90&CIK=59478">2014 proxy statement</a>, the 2013 total compensation of its five highest paid hired executives was<br /><br />- John C Lechleiter PhD, CEO                                     <b><i> $11,217,000</i></b><br /><br />- Derica W Rice, CFO                                                   <b><i>$5,176,822</i></b><br /><br />- Jan M Lundberg, PhD, EVP, Science and Technology   <b><i>$4,774,535</i></b><br /><br />- Michael J Harrington, General Counsel                         <b><i> $3,174,222</i></b><br /><br />- Erico A Conterno, President Lilly Diabetes                    <b><i>$3,009,041</i></b><br /><br />Note that all of these executives save Mr Harrington have also amassed more than 100,000 shares of company stock, and Dr Lechleiter has amassed more than 1,000,000.<br /><br />It should be no surprise, given our recent discussion (e.g., <a href="http://hcrenewal.blogspot.com/2014/04/finally-article-in-large-circulation.html">here</a>) of the currently symbiotic relationship among top health care corporations and academic medicine, that several of the members of the Lilly board of directors that has exercised stewardship over the company, and is thus responsible for these gargantuan compensation packages and the business practices discussed above are top academic leaders.  These include,<br /><br />- Alfred G Gilman, MD, PhD, Regental Professor Emeritus, recent (until 2009) executive vice presdient, provost, and dean of medicine, University of Texas Southwestern  <br /><br />- William G Kaelin Jr, MD, Professor of Medicine, Associate Director of Basic Science, Dana-Farber Cancer Center, Harvard University<br /><br />- Marschall S Runge MD, Executive Dean and Chair of the Department of Medicine, University of North Carolina Medical School<br /><br />- Katherine Baicker PhD, Professor of Health Economics, Harvard University School of Public Health  (I must note that Prof Baicker is also - amazingly - on the Medicare Payment Advisory Committee, MEDPAC).<br /><br />- Ellen R Marram, Trustee, New York-Presbyterian Hospital<br /><br />- Ralph Alvarez, President's Council, University of Miami<br /><br />- R David Hooper, Trustee, Children's Hospital of Colorado<br /><br />- Franklyn G Pendergast MD PhD, Professor, Mayo Medical School<br /><br />All but the newest directors were paid at least $250,000 a year by the company (and thus by the executives the directors are supposed to supervise), and all but the newest directors had accumulated tens of thousands of shares of stock or the equivalent as pay for their services.<br /><br /><br /><u>Medtronic</u><br /><br />Similarly, according to the company's<a href="http://phx.corporate-ir.net/phoenix.zhtml?c=76126&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTkwMjY0MzAmRFNFUT0wJlNFUT0wJlNRREVTQz1TRUNUSU9OX0VOVElSRSZzdWJzaWQ9NTc%3d"> 2013 proxy</a> (the latest now available), CEO Omar Ishrak made <b><i>$8,975,866</i></b> in 2013, and the next four highest paid executives all made over $2,500,000 each.   Mr Ishrak owned or could acquire the equivalent of more than 500,000 shares of stock, and the other top paid executives owned of could acquire from over 100,000 to over 1,000,000 shares of stock.<br /><br />Again, the executives were nominally supervised by a board of directors that included an academic and non-profit leader, Dr Victor J Dzau, MD former chancellor for health affairs at Duke University, and president-elect of the Institute of Medicine (note that we discussed Dr Dzau's conflicts of interest most recently <a href="http://hcrenewal.blogspot.com/2014/02/incoming-president-of-iom-outed-as.html">here</a>).  It also included a former government leader, Michael O Leavitt, former US Secretary of Health and Human Services; and a hospital leader, Preetha Reddy, Managing Director of Apollo Hospitals Enterprise Limited (India).  <br /><br /><u>NYU Langone Medical Center</u><br /><br />The Medical Center's<a href="http://www.guidestar.org/FinDocuments/2012/133/971/2012-133971298-09798bbc-9.pdf"> 2011 US form 990</a> is old, but the latest available, and is remarkably obscure, omitting, for example, mentioning the titles of any of the people listed as highest paid officers and employees.  The current CEO, was listed as receiving total compensation of just over $2.000,000.  Four individuals then received over $1,000,000.  The 990 form also mentioned that the Medical Center provided some individuals with first class travel, tax gross-up payments, housing allowances, and reimbursement for personal services.  Neither the 990, nor the center's <a href="http://www.med.nyu.edu/about-us/who-we-are/medical-center-leadership/trustees">web-site</a> makes all the possible conflicts of interest of its trustees obvious.    <br /><br />So in summary, the large organizations, for-profit and non-profit, that are able to greatly increase their prices through planned obsolescence disguised as innovation, and oligopoly disguised as free markets, are able to make their top executives very rich, and also enrich those who are supposed to exercise stewardship over them.  <br /><br /><br /><b>Summary</b><br /><br />An extensive journalistic investigation revealed how certain aspects of chronic care in the US health care system are dominated by a few large organizations.  These organizations are able to charge very high prices, mainly through market domination, and with the aid of marketing and public relations that tout planned obsolescence as valuable innovation.  The leaders of these organizations have become wealthy, often fabulously so.  This state of affairs has not been challenged by those who are supposed to provide stewardship, including many prominent academics. <br /><br />The US health care system is the most expensive, on a per capita basis, in the world, and far more expensive than that in any other developed country.  Yet there is no evidence that its results are superior to those of other countries.  What evidence there is suggests in fact that our results are mediocre at best.<br /><br />The current example suggests how the US system differs from those of other countries.  It has an ostensible free market focus.  Yet the system appears more to be an oligopoly, with most of its market components dominated by a few large organizations, run as an oligarchy, by a small, overlapping in-group of managers, executives and their cronies, with elements of corporatism, that is with the cooperation of, rather than regulation by government entities and leaders <br /><br />A real free market health care system would include a level playing field.  This could only be achieved by the government acting as a fair umpire, not a crony.  Anti-competitive practices would have to end.  Oligopolies would have to be broken.  Deceptive marketing and public relations would have to be exposed.  Leaders would have to be made accountable, especially for putting patients' and the public's health ahead of their own enrichment.  All this would be horribly difficult, as the oligarchs have amassed much money and control, and would oppose, possibly violently, any effort to challenge them.  If we do not challenge them in the US, however, not only will our health care continue to become ever more expensive, less accessible, and less beneficial to patients, but we will all cease to be citizens of one of the first real democracies, and end up serfs instead. 

Planned Obsolescence Disguised as Innovation, Oligopoly Disguised as a Free Market, and the Enrichment of Oligarchs

The New York Times published another article in its series on the high cost of US health care.  This one, focused on the care of type 1 diabetes mellitus and other chronic diseases, shines some light …

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Finally, An Article in a Large Circulation Medical Journal with Systematic Data about Leaders of Academic Medicine Conflicted by their Service on Health Care Corporate Boards

<b>Background - a New Species of Conflict of Interest </b><br /><br />Since <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">2006</a>, we have posted repeatedly about  what was then a new species of severe <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a>.  This occurs when leaders of academic medical institutions or other health care non-profit organizations or non-governmental organizations (NGOs) also serve as members of <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20directors">boards of directors</a> of for-profit corporations  whose products and actions have major effects on health care.<br /><br />Most recently, we <a href="http://hcrenewal.blogspot.com/2014/03/american-board-of-internal-medicine.html">discussed </a>the cases of the current CEO of the National Quality Forum and past CEO of the American Board of Internal Medicine who was found to be on the board of for-profit hospital group purchasing organization Premier Inc, and had been on the board of its privately held but for-profit predecessors.  We then <a href="http://hcrenewal.blogspot.com/2014/02/incoming-president-of-iom-outed-as.html">discussed</a> the case of the incoming president of the US Institute of Medicine and former Chancellor of Health Affairs at Duke University who was on the boards of Alnylam Pharmaceuticals, Medtronic and Pepsico.  We next <a href="http://hcrenewal.blogspot.com/2014/03/turnabout-is-fair-play-why-university.html">discussed</a> the case of the current Dean of medicine at the University of Illinois who is on the board of Novartis.  <br /><br />We also recently <a href="http://hcrenewal.blogspot.com/2014/03/better-late-than-never-jama-article.html">posted</a> about the first time these sorts of severe conflicts of interest issue have been addressed in a large circulation medical journal.  A commentary in JAMA called for many such conflicts to be banned.<br /><br /><b>A Small Study of the Prevalence of a New Species of Conflict of Interest </b><br /><br />Now JAMA has just published a research letter which examined the prevalence of board members of large, for-profit, publicly held pharmaceutical companies who also were among the leadership of academic medical centers. [Anderson TS, Dave S, Good CB et al. Academic medical center leadership on pharmaceutical company boards of directors.  JAMA 2014; 311: 1353-5.  Link <a href="http://jama.jamanetwork.com/article.aspx?articleid=1853147">here</a>.]<br /><br />The authors looked at public data about 2012 board membership of the 47 biggest publicly held companies based on global prescription drug sales. They tabulated those who were also leaders at (apparently only US) academic medical centers.  <br /><br />The most important findings were:<br />- 19/47 companies (40%) had at least one board member who was a leader of an academic medical center (AMC)<br />- 16/17 US based companies had at least one board member who was also a leader of a US AMC<br />-  pharmaceutical company board members included 2 university presidents, 6 deans of medicine, 6 hospital or health system executives, 7 clinical department chairs or center directors<br />-  28 board members were also members of boards of trustees or directors of US hospitals, medical schools, or their parent universities.<br /><br /><b>Comments </b><br /><br />We have been trying to raise awareness of this issue since 2006.  Now we have some idea of the size of the problem.<br /><br />Keep in mind that this study did not attempt to determine the prevalence of academic medical center leaders on boards of smaller pharmaceutical companies, privately held companies, biotechnology or device companies, or other health care and health care related companies (e.g., for-profit hospital systems, health insurance companies, for-profit contract research organizations, for-profit medical education and communication companies, large companies with major health care components, etc, etc, etc)  It also did not attempt to determine the prevalence of leaders of other important health care non-profit organizations (e.g., hospitals and hospital systems, insurance companies, professional societies, patient advocacy groups, accrediting boards, etc, etc, etc) on health care or related corporate boards.  It also did not address leaders of health care organizations outside of the US.  So this study likely greatly underestimates the overall prevalence of and the number of people involved in what we first called a "new species of conflict of interest." <br /><br />But it is a start.  And publishing it in JAMA will begin to make more health care professionals, policy makers, and researchers, and more of the public at large aware of the problem.<br /><br />As I said before, it is very nice to see that the issue of what we once called a new species of conflict of interest finally has made the big time.  Whether it now gets any more traction remains to be seen.  Unfortunately, since conflicts of interest can be so profitable for the directly affected parties, I fully expect they will continue to oppose any restrictions.  The money they have made will likely be used to deploy marketing and public relations personnel and legal counsel to counter any attempts to try to make this aspect of health care more honest.<br /><br />As we have said again and again, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  Furthermore, this web is now strong enough to have effectively transformed US health care into an oligarchy or plutocracy.  Health care is effectively run by a relatively small group of people, mainly professional managers plus a few (lapsed?) health care professionals, who simultaneously run or influence multiple corporations and organizations.<br /><br />For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain. Health care professionals who care for patients, those who teach about medicine and health care, clinical researchers, and those who make medical and health care policy should do so free from conflicts of interest that might inhibit their abilities to put patients and the public's health first.<br /><br />Health care professionals ought to make it their highest priority to ensure that the organizations for which they work, or with which they interact also put patients' and the public's health ahead of private gain, especially the private gain of the organizations' leaders and their cronies.<br /><br />ADDENDUM (3 April, 2014) - see also comments by Paul Levy <a href="http://runningahospital.blogspot.com/2014/04/how-not-to-set-example.html">on the Not Running a Hospital blog</a>, <a href="http://1boringoldman.com/index.php/2014/04/01/at-first-glance/">on the 1BoringOldMan blog</a>, and by Ed Silverman (welcome back!) on <a href="http://blogs.wsj.com/corporate-intelligence/2014/04/01/why-people-who-influence-reseach-are-popular-in-pharma-boardrooms/">the WSJ Corporate Intelligence blog</a>. 

Finally, An Article in a Large Circulation Medical Journal with Systematic Data about Leaders of Academic Medicine Conflicted by their Service on Health Care Corporate Boards

Background - a New Species of Conflict of Interest Since 2006, we have posted repeatedly about  what was then a new species of severe conflicts of interest.  This occurs when leaders of academic med…

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No Fooling - When a Retired Conservative Politician Warns About Oligarchy...

then things must be getting really bad.<br /><br />Of course, we have been warning about <a href="http://hcrenewal.blogspot.com/search/label/oligarchy">oligarchy</a>, and related issues such as <a href="http://hcrenewal.blogspot.com/search/label/concentration%20of%20power">concentration of power</a>, <a href="http://hcrenewal.blogspot.com/search/label/oligopoly">oligopoly</a>  in health care for a long time.  Basically, we have been warning that health care is increasingly run by a small group of insiders, mostly professional managers/ executives, and their cronies, who often have multiple overlapping leadership positions (e.g., as we <a href="http://hcrenewal.blogspot.com/2014/03/better-late-than-never-jama-article.html">discussed</a> recently, leadership of one health care organization while being member of the board of another), or may interchange positions through the <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving door</a>.  It appears that this pattern is merely part of a larger one involving US and even global society.<br /><br />While warnings about the growing threat of oligarchy or plutocracy have mainly come from people (including your loyal Health Care Renewal bloggers) who might be regarded as out of the mainstream, that is changing.<br /><br />We have a striking local example. <br /><br />David Carlin is a former Majority Leader of the Rhode Island Senate.  While he is a Democrat, he could hardly be called a flaming leftist.  He just published an <a href="http://www.providencejournal.com/opinion/commentary/20140401-david-carlin-is-it-oligarchy-in-democracy-out.ece">op-ed</a> in the Providence Journal which opened,<br /><br /><blockquote class="tr_bq">I am not a leftist. Far from it. Not only have I become a conservative in my old age, but I find myself growing more conservative every month.</blockquote><br />He then went on,<br /><br /><blockquote class="tr_bq"> Nonetheless, I think those on the left are correct about one thing, at least. They are right when they warn us that the United States, where the top 1 percent of people own about 40 percent of the nation’s wealth, has a <b><i>dangerous imbalance of wealth</i></b>.<br /><br />Please don’t misunderstand. I am far from agreeing with the leftist notion that the ideal society would be one in which wealth is equally distributed. This is absurd. Nonetheless, <i>this great inequality of wealth is dangerous for America. For it is making the United States <b>less and less a democracy</b> (a form of government in which the people rule) and <b>more and more an oligarchy</b> (a form of government in which a small number of very rich people rule).</i></blockquote><br />He did propose a specific remedy for the problem.  However, he did warn of the consequences in dire terms.<br /><br /><blockquote class="tr_bq">in the United States we have a special problem. For we are and always have been philosophically democratic. We believe that government is legitimate to the degree — and only to the degree — that it is chosen by the people. <i>When we conclude that in reality our government is controlled by the rich and super-rich, not the people, we will experience a <b>great legitimacy crisis</b>; our government will no longer feel legitimate to us, and thus it will not receive the deference that legitimate authority is entitled to. <b>Lawlessness and disorder will follow.</b></i></blockquote><br />That is pretty strong, and when people like Mr Carlin start making such strong warnings, things must be really bad.<br /><br />In my humble opinion, there are already plenty of reasons to have doubts about whether the ostensible authorities in health care are legitimate.  Just to mention some recent examples: we have discussed how the leaders of two major prestigious non-profit health care organizations (look <a href="http://hcrenewal.blogspot.com/2014/02/incoming-president-of-iom-outed-as.html">here</a> and <a href="http://hcrenewal.blogspot.com/2014/03/american-board-of-internal-medicine.html">here</a>) and one major medical school (look <a href="http://hcrenewal.blogspot.com/2014/03/turnabout-is-fair-play-why-university.html">here</a>) were revealed to simultaneously be responsible for the governance of for-profit health care organizations, some of which had clear track records of ethical misadventures which cast doubt on the abilities of these leaders to uphold their organizations' missions.  Two of the three leaders subsequently dropped their outside board memberships, but not their leadership positions, and their previous actions in those positions have not been revisited. <br /><br />In health care, if we do not re-establish leadership which is accountable for putting the health of patients and the public ahead of self-interest, the deluge will not be far behind.  

No Fooling - When a Retired Conservative Politician Warns About Oligarchy...

then things must be getting really bad.Of course, we have been warning about oligarchy, and related issues such as concentration of power, oligopoly  in health care for a long time.  Basically, we hav…

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Turnabout is Fair Play - Why University of Illinois Students, Faculty and Alumni Should Question the Dean of Medicine about Novartis' Ethical Misadventures

Since 2006, we have posted repeatedly about  what was then a new species of severe conflicts of interest.  This occurred when leaders of academic medical institutions or other health care non-profit organizations or non-governmental organizations (NGOs) also serve as members of <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20directors">boards of directors</a> of for-profit corporations  whose products and actions have major effects on health care.<br /><br />Most recently, we <a href="http://hcrenewal.blogspot.com/2014/03/american-board-of-internal-medicine.html">discussed </a>the cases of the current CEO of the National Quality Forum and past CEO of the American Board of Internal Medicine who was found to be on the board of for-profit hospital group purchasing organization Premier Inc, and had been on the board of its privately held but for-profit predecessors.  We also <a href="http://hcrenewal.blogspot.com/2014/02/incoming-president-of-iom-outed-as.html">discussed</a> the case of the incoming president of the US Institute of Medicine and former Chancellor of Health Affairs at Duke University who was on the boards of Alnylam Pharmaceuticals, Medtronic and Pepsico.<br /><br />We also recently <a href="http://hcrenewal.blogspot.com/2014/03/better-late-than-never-jama-article.html">posted</a> about the first time these sorts of severe conflicts of interest issue have been addressed in a large circulation medical journal.  A commentary in JAMA called for many such conflicts to be banned.<br /><br />The JAMA article, and much of the discussion surrounding the NQF and IOM cases focused on how loyalties to outside for-profit corporations could affect leaders of academic and other non-profit organizations.  However, we also noted (e.g., <a href="http://hcrenewal.blogspot.com/2014/02/the-carefusion-dr-denham-nqf-leapfrog.html">here</a> and <a href="http://hcrenewal.blogspot.com/2014/02/incoming-president-of-iom-outed-as.html">here</a>) how company directors should be accountable for the actions of their companies, even if they also happen to also be academic or non-profit leaders. <br /><br />Thus, academic and non-profit leaders may find themselves in the awkward position of being held accountable for unethical or even illegal actions of the companies on whose boards they sit.  Such corporate actions may contradict the mission of the institutions whose leadership is their primary job, and whose mission they are supposed to uphold.  <br /><br />While we were writing about these somewhat convoluted, but very important issues, a fellow blogger discovered yet another academic leader serving on the board of a health care corporation, while simultaneously the media reported multiple examples of that corporation's ethical misadventures on his watch.  Those who care about that academic institution ought to question whether a leader accountable for such misadventures is fit to continue to lead.  Yet so far, no one has publicly juxtaposed this leaders' responsibilities to his institution's mission and how the corporation over which he is supposed to exercise stewardship has been taking actions that contradict that mission<br /><br /><b>The Dean of the College of Medicine at the University of Illinois Is a Director of Novartis</b><br /><br />Paul Levy, blogging on Not Running a Hospital, <a href="http://runningahospital.blogspot.com/2014/01/time-to-fire-somebody.html">noted </a>a print advertisement for the Intuitive Surgical daVinci robot.  The advertisement implied endorsements by academic surgeons at the University of Illinois.  Levy suggested that surgical faculty acting as salespeople for a device company appeared to violate the university code of conduct.  This <a href="http://runningahospital.blogspot.com/2014/01/where-is-ui-board-of-trustees.html">concern was heightened</a> by the status of several of the surgeons in the advertisement as clinical and academic leaders.     <br /><br />Mr Levy then <a href="http://runningahospital.blogspot.com/2014/01/how-fish-rots.html">discovered</a> that the Dr Dimitri Azar, Dean of the University of Illinois College of Medicine, to whom these surgeon report, was on the board of Novartis, the multinational pharmaceutical and device company.  Dr Azar's position is easily verified by consulting the <a href="http://www.novartis.com/about-novartis/people/board-directors.shtml">Novartis web-site</a>.  Mr Levy further discussed the case <a href="http://runningahospital.blogspot.com/2014/02/how-much-should-dean-be-paid-who-should.html">here</a> and <a href="http://runningahospital.blogspot.com/2014/02/all-in-days-work-700000-450000.html">here</a>.  Then he  <a href="http://runningahospital.blogspot.com/2014/03/a-matter-of-public-trust.html">reviewed</a>  the extensive dealings between the University of Illinois and Novartis and its subsidiaries, raising suspicion that the Dean's known involvement with the company may have lead to its favorable treatment by the university.<br /><br />But wait, there is another major dimension to this problem.  <br /><br /><b>Novartis' Recent Ethical Misadventures</b><br /><br />Novartis, over which Dr Azar is supposed to be exerting stewardship, has made a series of ethical missteps according to recent media reports.  I will summarize them in chronological order according to the date of media publication.<br /><br /><u>Novartis, Roche Fined for Anti-Competitive and Deceptive Practices in Italy to Encourage Sales of Lucentis</u><br /><br />According to a March 5, 2014 <a href="http://www.nytimes.com/2014/03/06/business/international/italy-fines-novartis-and-roche-in-collusion-case.html">article</a> in the New York Times, Novartis was fined for anti-competitive and deceptive practices,  <br /><br /><blockquote class="tr_bq">Italian antitrust authorities said on Wednesday that they had fined two Swiss pharmaceutical companies, Novartis and Roche Holdings, a total of $250 million for <i>colluding to keep doctors from prescribing a relatively inexpensive eye treatment in favor of a more expensive drug.</i><br /><br /><div class="story-body-text story-content" data-para-count="436" data-total-count="723" itemprop="articleBody">The authorities said the two companies had sought to steer doctors away from Avastin, an anticancer drug developed by Genentech that has been used for years as an off-label treatment for common eye problems. Instead, they said, the companies had tried to 'channel demand toward the much more expensive drug Lucentis, through an artificial distinction between the two products,' essentially by <i>overstating the dangers of Avastin use.</i></div><div class="story-body-text story-content" data-para-count="235" data-total-count="958" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="235" data-total-count="958" itemprop="articleBody">It is not the first time such substitution efforts have brought an unwanted spotlight: Genentech got into trouble in the United States in 2010, when it was found to be offering doctors <a href="http://www.nytimes.com/2010/11/04/business/04eye.html?pagewanted=all" title="Previous coverage of the rebates.">secret rebates</a> to prescribe Lucentis over Avastin.</div><br />Novartis, which holds the rights to market the two drugs outside the United States, has been <i>fined 92 million euros by the Italian regulators. </i>And Roche, which acquired Genentech in 2009, was fined 90.5 million euros, for a total of about $250 million in the Italian case. </blockquote><br />Given that many drug companies have been cited for marketing their products for unapproved, or off-label uses, it is ironic that in this case, Novartis managers said they were shocked, shocked by the ruling because it could encourage off-label use:<br /><br /><blockquote class="tr_bq"> Novartis said in a statement that the Italian decision 'openly encourages and promotes the widespread unlicensed intravitreal use of Avastin contrary to the requirements of European and Italian regulatory law,' and 'undermines the European regulatory framework designed to protect patient safety.'</blockquote><br />The NY Times also reported that one method the two companies were alleged to use to encourage Lucentis rather than Avastin use was to launder their message through patient advocacy groups,<br /><br /><br /><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="230" data-total-count="4756" itemprop="articleBody">The Italian authorities discovered numerous messages between Roche and Novartis in which the two companies discussed what kinds of communications would be needed to induce doctors and hospitals to adopt the more expensive product.</div><div class="story-body-text story-content" data-para-count="230" data-total-count="4756" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="313" data-total-count="5069" itemprop="articleBody">According to one such message from early 2013, cited in documents in the case released Wednesday, growing cost pressure in Italy and France to use Avastin had 'reinforced the political dimension of the debate,' and 'further reinforcement of the Lucentis value proposition to all stakeholders is critical.'</div><div class="story-body-text story-content" data-para-count="239" data-total-count="5308" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="239" data-total-count="5308" itemprop="articleBody">Another message called for the companies to '<i>work with diabetes patient groups to increase voiced concerns about safety risks of unlicensed therapies' — a reference to Avastin</i> — for an eye condition known as diabetic macular edema.</div></blockquote><div class="story-body-text story-content" data-para-count="239" data-total-count="5308" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="239" data-total-count="5308" itemprop="articleBody"><u>Novartis Paid Doctors to Act as Marketers for Starlix and Other Drug</u></div><div class="story-body-text story-content" data-para-count="239" data-total-count="5308" itemprop="articleBody"><br /></div>After the New York state attorney general filed suit against Novartis, a March 15, 2014 Newsday <a href="http://www.newsday.com/news/health/novartis-gave-doctors-thousands-to-prescribe-pills-feds-allege-1.7404245">article</a> included interviews with physicians that suggested how the company turned them into disguised marketers:<br /><br /><blockquote class="tr_bq">Dr. Howard Brand says he had <i>one goal</i> when he gave a speech at a Miami hotel in the early 2000s -- <i>to tout the diabetes pill Starlix for the pharmaceutical company Novartis. </i><br /><br />The giant Swiss drugmaker, which reported $57.9 billion in global sales in 2013, paid the Stony Brook endocrinologist $1,500 for his talk at a doctors' meeting, Brand said in an interview. Novartis also paid for Brand's airfare and his weekend hotel stay, he said.<br /><br />'<i>It was self-serving</i>, but I also thought it was a benefit to patients,' said Brand,...</blockquote><br />Furthermore,<br /><br /><blockquote class="tr_bq"> Brand, the Miami speaker, said in an interview that investigators had not approached him about the payments he accepted.<br /><br />He said Novartis paid him a total of $10,000 to $12,000 for speeches, mostly at restaurant dinners it sponsored. The payments, which Brand said he received before 2010, are not reflected on the Novartis website.<br />'<br />Even [with] the notion that <i>we were paid solicitors</i>, I think people really paid attention,' he said. 'Of course, a lot of doctors just enjoyed going to dinner.'<br /><br />Brand said he accepted more than $60,000 in speaker's fees from drugmakers, including Novartis, in one two-year period. </blockquote><br /><br />Another physician allowed that Novartis furnished the material for his "educational" talks,<br /><br /><blockquote class="tr_bq">Dr. Howard Hertz, a Babylon internist, confirmed that he had received $4,000 from Novartis in 2010 and 2011 for talking about its hypertension drugs to colleagues. Hertz said he <i>dealt with a Novartis sales rep who brought information about the company's pills to his office. 'He would educate me about the product, give me slides to study,</i>' he said.<br /><br />Hertz said the <i>slides were on CDs and made him an expert</i> on Novartis drugs such as Diovan, a blood pressure pill, Lotrel and Valturna. He said he spoke mostly about Diovan and Lotrel.<br /><br />'We had dinners whereby I would speak about the products and speak to the colleagues,' Hertz said. 'I became somewhat of an expert in these products.'</blockquote><br />Note that Dr Hertz's expertise seemed to come exclusively from information provided by a company salesperson, making it obvious that he was not hired for his prior expertise as a physician.<br /><br />The prosecutors allege that Novartis' payments of some $65 million amounted to illegal kickbacks.  This is only an allegation.  However, it seems obvious that Novartis paid physicians to act as salespeople.  Newsday asked bioethicist Arthur Caplan about these actions,<br /><br /><blockquote class="tr_bq">'To even hear about it just takes my breath away,' Caplan said. 'It sounds like <i>egregious, inexcusable violations of agreed upon legal and ethical standards </i>. . . with an inexcusably complicit group of physicians,' Caplan said.</blockquote><br /><u>Japanese Hospital Investigation Alleged Novartis Manipulated Research</u><br /><br />A March 17, 2014 <a href="http://www.fiercepharma.com/story/tokyo-hospital-exec-says-novartis-employees-deeply-involved-leukemia-drug-t/2014-03-17">article</a> in FiercePharma stated that Japanese investigators found that Novartis had manipulated clinical research to make its results appear more favorable to the company's products,<br /><br /><blockquote class="tr_bq">Novartis employees were more involved in a Japanese drug study than previously suspected, a Tokyo hospital official said. In an investigative report released last week, the University of Tokyo Hospital said doctors not only let Novartis  employees collect patient data from various trial sites but also allowed the Swiss drugmaker into its records on all 255 trial participants, Japanese media reports.<br /><br />Plus, at least one Novartis employee was involved in planning the trial, designed to compare side effects of multiple leukemia treatments, the hospital found, according to Japan's <i>Mainichi</i> news. Those treatments included Tasigna<a href="http://www.fiercepharma.com/tags/tasigna"></a>, the company's follow-up to the hugely successful Gleevec (imatinib).<br /><br />In fact, according to<i> NHK World</i>, hospital director Takashi Kadowaki said Friday that Novartis employees were 'virtually managing the study.' </blockquote><br /><a href="http://mainichi.jp/english/english/newsselect/news/20140315p2a00m0na006000c.html">According to Mainichi</a>, this sort of clinical research manipulation is taken very seriously in Japan,<br /><br /><blockquote class="tr_bq"> Senior Ministry of Health, Labor and Welfare officials called the case <i>a serious situation and said the researchers involved showed a lack of ethics. </i>They called for a detailed investigative report from the hospital and are <i>considering punitive measures</i>. The ministry will consider a new law to prevent <i>corruption in clinical tests </i>in the wake of a scandal involving the clinical trial of antihypertensive drug Valsartan.</blockquote><br />It is obvious this story is not from the US, because the drug company has already apologized,<br /><br /><blockquote class="tr_bq"> A representative for Novartis Pharma's PR division said, '<i>We want to apologize to patients and doctors</i>. We must refrain from comment on the investigation, which is being handled outside our company.'</blockquote><br /><u>Indian Regulator Cancels Import License Alleging Fraud by Novartis to Market Veterinary Drug</u><br /><br />A March 18, 2014 <a href="http://www.business-standard.com/article/companies/novartis-might-face-legal-action-penalty-for-faking-documents-114031800760_1.html">article</a> in the New Delhi Business Standard told how Indian regulators accused Novartis of fraud, opening with,<br /><br /><blockquote class="tr_bq">Swiss drug maker Novaris is likely to face legal action for allegedly <i>faking documents to seek registration of its veterinary product Tiamulin Hydrogen Fumarate (80 per cent granules) in India</i>. The drug regulator, Drugs Controller General of India (DCGI)), has <i>already cancelled the company’s import licences as well as existing registration certificate for the product.</i></blockquote><br /><b>Summary</b><br /><br />So in just the last few weeks, evidence appeared that Novartis engaged in collusive anti-competitive and deceptive practices marketing drugs in Italy, paid physicians to act as marketers in the US, manipulated drug studies in Japan, and lost an import license in India due to alleged fraud.  By the way, in 2013, Novartis was fined for anti-competitive practices in its marketing of Fentanyl by the European Commission (look <a href="http://hcrenewal.blogspot.com/2013/12/the-camels-aching-back-johnson-and.html">here</a>), and in 2011 its Sandoz subsidiary settled allegations of misreporting prices in the US for $150 million (look <a href="http://hcrenewal.blogspot.com/2011/12/legal-settlements-have-become-so-common.html">here</a>)   Other Novartis misadventures from 2010 and earlier appear <a href="http://hcrenewal.blogspot.com/search/label/Novartis">here</a>.  So Novartis has quite an impressive, if not infamous record of ethical failures.<br /><br />While he is Dean of medicine at the University of Illinois, Dr Dimitri Azar is also a director of Novartis, and hence has a fiduciary duty for the company's stewarship.  While questioning Dr Azar's role in the participation of his faculty in advertising for Intuitive Surgical, perhaps those who care about the reputation of the University of Illinois and its ability to fulfill its mission ought to ask how the poor ethical track record of the company Dr Azar is supposed to be overseeing reflects on his ability to defend the mission of the university and the medical school.<br /><br />While parties that enable or enter into arrangements that create conflicts of interest in health care may be thinking mainly of the advantages that they may accrue, many of these arrangements create accountability and obligations, even if they are honored mainly in the breach.  If leaders of academic medicine and health care non-profit organizations insist on becoming directors, and hence stewards of for-profit health care corporations, they ought to be held accountable for the actions of these corporations, and how these actions reflect on their primary obligations to the academic and non-profit organizations they have also pledged to serve.<br /><br />True health care reform would make health care leaders accountable for putting patients' and the public's health ahead of their own self-interest. <br /><br />

Turnabout is Fair Play - Why University of Illinois Students, Faculty and Alumni Should Question the Dean of Medicine about Novartis' Ethical Misadventures

Since 2006, we have posted repeatedly about  what was then a new species of severe conflicts of interest.  This occurred when leaders of academic medical institutions or other health care non-profit o…

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Better Late than Never - JAMA Article Advocates Banning Academic Medical Leaders from Serving on Many Health Care Corporate Boards

Will wonders never cease? Eight years after we started posting about this issue, it has made it into a large circulation medical journal, albeit not completely<br /><br /><b>A JAMA Commentary Decries Leaders of Academic Medical Centers Serving on Boards of Organizations with Conflicting Priorities </b><br /><br />A recent JAMA commentary(1) noted the importance of conflicts of interest affecting top leaders of academic medicine, <br /><br /><blockquote class="tr_bq">Conflict of interest is particularly relevant for those in the upper echelons of academic health system leadership—presidents, vice presidents, provosts, deans, chief executive officers, and the senior administrators who report to them. </blockquote><br />(The article oddly omitted discussing conflicts of interest affecting the boards of trustees of such institutions, who are charged with their stewardship.)<br /><br />Anyway, the authors' rationale was that, <br /><br /><blockquote class="tr_bq">Unlike most faculty and staff, senior institutional officials are involved in financial and business decisions, including purchasing, resource allocation, and development of corporate partnerships, and have fiduciary responsibility to the entire institution. In addition, it is critical that the public, students, employees, and faculty maintain confidence in the integrity of institutional leaders. Leaders have a responsibility to set an example for others in their institution, especially for those training to be health care professionals.<br /><br />Independence and integrity of judgment are core precepts of professionalism. Every employee, faculty member, and student in an academic health system should feel confident that their leaders are making decisions based on the best interests of the institution and not driven by biases secondary to financial connections to outside corporate entities. </blockquote><br />So, <br /><br /><blockquote class="tr_bq">Having a fiduciary responsibility to 2 separate entities is at best a very difficult situation. Will the leader direct business inappropriately to the outside company on whose board he or she sits? Will the leader inappropriately use information about the institution he or she leads to influence decisions by the outside corporation? It is difficult to separate these types of activities and decisions. In addition, there are administrative costs associated with the management of this level of conflict, and such relationships might have a 'chilling effect' on other companies that could do business with the academic health system. Beyond service on fiduciary boards, undertaking any paid role (consulting, participation on advisory boards, etc) with an outside entity with interests that overlap those of the leader’s institution raises the same issues. </blockquote><br />The authors stressed that the most intense conflicts are generated by service on the boards of directors of "organizations with interests that overlap those of the academic health system."  Presumably they would have included among such organizations health care corporations that sell goods or services that might be used within academic medical centers, and/or be the subject of teaching or research by faculty at these centers, although the article did not make that explicit.<br /><br />The authors suggested such conflicts are not infrequent, noting a survey by Campbell et al of department chairs in academic medical institutions that showed a majority had some sort of relationships with industry, although they did not specify what these relationships were.  In fact, the Campbell article did report that 11% of department chairs admitted to being on the board of directors of companies that had activities that related to the chairs' academic or administrative responsibilities.(2) <br /><br />Finally, the authors called for banning most such conflicts<br /><br /><blockquote class="tr_bq"><span class="Paragraph 0" id="scm6MainContent_ucArticleContent_rptSections_lblSection_5">the fiduciary responsibilities of presidents, provosts, vice presidents, deans, chief executive officers, and those who report to them should <b><i>preclude a paid relationship with an outside entity in related and relevant areas,... </i></b></span> </blockquote><br />Note however that they did offer some loopholes.<br /><br /><blockquote class="tr_bq"><span class="Paragraph 0" id="scm6MainContent_ucArticleContent_rptSections_lblSection_5">unless a case can be made that there is a compelling institutional interest in the leader’s service in such a role, or if the role with the outside organization is outside the scope of the leader’s role at the academic health system.</span></blockquote><br />Despite the omissions and loopholes, this is a very significant article.  It is the first challenge to such severe conflicts of interest affecting academic medicine to appear as an article in a major medical journal, at least to my knowledge.  <br /><br /><b>You Heard It Here First</b><br /><br />However, on Health Care Renewal we have been attempting to challenge such conflicts for at least eight years. In 2006 we first <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">discussed</a> a newly discovered species of conflict of interest in health care, in which leaders of medical or health care organizations were simultaneously serving on boards of directors of health care corporations.<br /><br />We posited these conflicts would be particularly important because being on the board of directors entails not just a financial incentive.  It ostensibly requires board members to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. <a href="http://www.amazon.com/Corporate-Governance-Robert-G-Monks/dp/1405116986"><i>Corporate Governance</i></a>, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]  Of course, after the global financial collapse of 2008 made us sadder and a little wiser, we realized that many board members actually seem to have unyielding loyalty to their cronies among top management.  However, in any case, the stated or actual interests of a member of the board of a health care corporation, like a pharmaceutical company or medical device company, could be very different and at odds with the mission of an academic medical institution or a non-profit ostensibly dedicated to improving health care quality.<br /><br /><b>Vivid Cases Would Strengthen the Argument</b><br /><br />It is odd that the JAMA article included very little evidence about the occurrence of such conflicts of interest.  It really is not hard to find.  Since 2006, we have discussed numerous cases of such conflicts of interest.<br /><br />The case that first attracted <a href="http://hcrenewal.blogspot.com/2006/01/california-nightmares-more-troubles-at.html">our attention</a> was that of Marye Anne Fox, the then Chancellor of the University of California - San Diego, a major campus of the state university that includes a medical school.  January, 2006 media reports noted that Chancellor Fox was simultaneously servingon 10 corporate boards, including those of two health care corporations, Boston Scientific, a medical device company, and Pharmaceutical Product Development Inc (PPDI), a for-profit contract research organization.  At the time, I wrote,<br /><br /><blockquote class="tr_bq">having ultimate leadership responsibilities for a medical school and medical center, while also having ultimate fiduciary responsibilities for the management of a medical device company and a contract medical research company amounts to the biggest conflicts of interest I have ever seen.   </blockquote><br />Nonetheless, beyond local media, the case got little attention at the time.  What attention it did get focused on the magnitude of Chancellor Fox's commitments to outside organizations, not the conflicts they apparently caused (look <a href="http://hcrenewal.blogspot.com/2006/02/academic-medical-leaders-as-corporate.html">here</a>).  Chancellor Fox apparently retired from the PPDI board in 2008 (look <a href="http://www.grace.com/about/leadership/BoardOfDirectors.aspx">here</a>) but did not retire from the Boston Scientific Board until 2011 (look <a href="http://www.massdevice.com/news/boston-scientific-co-founder-john-abele-leave-board">here</a>).  <br /><br />Since then, we found many more striking cases.<br />-  A month later, there was the <a href="http://hcrenewal.blogspot.com/2006/02/tale-of-three-ironies-university-of.html">case</a> of the president of the University of Miami, a board member of for-profit health insurance company UnitedHealth, whose lowest paid employees were on strike to protest their lack of health insurance, among other issues.<br />-  It turned out the UnitedHealth board in particular seemed to be a refuge for multiple academic leaders, at least one of whom seemed partly responsible for allowing the then UnitedHealth CEO to collect many backdated stock options (look <a href="http://hcrenewal.blogspot.com/2006/08/more-entangled-web-unitedhealth-case.html">here</a>)..<br />-  Then there was the 2008 case of the conflict of interest involving an anti-health company.  After Virginia Commonwealth University was criticized for taking money from giant tobacco company Philip Morris for medical research, it turned out that the then president of the university, Eugene Trani, was on the board of another tobacco company, Universal Corp (see post <a href="http://hcrenewal.blogspot.com/2008/05/worse-variant-of-new-species-of.html">here</a>).<br />-  Then, in 2009, some attributed the problems at George Washington University's medical school that caused it to be put on probation to the conflict of interest of its provost and vice president for health affairs, John F Williams, who also sat on the board of Universal Health Services, which owned the university hospital (look <a href="http://hcrenewal.blogspot.com/2009/02/conflicts-of-interest-and-george.html">here</a>).<br /> We posted about a number of other colorful cases since then (look <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20directors">here</a>)<br /><br /><br />Although this evidence is admittedly case based and therefore anecdotal, it could be used to highlight the importance of the problem and develop support for its solution. <br /><br /><b>A Welcome Addition to Previous Recommendations about Countering Conflicts of Interest</b><br /><br />For whatever reason, this issue somehow seemed to escape the attention of many of those who have written about conflicts of interest in health care.  Even those who advocated taking a harder line on conflicts of interest have generally avoided this issue.<br /><br />Brennan et al made recommendations about reducing conflicts of interest in 2006, but focused on students and faculty, not top leaders and executives (see post <a href="http://hcrenewal.blogspot.com/2006/02/academic-medical-leaders-as-corporate.html">here</a>).(3)  The 2009 <a href="http://www.iom.edu/Activities/Workforce/ConflictOfInterest.aspx">Institute of Medicine report</a> set relatively tough standards for managing conflicts of interest affecting clinical research and teaching, which unfortunately since have largely been ignored.  It did call for senior institutional officials to disclose their conflicts of interest, and for institutional boards of trustees to form conflicts of interest committees that would exclude conflicted individuals, but otherwise did not address conflicts of interest affecting academic leaders or institutional trustees.  The 2013 <a href="http://www.pewhealth.org/reports-analysis/reports/conflicts-of-interest-policies-for-academic-medical-centers-85899514090">Pew Charitable Trusts Conflicts-of-Interest Policies for Academic Medical Centers </a>suggested restrictions on conflicts affecting faculty, trainees, and students, but again did not mention senior institutional leaders or boards of trustees.<br /><br /><b>Conclusion </b><br /><br />So it is very nice to see that the issue of what we once called a new species of conflict of interest finally has made the big time.  Whether it now gets any traction remains to be seen.  Unfortunately, since conflicts of interest can be so profitable for the directly affected parties, I fully expect they will continue to oppose any restrictions.  The money they have made will likely be used to deploy marketing and public relations personnel and legal counsel to counter any attempts to try to make this aspect of health care more honest.<br /><br />As we have said again and again, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain. Health care professionals who care for patients, those who teach about medicine and health care, clinical researchers, and those who make medical and health care policy should do so free from conflicts of interest that might inhibit their abilities to put patients and the public's health first.  <br /><br /><br /><b>References</b><br /><br />1. Pisano ED, Golden RN,Schweitzer L. Conflict of interest policies for academic health system leaders who work with outside corporations.  JAMA 2014<span id="scm6MainContent_lblClientName">;311(11):1111-1112. doi:10.1001/jama.2014.788</span>  Link <a href="https://jama.jamanetwork.com/article.aspx?articleid=1841978">here</a>.<br /><br />2.  Campbell EG, Weissman JS, Ehringhaus S et al.  Institutional academic-industry relationships.  JAMA <span id="scm6MainContent_lblClientName">2007;298(15):1779-1786. doi:10.1001/jama.298.15.1779.  Link <a href="http://jama.jamanetwork.com/article.aspx?articleid=209192">here</a>.</span><br /><span id="scm6MainContent_lblClientName"></span><span id="scm6MainContent_lblClientName">3,  Brennan TA, Rothman DJ, Blank L et al.  Health industry practices that create conflicts of interest.  a policy proposal for academic medical centers.  JAMA  </span><span id="scm6MainContent_lblClientName">2006;295(4):429-433. doi:10.1001/jama.295.4.429  Link <a href="http://jama.jamanetwork.com/article.aspx?articleid=202261">here</a>.</span>

Better Late than Never - JAMA Article Advocates Banning Academic Medical Leaders from Serving on Many Health Care Corporate Boards

Will wonders never cease? Eight years after we started posting about this issue, it has made it into a large circulation medical journal, albeit not completelyA JAMA Commentary Decries Leaders of Acad…

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American Board of Internal Medicine Policy Condones Keeping Conflicts of Interest Secret

The latest complication of the CareFusion/ Dr Denham/ NQF/ Dr Cassel/ ABIM case was the revelation that the current president of the NQF, Dr Christine Cassel, after resigning her position on the board of directors of for-profit publicly held group purchasing organization Premier Inc, was found to have been on the board of for-profit privately held predecessor of Premier Inc since 2008 (see post<a href="http://hcrenewal.blogspot.com/2014/03/the-plot-of-carefusion-dr-denham-nqf.html"> here</a>).  Before Dr Cassel was CEO of NQF, she had been the president and CEO of the American Board of Internal Medicine for 10 years.  So apparently she was on the board of the predecessor of Premier Inc for about five years while she was leading the ABIM.<br /><br />This relationship appears to be as serious a conflict of interest for Dr Cassel in her previous role as leader of the ABIM as it was for her current role as leader of the NQF.  Since she had this conflict for so long as leader of the ABIM without public disclosure, it seems logical to ask whether she was a long-term violator of ABIM policy, and hence sort of a long-term rogue CEO?<br /><br />To answer that, one needs to review the ABIM <a href="https://www.abim.org/conflict-of-interest-policies.aspx">conflict of interest policy</a>.<br /><br /><b>What Sort of Conflicts of Interest Does the ABIM Ban?</b><br /><br />The official wording is: <br /><br /><blockquote class="tr_bq">It is the policy of the Board that Directors, Subspecialty Board and Committee members, consultants and other individuals involved in developing ABIM products will not be<i> employed (as staff or as a consultant) at greater than fifty percent by a commercial entity</i>, except in such instances where explicit exceptions to the policy have been made by the Board. Unless a compelling reason is presented for granting an exception, such individuals will be asked to resign their position of service to the Board.</blockquote><br />Let us parse that a bit.  The policy applies to the leadership of the ABIM, Directors, Subspecialty Board and Committee members, consultants, and individuals involved in developing products, so it applies broadly.<br /><br />However, conflicts are only banned when they exceed a 50% time commitment.  But the time commitments required by many sorts of relationships among physicians and health care corporations are ill-defined.  For example, in the initial public offering <a href="http://investors.premierinc.com/common/download/download.cfm?companyid=AMDA-24J90L&fileid=694238&filekey=8152d7d0-9413-4cdb-920c-e10edc2d3c05&filename=Premier_IPO_Prospectus.pdf">prospectus</a> for Premier Inc, the public document that announced her membership on the new public company's board, there is no information about the time commitment required by this position.<br /><br />Also, physicians can earn large amounts of money for relatively small investments of time.  For example, not only can members of boards of directors make hundreds of thousands of dollars for ill defined time commitments unlikely to approach 10% full time equivalent, but also, <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders</a> acting as primarily marketing consultants can also earn hundreds of thousands of dollars for undocumented time commitments, and physicians can earn hundreds of thousands or millions of dollars from royalty payments from patent holdings that require no current work (look<a href="http://hcrenewal.blogspot.com/2007/11/orthopedic-device-makers-reveal.html"> here</a> for example).  So a physician could easily earn hundreds of thousands or millions of dollars from health care corporations without approaching a nominal 50% time commitment.  I suspect that this ban would apply to almost no one other than a full-time corporate employee. <br /><br /><br />Furthermore, the policy is not absolute.  Exceptions can be made for "compelling reasons," which are not further defined.  <br /><br />This is thus a very weak element of the policy  <br /><br /><b>How are Conflicts of Interest that are Not Banned Managed?</b><br /><br />The policy states,<br /><br /><blockquote class="tr_bq">Given that prohibition of all financial interest in commercial entities would excessively restrict the pool of eligible candidates for Board membership, the Board's policy to regulate conflicts of interest consists of disclosure, self-monitored (and Chair-overseen) abstention from participation in decision-making that relates to the conflict, and adjudication of potential conflicts of interest situations by the Conflict of Interest Committee of the Board of Directors.<br /><br />Individuals (non-staff) involved in developing ABIM policy and products — ABIM Directors, Subspecialty Board Directors and Committee members, consultants, the President and relevant staff members will be requested at the time of their appointment and annually thereafter to execute a disclosure.</blockquote><br />I would note that the rationale is highly questionable.  One often hears from apologists for conflicts of interest that all competent doctors are conflicted because health care corporations identify all the most expert doctors and hire them as speakers, consultants, etc (look <a href="http://hcrenewal.blogspot.com/2009/09/latest-version-of-argument-that-we-are.html">here</a> for example).  We have shown examples on this blog of some less than stellar individuals with extensive financial involvements with health care corporations.  For example, we have posted (<a href="http://hcrenewal.blogspot.com/2007/06/which-physicians-pharmaceutical.html">here</a>, <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2011/01/im-not-here-to-sell-drugs-then-why-use.html">here</a>) about physicians dubbed key opinion leaders by pharmaceutical companies who lacked board certification, had been subject to sanctions by state medical boards, had received warnings from the FDA, had lost hospital privileges, and had been convicted of crimes. On the other hand, there probably are quite a few smart, dedicated, expert physicians who eschew major financial involvement with health care corporations. <br /><br />The policy goes on to state that for some individuals, the management would be recusal from participation in relevant decisions,<br /><br /><blockquote class="tr_bq"> Test Committees and other policy committees will be expected to discuss the conflict of interest policy, and to share relevant disclosures, with the expectation that committee members will disclose any significant actual or perceived conflicts and abstain from discussion where such conflicts exist. In the event that a potential conflict of interest situation arises about which explicit policy does not exist, the Conflict of Interest Committee of the Board will hear and judge the appeal.</blockquote><br />Note that recusal may be inadequate management.  Committees tend to learn to get along with each other.  The views of committee members who have to recuse themselves may be well known, and may be supported by their fellow members even when their recused colleagues are not in the room.<br /><br />Worse, the policy says nothing about whether higher level ABIM leaders even need to recuse themselves.  The recusal policy apparently only applies to committee members.  There seems to be no policy about management of conflict affecting<br /><br />So the management of conflicts of interest proposed by the ABIM document seems to be rather minimalist.<br /><br /><br /><b>Who Makes Decisions about ABIM Conflicts of Interest?</b><br /><br />The policy states that disclosures will be made to,<br /><ul><li><blockquote class="tr_bq">President and Chair of the Board;</blockquote></li></ul><blockquote></blockquote><ul><li><blockquote>The chairs of the relevant Subspecialty Boards, Test-Writing Committees, and other Committees of the Board, members who serve on the relevant Boards and Committees, and staff working with the respective committees;</blockquote></li></ul><blockquote></blockquote><ul><li><blockquote>The Conflict of Interest Committee members and Conflict of Interest Committee staff,</blockquote></li></ul>As noted above,<br /><br /><blockquote class="tr_bq">adjudication of potential conflicts of interest situations[would be] by the Conflict of Interest Committee of the Board of Directors.</blockquote><br />However, again it is not clear whether they can adjudicate conflicts affecting anyone other than test and policy committee members.  Furthermore, whether anyone oversees conflicts affecting members of the Board of Directors is not clear.<br /><br />Thus it is not clear who, if anyone, manages conflicts of interest affecting the top ABIM leaders, particularly the CEO and members of the board of trustees.  This aspect of the policy seems ambiguous. <br /><br /><b>How are Conflicts of Interest Publicly Disclosed?</b><br /><br />The short answer is<i> they are not.</i>  The relevant wording is:<br /><br /><blockquote class="tr_bq">Information that is disclosed will be<b><i> kept confidential</i></b> except to the <br /><ul><li>President and Chair of the Board;</li><li>The chairs of the relevant Subspecialty Boards, Test-Writing Committees, and other Committees of the Board, members who serve on the relevant Boards and Committees, and staff working with the respective committees;</li><li>The Conflict of Interest Committee members and Conflict of Interest Committee staff,</li></ul>except as required for the purposes of continuing medical education.</blockquote><br />Let me reiterate, conflicts of interest are NOT PUBLICLY DISCLOSED.  They are kept confidential, secret, hidden, opaque.  Only the insiders listed above may know about them.<br /><br />We have been discussing the prevalence and severity of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest </a>affecting health care professionals and policy-makers, and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional conflicts of interest </a>affecting health care organizations for years.  Based on the principle that sunlight is the best disinfectant, many now agree that disclosure of these conflicts of interest is a necessity, although there is considerable discussion about whether the current movement to make conflicts of interest public will reduce their effects.  However, in my humble opinion, concealing conflicts of interest is inherently dishonest.   Yet that is the policy of the American Board of Internal Medicine. <br /><br /><b>Summary</b><br /><br />So, while it appears that the former president and CEO of the ABIM had a severe conflict of interest generated by her membership on the board of directors of a privately held for-profit group purchasing organization, her failure to disclose it publicly did not violate ABIM policy.<br /><br />The reason is that the ABIM policy on conflicts of interest appears to be extremely weak and ambiguous.  Worse, it condones keeping conflicts of interest secret, which to me appears inherently dishonest and unethical.<br /><br />This is very disturbing given that the ABIM has great influence on medical practice and health policy, previously was regarded as prestigious and trustworthy, and has been expanding the scope of its activities to make it even more influential, e.g., by now requiring physicians to participate in periodic ABIM sanctioned or sponsored activities and take repeated ABIM exams to "maintain" their board certification.<br /><br />In my humble opinion, if the ABIM wants to continue to be trusted as it has been in the past, it needs a wholesale revision of its conflict of interest policies, and meanwhile needs to completely make public in detail the conflicts of interest affecting individuals who lead it, make its policy, write its examinations, construct its educational and maintenance of certification activities, and produce its other "products."  The ABIM ought to consider suspending attempst to expand its influence, e.g., by intensifying its requirements for maintenance of certification, until it has disclosed all relevant conflicts and improved its conflict of interest policies.<br /><br />As we have said again and again, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain.  <br /><br />

American Board of Internal Medicine Policy Condones Keeping Conflicts of Interest Secret

The latest complication of the CareFusion/ Dr Denham/ NQF/ Dr Cassel/ ABIM case was the revelation that the current president of the NQF, Dr Christine Cassel, after resigning her position on the board…

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