healthy4u: conflicts of interest

Health Care Corruption, "No Dirty Little Secret," but "An Open Sore" - Lessons from India for the US

<a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">Health care corruption</a> is widely prevalent around the globe, but remains the great unmentionable. Introduction: Global Health Care Corruption We have discussed health care corruption whenever we have an opportunity, but rarely does the topic appear in the English language media or in English language medical and health care journals, particularly in the US.  Some might think that this is because health care corruption is not so prevalent in the US and other "developed" countries.  However, our <a href="http://hcrenewal.blogspot.com/2013/07/43-believe-that-us-health-care-corrupt.html">most read post of all time</a> was about a Transparency International global survey that found that fully 43% of Americans believe our health care is corrupt.  A recent editorial in the BMJ(1) opened thus, <blockquote class="tr_bq">Healthcare is a high risk sector for corruption. Best estimates are that between 10% and 25% of global spend on public procurement of health is lost through corruption. This is big bucks. Total global spend on healthcare is more than $7 trillion each year. Corruption takes many forms, depending on the country’s level of development and health financing system. The United States, for example, lost between $82bn and $272bn in 2011 to medical embezzlement, mostly related to its health insurance system. No country is exempt from corruption. Patients everywhere are harmed when money is diverted to doctors’ pockets and away from priority services. Yet this complex challenge is one that medical professionals have failed to deal with, either by choosing to enrich themselves, turning a blind eye, or considering it too difficult. Transparency International, a watchdog on these matters, defines corruption as the abuse of entrusted power for private gain, which in healthcare encompasses bribery of regulators and medical professionals, manipulation of information on drug trials, diversion of medicines and supplies, corruption in procurement, and overbilling of insurance companies. This is no dirty little secret. It is one of the biggest open sores in medicine.</blockquote> When health care corruption is actually discussed in polite circles, including the scholarly literature about medicine and health care, the discussion usually refers to corruption elsewhere.  In particular, in developed countries, discussion of health care corruption usually focuses on less developed countries. Thus, maybe it should not be a surprise that the editorial by Jain et al accompanied another BMJ article about health care corruption in India. Yet by reading between their lines, both articles have global application, and are just as relevant to those nations in which the powers that be seem to have smugly concluded that health care corruption is only a problem in benighted third world countries. A Personal View on Health Care Corruption in India David Berger a UK trained general practitioner (GP), discussed the corruption he found while volunteering in India.(2)  His introduction was, <blockquote class="tr_bq">'The corruption strangles everything, Sir. It’s like a cancer.' Accompanied by apologetic shrugs and half smiles, statements like this are commonly heard in India. I knew this was the case before I went to work as a volunteer physician in a small charitable hospital in the Himalayas, but what I didn’t realise was how far the corruption permeates the world of medicine and the corrosive effect it has on the doctor-patient relationship.</blockquote> Berger raised several issues: Neoliberalism and Privitization <blockquote class="tr_bq">The healthcare system itself is a model of inequity; it is one of the most privatised in the world, with out of pocket expenditure on healthcare at more than 70%, far higher even than in the United States. This phenomenon is at least partly the result of the neoliberal World Bank policies of the 1990s, which mandated a reduction in public financing of healthcare, fuelling growth of the private sector. The latest in technological medicine is available to people who can pay, albeit at a high price,...</blockquote> Kickbacks to Physicians for Referrals This is a common form of corruption in India. <blockquote class="tr_bq">all investigations attract a 10-15% kickback to the referring doctor. One day, the marketing executive for this clinic had turned up at the hospital with an envelope full of cash—the commission for investigations ordered in the past few months. The senior doctor refused it and stipulated that in future the commission was to be paid back to patients, which is why the resident had to sign the form. The country’s doctors and medical institutions live in an 'unvirtuous circle' of referral and kickback that poisons their integrity and destroys any chance of a trusting relationship with their patients.</blockquote> Kickbacks from Pharmaceutical Firms <blockquote class="tr_bq">There is also widespread corruption in the pharmaceutical industry, with doctors bribed to prescribe particular drugs. Tales are common of hospital directors being given top of the range cars and other inducements when their hospitals sign contracts to prescribe particular antibiotics preferentially. I met a former pharmaceutical sales executive who left the industry, sickened by the corrupt practices he was supposed to employ. Working for one of the largest drug companies in the country, he was expected to bribe doctors with money and luxury goods. The crunch came when a doctor demanded that the company fly him to Thailand for a holiday and then provide him with prostitutes at his home. When the company representative queried this, his manager told him to comply, and he felt he had no choice but to resign, protesting that he was 'not a pimp.'</blockquote> Huge Fees Charged to Medical Students <blockquote class="tr_bq">Endemic corruption extends to medical studies themselves. In another 'unvirtuous circle,' students can have to pay very large “donations” (perhaps $200 000 or more, some 20 times the average doctor’s annual salary) to get into the rapidly increasing number of private medical colleges and to get on to sought after postgraduate training schemes. This means that doctors can have high levels of debt or family obligation when qualifying, which is a strong incentive against working as generalists in rural areas and favours them practising technological medicine for maximum profit in urban areas to try to recoup their investment.</blockquote> The US Parallels All the issues above have clear parallels in the US.  But in the US, hardly anyone talks about health care corruption as a local or national problem.    Neoliberalism and Privitization The US is known for its increasingly private health care system, pushed by the ideology of "neoliberalism" or "<a href="http://hcrenewal.blogspot.com/search/label/economism">economism</a>."  US health insurance is mostly provided by private, for-profit corporations, not non-profits, or government agencies.  US hospitals and hospital systems are increasingly private, as are other organizations that provide direct health care, e.g., <a href="http://hcrenewal.blogspot.com/search/label/hospices">hospices</a>.  US physicians are increasingly <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">corporate employees</a>.  India may be more privatized, but the US is close behind.  Kickbacks to Physicians for Referrals We have frequently posted about cases in which there was good evidence that physicians in the US got <a href="http://hcrenewal.blogspot.com/search/label/kickbacks">kickbacks</a>, or bribes.  Most involved legal settlements of cases in which there were allegations of widespread kickbacks.  Some of them involved kickbacks for referrals (e.g., the settlement involving Omnicare in 2013, look <a href="http://hcrenewal.blogspot.com/2013/10/there-they-go-again-omnicare-to-settle.html">here</a>).  On the other hand, resolution of cases involving kickbacks to small groups of physicians for referrals are so common in the US that we rarely discuss individual examples. For example, I found the following headlines from the last few weeks: <blockquote class="tr_bq"><a href="http://6abc.com/news/nj-arrests-more-than-12-in-alleged-kickback-scheme/134025/">NJ Arrests More than 12 in Alleged Kickback Scheme</a> <a href="http://www.nj.com/morris/index.ssf/2014/06/randolph_doctor_jailed_for_20_months_for_role_in_massive_kickbacks_scheme.html">Randolph Doctor Jailed for 20 Months for Role in Massive Kickback Scheme</a> <a href="http://www.ocregister.com/articles/ahmed-626942-indictment-million.html">O.C. Grand Jury Indicts 15 Doctors  </a>  </blockquote> We have also written extensively about how <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">corporate physicians</a> are pushed to avoid "leakage," that is referral of patients to health care facilities not owned by their corporate employees (e.g., look <a href="http://hcrenewal.blogspot.com/2011/02/new-steward-health-care-will-superbowl.html">here</a>).  Kickbacks from Pharmaceutical Firms We have posted about numerous examples of widespread <a href="http://hcrenewal.blogspot.com/search/label/kickbacks">kickbacks</a> given by health care corporations, particularly pharmaceutical, biotechnology, and medical device companies, to physicians to enhance their prescriptions for or use of their products.  Most recent examples include legal settlements by Pfizer about kickbacks to promote use of Neurontin (one of many by that company, look <a href="http://hcrenewal.blogspot.com/2014/06/justice-delayed-is-justice-denied.html">here</a>); by Medtronic to promote use of its pacemakers and defibrillators (look <a href="http://hcrenewal.blogspot.com/2014/06/fool-me-twice-boehringer-ingelheim.html">here</a>); and by Johnson and Johnson to promote use of Risperdal (look <a href="http://hcrenewal.blogspot.com/2013/11/another-and-huge-22-billion-settlement.html">here</a>).  Moreover, we have discussed many examples of physicians paid as "consultants" or given "honoraria" for talks by companies whose goal was to use these physicians as "<a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders</a>," actually covert marketers for their drugs or devices.  Many of the <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest </a>we have discussed actually seemed to involve kickbacks or bribes, even though some physicians and policy-makers like to refer to them as "collaborations" with industry to increase "innovation."  Huge Fees Charged to Medical Students The huge tuition charged US medical students, their huge resulting debt, and their resulting tendency to pursue procedural specialties rather than cognitive specialties, particularly primary care, have become cliches. So it seems that the US has some of the same possible risk factors for corruption as does India, that there are many cases in the US of activities that are called corruption in India, and that a near majority of US citizens feel their health care is corrupt.  But health care corruption remains a largely taboo topic in the US.  Summary: Some General Approaches The editorial by Jain et al that to its authors' credit emphasized that health care corruption is a global problem suggested some general approaches to corruption(2) <blockquote class="tr_bq">Good governance, transparency, and zero tolerance must form the basis of any anti-corruption strategy. Changes must be implemented in society at large for reform to be sustained. Better governance requires rigorous legislation and functioning administrative mechanisms to provide fiscal oversight. Ethical standards of conduct must be explicitly established and staff held accountable for their performance. Punitive measures should be available to serve as a deterrent. Honest behaviour must be rewarded. These policies may be ineffective, however, unless healthcare professionals are assured of a decent salary and fair opportunities for professional growth</blockquote> Also <blockquote class="tr_bq">Simple and effective channels for complaints must be established, and appropriate legal support and protection provided to whistleblowers. Looking deeper, underlying issues such as education and social justice must not be forgotten if the battle against corruption is to be sustained and eventually won. Answers may also lie outside the world of medicine. </blockquote> Note that we have discussed all these approaches: <a href="http://hcrenewal.blogspot.com/search/label/accountability">accountability</a>, <a href="http://hcrenewal.blogspot.com/search/label/transparency">transparency</a>, <a href="http://hcrenewal.blogspot.com/search/label/governance">governance</a>, <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20trustees">boards of trustees</a>, <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20directors">boards of directors</a>, <a href="http://hcrenewal.blogspot.com/search/label/ethics%2F%20integrity%20policies">ethics and integrity policies</a> , <a href="http://hcrenewal.blogspot.com/search/label/impunity">impunity</a>, <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a>, and education about corruption (look <a href="http://hcrenewal.blogspot.com/2010/12/lancet-emphasizes-threats-to-academic.html">here</a>).  Not that any of them have been widely adopted. So to repeat an ending to <a href="http://hcrenewal.blogspot.com/2013/07/43-believe-that-us-health-care-corrupt.html">one of my previous posts</a> on health care corruption....  if we really want to reform health care, in the little time we may have before our health care bubble bursts, we will need to take strong action against health care corruption.  Such action will really disturb the insiders within large health care organizations who have gotten rich from their organizations' misbehavior, and thus taking such action will require some courage. References 1.  Jain A, Nundy S, Abbasi K. Corruption: medicine's dirty open secret.  Brit Med J 2014.  Link <a href="http://www.bmj.com/content/348/bmj.g4184">here</a>.  2.  Berger D. Corruption ruins the doctor-patient relationship in India.  Brit Med J 2014.  Link <a href="http://www.bmj.com/content/348/bmj.g3169">here</a>.

Health Care Corruption, "No Dirty Little Secret," but "An Open Sore" - Lessons from India for the US

Health care corruption is widely prevalent around the globe, but remains the great unmentionable.Introduction: Global Health Care Corruption We have discussed health care corruption whenever we have a…

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01 Jul 2014

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) Two Somewhat Redundant Lancet Articles 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) <blockquote class="tr_bq">After returning from Uganda, Desmond-Hellmann joined the nascent Taxol development programme at Bristol-Myers Squibb, 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 pipeline went stratospheric, and took Desmond-Hellmann with it. By 2009 she had been promoted to President of Product Development, having overseen the introduction of two of the first gene-targeted therapies for cancer, bevacizumab and trastuzumab.</blockquote> After Genentech was bought out by Roche, Dr Desmond-Hellmann became Chancellor of the University of California, San Francisco, <blockquote class="tr_bq">Over the next 5 years, Desmond-Hellmann instituted wide-ranging reforms 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 'specifically avoided being on pharma and biotech boards'.</blockquote> The article suggested we should expect nothing but great things from Dr Desmond-Hellmann at the Gates Foundation, <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> The second article used remarkably similar wording(2), e.g., regarding her career in the pharmaceutical business, <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 part of pharmaceutical folklore, as Desmond-Hellmann helped to mastermind one of the most profitable drug-development pipelines in history, including the approval of two of the first targeted cancer therapies, for Genentech.</blockquote> Also, regarding her career at UCSF,(2) <blockquote class="tr_bq"> Desmond-Hellmann from embarking on a programme of structural reforms to cut administrative inefficiency and forge closer links with private industry, something that still stirs up controversy. 'There definitely were concerns, and there remain concerns in academia, about conflicts of interest, privatisation. 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 importance of public—private partnerships for driving innovations that ultimately benefit society.</blockquote> Finally, regarding expectations for her performance in the future, <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, she seems to be made for it.</blockquote> 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, -  Dr Desmond-Hellmann had a brilliant career in the pharmaceutical/ biotechnology business, and was responsible for the development of several important cancer drugs -  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  -  Dr Desmond-Hellmann is likely to be very successful as Gates Foundation CEO. What the Articles Did Not Say 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, Defending $55,000/ Year Bevacizumab 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) <blockquote class="tr_bq">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, at AACR. Hellmann and others argue that with these drugs’ potential to alleviate the huge societal burden of cancer, biologics are worth the cost. 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. 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, said Genentech spokesperson Edward Lang. 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. 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.</blockquote> 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 total compensation was $8,361,348 in 2007 and $7,820,142 in 2006. In 2007, her total compensation was equal to 0.3% of the firm's total net income. 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. 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.  Investments in Tobacco Stocks 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 kind of shocking, but at least she got rid of it,...” 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: <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> The Lancet articles were silent on this issue.   Questions Whether Industry Partnerships Threaten the University Mission 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. Dismissing Concerns about Conflicts of Interest 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 "start a company or work with a company to commercialize a product."  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. Minimizing Concerns about Conflicts of Interest due to Membership on the Board of Corporations with Health Care Agendas 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.  Privatizing UCSF 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.)     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 <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>. The autonomy coming from the separation, Desmond-Hellmann argued at the time, 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> However, the same article noted that the current University of California President, <blockquote class="tr_bq">dismissed as 'loose talk' a more than two-year-old plan for UCSF to weaken its ties to the larger UC system. '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.   Summary 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. 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, <blockquote class="tr_bq">Our foundation is teaming up with partners around the world to take on some tough challenges: extreme poverty and poor health in developing countries, and the failures of America’s education system.</blockquote> 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. 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. 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.  References 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>. 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>. 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>. 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)

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05 May 2014

American Board of Internal Medicine Quietly Discloses Some Conflicts of Interest

We recently <a href="http://hcrenewal.blogspot.com/2014/03/american-board-of-internal-medicine.html">discussed</a> the American Board of Internal Medicine's exceedingly weak conflict of interest policy.  This came to light after the board's previous president was revealed to have simultaneously served for years on the board of directors of a privately held for-profit hospital purchasing organization. The susceptibility of ABIM leadership to conflicts of interest is particularly important because the board, in its role as the de facto sole source of credentialing for all US internists and internal medicine sub-specialists, sets what these physicians need to know to pass the certifying examinations. Conflicts of interest raise doubts about whether the examinations may be used to further commercial agendas and similar vested interests. Furthermore, the ABIM has been willfully expanding its scope into "maintenance of certification," that is, into requiring physicians to engage in ABIM educational and evaluation activities to maintain their previously obtained certification.  They have been criticized in particular (e.g., <a href="http://www.medscape.com/viewarticle/822914">here</a> and <a href="http://drwes.blogspot.com/2014/03/is-maintenance-of-certification-our.html">here</a>) for pursuing maintenance of certification in the absence of clear evidence that it improves physician performance or patients' outcomes.  Conflicts of interest affecting MOC raise further doubts that this "innovation" may also be about furthering commercial interests. ABIM Begins Conflict of Interest Disclosure Now it appears that the ABIM is beginning to disclose more about its leadership's conflicts of interest.  One of our scouts notified me that the ABIM web-site now provides disclosures for the members of its <a href="http://www.abim.org/about/governance/board-of-directors.aspx">board of directors and officer,</a> <a href="http://www.abim.org/about/governance/abim-council.aspx">council,</a> and <a href="http://www.abim.org/about/executives.aspx">executives</a>. There seem to be limits to these disclosures.  As far as I can tell,They do not reflect a change in the preexisting ABIM <a href="http://www.abim.org/conflict-of-interest-policies.aspx">conflict of interest policy</a>, which still calls for conflicts to be disclosed, but only to ABIM leadership, while they are otherwise kept confidential.  Nor were these disclosures accompanied by any further explanation that I can find.  The disclosures include multiple categories, consulting relationships, peer educational activities, promotional activities, grants, intellectual property, stock/option, gift/ donations, expert witness, leadership in professional organizations, and other, which are not otherwise defined.  It was not clear, however, whether the disclosures covered services on corporate advisory boards or boards of directors, or service as executives or founders of companies.  The time course of the disclosed relationships were not clear.  Finally, ttere are no disclosures about members of <a href="http://www.abim.org/about/examInfo/committee.aspx">exam writing committees of sub-specialty board members</a> Nonetheless, the disclosures do give an idea of the scope of conflicts of interest affecting ABIM leadership.  Because the disclosures have not otherwise been publicized, I thought it would be worthwhile to summarize them here. Prevalence of Conflicts Of the 12 officers and directors, 8 disclosed relationships with for-profit health care corporations Of the 15 council members (one of whom is also a director), 9 revealed conflicts. Of the 12 executives, 5 revealed conflicts. Thus, a majority of ABIM physician leadership, and nearly a majority of  ABIM executives disclosed conflicts of interest. Nature of Conflicts The conflicts were predominantly consulting relationships, grants, holdings of patents, or of stocks or options.  The conflicts of the officers, directors and council members primarily involved pharmaceutical, biotechnology and device companies.  Several officers, directors and council members had two kinds of relationships with the same company, for example, consulting relationships and grant funding. It was striking that 15 companies had multiple relationships with officers, directors and council members.  All were large pharmaceutical, biotechnology, and device companies.  They were AbbVie (1 consulting relationship 2 grants) Amgen (1 consulting, 1 grant, 2 stock holdings) AstraZeneca (3 consulting, 1 grant) Bristol-Myers-Squibb (2 consutling, 2 grants, 1 stocks) Celgene (2 consulting, 1 grant) Gilead (1 consulting, 2 grants, 1 stocks) Johnson and Johnson (1 consulting, 2 grants [one through Janssen], 2 stocks) Eli Lilly (1 consulting, 1 grant) Medtronic (2 consulting, 1 grant) Merck (2 consulting, 2 stocks) Novartis (2 grants, 1 stocks) Pfizer (1 consulting, 1 grant, 2 stocks) Roche (1 consulting, 2 stocks) Teva (1 consulting, 1 stocks) Millennium (1 consulting, 1 grant) The officers, directors, and council members additionally had relationships with a vast number of companies, including in attempted alphabetical order: Abbott Laboratories, Agios, Allos, AllScripts, Arrowhead, Biocontrol Medical, Cephalon, Cephied, CorAssist, Cornovus, CVRx, Covidien, Dr Redy's Labs, Emergent Biosolutions, Express Scripts, Genentech, Gen-Probe, Hologic, Human Genome Sciences, Incyte,  ION(?), miRNA Therapeutics, Peluton Therapeutics, Pharmacyclics, Regeneron, Repros Therapeutics, Research to Practice (owned by AmerisourceBergen) Prime Healthcare, Rigel, Seattle Genetics, Sunesis, TG Therapeutics, UnitedHealthcare, Value Capture, Viamet, Ventrigen, Vertex, XCenda,  and ZS Pharma. Thus, the conflicts of interest were extensive, and involved major health care corporations. Summary The American Board of Internal Medicine is to be congratulated for taking steps towards more transparency and honesty about conflicts of interest affecting its leadership.  However, the steps were baby steps.  Lacking still are definitions and time courses of the relationships disclosed, assurances of the completeness of disclosure of all relevant relationships, assurances that disclosure is now the policy going forward, and disclosures for members of committees and sub-specialty boards who are also very influential in constructing examinations and maintenance of certification activities.  These ought to be addressed. The disclosures reveal that the conflicts of ABIM leadership were extensive.  While disclosure is good, disclosure does not assure physicians and the public that certification and now maintenance of certification are not influenced by marketing needs and other commercial interests.  In my humble opinion, the ABIM now ought to phase out, as quickly as possible conflicts of interest affecting those who make its policy, write its exams, and conduct its other activities that can influence physician behavior, decisions made for patients, and health policy.  Also, in my humble opinion, the ABIM ought to suspend its efforts to promote maintenance of certification until it has greatly reduced the conflicts of interest that may affect this effort.

American Board of Internal Medicine Quietly Discloses Some Conflicts of Interest

We recently discussed the American Board of Internal Medicine's exceedingly weak conflict of interest policy. This came to light after the board's previous president was revealed to have simultaneous…

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24 Apr 2014

Knee Deep in the Hoopla - "A Triumph of Medical Technology" Sans Evidence of Superiority from Published Randomized Double Blind Controlled Trials

With the publication of several new articles in the prestigious New England Journal of Medicine, the buzz about Sovaldi (sofosbuvir - Gilead), a new oral treatment of hepatitis C, has become feverish.  The drug had been hailed as near miraculous, and the only debate has been about its near stratospheric cost (look <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">here</a>).  This week, of all weeks, however we should be extremely skeptical about expensive drugs promoted as the cures of our most feared ills.  This week a series of articles appeared in the British Medical Journal showing that there was no evidence to support the clinical value of the  antiviral drugs stockpiled for governments as proof against dreaded influenza epidemics (look <a href="http://www.bmj.com/content/348/bmj.g2695">here</a> to start).   The Latest Buzz As we <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">posted earlier</a>, the discussions contrast the ostensibly near miraculous aspects of the drug's performance with its extremely high price.  For example, a few days ago the Los Angeles Times <a href="http://www.latimes.com/science/la-sci-hepatitis-c-cure-20140412,0,3083638.story">reported</a>, <blockquote class="tr_bq">In a series of clinical trial results, a new generation of antiviral medications was able to clear the liver-ravaging virus from virtually all patients' bloodstreams in as little as eight weeks. Even in patients with the most stubborn infections, the new drugs were capable of suppressing the virus completely at rates well over 90%. The treatments, however, come with a steep price tag.</blockquote> So, <blockquote class="tr_bq">The new medications are 'a triumph of modern medical technology,' said Dr. Jeffrey Tice, a UC San Francisco physician who was not involved in any of the clinical trials.</blockquote> Accompanying the research reports in the New England Journal was a commentary by Dr Raymond T Chung and Dr Thomas F Baumert.  Its title proclaimed Sovaldi and similar drugs also to be part of "The Arc of Medical Triumph."(1)  Buried in the commentary's <a href="http://www.nejm.org/action/showSupplements?doi=10.1056%2FNEJMp1400986">supplementary material</a> was a<a href="http://www.nejm.org/doi/suppl/10.1056/NEJMp1400986/suppl_file/nejmp1400986_disclosures.pdf"> link</a> to disclosure forms that showed that: <blockquote class="tr_bq">Dr Chung reports grant support from Gilead Sciences [the manufacturer of Sovaldi], Mass Biologics, Vertex and Merck, and personal fees from Abbvie, Enanta and Idenix.</blockquote> Note that Abbvie and Merck are also at work on antiviral treatments for hepatitis C. and <blockquote class="tr_bq">Dr Baumert reports several patents ... and pending patents [apparently that could be conflicts of interest] </blockquote> It is clear that there have been major scientific advances in the characterization of the hepatitis C virus, and development of multiple new antiviral agents which promise to treat that infection.  Furthermore, clearly there is reason for hope for treatment of hepatitis C that prevents its long-term complications and averts premature death. (Of course, that hope could be a bit stronger in the hearts of those who have financial relationships with the corporations that stand to profit from sales of these drugs.) But it is not obvious that there is sufficient clear evidence from clinical research, particularly from double-blind randomized controlled trials (RCTs), that shows the newest treatments will provide triumphal benefits to patients that outweigh their possible harms. One Published Unblinded RCT Compared Sovaldi to Peg-Interferon In our <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">previous post</a>, written after the immense price of the new drug in the US became apparent, we questioned whether the evidence from controlled trials then available would justify the hype, and the high price. We looked at what appeared to be the then single best available study. The <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1214853">most prominent randomized controlled trial of Sovaldi for patients who had not had previous therapy for hepatitis C</a> that had been published by March, 2014, appeared in the New England Journal of Medicine in May, 2013.(2)   While it provided some reason for hope, it did not provide clear evidence that Sovaldi was a miracle drug. The study showed that Sovaldi plus ribavirin produced the same rate of sustained virologic response (SVR), 67%, as did the previously accepted standard treatment, peg-interferon plus ribavirin, again 67%.  (SVR means that the hepatitis C virus has become undetectable in the patient's blood, and is believed, but not proven to represent a cure.) While Sovaldi had lower rates of unpleasant side effects than did peg-interferon, these rates were not negligible. For example, the rate of nausea after peg-interferon was reported to be 29%, but after Sovaldi it was still 18%.  Given that the trial was unblinded, and that some of these side effects have a subjective element, these figures could have been biased due to patient expectations that the new drug would have fewer side effects. Furthermore, Sovaldi appeared to produce higher rates of severe adverse effects (3%) than peg-interferon (1%).  However, the article did not mention any deaths in either treatment group.  When I later reviewed the  <a href="http://www.nejm.org/doi/suppl/10.1056/NEJMoa1214853/suppl_file/nejmoa1214853_appendix.pdf">supplemental data</a> available on the web from the May, 2013 article, I found that buried within this information were the facts that two people died during treatment with Sovaldi, and one after treatment with peg-interferon.  So, the rate of  severe adverse effects or death after Sovaldi treatment was more than double (9/256 ) than that after peg-interferon (4/243).  It is very curious and concerning that the authors chose not to mention deaths of study subjects in the paper that reported their trial results.    Finally, the trial, like just about all previous trials of treatment of hepatitis C, did not follow patients long-term, and hence could not show whether treatment actually resulted in better clinical outcomes, for example, longer survival, decreased rates of severe liver disease, etc.  We thus concluded that there really was no clear evidence that Sovaldi was really a miracle drug, which could cure more people, in fact, nearly everyone, compared to standard therapy, yet with fewer side effects and more safety. Any Evidence from Other Controlled Trials? We looked through the newly published articles, the articles they cited, and the official US label for sofosbuvir to see if there is any other evidence from controlled trials to support the triumphant claims about sofosbuvir.  To simplify this casual, not systematic review, we only looked at articles about patients who had not been previously treated for hepatitis C. The <a href="http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/ucm377920.htm">drug label</a> mentioned a controlled trial that compared sofosbuvir to placebo.  The POSITRON study (study 107) was a trail that compared Sovaldi and ribavirin to placebo in patients who are "interferon intolerant, ineligible or unwilling."  The overall SVR in the treated group was 78%.  The label did not mention adverse effects rates in this trial, and as far as I can tell, it was not published.  Again, while the SVR was good, it was NOT over 90%.  As far as I could tell, the results of this study have not otherwise been published.  The new studies in the New England Journal, and the studies cited by one of them were NOT double-blind randomized controlled trials of sofosbuvir versus some other treatment, or versus placebo for that matter. For example, the study by Afdhal et al in the New England Journal considered sofosbuvir in combination with another new drug from Gilead, ledipasvir.  However, this was an open label (unblinded) study that compared patients given different durations of treatment with both sofosbuvir and ledipasvir with or without ribavirin.  It did NOT directly compare sofosbuvir (or ledipasvir) to any other treatment, or to placebo.(3) Another study by Sulkowski et al in the NEJM focused on previously treated patients. Cited by Afdhal et al were studies by Osinusi et al (an unblinded study that compared different doses of ribavirin given to patients also who all received sofosbuvir)(4); Lawitz et al (an unblinded study that compared different durations of treatment for both sofosbuvir and ledipavir with or without ribavirin)(5); and Gane et al (a study that compared various drugs again all added to sofosbuvir)(6).  Again, NO study compared sofosbuvir to any other treatment, or to placebo. Thus so far I have been unable to find any additional studies that compared Sovaldi (sofosbuvir) to any other potential treatments for hepatitis C.  Without a comparison to another treatment, it is not possible to tell whether the high rates of patients whose blood tests show no detectable hepatitis C virus in the short-term after treatment were due to the excellence of the treatment, or due to selection of patients with particularly good prognoses.   Recall that there is evidence that some patients with hepatitis C spontaneously clear their blood of hepatitis C, and become spontaneously cured (see our <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">previous discussion</a>, and particularly the study by Seeff et al[7]).  There is evidence that the studies above may have been designed to only include patients with the best prognoses.  They generally were designed with very complicated, restrictive and subjective inclusion and exclusion criteria that could have eliminated all but the healthiest patients.  For example, according to the <a href="http://www.nejm.org/doi/suppl/10.1056/NEJMoa1402454/suppl_file/nejmoa1402454_protocol.pdf">study protocol</a> found in the <a href="http://www.nejm.org/action/showSupplements?doi=10.1056%2FNEJMoa1402454">supplementary material</a> for the study by Afdhal et al, patients with "clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol" would have been excluded, as would have "subjects currently under evaluation for a potentially clinically-significant illness (other than HCV)...." So, while many articles about sofosbuvir (Sovaldi) have appeared recently, in my humble opinion they do not provide strong clear evidence that this drug is extremely effective and remarkably safe, i.e., that the drug is a "triumph" that will cure nearly everyone without risk or harm to them, and therefore warrants a princely price. Summary While the buzz about Sovaldi intensifies, there still seems to be little clear evidence to justify extravagant claims made for it, or the extravagant price demanded for it.  Yet there seems to be a bandwagon building to somehow pay whatever it takes to provide the "triumph" of medical science to every patient who needs it.  At the current price, that should make the CEO of Gilead even richer (increases in the stock price after the $84,000/ course drug price was announced already turned him into a billionaire on paper, look <a href="http://www.bloomberg.com/news/2014-03-03/gilead-ceo-becomes-billionaire-on-84-000-hepatitis-drug.html">here</a>.)  As noted above, it is not clear what benefits such a costly policy would bring to patients, and at what risks. We have discussed how our current policy of letting corporations sponsor and run the clinical research meant to assess their own products has lead to widespread <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of research</a> to make their products look better, and sometimes <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of research</a> that cannot be manipulated into making their products look good.  This should make health care professionals, policy makers, and the public extremely skeptical of every over-hyped new "innovation."  So far, there seems to be no public skepticism about this latest, and seemingly most expensive pharmaceutical "triumph." The US health care system, and to some extent the health care systems in most developed countries are experiencing ever higher prices.  Much of these prices' effects seem to drive up remuneration of health care executives and managers, but whether they buy better care or outcomes for most people is not so clear.  The ever rising prices seem to be buoyed by endless enthusiasm for new tests, treatments, programs, and unbridled faith in the benefits of all new technology.  It is not clear how much of that is due to evidence, how much is based on ideology and unquestioning faith in technological progress, and how much is driven by marketing and public relations, which not always may be entirely honest and free from deception. Evidence-based medicine rigorously applied suggests that individual health care and health policy decisions should be driven by the best available evidence, mostly from clinical research, about the benefits and harms of tests, treatments, programs, and so on, in the context of what outcomes matter to patients.  The skepticism EBM should engender could lead to health care that is more about patients and their outcomes, and less about ideology, hype, and hucksterism. If only such skepticism were easier to find. References 1.  Chung RT, Baumert TF.  Curing chronic hepatitis C - the arc of medical triumph.  N Engl J Med 2014:  Link<a href="http://www.nejm.org/doi/full/10.1056/NEJMp1400986"> here</a>. 2.   Lawitz E, Mangia A, Wyles D et al.  Sofosbuvir for previously untreated chronic hepatitis C infection.  N Engl J Med 2013; 368: 1878-1887.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1214853">here</a>. 3.  Afdhal N et al.  Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection.  N Engl J Med 2014: Link<a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1402454"> here</a>. 4.  Orinusi A Meissner EG, Lee YJ et al. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial.  JAMA 2013; 310: 804.  Link <a href="http://jama.jamanetwork.com/article.aspx?articleid=1733720">here</a>. 5.  Lawitz E, Poordad FF, Hyland RH et al.  Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised phase 2 trial.  Lancet 2013; 383: 515.  Link <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2962121-2/abstract">here</a>. 6.  Gane EJ, Stedman CA, Hyland RH et al.  Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection.  Gastroenterology 2013.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/24262278">here</a>. 7.  Seeff LB, Hollilnger B, Alter HJ et al.  Long-term mortality and morbidity of transfusion- associated non-A, non-B, and type C hepatitis: a National Heart Lung and Blood Institute Collaborative Study.  Hepatology 2001; 33: 455-463.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/11172349">here</a>. ADDENDUM (21 April, 2014) - Also see the post on "breakthrough cures?" by Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2014/04/breakthrough-cures-reasons-for.html">on the Hooked: Ethics, Medicine and Pharma blog</a>.

Knee Deep in the Hoopla - "A Triumph of Medical Technology" Sans Evidence of Superiority from Published Randomized Double Blind Controlled Trials

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16 Apr 2014

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. Planned Obsolescence Disguised as Innovation The article first discussed the brave new world of type 1 diabetes treatment.  The introductory theme was: <blockquote class="tr_bq">Today, the routine care costs of many chronic illnesses eclipse that of acute care because new treatments that keep patients well have become a multibillion-dollar business opportunity for device and drug makers and medical providers.</blockquote> Much of modern diabetes treatment seems to depend on medical devices and disposable medical supplies: <blockquote class="tr_bq">That captive audience of Type 1 diabetics has spawned lines of high-priced gadgets and disposable accouterments, 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. A steady stream of new models and updates often offer dubious improvement: 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> Of course, the device and supply manufacturers claim that the high prices reflect the value of the wondrous new innovations: <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> Yet now the Times reporter was able to find physicians who claim the "innovations" are really just the latest version of planned obsolescence: <blockquote class="tr_bq">Diabetes experts say a good part of what companies label as innovation amounts to planned obsolescence. 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, <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"> </div><div class="story-body-text story-content" data-para-count="109" data-total-count="4115" itemprop="articleBody">'People don’t need a meter that talks to them,' he added. 'There’s an incredible waste of money.'</div></blockquote> Pharmaceutical companies have also discovered this model. <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> In particular, <blockquote class="tr_bq">Synthetic human insulin is safer for patients, who sometimes developed reactions to animal insulin. But it is made by only three companies: Eli Lilly, Sanofi and Novo Nordisk. 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. <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> Of course, the pharmaceutical companies also claim that it's all about innnovation, <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, <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. 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> 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, <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"> </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> 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.  Oligopoly Disguised as a Free Market 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, <blockquote class="tr_bq"><a href="http://www.medtronic.com/">Medtronic</a> is the dominant insulin pump manufacturer, serving 65 percent of American patients and the majority of those worldwide. Though smaller companies sell cheaper pumps, it is hard to make inroads: 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> Of course, Medtronic public relations will justify it all again based on innovation, <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> 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, <blockquote class="tr_bq">Dr. Kivi was on high doses of steroids for debilitating joint pain that left him unable to walk at times. But when his last three-hour infusion at NYU Langone Medical Center’s outpatient clinic generated a bill of $133,000 — 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> However,  this pricing appears to have been facilitated by the hospital's increasing market domination generated by its purchase of physician practices, <blockquote class="tr_bq">He had moved his care to NYU Langone to follow his longtime doctor, who had 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, according to Medicare data.</blockquote> 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. Enrichment of the Oligarchs 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? It does not appear to be the health care professionals, <blockquote class="tr_bq">Meanwhile, as the price of supplies rises, endocrinologists remain among the lowest-paid specialists in American medicine, meaning severe physician shortages in many areas and long waits to see a doctor.</blockquote> 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. Eli Lilly 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 - John C Lechleiter PhD, CEO                                      $11,217,000 - Derica W Rice, CFO                                                   $5,176,822 - Jan M Lundberg, PhD, EVP, Science and Technology   $4,774,535 - Michael J Harrington, General Counsel                          $3,174,222 - Erico A Conterno, President Lilly Diabetes                    $3,009,041 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. 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, - Alfred G Gilman, MD, PhD, Regental Professor Emeritus, recent (until 2009) executive vice presdient, provost, and dean of medicine, University of Texas Southwestern  - William G Kaelin Jr, MD, Professor of Medicine, Associate Director of Basic Science, Dana-Farber Cancer Center, Harvard University - Marschall S Runge MD, Executive Dean and Chair of the Department of Medicine, University of North Carolina Medical School - 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). - Ellen R Marram, Trustee, New York-Presbyterian Hospital - Ralph Alvarez, President's Council, University of Miami - R David Hooper, Trustee, Children's Hospital of Colorado - Franklyn G Pendergast MD PhD, Professor, Mayo Medical School 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. Medtronic 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 $8,975,866 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. 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).  NYU Langone Medical Center 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.    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.  Summary 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. 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. 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 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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14 Apr 2014

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 <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. 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.  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. A Small Study of the Prevalence of a New Species of Conflict of Interest 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>.] 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.  The most important findings were: - 19/47 companies (40%) had at least one board member who was a leader of an academic medical center (AMC) - 16/17 US based companies had at least one board member who was also a leader of a US AMC -  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 -  28 board members were also members of boards of trustees or directors of US hospitals, medical schools, or their parent universities. Comments We have been trying to raise awareness of this issue since 2006.  Now we have some idea of the size of the problem. 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." 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. 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. 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. 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. 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. 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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03 Apr 2014

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

then things must be getting really bad. 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. 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. We have a striking local example. 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, <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> He then went on, <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 dangerous imbalance of wealth. 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, this great inequality of wealth is dangerous for America. For it is making the United States less and less a democracy (a form of government in which the people rule) and more and more an oligarchy (a form of government in which a small number of very rich people rule).</blockquote> He did propose a specific remedy for the problem.  However, he did warn of the consequences in dire terms. <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. When we conclude that in reality our government is controlled by the rich and super-rich, not the people, we will experience a great legitimacy crisis; our government will no longer feel legitimate to us, and thus it will not receive the deference that legitimate authority is entitled to. Lawlessness and disorder will follow.</blockquote> That is pretty strong, and when people like Mr Carlin start making such strong warnings, things must be really bad. 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. 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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01 Apr 2014

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. 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. 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. 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.  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.  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 The Dean of the College of Medicine at the University of Illinois Is a Director of Novartis 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.     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. But wait, there is another major dimension to this problem.  Novartis' Recent Ethical Misadventures 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. Novartis, Roche Fined for Anti-Competitive and Deceptive Practices in Italy to Encourage Sales of Lucentis 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,  <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 colluding to keep doctors from prescribing a relatively inexpensive eye treatment in favor of a more expensive drug. <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 overstating the dangers of Avastin use.</div><div class="story-body-text story-content" data-para-count="235" data-total-count="958" itemprop="articleBody"> </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> Novartis, which holds the rights to market the two drugs outside the United States, has been fined 92 million euros by the Italian regulators. 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> 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: <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> 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, <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"> </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"> </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 'work with diabetes patient groups to increase voiced concerns about safety risks of unlicensed therapies' — a reference to Avastin — 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"> </div><div class="story-body-text story-content" data-para-count="239" data-total-count="5308" itemprop="articleBody">Novartis Paid Doctors to Act as Marketers for Starlix and Other Drug</div><div class="story-body-text story-content" data-para-count="239" data-total-count="5308" itemprop="articleBody"> </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: <blockquote class="tr_bq">Dr. Howard Brand says he had one goal when he gave a speech at a Miami hotel in the early 2000s -- to tout the diabetes pill Starlix for the pharmaceutical company Novartis.  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. 'It was self-serving, but I also thought it was a benefit to patients,' said Brand,...</blockquote> Furthermore, <blockquote class="tr_bq"> Brand, the Miami speaker, said in an interview that investigators had not approached him about the payments he accepted. 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. ' Even [with] the notion that we were paid solicitors, I think people really paid attention,' he said. 'Of course, a lot of doctors just enjoyed going to dinner.' Brand said he accepted more than $60,000 in speaker's fees from drugmakers, including Novartis, in one two-year period. </blockquote> Another physician allowed that Novartis furnished the material for his "educational" talks, <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 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,' he said. Hertz said the slides were on CDs and made him an expert on Novartis drugs such as Diovan, a blood pressure pill, Lotrel and Valturna. He said he spoke mostly about Diovan and Lotrel. '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> 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. 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, <blockquote class="tr_bq">'To even hear about it just takes my breath away,' Caplan said. 'It sounds like egregious, inexcusable violations of agreed upon legal and ethical standards . . . with an inexcusably complicit group of physicians,' Caplan said.</blockquote> Japanese Hospital Investigation Alleged Novartis Manipulated Research 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, <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. 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 Mainichi 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). In fact, according to NHK World, hospital director Takashi Kadowaki said Friday that Novartis employees were 'virtually managing the study.' </blockquote> <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, <blockquote class="tr_bq"> Senior Ministry of Health, Labor and Welfare officials called the case a serious situation and said the researchers involved showed a lack of ethics. They called for a detailed investigative report from the hospital and are considering punitive measures. The ministry will consider a new law to prevent corruption in clinical tests in the wake of a scandal involving the clinical trial of antihypertensive drug Valsartan.</blockquote> It is obvious this story is not from the US, because the drug company has already apologized, <blockquote class="tr_bq"> A representative for Novartis Pharma's PR division said, 'We want to apologize to patients and doctors. We must refrain from comment on the investigation, which is being handled outside our company.'</blockquote> Indian Regulator Cancels Import License Alleging Fraud by Novartis to Market Veterinary Drug 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, <blockquote class="tr_bq">Swiss drug maker Novaris is likely to face legal action for allegedly faking documents to seek registration of its veterinary product Tiamulin Hydrogen Fumarate (80 per cent granules) in India. The drug regulator, Drugs Controller General of India (DCGI)), has already cancelled the company’s import licences as well as existing registration certificate for the product.</blockquote> Summary 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. 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. 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. True health care reform would make health care leaders accountable for putting patients' and the public's health ahead of their own self-interest.

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

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25 Mar 2014

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