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

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 conf...

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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 ...

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Too Good to be True - Sovaldi Kerfuffle Focuses on Price, While Ignoring Limits of Evidence about Effectiveness and Safety

There seems to be rising skepticism about the prices we pay for the latest drugs, devices, and health care programs, especially in the US.  However, our faith in the near miraculous properties of the newest technology appears to go on unabated.  Skepticism, driven by the rigorous thinking that ought to be engendered by the dutiful application of the principles of <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine</a>, is rarely in evidence. The latest example is of how concern about the sky high price of one new medication seems to have eclipsed any skepticism about how much good that medicine may do for patients. The Sovaldi Pricing Kefuffle Starting in early March, 2014, a media discussion began about the extremely high price set for a new drug for the treatment of hepatitis C.  As first<a href="http://www.washingtonpost.com/national/health-science/costly-hepatitis-drug-sovaldi-rattles-industry/2014/03/01/86cab0b4-a091-11e3-9ba6-800d1192d08b_story.html"> reported</a> by the Washington Post, <blockquote class="tr_bq">When the Food and Drug Administration approved a medication called Sovaldi [sofosbuvir, Gilead] in December, it was hailed as a breakthrough in the fight against hepatitis C, a blood-borne disease that affects 3.2 million Americans and kills more people in the U.S. annually than AIDS. Then California-based Gilead Sciences, the manufacturer, announced the price: $84,000 for a 12-week course, more than what many cancer treatments cost in a year. </blockquote> The coverage focused on whether the price could possible be justified, while it generally conceding that the drug was a huge advance that was genuinely valuable. For example, the Post article noted, <blockquote class="tr_bq">The drug has also prompted a new round of hand-wringing over a larger issue: the escalating cost of specialty drugs, which are designed to treat chronic illnesses such as rheumatoid arthritis and multiple sclerosis and sometimes require special handling. While these therapies are delivering body blows to some of the world’s most pernicious diseases, they also are testing the limits of what society is willing to pay for sought-after treatments or cures. </blockquote> The articles justified the drug's value with several assertions: Sofosbuvir cures nearly everyone of hepatitis C For example, the Post article stated, <blockquote class="tr_bq">Sovaldi promises to cure nearly all sufferers... </blockquote> Similarly, a report by the authoritative <a href="http://www.kaiserhealthnews.org/stories/2014/march/03/insurers-debate-who-should-get-costly-hepatitis-c-drug.aspx">Kaiser Health News</a> stated that the drug has, <blockquote class="tr_bq">a success rate of better than 90 percent.</blockquote> A Bloomberg<a href="http://www.bloomberg.com/news/2014-03-03/gilead-ceo-becomes-billionaire-on-84-000-hepatitis-drug.html"> article</a> quoted Dr Leonard Berkowitz, chief of infectious disease as Brooklyn Hospital Center as saying the drug is <blockquote class="tr_bq">producing 'spectacular improvements' in cure rates....</blockquote> Going even farther, a Denver Post <a href="http://www.denverpost.com/news/ci_25275400/hepatitis-c-breakthrough-drug-sovaldi-promises-high-cure">article</a> quoted Dr Greg Everson, a hepatologist at the University of Colorado, <blockquote class="tr_bq">The word is cure.  To me, the cure of hep C is one of the most significant medical developments of the last 50 years.</blockquote> Sofosbuvir is extremely safe and has few side effects For example, the Post article stated Sovaldi is <blockquote class="tr_bq">a once-daily pill that has far fewer side effects [than other treatments] </blockquote> The Bloomberg article again quoted Dr Berkowitz as saying the drug has <blockquote class="tr_bq">minimal toxicity</blockquote> The Denver Post quoted Dr Everson, <blockquote class="tr_bq">the side effects are almost nonexistent - mild headache and fatigue.</blockquote> Without treatment, hepatitis C leads to very bad outcomes For example, the Post article stated, <blockquote class="tr_bq">The disease can go undetected for years and can eventually lead to cancer or cirrhosis of the liver. </blockquote> Kaiser Health News added, <blockquote class="tr_bq">If left untreated, hepatitis C can cause liver damage over the course of decades. </blockquote> An<a href="http://articles.latimes.com/2014/mar/09/business/la-fi-hepatitis-c-drug-costs-20140310"> article</a> in the Los Angeles Times noted, <blockquote class="tr_bq">Left unchecked, some hepatitis C infections result in liver damage, liver cancer or death.</blockquote> The Denver Post again quoted Dr Everson, <blockquote class="tr_bq">It's a devastating disease. [Also,] It can smolder for years without symptoms, then it destroys the liver - cirrhosis, cancer.</blockquote> Sofosbuvir prevents nearly all these bad outcomes. This was more implied by the media than directly stated, although the Los Angeles Times did quote an executive vice president of Gilead, the manufacturer of Sovaldi, <blockquote class="tr_bq">Sovaldi ... results in very high cure rates that can avoid future costs related to disease progression or treatment failure....</blockquote> Only the New York Times provided just a hint of skunk odor at the garden party.  Its later <a href="http://www.nytimes.com/2014/03/22/business/lawmakers-attack-cost-of-new-hepatitis-drug.html">article</a> on some US congress members' attempt to investigate the pricing of Sovaldi contributed, But most people with hepatitis C never experience serious liver problems.  So many people would be fine without treatment. That little bit of odor notwithstanding, one could ask what is not to like about this drug.  But the coverage really focused on how many people felt the cost was still just too high.  Unstated, but again implied was the notion that these complaints were just sour grapes.  How could anyone begrudge a mere $84,000 for a safe, extremely effective curative drug that would prevent severe morbidity and premature death, yet cause almost no significant side effects? The problem is that the evidence that actually supports the "value proposition" for Sovaldi is actually not clear at all.  The bigger problem is that so far, discussion of this evidence in the media seems to be absent. The Evidence about Treatment of Hepatitis C Let us consider the assertions above, and what evidence there may be to support them,  in slightly different order. Without treatment, hepatitis C leads to very bad outcomes The earliest research on hepatitis C focused on patients who already had severe complications of the disease.  Thus, as Seeff et al wrote in 2000(1), <blockquote class="tr_bq">retrospective studies of person who have chronic, clinically obvious HCV infection may overemphasize more serious outcomes because they risk omitting persons with subclinical infection as well as those in whom infection spontaneously resolves.</blockquote> Yet popular conceptions of hepatitis C, especially those reflected by the current Sovaldi pricing kerfuffle, seem to reflect only the experience of the most unfortunate hepatitis C patients.  In contrast, studies that have followed cohorts of patients who have evidence of early hepatitis C infection show very different results. In 1999, Kenny-Walsh and colleagues reported a cohort of 390 women who had tested positive for hepatitis C after receiving infected immune globulin.(2)  They were able to follow them for 17 years.  In that time period, 43% of the women had no or minimal inflammation of the liver; 49% had no evidence of liver fibrosis; and only 2% had developed fibrosis. In 2000, Seeff and colleagues reported 45 years of follow up of young military men who were found to have evidence of hepatitis C infection from analysis of long stored frozen serum.  Only one (less than 3%) of their admittedly small cohort of 34 positive men had been found to have any sort of liver problem in that time period.(1) In 2001, Seeff and colleagues reported 20-year follow up of several cohorts including 222 patients who developed hepatitis characterized by abnormal liver enzymes after blood transfusion and for whom retrospective tests on stored blood revealed hepatitis C at that time.(3)  The total mortality over 20 years of the hepatitis C patients was not greater than a group of control patients who had been transfused but did not develop clinical hepatitis.  51% of the hepatitis C infected patients had no evidence of chronic hepatitis.  23% had no evidence of continuing hepatitis C infection. These admittedly old studies show that a significant minority of patients with hepatitis C infection spontaneously resolve their infections, and that a majority of patients have no evidence of significant liver disease over decades of observation.  Cirrhosis is actually a relatively rare outcome of hepatitis C infection, and there is no clear evidence that hepatitis C infection increases total mortality. Of course, once a patient with hepatitis C has been unfortunate enough to develop clear liver disease, that patient's prognosis is not so good. Thus, there is no clear evidence that the majority of patients with hepatitis C infection could benefit from anti-viral treatment given prior to development of any significant complications of the infection, because the majority of such patients may never develop any adverse effects of the infection.  Thus it is not at all obvious that any current hepatitis C treatment could be widely life-saving. Treatment Prevents Nearly All Bad Outcomes There have been no long-term randomized controlled trials of any anti-viral treatment for hepatitis C that evaluated clinical outcomes like cirrhosis, liver failure, liver cancer, need for transplantation or death.  All trials of all agents have been relatively short term, and focused on reduction or elimination of detectable virus from the blood as an outcome.  As detailed in the latest evidence report from the US Preventive Services Task Force,(4) there have been observational studies that compared patients who were treated and had sustained virological responses (elimination of detectable virus from the blood) and those who did not in terms of long-term outcomes.  Such observational studies are liable, however, to confounding.  Patients who are willing to take treatment, fully comply with treatment, and respond better to therapy may be systematically different from those who refuse treatment, do not adhere to treatment, or whose treatment is not initially successful.  Most of these studies were considered to be of poor methodological quality, although the best, still only considered of fair quality, did show an association between virological responses and clinical outcomes.  There have been no studies of the comparative effectiveness of different anti-viral treatments. Thus, the evidence that anti-viral treatment for hepatitis C prevents any bad clinical outcomes, like cirrhosis, liver failure, liver cancer, or premature death is unclear. Now to consider the best evidence available about sofosbuvir. Sofosbuvir cures nearly everyone of hepatitis C So far, the best study reported about sofosbuvir seems to be one in the New England Journal of Medicine in 2013.(5)  This report included an open-label (not blinded) controlled trial called FISSION of sofosbuvir plus ribivirin versus peginterferon alfa-21 plus ribivirin.  Its primary outcome measure was viral response 12 weeks after therapy (which lasted 12 weeks in the first group, 24 in the second).  The proportion of patients with responses 12 weeks after therapy were 67% in both groups.  Patients who received sofosbivir had lower rates of the common, uncomfortable complications attributed to interferon therapy than those who received peginterferon (e.g., fatigue, 36% versus 55%; nausea, 18% versus 29%).  However, while small, the proportion of patients with serious adverse events, not further defined in the article, were higher in the sofosbivir group, 3% versus 1%. Note that the above report also included what was euphemistically called a "single-group, open-label study."  This seems to be a fancy name for what is usually called a case series, that is, a series of patients given a particular treatment, without a control group.  The consensus in the evidence-based medicine community has long been that barring miraculous results, case series are nearly useless as evidence about treatments, primarily because it is not possible to separate the effects of the patient selection process from the treatment on the apparent outcomes.  Why this case series was included in the report is a secret known only to New England Journal editors. So setting aside that distraction, it is not obvious that sofosbivir increases even short-term virological response (at 12 weeks after treatment) compared to the best previously available treatment.  There is no evidence that sofosbivir can cure nearly everyone.  (Much of the enthusiasm seems to come from blood tests on treatment, disregarding the results shortly after treatment.)  These are not "spectacular" results." Sofosbuvir is extremely safe and has few side effects From the above trial results, it is not obvious that the drug is extremely safe.  In fact, there is a suggestion that it may lead to an increase in serious adverse effects. While the drug does seem to produce fewer bothersome adverse effects, even the rates of these symptoms in those treated are not negligible. Summary While there is concern about the gargantuan price asked for Sovaldi, the new treatment for hepatitis C, there seems to be little skepticism about the near miraculous claims made for the value of the new drug.  In fact, it almost appears that the debate about the price is reinforcing current dogma which promises nearly universal cures without major risks.  Yet the evidence is that many, perhaps most patients with hepatitis C will not benefit from treatment, and that the new drug is not much more, or any more likely to cure patients than older drugs.  Meanwhile, the evidence that the new drug is safer and causes fewer adverse effects is weak at best. 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 lead to health care that is more about patients and their outcomes, and less about ideology, hype, and hucksterism. References 1.  Seeff LB, Miller RN, Rabkin CS et al.  45-year follow-up of hepatitis C virus infection in healthy young adults.  Ann Intern Med 2000; 132: 105-111.  Link <a href="http://annals.org/article.aspx?articleid=713226">here</a>. 2.  Kenny-Walsh E, for the Irish Hepatology Research Group.  Clinical outcomes after hepatitis C infection from contaminated anti-D immune globulin.  N Engl J Med 1999; 340: 1228- 1233.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJM199904223401602">here</a>. 3. 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>. 4. Chou R, Hartung D, Rahman B et al.  Comparative effectiveness of antiviral treatment for hepatitis C virus infection in adults: a systematic review.  Ann Intern Med 2013; 158: 114.-123.  Link <a href="http://annals.org/article.aspx?articleid=1402433">here</a>. 5.  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>.

Too Good to be True - Sovaldi Kerfuffle Focuses on Price, While Ignoring Limits of Evidence about Effectiveness and Safety

There seems to be rising skepticism about the prices we pay for the latest drugs, devices, and health care programs, especially in the US. ...

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Senate Majority Leader Harry Reid on Bad Health IT: "People Aren’t Educated on How to Use the Internet"

The ultimate "blame the user" excuse for bad health IT comes from, of all places, Senate Majority Leader Harry Reid: <blockquote class="tr_bq">Washington Free Beacon <a href="http://freebeacon.com/issues/harry-reid-people-arent-educated-on-how-to-use-the-internet/">http://freebeacon.com/issues/harry-reid-people-arent-educated-on-how-to-use-the-internet/</a> <time class="entry-date" datetime="2014-03-26T13:16:44+00:00" pubdate="">March 26, 2014 1:16 pm</time> Senate Majority Leader Harry Reid (D., Nev.) said the fault of struggling to sign up on the Obamacare exchanges didn’t lie with the faulty website, but with the people who weren’t “educated on how to use the Internet.” Explaining the reasoning behind the latest Obamacare delay, Reid said too many people just didn’t know to use their computer properly and needed more time. Apparently, it had nothing to do with the well-documented <a href="http://youtu.be/AAtgsizDWV0">failings of the website</a> that have embarrassed the White House for months.  [Really?  What an amazing theory about IT difficulties - ed.] “We have hundreds of thousands of people who tried to sign up who didn’t get through,” he said. “There are some people who are not like my grandchildren who can handle everything so easily on the Internet, and these people need a little extra time. It’s not — the example they gave us is a 63-year-old woman came into the store and said, ‘I almost got it. Every time I just about got there, it would cut me off.’  </blockquote> Obviously due to user error, not due to poor health IT. <blockquote class="tr_bq">We have a lot of people just like this through no fault of the Internet, but because people are not educated on how to use the Internet.”</blockquote> It's not the software designer's or website's fault, it's the fault of Americans, most of whom are dummies and who should know how to get around bad health IT's flaws.  Wow. That's why physicians complain about health IT too, no doubt.  They're dummies. Maybe Mr. Reed should speak with the inventor of the Internet, former Veep Al Gore, about that.  Mr. Gore can perhaps write a better "Internet Instruction Manual for Dummies." (I'll bet most of the dummies who "do not know how to use the Internet" have no problems using Amazon.com or eBay.) -- SS

Senate Majority Leader Harry Reid on Bad Health IT: "People Aren’t Educated on How to Use the Internet"

The ultimate "blame the user" excuse for bad health IT comes from, of all places, Senate Majority Leader Harry Reid: Washington Fr...

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James Fallows - The Atlantic - "The Use and Misuse of Information Technology in Health Care"

<a class="author-name" href="http://www.theatlantic.com/james-fallows/">James Fallows</a>, a national correspondent for The Atlantic, wrote "The Use and Misuse of Information Technology in Health Care: Several Doctors Reply" at <a href="http://www.theatlantic.com/health/archive/2014/03/the-use-and-misuse-of-information-technology-in-health-care-several-doctors-reply/284601/">http://www.theatlantic.com/health/archive/2014/03/the-use-and-misuse-of-information-technology-in-health-care-several-doctors-reply/284601/</a> It includes several physician responses to an interview with health IT hyper-enthusiast David Blumenthal, former ONC director, at <a href="http://www.theatlantic.com/magazine/archive/2014/04/the-paper-cure/358639/">http://www.theatlantic.com/magazine/archive/2014/04/the-paper-cure/358639/</a>. It would be a poor use of your time for me to add commentary.  Simply read the pieces at the links above. The doctors' responses piece speaks for itself. (Actually. I will add commentary:  the sum total of all my posts on health IT here at HC Renewal blog dating to 2004, and all my writing at my site at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases">http://cci.drexel.edu/faculty/ssilverstein/cases</a>/ dating to 1998.) -- SS

James Fallows - The Atlantic - "The Use and Misuse of Information Technology in Health Care"

James Fallows , a national correspondent for The Atlantic, wrote "The Use and Misuse of Information Technology in Health Care: Several ...

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This EHR "glitch" killed three-year-old Samuel Starr - but patient safety was not compromised

Actually, safety was compromised. I have written repeatedly that the term "glitch", an often-seen euphemism (usually accompanied with the phrase "but patient care/patient safety was not compromised"), is really a term for life-threatening health IT bugs and malfunctions.  See query link <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> for examples of health IT "glitches" (retrieves multiple posts). <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhpyDXrISVqufhC1OX4Qiik6pFNxIueFaUkAZrjyxcKT2cpNF9zcS9pQkHYWyZMp8RxM6gPn8BG3vZAXtqUOUpVbf5Fv4AHrXgzHfB_JoT6Ou4Kup25VRYDSx5S_okwyCWmdy3K5LekH52x/s1600/Main-Samuel-Starr-3204412.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhpyDXrISVqufhC1OX4Qiik6pFNxIueFaUkAZrjyxcKT2cpNF9zcS9pQkHYWyZMp8RxM6gPn8BG3vZAXtqUOUpVbf5Fv4AHrXgzHfB_JoT6Ou4Kup25VRYDSx5S_okwyCWmdy3K5LekH52x/s1600/Main-Samuel-Starr-3204412.jpg" width="150" /></a></div> Here's a "glitch" that tragically killed this boy: <blockquote class="tr_bq">Three-year-old boy dies after new NHS computer system delays heart treatment Mar 05, 2014 By James Tute <a href="http://www.mirror.co.uk/news/uk-news/samuel-starr-death-nhs-computer-3209365">http://www.mirror.co.uk/news/uk-news/samuel-starr-death-nhs-computer-3209365 </a> Coroner Maria Voisin rules that new booking system meant he did not receive life-saving treatment A three-year-old boy died in his parents' arms after a new NHS computer system failed to schedule him for a vital heart scan, a coroner has ruled. Samuel Starr was born with a congenital cardiac defect and needed surgery not long after he was born in 2010. Although he made a good recovery doctors said he would need regular tests to check on his progress. But he did not have a scan until 20 months after his first major operation because of a delay following the introduction of a new computer system, Cerner Millennium. When he finally had the appointment doctors found Samuel needed open heart surgery. During the procedure, Samuel had a stroke. A month later, after further complications, he died in the arms of his devastated parents, Catherine Holley and Paul Starr, at Bristol Royal Hospital for Children.</blockquote> There are some in my field who would (and have) called incidents like this "anecdotes" or "bumps in the road." Yet, as I've recently posted, an internationally-renowned healthcare safety tester, ECRI Institute (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>), and the medical malpractice insurer of the Harvard medical community, CRICO (<a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a>), have confirmed cases like this are no mere anecdotes.  I estimate from their numbers, and from cases known to me personally and from descriptions of others, that on the order of ten thousand (that's likely low) patients annually are being injured and/or die as a result of bad health IT in the U.S. alone.  Lack of transparency about such incidents impairs knowing the true numbers. <blockquote class="tr_bq">Ms Holley wept as she told the hearing of the moment she kissed her son goodbye, saying: "He was a kind and gentle boy with a great understanding of the world. "As we read Samuel his favourite stories, he died in our arms." Avon Coroner Maria Voisin, recording a narrative conclusion, ruled the booking system meant Samuel was not seen and did not receive treatment.</blockquote> This case somewhat reminds me of the case of a newborn whose x-ray test was done, but never looked at due to a bug in the software that scheduled films to be read, see <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a>, case #2 <blockquote class="tr_bq">Concluding a three-day inquest at Flax Bourton Coroner's Court in North Somerset, Ms Voisin said: "Samuel Starr was born with a complex cardiac disease. "He required surgery and regular check-ups at outpatients to manage his conditions.  "Due to the failure of the hospital outpatients booking system there was a five month delay in Samuel being seen and receiving treatment. "Samuel's heart was disadvantaged and he died following urgent surgery."</blockquote> Just a "glitch." <blockquote class="tr_bq">Doctors diagnosed that Samuel had a restricted pulmonary artery - causing blood to easily flow away from his heart to his lungs - during a 20-week scan in pregnancy ... On March 3, 2010, Samuel underwent open heart surgery at Bristol Royal Hospital for Children. He was discharged six days later and referred to the Paediatric Cardiac Clinic at the Royal United Hospital (RUH) in Bath for check-ups. In October 2010, Samuel had his first check-up, in which an echocardiogram, also known as an "echo", was carried out. Ms Holley said she was told the procedure would be next carried out early in the new year. But it did not happen until April 2011 and an echo was not performed.  Paediatric cardiologist Dr Andrew Tometzki told the inquest he did not "deem it necessary" on that day to carry out the echo scan. Dr Tometzki then ordered a further review - where an echo scan would be carried out - in nine months' time. Samuel's parents did not receive information about the check-up and raised their concerns with community children's nurse Clare Mees. Ms Mees, who works for Sirona Lifetime Services, said she would chase up the matter with Dr Tometzki's secretary. Medical secretary Annabelle Attridge insisted she had taken details and forwarded them on to a dedicated appointments team. However, the inquest heard "glitch problems" with a new booking system meant the appointment was not logged.  </blockquote> Apparently not due to human fault: <blockquote class="tr_bq">Paediatric clinic co-ordinator Donna McMahon said while Samuel's medical records had been created on the new Millennium computer programme, no appointments had been transferred across.</blockquote> Just a "glitch."  Just a "bump in the road." <blockquote class="tr_bq">Ms McMahon said she was first aware of the appointment delay when she received an email from nurse Ms Mees in May 2012. Samuel did not have the vital check-up until June 21. Coroner Ms Voisin added: "This overall failure led to a five month delay in Samuel being seen by his cardiologist. "This meant Samuel had not been seen for five months and had not had an echo for 20 months." His parents were horrified when Dr Tometzki informed them Samuel required heart surgery that spring.</blockquote> Just a "glitch."  Just a "bump in the road." <blockquote class="tr_bq">... "Just hours before his operation Samuel was dancing around the ward and telling the nurses all about Spiderman - we had to remind him to quieten down," Ms Holley said. Samuel's chest was closed on August 8. As he was brought out of sedation on August 9, he suffered a stroke and cardiac arrests. "It is clear that if the surgery had been performed earlier, the procedure would have been the same," Ms Voisin said. But she said expert evidence found that as time went on "the more complicated the surgery is, as the more disadvantaged the heart is and the more difficult it is to get over the operation".</blockquote> Delays in care of fragile patients - in this case a young child, but in many other cases, ED and ICU patients of all ages - is very unwise. <blockquote class="tr_bq">Samuel's condition continued to deteriorate and on September 6 his parents were recommended for treatment to be withdrawn after he had a second cardiac arrest. The coroner said she would not write a report making recommendations to the hospital, as changes had already been implemented.</blockquote> Likely, workarounds to bad health IT, inviting future catastrophe. In my view, many cases such as this never make headlines, as the findings ignore the role of the IT and blame people, cases are settled with gag clauses, patients (who survive) or family are never told of the role of the IT, or lawsuits prove too expensive or too unpleasant to pursue. But patient safety is never compromised by "glitches", and regulation will just stifle innovation. My condolences to the parents.  I've suffered a death in my own family as a result of health IT, and I'm a specialist in the field.  Laypeople have no chance. One should pray the next child affected in this way is not one's own. -- SS Mar. 25, 2014 addendum:   Also see these related posts, the first mentioning "teething problems", another euphemism for potentially-deadly EHR malfunctions: <blockquote class="tr_bq">Cerner's Blitzkrieg on London: Where's the RAF?  <a href="http://hcrenewal.blogspot.com/2010/08/cerners-blitzkrieg-on-london-wheres-raf.html">http://hcrenewal.blogspot.com/2010/08/cerners-blitzkrieg-on-london-wheres-raf.html</a>  North Bristol Hits Appointment Problems: Another "Our Lousy IT Systems Screwed Up, But Patient Safety Was Never Compromised" Story <a href="http://hcrenewal.blogspot.com/2012/01/another-our-crappy-computers-screwed-up.html">http://hcrenewal.blogspot.com/2012/01/another-our-crappy-computers-screwed-up.html</a></blockquote> -- SS

This EHR "glitch" killed three-year-old Samuel Starr - but patient safety was not compromised

Actually, safety was compromised. I have written repeatedly that the term "glitch", an often-seen euphemism (usually accompanied w...

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

Since 2006, we have posted repeatedly about  what was then a new species of severe conflicts of interest.  This occurred when leaders of academic medical institutions or other health care non-profit organizations or non-governmental organizations (NGOs) also serve as members of <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20directors">boards of directors</a> of for-profit corporations  whose products and actions have major effects on health care. 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

Since 2006, we have posted repeatedly about what was then a new species of severe conflicts of interest. This occurred when leaders of aca...

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