healthy4u: You heard it here first

A Real Example of Public Relations Talking Points to Justify Outsize Executive Compensation - and Why We Should No Longer be Fooled

We frequently discuss outsize <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive compensation</a> in health care organizations as both a symptom and a cause of these organizations' poor leadership and governance, and hence of widespread health care dysfunction. The Latest Stories of Huge CEO Pay Stories of gargantuan compensation appear almost daily.  For example, some headlines about pay at hospitals and hospital systems in the last few months included, <blockquote class="tr_bq"><a href="http://www.gjsentinel.com/news/articles/millionaire-health-care">Millionaire health care?</a> With high costs and insurance premiums in Garfield County, focus falls on pay of a hospital’s chief executive <a href="http://www.masslive.com/politics/index.ssf/2014/05/audit_faults_umass_medical_sch.html">Audit faults UMass Medical School for improper documentation of $2 million in bonus compensation</a> <a href="http://www.tennessean.com/story/news/health/2014/05/25/saint-thomas-ceos-salary-benefits-soar/9556721/">St Thomas CEO's salary, benefits soar</a> <a href="http://bangordailynews.com/2014/06/07/news/state/mainehealth-defends-executive-pay-despite-major-cuts/">MaineHealth defends top executives' pay despite major cuts</a></blockquote> Then there were stories about the amazing pay given to CEOs of top for-profit health insurance companies, e.g., <a href="http://ifawebnews.com/2014/05/30/single-payer-advocate-reports-pay-increases-for-many-health-carrier-ceos-in-2013/">via IFAwebnews,</a> <blockquote class="tr_bq">According to research published by a single-payer advocacy group, average compensation for nine CEOs at large health insurance companies rose by more than 19% in 2013, with some chief executives seeing steep increases in pay, while others received less remuneration. Healthcare-NOW!, a non-profit that says its goal of single-payer health coverage is also known as 'improved Medicare for all,' analyzed recent financial reports of the Fortune 500 health insurance carriers. According to Healthcare-NOW!, the highest compensation increase went to Aetna CEO Mark Bertolini, who received a $30.7 million compensation package in 2013. The Bertolini pay package, which included a large “special one-time performance-based retention award,” represented a 131% increase over his $13.3 million compensation in 2012. Molina Healthcare and Centene, insurers that specialize in privately managed Medicaid plans, roughly doubled CEO compensation in 2013. J. Mario Molina received $11.9 million, up from $5 million in 2012, while Centene’s CEO Michael Neidorff made $14.5 million, up from $8.5 million. Overall, average CEO pay across Fortune 500 health insurers rose from $11.6 million in 2012 to $13.9 million in 2013.</blockquote> Here we go again.  In May, 2014, I <a href="http://hcrenewal.blogspot.com/2014/05/more-stories-of-million-dollar-plus.html">summarized</a> how discussion of executive compensation, particularly in non-profit hospitals and hospital systems, seemed to follow a clear pattern. <blockquote class="tr_bq">The Pattern Nearly all non-profit hospitals must release minimal data on the total compensation of a few of the highest paid executives.  When these reports come out, sometimes the local media take a look, either at an individual hospital or hospital system, or at a number of local hospitals.  They almost inevitably find that some, usually most executives make what appears to be lots of money.  This could be hundreds of thousands of dollars at small community hospitals, or millions of dollars at larger hospitals and hospital systems.  Sometimes the reports end there.  Sometimes the reporters ask hospital representatives or local experts to explain the apparently exalted compensation figures.  The Talking Points  The explanations are usually very similar, and so we have called this part of The Pattern The Talking Points. It seems nearly every attempt made to defend the outsize compensation given hospital and health system executives involves the same arguments, thus suggesting they are talking points, possibly crafted as a public relations ploy.   We first listed the talking points <a href="http://hcrenewal.blogspot.com/2011/09/talking-points-sans-original-thought-to.html">here</a>, and then provided additional examples of their use <a href="http://hcrenewal.blogspot.com/2011/09/more-repeats-of-talking-points.html">here</a>, <a href="http://hcrenewal.blogspot.com/2012/03/example-of-how-complex-takes-control.html">here</a> <a href="http://hcrenewal.blogspot.com/2012/12/health-care-hired-managers-not-playing.html">here,</a> <a href="http://hcrenewal.blogspot.com/2013/05/executive-compensation-as-legal.html">here</a>, <a href="http://hcrenewal.blogspot.com/2013/06/no-blues-but-lots-of-green-for-st-louis.html">here,</a> and <a href="http://hcrenewal.blogspot.com/2013/08/should-we-cry-for-non-profit-hospital.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2013/08/the-long-con-charitable-hospitals-make.html">here</a>.  They are: - We have to pay competitive rates - We have to pay enough to retain at least competent executives, given how hard it is to be an executive - Our executives are not merely competitive, but brilliant (and have to be to do such a difficult job). The talking points are usually supplied by hospital public relations personnel, sometimes by hospital trustees or executives, sometime by various health care consultants.  The talking points are rarely questioned.</blockquote> There Really Were Talking Points, at Least at Cigna I hypothesized that perhaps public relations managers at various hospitals might actually have organized these talking points, since so many news stories of executive compensation in health care seemed to faithfully follow the pattern.  That was, however, speculation.  However, now there is anecdotal evidence that public relations executives really did use these talking points to defend their bosses' compensation. Wendell Potter is the former head of public relations for for-profit health insurance company Cigna who defected, and now advocates for honest, fair health care.  On June 9, 2014, he <a href="http://wendellpotter.com/2014/06/skyrocketing-salaries-for-health-insurance-ceos/">wrote</a> in <a href="http://wendellpotter.com/blog/">his blog</a> about the latest revelations about outrageous executive compensation given to health insurance CEOs (as summarized above).  <blockquote class="tr_bq">When I handled financial communications for Cigna, the day I dreaded most every year was the day we filed the company’s proxy. That’s because I knew I would get calls from reporters wanting to know how we could justify paying the CEO so much when most other employees were lucky to get 3 percent raises. I always had talking points drafted with plenty of help from the company’s lawyers and HR executives. They didn’t vary much from year to year. Basically, all I said was, hey, this is a very big company, the CEO has a very big job and his pay is in line with what other firms of similar size pay their top guys.</blockquote> So there you are.  First, at least at this company, it appears that an important responsibility of the company public relations department was to defend the CEOs pay.  In my humble opinion, this confirms my suspicion that corporate public relations and marketing often put the personal interests of the top company executives ahead of everything else, including the interests of shareholders of for-profit companies in fair executive compensation, and the interests of patients in reasonable health care costs. Second, there really were talking points used at least in this company's public relations that were pretty similar to those I hypothesized:  - We have to pay competitive rates = "his pay is in line with what other firms of similar size pay their top guys." - We have to pay enough to retain at least competent executives, given how hard it is to be an executive = " this is a very big company, the CEO has a very big job" - Our executives are not merely competitive, but brilliant (and have to be to do such a difficult job) = by implication. You heard it here first. So maybe we should all be a lot more skeptical about executive compensation.  Unfortunately, Mr Potter suggests we may be getting less so. <blockquote class="tr_bq">I made frequent use of those talking points the first couple years. But toward the end of my 15 years at the company, I would rarely get more than one or two calls. By 2008, the year I left, the phone didn’t ring at all, at least not from the media. Fewer and fewer reporters even bothered to look at the proxy statements.</blockquote> Of course, that may have something to do with the general decline of journalism, perhaps partially due to the transformation of journalism into a pursuit of a few big corporations, lead by overly compensated executives. Furthermore, instead of the talking points, consider some recent ideas about causes and effects of excess executive compensation.  We have discussed some of these frequently, but here are some recent versions. Causes of Excess Executive Compensation Cronies on the Board - from an Associated Press story <a href="http://www.usnews.com/news/business/articles/2014/05/27/the-ceo-got-a-huge-raise-you-didnt-heres-why">via US News and World Report</a>, <blockquote class="tr_bq">Some board members defer to a CEO's judgment on what his or her own compensation should be. There's a good reason: Many boards are composed of current and former CEOs at other companies. And in some cases, board members are essentially hand-picked or at least vetted by the CEO. Not surprisingly, the boards' compensation committees offer generous bonuses.</blockquote> In more detail, from <a href="http://www.startribune.com/opinion/commentaries/258379541.html">an op-ed in the Minneapolis-St Paul Star Tribune</a>, <blockquote class="tr_bq"> Under current practice, a nominating committee made up of current board members selects nominees to be presented to the shareholders for approval. Since there are rarely any more nominees than open positions, being nominated virtually assures election. These elections are the same as what you would expect in a communist country where voters vote yes or no on a single candidate.  The nominating committee is usually selected by the board chairman and the CEO (in too many cases, the same person). The CEO and the chairman are almost always on the nominating committee. It is in the CEO’s interest to select board members whose loyalty can be trusted. In many cases, a nominee’s primary qualification is loyalty to the CEO and the board chairman, with little knowledge of or experience in the business. Often there is a prior business or personal relationship to the nominee and very often the CEO and/or the chairman serves on the board of a nominee, a cozy mutual back-scratching arrangement. Serving on the board is prestigious and lucrative and abounds in perks. Besides cash and/or stock options or grants, perks such as company-paid travel to foreign trade shows, board meetings in posh resorts (with spouses, of course) and other company benefits make continuing on the board the first priority of most board members, with shareholder interests a distant second priority. This is akin to a politician whose first priority is to get re-elected and whose constituents’ interests come next.  To maintain continuation of this bonanza of benefits, the board member must be assured of being renominated by the nominating committee. Since the CEO and the chairman are on the nominating committee, which they selected, they have great influence over the ultimate choices for nominees. Now, if you are a board member and want to be assured of being renominated, it pays (literally) to be looked upon favorably by the CEO and the chairman. </blockquote> Note that both of these accounts referred to for-profit corporations, but could easily apply to boards of non-profit organizations as well.   Note further that crony boards violate the expectations of their charges, which are to defend the organizations' mission and the interests of all their stakeholders, not just a few top executive cronies. The Ratchet, or "Lake Wobegon" Effect -  from an Associated Press story <a href="http://www.usnews.com/news/business/articles/2014/05/27/the-ceo-got-a-huge-raise-you-didnt-heres-why">via US News and World Report</a>, <blockquote class="tr_bq">Robert Solow, a Nobel Prize-winning economist, recently observed that CEOs live in 'Lake Wobegon,' that fabled town created by radio show host Garrison Keillor where, it is said, 'all the children are above average.' Solow didn't mean it as a compliment. Corporate boards often set CEO pay based on what the leaders of other companies make. No board wants an 'average' CEO. So boards tend to want to pay their own CEO more than rival CEOs who are chosen for benchmarking compensation packages. This will 'naturally create an upward bias' in pay, Charles Elson and Craig Ferrere of the University of Delaware concluded in a 2012 paper. '(T)he compounded effect has been to create a significant disparity between the pay of executives and what is appropriate to the companies they run.'</blockquote> Note that the Lake Wobegon effect is based on a logical fallacy.  All CEOs cannot be above average.  CEOs as "Great Men" - from an <a href="http://www.washingtonpost.com/opinions/great-men-great-pay-why-ceo-compensation-is-sky-high/2014/06/12/6e49d796-d227-11e3-9e25-188ebe1fa93b_story.html">op-ed in the Washington Post</a>, <blockquote class="tr_bq">It is a system that rests on the Great Man theory of history: a school of thought that attributes virtually all important developments through time to heroic individuals. Think back to Jack Welch’s 20-year reign as chief executive of General Electric. He was lauded as a corporate leader and management guru who, seemingly single-handedly, grew the company’s revenue and market capitalization many times over. Before long, GE had become a synonym for Jack Welch (or was it the other way around?).</blockquote> The theory is from the 19th century, <blockquote class="tr_bq"> As a historian trying to parse America’s enthrallment with superstars, I keep coming back to the Great Man theory of history. Popularized in the mid-19th century by the Scottish essayist Thomas Carlyle, this concept holds that history is largely attributable to the actions of great individuals, who because of their personal (and often mysterious) qualities — such as intelligence, wisdom, deftness, goodness and energy — use their agency to make a big impact. 'In all epochs of the world’s history,' <a href="http://grammar.about.com/od/classicessays/a/On-Heroes-And-Hero-Worship-By-Thomas-Carlyle.htm" title="grammar.about.com">Caryle wrote</a> in his 1841 book, <a href="http://www.amazon.com/gp/product/1461064619?ie=UTF8&camp=1789&creativeASIN=1461064619&linkCode=xm2&tag=thewaspos09-20" title="www.amazon.com">'On Heroes, Hero-Worship and the Heroic in History,''</a> 'we shall find the Great Man to have been the indispensable saviour of his epoch.'</blockquote> But it makes no real sense, <blockquote class="tr_bq"> Such lionization is misplaced. Operating a sustainable enterprise, as any executive, manager or employee knows well, is inherently a team sport. Across companies and industries, this activity depends on many people working in concert in all kinds of groups, at all levels of the organization. Such interdependence means that it is hard to precisely delineate, much less quantify, any one individual’s contribution, even that of the most senior manager, to a firm’s performance.</blockquote> This is particularly true in health care, and particularly in organizations that provide direct patient care.  In my humble opinion, it is ridiculous to lionize managers when health care professionals actually take care of patients, using tests and treatments developed by other professionals and scientists.  Effects of Excess Executive Compensation Declining Morale of all Other Employees -  from an Associated Press story <a href="http://www.theguardian.com/business/2014/may/27/us-ceo-median-package-rise-10m">via the UK Guardian</a>, <blockquote class="tr_bq"> 'There's this unbalanced approach, where there's all this energy put into how to reward executives, but little energy being put into ensuring the rest of the workforce is engaged, productive and paid appropriately,' says Richard Clayton, research director at Change to Win Investment Group, which works with labor union-affiliated pension funds.</blockquote> The CEO Disease - per Dan Quiggle, who invented the term, <a href="http://www.exchangemagazine.com/morningpost/2014/week24/Thursday/14061910.htm">in Exchange Magazine</a>, which leads to: <blockquote class="tr_bq">You either hear really good things from your people…or nothing at all. You don’t trust the feedback you receive. You take criticism too personally. In general, your employees don’t seem engaged. Your best employees are unhappy or leaving. You don’t connect with people in a way that leads to loyalty.</blockquote> That is, bad management, and hence... Poor Organizational Performance - from a <a href="http://www.forbes.com/sites/susanadams/2014/06/16/the-highest-paid-ceos-are-the-worst-performers-new-study-says/">Forbes column by Susan Adams</a>,  Across the board, the more CEOs get paid, the worse their companies do over the next three years, according to extensive <a href="http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1572085">new research</a>. This is true whether they’re CEOs at the highest end of the pay spectrum or the lowest. 'The more CEOs are paid, the worse the firm does over the next three years, as far as stock performance and even accounting performance,' says one of the authors of the study, Michael Cooper of the University of Utah’s David Eccles School of Business. Since most health care CEOs seem to know more about finance and health care, I wonder if this effect is even more pronounced on health care quality and patient outcomes? Income Inequality and a Declining Economy - from <a href="http://www.fiercehealthcare.com/story/ceo-compensation-time-reign-skyrocketing-salaries-incentives/2014-06-19">an editorial in FierceHealthcare</a>, <blockquote class="tr_bq">Indeed, the continual <a href="http://www.fiercehealthfinance.com/story/healthcare-ceo-pay-skewing-economy/2014-06-12" target="_blank">rise of executive paychecks may contribute to inequities in the U.S. economy</a>, according to a new Roosevelt Institute paper, 'Taking Stock: Why Executive Pay Results in an Unstable and Inequitable Economy.' 'The toxic combination of stock-based executive pay and open-market stock repurchases has contributed to not only the growing concentration of income at the top but also the failure of the U.S. economy to sustain existing middle-class jobs and create new ones,' wrote author William Lazonick, professor and director of the Lowell Center for Industrial Competitiveness at the University of Massachusetts.</blockquote> Civil Unrest - from a <a href="http://www.washingtonpost.com/opinions/robert-j-samuelson-the-ceo-aristocracy-may-not-be-worth-all-that-money-they-get/2014/06/22/d0bbd596-f888-11e3-8aa9-dad2ec039789_story.html">Washington Post op-ed by Robert J Samuelson</a>, <blockquote class="tr_bq">Americans dislike aristocracies. Unless companies can find a more restrained pay system, they risk an anti-capitalist public backlash. This is the ultimate danger.</blockquote> Summary So far, the rise of executive compensation in health care has been inexorable.  Much of the public and many health care professionals have been lulled into complacency, or paralyzed by learned helplessness.  Yet the talking points used to justify outrageous executive pay are nonsense.  Rising compensation seems to be really due to crony capitalism, logical fallacies, and false historical analogies.  Rising pay may lead to poor management, poor organizational performance, worsening social inequality, a failing economy, and ultimately civil unrest.  Although the transition of executives into a new aristocracy is a society wide, if not a global problem, we in health care cannot be complacent that someone else will solve it.  True health care reform would enable accountable leadership that puts the health care mission and patients' and the public's health ahead of personal gain.

A Real Example of Public Relations Talking Points to Justify Outsize Executive Compensation - and Why We Should No Longer be Fooled

We frequently discuss outsize executive compensation in health care organizations as both a symptom and a cause of these organizations' poor leadership and governance, and hence of widespread health c…

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25 Jun 2014

Sovaldi - a "Revolution" in Clinical Care, or in Marketing and Public Relations?

The continuing public discussion of the sky high price Gilead has set for Sovaldi (sofosbuvir,) its new antiviral drug for hepatitis C, continues to avoid considering the lack of good evidence that the drug is as safe and effective as its proponents claim. We first <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">posted</a> about the Sovaldi debate on March 27, 2014, and its focus on price rather than the quality of the evidence underlying loud claims about the miraculous qualities of the drug.  We suggested that there is no good evidence supporting claims that most hepatitis C patients have very bad outcomes if untreated, treatment prevents most bad outcomes, Sovaldi cures nearly all patients, and Sovaldi has very few side effects. In a subsequent post we wrote that initially, "no one but your humble blogger seemed to be <a href="http://hcrenewal.blogspot.com/2014/04/knee-deep-in-hoopla-triumph-of-medical.html">publicly skeptical </a>about published assertions that the drug was some sort of modern miracle, and a triumph of medical science." On May 7, we <a href="http://hcrenewal.blogspot.com/2014/05/some-authoritative-skepticism-about.html">noted</a> an assessment by the German Institute for Quality and Efficiency in Health Care (IQWiG) of information submitted by "industry" (presumably Gilead) to the German government.  This assessment found multiple problems with the evidence, including limited generalizability, problems with randomization, lack of information about important outcomes, and lack of ability to quantify benefit.   Also  the US based Institute for Clinical and Economic Review noted that there was little evidence that compared to previous treatments, Sovaldi is better, and no evidence that Sovaldi produces cures in the long term. Nonetheless, the notions that the evidence supporting Sovaldi (and perhaps other similar drugs) is weak, and that the drugs therefore should not yet be considered miracle cures have not seemingly affected the public discussion.  Examples of the Latest Discussion Washington Post/ Kaiser Health News On May 12, 2014, in an <a href="http://www.kaiserhealthnews.org/stories/2014/may/12/medicare-struggling-with-hepatitis-c-cure-costs.aspx">article</a> on the dilemma the drug's US price of $1000/ pill presents to Medicare, Richard Knox wrote this about a patient with the infection: <blockquote class="tr_bq">Previous drug treatments didn't clear the virus from Bianco's system. But it's almost certain that potent new drugs for hep-C could cure him. </blockquote> In other words, the article asserted that Sovaldi and similar drugs cure nearly everyone with hepatitis C, even those not cured by previous treatment.  Reuters On May 20, 2014, in an <a href="http://www.reuters.com/article/2014/05/20/us-insurance-gilead-sciences-drugcosts-idUSKBN0E029U20140520">article</a> about how US health insurers are balking at the price of Sovaldi, was this statement by the main trade organization for US for-profit health care insurers, America's Health Insurance Plans (AHIP), <blockquote class="tr_bq">Sovaldi has shown tremendous results, and it's the kind of medical innovation we need to sustain. </blockquote> In the article's text was the assertion, <blockquote class="tr_bq">The new drug has demonstrated an ability to cure well over 90 percent of patients in just 12 weeks or less with few side effects. Prior to the Sovaldi approval, hepatitis C treatments took 24 or 48 weeks, cured about 75 percent of patients and involved many more pills as well as injectable interferon that causes flu-like symptoms and other side effects that led many people to avoid or discontinue treatment.</blockquote> In other words, the article asserted that Sovaldi can cure over 90% of patients compared to the cure rate of 75% provided by previously available treatments, and implied Sovaldi has fewer side effects. CNBC On May 22, 2014, in an <a href="http://nbr.com/2014/05/22/the-84000-question-will-focusing-on-drug-prices-rein-in-costs/">article</a> on the high costs of new drugs, a quote from Dr Douglas Dieterich, "a liver disease specialist at Mount Sinai Hospital," who "has consulted for pharmaceutical companies, including Gilead," appeared, <blockquote class="tr_bq">I don’t think there’s any question that treating patients with hepatitis C will lower overall health-care costs in the coming 20 years,... If we could get rid of the liver disease in these patients with hepatitis C, prevent them from dying of liver cancer, cirrhosis and liver failure, then there’s no question the cost will be less.</blockquote> The implication was that the new drugs can get rid of the disease, that is, cure it, and in doing so prevent early mortality, cirrhosis, and liver failure. CTV The discussion of Sovaldi in Canada seems similar. On May 25, 2014, an <a href="http://www.ctvnews.ca/health/hepatitis-c-drugs-show-promise-but-price-is-too-high-for-most-patients-1.1837917">article</a> on the high cost of hepatitis C drugs in Canada from CTV, "Canada's largest private broadcaster," (look<a href="http://www.ctv.ca/About/Corporate-Info/About.aspx"> here</a>) quoted a Canadian physician, <blockquote class="tr_bq"> Dr. Curtis Cooper, director of the viral hepatitis program at the Ottawa Hospital, said the drugs Sovaldi and Galexos offer a revolution for patients with the hepatitis C virus (HCV). 'It only requires 12 weeks of treatment and (they) are producing cure rates of 90 to even 100 per cent,' he told CTV News.</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div> And later, addressing the treatment of a particular patient, <blockquote class="tr_bq">We're talking about curative therapies, which could potentially save her from liver failure, save her from liver cancer</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Again, the assertions were that the drug cures 90%, maybe 100% if patients, and that cure will prevent liver failure and cancer.</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Is There Any Good Evidence?</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Again, while there is much discussion, and some outrage over the $1000 per pill price of Sovaldi in the US (in Canada, a bargain at Canadian $650 per pill), all the discussion seems to assume that the pill is really a "revolution" (as per CTV), that provides</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">- cure rates of 90 - 100%, much better than previously available treatments</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">- lower adverse effect rates than than those caused by previously available treatments</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">-  prevention of complications of hepatitis C, including cirrhosis, liver failure, liver cancer, and early death.</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">I have found just one recent media article that throws a bit of evidence-based cold water on these claims, and refers to a new systematic review that should be generating a lot of interest, and provoking much more skepticism about the drug, but so far is not. </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">The Single Skeptical Article </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">On May 22, 2014, a MedPage Today article noted a new systematic review of sofosbuvir (Sovaldi) that had a very different message from the articles above.  In summary,</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq">The evidence base for one of the star hepatitis C drugs is poor and the guidelines for its use are flawed, according to a report obtained by the <a href="http://medicaiddirectors.org/about" target="_blank">National Association of Medicaid Directors</a>. According to the report, studies of sofosbuvir (Sovaldi) are generally of poor quality, mostly directed by the drug's maker, and don't answer key questions, including whether the drug is better and safer than the current standard of care. The only available guidelines for its use -- guidelines created by the <a href="http://www.aasld.org/" target="_blank">American Association for the Study of Liver Diseases</a> and the <a href="http://www.idsociety.org/" target="_blank">Infectious Diseases Society of America</a> -- are 'methodologically flawed,' according to the report, which was prepared by the<a href="http://www.ohsu.edu/xd/research/centers-institutes/evidence-based-policy-center/" target="_blank"> Center for Evidence-Based Policy</a> at Oregon Health and Science University in Portland (OHSU). In addition, their authors and sponsors had 'multiple and significant conflicts of interest,' the report argued.</blockquote> The Report from the Center for Evidence-Based Policy The report is public, available without cost direct form the Center (email < centerebp@ohsu.edu> ), although not yet directly available on the web.  It directly addresses all four of the major claims made about Sovaldi that we discussed in our <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">first post</a> n the topic. </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">- Most hepatitis C patients have very bad outcomes if untreated The report cited the best data about outcome prevalence, <blockquote class="tr_bq">approximately 15% to 25% of people infected with HCV will clear the virus during the acute stage without treatment.  Seventy-five to 85% of infected individuals will develop a chronic HCV infection, and 60% to 70% of patients with chronic infection will develop chronic liver disease.  Over 20 to 30 years, 5% to 20% of infected patients will develop cirrhosis and 1% to 5% will die of cirrhosis or liver cancer.</blockquote> Although a majority of chronically infected patients will develop some liver disease, only a minority will develop cirrhosis or liver cancer. </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">- Treatment prevents most bad outcomes The report stated, <blockquote class="tr_bq">Because of the slow progression of the disease, clinical trials have not evaluated these patient-important conditions [cirrhosis, hepatocellular carcinoma, decompensated liver disease, liver transplant, or death] as trial outcomes.  Instead a surrogate endpoint of sustained virologic response (SVR) has been used to measure success of treatment.  The SVR is defined as undetectable HCV-ribonucleic acid (RNA) levels.  The standard measure of treatment success has been SVR at 24 weeks post treatment (SVR24). Several long-term studies of patients with chronic HCV infection have shown an association between achieving SVR24 and patient-important clinical outcomes.</blockquote> So there is no direct evidence that treatment prevents any of the bad outcomes.  There is only indirect evidence that treatment may reduce the rate of some bad outcomes.  For example, <blockquote class="tr_bq">A 2014 observational study of a VA population found that ... the 5180 (4%) of patients who were able to achieve an undetectable viral load with interferon-based treatment had a 45% reduction in the risk of death ... and 27% reduction in the composite clinical endpoint ... of newly diagnosed cirrhosis, HCC [hepatocellular carcinoma], or liver related hospitalization.</blockquote> However, at best, based on an observational analysis that could have been biased, treatment only may have prevented a minority of bad outcomes. </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">- Sovaldi cures nearly all patients</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> As we noted earlier, there have been only two randomized controlled trials published that compared sofosbuvir with anything else.  One compared it to placebo, and one was the trial we discussed earlier that compared it sofosbuvir with ribavirin to pegylated interferon with ribavirin.  (Look <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">here</a>.)   <blockquote class="tr_bq">All other studies were designed to refine drug dose, drug combination or duration of treatment.</blockquote> Also, <blockquote class="tr_bq">All studies were rated as having a high risk of bias.  No study was judged to have good applicability....  The overall summary judgement for each of the published studies yielded a rating of poor.</blockquote> Furthermore, the review found even more problems with the only study that compared sofosbuvir to active treatment (peg-interferon) than we did.  In particular, that study did not compare sofosbuvir with ribavirin to the current standard regimen of PEG plus weight-based ribavirin.  Instead, it compared it to a regimen that included low dose ribavirin.  By comparing sofosbuvir plus a higher dose or ribavirin, an active drug, to a peg-interferon plus a lower dose of ribavirin, the study design seemed designed to artificially enhance the efficacy of the sofosbuvir containing regimen.   Furthermore, the study did not assess the measure of sustained viral response at 24 weeks currently accepted as the best surrogate variable.  Instead it used SVR at 12 weeks, which may be correlated with SVR24 but is often higher. Thus this choice of endpoint seemed designed to increase the apparent efficacy of the regimens it evaluated.  So sofosbuvir has so far been compared to another active anti-viral regimen against hepatitis C in only one study.  That study was poorly designed and implemented, and its problems seemed likely to enhance the apparent efficacy of sofosbuvir.  Nonetheless, that one study did not show that sofosbuvir was more efficiacious, or safer than peg-interferon. </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">- Sovaldi has very few side effects. </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div>The review had this summary, <blockquote class="tr_bq">The FDA compiled reports of adverse events from four trials....  There were no treatment-related deaths reported [note that we found there were deaths in the one trial that compared sofosbuvir to PEG, look <a href="http://hcrenewal.blogspot.com/2014/04/knee-deep-in-hoopla-triumph-of-medical.html">here</a>]. Approximately 78% of patients receiving placebo, 88% of patients on SOF + RBV treatment and 95% of patients receiving PEG + SOF +RBV reported a side effect from treatment.  The most common side effects were fatigue, anemia, nausea, rash, headache, insomnia and pain....</blockquote> Thus it seems likely that Sovaldi has a lot of side effects, and whether it has fewer than standard treatment is unclear.  Furthermore, <blockquote class="tr_bq">studies on sofosbuvir were small, included populations that were healthier than the general hepatitis C population, were of short duration and had limited follow-up.  In many of the studies, the manufacturer was responsible for recording and reporting adverse events.  In general, reporting of adverse events is often incomplete and discrepancies between clinical trial reports and publications are common....  All of these factors would lead to a bias in under-reporting the true nature of adverse events.</blockquote> Thus there is no good evidence that sofosbuvir has few side effects, or is dramatically safer than older treatments. Summary While there continues to be concern, if not outrage, that the latest treatment for hepatitis C is priced at $1000 per pill, most of those expressing concern seem to assume that the pill is a wonder drug, promising nearly everyone a cure without major side effects.  However, as we first noted in March, 2014, there is no strong evidence to that effect.  In fact, now three skeptical looks at the evidence by people with more resources and perhaps more expertise than we possess have shown similar conclusions. It is a tribute to the power of the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a> that there has been almost no recognition by physicians and other health professionals, journalists, and most amazingly, insurance companies who stand to lose billions paying for Sovaldi, that there is little good evidence that Sovaldi works, much less is superior to previous treatments.  Instead, even America's Health Insurance Plans thought the drug had "tremendous results," not very different from the assertion by the drug's manufacturer that the drug provides "a finite cure," (as reported by Reuters).  One might think that the insurance companies have enough money to invest in some real evidence-based medicine experts who could provide a skeptical assessment of the pricy new drugs and devices for which these companies may pay.  Is it that the commercial insurers are so now so dominated by generic managers who know nothing about health care, medicine, or biomedical science, much less evidence-based medicine that they are unable to resist the marketing and public relations hype? The Sovaldi case is a signal example of how our health care system is awash in marketing hype and public relations buzz that has swamped rational skeptical thinking about logic and evidence.  That marketing and PR is ever enriching managers while it will send the rest of us, health care professionals included, to the poor house.  And all the money we spend will not buy us the promised miracles and triumphs. As we have said until blue in the face, true health care reform would bring some skeptical thinking and regard for evidence and logic into the health policy discussion.

Sovaldi - a "Revolution" in Clinical Care, or in Marketing and Public Relations?

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28 May 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

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

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

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

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

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20 Mar 2014

A Legal Settlement of One Aspect of the Fall of AHERF, Only 15 Years Later

It only took 15 years, but litigation related to one of the most important, but obscure cases of bad health care leadership and governance from the 1990s was finally settled.    Background The Allegheny Health Education and Research Foundation (AHERF) was a large integrated health care system formed out of multiple mergers.  AHERF went bankrupt in 1998, leading to massive layoffs, hospital closures, and the near dissolution of a medical school (which ended up taken over by Drexel University).  We last discussed the case in 2012 <a href="http://hcrenewal.blogspot.com/2012/04/pittsburgh-experiment-ii-another-echo.html">here</a>.. A summary of other important points about it is appended below.  As we <a href="http://hcrenewal.blogspot.com/2008/07/10-years-later-eerie-echo-of-fall-of.html">noted</a> in 2008, although the AHERF bankruptcy appears to be the largest failure of a not-for-profit health care corporation in US history, its story has produced remarkably few echoes for doctors, other health care professionals, health care researchers, and health policy makers. I often use the fall of AHERF as an example in talks, at least the few talks I am allowed to give on such unpleasant subjects. Rarely have more than a few people in the audience heard of AHERF prior to my discussion of it. I only could locate <a href="http://content.healthaffairs.org/cgi/reprint/19/1/7.pdf">one article </a>in a medical or health care journal that discussed the case in detail, but was written too early to address it very completely [Burns LR, Cacciamani J, Clement J, Aquino W. The fall of the house of AHERF: the Allegheny bankruptcy. Health Aff (Millwood) 2000; 19: 7-41.]  I doubt the case is used for teaching in most medical or public health schools, although it.was a formative influence on my <a href="http://www.ncbi.nlm.nih.gov/pubmed/12719032">2003 article</a> on health care dysfunction [Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14: 123-130] and on this <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> blog.  (A book about the case, Merger Games, by Judith Swazey, was published in 2012, and is available <a href="http://muse.jhu.edu/books/9781439907191">here</a> as  a set of PDF files from Project Muse for those with the proper password, but it has not yet had much of an impact, and I confess I have not yet read it.)  The lack of discussion of such a significant case is a prime example of the <a href="http://hcrenewal.blogspot.com/2007/08/bling-bling-poltical-correctness-and.html">anechoic effect</a>.  One Legal Settlement, 15 Years Later, for a Secret Amount But a brief echo of the case did appear in a brief <a href="http://triblive.com/news/allegheny/3875012-74/aherf-settlement-creditors">article</a> in the Pittsburgh Tribune Review published in April, 2013: <blockquote class="tr_bq"><div class="News-body-text"> Lawyers would not say Tuesday how much money an accounting firm will pay to settle a 13-year-old lawsuit claiming it helped destroy one of the state's largest health care systems. </div><div class="News-body-text"> </div><div class="News-body-text"> 'It will result in a very significant recovery,' James Jones, one of the lawyers representing the unsecured creditor of the Allegheny Health Education and Research Foundation, said during a settlement hearing in Pittsburgh federal court. </div><div class="News-body-text"> </div><div class="News-body-text">The creditors in 2000 sued Coopers & Lybrand LLP, the predecessor of PricewaterhouseCoopers LLP, claiming that if auditors in 1996 and 1997 had informed AHERF's board about the foundation's true financial condition, it would have acted to avoid a bankruptcy that resulted in huge losses. The foundation's assets included the Allegheny General Hospital system. </div></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> It seems only fitting, given how anechoic this case has been, that much about this settlement remains obscure,</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq"><div class="News-body-text"> U.S. District Judge David Cercone, in a joint session with U.S. Bankruptcy Judge Judith Fitzgerald, approved the settlement with PricewaterhouseCoopers. </div><div class="News-body-text"> </div><div class="News-body-text"> The company disputes the method the committee used to calculate losses and denies liability in the settlement. </div><div class="News-body-text"> </div><div class="News-body-text">Joseph McDonough, a lawyer for PricewaterhouseCoopers, agreed the settlement amount is significant. He and Jones declined comment. </div><div class="News-body-text"> </div><div class="News-body-text">Jones said during the hearing that a trial could have lasted 40 days. Preparation for the case generated more than 200 depositions, 19 expert opinions and more than a million documents, he said. </div><div class="News-body-text"> </div><div class="News-body-text">The committee sent more than 3,500 notices to creditors about the proposed settlement, and none objected, he said. </div><div class="News-body-text"> </div><div class="News-body-text">Both sides agreed to keep the amount secret, and they discussed with Fitzgerald how to avoid releasing the amount in filings for related bankruptcy action. </div></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Maybe if the case had somehow generated more echoes, health care professionals and policy makers, and patients and the public at large might have learned some of its lessons.  The story of AHERF is not merely that of an unlucky bankruptcy. It shows what can go wrong when health care is taken over by <a href="http://hcrenewal.blogspot.com/search/label/generic%20managers">generic managers</a> who adapt the latest management fads, and health care decision making is ruled by <a href="http://hcrenewal.blogspot.com/search/label/marketing">marketing</a>, <a href="http://hcrenewal.blogspot.com/search/label/public%20relations">public relations</a> and <a href="http://hcrenewal.blogspot.com/search/label/propaganda">propaganda</a> instead of evidence and logic, and allows power to be <a href="http://hcrenewal.blogspot.com/search/label/concentration%20of%20power">concentrated</a> in organizations run by<a href="http://hcrenewal.blogspot.com/search/label/imperial%20CEO"> imperial CEOs</a>.  .</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">We did not get a chance to learn this history, so we seem bound to repeat it.   </div></div> Appendix Some important points about AHERF not found above (see also <a href="http://www.acponline.org/chapters/ri/nl-fall04.pdf">this narrative</a>, starting on page 5): <ul><li>AHERF, one of the largest health care systems of its day, was built by the poster-boy for health care imperial CEOs, Sherif Abdelhak.</li><li>Abdelhak, who <a href="http://www.post-gazette.com/aherf/part2.asp">started as food services purchasing manager </a>at Allegeheny General Hospital, was repeatedly hailed as a "visionary" (<a href="http://www.acponline.org/journals/news/mar97/phillymc.htm">in the March, 1997, ACP Observer</a>) a "genius," and the like. His plans to create a huge integrated health care system were part of the wave of the future. Abdelhak was even invited to give the prestigious John D Cooper lecture at the annual meeting of the American Association of Medical Colleges (AAMC), which was published in Academic Medicine [Abdelhak SS. How one academic health center is successfully facing the future. Acad Med 1996; 71: 329-336.] He proclaimed that "we will need to create new forms of organization that are more flexible, more adaptive, and more agile than ever before." And he announced that "my aim as chief executive has been to unleash the creativity and productive potential of every individual and to provide an environment that encourages teamwork" </li><li>While Abdelhak was making these grandiose promises, he paid himself and his associates very well. For example, he received $1.2 million in the mid-1990s, more than three times the average then for a hospital system CEO. He lived in a hospital supplied mansion worth almost $900,000 in 1989. Five of AHERF's top executives were in the top 10 best paid hospital executives in Philadelphia.</li><li>Although Abdelhak talked of teamwork, he warned the combined faculty of the new Allegheny University of the Health Sciences (AUHS): <a href="http://www.post-gazette.com/aherf/part6.asp">"Don’t cross me or you will live to regret it."</a></li><li>As AHERF was hemorrhaging money, Abdelhak continued to pay himself and his cronies lavishly.</li><li>After the AHERF bankruptcy, which was at the time the second largest bankruptcy recorded in the US, Abdelhak was charged with numerous felonies involving receiving charitable assets. In a plea bargain, <a href="http://www.post-gazette.com/localnews/20020830abdelhak0830p4.asp">he pleaded no contest </a>to misusing charitable funds, a misdemeanor, and was sentenced to more than 11 months in county prison.</li></ul>Posted by Roy M. Poses MD to the Health Care Renewal blog

A Legal Settlement of One Aspect of the Fall of AHERF, Only 15 Years Later

It only took 15 years, but litigation related to one of the most important, but obscure cases of bad health care leadership and governance from the 1990s was finally settled. Background The Alleghen…

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12 Jun 2013

A New ECRI Institute Study On Health Information Technology-Related Events

As I wrote <a href="http://hcrenewal.blogspot.com/2012/12/pennsylvania-patient-safety-authority.html" target="_blank">here</a>, I was a reviewer of the report in the PA-based, ECRI Institute-conducted study "The Role of the Electronic Health Record in Patient Safety Events."  ECRI studied the Pennsylvania Patient Safety Reporting System database for HIT-related errors.    <blockquote class="tr_bq">The <a href="http://www.ecri.org/" target="_blank">ECRI Institute</a> is an independent organization renowned for its safety testing of medical technologies and reporting on same, and that "researches the best approaches to improving the safety, quality, and cost-effectiveness of patient care."  I've mentioned it and its bylaws in this blog in the past as a model for independent, unbiased testing and reporting of healthcare technologies. </blockquote> The full report in PDF is <a href="http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2012/Dec;9%284%29/documents/113.pdf" target="_blank">at this link</a>.  In the report, the Pennsylvania Patient Safety Authority analyzed reports of EHR-related events from a state database (the Pennsylvania Patient Safety Reporting System or PA-PSRS, pronounced "PAY-sirs") of reported medical errors and identified several major themes. My review input led to a discrete "limitations" section.  Also, my invited July 2012 presentation to the PA Patient Safety Authority "Asking the Right Questions: Using Known HIT Safety Issues to Improve Risk Reporting and Analysis" with ECRI in attendance (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt" target="_blank">link to PPT here</a>) on the danger of limited datasets due to systematic impediments to information diffusion was apparently taken seriously.  ECRI decided to do something about the knowledge gap, and they asked the right questions. They've just released this summary of a new study they conducted.  I have a few comments which follow:    <blockquote class="tr_bq"><a href="http://www.prnewswire.com/news-releases/ecri-institute-pso-uncovers-health-information-technology-related-events-in-deep-dive-analysis-190064661.html" target="_blank">ECRI Institute PSO Uncovers Health Information Technology-Related Events in Deep Dive Analysis</a> Data transfer, data entry, system configurations, and more identified as serious problem areas   PLYMOUTH MEETING, Pa., Feb. 6, 2013 /PRNewswire-USNewswire/ -- The federal government is spending about $19 billion to encourage hospitals, physician practices, and other healthcare organizations to invest in their health information technology (HIT) infrastructure with the goal of improving patient safety and quality through the Health Information Technology for Economic and Clinical Health (HITECH) Act. Concerned about the unintended consequences of HIT and the potential for errors to cause patient harm, <a href="https://www.ecri.org/PatientSafetyOrganization/Pages/default.aspx" target="_blank">ECRI Institute Patient Safety Organization</a> (PSO) recently conducted a PSO Deep Dive™ analysis on HIT-related safety events. Their just-released 48-page report identified five potential problem areas, which can be assessed with the accompanying toolkit. The <a href="https://eshop.ecri.org/p-140-pso-deep-dive-health-information-technology.aspx" target="_blank">report and toolkit are available for purchase</a> [appx. $350 U.S. - ed.] without membership in ECRI Institute PSO. "Minimizing the unintended consequences of HIT systems and maximizing the potential of HIT to improve patient safety should be an ongoing focus of every healthcare organization," says Karen P. Zimmer , MD, MPH, FAAP, medical director, ECRI Institute PSO. Based on [voluntary - ed.] reports submitted to the PSO from participating organizations, ECRI Institute PSO experts identified the following key HIT-related problems: <ul type="disc"><li>inadequate data transfer from one HIT system to another </li><li>data entry in the wrong patient record </li><li>incorrect data entry in the patient record </li><li>failure of the HIT system to function as intended </li><li>configuration of the system in a way that can lead to mistakes </li></ul> To collect enough reports for meaningful evaluation, ECRI Institute PSO asked participating organizations to submit standardized data about HIT events during a nine-week period. This enabled ECRI Institute PSO to identify patterns and trends from the aggregated data and share the findings, as well as its recommendations. The data in the PSO Deep Dive represents only that collected using the Agency for Healthcare Research and Quality (AHRQ) HIT Common Formats.  [Not the improved formats developed by AHRQ in their <a href="http://healthit.ahrq.gov/HealthITHazardManagerFinalReport" target="_blank">IT Hazards Manager project</a>, still in development - ed.]  ECRI Institute PSO data encompasses over 800 HIT-related events. According to the report, HIT must be considered in the context of the environment in which it operates during the three phases of any HIT project: planning for new or replacement systems, system implementation, and ongoing use and evaluation of the system. "Shortsighted approaches to HIT can lead to adverse consequences," caution the authors. "Healthcare organizations should consider the findings and recommendations in the PSO Deep Dive as part of their effort to achieve those goals," adds Zimmer. The HIT PSO Deep Dive findings were published in a 48-page report and toolkit with self-assessment questionnaire and action plan form available to all ECRI Institute PSO Members and its partner PSO members. The table of contents of the report is available for <a href="https://www.ecri.org/EmailResources/PSRQ/ECRI_Institute_PSO_Deep%20Dive_HIT_TOC.pdf" target="_blank">free viewing/download</a>. Additional information will be presented in ECRI Institute PSO's Monthly Brief free e-newsletter March edition; go to <a href="https://www.ecri.org/psobrief" target="_blank">www.ecri.org/psobrief</a> to sign up. The full report and toolkit are also <a href="https://eshop.ecri.org/p-140-pso-deep-dive-health-information-technology.aspx" target="_blank">available for purchase</a>. For questions about this topic, or for information about purchasing the report, please contact ECRI Institute PSO by telephone at (610) 825-6000, ext. 5558; by e-mail at <a href="mailto:pso@ecri.org" target="_blank">pso@ecri.org</a>; by fax at <a href="tel:%28610%29%20834-1275" target="_blank" value="+16108341275">(610) 834-1275</a>, or by mail at 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA.</blockquote> From the free linked TOC document: Key Recommendations <ul><li>Enlist leaders’ commitment and support for the organization’s health IT projects.</li></ul><ul><li>Involve health IT users in system planning, design, and selection.</li></ul><ul><li>Conduct a review of workflow and processes to determine how they must be modified.</li></ul><ul><li>Evaluate the ability of existing IT systems within the organization to reliably exchange data with any health IT system under consideration.</li></ul><ul><li>Conduct extensive tests before full implementation to ensure that the health IT system operates as expected.</li></ul><ul><li>Provide user training and ongoing support; educate users about the capabilities and limitations of the system.</li></ul><ul><li>Closely monitor the system’s ease of use and promptly address problems encountered by users.</li></ul><ul><li>Introduce alterations to a health IT system in a controlled manner.</li></ul><ul><li>Monitor the system’s effectiveness with metrics established by the organization.</li></ul><ul><li>Require reporting of health IT-related events and near misses.</li></ul><ul><li>Conduct thorough event analysis and investigation to identify corrective measures.</li></ul> My comments are these: <ul><li>The ECRI study, report and recommendations are quite welcome. </li></ul><ul><li>The case reports received were apparently voluntary and probably "conservative" and understated as hospitals are not happy to release data on problems and harms that can lead to, or support, litigation.   </li></ul><ul><li>The study was just 9 weeks long, and with a limited set of healthcare organizations participating.  800 HIT-related events were identified. </li></ul><ul><li> The relevant issues discovered in the events, as summarized in the bullet points above, are capable of causing clinician distraction, incorrect decisions, "use error" (as opposed to "user error", see <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">here</a>), patient harm, and death.  (I am aware of such issues in the press including harms and deaths, as readers here have read at links such as <a href="http://hcrenewal.blogspot.com/search/label/glitch" target="_blank">these</a> and <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">these</a> and <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">these</a> and <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">these</a>, and others about which I am providing expert-witness consultation and cannot share.) </li></ul><ul><li>I believe ECRI has now begun to peer below the water level, through the muck of industry control of the narrative, of what FDA CDRH leader Jeffrey Shuren MD JD referred to as "<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" target="_blank">the tip of the iceberg</a>" - i.e., the current level of knowledge of health IT difficulties, defects and harms. </li></ul><ul><li>The report is yet another red flag for a far more robust (and mandatory, in my view) post-marketing surveillance of health IT.   </li></ul><ul><li>Those who claim these findings are "anecdotes" (as <a href="http://hcrenewal.blogspot.com/2013/02/ama-news-ehr-sloppy-and-paste-and-why.html" target="_blank">here</a>) are looking increasingly foolish and cavalier. </li></ul> Finally, readers of this blog have been reading about these issues for years.  You heard it here first. -- SS

A New ECRI Institute Study On Health Information Technology-Related Events

As I wrote here, I was a reviewer of the report in the PA-based, ECRI Institute-conducted study "The Role of the Electronic Health Record in Patient Safety Events." ECRI studied the Pennsylvania Pati…

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09 Feb 2013

A Condemnation of Suppression of Medical Research... by Ben Goldacre in the New York Times

Amazingly, this topic now seems to be in the mainstream. The Goldacre Version in the New York Times in 2013 In his <a href="http://www.nytimes.com/2013/02/02/opinion/health-cares-trick-coin.html">op-ed</a>, Ben Goldacre introduced it thus: <blockquote class="tr_bq">the entire evidence base for medicine has been undermined by a casual lack of transparency. Sometimes this is through a failure to report concerns raised by doctors and internal analyses, as was the case with Johnson & Johnson. More commonly, it involves the suppression of clinical trial results, especially when they show a drug is no good.</blockquote> He noted that this problems was supposed to be fixed by the registration of clinical trials, and by changes in editorial policies at medical journals: <blockquote class="tr_bq">many in the industry now claim it has been fixed. But every intervention has been full of loopholes, none has been competently implemented and, lastly, with no routine public audit, flaws have taken years to emerge. <div itemprop="articleBody"> </div><div itemprop="articleBody"> The Food and Drug Administration Amendments Act of 2007 is the most widely cited fix. It required that new clinical trials conducted in the United States post summaries of their results at clinicaltrials.gov within a year of completion, or face a fine of $10,000 a day.  But in 2012, the <a href="http://www.bmj.com/content/344/bmj.d7373">British Medical Journal</a> published the <a href="http://www.bmj.com/content/344/bmj.d7373">first open audit of the process</a>, which found that four out of five trials covered by the legislation had ignored the reporting requirements. Amazingly, no fine has yet been levied. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">An earlier fake fix dates from 2005, when the International Committee of Medical Journal Editors <a href="http://www.icmje.org/clin_trial.pdf">made an announcement</a>: their members would never again publish any clinical trial unless its existence had been declared on a publicly accessible registry before the trial began. The reasoning was simple: if everyone registered their trials at the beginning, we could easily spot which results were withheld; and since everyone wants to publish in prominent academic journals, these editors had the perfect carrot. Once again, everyone assumed the problem had been fixed. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">But four years later we discovered, in <a href="http://jama.jamanetwork.com/article.aspx?articleid=184503">a paper from The Journal of the American Medical Association</a>, that the editors had broken their promise: more than half of all trials published in leading journals still weren’t properly registered, and a quarter weren’t registered at all. </div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">Goldacre's conclusions were:</div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody">Withholding data not only misleads doctors and patients; it’s an insult to the patients who have participated in clinical trials, believing that they were helping to improve medical knowledge. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Medicine routinely overcomes enormous technical challenges, and there is nothing complicated about the changes needed to prevent Johnson & Johnson, or Roche — or anybody — from withholding information.</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">Hear, hear! </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Our Version, Starting in 2003 </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Note that 10 years ago, in 2003, in my article on American health care dysfunction that could have been only published in Europe, (Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Intern Med 2003 Mar;14(2):123-130.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/12719032">here</a>)  I noted that an important cause of this dysfunction is that:</div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody">the scientific basis of medicine is increasingly under attack.</div><div itemprop="articleBody"> </div><div itemprop="articleBody">The integrity of medical research has been violated by the deliberate suppression of its results.</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">At that time, I suggested one solution would be:</div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody">Medical schools and universities must re-affirm their support of scholarly work in the spirit of free enquiry,...</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">Furthermore, in <a href="http://hcrenewal.blogspot.com/2004/12/another-facet-of-ssri-suppression-of.html">one of our first posts</a> on Health Care Renewal in December, 2004, in the context of the discovery of internal company documents (in this case, from Eli Lilly) that showed that information about the adverse effects of a drug (in this case, increased aggression associated with fluoxetine, that is, Prozac), we wrote,</div><div itemprop="articleBody"> </div><blockquote class="tr_bq">The increasingly complex story of suppression of SSRI research seems to be part of a growing epidemic of suppression of medical research. </blockquote><blockquote class="tr_bq">Let's say it again. Withholding data from clinical research is unethical because: 1. it breaks the promise to research subjects that their voluntary participation has scientific or social value, but undisseminated research has no value; (See <a href="http://jama.ama-assn.org/cgi/reprint/283/20/2701.pdf">Emanuel EJ et al. What makes clinical research ethical? JAMA 2000; 283: 2701-2711.</a>) 2. it impedes scientific progress; 3. it prevents patients from receiving the best possible medical care. </blockquote><blockquote class="tr_bq"><div itemprop="articleBody">But until this unethical behavior starts having negative consequences for its perpetrators, the epidemic of research suppression is likely to continue. </div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">Note the similarity to what Goldacre published in the Times yesterday.  <a href="http://hcrenewal.blogspot.com/search/label/You%20heard%20it%20here%20first">You heard it here first</a>. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Summary </div><div itemprop="articleBody"></div><div itemprop="articleBody">To date we have published 102 posts with the label "<a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of medical research</a>."  Obviously, Ben Goldacre's NY Times op-ed shows that suppression of research still rarely leads to negative consequences for its perpetrators.  Obviously, by making drugs, devices, and other health care interventions appear safer and more effective than they really are, suppression of medical research has lead to huge revenues for health care corporations, and has made many health care executives exceedingly rich, and many of the health care professionals and academic leaders who have enabled or implemented research suppression somewhat rich.  In the face of such <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a>, until we end the <a href="http://hcrenewal.blogspot.com/search/label/impunity">impunity</a> of those who suppress medical research (and by the way, those who authorize, direct, or implement all sorts of other unethical, criminal and corrupt behavior we discuss on Health Care Renewal) things will not get better.  I can only hope that having this subject appear in a New York Times op-ed may lead to some real progress. ADDENDUM (2 February, 2013) - see also <a href="http://1boringoldman.com/index.php/2013/02/02/watchful-waiting-no-more/">comments</a> on 1BoringOldMan blog.  </div><div itemprop="articleBody"> </div>

A Condemnation of Suppression of Medical Research... by Ben Goldacre in the New York Times

Amazingly, this topic now seems to be in the mainstream.The Goldacre Version in the New York Times in 2013 In his op-ed, Ben Goldacre introduced it thus:the entire evidence base for medicine has been …

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02 Feb 2013

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