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How to Fix EMRs: Shoreline Pools, Electronic Medical Records and Criminally Negligent Homicide

There are many parallels between the health IT sector (with known injuries and deaths [1]; deliberate lack of regulatory enforcement in part due to regulatory capture [2]; willfull blindness and special pleadings by vendors and purchasers regarding the dangers of the devices [3]; 'certification' standards that ignore safety [4], and other cavalier practices), and this tragic story below: <blockquote><a href="http://www.connecticutpersonalinjurylawblog.com/2011/04/swimming-pool-maker-pleads-guilty-to-criminally-negligent-homicide.shtml">Swimming pool maker pleads guilty to criminally negligent homicide</a> Source: Claims Journal "<a href="http://www.claimsjournal.com/news/east/2011/04/15/184540.htm" target="_blank">Pool Company Admits Guilt in Connecticut Boy's Drowning</a>" John Christoffersen, April 15, 2011 After the tragic drowning of a 6-year-old Connecticut boy in 2007, his parents have brought a lawsuit against the swimming pool company. The lawsuit against Shoreline Pools detailed statistics of pool entrapment deaths and injuries caused by unsafe drains. It presented nationwide evidence that more than 150 adults and children have been seriously hurt or killed in <a href="http://www.williamswalshandoconnor.com/Catastrophic-Injuries/Wrongful-Death.shtml" target="_blank">fatal accidents</a> from the lack of automatic pool pump shutdown devices since 1985. [FDA is well aware of deaths and injuries caused by health IT products, and they admit their data is likely just the 'tip of the iceberg.' See <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">Internal FDA memorandum on HIT risks</a> to Jeffrey Shuren MD JD, Director, Center for Devices and Radiological Health - ed.] In a court case involving product liability, a designer or manufacturer is held accountable for product safety [except in the <a href="http://www.emrupdate.com/forums/t/27502.aspx" style="font-weight: bold; font-style: italic;">deliberately-unregulated</a> health IT sector, that may employ Joint Commission Safety Standard-violating '<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda">gag' and 'hold harmless</a>' contract clauses as well - ed.] and may be separately liable for civil damages when a product is linked to wrongful deaths. One industry expert speculated that some swimming pool companies may not have been installing the drain safety device on purpose, hoping that the requirements of the state code would be overturned by industry pressure. [That is, regulatory influence and capture - ed.] Criminal Consequences The swimming pool company and its president have pleaded guilty to charges relating to the wrongful death of a Connecticut boy who drowned when his arm became trapped in a pool drain. Shoreline Pools and its president admitted guilt for failing to install a required safety device that would have detected a blockage and shut down the drain pump, preventing the boy's death. Shoreline Pools will pay $150,000 to purchase swimming pool safety ads as part of its court agreement and guilty plea to second-degree manslaughter. A manslaughter charge against the company president was plea-bargained down to criminally negligent homicide [in effect, it probably was second degree manslaughter, but got reduced as a result of court process - ed.], a misdemeanor carrying less consequential weight. The pool company executive, escaping jail time, has been ordered to perform 500 hours of community service and bring 100 swimming pools up to legal safety standards. At trial, the swimming pool company president said he was not aware of a 2004 state law that mandated the drain safety device [he and the company knew, should have known, or should have made it their business to know, just as health IT companies know, should have known, or should make it their business to know about the toxic effects of their products - ed.] but prosecutors were able to show that the law and the device were both well promoted at trade shows and in safety awareness campaigns among pool manufacturers, even as soon as two full years before the boy's drowning. [Admonitions about heath IT safety risks have been available for far longer - ed.] </blockquote> Judgments of criminally negligent homicide or manslaughter against the designers and purchasers of clinical IT, and health IT and hospital executives, would go a long way to improving health IT safety. Such judgments would likely go far further than the typical "community building workshops" and other selective-attendance, "consensus" government committee meetings now underway. This seems an area wide open for tort actions. -- SS [1] <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">Internal FDA memorandum on HIT risks</a> to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). "Not Intended for Public Use." Feb. 23, 2010. (My description/commentary on the memorandum is <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">at this link</a>). [2] Statements of Jeffrey Shuren, Director, CRDH, Feb. 25, 2010, HHS - Health Information Technology (HIT) Policy Committee Adoption/Certification Workgroup, <a href="http://www.emrupdate.com/forums/t/27502.aspx">http://www.emrupdate.com/forums/t/27502.aspx</a> [3] Statements of Barry Chaiken, MD, MPH, FHIMSS, former Chairman of the Board of health IT trade group <a href="http://www.himss.org/">HIMSS</a>, see <a href="http://hcrenewal.blogspot.com/2010/07/barry-chaiken-md-mph-lets-be-patient.html">http://hcrenewal.blogspot.com/2010/07/barry-chaiken-md-mph-lets-be-patient.htm</a>l [4] Hoffman, Sharona and Podgurski, Andy, Meaningful Use and Certification of Health Information Technology: What About Safety? (October 25, 2010). Journal of Law, Medicine and Ethics; Case Legal Studies Research Paper No. 2010-34. Available at SSRN: <a href="http://ssrn.com/abstract=1697587">http://ssrn.com/abstract=1697587</a> -- Originally posted at Healthcare Renewal http://hcrenewal.blogspot.com by S. Silverstein, MD

How to Fix EMRs: Shoreline Pools, Electronic Medical Records and Criminally Negligent Homicide

There are many parallels between the health IT sector ( with known injuries and deaths [1]; deliberate lack of regulatory enforcement in pa...

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Was the Wright Medical CEO Really "Pleased" to "Continue Our Commitment to the Highest Standards of Legal and Ethical Conduct?"

This story fits into the "if you believed that one, I have a bridge to sell you" category.  Let's go back seven months to 2010, when we <a href="http://hcrenewal.blogspot.com/2010/10/wright-medical-settles-but-wait-there.html">discussed</a> the legal settlement, which included submission to deferred prosecution and corporate integrity agreements by Wright Medical, a device manufacturer.  We noted that the company CEO, one Gary D Henley, said he was "pleased to announce these agreements and look[ing] forward to working with the independent monitor as we continue our commitment to the highest standards of ethical and legal conduct."  At the time, we wondered whether the only real reason he was pleased was that he got to keep his job (with total compensation of greater than $2 million a year) and hang onto his stock options (then consisting of 436,601 shares). Now it is 2011, and the Memphis Daily News <a href="http://www.memphisdailynews.com/editorial/Article.aspx?id=58418">reported</a> that last month, Mr Henley was out of a job: <blockquote>It was just last month that [Chairman David] Stevens was appointed interim president and CEO after Gary D. Henley resigned from the position, which he had held since 2006. Stevens at that time asked not to be considered for the permanent position. Henley tendered his resignation prior to a board of directors meeting called to discuss management’s oversight of the company’s ongoing compliance program. The board accepted Henley’s resignation, but deemed it to be without 'good reason' under the terms of his employment agreement, making him ineligible for severance.</blockquote> He was accompanied out the door by <blockquote>Frank S. Bono, the company’s senior vice president and chief technology officer, for failing to exhibit appropriate regard for Wright’s ongoing compliance program.</blockquote> It appeared that the previous company leadership may not have been all that "pleased" to work with external monitors to "continue our commitment to the highest standards of ethical and legal conduct." The Daily News also reported: <blockquote>Wright Medical Group Inc. on Thursday announced that it received a letter from the United States Attorney’s Office for the District of New Jersey pursuant to Paragraph 50 of the Deferred Prosecution Agreement stating that the USAO believes Wright Medical Group knowingly and willfully breached material provisions of the DPA.</blockquote> Also, Corporate Counsel <a href="http://www.law.com/jsp/cc/PubArticleCC.jsp?id=1202493182276&US_Attorney_Accuses_Wright_Medical_Group_of_Breaching_Deferred_Prosecution_Agreement">reported</a>: <blockquote>Two days after its general counsel departed abruptly, the Wright Medical Group, Inc., said Thursday that the U.S. attorney’s office believes the company 'has knowingly and willfully' breached its deferred prosecution agreement. As a result, the company said it could face 'significant liability' including potential criminal and civil litigation. It also faces possible exclusion from federal health care programs such as Medicare, 'which would have a material adverse effect on our financial condition.' The Tennessee-based company revealed the legal problems in 8-K filings on Wednesday and Thursday with the Securities and Exchange Commission. Wright has declined further comment.</blockquote> One explanation for the company's pessimism: <blockquote>The board recently received a tip about non-compliance and hired unnamed outside counsel to conduct an internal investigation. The probe found 'credible evidence of serious wrongdoing,' which the board communicated to the U.S. attorney’s office on Wednesday.</blockquote> The Memphis Daily News noted that another slew of managers just went out the door: <blockquote>Raymond Kolls, senior vice president, general counsel and secretary, Alicia Napoli, vice president of Clinical and Regulatory Affairs, and Cary Hagan, senior vice president of EMEA Commercial Operations, have all stepped down from their positions.</blockquote> So should we believe Wright Medical Chairman and now interim CEO Stevens when he said: <blockquote>The board is committed to maintaining the highest standards of ethical conduct and we remain diligent in ensuring that Wright Medical complies with all applicable laws and regulations...</blockquote>? Are you looking to buy a bridge? I know a nice one in Brooklyn. More seriously, day in and day out we hear righteous, if not pompous pronouncements from health care organizational leaders about their organizations' integrity, brilliant performance, quality of care, devotion to patients, etc, etc, etc. Meanwhile, we have seen an astonishing <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade of legal settlements</a>, sometimes including guilty pleas to <a href="http://hcrenewal.blogspot.com/search/label/bribery">bribery</a>, <a href="http://hcrenewal.blogspot.com/search/label/fraud">fraud</a>, <a href="http://hcrenewal.blogspot.com/search/label/kickbacks">kickbacks</a>, and other <a href="http://hcrenewal.blogspot.com/search/label/crime">crimes</a> by top health care organizations.  This parade raises serious questions about the performance and integrity of some of our biggest and best known health care organizations. In nearly all cases, these settlements did not include specific negative consequences for those who authorized, directed or implemented the bad behavior that caused the need for the settlements. In nearly every case, the top leaders of the organizations continued to get generous compensation, often more generous than Mr Henley's $2 million plus a year. Yet rarely does the media, much less health care scholarship check back later to see if the righteous pronouncements turned out to be true. Rarely do they check back to see if the settlements lead to better behavior. Here is one vivid anecdote that suggests that the pronouncements may be nothing more than vapid PR, and the settlements lead to no change in behavior as long as the people who were in charge when the bad behavior occurred remain in charge, and richly remunerated. So the next time you see a corporate health care CEO's boasts, think about that bridge in Brooklyn To reprise: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich. [Originally posted on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> by Roy Poses]

Was the Wright Medical CEO Really "Pleased" to "Continue Our Commitment to the Highest Standards of Legal and Ethical Conduct?"

This story fits into the "if you believed that one, I have a bridge to sell you" category. Let's go back seven months to 2010...

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Has the Heart Rhythm Society Become More Like a Marketing Firm?

ProPublica's and USA Today's joint investigation of one medical society's ties to industry has created a stir.  (The full ProPublica version is <a href="http://www.propublica.org/article/medical-societies-and-financial-ties-to-drug-and-device-makers-industry">here</a>.)  It's worth doing a little reading between the lines to see its further implications. The Basic Story The story focused first on the annual meeting of the Heart Rhythm Society (HRS), a sub-specialized medical society for cardiologists who specialize in electrical or rhythm disorders.  The meeting seemingly has become a giant marketing opportunity, supported by $5 million in industry money, in which practically every flat surface became a medium for advertising.  (The ProPublica article included multiple pictures of branded items from carpets in the exhibit halls to the backs of the seats in shuttle buses.) Also, <blockquote>St. Jude Medical adorns every hotel key card. Medtronic ads are splashed on buses, banners and the stairs underfoot. Logos splay across shuttle bus headrests, carpets and cellphone-charging stations. At night, a drug firm gets the last word: A promo for the heart drug Multaq stood on each doctor’s nightstand Wednesday.</blockquote> Then reporters Charles Ornstein and Tracy Weber looked at the HRS as a whole, noting that half the society's total income comes from industry, and "<a href="http://www.propublica.org/documents/item/heart-rhythm-society-disclosure-of-relationship-2011-2012">Twelve of 18 directors</a> are paid speakers or consultants for the companies, one holds stock, and the outgoing president disclosed research ties, according to the society’s website, which does not specify how much they receive."  Furthermore, "Two of the society’s biggest funders — <a href="http://www.propublica.org/documents/item/88080-boston-scientific-settlement-agreement">Boston Scientific</a> and <a href="http://www.propublica.org/documents/item/88081-st-jude-settlement-agreement">St. Jude Medical</a> — have paid millions since 2009 to settle federal allegations that they improperly paid kickbacks to unidentified physicians to use their cardiac devices. Neither company admitted wrongdoing." The article raised tantalizing questions and implied others, but despite the reporters' best attempts, leaders of the HRS and their defenders failed to address them.  Their failure to grapple with the real issues is to me the most disturbing part of the story. Why Take the Money? ProPublica published a <a href="http://www.propublica.org/article/the-heart-rhythm-society-responds-to-propublicas-questions">companion piece </a>consisting of questions to and responses from the HRS President, Dr Douglas L Packer, and President-Elect, Dr Bruce L Wilkoff. The first response was the rationale for taking the money: <blockquote>Advances in electrophysiology depend on a collaborative relationship between physicians and industry....</blockquote> Later, <blockquote>It is imperative that we interact with industry to develop better therapies and test them thoroughly in rigorous clinical trials. </blockquote> This response is very common from physicians and other health professionals defending relationships with industry. Note that this response, similar to previous ones, is off the point. The issue is not all relationships with industry. It is about relationships in which industry pays people, or in this case, a group of people for purposes not always clear, but when clear are related to marketing. Payments from industry to physicians and health professionals are not necessary for collaboration. If the goal is innovation and development of therapies, how is that supported by payments to a medical society to provide marketing opportunities? Why Subject the Meeting Attendees to All That Advertising? Much of the money received by the society was obviously for marketing purposes. The effect of these payments was the advertising barrage noted above. So the obvious questions are: is it beneficial for the society to expose its members and other meeting attendees to all this marketing?  Should making its members accessible to marketing be a major part of the society's activities? When <a href="http://www.propublica.org/article/the-heart-rhythm-society-responds-to-propublicas-questions">questioned by ProPublica</a>, the organization's leadership evaded: <blockquote>Q. Items at your conference—from key cards to newspaper wraps—are available for sponsorships. What is the purpose of these sponsorships? Does the livelihood of the organization depend on them? Do the ads have an impact on what your members buy and use in their practices? A. The Heart Rhythm Society offers sponsorship opportunities at the annual scientific sessions to provide advertising opportunities for participating exhibitors. Approximately 50 percent of the revenue for the annual scientific sessions is generated by industry in a combination of exhibit space rental (largest), sponsorship/promotional advertising opportunities, unrestricted educational grants and exhibitor office suites. The society does not collect data or ask attendees if sponsorship or advertising impacts their purchase decisions. </blockquote> Very few people quoted in the ProPublic series ventured to defend the marketing onslaught. There was only this. In a <a href="http://www.propublica.org/article/heart-docs-reject-claims-of-bias-from-industry-money">newer follow up article</a>, Chris Ornstein quoted meeting attendees with similar sentiments: <blockquote>'I’ve always been rather offended that people who aren’t doctors think I’m susceptible to bribes and corruption,' [Raleigh, NC electophysiologist Dr Mark] Englehardt said. 'A lot of what you learn about products is from people that sell the products. … You have to learn it somewhere.'</blockquote>Note that the good Dr Englehardt lead off by invoking a <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw-man fallacy</a>. Being influenced by advertising is not the same as taking bribes. No one accused those attending the conference of taking bribes. More importantly, his argument in favor of advertising invoked a <a href="http://www.iep.utm.edu/fallacy/#False%20Dilemma">false dilemma</a> (or false dichotomy). There certainly are sources of information about products, and particularly about electrophysiologic devices, beyond manufacturers' advertising.  The choice is not simply ignorance versus advertising. Others merely sought to minimize the harms of exposure to so much advertising. For example, one of the HRS' defenders, who not coincidentally runs a much larger medical society, which also has had its issues with its extensive ties to industry, (look <a href="http://hcrenewal.blogspot.com/search/label/American%20College%20of%20Cardiology">here</a>) said: <blockquote>The 'circus element' of the exhibit booths doesn’t unduly influence attendees, [CEO of the American College of Cardiology Jack] Lewin said. 'I don’t buy a soft drink just because of the advertising… I buy it because I like it.'</blockquote> Maybe not, but the analogy may not be apt. Furthermore, we have seen a stream of physicians, other health professionals, and academics deny that they are influenced by marketing or monetary incentives. It is hard to believe, however, that industry would spend so much trying to influence opinions without some evidence that the money provides some results. In addition, most people seem to lack insight about what influences their opinions, especially when consciously admitting such influence might threaten their self-image. On the other hand, the follow-up article also noted: <blockquote>Some doctors acknowledged that the corporate barrage must have some effect. 'I hope not, but I’m certain that it does,' said Dr. Christopher Conley of Nashville, Tenn. 'I’m sure the companies do their own research. They wouldn’t be here, they wouldn’t be putting all this money out if it didn’t influence people.'</blockquote> It seems obvious that all the advertising was meant to sell products. It seems unlikely that marketers spend so much money without some reason to believe it would have an effect. Even if it had little effect, was there any benefit to selling all that marketing space that would counter-act one glaringly obvious harm? By raising so much money from such obvious and widespread marketing, the Cardiac Rhythm Society meeting is liable to be viewed more as a marketing event than a serious scientific or professional venue. Is It a Professional Society, or a Marketing Firm? As noted above, accepting so much money for such a large marketing presence at its national meeting makes the Heart Rhythm Society appear to resemble a marketing firm.  Other information revealed by ProPublica increases the apparent similarity.  Societies are groups of people who gather for a common purpose.  Medical societies ought to be groups of doctors who gather for common purposes, usually including promoting their own professional interests and upholding professional values.  They typically used to convene meetings for educational or advocacy purposes, and publish journals or other media.  Thus their typical sources of revenue could be dues, meeting registrations, and subscription and similar fees.  However, as noted above, half of the Heart Rhythm Society's budget comes from industry, specifically "from makers of drugs, catheters and defibrillators used to control abnormal heart rhythms,"<a href="http://www.propublica.org/article/medical-societies-and-financial-ties-to-drug-and-device-makers-industry"> according to ProPublica.</a>  The picture was similar in 2009.  I reviewed the organization's most recent (2009) financial disclosure (990 form) filed with the US Internal Revenue Service and made <a href="http://www.guidestar.org/FinDocuments//2009/042/694/2009-042694458-06074ec3-9.pdf">available to the public by Guidestar</a>.  In that year, the organization's total revenues were $14,772,708.  Revenues from "grants and sponsorships" were $4,061,883 and from annual meeting exhibits were $3,065,750, for a total of $7,127,633.  So only about half of the society's revenues came from traditional sources, including meeting registration ($4,749,974) and dues ($1,513,361).  Given that some of the registration fees doubtless came from industry attendees, and some product sales ($212,298) and royalties ($511,760) also came from industry sources, the organization's revenue makes it appear at least at least as much like a marketing firm as a medical society.  Note that one group of beneficiaries of this industry largess was the organization's paid managers.  The 990 form listed eight executives who made over $150,000 a year in the worst years so far of the Great Recession.  Its CEO received total compensation of $532,691.  His compensation used 3.6% of the organization's total revenue.  Moreover, the majority of the Heart Rhythm Society's board and officers have major ties to manufacturers of drugs and devices used in the diagnosis and treatment of heart rhythm problems.  As noted above, 12/18 directors were found to have ties to the companies which advertised at the meeting.  Perusal of disclosure forms which the Society, to its credit, does make public <a href="http://www.hrsonline.org/About/Governance/bot_10.cfm">here</a>, revealed only three of 20 officers and directors who had nothing to disclose in 2011-12. The current President, Dr Douglas L Packer, had two pages of disclosures, including 10 different device or biotechnology companies from whom he got "significant" (over $10,000) grants or royalty income.  Many other board members and officers had "significant" financial relationships, consulting/ honoraria, speakers' bureau membership, equity interests, with drug, biotechnology, or device companies which make products relevant to cardiac rhythm disorders.   The leaders of the society asserted their ability to "manage" industry relationships: <blockquote>Due to thorough policies and procedures in place for working with industry, the Heart Rhythm Society is comfortable identifying and managing various interactions with industry. Additionally, the society seeks multiple supporters for its educational programs in order to avoid the perception that programs are tied to a specific company. The society has sufficient measures in place to prevent undue influence from industry or introduction of industry bias into HRS-sponsored educational programs, research, scientific documents and policy initiatives. </blockquote> Later, when directly questioned about the implications of receiving half the organization's funding from industry, they evaded again: <blockquote>Q. Some researchers on conflicts of interest say that when a medical society receives half of its funding from industry, it is codependent on them and therefore will—consciously or not—avoid criticizing the products they make. How would you respond? A.  The Heart Rhythm Society’s first and foremost concern is to provide effective and appropriate treatment options to our patients.  It is imperative that we interact with industry to develop better therapies and test them thoroughly in rigorous clinical trials. For this reason, we believe that interacting with industry is not inherently wrong with the correct measures in place to mitigate the possibility of conflicts of interest. Moreover, the Society maintains a neutral position on all products and services offered by industry. The U.S. Food and Drug Administration is our source for information about new products, safety alerts and drug recalls. </blockquote> Half of the organization's revenues come from industry, and the organization is willing to expose its meeting attendees to a barrage of advertising to obtain most of these revenues. Providing such advertising does not seem to maintaining "a neutral position." Do its leaders really mean that this proportion of support has no influence on them or how the organization is run? Nearly all the organization's officers and directors have their own financial relationships with industry. Do they really think that these relationships have no effect on their thinking? Would the leaders be indifferent to losing half of the organization's financial support and their own personal financial relationships with industry? If they would not be indifferent to this eventuality, can they argue they are uninfluenced?  Would the organization's CEO, whose compensation is over 3% of the organization's total revenue, be indifferent to a decrease of 50% in that revenue?  If not, could he be uninfluenced by the source of this revenue? Summary: Why Pay Dues to a Marketing Firm? As health care dysfunction has gotten worse over the years, as costs rise, access falls, and quality stagnate, as physicians are subject perverse incentives and deceptive marketing, as the medical research literature has been suppressed and manipulated, there have been surprisingly few responses from medical societies.  The case study provided by ProPublica of one such society suggests one reason why.  Medical societies seem to behave increasingly like marketing firms.  The majority of their revenue may not come from their members.  They may be willing to subject their members to a flood of marketing to make more money.  Their leaders may have extensive relationships with industry.  Their paid managers may be dependent on industry revenue for out sized compensation. If medical societies have come to resemble marketing firms, is it any wonder that they have not spoken up against the commercialization of health care, even when the result has not been good for physicians' core values?  But in that case, why would physicians who care about their patients and their core values want to belong and pay dues to marketing firms?  Inquiring minds want to know.... Maybe physicians should only join medical societies that really act like medical societies. For further discussion in the blogsphere, see <a href="http://gooznews.com/?p=2811">this post</a> by Merrill Goozner on the GoozNews blog, <a href="http://brodyhooked.blogspot.com/2011/05/new-from-propublica-medical-specialty.html">this post</a> by Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, <a href="http://carlatpsychiatry.blogspot.com/2011/05/lub-dub-lub-lub-lub-dubka-ching.html">this post</a> by Daniel Carlat on the Carlat Psychiatry blog, and<a href="http://pogoblog.typepad.com/pogo/2011/05/pharma-medical-device-industries-buying-influence-with-medical-advocacy-groups.html"> this post</a> by Paul Thacker on the Project on Government Oversight blog.

Has the Heart Rhythm Society Become More Like a Marketing Firm?

ProPublica's and USA Today's joint investigation of one medical society's ties to industry has created a stir. (The full ProPub...

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Logical Fallacies to Defend CEOs from Responsibility for their Companies' Bad Actions

There is now quite a kerfuffle over the US Department of Health and Human Service's threat to to stop doing business with the CEO of Forest Laboratories.  As we noted <a href="http://hcrenewal.blogspot.com/2011/04/will-pharmaceutical-ceo-finally-be-held.html">here</a>, his company pleaded guilty to obstruction of justice and misbranding, and agreed to pay a $313 million fine.  The major allegations by the government were that the company marketed antidepressants to children when they had only previously been approved for adults. Their marketing tactics allegedly included suppressing negative studies, and paying physicians to prescribe the drugs. The kerfuffle involves a number of ostensible authorities and pundits defending the CEO, and challenging the government's attempts to hold him responsible for his company's actions.  The kerfuffle also provides some splendid examples of logical fallacies deployed in defense of the powers that be.  Double Standards: Avoiding Blame for Failures While Taking Credit for Successes The greatest angst seemed to be generated that Mr Solomon could be sanctioned for actions which he did not directly take.  First, the Wall Street Journal <a href="http://online.wsj.com/article/SB10001424052748704123204576283283851626952.html">reported</a> that: <blockquote>Forest Labs representatives said they were shocked when the intent-to-ban notice was received a few weeks later, because Mr. Solomon wasn't accused by the government of misconduct. Forest is sticking by its chief. 'No one has ever alleged that Mr. Solomon did anything wrong, and excluding him [from the industry] is unjustified,' said general counsel Herschel Weinstein. 'It would also set an extremely troubling precedent that would create uncertainty throughout the industry and discourage regulatory settlements.'</blockquote> Later in the same article, there was more dismay that Mr Solomon should suffer any negative consequences for the actions of someone else: <blockquote>Lawyers not involved in the Forest case said the attempt to punish an executive who isn't accused of misconduct could tie up the industry's day-to-day work in legal knots. 'This 'gotcha' approach to enforcement runs the risk of creating a climate within organizations that is inconsistent with the spirit of innovation that is critical to the industry,' said Allen Waxman of Kaye Scholer LLP in New York, who was formerly an in-house counsel at a drug maker.</blockquote>However, Mr Solomon is not a janitor.  He was the company CEO, and was paid a fortune ostensibly because he was responsible for everything going on in the company. In fact, the most <a href="http://ir.frx.com/phoenix.zhtml?c=83198&p=IROL-secToc&TOC=aHR0cDovL2lyLmludC53ZXN0bGF3YnVzaW5lc3MuY29tL2RvY3VtZW50L3YxLzAwMDAwMzgwNzQtMTAtMDAwMDE2L3RvYy9wYWdl&ListAll=1">recent (2010) company proxy statement</a> included this description of Mr Solomon: <blockquote>We believe that Mr. Solomon's experience as a senior executive in our industry, his in-depth knowledge of our Company and its day-to-day operations, and his strong strategic vision for the Company qualify him to serve on the board. [italics added for emphasis]</blockquote>These attributes presumably also justified his total compensation, which was $8,267,236 in 2010. If Mr. Solomon's outsize compensation was based on his strategic vision, informed by his "in-depth knowledge of ... [the] Company and its day-to-day operations," how could his defenders claim he knew nothing and had no responsibility for its detailed and in-depth efforts to deceptively market antidepressants to children and adolescents? (See posts <a href="http://hcrenewal.blogspot.com/2011/04/will-pharmaceutical-ceo-finally-be-held.html">here </a>and <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a> for details of that marketing scheme as revealed in court documents.)  This appears to be a double-standard (as found in <a href="http://www.iep.utm.edu/fallacy/">this alternative catalog</a> of logical fallacies). By the way, also note how Mr Waxman invoked the "innovation meme," i.e., that any regulation of the company or restrictions on its actions will prevent innovation. The same meme was invoked by a business school professor in one of the first attempts to defend this corporate executive from any attempts to hold him accountable for his company's bad behavior (see post <a href="http://hcrenewal.blogspot.com/2011/04/will-pharmaceutical-ceo-finally-be-held.html">here</a>).  As I noted earlier, "innovation" is used so often to excuse almost any action by large health care corporations that I suspect the meme was developed by  corporate public relations. Straw-Men and Double-Standards: Barring Mr Solomon vs "Imagined" Actions and Treatment of Foreign Leaders Another protest was that the government's actions were disproportionate, especially how they treated other cases, as <a href="http://spectator.org/archives/2011/05/03/hard-on-drug-execs-soft-on-dic">written</a> by Robert Goldberg in the Spectator: <blockquote>Now it turns out that Team O is tougher on drug company CEOs than it is on brutal dictators and a movement whose goal is wiping out Israel. The administration is applying a little used government approach to knee-capping executives it doesn't like by threatening that HHS won't allow Forest Laboratories to sell medications to Medicare, Medicaid, and other government health programs (which means every health plan under Obamacare) unless it tosses the company's CEO, Howard Solomon. According to news accounts, the action is being taken because government lawyers claim that just fining the company billions isn't stopping illegal behavior. But neither Mr. Solomon nor Forest has been found guilty of any wrongdoing.</blockquote> Mr Goldberg also asserted, as in the examples above, that Mr Solomon was not personally found guilty.  This may be so, but given that his company gave him credit for all the good resulting from the company's day-to-day actions, denying his responsibility for day-to-day actions gone bad is a double standard. Furthermore, Mr Goldberg's assertion that Forest was not found guilty is at best a quibble, and at worse, an untruth. As we noted above, the company pleaded (but was not "found) guilty to several charges, a felony and a misdemeanor. Mr Goldberg then developed another kind of fallacy, this time by comparing the government's treatment of Mr Solomon with some hypothetical actions: <blockquote>Can you imagine the administration using this tactic against health IT firms, unions, the New Black Panthers, ACORN, or investment banks? For different reasons for each, the answer is 'No.'</blockquote>This appears to be a compounded set of <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw men fallacies</a>.  No one knows whether the government would use these tactics in future hypothetical cases.  What one may imagine could occur in such hypothetical cases is not directly comparable to what has occurred in the current case.  Invoking these imagined future actions amounts to invoking straw men.    Mr Goldberg got even more imaginative, comparing the government's actions vis a vis Mr Solomon to its actions in the foreign policy realm: <blockquote>Meanwhile the threat against Forest and its CEO is more draconian than actions the Obama administration is taking against Assad. The dictator who has slaughtered his people, aided Iran, built a uranium-enrichment facility, staged the Hezbollah takeover of Lebanon, and whose country is soon to be part of the UN Human Rights Council has received a stern warning from the president but nothing more.</blockquote>Of course, it is one thing for a government agency to decide not to do business with an individual within the country whose company admitted to violating the law. It is another thing for a government to attempt to take "actions" against a foreign leader over whom the government has no legal authority.  So here is another kind of double-standard (see<a href="http://www.iep.utm.edu/fallacy/"> this alternative catalog</a> of logical fallacies.) Straw Man: The Case of Rituxan Meanwhile, in Forbes, Charles L Hooper and David R Henderson <a href="http://www.forbes.com/2011/05/05/forest-laboratories-profits-health.html">argued</a> that Forest Laboratories' actions do not merit any punishment at all, not of the company nor of Mr Solomon: <blockquote>But it's bad to market unapproved drugs and to promote drugs for unapproved uses, right? Not exactly.</blockquote> First, Hooper and Henderson argued that Forest Laboratories' off-label marketing of l-thyroxine (a thyroid hormone) was a mere technicality. This appears to be mainly a distraction, since most of the case involved marketing antidepressants.  In any case, they then argued that: <blockquote>The fact is that off-label uses of drugs have saved lives. Consider Genentech and Biogen Idec's Rituxan, which the FDA approved in 1997 for relapsed or refractory CD20-positive B-cell low-grade non-Hodgkin's lymphoma (NHL).</blockquote> Of course, the Forest Laboratory case did not involve punishing physicians for off-label uses of any drug. It involved punishing Forest Laboratories and possibly its CEO for the marketing of drugs for off-label uses. The drugs involved were obviously not Rituxan. They did include Celexa, an antidepressant, which no one ever claimed is a life-saving drug (but which is a member of a class of drugs that may be ineffective and may increase the risk of suicidal ideation or even action in children and adolescents, the groups for which it was marketed off-label by Forest Laboratories).   So the attempt to invoke Rituxan, as if someone was proposing restrictions on its off-label use, was another <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw man</a>.    Summary So once again we see how logical fallacies are used to defend the powers that be in health care.  Once again, note that the these logically challenged defenses come from those with financial ties to the same powers that be.  (In addition to the affiliations noted above, Mr Goldberg is <a href="http://www.cmpi.org/about-us/founders/">Vice President of the Center for Medicine in the Public Interest</a>, which SourceWatch <a href="http://www.sourcewatch.org/index.php/Center_for_Medicine_in_the_Public_Interest">describes</a> as a "pharmaceutical industry front group," while Charles L Hooper is "president of Objective Insights, a company that consults for pharmaceutical and biotech companies.") Let us see if anyone can offer a logical argument why health care corporate CEOs should not be held responsible for their corporations' misbehavior, or if anyone without financial ties to such corporations is willing to defend such lack of responsibility.  Meanwhile, to repeat again and again,  we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Logical Fallacies to Defend CEOs from Responsibility for their Companies' Bad Actions

There is now quite a kerfuffle over the US Department of Health and Human Service's threat to to stop doing business with the CEO of For...

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Merck KGaA Settles, Again

They just keep marching along, legal settlements, that is.  The latest entry in the parade is Merck KGaA (of Switzerland, not to be confused with the American Merck and Co, Inc), as per the AP, <a href="http://abcnews.go.com/Business/wireStory?id=13528024">via ABC News</a>: <blockquote>The Department of Justice said Wednesday that multinational drugmaker Merck Serono SA has agreed to pay $44.3 million to settle allegations that it illegally promoted one of its drugs using kickbacks to doctors. Federal prosecutors said that Merck Serono and EMD Serono allegedly made inappropriate payments to hundreds of doctors for prescribing its multiple sclerosis drug, Rebif, between 2002 and 2009. Merck Serono paid to send doctors to various training meetings and conferences at upscale resorts and other locations, according to the Department of Justice.</blockquote> Of course, while agreeing to pay out the money, the company denies everything: <blockquote>The company pointed out in a statement: 'the settlement contains no claims that unnecessary prescriptions for Rebif were written, no allegations of patient harm and no admission of fault by the company.'</blockquote> One wonders whether $44 million is now such a trivial amount to a large health care corporation that companies are willing to pay so much just to avoid the inconvenience of a trial? Or did perhaps the company leadership worry it might lose this trial? Note that regardless of the above company statement, the US Department of Justice asserted that the company made "improper payments" to physicians "For prescribing its drugs." So, unlike some of the many settlements we have discussed which involved only financial improprieties, this one allegedly involved actions that corrupted physicians. As we have noted previously, Transparency International defines corruption as "abuse of entrusted power for private gain." Physicians are entrusted to make decisions for individual patients for the patients' good. Accepting payments from a drug company to prescribe a particular good appear to be an abuse of such entrusted power, obviously for private gain. So the sorts of behavior that allegedly resulted in this settlement are particularly pernicious for medical professionalism, as well as for the good of patients. Nonetheless, despite protestations that they are going to get tough, US law enforcement seems unwilling to hold any individual accountable for this sort of behavior. Granting individual impunity, though, seems to provide no deterrent against future bad behavior.  For example, as we noted <a href="http://hcrenewal.blogspot.com/2010/12/mylan-settles-merck-kgaa-pays-fine.html">here</a>, Merck KGaA had to pay a settlement last year of claims that its previous subsidiary, Mylan, reported falsely inflated claims.  That legal action also imposed no negative consequences on individuals.  This legal action had been in the works since at least 2007, but as noted above, the actions that lead to the current settlement continued through 2009.  So, to repeat, repeat, repeat: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Merck KGaA Settles, Again

They just keep marching along, legal settlements, that is. The latest entry in the parade is Merck KGaA (of Switzerland, not to be confused...

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"We're Only In It for the Money" - Big Businesses Pretending to be Medical Schools Discussed in Main-Stream Medical Journal

This is a first, the contention that medical schools are only in it for the money has appeared in a prestigious, main-line, large-circulation medical journal(1). The author started by noting that medical schools are now academic in name only. <blockquote>US medical schools have evolved into big businesses that derive most of their income by providing healthcare services and securing extramural research grants. In 2009, for example, 53% of medical school revenues came from clinical services and 29% from extramural grants. By comparison, less than 4% came from tuition.</blockquote> These big businesses disguised as academic institutions behave like other big businesses: <blockquote>Academic medical centers vie for clinical market share through direct-to-consumer advertising. To increase referrals, they offer free continuing medical education that boost the visibility of their most profitable services to community providers. Physicians with MBA degrees are becoming increasing common at academic medical centers....</blockquote> Then University of Utah cardiology professor Matthew Movsesian clearly asserted that faculty realize that they are only valued for the money they bring in: <blockquote>It's worth noting that medical school faculty members perceive that their-revenue-generating activities are of paramount importance in the eyes of academic leadership. In a recent survey of US medical schools, 51% of respondents agreed that 'the administration is only interested in me for the revenue I generate'; a less extreme statement might have elicited [even] more widespread concurrence. Emphasis on revenue generation by faculty is evident in the incentive plans that typically compensate clinicians in proportion to the billable services they provide. And researchers understand that their salaries for time spent on research must be paid, sometimes in full, from extramural grants.</blockquote> Dr Movsesian implied who the main beneficiaries of this revenue generation are: <blockquote>Executives at these teaching institutions are paid industry-level salaries.</blockquote> All of this should be familiar to those who have been reading <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>.  We first wrote about how medical school leaders mainly evaluated faculty by their revenue generation, and dismissed those who did not generate sufficient revenue as "welfare recipients," <a href="http://hcrenewal.blogspot.com/2007/04/medical-schools-to-faculty-show-me.html">here</a> in 2007.  We discussed the survey that revealed that medical school faculty realize their supervisors only value their revenue generation <a href="http://hcrenewal.blogspot.com/2010/12/american-medical-schools-are-only-in-it.html">here</a> in 2010.  But the first post was derived from an interview in the SGIM newsletter, and the survey noted above so far is only publicly available in an on-line abstract.  To my knowledge, the notion that medical schools have abandoned their primary mission of discovering and disseminating the truth in favor of making money, perhaps mainly for the benefit of their top leaders, has not heretofore appeared in a main-stream medical or health care journal.  So this new publication marks an important weakening of the anechoic effect. Late in 2010, we discussed an important new report in the Lancet about the reform of global health care education(2)(see post <a href="http://hcrenewal.blogspot.com/2010/12/health-professionals-for-new-century.html">here</a>).  It hinted at some of the threats to the academic medical mission we have long discussed on Health Care Renewal.  An accompanying editorial stressed the need to uphold the academic mission, implying that it was in some way threatened, but again did not discuss what actually threatened it.(3)(See our post <a href="http://hcrenewal.blogspot.com/2010/12/lancet-emphasizes-threats-to-academic.html">here</a> which listed some of threats that should be considered.  The threats are reprinted in the box below.)  Now the peril to the mission of US medical, and by extension, perhaps global health care education has made it into polite discussion.  Maybe it is not too late to address threats to global health care education before the system collapses from its internal contradictions. Threats to the Global Health Care Education Mission (the "Thirteen Plagues") <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>, is largely concerned with threats to health care's core values, including threats to the mission of academic medicine, largely from concentration and abuse of power.  The largest set of threats come from the ascendancy of financial goals amidst the commercialization of health care (mentioned briefly both in Frenk et al and the editorial).   <li>Abandonment of traditional prohibitions of the commercial practice of medicine - In the US, a Supreme Court decision was interpreted to mean that medical societies could no longer regulate the ethics of their members.  Until 1980, the US American Medical Association had  ruled that the practice of medicine should not be "commercialized, nor treated as a commodity in trade."  After then, it ceased trying to maintain this prohibition.  The result was increasing, now rampant commercialization.  See posts  <a href="http://hcrenewal.blogspot.com/2007/12/relman-in-jama-on-threats-to-physicians.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/06/why-did-us-physicians-give-up-their.html">here</a>.</li> <li>Making money takes precedence over education -  A recent survey showing that more than half the faculty at multiple US medical schools felt they were valued more for how much money they brought in than their teaching or patient care abilities (<a href="http://hcrenewal.blogspot.com/2010/12/american-medical-schools-are-only-in-it.html">here</a>), confirming previous anecdotal reports (see <a href="http://hcrenewal.blogspot.com/2007/04/medical-schools-to-faculty-show-me.html">here</a>).  </li> <li>The medical school re-imagined as a biotechnology company -  In 2000, a Vice President of the American Association of Medical Colleges(4) wrote that research universities must respond to "societal demands that they become engines of economic development…."  Many universities now defend lax conflict of interest policies with similar arguments.  For more details, go <a href="http://hcrenewal.blogspot.com/2010/11/who-you-gonna-call-how-should-young.html">here</a></li> <li>Faculty become employees of industry - For numerous examples of this and other kinds of conflicts of interest, go <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">here</a>.  A survey by Campbell et al suggested that approximately two-thirds of medical academics get significant payments from industry.(5)</li> <li>Academics become "key opinion leaders" paid to market drugs and devices - Marketers regard "key opinion leaders" as salespeople who appear more credible because of their professional guise.  See anecdotal evidence <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">here</a>. </li> <li>Control of clinical research given to commercial sponsors - A study by Mello et al showed how universities' grant administrators are willing to sign contracts giving commercial sponsors control over key aspects of human research studies.(6)  See post <a href="http://hcrenewal.blogspot.com/2005/05/troubling-study-of-contracts-between.html">here</a>. </li> <li>Conflicts of interest allow manipulation and suppression of clinical research - Commercially sponsored research design, implementation, and dissemination are often <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a> to favor the sponsor's interests.  When such manipulation fails to produce favorable results, the results may simply be <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a></li> <li>Academics take credit for articles written by commercially paid ghost-writers - Such <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">ghost-writing</a> is often part of organized <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing">stealth marketing</a> campaigns.  </li> <li>Whistle blowers are discouraged, or worse, and academic freedom is damaged.  Discussion of some examples of what may happen to whistle blowers is <a href="http://hcrenewal.blogspot.com/search/label/whistle-blowers">here</a>.  The survey mentioned earlier (<a href="http://hcrenewal.blogspot.com/2010/12/american-medical-schools-are-only-in-it.html">here</a>) showed that about one-third of faculty fear they may be punished for speaking  out. </li> <li>Leadership of academic medical centers by businesspeople - <a href="http://hcrenewal.blogspot.com/search/label/ill-informed%20management">Ill-informed management</a> may result from leaders who have no background or training in actual health care.  </li> <li>Leaders of teaching hospitals and universities become millionaires -  A recent example is <a href="http://hcrenewal.blogspot.com/2010/08/more-hospital-ceos-join-millionaires.html">here</a>, and more may be found <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">here</a>.  Leaders of academic medical centers and the parent universities of medical schools often make more than $1 million a year in the US.  When such amounts are in play, executives may focus more on short-term measures that lead to even more pay than on upholding the mission. </li> <li>Medical school leaders become stewards (as members of boards of directors) of for-profit health care corporations - A recent example is <a href="http://hcrenewal.blogspot.com/2010/12/duke-divinity-students-protest-pay-of.html">here</a>, and a summary of how we discovered this phenomenon in 2006 is <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">here</a>.   The conflict of interest is severe because directors of for-profit corporations are supposed to have unyielding loyalty to the interests of the corporation and its stockholders, although they are frequently accused of acting mainly as cronies of the top hired executives (see <a href="http://hcrenewal.blogspot.com/2010/07/new-york-times-reports-university.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/01/one-small-step-towards-reducing.html">here</a>).</li> <li>Leaders of failed finance firms become stewards of academic medicine - We have found numerous examples, recently <a href="http://hcrenewal.blogspot.com/2010/04/failed-leaders-of-citigroup-as-leaders.html">here</a>, <a href="http://hcrenewal.blogspot.com/2010/04/wamu-worry-more-overlaps-between.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2010/03/members-of-board-of-now-bankrupt-lehman.html">here</a>, of top executives and/or board members of the finance firms who helped bring on the global financial collapse also being trustees of medical schools, academic medical centers, or their parent universities.  Such "stewards" may bring to the academic environment the "greed is good" culture now pervasive in finance.  </li> Reference 1.  Movsesian M. Intramural conflicts of interest warrant scrutiny, too. Nature Medicine 2011; 17: 21. Link <a href="http://www.nature.com/nm/journal/v17/n5/full/nm0511-534.html">here</a>. 2.  Frenk J, Chen L, Bhutta ZA, Cohen J, Crisp N, Evans T et al. Health professionals for a new century: transforming education to strengthen health systems in an interdependent world.  Lancet 2010; 376: 1923-1958.  Link <a href="http://www.rockefellerfoundation.org/uploads/files/cc71deb1-1dd6-4a97-a4e3-678f520a0bc6-lancet.pdf">here</a>. 3.  Horton R. A new epoch for health professionals' education.  Lancet 2010; 376: 1875-7.  Link <a href="http://www.lancet.com/journals/lancet/article/PIIS0140-6736%2810%2962008-9/fulltext">here</a>. 4. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. Link <a href="http://jama.ama-assn.org/cgi/content/full/284/17/2234">here</a>. 5. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMsa064508">here</a>. 6. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21. Link <a href="http://content.nejm.org/cgi/content/short/352/21/2202">here</a>. Title with apologies to the late Frank Zappa.

"We're Only In It for the Money" - Big Businesses Pretending to be Medical Schools Discussed in Main-Stream Medical Journal

This is a first, the contention that medical schools are only in it for the money has appeared in a prestigious, main-line, large-circulatio...

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Who Is Really "Bullying?" - Academic Leaders and the Stifling of Critics of Conflicts of Interests

Universities, which are supposed to discover and disseminate knowledge, ought to be the foremost defenders of free speech and a free press.  However, in the past decades, university executives have become notorious for trying to control speech that offends their political sensibilities (for numerous examples, see the FIRE - Foundation for Individual Rights in Education <a href="http://thefire.org/">web-site</a>.)  It seems that academic leaders get even more upset when their or their faculties' conflicts of interest are criticized, as demonstrated by updates about two important cases we have discussed. Columbia University We recently <a href="http://hcrenewal.blogspot.com/2011/04/henry-kissinger-icelands-promoter.html">posted</a> about reactions at the university to revelations in the movie "Inside Job" that the Dean of the Business School and one of its prominent professors failed to disclose pay they received that might have motivated their enthusiastic promotion of economic policies that helped contribute to the Great Recession.  These reactions occurred six months after the movie came out.  A Columbia Spectator student columnist <a href="http://www.columbiaspectator.com/2011/04/26/compromising-memory">asked</a> why it took so long: <blockquote>Why have students waited until April to address the consequences of “Inside Job” when the film was released in October? Why has our reaction been delayed by seven months?</blockquote> Her postulated answer: <blockquote> Why should Columbia need an outside documentary to point out its ethical failures? Embedded in the Spectator news article about the film—published April 15— is a quote from University Senator Liya Yu that offers a frightening answer to our question about the delayed student reaction. 'I think people in the Business School haven’t responded because they are afraid,' Yu was quoted saying. 'If you are the dean of a school, obviously all the students are going to be dependent on you for their careers and futures. It’s hard for them to do anything.' I think this explanation extends to students beyond those currently enrolled in the Business School. In fact, its implications pose a threat to student journalism as a whole. For the first time in history, everything that a student journalist writes during his or her time in college is published on the Internet. This is a good thing for many reasons: It increases readership, allows writers to cross-reference easily, etc. But it also creates a permanent, compromising memory that is available forever to anyone who seeks it. From the moment the college application process began, we were told that the content of our Facebook profiles could be used against us in admissions. We have learned to censor our traceable online behavior so as not to compromise our professional or educational prospects. Unfortunately, this has led to journalistic over-caution. We fear that anything we say now will be used against us later. And maybe it’s true. After all, not enough time has passed for us to take a careful account of the degree to which students’ first publications can affect their futures. Even editors have advised me to mitigate the strongest claims in my columns for fear of consequences to come. Perhaps they are right. But the most insidious kind of censorship—the hardest to recognize, the hardest to combat—is self-censorship, the persistent imaginative failure that prevents us from even recognizing what we should be writing about. In the Internet age, bravery in student journalism is not trailing a military unit on the Iraqi front lines. Rather, it is the willingness to address controversial issues as they surface, not once these points of view have become popular. Our brand of fear—which is frankly selfish—censors our thoughts almost unnoticed. Next time, let’s skip the delayed reaction. I for one hope to do better.</blockquote> So students may fear challenging conflicted faculty or administrators for fear of immediate academic punishment and future harm to career prospects in a society in which criticism of acquisitive leaders is decreasingly tolerated. University of Minnesota Earlier this year we <a href="http://hcrenewal.blogspot.com/2011/02/university-of-minnesota-where-nothing.html">posted</a> about the troubling case of the death of an ostensibly voluntary participant in a clinical trial at the University of Minnesota years ago.  A particular concern was whether the money they received from the trial's sponsor influenced faculty and university leaders to overlook problems that might have put patients at risk in a trial whose main goal was marketing, not science. The case got recent attention in an article by Dr Carl Elliott, a university professor of bioethics, and a letter he signed with other faculty requesting a new university inquiry into the case.  Not only did the university administration rebuff this request, but it now seems to be looking for ways to deter any future criticism of the institution's human research.  As <a href="http://chronicle.com/article/Some-U-of-Minnesota-Faculty/127261/">reported</a> in the Chronicle of Higher Education, <blockquote>At the prompting of the University of Minnesota's general counsel, a committee of the University Senate has taken up the question of how faculty should collectively respond to "factually incorrect attacks" on particular faculty research. Some faculty members say that direct appeal from the general counsel, Mark B. Rotenberg, is an attempt to quiet some faculty members' criticism of drug trials conducted at the university, including one seven years ago in which a participant, Dan Markingson, committed suicide. Before they took up the general counsel's question at a meeting this month, members of the university's Academic Freedom and Tenure Committee were provided with copies of material related to that case, including a letter sent by eight bioethicists to the Board of Regents last fall, asking it to appoint a panel of outside experts to examine the ethical issues raised by the death. Committee members discussed with two administrators who attended that meeting, on April 8, whether faculty members have a responsibility to respond to attacks on fellow faculty members, according to minutes from the meeting; failure to do so, one professor said, could be seen as parallel to 'bullying.'</blockquote> Professor Carl Elliott, who wrote the <a href="http://motherjones.com/environment/2010/09/dan-markingson-drug-trial-astrazeneca">Mother Jones article </a>that brought the recent unpleasantness of the Markingson case back into the public view, was concerned: <blockquote>In an interview, Mr. Elliott said the general counsel's actions are troubling. Instead of fostering an open discussion about research practices, Mr. Rotenberg, and by extension the university administration, is attempting to use the faculty senate as a 'stalking horse' for intimidation and punitive action, Mr. Elliott said.</blockquote> It defies common sense that Dr Elliott, representing only his own intellect and knowledge of ethics, was the "bully" in this case, while Mr Rotenberg, representing the university hierarchy, and the faculty members who ran the trial in which Mr Markingson died were the victims. As University of Minnesota faculty member Karen-Sue Taussig, a medical anthropologist, said <a href="http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=5340&blogid=140">per the Bioethics Forum</a>: <blockquote>I was worried the committee might be being used to intimidate a member of the faculty who was critical of the University. It seemed to me that there was a logical inconsistency in the University counsel's position: he did not provide any evidence that any individual faculty member felt chilled by Carl's work, yet his bringing up the issue clearly posed the threat of chilling Carl's speech. . . . In short, I was concerned about the possibility of an Orwellian attempt to invoke academic freedom in order to chill academic freedom.</blockquote> By the way, there is also nothing to suggest that Dr Elliott's work was "factually incorrect."  Per the Bioethics Forum: <blockquote>Philosopher and historian of science Ken Waters, who also attended the second meeting, was just as concerned. 'The University's general council planted a false question, the implicature of which [the committee] seemed to be uncritically accepting (that Carl was advancing factually incorrect claims),' he wrote to me in an e-mail. 'And in planting the question, the counsel was trying to turn the tables and squelch my colleagues' academic freedom by somehow suggesting that they were impinging upon the academic freedom of others.'</blockquote> In the 1980s and 1990s, university administrators tended to attack speech they felt was hurtful to minorities and women, using speech codes (again as has been amply demonstrated by <a href="http://www.thefire.org/">FIRE</a>). Now they seem most sensitive to speech critical of their own exercise of power, and of the cozy financial relationships that generate conflicts of interest and threaten the academic mission.  Furthermore, now that it has become fashionable to decry "bullying," "anti-bullying" initiatives may become the chief way to quell criticism that make academic leaders uncomfortable. Summary At one time, university administrators and favored faculty justified attacks on free enquiry, a crucial part of the academic, by claiming a higher political or social purpose.  Now they seem to be willing to trash the core values of academia to stifle critics of their own actions, especially those involving lucrative conflicts of interest.   Such actions may be a major cause of the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>. Increasingly, academic institutuions seem to be run more for the personal benefit of their leaders and their cronies than to discover and disseminate knowledge.  True health care reform would return academic medicine to its fundamental purpose, and return its leadership to those who would uphold the mission rather than fill their pockets.   Hat tip to Ed Silverman <a href="http://www.pharmalot.com/2011/04/a-seroquel-clinical-trial-and-academic-freedom/">in the PharmaLot blog</a> re the University of Minnesota case.  See also comments by Prof William Gleason in the Periodic Table blog, e.g.,<a href="http://ptable.blogspot.com/2011/04/whos-making-factually-incorrect.html"> here</a> and <a href="http://ptable.blogspot.com/2011/04/should-general-counsel-at-university-of.html">here</a>, and by Gary Schwitzer <a href="http://www.healthnewsreview.org/blog/2011/04/questions-about-academic-freedom-in-continued-scrutiny-of-seroquel-trial-suicide.html">in the HealthNewsReview blog</a>.

Who Is Really "Bullying?" - Academic Leaders and the Stifling of Critics of Conflicts of Interests

Universities, which are supposed to discover and disseminate knowledge, ought to be the foremost defenders of free speech and a free press. ...

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