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Another Blow to the Health IT Idealists: Sony CEO Howard Stringer, and HHS OIG, on Information Security

In a series of Healthcare Renewal posts such as those linked below, I pointed out that healthcare IT information security was largely a pipe dream, and that plans to create a national network of health information, while a seductive idea dating to the beginnings of computer networking, is not a good idea now. <ul><li>"<a href="http://hcrenewal.blogspot.com/2010/02/networked-emrs-and-healthcare.html">Networked EMR's and Healthcare Information Security: Practical When Massive IT Security Breaches Continue</a>?",</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/02/networked-interoperable-secure-national.html">Networked, Interoperable, Secure National Medical Records a Castle in the Sky?</a>",</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/01/it-flaws-and-coverups-of-same-why-i.html">Operation Aurora And a Widespread Reluctance to Discuss IT Flaws: Is Universal Healthcare IT Really a Good Idea in 2010?</a>",</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/10/medical-data-breach-of-week-but-your.html">Medical data breach of the week - but your EMR data is secure, trust us, we're IT experts</a>", </li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/11/insurers-test-data-profiles-to-identify.html">Insurers Test Data Profiles to Identify Risky Clients</a>",</li></ul><ul><li>and <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">others</a></li></ul> Now you can hear it from another source: The CEO of one of the world's largest electronic companies, Sony. Emphases mine: <a href="http://online.wsj.com/article/SB10001424052748703421204576328982377107892.html"></a><blockquote><a href="http://online.wsj.com/article/SB10001424052748703421204576328982377107892.html" style="font-weight: bold;">Sony CEO Warns of 'Bad New World' </a> Wall Street Journal May 8, 2011 TOKYO—After spending weeks to resolve a massive Internet security breach, <a class="companyRollover link11unvisited" href="http://online.wsj.com/public/quotes/main.html?type=djn&symbol=SNE">Sony</a> Corp. Chief Executive <a class="topicLink" href="http://topics.wsj.com/person/s/howard-stringer/243">Howard Stringer</a> said he can't guarantee the security of the company's videogame network or any other Web system in the "bad new world" of cybercrime. Mr. Stringer's comments in a phone interview Tuesday, ahead of a New York roundtable discussion with reporters, come on the heels of a trying month for Sony. The company partially restored two of its online game systems and a streaming movie and music service over the weekend after shutting the services for several weeks when a breach compromised the personal information of more than 100 million account holders. While Sony has restored part of the PlayStation Network—an online game system for its PlayStation 3 videogame console—in the U.S. and Europe and bolstered security measures, Mr. Stringer, 69 years old, said maintaining the service's security is a "never-ending process" and he doesn't know if anyone is "100% secure." He said the security breach at PSN, Sony Online Entertainment, an online game service for personal-computer users, and its Qriocity streaming video and music network his company could lead the way to bigger problems well beyond Sony, or the gaming industry. He warned hackers may one day target the global financial system, the power grid or air-traffic control systems. [And healthcare, where identity theft, data alteration, and data destruction might occur - ed.] <div style="overflow: hidden; text-decoration: none; border: medium none;"> <div style="overflow: hidden; text-decoration: none; border: medium none;"></div></div></blockquote><div style="overflow: hidden; text-decoration: none; border: medium none;"><div style="overflow: hidden; text-decoration: none; border: medium none;"> I really don't think this is the time to be setting up a national health information network. Beyond that, I offer no additional comments, other than that regarding the impossibility of keeping healthcare information secure on a national or even regional network, you may have heard it first here at Healthcare Renewal. It would be prudent and consistent with the Hippocratic Oath to tone down our grandiose expectations and grandiose plans for these technologies in healthcare. If you feel insecure yet, just wait a moment. Going from very, very bad to very much worse: An independent audit of ONC's and CMS's security programs by the HHS OIG (Office of the Inspector General) produced concerning if not alarming results to say the least: <a href="http://www.healthleadersmedia.com/content/FIN-266313/HIT-Security-Problems-Found-at-CMS-ONC"></a><blockquote><a href="http://www.healthleadersmedia.com/content/FIN-266313/HIT-Security-Problems-Found-at-CMS-ONC" style="font-weight: bold;">Federal Audits Find HIT Security Problems at CMS, ONC </a> John Commins, for HealthLeaders Media May 18, 2011 Audits of the federal agencies charged with implementing and monitoring security measures for healthcare information technology identified this week lax oversight and insufficient standards for healthcare providers. The audits were conducted by the Department of Health and Human Services' Office of Inspector General, and targeted HIT security standards, privacy protection under HIPAA, and other security measures at the Centers for Medicare & Medicaid Services, and the Office of the National Coordinator. "These two reports are being issued simultaneously because OIG found weaknesses in the two HHS agencies entrusted with keeping sensitive patient records private and secure," OIG said in a media release. The CMS audit, Nationwide Rollup Review of the Centers for Medicare & Medicaid Services Health Insurance Portability and Accountability Act of 1996 Oversight, examined seven hospitals across the country and found 151 "vulnerabilities" in systems and controls that are designed to safeguard electronic protected health information. Those lapses included 124 "high impact vulnerabilities" such as unencrypted laptops and portable drives containing sensitive personal health information, outdated antivirus software and patches, unsecured networks, and the failure to detect rogue devices intruding on wireless networks, the OIG audit said. "These vulnerabilities placed the confidentiality, integrity, and availability of ePHI at risk. Outsiders or employees at some hospitals could have accessed, and at one hospital did access, systems and beneficiaries' personal data and performed unauthorized acts without the hospitals' knowledge," the OIG audit said. "As a result, CMS had limited assurance that controls were in place and operating as intended to protect electronic protected health information, thereby leaving ePHI vulnerable to attack and compromise. OIG's Audit of Information Technology Security Included in Health Information Technology Standards examined ONC's mandate under the HITECH Act to develop HIT security as part of a national HIT interoperability infrastructure. The audit found "no HIT standards that included general information IT security controls … which provide the structure, policies, and procedures that apply to a healthcare provider's overall computer operations, ensure the proper operation of information systems [which obviously also impacts patient safety - ed.], and create a secure environment for application systems and controls.</blockquote> That's not very reassuring. In fact, it is downright frightening. ONC has to learn such lessons from HHS OIG? Read the whole thing.I somewhat mordantly note that organizations such as ONC and CMS would probably never hire a person like me, who might actually kick-start true critical thinking on these issues. This is due to my non-bien pensant "bad attitudes", and lack of faith in cybernetic idols. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgmnwU_sH88Ham6kL2ikFt88_2qx899yg4zsSynC9_sggBBClRDUYMxnZnxfE06yrPqWhz7crbwSYQdkbQc8scVnH0kyg5Y9-g4MUsvHlEcswajJ_WzalDVaLBTGwwOB4RJ7rim6pJZRmDD/s1600/golden_calf.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5608090912264648962" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgmnwU_sH88Ham6kL2ikFt88_2qx899yg4zsSynC9_sggBBClRDUYMxnZnxfE06yrPqWhz7crbwSYQdkbQc8scVnH0kyg5Y9-g4MUsvHlEcswajJ_WzalDVaLBTGwwOB4RJ7rim6pJZRmDD/s320/golden_calf.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 305px; height: 217px;" /></a>Click to enlarge. A well-known idol of gold. Computer circuits use gold, no? -- SS </div></div>

Another Blow to the Health IT Idealists: Sony CEO Howard Stringer, and HHS OIG, on Information Security

In a series of Healthcare Renewal posts such as those linked below, I pointed out that healthcare IT information security was largely a pip...

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Global Fund Will Not Suppress Discussion of Health Care Corruption

Some good news to discuss, for a change.... We previously discussed losses from corruption reported by the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and by the Health Alliance International <a href="http://hcrenewal.blogspot.com/2011/02/after-publicity-about-losses-from.html">here</a>.  At the time, we noted that some experts in health care corruption praised the Global Fund for being transparent about the effects of corruption. However, last week there was concern that some elements within the Global Fund thought that the best response to losses due to corruption would be hiding them.  As reported by the AP (<a href="http://www.cbsnews.com/stories/2011/05/11/ap/health/main20061781.shtml">via CBS</a>):  <blockquote>A global health fund championed by celebrities and world leaders is considering scaling back its groundbreaking philosophy of full transparency about how it spends billions of dollars in health care in poor countries. Its decision could have broad consequences for the ways international aid groups operate. Revelations this year by The Associated Press about misspent funds and corruption among recipients of the money — and the donor backlash that has followed — have prompted leaders of the Global Fund to Fight AIDS, Tuberculosis and Malaria to propose scaling back on the investigations that uncovered the problems, and revealing less about them to donors and the public.</blockquote> But hardly everyone within Fund leadership wanted to abandon transparency: <blockquote>The Global Fund's internal watchdog fiercely opposes the proposed changes. In its latest progress report, obtained by the AP, Inspector General John Parsons warns the board that a move toward less transparency 'could be interpreted negatively and as a purposeful effort to suppress material information.'</blockquote> Also, <blockquote>The president of the board, Ethiopian Health Minister Tedros Adhanom Ghebreyesus, opposes any changes. 'Even the mere appearance of suppression of information is unacceptable. Scaling back, or the perception that we are retreating from, this commitment is something we simply cannot allow,' Tedros said. If anything, he added, 'we should increase our level of transparency.'</blockquote> Now, it looks like the transparency advocates won, at least in part. As again reported by the AP (<a href="http://www.cbsnews.com/stories/2011/05/13/ap/europe/main20062710.shtml">via CBS</a>): <blockquote>A multibillion-dollar fund that fights three killer diseases said Friday that it will make public more detailed information about money it has lost to corruption and mismanagement, but won't release other information critics have sought. The board of the $22 billion Global Fund to Fight AIDS, Tuberculosis and Malaria met this week to address a backlash among major donors over revelations by The Associated Press that the fund's internal watchdog was turning up losses of tens of millions of dollars of grant money. Board members decided to publish detailed accounting of losses and money recovered, the fund said, in an effort to distinguish between fraud and other problems such as poor accounting.</blockquote> However, <blockquote>The fund will not, however, provide other details from internal investigations and audits that might have made it possible to calculate how much of the money investigated is lost to corruption, or what percentage of the fund's overall disbursements are misspent.</blockquote> Also, <blockquote>The fund also is not making public an internal chart obtained by AP showing that in 12 nations where internal audits and investigations reviewed almost $576 million in spending, an average of 8 percent was lost to fraud, undocumented or unauthorized spending.</blockquote> Still, it is very good news that transparency won out in this case. Maybe the Global Fund leaders' decision will encourage more discussion of the severity of global health care corruption and its negative effects. On the other hand, it is bad news that even discussion of health care corruption remains controversial. In 2006, <a href="http://www.transparency.org/publications/gcr/gcr_2006">Transparency International's Global Corruption Report</a> asserted in its executive summary, " the scale of corruption is vast in both rich and poor countries."  As we summarized <a href="http://hcrenewal.blogspot.com/2011/02/after-publicity-about-losses-from.html">here</a>, the report discussed the scale and diversity of health care corruption, and the severity of its adverse effects.  Yet the very subject of global health care corruption remains as anechoic as many of the specific topics we discuss on Health Care Renewal. Also, as we have noted before, recently <a href="http://hcrenewal.blogspot.com/2011/02/after-publicity-about-losses-from.html">here</a>, there are very few if any meetings about global health care corruption, very few courses on it in medical or public health schools, no institutions specifically designed to address it, and no programs at the foundations and NGOs which are losing money to global health corruption to combat it.  Similarly, there are few efforts to promote accountability, integrity, transparency, honesty, and ethics in health care (aside from this blog and a few other similarly informal initiatives.)  What is wrong with that picture? We hope that the willingness of the Global Fund to discuss and admit it has a problem with health care corruption will make health care corruption a little less anechoic, and lead us closer to concrete steps to address it. PS - If anyone in our vast audience does know about any additional anti-corruption or conflict of interest, or pro-accountability, integrity, transparency, honesty and ethics initiatives, courses, meetings relevant to health care, please let me know and I will do my best to disseminate the information. [Posted on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> by Roy M. Poses MD]

Global Fund Will Not Suppress Discussion of Health Care Corruption

Some good news to discuss, for a change.... We previously discussed losses from corruption reported by the Global Fund to Fight AIDS, Tuberc...

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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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