healthy4u

Embedded Networks of Influence in Health Care: An Illustrative Case

At the 12th International Anti-Corruption Conference (IACC), sponsored by Transparency International, one of the <a href="http://www.12iacc.org/modules.php?name=Content&pa=showpage&pid=45">plenary sessions</a> was devoted to the topic of "embedded networks of influence."  The session description included this description of the topic as: <blockquote>the major stumbling block in the fight against corruption, namely, the power of 'embedded networks' in advancing personal or group interests through state institutions. The extent of their power can create what is known as “state capture” meaning democratic governance failure. It will take a close look at the influential role of private sector, especially of the multinational private sector.</blockquote>A recent <a href="http://chronicle.com/article/Fast-Growth-Strategy-Has-Its/127941">investigative report </a>in the Chronicle of Higher Education illustrated a striking case of how one key individual has affected health care through multiple connections to what can be regarded as embedded networks of influence, thus tying in to many of the topics we have discussed on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>. The article focused on the University of Miami and its current President, Donna Shalala. Let me summarize the set of relevant topics in roughly chronological order and note how the article links them to President Shalala. Speech Codes and Restrictions on Free Speech within Academia As I wrote in my 2003 article, (Poses RM. A cautionary tale: the dysfunction of the American health care system.  Eur J Int Med 2003; 14: 123-130.  Link <a href="http://www.ejinme.com/article/S0953-6205%2803%2900029-3/abstract">here</a>), speech codes and other restrictions on free speech within academia created the framework for the suppression of clinical research that may offend those with vested interests: <blockquote>Failure of universities to champion the academic freedom of their clinical researchers may stem from their abandonment of their own academic core value of free enquiry. There is abundant evidence that universities may restrict expression and limit academic freedom. In The Shadow University, Kors and Silverglate charged that 'universities have become the enemy of a free society.' Universities have punished faculty and students who raised unpopular viewpoints.</blockquote> In the Chronicle, <blockquote>Ms. Shalala, ... was previously president of Hunter College of the City University of New York and chancellor of the University of Wisconsin at Madison....</blockquote> <a href="http://www.shadowuniv.com/">The Shadow University</a>, the pioneering work on challenges to individual rights by leaders at academic institutions, dealt with Ms Shalala's role as a leading early proponent of silencing speech that offended academic leaders. <blockquote>Wisconsin chose to enact a speech code. On March 29, 1990, the Wisconsin ACLU joined a suit against the university, announcing that the important moral goals of toleration and equal opportunity 'can be accomplished through means other than the creation of rules which infringe upon the fundamental freedom to express ideas.' The speech code was drafted with the help of UW-Madison Law School professors Richard Delgado, Gordon Baldwin, and Ted Finman.... On June 9, 1989, upon recommendation by Chancellor Shalala, it was adopted by the Board of Regents...."</blockquote>The speech code was soon declared unconstitutional by a federal court, which held: <blockquote>the policy was unconstitutional precisely because 'the UW rule regulates its speech upon its content.'</blockquote>Ms Shalala then: <blockquote>recommended a new code to the regents in the spring of 1992, which they adopted in March.</blockquote>However, <blockquote>Faced with another lawsuit, the regents reversed themselves</blockquote>For these and similar efforts, as <a href="http://www.washingtonpost.com/wp-srv/politics/govt/admin/stories/shalala010893.htm">discussed</a> by Evans and Novak in 1993, Ms Shalala was dubbed "the Queen of PC" [political correctness]. Speech codes and other restrictions on free speech in the academic setting seem mainly to be used to target speech that administrators find offensive, including speech critical of management practices. This is echoed in the Chronicle story, which suggested how fearful University of Miami faculty now are of criticizing Ms Shalala: <blockquote>Others, including several current and former faculty members, outline their complaints in far more detail. But they do so anonymously, saying they don't want to tangle head-on with such a politically powerful president.</blockquote>Ms Shalala's prominence in academics, probably more due to rather that in spite of her hostility to free speech and free enquiry, may have enabled her to join another and even more powerful network of influence, this one at the center of the US political world.   The Rise of Commercial Health Insurance  In <a href="http://wendellpotter.com/deadlyspin/">Deadly Spin</a>, former CIGNA executive Wendell Potter documented how clever and unscrupulous use of public relations and marketing techniques enabled commercial health care insurance and managed care companies to increase dominance of US health care, while allowing health care costs to soar, and denying access to larger numbers of patients.  The Chronicle article briefly alluded to Ms Shalala's role in the rise of for-profit health insurance.  Despite being labelled "farthest to the left and most controversial of all President-elect Clinton's Cabinet appointments," again per Evans and Novak, Ms Shalala departed the University of Wisconsin in 1993 to become US Secretary of Health and Human Services. In that role, she presided over the administration's failed attempt at health care reform, as Potter wrote, <blockquote>When President Bill Clinton was forced to give up on comprehensive health care reform in 1994, the damage was far more extensive than anyone could have imagined - the administration's defeat emboldened health insurance companies to totally redefine the mission and methods of an industry that now strands nearly fifty million people without insurance. As I outlined..., insurers knew after the Clinton disaster that the coast was clear for them to abandon nonprofit practices, long-standing commitments to public service, and traditional insurance models and turn instead to satisfying Wall Street investors' desire to make money, by limiting spending on health care.</blockquote>Note that my only quibble with what Wendell Potter wrote is that it may be that the insurance companies' top executives, rather than their stockholders who benefited the most from these changes, as we will address below. Ms Shalala remained Secretary of HHS until 2001, but after the failure of the health care reform proposal in 1994, her department apparently did nothing to try to ameliorate the changes to health care that Potter described above. Bloated Executive Compensation Disproportionate to Any Measure of Organizational Performance We have frequently discussed how health care leaders now seem entitled to get huge amounts of <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">compensation</a> disproportionate to their organizations' performance and their responsibility for it.  Despite Ms Shalala's reputation in the 1990s as an extreme leftist, upon leaving her role in the Clinton administration, she almost immediately embraced the for-profit corporate model of health insurance. In a notable example of what now is called the "revolving door" that went unnoticed at the time,  Ms Shalala went from would be regulator of commercial managed care to leader of commercial managed care.  As noted by the Chronicle: <blockquote>Debates over ethical boundaries are not new to those involved in the university's growth surge. Ms. Shalala was on the compensation committee of the board of the health insurer UnitedHealth Group when it was caught in one of the nation's largest-ever stock-options scandals. She also received low-cost loans in 2002 as part of a favors-for-politicians scandal at Countrywide Financial Corporation. Both Ms. Shalala and [University of Miami medical school dean] Dr. Goldschmidt have served on the boards of companies directly or indirectly affected by the university's business decisions. The university had $30-million in annual business with UnitedHealth Group when Ms. Shalala was on its board.</blockquote>Note that Ms Shalala served as Secretary of Health and Human Services from 1993 to 2001, (see <a href="http://en.wikipedia.org/wiki/United_States_Secretary_of_Health_and_Human_Services">this list</a>), then joined the board of UnitedHealth Group within months (see <a href="http://www.bizjournals.com/twincities/stories/2001/05/21/daily20.html">this article</a>.) We discussed in considerable detail the ethical failings of UnitedHealth Group while Ms Shalala had fiduciary responsibility as a board member for its conduct. A particularly striking failing was how the board of directors granted sufficient back-dated stock options to the company's former CEO to make him a billionaire on paper.  The resulting <a href="http://hcrenewal.blogspot.com/2006/08/more-entangled-web-unitedhealth-case.html">scandal</a> was followed by his <a href="http://hcrenewal.blogspot.com/2006/10/another-really-big-one-bites-dust-ceo.html">resignation</a>.  Later, Dr McGuire was forced to <a href="http://hcrenewal.blogspot.com/2007/12/some-payback-by-former-managed-care-ceo.html">give back</a> some the options.  The <a href="http://hcrenewal.blogspot.com/2009/08/final-settlement-of-unitedhealth.html">final settlement</a> of the fiasco cost UnitedHealth $895 million, and Dr McGuire $30 million and the cancellation of 3.6 million stock options.  As we most recently summarized <a href="http://hcrenewal.blogspot.com/2010/08/despite-scandal-former-unitedhealth-ceo.html">here</a>, former CEO William McGuire was one of the top 10 best compensated CEOs of the first decade of the 21st century, despite the company's multiple ethical failings.  Conflicts of Interest, Especially Involving Key Opinion Leaders who Promote Marketing Objectives Cloaked in Academic Respectability We have extensively discussed the web of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> that now pervades health care. For academic health care leaders, the most intense kind of conflict of interest may be created by service on the board of directors of a for-profit health care corporation.  Note that corporate directors, as we have discussed previously, have a fiduciary duty to exhibit "unyielding loyalty" to the stockholders of the company and their interests  [Per Monks RAG, Minow N. <a href="http://www.amazon.com/Corporate-Governance-Robert-G-Monks/dp/1405116986">Corporate Governance</a>, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.].  We first <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">started to discuss</a> the intense conflicts of interest generated when leaders of academic medicine are also members of boards of directors of for-profit health care corporations in 2006.  The issue really made the big time in 2010 when the New York Times published <a href="http://www.nytimes.com/2010/08/01/business/01prez.html">a front page article</a> in its Sunday Business section about whether university presidents who also were corporate directors were part of an "academic-industrial complex."  As we noted above, Ms Shalala's service on the board of UnitedHealth Group created such a conflict, and she apparently presided a similar board level conflict of interest affecting her medical school dean.  A particularly pernicious kind of conflict of interest may be created when a company selling health care goods or services pays an academic to become a "<a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leader</a>."  Industry spokespeople and key opinion leaders themselves tout KOLs as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There are documented instances (e.g., see posts <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post <a href="http://hcrenewal.blogspot.com/2010/11/of-drug-talks-deception-and-denial.html">here</a>).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a> about marketing of Lexapro, and <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a> about Neurontin). The Chronicle recounted how Ms Shalala also was linked to one of the better known examples of industry paid KOLs: <blockquote>Dr. Goldschmidt did not fully report the income from such corporate associations on the medical school's financial-disclosure Web site, even while promoting the site as evidence of his faculty's commitment to openness. He also brought to Miami a repeat violator of financial-conflict-of-interest standards, Charles B. Nemeroff, to serve as a professor and chairman of the department of psychiatry and behavioral sciences.</blockquote>In a <a href="http://chronicle.com/article/U-of-Miamis-Deal-Making/127935/">companion article</a>, the Chronicle summarized Dr Nemeroff's career thus: <blockquote>Dr. Nemeroff had quit as chairman of Emory University's psychiatry department in December 2008 after the university received complaints about his secretly receiving money from GlaxoSmithKline and other pharmaceutical companies while helping promote their products.</blockquote>We (Dr Bernard Carroll more than yours truly)  have posted previously about Dr Nemeroff's exploits, including those at the University of Miami, <a href="http://hcrenewal.blogspot.com/search/label/Charles%20Nemeroff">numerous times</a>.  The Fall of Municipal Hospitals, the Rise of For-Profit Hospitals We have frequently discussed how the leaders have <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">undermined</a> health care organizations' core missions, and particularly how hospitals and hospital systems have strayed from their patient care mission to make more money. The Chronicle suggested how Ms Shalala's leadership of the University of Miami has enriched the institution's teaching hospital at the apparent expense of the local municipal hospital system: <blockquote>Another set of problems, cited by current and former university faculty and Jackson staff members, stems from the 2007 takeover of a facility that became the University of Miami Hospital, across the street from Jackson. The purchase has greatly expanded the university's ability to direct many of the area's most profitable patients and procedures to the new facility and to other university-owned hospitals, further worsening Jackson's own considerable budget woes.</blockquote>In addition, <blockquote>The university's patient-enrollment practices were part of the problem. The inspector general of the U.S. Department of Health and Human Services and the U.S. Attorney's Office for the Southern District of Florida are looking into the question of whether university doctors routinely enrolled Jackson patients in research projects without telling the hospital. In a 2008 letter from Jackson officials to university leaders, Nathan Anspach, who was vice president for physician services at the hospital, described a series of failed efforts 'to stop new clandestine research' at Jackson by university doctors. Meetings with university officials aimed at stopping the practice 'went badly,' Mr. Anspach wrote, and Dr. Goldschmidt, the medical-school dean, was 'outwardly annoyed' by Jackson's requests for information that would help it identify research patients in the building. Ms. Shalala was copied on at least some of the correspondence, including a 2006 letter in which Marvin O'Quinn, then-president and chief executive of the Jackson Health System, which runs Jackson Memorial, warned Dr. Goldschmidt about the legal risks of submitting claims for patient care that should be covered by a medical study. The current director of compliance at Jackson Health System, Diana Salinas, said the allegations are a matter of investigation by the two federal agencies. Ms. Shalala and Dr. Goldschmidt told The Chronicle that they were unfamiliar with the matter. 'This must not be a very big issue,' Ms. Shalala said, 'because none of the Jackson senior leadership has ever brought it up with me.'</blockquote>Finally, <blockquote>And the departing chief executive of the Jackson Health System, Eneida O. Roldan, whose appointment two years ago was supported by the university, said medical-school officials made clear from the start 'that they were going to take cardiology across the street.' Ms. Dixon-Shim, of the support-workers' union, is among those who say they've seen it happen. 'Most of the indigent patients, they're staying at Jackson,' she says. 'But most of the private patients, the physicians are taking them over to their area' at the university-owned hospitals.</blockquote>Note that we previously <a href="http://hcrenewal.blogspot.com/2011/02/send-mercenaries-guns-and-money.html">discussed</a> how Jackson's financial troubles lead to a bid by for-profit Steward Health Care to take it over. Summary So, through her mutiple roles that allowed her to serve at several key nodes of networks of influence in health care, one person has been linked to multiple dysfunctional aspects of US health care that arguably have been responsible for our increasing costs, declining access, and poor quality.  Note that these multiple roles seem to have been logically and even ideologically inconsistent, suggesting that multiplying her roles within the  networks may have been more compelling to her than logical or ideological rationales for particular actions. We have discussed before, the leadership of health care organizations has become incredibly interrelated, interlocked, and incestuous. It appears that top leaders of various health care organizations may be more familiar with and identify more with each other, and with other hired executives and managers, than with their organizations, their organizations' missions, and their organizations' professionals, staff, students, clients, and patients.  It now appears reasonable to characterize the relationships among health care leaders as embedded networks of influence.  So to repeat- I strongly believe that there needs to be much more investigation, academic, journalistic, and perhaps legal, of the identity, nature, and culture of the leaders of health care, and their relationships. A few bloggers cannot do it all. Obviously, <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">the anechoic effect</a> mitigates against medical and health care academics looking into their own leaders. However, failing to understand who is leading our march to the brink of health care failure ought not to be something such academics would want on their conscience. Finally, and obviously, health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

Embedded Networks of Influence in Health Care: An Illustrative Case

At the 12th International Anti-Corruption Conference (IACC), sponsored by Transparency International, one of the plenary sessions was devo...

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The Managers' Coup: How the "Hired Hands" Got "Paychecks as Big as Tajikistan"

We have frequently discussed the perverse incentives provided to the leaders of health care organizations.  They almost never pay a penalty for presiding over organizational actions that are unethical, harmful to patients, or even <a href="http://hcrenewal.blogspot.com/search/label/crime">criminal </a>(e.g., see posts <a href="http://hcrenewal.blogspot.com/2011/06/ucb-settles-pleads-guilty.html">here </a>and <a href="http://hcrenewal.blogspot.com/2011/06/two-more-settlements-one-more-corporate.html">here</a> for some very recent examples.)  However, they often collect outrageously huge <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">compensation</a> disproportionate to any reasonable measure of their organizations' performance.  (e.g., see posts <a href="http://hcrenewal.blogspot.com/2011/04/johnson-and-johnson-runs-afoul-of.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/03/despite-poor-financial-results.html">here</a> for relevant recent examples.) Now two news articles, based in turn on research studies, further illuminate how hired managers and executives have become so wealthy and unaccountable. The <a href="http://www.nytimes.com/2011/06/19/business/19gret.html">first news article</a> was in the New York Times, and was in turn based on an accounting study.  In summary, <blockquote>a recent, <a href="http://www.accountingobserver.com/Home/tabid/36/Default.aspx">immensely detailed report </a>in The Analyst’s Accounting Observer, a publication of R. G. Associates, an independent research firm in Baltimore. Jack Ciesielski, the firm’s president, and his colleague Melissa Herboldsheimer have examined proxy statements and financial filings for the companies in the Standard & Poor’s 500-stock index. In a report titled 'S.& P. 500 Executive Pay: Bigger Than ...Whatever You Think It Is,' they compare senior executives’ pay with other corporate costs and measures. </blockquote> Here are some of the major comparisons the report makes: - Paid More than the GDP of Tajikistan <blockquote>Total executive pay increased by 13.9 percent in 2010 among the 483 companies where data was available for the analysis. The total pay for those companies’ 2,591 named executives, before taxes, was $14.3 billion. That’s some pile of pay, right? But Mr. Ciesielski puts it into perspective by noting that the total is almost equal to the gross domestic product of Tajikistan, which has a population of more than 7 million. </blockquote> Again, note that all comparisons below refer only to these 2591 most highly paid executives of 483 companies, not all the companies' executives. - Paid More than Audit Expenses <blockquote>158 companies paid more in cash compensation to their top guys and gals last year than they paid in audit fees to their accounting firms.</blockquote> - Paid More than Income Taxes <blockquote>Thirty-two companies paid their top executives more in 2010 than they paid in cash income taxes. </blockquote> - Pay Rises While Stock Prices Fall <blockquote>The report calculated that at 179 companies in the study, the average value of stockholders’ stakes fell between 2008 and 2010 while the top executives at those companies received raises. </blockquote> - Paid a Substantial Fraction of Total Operating Revenue <blockquote>It identified 24 companies where cash compensation last year amounted to 2 percent or more of the company’s net income from continuing operations. </blockquote> The article used a health care example to illustrate this one: <blockquote>Topping this list is Allergan Inc., the health care concern whose top executives received, after taxes, an estimated $2.6 million in salaries last year. That amounted to 50 percent of what the company earned from continuing operations, the report said. </blockquote> Further details made this a particularly telling example of perverse incentives given to executives: <blockquote>Caroline Van Hove, an Allergan spokeswoman, said that the salaries were large when compared with net income in 2010 because one-time charges reduced earnings significantly that year; in previous years, she noted, earnings were far higher than executives’ pay. She also said the company’s C.E.O. had not received an increase in salary over the past three years. </blockquote> Parenthetically, some of the charges that affected Allergan's earnings were clearly due to a $375 million fine after a guilty plea to a federal misbranding charge and $225 million related civil penalties the company paid in 2010. As we noted in <a href="http://hcrenewal.blogspot.com/2010/09/at-end-of-summer-everybody-well-nearly.html">this post</a>, the US Department of Justice alleged that Allergan paid kickbacks to promote a drug for unapproved uses. Thus, what cost the company a major piece of its revenues were costs related to unethical behavior including one federal misdemeanor, and allegedly paying kickbacks to doctors to promote a drug for unapproved uses. However, while this behavior caused a marked drop in earnings, the research above showed the impunity of the executives who presided over this behavior, whose compensation held steady or rose. - Paid a Substantial Proportion of Research and Development Expenses <blockquote>Moving on to R.& D. costs, the report examined the 62 technology companies in its sampling that reported such an expense, excluding certain costs associated with acquisitions. Mr. Ciesielski found that the median level of executive pay was equal to 5.3 percent of these companies’ R.& D. expenditures. </blockquote> - Pay Equal to a Substantial Proportion of Market Capitalization <blockquote>Finally, there’s the comparison of executive pay with market capitalization. As Mr. Ciesielski noted, this calculation provides the biggest shock value. Eleven companies analyzed in the report gave top executives a combined pay package amounting to 1 percent or more of the companies’ average market value over the course of the year. </blockquote> To put it a different way, for a few corporations, the pay of the top five executives was equal to at least one percent of the total value of the corporations as measured by the value of all stock shares outstanding. In summary, the R. G. Associates' report suggests that the salaried executives, who the NY Times article reminded us are "hired hands," were generally paid amounts that seemed outrageously disproportionate to every metric used. Furthermore, a <a href="http://www.washingtonpost.com/business/economy/with-executive-pay-rich-pull-away-from-rest-of-america/2011/06/13/AGKG9jaH_story.html">second article </a>in the Washington Post provided an even more astonishing comparison. - Paid Enough to Become a Majority of the Richest Americans <blockquote>The largest single chunk of the highest-income earners, it turns out, are executives and other managers in firms, according to a landmark analysis of tax returns by economists Jon Bakija, Adam Cole and Bradley T. Heim. These are not just executives from Wall Street, either, but from companies in even relatively mundane fields such as the milk business. The top 0.1 percent of earners make about $1.7 million or more, including capital gains. Of those, 41 percent were executives, managers and supervisors at non-financial companies, according to the analysis, with nearly half of them deriving most of their income from their ownership in privately-held firms. An additional 18 percent were managers at financial firms or financial professionals at any sort of firm. In all, nearly 60 percent fell into one of those two categories.</blockquote> Summary So now it appears that the disproportionate compensation given to hired executives of large corporations, including health care corporations, have made them the majority of the very rich.  Most of the very rich are thus hired corporate employees, not company owners, not entrepreneurs, not even those who inherited wealth, or who are sports stars or rock musicians. This transformation of the face of the very wealthy has occurred at a time when the other employees of those corporations have generally stagnant incomes, and when those who have invested in those corporations, including many in the middle-class who have invested their retirement savings, have barely made money. So it turns out that in large corporations, including large health care corporations, it has become all about the top bosses.  The top bosses are likely to be paid enough to make them some of the richest US citizens.  Their pay likely comes off the top, so it has priority over profits and stock-holders gains, much less the pay of the lesser employees.  So it is clear that hired executives of large corporations have engineered perverse incentives for themselves that means never having to say they're sorry, never having to be accountable for anything the company does wrong.  Hence, there should be no mystery why US health care is the most expensive in the world, and despite its expense, is not very accessible and not of good quality.  The main culprit is a peculiar perversion of laissez faire capitalism in which the top managers have staged a coup, and have become the new oligarchs and plutocrats, and thus put their interests ahead of all others.  So to reform health care, we must reverse the managers' coup d'etat, and restore leadership of health care organizations that puts the mission, and the health of patients and the population first, and is accountable to corporate owners (when applicable) and to patients and the public.  But that will mean now going up against those who have made themselves the richest and most powerful people in the country and the world, who will not lightly give up their oligarchy.

The Managers' Coup: How the "Hired Hands" Got "Paychecks as Big as Tajikistan"

We have frequently discussed the perverse incentives provided to the leaders of health care organizations. They almost never pay a penalty ...

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EMRUpdate's thoughts on health IT

I had posted about my relative's travails at the EMRupdate.com site where I have written or cross-posted a number of essays over the years. The site's proprietor Nick Harrington of the U.K. replied. In <a href="http://www.emrupdate.com/members/Nick-Harrington/default.aspx">his bio</a>: <blockquote> Managing Director of UK based document management software vendor Ambay Software providing hosting and support to <a href="http://www.emrupdate.com/">emrupdate.com</a></blockquote> I recognized a number of familiar themes in his reply. In turn, I replied to his reply as follows: <a href="http://www.emrupdate.com/members/Nick-Harrington/default.aspx"></a><blockquote><a href="http://www.emrupdate.com/members/Nick-Harrington/default.aspx">Nick Harrington</a> <a href="http://www.emrupdate.com/forums/p/30458/118187.aspx#118187">replied on</a> Mon, Jun 20 2011 10:12 AM Dr. Silverstein, We're sorry for your loss. Genuinely. However, I don't think this is the right place for you to start a campaign against EMR. The Healthcare industry is making big progress in the quality of patient care directly as a result of using Information Technology. The single act of providing computerized Electronic Health Record for a patient - whatever shape or form from many vendors - makes available important medical information to the whole team involved in patient care. It allows information to be readily available, to be carried with the patient as they move within the health system, it allows Doctors to be more aware of previous treatments, drug regimes and how best to care for this patient now in this consultation or emergency. Unfortunately laying blame at the door of IT and Electronic Medical Records isn't at all reaslistic and is unlikely to win your anything more than genuine sympathy. Certinaly no support for your premise that EHR is a direct cause of death, however unfortunate its circumstances. I do wish you peace and strength in your sad bereavement. Nick</blockquote> My reply: Nick Harrington wrote: <blockquote> Dr. Silverstein, We're sorry for your loss. Genuinely. However, I don't think this is the right place for you to start a campaign against EMR.</blockquote> Thanks for the expression of sympathy. It is appreciated. A few clarifications though: I have never maintained a "campaign" against EMR. I merely hold views that experimentation on patients with problematic, poorly engineered, unregulated medical devices (that are deliberately given special accommodation with regard to the federal FD&C act per Jeff Shuren at CDRH, see <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">FDA Decides Regulating Implantable Defibrillator Medical Devices a "Political Hot Potato"; Demurs</a>), and without informed consent, is unethical. As per <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/regulation_and_oversight_hoffman.pdf">Hoffman & Podgurski</a> at Case Western School of Law, what I am against is the lawlessness of the industry today. Nick Harrington wrote: <blockquote>the Healthcare industry is making big progress in the quality of patient care directly as a result of using Information Technology</blockquote> Much current and emerging literature refutes that (such as the sampling <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">at this link</a>). In consideration of this literature, today's commercial health IT is not yet ready for large scale rollout from an ethical perspective. Doing so is experimentation by definition. Doing s, especially without patient awareness or consent, is in violation of decades of policy on human experimentation (e.g., see HHS "<a href="http://answers.hhs.gov/ohrp/categories/1562">Human Research Protections Frequent Questions</a>.") These are first principles, not open to debate. Even modest NIH research grant proposals involving health IT undergo strict review for human subjects (and researcher) protections. I know first hand, as a sat on a Study Section on health of the population and provided Medical Informatics expertise to such proposals. Nick Harrington wrote: <blockquote>"The single act of providing computerized Electronic Health Record for a patient - whatever shape or form from many vendors - makes available important medical information to the whole team involved in patient care. It allows information to be readily available, to be carried with the patient as they move within the health system, it allows Doctors to be more aware of previous treatments, drug regimes and how best to care for this patient now in this consultation or emergency."</blockquote> Ideally, yes. However, we're still quite far from the ideal. At present, what we have is an unknown level of "health IT roadkill" on the way to perfecting the technology. As predicted by the field of <a href="http://rkcsi.indiana.edu/">Social Informatics</a>, there are also other unanticipated and likely adverse side effects (such as at <a href="http://hcrenewal.blogspot.com/2011/06/blogscan-uk-unencrypted-laptop-health.html">link</a>), outcome unknown. Nick Harrington wrote: <blockquote>Unfortunately laying blame at the door of IT and Electronic Medical Records isn't at all reaslistic </blockquote>That depends in what setting, and to whom, the blame is laid. In any case, regarding my relative: may she rest in peace, and may my efforts [i.e., at whistleblowing on health IT problems] result in others not having to suffer similar mistakes at the hands of IT. Nick Harrington wrote: <blockquote>I do wish you peace and strength in your sad bereavement. Nick</blockquote> Thanking you kindly. -- SS

EMRUpdate's thoughts on health IT

I had posted about my relative's travails at the EMRupdate.com site where I have written or cross-posted a number of essays over the ye...

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A Biomedical Informatics Manifesto

Note: this essay was originally posted in Oct. 2008. In view of my relatives's injuries due to interference of EHR's in clinical processes, I think it worthy of reposting. <h3 style="text-align: center;" class="post-title entry-title">A Biomedical Informatics Manifesto </h3> <div class="post-header"> </div> <div style="text-align: center; font-style: italic;"><blockquote>"We need to recognize that in our society's efforts to improve healthcare, we are attempting to create virtual clinical tools for complex and unforgiving medical settings that happen to involve computers, and that facilitate healthcare, not information systems that happen to involve doctors and clinicians that (in line with the bellicose grandiosity characteristic of IT marketing) will "revolutionize" healthcare. - S. Silverstein (me - ed.) </blockquote></div><div style="text-align: center;"> </div>The American Medical Informatics Association is moving towards <a href="http://www.digitalhcp.com/hitw/newsletters/2007/03/13/amia-clinical-informatics/">having the field of Biomedical Informatics formally declared a medical subspecialty</a> with the help of a $300,000 grant from the Robert Wood Johnson Foundation. While this is good, it is a long time in coming. I have been thinking a great deal about the recent Joint Commission Sentinel Events Alert on the potential dangers of poorly conceived and implemented healthcare IT. I wrote on this issue at the post "<a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html">Joint Commission Sentinel Events Alert On Healthcare IT</a>". Noteworthy is the fact that the research of current Biomedical Informatics specialists and allies figure heavily in the Alert’s references. I can only wonder what motivated the Joint Commission to issue such a potentially industry-adverse advisory (adverse to common and profitable health IT industry practices that create these issues, that is) at this time. President-elect Obama, after all, has made HIT a significant part of his agenda. Perhaps as cases of HIT difficulty and patient harm become more commonly known, the Commission does not wish to appear to have been caught unaware as have other regulatory agencies in the face of recent turmoil in the housing and financial sectors. I have heard rumors from my readers, in fact, of major stories about HIT malfunction that might in fact reach a wide public audience in the coming years. Considering the turmoil in the housing, economic and investment sectors, perhaps the Joint Commission does not want to be seen in the same light as a Fannie Mae or an SEC. In any case, the alert's appearance raises a meta-issue: <blockquote style="font-weight: bold;">Why was such an alert even necessary?</blockquote> None of the issues the alert raises, ranging from safety risks, unintended and preventable adverse events that these implementations can create or perpetuate via fundamental errors of either commission or omission, ill conceived human-machine interfaces and organization/system design, etc. would be very commonplace if the teachings of 40+ years of Biomedical Informatics research was heeded. Some of those researchers could probably have written the Joint Commission alert on HIT in the 1960's. In fact, they largely did. Biomedical informatics research goes back to the pioneers such as the writings in 1968-9 of Dr. Donald Lindberg, (now director of the U.S. National Library of Medicine at NIH and a key figure in funding for Bioemedical Informatics postdoctoral training), the "Ten Commandments" of Octo Barnett regarding HIT in 1970, the five major reasons for lack of HIS success by Morris Collen in 1972, the four reasons for lack of HIT diffusion by Friedman and Gustafson in 1977, and many others [1]. Why has it taken forty years for this research to be reinvented and regurgitated by a major healthcare regulatory agency? How many billions of dollars have been wastefully spent, and how many patients have been adversely affected by <a href="http://iig.umit.at/efmi/badinformatics.htm">bad informatics</a>, in all those years? Biomedical informatics research currently includes the work of the formal departments and centers in the field such as <a href="http://www.nlm.nih.gov/ep/GrantTrainInstitute.html">these</a> funded by the NIH in the U.S. and others funded by their own universities, departments of Biomedical Informatics in <a href="http://www.amia.org/informatics/acad&training/international.asp">other countries</a>, sociologists (e.g., <a href="http://www.ssc.upenn.edu/soc/People/koppelross.html">Ross Koppel</a>, <a href="http://oldwww.bmg.eur.nl/personal/j.aarts/">Jos Aarts</a> to name just a few), <a href="http://rkcsi.indiana.edu/">social informatics</a> experts, the <a href="http://www.ischools.org/">iSchool</a> consortium, and many others working in a cross-disciplinary manner. In my own case, I have been <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm">writing on these issues</a> since my eye-opening experiences as a Chief Medical Informatics Officer (CMIO) in the mid-1990's at Delaware's largest healthcare organization. I am astonished that the issues I wrote of then are current today; I often hear the exact same stories from current CMIO's over a decade later. I can say that none of the Joint Commission warnings were necessary on my watch as CMIO; I was cognizant of all these problems as a result of several years of studying the issues in the time I spent in the deep cave known as the <a href="http://www.med.yale.edu/library/">Yale Cushing/Whitney Medical Library</a> during my Biomedical Informatics fellowship and faculty time, as well as by direct observation using the simple skills of a medical internist but applied to IT. My writings have been widely viewed (see my 2006 AMIA poster "Access Patterns to a Website on HIT Failure", ppt file at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/content/documents/FINAL_Healthcare%20IT%20Failure_Oct_19_2006.ppt">this link</a>). Yet, as a Google or other search engine search on "healthcare IT failure", "healthcare IT difficulty" or similar concepts demonstrates, explicit information on this topic remains curiously limited. On the contrary, a search on "medical malpractice" brings up literally millions of "hits." Why do the healthcare IT dangers that are the subject of the JC alert occur at all? A clue can be found in the following observations. The problem can be summed up like this: <blockquote style="font-weight: bold;">Biomedical Informatics as a specialty might as well be invisible. Amateurs rule HIT.</blockquote> (Note: I use the term "amateur" not in a pejorative sense, but in the sense that I am a <a href="http://www.arrl.org/">radio amateur or “ham”</a> with formal licensure after governmental examinations and significant technical and applied telecommunications experience. I am not a telecommunications professional, however, who should be, say, leading a critical telecommunications initiative for a hospital or large business.) Here is my most recent and indeed most personal evidence Biomedical Informatics is still largely invisible. My former chair of medicine from my residency, a consummate clinician trained at Yale and now Chief of Staff of an 800+ bed hospital complex, opined regarding an opening for a Director of Clinical IT at his organization (in reference to my application, which was summarily ignored by the IT department other than the typical form letter reply) that "I do not believe it is a Sine qua non that a physician be at the helm of the clinical informatics enterprise". He knew of my career path since my residency in the mid 1980's. Now, this same person wrote a letter of recommendation in 1992 to Yale's Center for Medical Informatics about my qualifications for a Biomedical Informatics postdoctoral fellowship at his alma mater. The letter indeed mentioned the evening in 1986 when I went "way outside the box" as a resident at his hospital and used my IT expertise to repair a CT scanner's computer that was malfunctioning and that had been abandoned for the evening by the vendor. My repair brought the CT scanner online, and changed the intervention on a mid 20's unknown male brought to the ED with profound mental status changes from a potentially catastrophic lumbar puncture to the appropriate neurosurgical intervention - to manage a huge hydocephalus caused by a benign obstruction within his brain. The patient survived. The statement directed towards me that "a physician is not a Sine qua non of a healthcare informatics initiative" thus clearly identifies me as "a physician", not a "formally trained and experienced biomedical informatics professional who is also a physician." (One would hopefully never hear that "a surgeon is not a Sine qua non of major abdominal surgery.") That the field of biomedical informatics could have been so invisible to such a person suggests to me the field is simply a Black Hole to others even less well informed about its practitioners: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj3K4lYjCXbg50q4TJL2Mc7qb2GnTGsqYtRJzTwm8eIvfGybtehlfBX3kkVwjuFeqMI_ZLz7fku2eyvWwM7XANIwcBuoPNf4lJ1EVQPXIhLhOyDestfCBQVNTCr26AWQNUjEC99xXNDdtte/s1600-h/Black_Hole.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5283808971247560578" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj3K4lYjCXbg50q4TJL2Mc7qb2GnTGsqYtRJzTwm8eIvfGybtehlfBX3kkVwjuFeqMI_ZLz7fku2eyvWwM7XANIwcBuoPNf4lJ1EVQPXIhLhOyDestfCBQVNTCr26AWQNUjEC99xXNDdtte/s200/Black_Hole.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 200px; height: 160px;" /></a>The environment around an invisible Black Hole. Is this how the healthcare industry sees the field of Biomedical Informatics? </div> Other occupations (I've personally seen IT personnel, MBA's, business consultants, "process re-engineers", 'techie' docs and nurses with just enough IT knowledge to be dangerous, social workers, and a cadre of others) are thus free to commit what I term "cross-occupational piracy" upon HIT. They do not do a stellar job of it. Thus, the Joint Commission alert becomes necessary. This phenomenon was also apparent in pharma. I note the following essay at the excellent blog "<a href="http://www.corante.com/pipeline/">In the Pipeline</a>" by medicinal chemist Derek Lowe, PhD, in a Dec. 19, 2008 post entitled "<a href="http://pipeline.corante.com/archives/2008/12/19/my_compound_goes_where_the_wild_goose_goes.php">My Compound Goes Where the Wild Goose Goes</a>" that: <blockquote style="font-family: arial;">A colleague and I got to talking yesterday about something that I'm sure many chemists have noticed. Have you ever chased down some reaction or compound in the literature, only to find yourself wild-goosing back to some obscure journal that no one has ever read - just because no one can be bothered to publish a modern procedure? Here's how that typically works. You run a SciFinder search on Molecular Structure X. A list with a dozen references comes up. There's a Tet. Lett. from 2002, but what are the chances it'll have any spectral data (or anything useful at all?) Ah, there's one from Tetrahedron in 1995, that should do. So you look over the PDF, search for your compound. . .there it is, number 17. Now to the experimental. . .and you find in the first paragraph that "Compound 17 was prepared according to a published procedure", footnote thirty-eight. And the footnote is to. . .ay, it's to a Chem. Ber. paper from 1932. Ausgezeichnet! Oh-kay. Back to that SciFinder reference list. How about that Tet. Lett. paper? Nope, on inspection, it turns out to reference the 1995 paper you just looked at. What else? There's a JOC from 1984, let's try that. Good ol' JOC, solid stuff. Well, digging up that PDF, you find that it refers to a 1980 paper from the same group from Synthesis. Hrm. So you chase that one down, there it is, compound 9, and the experimental for it is. . . footnoted to the 1932 paper. Again.</blockquote> What he is referring to is the "wild goose chase" that often plagues medicinal and other chemists in performing syntheses, essential to the drug discovery process. He is pointing out the use of the cheminformatics resource known as "<a href="http://en.wikipedia.org/wiki/Chemical_Abstracts_Service">SciFinder</a>" by the American Chemical Society. An ACS division provides the largest databases of publicly disclosed chemistry-related information and makes the information accessible through search and retrieval software such as SciFinder, along with links to the original literature and patents. SciFinder is an essential tool to the modern research chemist. Some pharmas (e.g., Pfizer) made this tool widely available to its scientists. Which makes my experience in Big Pharma astonishing, in that I as a science library director in a company with a declining pipeline of new drugs had to fight a long battle with a non medical, non science-background IT VP over ending rationing of said tool, among others, to save a few million $ per annum. I was dumbfounded. This in a drug giant boasting $60 billion in market clout and 60,000 employees. In the end, my department received only a fraction of what I asked for, and that was soon taken away (not from me personally, but from the scientists, ultimately) as budgets declined. My appeals to senior management as a Biomedical Informatics professional, a.k.a. information scientist, might as well have been invisible as well. I was ultimately laid off by the VP for my efforts, leaving laggards who had tolerated this mind-boggling, truly absurd situation that impaired drug discovery behind. Black hole <a href="http://en.wikipedia.org/wiki/OJ_287">OJ287</a>, mass of 18 billion Suns. Unfortunately, I <a href="http://hcrenewal.blogspot.com/2007/03/computer-debacle-broken-down-process-at.html">doubt FDA will issue a similar</a> alert about the dangers of research IT leadership by non scientists. In effect, the Joint Commission Sentinel Alert affords an opportunity for a return to some sanity in healthcare IT endeavors. It is my view that the Biomedical Informatics community and its allies need to leverage this perhaps first-ever acknowledgment from an organization with clout that HIT is not a harmless panacea and needs to be subject to informed discipline and rigor (as medicine itself). They need to leverage it to end the "black hole of invisibility", irrespective of the bureaucratic and prolonged process of having the field declared a medical subspecialty, the outcome of which is uncertain. The alert needs to be leveraged each and every time a Biomedical Informatics professional finds themselves being marginalized. It needs to be leveraged as a hammer. "Political correctness" (aptly abbreviated "PC", pun intended) on these matters ultimately gets patients killed. You know you're afflicted with the terminal PC bug when you feel reluctance to tell your CIO and IT personnel who lack training, knowledge and experience in clinical medicine, and who've just concluded contracts for the world's worst clinical IT without sufficient end user involvement, that they, in fact ... lack training, knowledge and experience in clinical medicine. When told that the CIO or IT people or the COO or the CFO or the MBA process re-engineers "know better" than informatics experts what clinicians should be doing and what they need to care for patients; that informatics experts don't have enough project management or other mundane experience; that they are too academic; that doctors don't do things with computers; that a biomedical informatics expert is not the "Sine qua non" of a major healthcare informatics initiative; that the vendor whose products impaired a national HIT initiative overseas has assured us their products are just dandy, and so forth ... ... the reply should itself be a well-justified bit of bellicosity. Biomedical informatics professionals should stand up, speak out, and make it count: <blockquote> "What part of 40+ years of Biomedical Informatics research and experience don't you understand?"</blockquote> -- SS Reference: [1] A History of Medical Informatics in the United States 1950-1990 (pp. 167-175), Morris F. Collen B.E.E., M.D., 1995, American Medical Informatics Association, ISBN 0-9647743-0-5.

A Biomedical Informatics Manifesto

Note: this essay was originally posted in Oct. 2008. In view of my relatives's injuries due to interference of EHR's in clinical pr...

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Blogscan: UK unencrypted laptop health breach affects more than 8.6 million records

From the blog "<a href="http://aushealthit.blogspot.com/2011/06/who-needs-hackers-when-there-are.html">Australian Health Information Technology</a>": <blockquote>Who Needs Hackers When There Are Accidents Like This? The PCEHR [Personally Controlled Electronic Health Record - ed.] Won’t Avoid Hacker Attention I Suspect. <div class="post-header"> </div> The following popped up a little while ago. By <a href="http://blogs.hcpro.com/hipaa/author/dnicastro/" title="Posts by Dom Nicastro">Dom Nicastro</a> Think the United States has its problems with securing patient health information? We’re not alone. London Health Programmes, a medical research organization based at the NHS North Central London health authority, has reported missing an unencrypted laptop containing information of 8.63 million patients and 18 million hospital visits, operations and procedures, according to today’s issue of <a href="http://www.thesun.co.uk/sol/homepage/news/3637704/Missing-Laptop-with-86million-medical-records.html">The Sun</a>. The data does not include names, “but patients could be identified from postcodes and details such as gender, age and ethnic origin,” according to the newspaper. Information on the laptop included records of cancer, HIV, mental illness and abortions. The computer was one of 20 lost, and officials have since recovered eight. The research organization “only just” reported the missing laptops to police although they went missing three weeks ago, according to the newspaper. The Information Commissioner’s Office, Great Britain’s independent authority that promotes data privacy for individuals, has issued a <a href="http://www.ico.gov.uk/%7E/media/documents/pressreleases/2011/ncl_statement_20110615.pdf">statement regarding the laptop theft</a>: “Any allegation that sensitive personal information has been compromised is concerning and we will now make inquiries to establish the full facts of this alleged data breach.” More here with a gruesome list of UK breaches. <a href="http://blogs.hcpro.com/hipaa/2011/06/unencrypted-laptop-health-breach-affects-more-than-8-million-records/">http://blogs.hcpro.com/hipaa/2011/06/unencrypted-laptop-health-breach-affects-more-than-8-million-records/</a> Clearly this sort of incident is made more significant when material like this is appearing regularly.</blockquote> We've posted numerous times at Healthcare Renewal on the impossible dream of electronic medical record privacy, security and confidentiality. See blog query links <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality">here</a> and <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">here</a>. -- SS

Blogscan: UK unencrypted laptop health breach affects more than 8.6 million records

From the blog " Australian Health Information Technology ": Who Needs Hackers When There Are Accidents Like This? The PCEHR [ Pers...

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UCB Settles, Pleads Guilty

Tromp, tromp, tromp.... the legal settlements keep marching along.  This latest story was reported by <a href="http://www.reuters.com/article/2011/06/09/ucb-settlement-idUSN0914441720110609">Reuters</a> and <a href="http://www.bloomberg.com/news/2011-06-09/ucb-pleads-guilty-to-illegal-off-label-marketing-of-epilepsy-drug-keppra.html">Bloomberg</a>.  The basics were, per Reuters: <blockquote>The American unit of Belgian pharmaceutical company UCB SA (UCB.BR) pleaded guilty on Thursday and will pay $34.4 million to settle criminal and civil charges that it illegally promoted a drug for migraines. The company pleaded guilty to one count of promoting the epilepsy treatment drug, Keppra, in the United States in 2004 for migraine treatment without the necessary approval from the Food and Drug Administration, the U.S. Department of Justice said.</blockquote> One atypical element here is that the company actually pleaded guilty to a crime. Another slightly off-key note came from the description of the activities constituting the illegal marketing, per Reuters: <blockquote>The company was accused of promoting Keppra with posters that claimed it was safe and effective for migraines and cited studies that it also claimed were independent -- but in fact were sponsored by UCB, according to the Justice Department. In those posters, UCB failed to disclose that its own trials had failed to demonstrate the drug was effective for migraines or that it had backed the studies, the agency said.</blockquote> Furthermore, per Bloomberg, <blockquote>UCB’s marketing included sponsorship of doctor-paid 'studies,' posters, publications and oral presentations about the supposed benefits of using Keppra to treat migraines. Prosecutors said UCB failed to disclose that a 2000 study showed that Keppra was not effective in preventing migraine. </blockquote> So the company did not deny accusations of deceptive marketing, and the suppression of a clinical study that failed to conform to marketing objectives. But most of the rest followed the usual routine. The settlement involved some sort of promises of better corporate behavior in the future, per Reuters: <blockquote>As part of the settlement, the company agreed to implement procedures and reviews to avoid and detect any future similar conduct. As a result, UCB will not face probation, according to the plea agreement filed in court.</blockquote> The penalty for the company was a fine that appeared to be big: <blockquote>UCB will pay about $8.6 million in criminal fines and forfeiture and another $25.8 million to settle parallel civil allegations involving false claims submitted to U.S. federal healthcare programs, according to the plea agreement.</blockquote> However, it was a pittance compared to the revenues generate by the product whose marketing was illegal, per Bloomberg: <blockquote>Keppra, with 942 million euros ($1.37 billion) in sales last year, is the company’s top-selling drug, according to data compiled by Bloomberg. </blockquote> The spokesperson for the government basically said, "that ought to teach them," again per Bloomberg, <blockquote>'UCB put its pursuit of profits ahead of its obligations to patients,' Ronald C. Machen Jr., U.S. attorney for the District of Columbia, said in an e-mailed statement. 'Today’s guilty plea and UCB’s $34 million payout should remind drug companies that try to cleverly design off-label marketing schemes that we will not allow them to compromise patient safety.' </blockquote> However, the company's leaders did not seem the least bit fazed, or contrite for that matter, per Reuters, <blockquote>'We are pleased to have resolved this matter and look forward to continuing to work with the many organizations with whom we partner to advance our mission of transforming the lives of people living with severe diseases,' said Greg Duncan, UCB's president for North American Operations.</blockquote> The contrast between the crime his company admitted, involving deceptive marketing and the suppression and a study that failed to fit marketing objectives, and the high minded mission seemed to cause Mr Duncan no cognitive dissonance. Or perhaps "transforming the lives of people" was meant more ironically? Left unsaid in the brief news reports was whether any individual who authorized, directed, or implemented the bad behavior, including, in this case, the deceptive marketing and suppression of clinical research, would pay any sort of penalty. It seems safe to assume that no one will go to jail, pay a fine, lose a job, or even be demoted.  Why the US Department of Justice thought that a small fine and no individual penalties would change corporate behavior, when the profits to be made are so large, in the absence of even a little bit of contrition by corporate leaders, was not exactly clear. So on and on the march goes. The <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade of settlements</a>, sometimes even involving guilty pleas of criminal convictions, now indicates how low the ethical standards of health care organizations have fallen. However, the lack of any consequences to individuals suggests that they have no incentive to rise. Again, despite promises of tougher treatment of individuals involved in health care corporate misbehavior from the government (see posts <a href="http://hcrenewal.blogspot.com/2011/05/fresenius-fined-82-million-for-false.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/06/attempt-to-hold-health-care-leaders.html">here</a>), the same old script plays out again and again. So I get to say twice in two days,,,, pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction. So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue.

UCB Settles, Pleads Guilty

Tromp, tromp, tromp.... the legal settlements keep marching along. This latest story was reported by Reuters and Bloomberg . The basics w...

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Two More Settlements, One More Corporate Integrity Agreement for Novo Nordisk

And the legal settlements for health care organizations keep right on marching along.  Here are the basics, <a href="http://online.wsj.com/article/SB10001424052702304259304576377430323510242.html">per</a> the Wall Street Journal, starting with the outline of the first settlement for Novo Nordisk: <blockquote>Drug maker Novo Nordisk A/S's U.S. affiliate has agreed to pay more than $25 million to end investigations by U.S. authorities related to the marketing of NovoSeven and several diabetes drugs. In one settlement, Novo Nordisk Inc., the U.S. affiliate, agreed to pay $25 million to end a probe and settle a civil lawsuit related to alleged improper marketing practices regarding Novo Seven, which is used to treat patients suffering from rare bleeding disorders. The complaint had alleged that Novo Nordisk promoted NovoSeven for unapproved uses. </blockquote>Here is the outline of the second settlement: <blockquote>Separately, the U.S. affiliate also agreed to pay $1.73 million in a settlement with the U.S. government to resolve allegations that its sales representatives accessed confidential patient information and submitted false Medicaid claims related to the marketing of diabetes drugs, including Novolin and Novolog. Federal prosecutors in Brooklyn, N.Y., had alleged Novo Nordisk representatives made payments to pharmacists in exchange for recommendations for Novolin and Novolog products. As part of their activities, the pharmacists, or Novo Nordisk sales representatives, accessed confidential patient information, according to the settlement agreement. </blockquote>Here is the usual pro forma denial by a company spokesperson that the company had done anything wrong: <blockquote>'We are committed to running our business according to high legal and ethical standards and have been cooperating with the government since the investigation began,' said Jim Shehan, corporate vice president and U.S. general counsel for Novo Nordisk Inc. 'With this settlement, we avoid the distraction and costs of a lengthy legal battle, which would not have been in the best interest of the company or its stakeholders.' Novo Nordisk denies any wrongdoing related to NovoSeven marketing....</blockquote>Also, <blockquote>Novo Nordisk didn't admit wrongdoing in the Novolin pact. </blockquote>By the way, here is the brief mention of the corporate integrity agreement: <blockquote>[Novo Nordisk] agreed to enter a five-year corporate integrity agreement with the U.S. Department of Health and Human Services in which it will add additional reporting and other procedures to its compliance program. </blockquote>Why would a company that professes "high ethical and legal standards" not contest allegations that it engaged in improper marketing, paid health care professionals to recommend its products, and instigated breaches of patient confidentiality?  Setting that aside, however, the coverage of this story <a href="http://articles.baltimoresun.com/2011-06-10/news/bs-md-factor-vii-20110610_1_factor-vii-novoseven-novo-nordisk">in the Baltimore Sun </a> raises further questions. First, how Novo Nordisk allegedly promoted Novo Seven, and the uses for which it was promoted are disturbing: <blockquote>the government [did not] back down from its charge that the company engaged in unlawful marketing that helped persuade the Army to treat combat casualties with a largely experimental drug that was not approved for such use by the Food and Drug Administration. Beginning in 2000, according to the government's claims, Novo Nordisk promoted the drug, also known as NovoSeven, to military doctors and entered into research agreements with Army hospitals. It provided funding for trials in which military officers participated, and gave 'donations and other gifts' to nonprofit foundations on behalf of military physicians. Those practices 'caused the military to use NovoSeven in its trauma patients,' the agreement states.</blockquote> There was no evidence that Novo Seven decreased the morbidity and mortality of battlefield trauma, but there were reasons to believe the drug increased thrombosis risk: <blockquote>Numerous clinical studies have since shown, however, that Factor VII is ineffective at controlling traumatic bleeding and can potentially cause blood clots that lead to heart attacks and strokes. </blockquote>This was not just paying physicians and institutions to market an expensive, but innocuous drug.  It was paying US military physicians and institutions to market a drug that put injured soldiers at risk, but gave them no benefit.  Given the degree of deference public officials give to the brave soldiers that serve the country on the battlefield, one would think that putting them at risk, and putting the honor of their officers and military institutions at risk ought to be a big deal, maybe a big deal requiring more than even a $25 million fine. On the other hand, although $25 million seems like a lot of money, it pales beside the amounts Novo Nordisk were making from Novo Seven: <blockquote>Last year Novo Nordisk reported annual sales of NovoSeven of almost $1.6 billion — mainly for treatment of hemophilia. Company officials say roughly 15 percent of its sales are for unapproved uses, or as much as $250 million last year.</blockquote> So while the settlement seems expensive compared to the cost of defending the suit in court, and it trades the distraction of a corporate integrity agreement for avoiding the "distraction" of further legal action, maybe a settlement equal to only one-tenth of the yearly sales of the relevant drug seemed a good deal for the company. Since the company was already laboring under a deferred prosecution agreement in the US related to charges of illegal foreign kickbacks (see <a href="http://hcrenewal.blogspot.com/2009/05/novo-nordisk-accepts-deferred.html">this post</a>), maybe adding a corporate integrity agreement did not seem like all that much distraction. On the other hand, the big question is: why was this deal a good one for the US government, or the people which it is supposed to protect? The amount involved only seems like a cost of doing business, and seems disproportionately small given that the allegations involved unlawful marketing that apparently threatened to corrupt US military doctors and hospitals, and were made against a company already under a deferred prosecution agreement for illegal kickbacks. Finally, since the impact of even the relatively small financial payment could be spread among all corporate employees and stockholders, and the deal involved no negative consequences for any individual who authorized, directed or implemented the bad behavior, why would it defer corporate insiders from authorizing or directing future bad behavior?  . We have heard a series of threats from US government officials that they are about to crack down on big health care companies that misbehave, and, in particular, actually try to impose some negative consequences on the people in those companies that authorized, directed, or implemented bad behavior (see <a href="http://hcrenewal.blogspot.com/2011/05/fresenius-fined-82-million-for-false.html">this post</a>). However, we continue to see settlements like this, involving relatively small financial penalties imposed on rather large corporations, and corporate integrity agreements and/or deferred prosecution agreements that do not obviously seem to change how the companies operate. Although a year ago we <a href="http://hcrenewal.blogspot.com/2010/06/attempt-to-hold-health-care-leaders.html">discussed</a> threats by the US government to hold health care leaders accountable using the "Responsible Corporate Officer Doctrine," which has been available since 1943, so far there is no evidence that this concept has been made operational. The continuing <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> now seems to have included most of the previously well reputed commercial health care firms in the US. The length of this march is an indication of how pervasive is bad behavior by such health care organizations, especially when the marchers were accused of behavior that appeared clinically, not just financially unethical. I assert again that pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction. So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable.    As long as they are not, expect the bad behavior to continue.

Two More Settlements, One More Corporate Integrity Agreement for Novo Nordisk

And the legal settlements for health care organizations keep right on marching along. Here are the basics, per the Wall Street Journal, st...

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