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Vested Interests and Their Influence on Physicians- New Understanding from Cognitive and Social Psychology

<a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">Evidence-based medicine</a> proposes patient care decisions based on the best evidence from critically reviewed clinical research, knowledge of biology and the biopsychosocial context, and patients' values and preferences.  Yet physicians often fail to make evidence-based decisions, despite many efforts to educate, or incentivize them to do so.  We used to think that the main reason was physicians' lack of knowledge and understanding of EBM, and human cognitive limitations that make such evidence-based thinking difficult.  However, now we realize that physicians are deluged by  attempts to influence their decisions so as to favor vested interests, whether or not that is good for patients. We have discussed various kinds of <a href="http://hcrenewal.blogspot.com/search/label/deception">deception</a> used in <a href="http://hcrenewal.blogspot.com/search/label/marketing">marketing</a> meant to increase physicians' prescriptions for drugs, and recommendations for devices and health care services.  Physicians have not proved to be very resistant to these methods. Now a new article provides a different perspective on how marketers use cognitive and social psychology to manipulate physicians.(1)  Sunita Sah's and Adriane Fugh-Berman's introduction stated, <blockquote class="tr_bq">Physicians often believe that a conscious commitment to ethical behavior and professionalism will protect them from industry influence.  Despite increasing concern over the extent of physician-industry relationships, physicians usually fail to recognize the nature and impact of subconscious and unintentional biases on therapeutic decision-making. Pharmaceutical and medical device companies, however, routinely demonstrate their knowledge of social psychology processes on behavior and apply these principles to their marketing. </blockquote> The article then listed a number of findings from social (and cognitive) psychology that marketers may use to their advantage on naive physicians. Psychological Mechanisms Promoting Acceptance of Conflicts of Interest and Dubious Marketing Ploys First, marketers may take advantage of cognitive biases and psychological mechanisms that allow physicians to accept marketing maneuvers while denying the effect of marketing on their decision making. Confidence and Over-Confidence <blockquote class="tr_bq">People are strongly influenced by messages delivered with confidence and do not take the trouble to ascertain the accuracy of these messages if doing so requires effort or money.</blockquote> I would add that many humans, including physicians, are also over-confident in the accuracy of their own judgments.  (In 1989 we showed  that physicians often were excessively confident in their judgments of patients' outcomes, in particular, about survival of critically ill patients.)(2) Of course, marketers often state their messages with great confidence regardless of their accuracy. So physicians need to try to restrain their own over-confidence, and be more skeptical of the confidence of others. Maybe this would just be an exercise in simple humility. Self-Serving (or Ego) Biases People tend to believe that the results of their decisions, or of their groups' decisions, are better than average.  This can be called the Lake Wobegon effect (from Garrison Keilor's fictional town in which all the children are above average.) We and others have shown that physicians may be overly optimistic about the outcomes of their own (versus others') patients, or their clinical units' (versus others') outcomes, again in the context of predicting survival of critically ill patients.(3)  We have also <a href="http://hcrenewal.blogspot.com/2010/07/where-no-hospital-ceos-are-below.html">posted</a> about how corporate boards of directors seem to almost always think that their hired executives are better than average, at least when determining their executive compensation. Similarly, Sah and Fugh-Berman wrote, <blockquote class="tr_bq">Physicians believe that their own prescribing behavior is unaffected by industry influence, although they concede that other physicians are susceptible to such influence.</blockquote> Furthermore, <blockquote class="tr_bq">Social psychology research confirms that people have a 'bias blind spot,' namely, they are more likely to identify the existence of cognitive and motivational biases in other than in themselves.</blockquote>But, as Dana and Lowenstein wrote, <blockquote class="tr_bq">It cannot both be true that most physicians are unbiased and that most other physicians are biased.</blockquote> So, to put it bluntly, physicians ought to be more humble about their own ability to resist outside influences and the resulting biases. Again, some simple humility might help. Cognitive Dissonance Sah and Fugh-Berman pointed out that <blockquote class="tr_bq">While articulating and believing in the importance of scientific objectivity, physicians' biases to accept industry gifts create cognitive dissonance; that is, discomfort that arises from discrepancy between conflicting beliefs, or between beliefs and behaviors.</blockquote> So, <blockquote class="tr_bq">Cognitive dissonance theory specifies three methods - not mutually exclusive - by which people manage or reduce dissonance.  Changing one of the dissonant beliefs, opinions or behaviors (possibly a difficult or painful process that requires sacrificing a pleasurable behavior or treasured belief); Lowering the importance of one of the discordant factors which can be accomplished by denial - forgetting or rejecting the significance of one or more of the conflicting cognitions; and adding consonant elements that resolve or lessen the dissonance (this may involve rationalizations to buffer the dissonance between conflicting cognitions.)</blockquote> Physicians may use denial and rationalization to reduce cognitive dissonance caused by their concurrent desire for relationships with marketers and others with vested interests on one hand, and their professionalism and its obligation to put patients' needs first on the other hand.  Sah and Fugh-Berman cited Chimonas and colleagues, <blockquote class="tr_bq">Denial included (a) avoiding thinking about the conflict of interest; (b) rejecting the notion that industry relationships affect physician behavior, and (c) disavowing or universalizing responsibility for problems that arose from conflicts of interest ('there's always a conflict of interest...').  Rationalizations included (a) asserting techniques that would help maintain impartiality and (b) reasoning that meetings with drug reps were educational and benefited patients.</blockquote> We have discussed various public justifications for accepting conflicts of interest by physicians and other health care decision makers that employed a variety of <a href="http://hcrenewal.blogspot.com/search/label/logical%20fallacies">logical fallacies</a> along these lines. So physicians need to re-examine their treasured beliefs and the gratification they get from relationships with industry (as opposed to those with patients, colleagues, friends and families).  They could remember the advice that no one can serve two masters. Sense of Entitlement Physicians' sense of entitlement, especially given the increasing stress upon them, may be used to rationalize relationships with drug, device and biotechnology companies since these corporations seem to be among their few friends (versus insurance companies, government agencies, and sometimes hospital administrations whom physicians feel may be more burdensome.).  So, in one study, <blockquote class="tr_bq">Implicitly reminding physicians of the burdens of medical training and their working conditions more than doubled reported willingness to accept gifts....</blockquote>So physicians need to reconsider that to which they feel entitled.  This is the third instance in which some humility might help.  Principles of Influence Used by Marketers Markets seem to also be well acquainted with the six principles of influence and persuasion identified by Cialdini and colleagues. Reciprocity <blockquote class="tr_bq">The norm of reciprocity - the obligation to help those who have helped you - is one of the guiding principles of human interaction</blockquote> This is the foundation of the effect of relatively small conflicts of interest, such as giving of small gifts. <blockquote class="tr_bq">Physicians pay off industry gifts through changes in their practice</blockquote> Furthermore, <blockquote class="tr_bq">Gifts associated with a subtle implicit request may be more likely to achieve compliance than gifts that call for explicit reciprocation. </blockquote>So physicians need to be wary of Greeks, or anyone else bearing gifts, even those less conspicuous than wheeled horses. Commitment and Consistence <blockquote class="tr_bq">Consistency is highly valued in our society and associated with rationality and stability.  After committing to a decision or opinion, people justify that choice or opinion by remaining consistent with it.</blockquote> So marketers try to get physicians to make small commitments to leverage larger ones.  This is <blockquote class="tr_bq">why drug reps, ask, for example, 'will you try my drug on your next five patients?'</blockquote>So physicians should remember there is no virtue in commitment to erroneous beliefs.  "A foolish consistency is the hobgoblin of little minds." - Ralph Waldo Emerson Social Proof This is basically the deliberate deployment of the logical fallacy of the <a href="http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html">appeal to common practice</a>. <blockquote class="tr_bq">Social proof, also referred to as social validation or conformity, is the practice of deciding what to do by looking at what others are doing. </blockquote> So, <blockquote class="tr_bq">If accepting industry gifts is a cultural norm in medicine, physicians will continue to do so.  The opinions of colleagues are often used by industry representatives to sway physicians to adopt a particular therapy.  </blockquote> This may be why industry works so hard to sign up health care academics. <blockquote class="tr_bq">Trainees in an institution, for example, are affected by the institution's stated policies but also - and sometimes more so - by what they see their mentors do.</blockquote>So physicians, who often pride themselves on independence, need to be skeptical about the need to follow the crowd. Liking or Rapport The more you like someone, the more you are apt to follow their advice, even if your feelings towards them have been manipulated. This is obviously why drug representatives, for example, are so nice to physicians. <blockquote class="tr_bq">Physicians often feel overworked, underpaid, and unappreciated [ed note -  and their is plenty of evidence, some of which we have discussed on this blog, that this is not unreasonable.]  Drug reps dispense sympathy, flattery, food, gifts, services and income-enhancing opportunities and seek to ask nothing in return but scholarly consideration of the benefits of drugs. </blockquote>So physicians need to reconsider who really are their friends, and be skeptical of "friends" with something to sell.  Authority and Security This is basically the deliberate deployment of the logical fallacy of the <a href="http://www.nizkor.org/features/fallacies/appeal-to-authority.html">appeal to authority</a>.  The best example is industry's efforts to recruit <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders</a>, that is health professionals who are perceived as authority figures, but have really been hired to market. <blockquote class="tr_bq">From an industry perspective, the best KOLs radiate status and authority while successfully convincing their peers (and perhaps themselves) of their illusory independence and lack of bias. </blockquote> Note that <blockquote class="tr_bq">KOL speakers not only influence audience members' prescribing behavior, but also - as predicted by cognitive dissonance theory - become more convinced themselves of the benefits of the products they endorse.</blockquote>So physicians need to be skeptical of those claiming to be authorities, especially when they are connected with people who have something to sell. Summary We used to strongly believe (and Dr Wally Smith and I used to teach a course to the effect that) the major barrier to true evidence-based practice was the cognitive limitations that physicians share with all humans.  We thought in terms of cognitive biases and the inappropriate use of cognitive heuristics leading physicians to inaccurately judge the probabilities of diagnoses and medical outcomes, and thus make less than optimal decisions. Now it seems apparent that the deliberate influencing of health professionals' judgments and decisions by external actors, mainly those interested in selling more products and services, but sometimes by those with ideological or political motives, is currently a much more important challenge to evidence based practice.  It looks like the influencers may be very knowledgeable about human cognitive limitations and how social psychology influences judgment and decisions, and may use this knowledge to pursue their vested interests, at the financial and physical expense of patients, and ultimately the public.  True health care reform would encourage professional education designed to increase resistance to external influences that put self-interest ahead of patients' and the public's health, and careful regulation that would decrease some of the more dangerous practices used.  Of course, much more resistance might be achieved if physicians used a little more common sense when dealing with people who are obviously trying to sell them on goods, services, or ideas.  A good proportion of the deceptive methods discussed above could be countered by remembering the usefulness of humility, skepticism, and a few simple aphorisms.    Again, as we have written repeatedly, not only should all conflicts of interest be disclosed for the sake of honesty, but physicians and other health professionals ought to consider repudiating most of all of them, maybe at some personal expense, but in the interest of re-establishing their commitment to putting the patient, not their own self-interest, or the vested interests of others, first.     References 1.  Sah S, Fugh-Berman A. Physicians under the influence: social psychology and industry marketing strategies.  J Law Med Ethics 2013; 14:  . Link <a href="http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2286433">here</a>: 2. Poses RM, Bekes C, Copare F, Scott WE.  The answer to "what are my chances, doctor?"  depends on whom is asked: prognostic disagreement and inaccuracy for critically ill patients.  Crit Care Med 1989; 17: 827-833.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/2752779">here</a>. 3. Poses RM,  McClish DK, Bekes C, Scott WE, Morley JN. Ego bias, reverse ego bias, and physicians' prognostic judgments for critically ill patients. Crit Care Med 1991; 19: 1533-1539.  Link here.

Vested Interests and Their Influence on Physicians- New Understanding from Cognitive and Social Psychology

Evidence-based medicine proposes patient care decisions based on the best evidence from critically reviewed clinical research, knowledge of biology and the biopsychosocial context, and patients' value…

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26 Sep 2013

A Plague of Bureaucrats - Now 10 Per Physician in US Health Care

There seems to be a reasonable argument that the US health care system is more dependent on the private sector, and in particular the for-profit private sector, than systems in other developed countries.  Advocates of private, for-profit health care often tout the private sector as more efficient and less bureaucratic than government.   However, a <a href="http://blogs.hbr.org/2013/09/the-downside-of-health-care-job-growth/">post by Robert Kocher in the Harvard Business Review blog</a>, of all places, noted that US health care is increasingly inflicted by a proliferation - perhaps a plague - of bureaucrats. Dr Kocher looked at employment of physicians, other health care professionals and clinical workers, and bureaucrats in a more recent time frame, 1990-2012.  The key findings were: <blockquote class="tr_bq"> Using data from the Bureau of Labor Statistics (BLS) and the American Medical Association, my colleagues and I found that from 1990 to 2012, the number of workers in the U.S. health system grew by nearly 75%. Nearly 95% of this growth was in non-doctor workers, and the ratio of doctors to non-doctor workers shifted from 1:14 to 1:16.</blockquote> Furthermore, <blockquote class="tr_bq"> Today, for every doctor, only 6 of the 16 non-doctor workers have clinical roles, including registered nurses, allied health professionals, aides, care coordinators, and medical assistants. Surprisingly, 10 of the 16 non-doctor workers are purely administrative and management staff, receptionists and information clerks, and office clerks. </blockquote> So, in summary, for every doctor, there are 6 clinical workers (nurses, aides, etc) and 10 bureaucrats (including managers). Note that this data appears compatible with 1983-2000 employment data we <a href="http://hcrenewal.blogspot.com/2005/04/growing-proliferation-of-managers.html">summarized</a> in 2005. During that period, the ranks of health care managers grew much faster than the ranks of physicians or nurses.  The growth rates from 1983 to 2000 were 1.39x (39%) for physicians, 1.54x (54%) for nurses, and a whopping 8.26x (726%) for managers. Another way to look at it is, in 1983 there was 1 manager for every 5.7 physicians and every 15.1 nurses. In 2000, there was 1 manager for every 0.96 physicians and every 2.9 nurses. Again, by 2000, the number of health care managers exceeded the number of physicians. There were more managers than any other species of health care worker other than nurses. So, by 2000, there was one manager per doctor.  By 2012, there were 10 bureaucrats, including managers, per doctor.  We have discussed the increasing power of managers, administrators and executives over health care.  Management gurus, such as Alain Enthoven, had advocated breaking the power of the supposed "physicians' guild" to reduce health care costs, and replacing physician leaders with managers (look <a href="http://hcrenewal.blogspot.com/2006/03/consequences-of-breaking-physicians.html">here</a>).  We have discussed the growing role of <a href="http://hcrenewal.blogspot.com/search/label/generic%20management">generic managers,</a> that is leaders trained only to manage, but not experienced in , and often not sympathetic to the values of health care.  Now there is increasing evidence that managers and bureaucrats are increasingly numerous in health care, the former somewhat and the latter greatly out-numbering physicians. We cannot scientifically prove that this plague of bureaucrats is responsible for US health care's mediocre quality and access, despite higher costs per capita than in any other developed country.  However, it does appear to be a reasonable hypothesis that increasing the relative numbers of health care professionals versus bureaucrats might produce at least more health care per dollar, if not also better health care per dollar.    This suggests that true health care reform requires decreasing the influence of generic management.  Health care leaders ought to be those with some knowledge of health care and some sympathy for its values. Such health care leadership might be less concerned with increasing bureaucracy, and more concerned with more and better actual care of actual patients.  (But do not expect such reforms to be popular with the very <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">well-paid</a> generic managers who now run health care, and hence do not expect such reforms to be easy to implement.)

A Plague of Bureaucrats - Now 10 Per Physician in US Health Care

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24 Sep 2013

Should "Diagnosing While Texting" Be Illegal?

I saw an interesting comment at Medscape in the comment thread of the article "<a href="http://www.medscape.com/viewarticle/809237">Do Your EHR Manners Turn Patients Off?</a>" (MedScape subscription required). <div style="margin-left: 40px;">Dr. [redacted] | Neurology I live in a town that has passed legislation criminalizing texting and driving. A driver is more impaired and distracted when texting than when intoxicated.  EHR's and the practice of medicine should be no different. Do you really believe that your physician is actually concentrating on the patient in front of them while their attention is primarily focused on entering data on a computer? The reality is that EHR's true value is data collection for statistical analysis by our government and there is an obvious deficiency for enhancing the physician-patient collaborative experience. </div><div> </div><div> </div><div>Medicine, like driving, is a very cognition, thinking and concentration-intense activity.   Failures lead to injury and death (although not quite as dramatically in the former compared to the latter).</div><div></div><div> I think the point about distraction the commenter makes is valid, or at least worthy of healthy consideration. Unless you're a health IT hyperenthusiast, that is (see <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html</a>).</div><div></div><div> -- SS </div>

Should "Diagnosing While Texting" Be Illegal?

I saw an interesting comment at Medscape in the comment thread of the article "Do Your EHR Manners Turn Patients Off?" (MedScape subscription required).Dr. [redacted] | NeurologyI live in a town that …

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23 Sep 2013

The Adventures of the Purloined Bequest, the Resident Heiress, and the Hidden Hospital System

The game is afoot again.  A series of recent articles in the media described a series of cases whose mysterious interrelationships Sherlock Holmes might have appreciated. The Purloined Bequest A singular <a href="http://online.wsj.com/article/SB10001424127887324324404579045331810905304.html">article </a>in the Wall Street Journal, entitled "Judge Rules in Case of Fortune Tied to Buffett," first made this case explicit, but some background is required to understand it. The story focused on Long Island College Hospital, in Cobble Hill, Brooklyn, New York.  [Full disclosure: this story got my attention particularly because I grew up nearby in Brooklyn, and was born at that hospital, which was also the local hospital my parents often used.]   LICH has long been the major community hospital for downtown Brooklyn. The story appeared to begin in 2011, per the WSJ, <blockquote class="tr_bq"> In 2011, Judge [Carolyn] Demarest approved the merger of LICH and SUNY Downstate on the condition it would keep the charitable hospital going. As part of the deal, the hospital transferred properties to Downstate estimated to be worth as much as $1 billion collectively, according to a previous court order.</blockquote> The merger was supposed to keep LICH in operation as a community hospital and provider of acute care to the poor.  However, things did not work out.  This year, however, Downstate announced plans to shut the hospital, leading to protests from Brooklyn residents and local politicians. <blockquote class="tr_bq">'It is clear that the premise upon which this Court authorized the transfer of assets has been defeated,' Justice Demarest wrote in her Aug. 20 decision, adding that Downstate had breached its contractual obligations. She cited a 'legal and moral responsibility' to correct her earlier error in approving the merger. She directed Downstate to return all assets to the hospital's previous owner, Continuum Health Partners Inc., which subsequently said it couldn't take the reins. The court is expected to review other proposals. </blockquote> The judge also discovered that hospital management had been raiding an large endowment fund intended for other purposes, <blockquote class="tr_bq">A New York state judge ruled this week that a struggling Brooklyn hospital must repay tens of millions of dollars it borrowed from an endowment set up by early investors with billionaire Warren Buffett. The ruling aims to rectify the previous use of the money by Long Island College Hospital, which is hurting financially and was scheduled to close. Mr. Buffett in July told The Wall Street Journal that his late friends, Donald and Mildred Othmer, would have felt 'betrayed' at the way the funds were spent.</blockquote> Apparently, <blockquote class="tr_bq"> The Othmers, natives of Omaha, Neb., who later lived in Brooklyn, were longtime friends of Mr. Buffett's, and each invested $25,000 with the billionaire in 1961. When they died—he in 1995 and she in 1998—they gave away a fortune estimated at $780 million, including the $135 million permanent endowment for the hospital. The Othmer wills stipulated the interest on the endowment could be used for operating expenses but the principal should be held 'in perpetuity.' In a series of court-approved transactions that began in 2000, the hospital borrowed from the funds repeatedly to meet short-term obligations and cover debts. The hospital argued that the money was necessary to keep the hospital afloat, which it said the Othmers would have wanted. The transfers depleted most of the endowment, a result that came to light after the Journal wrote about the situation in July.</blockquote> <a href="http://www.nytimes.com/2013/08/21/nyregion/judge-rejects-long-island-college-hospitals-ownership-deal.html">New York Times</a> and <a href="http://www.brooklyneagle.com/articles/dead-lich-could-net-suny-100-million">Brooklyn Daily Eagle</a> articles focused on the question of whether SUNY/ Downstate intended to close the hospital so it could sell its apparently valuable real estate assets in a now fashionable neighborhood, but not on how the hospital fell into these dire straits. There seem to be some lingering questions - -  If the losses and borrowing began in 2000, or earlier, who was responsible for them, given the current owners have only been in place since 2011? Note that the phrasing in the article above ("the hospital argued that the money was necessary to keep the hospital afloat") suggested that before SUNY took over, the hospital was independent.  However, the article mentioned, albeit only briefly in passing, that the hospital had a previous owner, Continuum Health Partners Inc. -  How were the losses explained when they occurred, and what was the rationale for  borrowing from restricted endowment as a response, instead of, for example, direct efforts to minimize losses or increase capital and revenue? Note that the article implied that when SUNY acquired LICH, it acquired some very valuable real estate.  Why did the previous management of LICH not consider selling off some of this real estate to resolve its debts? -  Did mismanagement of the hospital lead to excess losses, and did borrowing funds from the principle of the hospital's endowment to offset these losses amounted to more mismanagement?   Meanwhile, a second even more bizarre story about another New York City hospital almost simultaneously got media attention. The Resident Heiress The case first made it into the media in 2012, when the tabloid New York Post <a href="http://nypost.com/2012/09/02/beth-israel-medical-center-shook-down-heiress-huguette-clark-for-13-million-relatives-say/">reported</a>, <blockquote class="tr_bq">Beth Israel Medical Center milked reclusive copper heiress Huguette Clark for more than $13 million in fees, donations and even a priceless painting during her 20-year stay as a patient — and greedy executives angled for $125 million more, her relatives allege in shocking new court filings over Clark’s estate. The alleged shakedown was illuminated in an e-mail in which hospital board member and former CEO Dr. Robert Newman referred to Clark as 'the biggest bucks contributing potential we’ve ever had,' according to court papers. He told a colleague her 'potential has been overwhelming[ly] unrealized.' At one point, he suggested to Clark that she pay nearly one-third of her estimated $400 million fortune to keep the now-shuttered Beth Israel North on the Upper East Side open so she could keep living in the room she had refused to leave for 15 years despite being in good physical health, the papers allege. But instead of addressing Clark’s crippling anxiety, hospital honchos played on her fears, engaging in 'a concentrated effort, orchestrated at the highest board and executive levels,' to get her money, court documents obtained by The Post allege. Clark’s death last year at age 104 set off a battle over her estate. Her distant relatives claim lawyer Wallace Bock, accountant Irving Kamsler, private-duty nurse Hadassah Peri and the Beth Israel administrators manipulated the feeble Clark for her money. The nurse, who received cash and gifts from Clark, stands to inherit nearly $34 million and Clark’s priceless doll collection in the now-disputed will. Beth Israel is to get $1 million. The Paris-born Clark inherited her money from her father, William, a rail and mining baron and former US senator whose wealth rivaled the Rockefellers’. She went to Beth Israel North in 1991, when she was 85, after a doctor found her emaciated and ill in one of her three sprawling Fifth Avenue apartments. She spent the last two decades of her life in dismal hospital rooms with the shades drawn and door shut even though there was 'no medical basis for keeping her' past the first few months, documents show. Clark was 'the perfect patient' for the hospital, her relatives charge, noting, 'She required no medical care, possessed enormous wealth, paid over $800 a day for her room, and became progressively more dependent on the hospital.' 'Beth Israel had a plan to subtly, but ever so persistently, court Huguette for the purpose of garnering gifts and ultimately do a will in favor of the hospital,' court papers claim.</blockquote> This case also seems to be about wealthy donors and hospital executives.  Yet what makes it most bizarre are the circumstance of Ms Clark's hospital stay.  As a former intern, resident, fellow, and teaching hospital attending, I can attest that most hospital administrators are concerned, if not obsessed, with discharging patients quickly.  Hospital stays are currently paid by most insurers according to the patients' diagnoses, but not their length of stay.  Long stays cost hospitals money.  Furthermore, unnecessarily long stays use up resources that could better serve acutely ill and injured patients.  Yet Ms Clark stayed an astounding 20 plus years, without any obvious medical rationale.  No hospital official contested the fact that Ms Clark stayed that long in the NY Post article. Furthermore, in a 2013 New York Times <a href="http://www.nytimes.com/2013/05/30/nyregion/hospital-caring-for-an-heiress-pressed-her-to-give-lavishly.html">article,</a> the hospital's lawyer, defending a parallel attempt to recover the money donated to the hospital, wrote <blockquote class="tr_bq"> Beth Israel had provided Mrs. Clark with 'a well-attended home where she was able to live out her days in security, relative good health and comfort, and with the pleasures of human company.' Besides, he said, the amount of money she gave to Beth Israel was “not very large considering her vast wealth.”</blockquote> Furthermore, a member of the Beth Israel fund-raising staff wrote in a memo disclosed during litigation, <blockquote class="tr_bq"> She was well enough by then to go home to her spacious apartment at Fifth Avenue and 72nd Street, overlooking Central Park, Ms. [Cynthia L] Cromer said, but 'she asked if she might stay in the hospital longer: she feels comfortable and safe, and her apartment is being renovated.'</blockquote> Never mind that the fundamental mission of the hospital is to provide acute care for the sick and injured, not to provide comfortable retirement housing. But hospital managers are apparently on record acknowledging that the hospital was basically providing Ms Clark with services that are normally available in a retirement community, not services that acute care hospitals normally provide anyone   There is no evidence that the hospital ever provided similar services to any other patients.  The obvious mystery, then, is - why no one at the hospital, no doctor, nurse, or manager, or no visitor, regulator, accrediting agency, insurer ever questioned why the hospital was providing a long-term residence to a former patient? No answer to the question has appeared in any coverage I have seen of this case, including a September, 2013,.NY Times followup <a href="http://www.nytimes.com/2013/09/15/nyregion/the-two-wills-of-the-heiress-huguette-clark.html">article</a> on the occasion of the case nearing trial.  In the absence of a creditable explanation for this strange distortion of the hospital mission, - is there any other conclusion than that its purpose was to extract a large amount of money from a vulnerable, rich, but no longer acutely ill former patient? This would suggest an unusual but monumentally unethical kind of hospital mismanagement. So we have two recent stories about major, unusual, apparently severe mismanagement by hospital executives.  These stories were reported as if they were independent. However, buried in the original NY Post article, but unmentioned in either of the major NY Times articles, however, was a hint of how this case and that above of the purloined inheritance appeared to be linked. The Hidden Hospital System The NY Post article referred thus to the Beth Israel CEO who allegedly pushed Ms Clark for contributions, <blockquote class="tr_bq"> Newman, former CEO of Continuum Health Partners, Beth Israel’s parent organization, took the unusual step of offering to help Clark complete a will so 'some faceless bureaucrat of the government' wouldn’t get his hands on her estate, court papers say.</blockquote> Quick Watson, did you see that? Continuum Health Partners was the "parent organization" of Beth Israel Hospital during at least some of the time Ms Clark was in residence there.  Continuum Health Partners also was the "previous owner" of Long Island College Hospital during at least some of the time it apparently was suffering large losses and its endowment was being depleted.  So were both these stories really about the same organization, the same hospital system? Digging a little further, per its <a href="http://www.linkedin.com/company/continuum-health-partners/products">own LinkedIn page</a>, <blockquote class="tr_bq"> Continuum Health Partners, Inc. was formed in 1997 as a partnership of three venerable institutions — Beth Israel Medical Center, St. Luke's Hospital, and Roosevelt Hospital.</blockquote> So while the hospital system did not exist when Ms Clark first entered Beth Israel Hospital, the heiress' "care" was under the control of the organization apparently from 1997 to the day she died. Furthermore, as noted in a 2011 Chronicle of Higher Education article, <a href="http://www.innovativeresourcesgroup.com/archive/89-latest-and-greatest/314-from-mergers-that-didnt-stick-lessons-emerge-for-other-charities">available from </a>Innovative Resources Group Inc, <blockquote class="tr_bq"> If there was a honeymoon after the merger of Long Island College Hospital, in Brooklyn, with Continuum Health Partners, in New York in 1998, few remember it. The bickering began early and dragged on for years, but divorce didn’t seem inevitable until the doctors went public.</blockquote> So the hospital system called Continuum Health Partners took over Long Island College Hospital in 1998 and held it for 13 years.  Furthermore, apparently LICH was part of Continuum Health Partners during the time when its losses rose and the Othmer bequest was depleted.  For example, from the CHE article, <blockquote class="tr_bq">  Several physicians told a crowd gathered outside the hospital’s entrance in 2008 that Continuum had withheld money from the 150-year-old institution, needlessly cutting patient services and endangering the hospital’s future.</blockquote> Also in 2008, the Brooklyn Heights Blog <a href="http://brooklynheightsblog.com/archives/3845">reported</a> this response to a question about finances from the Continuum Health Partners CEO, Stanley Bazenoff, <blockquote class="tr_bq"> LICH faces an immediate fiscal crisis. Unless action is taken quickly, he said, LICH will not have cash on hand to meet payrolls and other current expenses. He ascribed LICH’s problem to three factors. First, the hospital carries a heavy debt burden–approximately $150 million in long-term bonds financed through the New York State Dormitory Authority and $25 million in short-term commercial paper–which results in annual debt service (including interest and amortization) cost of approximately $22 million. Second, LICH has an operating deficit, presently about $40 million on an annual basis,...</blockquote> Denis Hamill, a columnist for the New York Daily News, made this accusation in a February, 2013, <a href="http://www.nydailynews.com/new-york/hamill-lich-merged-death-article-1.1266344">editorial</a>: <blockquote class="tr_bq">Under Continuum, the once-profitable LICH ran up $300 million in debt from pure administrative malpractice. And then Brezenoff brokered the smelly SUNY Downstate merger, with state taxpayers absorbing the $300 million debt.</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> So it certainly looks like there is an argument that Continuum Health Partners, under its CEO, Stanley Bazenoff, was responsible for the manipulation of pseudo-patient and rich heiress Hughette Clark to secure a large donation, and the nearly simultaneous depletion of Long Island College Hospital's finances, including a large bequest that was supposed to be untouchable.</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Not surprisingly, Mr Bazenoff, described by Mr Hamill as <blockquote class="tr_bq">a ruthless powerbroker ... whose nickname at LICH is Darth Vader </blockquote> and <blockquote class="tr_bq">a quintessential member of what muckraker Jack Newfield called The Permanent Government of New York  </blockquote> also seems to have gotten rich in his position as leader of Continuum Health Partners, along with his other top managers.   The blog LICH Watch <a href="http://lichwatch.blogspot.com/2011/03/salary-scandal-at-hospitals.html">found</a> these results from the system's 2009 IRS 990 report,</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq">here are some highlights, figures for Continuum employees who, hm, earned more than a million dollars for the year: Chandra Sen, MD, $2,109,204 Stanley Brezenoff, $2,014,413 Kathryn C. Meyer, Esq. $1,049,807 John Collura, $1,307,556 Gail Donovan, $1,365,354</blockquote>  A 2011 New York Post <a href="http://nypost.com/2011/03/16/nonprofit-hosp-bigs-megabucks/">article</a> stated,</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq"> Stan Brezenoff, CEO of Continuum Health Partners, overseeing such hospitals as Beth Israel, St. Luke’s and Roosevelt, pulled in about $3.5 million. </blockquote>  So this leads to yet more mysteries, first about the individual cases when viewed as occurring within one large hospital system:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">-  Why were Long Island College Hospital's finances addressed as if it were an independent entity, when it was in fact just a subsidiary of Continuum Health Partners? </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> -  Why was Continuum Health Partners role in the hospital's enlarging debt and depleting endowment not discussed?</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> Similarly,</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> -  Why was the bizarre treatment of Hughette Clark attributed to "Beth Israel executives," but not Continuum Health Executives, when Beth Israel was also just a subsidiary of Continuum Health? </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Then there is the larger mystery,</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> -  Why have these two cases been discussed as completely independent, when they appear to be part of a pattern of conduct by Continuum Health Partners management? </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Summary</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">While we continue to see cases, some amazingly bizarre, suggesting mismanagement and unethical management of hospitals and hospital systems, there seems to be an amazing lack of curiosity about how they occurred and what their implications may be.  This lack of curiosity is so profound that no one seems to have noticed that two vivid and strange cases getting prominent media notice in the same city and the same time involved the same large hospital system. </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Health care organizations seem to become ever larger.  Such enlarging organizations can concentrate their power, dominate their "markets," and hence increase their revenues and the compensation of their top hired managers.  Without any countervailing force, they push seemingly inexorably towards oligopoly and then monopoly.</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Furthermore, the cases of the purloined bequest and the resident heiress show that ever larger organizations with ever more complex structures are ever better at hiding the accountability of their top hired managers.  We have previously noted, e.g. <a href="http://hcrenewal.blogspot.com/2010/10/glaxosmithkline-subsidiary-pleads.html">a case</a> in which a subsidiary of GlaxoSmithKline pleaded guilty to crimes involving production of adulterated drugs, thus shielding GSK and its management from responsibility, how subsidiaries of large corporations may plead guilty to crimes, thus absolving their parent organizations and its managers of any blame. In the current cases, it seems that somehow a large health care system was able to avoid accountability by letting its component hospitals appear to be independent.  Yet it is the larger system that was booking the revenue and making millionaires out of its hired managers.  This seems to show how concentration of power into ever more complex organizations can be used to enhance the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, making mismanagement and those accountable for it ever more obscure. </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">As we have said until blue in our collective faces, if we do not hold the real leaders of health care accountable for their actions and the actions of their organizations on their watches, we can expect continued misbehavior, and hence continued health care dysfunction.   </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div> It's appropriate to conclude with this, a video of Jeremy Brett in A Scandal in Bohemia, from the first season of the show as first shown on PBS. <iframe allowfullscreen="" frameborder="0" height="315" src="//www.youtube.com/embed/shLYcUVOMb4?list=PL2VjH97HFEqmNfN8aQ5qiv90kPM7ncZ7U" width="560"></iframe>

The Adventures of the Purloined Bequest, the Resident Heiress, and the Hidden Hospital System

The game is afoot again. A series of recent articles in the media described a series of cases whose mysterious interrelationships Sherlock Holmes might have appreciated.The Purloined BequestA singula…

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19 Sep 2013

UnitedHealth's Latest Blunders Include Lax Fraud Detection, Recalled EHRs - So Why is its CEO Worth $13.9 Million, or is it $34.7 Million?

We managed to go four months since our last post about UnitedHealth, but sure enough, the company that keeps on giving... examples of poor management to contrast with ridiculous management pay... has done so again. There were two obvious examples of poor management that recently appeared in the media. Lax Fraud Dection The background, as noted in a Kaiser Health News <a href="http://www.kaiserhealthnews.org/Stories/2013/September/15/medicaid-managed-care.aspx">article</a> published in September, is that it is now fashionable for American states to outsource some or most of their Medicaid health insurance programs to managed care organizations, often for-profit, as is UnitedHealth.  These programs are meant to provide insurance to the poor and disabled.  Yet once they have outsourced Medicaid, the states may be reluctant to cancel contracts, even if the outsourcing is not working: <blockquote class="tr_bq"> In Florida, a national managed care company’s former top executives were convicted in a scheme to rip off Medicaid. In Illinois, a state official concluded two Medicaid plans were providing 'abysmal' care. In Ohio, a nonprofit paid millions to settle civil fraud allegations that it failed to screen special needs children and faked data. Despite these problems, state health agencies in these - and other states - continued to contract with the plans to provide services to patients on Medicaid, the federal-state program for the poor and disabled. Health care experts say that’s because states are reluctant to drop Medicaid plans out of fear of leaving patients in a bind. 'You probably won’t find many examples of states flat out pulling the plug. That’s sort of the nuclear option,' said James Verdier, a senior fellow at Mathematica Policy Research, a nonpartisan think tank. </blockquote>Never mind that leaving such programs as is means taking money meant to finance care for the poor and using it to finance fraud, and reward managed care organizations for failing to find fraud. One of the examples, but not a new one, used in the Kaiser Health News article, involved UnitedHealth: <blockquote class="tr_bq">Linda Edwards Gockel, spokeswoman for the Texas Health and Human Services Commission, said that in 2009, officials were concerned about a pilot program in the Dallas-Fort Worth area run by Evercare, a subsidiary of <a href="http://www.unitedhealthgroup.com/" target="_blank">UnitedHealth Group</a>. The program, which coordinated care and long-term services for elderly and disabled people, had been fined more than $600,000 for not providing proper access to care and failing to coordinate services. Gockel said Texas decided to cancel the contract 15 months early, but continued to do business with Evercare because the problems in Dallas-Fort Worth weren’t affecting services it was providing elsewhere.</blockquote> Then in July, NJ.com <a href="http://www.nj.com/politics/index.ssf/2013/07/nj_comptrollers_report_finds_hmos_fraud_detection_efforts_lax_in_medicaid.html">reported</a> an investigation by the state of New Jersey into UnitedHealth's ability, or lack thereof, to detect fraud in the Medicaid managed care program it runs for the state. <blockquote class="tr_bq"> An HMO that earned $1.7 billion from 2009 to 2010 by providing Medicaid coverage to 350,000 low-income and disabled New Jerseyans didn't try very hard to detect fraudulent billing — identifying only $1.6 million, or one-tenth of one percent in improper payouts, according to a report the Office of the State Comptroller released today.</blockquote> UnitedHealth did not even come close to fulfilling its obligations to provide sufficient resources to fight fraud: <blockquote class="tr_bq">The HMOs in the Medicaid program are required to dedicate one investigator for every 60,000 Medicaid clients. At that ratio, United's special investigations unit should have been comprised of about six employees whose sole focus is to detect fraud and abuse by medical providers and patients. Instead, United reported it had dedicated the equivalent of two investigators during the two-year study period based on the amount of hours devoted to the unit. Upon scrutiny, the comptroller found United 'overstated' its staffing levels; the unit had one investigator, the report said. </blockquote> Note that this abject failure appeared to violate the contract UnitedHealth had with the state, <blockquote class="tr_bq">UnitedHealthcare Community Plan of New Jersey failed to hire enough investigators and train them properly, in violation of the managed care company's contract with the state, according to the report. </blockquote> Presumably, if fraud led to excess program expenses, it would be New Jersey, not UnitedHealth who ultimately had to pay them.  Again, it appears that money meant of pay for health care for the poor and disabled was diverted to fraudsters, and to revenue for UnitedHealth (partly because the latter did not see fit to spend enough money up front to detect the fraud.)  Of course, such management by UnitedHealth helped to increase its already fat revenue stream. Faulty Electronic Health Records In September, Bloomberg <a href="http://www.bloomberg.com/news/2013-09-10/unitedhealth-recalls-digital-health-record-software.html">reported</a> that UnitedHealth had to recall electronic health record software because of faults that likely increased the risk of bad patient outcomes, <blockquote class="tr_bq">UnitedHealth Group Inc has recalled software used in hospital emergency departments in more than 20 states because of an error that caused doctor’s notes about patient prescriptions to drop out of their files. Certain versions of the software made by the largest U.S. health insurer had a bug that didn’t print information related to the medication and failed to add data to patients’ charts,according to a document filed with the U.S.Food and Drug Administration and <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=119832" rel="external" title="Open Web Site">posted</a> July 29. The technology is used in 35 facilities in states including California<a href="http://topics.bloomberg.com/california/"></a>, New Jersey, and Florida<a href="http://topics.bloomberg.com/florida/"></a>, the document shows. The recall began June 21. There were no reports of patient harm and each facility was notified and received a digital fix, said Kyle Christensen, a spokesman for the UnitedHealth division that makes the <a href="http://www.picis.com/solutions/emergency-department/ed-pulsecheck.aspx" rel="external" title="Open Web Site">Picis ED PulseCheck</a> software that was recalled. The incident shows how software errors can create dangers for patients at a time when digital health records are being implemented as a cornerstone of President  Barack Obams's modernization of the nation’s health-care system. </blockquote> The "bug" could potentially harm patients, <blockquote class="tr_bq"> Doctor’s notes are critical for some medications, as they contain directions about diet and use. Failure to include the instructions could lead to serious injury or death, [University of Pennsylvania adjunct professor of sociology and medicine Ross] Koppel said.</blockquote> It turns out that the Picis software has had other problems that could have increased the risk of harm to patients, <blockquote class="tr_bq">An online database maintained by the FDA shows that Picis Inc., a Wakefield, Massachusetts-based company that UnitedHealth acquired in 2010 for an undisclosed price, has reported six recalls involving electronic health record software since 2009. One <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=104224" rel="external" title="Open Web Site">incident</a> in 2011 involved anesthesia-management software sold nationwide that in one instance displayed a patient’s medical information in another patient’s file. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=86830" rel="external" title="Open Web Site">Another</a>involved software sold worldwide where on an unspecified number of occasions, the program failed to display the discontinued status on medication orders. Others included glitches that caused a <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=103528" rel="external" title="Open Web Site">failure</a> to display appropriate allergy interaction warnings, the <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=89514" rel="external" title="Open Web Site">freezing</a> of administrative controls, and other issues.</blockquote> Note that it is the same Picis software that our blogger, InformaticsMD, has alleged lead to the death of his mother, <blockquote class="tr_bq"> Alleged flaws in electronic health records have led to lawsuits. Scot Silverstein, a doctor and health-care informatics professor at  Drexel University, sued Abington Memorial Hospital in Pennsylvania in 2011 over the death that year of his 84-year-old mother. He blamed her death on a flaw in her electronic health record that he claims caused a critical heart medication to vanish from her file. One of the systems involved was made by Picis, according to his lawsuit. Picis is not being sued.</blockquote> Linda Millevoi, a spokeswoman for Abington Memorial, declined to comment. The latest InformaticsMD posts on this case are <a href="http://hcrenewal.blogspot.com/2013/09/a-new-and-quite-perverse-hospital-ploy.html">here</a> and <a href="http://hcrenewal.blogspot.com/2013/08/a-good-way-to-cynernetically-harm-or.html">here</a>. Summary These cases are just the latest in a long list of blunders and ethical missteps made by UnitedHealth and its top management.  The most significant examples of the latter about which we have posted appear in the appendix at the end.  The latest examples likely diverted money that should have supported health care for the poor, and and may have put patients' health and lives at risk. Yet UnitedHealth is now the largest US health insurance company, and it has succeeded in making its current and former CEO fabulously wealthy.  According to filings with the US Security and Exchange Commission (SEC), its current CEO, Stephen J Hemsley, got $13.9 million in 2012, up from $13.4 million in 2011, as we posted <a href="http://hcrenewal.blogspot.com/2013/05/unitedhealth-ceo-continues-to-prosper_3.html">here</a>.  However, an <a href="http://apps.startribune.com/top_100_exec_comp/topCeoView.php">analysis</a> by the Minneapolis Star-Tribune that took into account stock gains and shares vesting suggested he got $34,721,122 in 2012, admittedly down from a breathtaking $48,075,614 in 2011.  The previous UnitedHealth once was worth over a billion dollars due to back dated stock options, some of which he had to give back, but despite all the resulting legal actions, was still the ninth best paid CEO in the US for the first decade of the 21st century (look <a href="http://hcrenewal.blogspot.com/2010/08/despite-scandal-former-unitedhealth-ceo.html">here</a>). So UnitedHealth continues to provide us with examples of how top leaders of health care organizations can become tremendously rich, despite, or perhaps because of repeated mismanagement and apparently unethical management on their watches.  Only when we make health care leaders truly accountable for their organizations, and especially for their organizations' ethics and effects on patients' and the public's health will be begin to challenge health care dysfunction. (Note to readers recently joining us from countries other than the US - UnitedHealth is a multi-national that claims to operate in 33 countries (look <a href="http://careers.unitedhealthgroup.com/why-work-here/our-locations.aspx">here</a>).  For example, its UK web-site is <a href="http://www.unitedhealthuk.co.uk/">here</a>.  So beware the export of bad management for enhanced prices.)    Appendix - UnitedHealth's Ethical Lapses  - as <a href="http://www.courant.com/business/hc-natbizdigbrf0530.art2may30,0,109447.story">reported</a> by the Hartford Courant, "UnitedHealth Group Inc., the largest U.S. health insurer, will refund $50 million to small businesses that New York state officials said were overcharged in 2006." - UnitedHalth promised its investors it would continue to raise premiums, even if that priced increasing numbers of people out of its policies (see post <a href="http://hcrenewal.blogspot.com/2008/05/commercial-managed-care-organizations.html">here</a>); - UnitedHealth's acquisition of Pacificare in California allegedly lead to a "meltdown" of its claims paying mechanisms (see post <a href="http://hcrenewal.blogspot.com/2008/01/bungled-not-brilliant-results-of.html">here</a>); - UnitedHealth's acquisition of Sierra Health Services allegedly gave it a monopoly in Utah, while the company allegedly was transferring much of its revenue out of the state of Rhode Island, rather than using it to pay claims (see post <a href="http://hcrenewal.blogspot.com/2007/03/unitedhealth-declares-health-care.html">here</a>) - UnitedHealth frequently violated Nebraska insurance laws (see post <a href="http://hcrenewal.blogspot.com/2007/01/on-performance-on-one-supposedly.html">here</a>); - UnitedHealth settled charges that its Ingenix subsidiaries manipulation of data lead to underpaying patients who received out-of-network care (see post <a href="http://hcrenewal.blogspot.com/2009/01/unitedhealth-and-ingenix-settles.html">here</a>). - UnitedHealth was accused of hiding the fact that the physicians it is now employing through its Optum subsidiary in fact work for a for-profit company, not directly for their patients (see post <a href="http://hcrenewal.blogspot.com/2011/07/here-comes-your-new-doctor-brought-to.html">here</a>).

UnitedHealth's Latest Blunders Include Lax Fraud Detection, Recalled EHRs - So Why is its CEO Worth $13.9 Million, or is it $34.7 Million?

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17 Sep 2013

An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT

From <a href="http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia">http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia</a>: <blockquote class="tr_bq">The Food and Drug Administration Safety Innovation Act (FDASIA) Health IT Policy Committee Workgroup is charged with providing expert input on issues and concepts identified by the Food and Drug Administration (FDA), Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC) to inform the development of a report on an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications that promotes innovation, protects patient safety, and avoids regulatory duplication.</blockquote> My Open Letter to the Committee's chair speaks for itself: <blockquote class="tr_bq">From: Scot Silverstein Date: Mon, Sep 16, 2013 at 9:39 AM Subject: ONC FDASIA Health IT Policy Committee's recommendations on Premarket Surveillance To: David Bates Sept. 16, 2013 David Bates, Chair, ONC FDASIA Health IT Policy Committee via email     Dear David, I am disappointed (and in fact appalled) at the ONC FDASIA Health IT Policy Committee's recommendations that health IT including typical commercial EHR/CPOE systems not be subjected to a premarket testing and validation process.  I believe this recommendation is, quite frankly, negligent. [1] As you know, my own mother was injured and then died as a result of EHR deficiencies, and nearly injured or killed again in the recuperation period from her initial injuries by more health IT problems in a second EHR used in her care.  In my legal consulting and from my colleagues, as well as from the literature, I hear about other injuries/deaths and many "near misses" as well.  That your recommendations came in the face of the recent ECRI Deep Dive study is even more appalling, with the latter's finding of 171 health IT-related incidents in 9 weeks from 36 member PSO hospitals, resulting in 8 injuries and 3 possible deaths, all reported voluntarily. [2] It is my expert opinion the issues that cause these outcomes would never have made it into production systems, had a reasonable, competent, unbiased premarket testing and validation process been in place. Consequently, I have shared the FDASIA HIT Policy Committee's recommendations with the Plaintiff's Bar, and will use its recommendations in my presentations to various chapters of the American Association for Justice (the trial lawyer's association) - as well as to interested Defense attorneys so they may advise their clients accordingly. I am also making recommendations that in any torts, individual or class, regarding EHR problems that would likely have been averted with competent premarket testing and validation, that the FDASIA HIT Policy Committee members who agreed with the recommendation be considered possible defendants. I am sorry it has come to this. Please note I am also posting this message for public viewing at the Healthcare Renewal weblog of the Foundation for Integrity and Responsibility in Medicine (FIRM). Sincerely, Scot Silverstein, MD Consultant/Independent Expert Witness in Healthcare Informatics Adjunct Faculty, Drexel University, College of Computing and Informatics Notes: [1] FDA Law Blog, Recommendations of FDASIA Health IT Workgroup Accepted, September 11, 2013, available at <a href="http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/recommendations-of-fdasia-health-it-workgroup-accepted.html">http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/recommendations-of-fdasia-health-it-workgroup-accepted.html</a>: "Of particular interest is the recommendation that health IT should generally not be subject to FDA premarket requirements, with a few exceptions:  medical device accessories, high-risk clinical decision support, and higher risk software use cases." [2] "Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI 'Deep Dive' Study of Health IT Events" , Feb. 28. 2013, available at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>.</blockquote> ----------------------------------------------- Note: the following are listed on the linked site above as members of the committee: <div>Member List</div><ul><li>David Bates, Chair, Brigham and Women’s Hospital</li><li>Patricia Brennan, University of Wisconsin-Madison</li><li>Geoff Clapp, Better</li><li>Todd Cooper, Breakthrough Solutions Foundry, Inc.</li><li>Meghan Dierks, Harvard Medical Faculty, Division of Clinical Informatics</li><li>Esther Dyson, EDventure Holdings</li><li>Richard Eaton, Medical Imaging & Technology Alliance</li><li>Anura Fernando, Underwriters Laboratories</li><li>Lauren Fifield, Practice Fusion, Inc.</li><li>Michael Flis, Roche Diagnostics</li><li>Elisabeth George, Philips Healthcare</li><li>Julian Goldman, Massachusetts General Hospital/ Partners Healthcare</li><li>T. Drew Hickerson, Happtique, Inc.</li><li>Jeffrey Jacques, Aetna</li><li>Robert Jarrin, Qualcomm Incorporated</li><li>Mo Kaushal, Aberdare Ventures/National Venture Capital Association</li><li>Keith Larsen, Intermountain Health</li><li>Mary Anne Leach, Children’s Hospital Colorado</li><li>Meg Marshall, Cerner Corporation</li><li>Mary Mastenbrook, Consumer</li><li>Jackie McCarthy, CTIA - The Wireless Association</li><li>Anna McCollister-Slipp, Galileo Analytics</li><li>Jonathan Potter, Application Developers Alliance</li><li>Jared Quoyeser, Intel Corporation</li><li>Martin Sepulveda, IBM</li><li>Joseph Smith, West Health</li><li>Paul Tang, Palo Alto Medical Foundation</li><li>Bradley Thompson, Epstein Becker Green, P.C</li><li>Michael Swiernik, MobileHealthRx, Inc.</li></ul>Federal Ex Officios <ul><li>Jodi Daniel, ONC</li><li>Bakul Patel, FDA</li><li>Matthew Quinn, FCC</li></ul>  -- SS

An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT

From http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia:The Food and Drug Administration Safety Innovation Act (FDASIA) Health IT Policy Committee Workgro…

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16 Sep 2013

Quality vs Costs of US Corporate Owned but Offshore Medical Schools

Background: Off-Shore Medical Schools for US Students Owned by US Corporations While US health care appears to be more corporate than health care in any other developed country, one part of health care that has remained a bit less corporate is medical education.  In particular, no US medical school is a for-profit venture, to my knowledge.  (This just makes US <a href="http://hcrenewal.blogspot.com/search/label/medical%20schools">medical education</a> a bit less corporate than the rest of health care because, as we have discussed endlessly, academic medical institutions in the country have frequent <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional conflicts of interest</a>, and their boards of trustees, administration, and faculty have frequent individual c<a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">onflicts of interest.</a>)  Nonetheless, there are many Americans attending for-profit medical schools owned and run by US based corporations.  It is just that these schools are not physically located in the US.  Since the number of US citizens who want to go to medical school has been greatly exceeding the capacity of US medical schools, many who want to become physicians have sought medical training in other countries.  Some go to medical schools outside of the US which are primarily operated to provide doctors to the countries in which they operate. However, the limited availability of places available in such schools for foreign students, and the difficulties of training in unfamiliar medical systems and often in unfamiliar languages limit the attractiveness of this option. Enter American entrepreneurs into the picture, who realized they could set up schools in willing locations (often in small countries in the Caribbean) meant to educate Americans in English.  While there are plenty of reasons to be concerned about the role US based medical schools play in the dysfunction of US health care, there may even be more reasons to be concerned about for-profit, US owned, but off-shore medical schools that cater to US students.  Yet although such schools now train a large number of students, they tend to fly under the radar. Reasons for Concern about US Corporate Owned but Off-Shore Medical Schools In 2010, we <a href="http://hcrenewal.blogspot.com/2010/01/to-whom-does-leading-off-shore-medical.html">posted </a>about an investigative report in the St Petersburg (FL) Times that provided reasons for concern.  These included suggestions of quality problems, such as high attrition rates, high rates of failure to complete residency training and lack of quality controls over clinical education, high costs imposed on students, and the role of extremely well compensated executives with no apparent knowledge of medical education. Now Bloomberg has published another <a href="http://www.bloomberg.com/news/2013-09-10/devry-lures-medical-school-rejects-as-taxpayers-fund-debt.html">report </a>on for-profit, US owned Caribbean medical schools that underscores these concerns.  The report focused on schools owned by the US based, publicly traded DeVry Inc.  These include American University of the Caribbean School of Medicine, <a href="http://www.aucmed.edu/">located in St Maarten</a>, and Ross University School of Medicine, <a href="http://www.rossu.edu/about/">located in Dominica</a>...  Quality Concerns - Attrition <blockquote class="tr_bq"> Many DeVry students quit, particularly in the first two semesters, taking their debt with them. While the average attrition rate at U.S. med schools was 3 percent for the class that began in the fall of 2008, according to the AAMC, DeVry says its rate ranges from 20 to 27 percent. </blockquote> One reason for this is that for-profit schools may take students who are less academically qualified, <blockquote class="tr_bq"> Many of those students, ..., failed to gain admission to U.S. schools, where the mean score on the Medical College Admission Test, or MCAT, was <a href="https://www.aamc.org/download/321494/data/2012factstable17.pdf" rel="external" title="Open Web Site">31.2</a> out of a possible 45 last year. At DeVry’s schools, the average score was 25. </blockquote> - Time to Completion of Training <blockquote class="tr_bq"> Of those who remained, <a href="http://www.aucmed.edu/gainful-employment-disclosures/" rel="external" title="Open Web Site">66 percent of AUC students</a> <a href="https://www.rossu.edu/medical-school/student-consumer-info.cfm" rel="external" title="Open Web Site">and 52 percent of students</a> at DeVry’s other Caribbean medical school, <a href="http://www.rossu.edu/medical-school/" rel="external" title="Open Web Site">Ross University School of Medicine,</a> finished their program -- typically two years of sciences followed by two years of clinical rotations -- on time in the academic year ended on June 30, 2012. </blockquote> - Difficulty Obtaining Residencies <blockquote class="tr_bq"><a href="http://www.nrmp.org/" rel="external" title="Open Web Site">The National Resident Matching Program</a> says 94 percent of fourth-year students schooled in the U.S. landed a <a href="http://b83c73bcf0e7ca356c80-e8560f466940e4ec38ed51af32994bc6.r6.cf1.rackcdn.com/wp-content/uploads/2013/08/resultsanddata2013.pdf" rel="external" title="Open Web Site">first-year match in 2013</a>, while 53 percent of U.S. citizens trained internationally did. DeVry students fare better than the average foreign-trained student. Of the 914 Ross students who applied for residency in 2013, 76 percent, or 699, earned places. Another 41 had preliminary one-year spots, which would require the students to win a second residency in order to be eligible for a medical license in 48 states. Of the 268 AUC students who applied for residency, 212, or 79 percent, got matches, and seven more had one-year slots. The remainder of the students failed to win a residency. </blockquote> - Lack of Standards The Bloomberg article also emphasized the fact that the US owned corporate off-shore schools do not have to meet the same accreditation standards as do US based schools: <blockquote class="tr_bq">  <a href="http://www.accredmed.org/" rel="external" title="Open Web Site">The Accreditation Commission on Colleges of Medicine</a>, an Ireland-based body, accredits four Caribbean medical schools, including AUC, according to its website. </blockquote> High Costs While the quality of education provided by US owned corporate off-shore medical schools may be questioned, there is no doubt about their high costs. <blockquote class="tr_bq"> First-year tuition on Dominica costs <a href="http://www.rossu.edu/medical-school/admissions/Tuition-and-Fees.cfm" rel="external" title="Open Web Site">$56,475,</a> based on the three terms Ross divides the year into. That compares with a median of <a href="https://www.aamc.org/download/152968/data" rel="external" title="Open Web Site">$50,309</a> for tuition and fees at private U.S. medical schools in the 2012-to-2013 school year. </blockquote> These costs are of particular concern because many students of off-shore schools amass impressive amounts of debt.    <blockquote class="tr_bq"><a href="http://www.devryinc.com/" rel="external" title="Open Web Site">DeVry</a>, which has two <a href="http://www.devryinc.com/our-institutions/auc-med.jsp" rel="external" title="Open Web Site">for-profit medical schools</a> in the Caribbean, is accepting hundreds of students who were rejected by U.S. medical colleges. These students amass more debt than their U.S. counterparts -- a median of <a href="http://www.aucmed.edu/gainful-employment-disclosures/" rel="external" title="Open Web Site">$253,072</a> in June 2012 at AUC versus <a href="https://www.aamc.org/download/152968/data" rel="external" title="Open Web Site">$170,000 for 2012 graduates</a> of U.S. medical schools. And that gap is even greater because the U.S. figure, compiled by the Association of American Medical Colleges, includes student debt incurred for undergraduate or other degrees, while the DeVry number is only federal medical school loans. </blockquote>  These high debt loads are enabled by US government loans, even though the schools are not located or accredited in the US. <blockquote class="tr_bq">And though neither AUC nor Ross, in the island nation of Dominica, is accredited by the body that <a href="http://www.lcme.org/" rel="external" title="Open Web Site">approves medical programs in the U.S</a>., students at both schools are eligible for loans issued by the U.S. Education Department.</blockquote> In addition, <blockquote class="tr_bq"> Students at the four schools -- the two DeVry schools, along with <a href="http://www.sgu.edu/school-of-medicine/" rel="external" title="Open Web Site">St. George’s University School of Medicine</a> and, since July, <a href="http://www.saba.edu/saba/" rel="external" title="Open Web Site">Saba University School of Medicine</a> -- are also eligible for tuition benefits from the U.S. Department of <a href="http://topics.bloomberg.com/veterans-affairs/">Veterans Affairs</a>. </blockquote> Leadership  The Bloomberg article briefly questioned the motivations of DeVry leadership, quoting David Bergeron, previously of the US Department of Education <blockquote class="tr_bq">If they have to make a choice between students and profit, they choose profit</blockquote> They may do so because the off-shore medical schools bring in a lot of money <blockquote class="tr_bq">DeVry got 34 percent of its revenue in the <a href="http://investors.devryinc.com/Investor-Relations/Press-Releases/Press-Releases/Press-Release-Details/2013/DeVry-Announces-Fourth-Quarter-and-Full-Year-2013-Results/default.aspx" rel="external" title="Open Web Site">year ended on June 30</a> from medical and health-care education, including a chain of U.S. nursing schools. The unit contributed $673 million of DeVry’s $1.96 billion in revenue, up more than sevenfold from $91 million in fiscal 2005. 'The diversification strategy is working,' Chief Executive Officer Daniel Hamburger said at an <a href="http://investors.devryinc.com/files/doc_presentations/dv_william_blair_061313_final_web.pdf" rel="external" title="Open Web Site">investor conference in Chicago</a> in June. 'About a third now of our enrollment is in the growing field of health-care education.'</blockquote> It seems clear that this revenue stream is greatly dependent on US government money   <blockquote class="tr_bq">DeVry acquired AUC in 2011 for <a href="http://investors.devryinc.com/Investor-Relations/Press-Releases/Press-Releases/Press-Release-Details/2011/DeVry-Inc-Announces-Acquisition-of-American-University-of-the-Caribbean1126184/default.aspx" rel="external" title="Open Web Site">$235 million</a>, attracted partly by the school’s eligibility for federal loans, says Harold Shapiro, <a href="http://www.devryinc.com/about-us/board-of-directors.jsp" rel="external" title="Open Web Site">DeVry’s chairman</a> and a <a href="http://www.princeton.edu/%7Ehts/" rel="external" title="Open Web Site">former president of Princeton University.</a>   'Access to federal student loans is very important for a lot of DeVry programs, including that one,' says Shapiro, 78, an economist by training, who plans to <a href="http://investors.devryinc.com/Investor-Relations/Press-Releases/Press-Releases/Press-Release-Details/2013/Harold-Shapiro-to-Retire-from-DeVry-Board-of-Directors/default.aspx" rel="external" title="Open Web Site">retire</a> from DeVry in November after 12 years on the board and five years as chairman. 'Obviously, it’s part of what makes it work.' </blockquote> A Quick and Dirty Look at Costs vs Value As I noted earlier, little seems to be written about the commercial nature of the US owned, but off-shore medical schools that purportedly educate a growing number of US citizens.  I thought I would try to add a little to the Bloomberg article by trying to see if I could find any other obvious way to contrast the quality of the Caribbean based schools with their high costs. As noted above, the tuition at one DeVry medical school was more than 10 percent higher than the median for US schools. For comparison, I thought I would make some sort of quick assessment of the faculty of one DeVry school, Ross University School of Medicine.  That turned out to be easier than I thought it would be. My first stop was the <a href="http://www.rossu.edu/medical-school/faculty/faculty.cfm">web-page</a> that conveniently lists all of the school's faculty and administration.  I assumed that this would be cumbersome to use.  After all, a typical US medical school has a huge faculty, divided among pre-clinical departments (anatomy, physiology, biochemistry, etc), and clinical departments (usually one for each important specialty and or sub-specialty).  I thought I would start with the Ross department of internal medicine (since my background is in internal medicine).  Imagine my surprise when I discovered that Ross does not have individual departments for clinical disciplines, but simply one Department of Clinical Medicine. Imagine my further surprise when I reviewed its membership.  The web-page lists all of 31 people in this department.  The list, with a summary of the individuals' positions at the school, and previous training appears below in the appendix. The qualifications of this small number of clinical faculty were mixed at best. - Note that of the 31, 8 are not actually faculty, but staff (color coded pink) - Of the 23 actual faculty, only 5 seem to have received their medical degree and residency training in the US (color coded blue).  In addition, one received US residency training after medical school in South Africa.  (This is relevant because this school caters to US students, emphatically not students from Dominica.) - Of the remaining 18 faculty, for 10 no background information was supplied (color coded green). While the number of clinical faculty was small, keep in mind that Ross University School of Medicine is very large: <blockquote class="tr_bq">Ross typically enrolls 900 to 950 students per <a href="http://www.rossu.edu/medical-school/calendar/13" rel="external" title="Open Web Site">academic year</a>, who start in either January, May or September.  That’s about seven times the average of 139 for the 2013 graduating class of U.S. med schools, according to figures from the AAMC. </blockquote> Yet a typical American school has orders of magnitude more faculty for almost one order of magnitude less students.  For example, my own medical school, <a href="http://brown.edu/academics/medical/about-us/facts-and-figures">Alpert Medical School of Brown University</a>, has 457 students in four classes, and has 180 campus-based and 652 hospital-based faculty.  Its Department of Internal Medicine, just one of many clinical departments, is much larger than Ross University's single Department of Clinical Medicine. While the argument could be made that Ross only provides the first two years of medical education at its Dominica campus, and farms out the rest to a variety of hospitals in the US, keep in mind that the second year of a typical medical school curriculum is clinical topics and taught by faculty in clinical departments, often hospital based.   So what in the world is the rationale for charging a higher tuition rate than a typical US based medical school, when the school only has to support a tiny faculty whose qualifications do not seem sufficient to demand a high price? Summary Based on admittedly limited information mainly from media sources, we find that US corporate owned but off-shore based medical schools make large amounts of revenue, charge their large student bodies big amounts for tuition, yet provide proportionately minuscule numbers of not clearly all well-qualified faculty, producing high attrition and residency completion rates.  Yet these schools' revenue streams are derived mainly from US government loans, made even if many students will not eventually obtain medical qualification and work as physicians.  This seems like a great deal for the corporate executives and perhaps stockholders, but a poor deal for the students and the US tax-payers who support them. We see another aspect of the US health care system in which money seems to trump mission, facilitated by an unseemly alliance between wealthy corporate executives and bad US government policy.  We need to reexamine our fascination for "market based" approaches to health care, when almost nothing about any part of health care resembles, or could resemble a free market (see this post).  We need to make health care more transparent, and shine more sunshine on the nooks and crannies, like off-shore but US corporate owned medical schools.  We need to facilitate health care leadership and governance that puts patients' and the public's health first, way ahead of the personal enrichment of the participants.   Appendix  "Faculty" Listing for Ross University School of Medicine Department of Clinical Medicine  Jane Bateson - "Data Analyst & Research Associate" Anne M Beaudoin - "Operations Specialist" Liris Benjamin - "Associate Professor," "Doctorate in Physiology from the University of West Indies" Lisa Buckley - "Simulaton Cordinator" Yasmin Burnett -"Associate Professor" [no further details listed] Diana Callender - "Professor and Chair" "graduate of the University of the West Indies where she completed her MBBS and Residency in Clinical Hematology." Terri Carlson- "Associate Professor," "Creighton University Medical School in Omaha, Nebraska and completed residency training in Family Practice at University of California, San Francisco in 2001." John Charyk - "Assistant Professor," "medical school at Georgetown University in Washington DC. In 1981 he completed his family medicine residency program at the University of Colorado in Denver." Phillip E. Cooles - "Professor," "BSc at King's College, London, then a medical degree at St George's Hospital medical school, and then a residency in internal medicine in Aberdeen, completing the MRCP" Lauri Costello - "Assistant Professor," "UC Davis for medical school then further north to Spokane Washington for her residency at Family Medicine Spokane," Hedda Dyer - "Associate Professor," "University of Edinburgh Medical School with a bachelor of Medicine and Surgery (MB CHB). She is a Member of the Royal College of Surgeons of Edinburgh, Scotland (MRCS Ed)" Sean Fitzgerald - "Assistant Professor" [no further details] Lyudmyla Golub - "Associate Professor," "Doctor of Medicine degree in 1983 from Vinnitsa National Medical University, Ukraine. She completed an Internship in Surgery at Vinnitsa Teaching Hospital #3, Ukraine" Lata Gowda - "Harvey Facilitator" Aimee Hougaboom - "Simulation Coordinator" David Johnson * - "IME Facilitator" Sybille Koenig - "Coordinator, Standardized Patients Program" Jaya Kolli - "Professor," "undergraduate degree at the Guntur Medical College, Andhra University, India. He went on to the Government General Hospital/Guntur Medical College, Nagarjuna University, in Guntur, India and completed a residency in Internal Medicine" Kamalendu Malaker * - "Visiting Faculty" [no further details] Ganendra Mallik - "Associate Professor" [no further details] Sanghita Mallik - "Assistant Professor" [no further details] Robert Nasiiro - "Professor" [no further details] Worrel Sanford * - "adjunct Assistant Professor" [no further details] Robert Sasso - "Professor" [no further details] Harold Schiff - "Associate Professor," "board certified neurologist, trained at Boston City Hospital, Boston University and has a fellowship in Behavioral Neurology, Higher Cognitive Function and Geriatric Neurology. He graduated from the University of the Witwatersrand, Johannesburg South Africa" Nancy Selfridge - "Associate Professor" "medical training and MD degree from Southern Illinois University School of Medicine" Rose-Claire St. Hilaire * - "IME Instructor" [no further details] Lynn Sweeney - "Assistant Professor,"graduated from the University Of Tennessee School Of Medicine in 1987. She completed residency in emergency medicine at the University of Arkansas for Medical Sciences" Valarie Thomas - "Assistant Professor," "D.V.M. degree from the Universidad Agraria de La Habana in Havana Cuba" Nash Uebelhart - "Assistant Professor," [no further details] Miscilda Vital-Harrigan - "Assistant Professor," [no further details]

Quality vs Costs of US Corporate Owned but Offshore Medical Schools

Background: Off-Shore Medical Schools for US Students Owned by US Corporations While US health care appears to be more corporate than health care in any other developed country, one part of health car…

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13 Sep 2013

Why Trust Drug Company Executives After One Admits Commercially Sponsored Clinical Research Is All About "Competitive Advantage?"

Mickey, the semi-anonymous blogger on 1BoringOldMan, wrote a <a href="http://1boringoldman.com/index.php/2013/09/12/right-on-the-money/">righteously angry post</a> in support of transparent clinical research.  As we have noted frequently, clinical trials done on human subjects are often <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a> to increase the likelihood of results favorable to commercial sponsors, or <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a> when even such manipulation does not produce the desired results. Note that such suppression and manipulation degrade the scientific value of the studies, impede the <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine</a> process to rationally apply clinical research evidence to improve the health of patients and the public, and violate the trust of research subjects who volunteer to participate based on the assumption that clinical research is meant to improve patient care and public health, and contribute to science, not just secure commercial advantage.   A European initiative to combat suppression of clinical research has been opposed by a lawsuit from US pharmaceutical manufacturers AbbeVie, spun off from Abbott Laboratories, and Intermune.  The European Medicines Agency had been willing to to make public unpublished patient level data from commercially sponsored clinical trials.  The lawsuit has shut down the process, and is meant to shut it down permanently, claiming that the clinical data, obtained from volunteer research subjects, includes "trade secrets." As <a href="http://1boringoldman.com/index.php/2013/09/12/right-on-the-money/">summarized </a>by Mickey, their motivation seems to be to conceal how pharmaceutical manufacturers and other commercial sponsors of human research use this research for promotional, rather than scientific purposes. An AbbeVie lawyer asserted that some adverse effects data should be kept confidential, and that "internal tactical decisions on how we are going to run a study, engage with regulators, and confront and solve problems and challenges we have uncovered during clinical trials" should also be kept secret because revealing them could "give other companies a tremendous competitive advantage," never mind whether keeping secrets could undermine science, decrease the study's usefulness to aid clinical and policy decision making, and break the implicit contract between researchers and study subjects. It is becoming more obvious that many drug company executives, and other leaders of large health organizations, may care more about "competitive advantage" than patients, science or the public good, as Mickey points out.  So much for that advertising puffery  about drug development to improve patient health.  Thus it may be ridiculous to think that these executives they will negotiate to improve transparency of clinical research in good faith when doing so could decrease such advantage, again no matter what the effect on patients, public health, or science. On this case there is an opportunity to speak out, Dr David Healy has a <a href="http://www.change.org/petitions/richard-gonzalez-of-abbvie-and-daniel-welch-of-intermune-drop-your-legal-action-blocking-access-to-ema-clinical-trial-data?utm_source=guides&utm_medium=email&utm_campaign=petition_lonely">petition up on Change.org</a> to oppose the AbbeVie and Intermune lawsuit which might get some notice if there are enough signatures.

Why Trust Drug Company Executives After One Admits Commercially Sponsored Clinical Research Is All About "Competitive Advantage?"

Mickey, the semi-anonymous blogger on 1BoringOldMan, wrote a righteously angry post in support of transparent clinical research. As we have noted frequently, clinical trials done on human subjects ar…

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12 Sep 2013

A New And Quite Perverse Hospital Ploy to Defend Medical Malpractice - Blame the Dead Patient? Two Examples

I did not think hospitals would ever get to the level of perversity, in defense of EHRs and EHR-related malpractice, seen herein. Just a few days ago I came across the following article on a web search. It is an astonishing story of a 49 year old man who died in part because an ED physician in a Suffern, NY hospital did not know how to use the EHR that had life saving diagnostic information within, and the hospital attempted to BLAME THE PATIENT for not "explaining his medical history thoroughly enough" to the ED doctor. You read that correctly. Ironically and sickeningly, yesterday my dead mother and I just had something similar done to us by a suburban Philadelphia hospital, Abington Memorial, as below: <blockquote class="tr_bq">Family Awarded $3.4 Million After ER Misses Aneurysm</blockquote><blockquote><a href="http://blogs.lawyers.com/2012/02/family-awarded-3-4-million-after-er-misses-aneurysm/">http://blogs.lawyers.com/2012/02/family-awarded-3-4-million-after-er-misses-aneurysm/</a> Posted February 17, 2012 in Medical Malpractice by writer <a href="http://blogs.lawyers.com/author/kasea/">Aaron Kase</a> It’s gospel in health care– if you have chest pains, get to the emergency room, especially if you have a history of heart problems. But an inexperienced ER doctor in New York thought his patient’s complaints weren’t serious, and sent him home with muscle relaxers. The result was deadly. A Rockland County jury Wednesday awarded $3.4 million to the family of Michael McKenzie, who was discharged from the Good Samaritan Hospital in Suffern in 2007 after complaining of chest pains and other symptoms consistent with a serious heart problem. The hospital determined that McKenzie, 49, was not having a heart attack, then ER doctor Michael Kane diagnosed him with a muscle strain and sent him home with muscle relaxers. Two days later, McKenzie was found dead in his house by his 10-year-old son, killed by an aortic aneurysm. The hospital should have found the aneurysm, argued Anthony DiPietro, the attorney for McKenzie’s family.”They just blew it,” says DiPietro, who headquarters his practice in New York City. “He had textbook signs of an aortic dissection [bleeding into the wall of the main artery that carries blood from the heart]: Chest pain, back pain, shortness of breath, sudden onset, woke him up from sleep, and he wasn’t doing any activities when it happened.” Compounding the hospital’s error, McKenzie had a history of heart problems that should have pointed them toward the correct diagnosis. In 2003, he had been diagnosed with a dilated aortic root, or enlarged artery, with is a huge red flag for a future rupture. Good Samaritan knew about the dilated root because they had noted it in his chart during a heart procedure McKenzie had undergone the year before his death. But the doctor, who had been at the hospital less than a month and was working unsupervised, never knew about McKenzie’s history. Why not? Because he didn’t know how to use the hospital’s electronic medical records system.</blockquote> That's beyond pathetic, but it gets worse.  Far worse: <blockquote class="tr_bq">“He admitted it as part of his deposition,” DiPietro says. “They equivocated. First they said the system wasn’t working [an apparent attempted mistruth - ed.], but then he said he really didn’t know how to use it yet.” According to a local news report, the doctor was certified in obstetrics and gynecology at the time, and didn’t receive his certificate in emergency medicine until the following year. The hospital argued that the aneurysm wasn’t present when McKenzie visited their ER–despite the fact that his certificate of death stated it had been present for days. The hospital also claimed that McKenzie was responsible for his own death because he didn’t explain his medical history thoroughly enough– the same history that was documented in the hospital’s own records. </blockquote> Let me repeat that for emphasis: The - hospital - also - claimed - that - McKenzie - was - responsible - for - his - own - death - because - he - didn’t - explain - his - medical - history - thoroughly  - enough– the - same - history - that - was-  documented - in - the - hospital’s - own - records. A hospital dares blame a likely frightened-out-of-his-wits patient presenting to their ED with chest pain, back pain, shortness of breath, of sudden onset that woke him up from sleep, for his own death?    That, readers, is the most perverse hospital behavior I have ever encountered since entering medicine in 1977 (actually 1972-3 in summer NSF programs at Hahnemann Hospital in Philadelphia). Not to mention, of course, that said patient cannot defend himself, because he's dead and buried... <blockquote class="tr_bq">In fact, in a highly unusual move, the judge in the case allowed doctors to recount conversations they had with McKenzie to the jury, statements usually prohibited under New York’s “Dead Man’s Statute” designed to keep hearsay out of the courtroom.  </blockquote> It's a very special hearsay indeed when the hear-sayers know the patient is in his grave and cannot respond. <blockquote class="tr_bq">The tilted playing field notwithstanding, the jury nevertheless found the hospital negligent and awarded $3.4 million to McKenzie’s widow, two adult daughters and now 14-year-old son. The money couldn’t come soon enough– the widow, now sole provider for her son, recently lost her job and their home went into foreclosure. “Hopefully this will allow them to keep the house,” DiPietro says.</blockquote> The ironically-named hospital planned an appeal: <blockquote>A Good Samaritan spokesperson said the hospital plans to appeal.</blockquote> I will attempt to find if the dockets are publicly accessible. So, to recap, an ED doc didn't know how to use an EHR that contained lifesaving diagnostic information misses an aneurysm, the patient dies, and the defense attempts to blame the patient for his own death for (allegedly) not telling the doctor thoroughly enough about his own medical condition, i.e., the frightened, in-severe-pain patient didn't know medicine but should have - doesn't everyone? ------------------- I could almost not believe this story, thinking maybe it was exaggerated - until just a few days later I EXPERIENCED THE SAME ISSUE MYSELF, PERSONALLY. As substitute plaintiff in the death of my mother in 2011 due to a 2010 medication reconciliation failure at Abington Memorial Hospital, as mentioned on this blog and in the press (e.g., Bloomberg News, <a href="http://www.bloomberg.com/news/2013-06-25/digital-health-records-risks-emerge-as-deaths-blamed-on-systems.html">http://www.bloomberg.com/news/2013-06-25/digital-health-records-risks-emerge-as-deaths-blamed-on-systems.html</a> and Kaiser Health News, <a href="http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx">http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx</a>), the hospital responded (finally) to the points raised in the Complaint filed in October 2011, after exhausting many procedural delay tactics. The are attempting to blame my mother, who I took to the ED while she was in process of nearly having a stroke, and me as well for her injuries. From their Sept. 9, 2013 filing: <blockquote class="tr_bq">... 41. The injuries allegedly sustained by [substitute] Plaintiffs decedent [my dead mother - ed.] were caused in whole or in part or the same may have been contributed to by the actions of the Plaintiffs decedent [my dead mother - ed.], and accordingly, any claim for damages is barred or the damages recoverable herein must be reduced in accordance with the provisions of the Pennsylvania Comparative Negligence Act, as may be applied to facts disclosed in discovery.</blockquote> They're apparently claiming (quite falsely, as I was there) that my mother, brought to the ED by me with a headache and suffering cerebral ischemia, never advised the doctors and nurses about her heart medication Sotalol (which was in their ED and floor EHR's from prior visits - just as in the aneurysm case above) that they summarily terminated, leading to disaster, so that her injuries and death are her own fault.  Of course, my mother is dead, so only I can speak for her. They also attempt to blame me for my mother's harm and death, a layperson (I have not practiced medicine in over 21 years): <blockquote class="tr_bq">54. Upon information and belief, Scot Silverstein’s actions and/or omissions may have been the cause or one of the causes of the harm suffered by the Decedent and/or her Estate.</blockquote><blockquote>55. Upon information and belief Scot Silverstein may be contributorily or comparatively negligent for any harm to the decedent and/or her Estate.</blockquote> They also falsely claim I never informed medical staff about my mother's heart medication, nothwithstanding their own medication reconciliation (verification) policy calls for a best-effort complete re-verification of medications from all available sources at every transition of care, such as when she went from ED to ICU, and then ICU to floor, when I was not present.  Such resources would include, among others:  1) me, via telephone (not used);  2) the patient (apparently this resource was not used); 3) past EHR visit med lists showing the heart medication (also, apparently not used).  As the Abington Hospital filing was signed and verified by their VP "Patient Advocate" / Director of Risk Management <a href="http://www.corporationwiki.com/Pennsylvania/Abington/regina-sturgis/81813980.aspx">Regina Sturgis</a>, considering these cases, I must ask the question if the practice of "blaming the harmed or dead patient" for their harm is a risk management strategy taught in the seminars these folks attend. Blaming dead patients or their families for harm from medical misadventures is absolutely horrifying.  It shows disrespect for the dead and is depraved, especially coming from a hospital, I think any prospective patient would agree. -- SS

A New And Quite Perverse Hospital Ploy to Defend Medical Malpractice - Blame the Dead Patient? Two Examples

I did not think hospitals would ever get to the level of perversity, in defense of EHRs and EHR-related malpractice, seen herein.Just a few days ago I came across the following article on a web search…

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10 Sep 2013

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