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A Confidentiality Clause or an Oath of Fealty?

The advancement of modern scientific medicine depends on the search for and dissemination of truth. Academic medicine, like the rest of academia, ought to be based on openness, transparency, and academic freedom. The 1940 American Association of University Professors (AAUP)<a href="http://www.aaup.org/AAUP/pubsres/policydocs/contents/1940statement.htm"> Statement of Principles on Academic Freedom and Tenure</a> opened with: <blockquote>The common good depends upon the free search for truth and its free exposition. </blockquote>Yet we have written about dark clouds of secrecy spreading over medicine and health care. The increasingly powerful leaders of health care increasingly use opacity and secrecy to keep what they are doing out of the public eye. We have frequently discussed the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, how it is just not done to discuss certain topics, particularly those related to the adverse effects of bad (ill-informed, incompetent, self-interested, conflicted, or corrupt) leadership and bad (opaque, unaccountable, mission-hostile, unethical) governance of health care organizations.  People may feel it is unseemly to speak badly of renowned institutions such as hospitals and universities.  People with conflicts of interest may not be inclined to criticize those who pay them.  Now people employed by contemporary health care organizations may have to pledge theri silence to keep their jobs. The latest story in this regard comes from Virginia Commonwealth University (VCU), which includes VCU Health Systems, and MCV Hospital and Physicians.  (Full disclosure: I was a VCU full-time faculty member from 1987-1994, and still am on the adjunct faculty.)  In 2008, the VCU President resigned after the university's secret research contract with a tobacco company, and the President's own position on the board of directors of another tobacco company were revealed (see blog post <a href="http://hcrenewal.blogspot.com/2008/08/after-controversy-over-tobacco-money.html">here</a> and others <a href="http://hcrenewal.blogspot.com/search/label/Virginia%20Commonwealth%20University">here</a>). Michael Rao, the President since 2008, is now under outside review after it was revealed that he required his staff to sign a secrecy pledge.  The <a href="http://www2.timesdispatch.com/news/local-news/2010/nov/17/vcuu17-ar-658103/">story</a> appeared in the Richmond Times-Dispatch: <blockquote>Virginia Commonwealth University President Michael Rao asks employees who work in his office to sign an unusual <a href="http://static.mgnetwork.com/rtd/pdfs/vcuu17.pdf">confidentiality agreement</a> that bars them from talking about what they observe about him or his family. The prohibition goes beyond the standard agreement that university employees sign acknowledging that they can't disclose personal or proprietary information. The agreement, a copy of which was obtained by the Richmond Times-Dispatch, covers interactions at Rao's office and at his residence. It bars disclosure not just to the news media, family or friends, but also to colleagues, 'clergy and attorneys, or to any other person not otherwise identified.' 'I agree that any such disclosure in violation of this nondisclosure agreement could result in irreparable damage and harm to VCU, President Rao, and/or his family'" the agreement states. 'Any such violation or anticipated violation' would entitle Rao to seek 'injunctive relief' in Richmond or Henrico County circuit courts. VCU spokeswoman Pam Lepley said she could not comment immediately yesterday. Several current or former employees of the president's office confirmed that they had been asked to sign the agreement, including Kimberley Busch, Rao's former scheduler. She described it as a 'what happens in the president's office stays in the president's office' agreement.</blockquote> The newly uncovered confidentiality clause provoked strong criticism: <blockquote>Raymond D. Cotton, a Washington attorney who specializes in higher-education governance, said such a confidentiality agreement is highly unusual and goes against the culture of openness and transparency in higher education. 'There is this concept of academic freedom that is broader than the First Amendment,' he said.</blockquote> In fact, since Virginia Commonwealth University is a state-supported institution, the confidentiality clause may be unconstitutional, as <a href="http://www.wtvr.com/news/wtvr-mark-on-vcu-president-111810,0,1379760.story">reported</a> by WTVR: <blockquote>Kent Willis with the Virginia American Civil Liberties Union said the agreement doesn't pass constitutional muster. 'A public employee, no matter where they are in the government, has a right to speak out on matters of public concern,' Willis said. 'That's a U.S. Supreme Court case, it's guaranteed to every public employee by the First Amendment to the Constitution.' Willis said there are numerous legal issues raised by the contract. But, he said, the bottom line problem with the contract 'is the attitude. This is a contract that says 'I'm not transparent. I don't want you to know what is going on. I'm running a closed shop.''</blockquote> Times-Dispatch columnist Michael Paul Williams <a href="http://www2.timesdispatch.com/news/2010/nov/19/mike19-ar-663326/">wrote</a>: <blockquote>VCU, we have a problem. This confidentiality agreement does not inspire confidence. The lack of transparency only gives the appearance that someone's hiding something.</blockquote> He also further quoted Kent Willis: <blockquote>Rao's contract 'fails to address this whistle-blower right and could create conflicts for employees, who are silenced by the employment contract,' yet have a constitutional right to speak out on some matters, Willis said. And as Willis points out, even if a person's constitutional right trumps the contract, how many employees are willing to take that risk? 'Particularly disturbing is the prohibition against talking to an attorney,' he said. 'If an employee believes something illegal is going on at work, an attorney is precisely the person he or she should be talking with.'</blockquote> We just <a href="http://hcrenewal.blogspot.com/2010/07/stifling-whistle-blowers-old-and-new.html">posted</a> about how a pharmaceutical company included a confidentiality clause in a consulting contract, suggesting the deliberate creation of a conflict of interest in order to prevent criticism of the company's products or practices.  However, in several ways, the present example is more insidious.  First, it involves a university, whose mission is to discover and disseminate the truth.  Thus, as noted above, the confidentiality agreement subverts the university's core mission.  Second, it was required of full-time employees who wanted to keep  their jobs, making choose between secrecy and unemployment.  Third, it was particularly harsh, addressing incipient as well as actual disclosure, and including injunctive relief as well as the threat of  termination.  Fourth, it protected not just the organization and its products, but personally protected the organization's leader and his family.  It was not just a contract, but an oath of fealty, as if the CEO were nobility, or even royalty. The good news is that this confidentiality agreement now sits in the glare of sunlight.  One does wonder, however, how many other such agreements are already in force so that the would be nobility who now run too much of health care to avoid any embarassing revelations about what their leadership really is about. We are a long way from the transparency that true health care reform requires.

A Confidentiality Clause or an Oath of Fealty?

The advancement of modern scientific medicine depends on the search for and dissemination of truth. Academic medicine, like the rest of acad...

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Citizen Journalism: Why I Blog on Healthcare Informatics

I am teaching my current students about alternate media, a.k.a. citizen journalism, also known as "blogging", in a course on organizational and social aspects of healthcare informatics.I am using a (de-identified) personal experience as an example of why alternate media is valuable in getting "inconvenient" memes into circulation. In addition to recent articles such as "<a href="http://www.bmj.com/content/340/bmj.c1409.extract">The Problems with Peer Review</a>" (in the British Medical Journal by Mark Henderson, Science Editor, the Times, London. BMJ 2010;340:c1409), "<a href="http://psychrights.org/research/Digest/Science4Sale/LacasseLeoOnGhostwritingPLoS2010.pdf">Ghostwriting at Elite Academic Medical Centers in the United States</a>" (LaCasse & Leo, PLoS Medicine, February 2010, Volume 7, Issue 2) and others about <a href="http://hcrenewal.blogspot.com/2009/08/has-ghostwriting-infected-experts-with.html">ghostwriting</a> and other ills affecting the conventional biomedical literature, I provided my students the personal example below. I thought the example might be interesting to blog readers as well.Here is the example I used with my students:<blockquote>Regarding a paper I wrote a few years ago and that I ultimately simply posted on Scribd, "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT" (<a href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT">link</a>), an anonymous peer reviewer had this to say when I submitted it to "journal XYZ": <blockquote style="margin-right: 0px;" dir="ltr"> Comments to the Author This paper addresses a potentially important issue but adds little that is new or that goes beyond what a reader might find in a major city newspaper. Proposing a classification of sources of UC and analysis of reasons for undereporting of each type in the resulting classification could be a useful addition to the field.</blockquote> This was certainly an ironic if not bizarre comment. A paper on a scarcity of data on unintended consequences of health IT due to a "closed culture" in the HIT industry does not add anything new "beyond what one might find in a major city newspaper?" Unfortunately, the anonymous peer review process does not allow me to ask what newspaper this reviewer reads, but it was clear to me this reviewer was 1) attempting to prevent the paper's publication and 2) "moving the goalposts" to delay it or have the focus on scarcity removed by seeking for me to "propose a classification of sources of UC" (tangential or even irrelevant to the paper's topic). I felt it likely the review of a revised paper by this reviewer would have led to negative comments on any proposed classification schema. Worse, was this, in a dialog via several emails I've condensed for readability. It is very likely it came from the same reviewer above: <blockquote style="margin-right: 0px;" dir="ltr"> EDITOR OF JOURNAL XYZ: I suggest Scot that you modify this into an editorial. One reviewer recognized the writing and asked me if this may have been pre-published on a blog. Any possibility for that?</blockquote> In other words, I was being accused by the anonymous reviewer of possibly violating the ethics of journal publication and the contract I signed to not pre-publish (the journal has exclusive rights). My response: <blockquote style="margin-right: 0px;" dir="ltr"> SS: No, this work was entirely original, written from a clean slate, and was not pre-published on a blog. I would think the reviewers would know me better than that in terms of integrity.</blockquote> The editor shot back: <blockquote style="margin-right: 0px;" dir="ltr"> EDITOR: My response as well. Good - looking forward to the edits. Happy snow day</blockquote> I reminded the editor: <blockquote style="margin-right: 0px;" dir="ltr"> SS: Not to mention the extensive footnotes showing where I sourced my material. In an age of search engines, I have to ask the following: - was the person who raised this concern so technologically limited they were unable to search themselves to answer their own question? - did this person have such a lack of trust they felt compelled to make such a statement? - did this person raise this due to bias against the fundamental thesis of the paper? I think it's fair to say there is very, very strong pushback against articles such as this being published. I have to consider whether it's worth my while to continue, or to withdraw the paper. </blockquote> At which point I received the following revealing comment from the editor: <blockquote style="margin-right: 0px;" dir="ltr"> EDITOR: I think, Scot, that you have a talent for sniffing out problems, dangers, risk, failures and by addressing them in your head on ways, you are likely to make enemies. You are doing a valuable job, but you have to realize that people are threatened by you. That's why the respond in this manner. Not that it is excusable, but it is understandable.</blockquote> I decided it was not worth revising the paper due to that reviewer's comments and the editor's observations, and therefore disseminated the paper via the Healthcare Renewal blog and Scribd. </blockquote>(I note that "making enemies" by directly confronting possible risks of a new technology in healthcare suggests skewed priorities among those so affected.) While I believe the current Wikileaks web exposures have gone insanely too far, as those incidents involved exposure of sensitive material held illegally that could people to be harmed, damage international relations, and cause other unforeseen ill effects, the web has proven valuable for dissemination of one's ideas that have not been able to escape the gravity of the sometimes "peer review Black Hole."-- SS

Citizen Journalism: Why I Blog on Healthcare Informatics

I am teaching my current students about alternate media, a.k.a. citizen journalism, also known as "blogging", in a course on orga...

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Prominent Health Care Policy Advice from People Sans Health Care Expertise

It is two days after the US Thanksgiving holiday, and one thing I am thankful for is the continued hilarity generated by health care corporate CEOs who pretend to be health care experts.  Of course this all really is not so funny, because the bogus expertise appears not in MAD Magazine, but in the most respected media outlets with the most influence over health care policy.  This week's example comes from the Wall Street Journal's vaunted CEO Council.  A <a href="http://online.wsj.com/article/SB10001424052748703688704575620850148494216.html">summary</a> of its health care panel appeared early this week in that newspaper. The panel included Angela Braly President and CEO, Wellpoint Inc., William A. Hawkins Chairman and CEO, Medtronic Inc., and Klaus Kleinfeld Chairman and CEO, Alcoa.  Angela Braly, a lawyer with no obvious record of direct experience in health care or related fields (see her bio <a href="http://www.wellpoint.com/business/bios.asp?officerName=Angela_Braly">here</a>), received total compensation from WellPoint of more than $13 million in 2009, while presiding over various snafus and ethical missteps (most recently <a href="http://hcrenewal.blogspot.com/2010/08/being-health-insurance-executive-means.html">here</a>, and with a further catalog <a href="http://hcrenewal.blogspot.com/search/label/WellPoint">here</a>.)   William Hawkins, who has an undergraduate degree in engineering, and an MBA, <a href="http://www.startribune.com/business/98645844.html">received</a> total compensation from Medtronic of over $9 million in fiscal 2010.  His direct involvement in health care or related fields apparently ended after his undergraduate years, when he was said to have done research in pathology (see his bio <a href="http://wwwp.medtronic.com/Newsroom/Biography.do?itemId=1100621535750&lang=en_US">here</a>).   He presided over Medtronic's <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">settlement </a>of thousands of patients' lawsuits that alleged injuries due to a faulty lead on one model of a Medtronic implantable cardiac defibrillator for over $200 million.  The company's other recent questionable activities may be found <a href="http://hcrenewal.blogspot.com/search/label/Medtronic">here</a>.  Dr Kleinfeld's doctorate is in strategic management, but he has no obvious health care background (see his bio <a href="http://www.alcoa.com/global/en/about_alcoa/corp_gov/directors/Kleinfeld.asp">here</a>.)   (The panel apparently had a "subject expert," Dr Risa Lavizzo-Mourey, a physician who is now CEO of the Robert Wood Johnson Foundation, but she was not quoted directly in the WSJ edited transcript.) So what could we expect from a panel on health care that included no one with direct experience or expertise in health care, but two CEOs who managed to become extremely wealthy courtesy their employment by health care companies?  Here is Ms Braly on changing incentives: <blockquote>This really gets to the fact that right now we have a fee-for-service payment system, so we pay for quantity rather than quality. And very importantly, we think we need to redesign the way in which we reimburse for health care.</blockquote> So, <blockquote>Reimbursement could come in the form of accountable care organizations or patient-centered medical homes or pay-for-performance or risk sharing. There are a number of ways—and we didn't want to be completely prescriptive in terms of what that reimbursement formula would be.</blockquote> The issue is not quantity versus quality, but cognitive, including primary care vs procedures. Ms Braly completely ignores how the government takes only the advice of the RUC to set physician payments, and how her company just apes that example (see posts <a href="http://hcrenewal.blogspot.com/search/label/RUC">here</a>). Ms Braly also completely ignored how her company could actually try to change reimbursement on its own. There is no law that says it must follow the example set by Medicare. So what she said about changing "delivery incentives" is just nonsense, to use a polite term. Then we have Dr Kleinfeld ostensibly on transparency, but really on thinking about health care as if it were done on a production line: <blockquote>Let me first talk about the transparency aspect. It was very informative to hear from those that are in the industry how big a variation you have in practices across the board. If I were to look at a set of factories that make the same thing, and one does it in five days and the other one in 10 days, and the one that does it in five days is cheaper than the one that does it in 10 days, why would I not bring everybody down to the five days? So the question is, what hinders the health-care industry from applying the same mechanics? There was agreement that today for every important disease category there are also quality indicators that are accepted that you could use to see what is the quality delivered. Once you control the process, once you bring the quality up, the costs go down.</blockquote> Dr Kleinfeld does not seem to realize that health care involves taking care of unique patients. Even when patients have common problems, they have unique mixtures of other medical problems and personal characteristics. The physician's most basic pledge is to do what is best for each individual patient. Treating them as if they were identical widgets on a production line makes absolutely no sense.  One cannot apply the "same mechanics" that apply on a production line, because actually taking care of patients is not done, and does not at all resemble what happens on a production line. It goes without saying that Dr Kleinfeld seems to have no idea how complex and fraught with error the process of measuring quality in health care actually is. His remarks again, to put it politely, were nonsense. Finally, there was Mr Hawkins in a similar vein: <blockquote>Contrary to popular belief, we actually have very good medical care in this country, and with the proliferation of evidence-based medicine, we have determined that there are best practices for how we can treat hypertension or some of the neurodegenerative diseases or diabetes. And the reality is, as you look across different systems, there's a lot of variability in what people are doing. We talked about the importance of publishing or being very clear about what are the best practices for dealing with hypertension, and then making sure that we have the means by which people will be held accountable moving forward in that area.</blockquote> Maybe we should acknowledge that at least Mr Hawkins tried to concentrate on hypertension, which may have a slightly more secure evidence base than some other conditions. But the implication still is that there are "best practices" when the complexity of real patients in a real health care context makes figuring out what really is best for individual patients very challenging. Maybe that is why we used to try to leave such decisions up to doctors, other health professionals, and their patients. However, it seems that the CEOs of big health care corporations seem to feel the need to justify their ridiculous total compensation by opining on health care topics that are completely beyond their experience, training, and expertise. The real problem is that probably because of the assumption that those huge salaries must correlate with huge expertise and intelligence, their opinions are taken seriously. The quotes above did not come from MAD Magazine. They came from a highly respected and prestigious conference sponsored by and whose results were published by the Wall Street Journal. To truly reform health care, we need to stop pretending that general business or law training makes someone a health care expert, and that being paid a lot of money by a health care corporation makes one a bigger health care expert.   We need to go back to developing health care policy with the help of people who actually know something about health care, and who are not paid by particular health care corporation to support their vested interests.

Prominent Health Care Policy Advice from People Sans Health Care Expertise

It is two days after the US Thanksgiving holiday, and one thing I am thankful for is the continued hilarity generated by health care corpora...

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ACO = Arrogant Clinical or Aggressive Care Oligopoly?

In the 1970s, it was managed care organizations.  In the 1990s, it was vertically integrated health care systems.  In the 2010s, the fashionable concept for improving health care, apparently beloved by left-wing policy wonks and right-wing health care executives is the "accountable care organization." (ACO).  Development of the ACO is funded by the recently passed US health care reform legislation.  The <a href="https://www.cms.gov/OfficeofLegislation/Downloads/AccountableCareOrganization.pdf">official definition </a>of ACO from the US Center for Medicare and Medicaid Services is:  <blockquote>An Accountable Care Organization, also called an 'ACO' for short, is an organization of health care providers that agrees to be accountable for the quality, cost, and overall care of Medicare beneficiaries who are enrolled in the traditional fee-for-service program who are assigned to it.</blockquote> Oddly enough, that seems like it could also describe a 1970s managed care organization, or a 1990s vertically integrated health care system. The only real difference is the idea that the ACO would be paid fees for service. All these similar concepts embody the notion that health care needs to be highly organized into big, bureaucratic organizations to improve quality and access while controlling costs. Back in August, we <a href="http://hcrenewal.blogspot.com/2010/08/how-oligopolists-rationalize-their.html">warned</a>: <blockquote>There seems to be a strange and increasing alliance between politically- correct academic theorists and proponents of raw economic power. The theorists' notion of "accountable care organizations" seems to have become a great foil for would-be monopolists, yet the theorists have done nothing to show how their creation would really bring "power to the people." Meanwhile, maybe 'ACO' should stand for 'aggressive care oligopoly.' Meanwhile, be extremely skeptical of the latest health care fad, especially when it is supported both by academics and CEOs. </blockquote> I am not sure you really heard it here first, but you did hear it here early. Now, three months later, our doubts have become main-stream. Revisiting Sutter Health n California, National Public Radio continued to <a href="http://www.npr.org/2010/11/18/131413075/as-hospital-system-expands-patient-advocates-worry">document</a> the increasing market dominance of the Sutter Health system (which we discussed in August <a href="http://hcrenewal.blogspot.com/2010/08/how-oligopolists-rationalize-their.html">here</a>) as it marches toward becoming an ACO: <blockquote>Through new construction and expanding its doctors' groups, Sutter Health is enhancing its position as one of the most dominant hospital systems in California. In addition, Sutter is further ahead of many competitors in fashioning itself into a so-called accountable care organization, responsible for coordinating care between hospitals, specialists and primary doctors.</blockquote> A <a href="http://www.npr.org/2010/11/18/131410569/big-hospital-chains-use-clout-to-dictate-premiums">companion article </a>gave examples of how this emerging ACO is becoming increasingly oligoplistic: <blockquote>Hospital prices in the Sacramento region are among the highest in California, driven in large part by the negotiating clout of the hospital chain Sutter Health. Over the last decade and a half, Sutter has gradually accumulated hospitals and amassed a roster of doctors who contract exclusively with the company. Sutter is now one of the largest hospital chains in California with 24 acute care hospitals. 'In this Roseville market, which is a big suburban area, the hospital is Sutter,' says John Murray, a veteran insurance broker. 'It's a lock right now. Because Sutter dominates the market, major insurance companies, like Blue Cross and Aetna, can't sell policies that exclude Sutter hospitals and doctors. That dependence means the hospital chain can dictate high prices.'</blockquote>Concerns about Sutter's market dominance are also increasing: <blockquote>'As Sutter gets bigger,' says Anthony Wright, executive director of Health Access California, a nonprofit advocacy group based in Sacramento, 'it can dictate higher prices and is less accountable for ensuring good quality because it has a lock on certain markets.'</blockquote>Doubts in the New York Times In the New York Times, Robert Pear <a href="http://www.nytimes.com/2010/11/21/health/policy/21health.html">reported</a>: <blockquote>When Congress passed the health care law, it envisioned doctors and hospitals joining forces, coordinating care and holding down costs, with the prospect of earning government bonuses for controlling costs. Now, eight months into the new law there is a growing frenzy of mergers involving hospitals, clinics and doctor groups eager to share costs and savings, and cash in on the incentives. They, in turn, have deployed a small army of lawyers and lobbyists trying to persuade the Obama administration to relax or waive a body of older laws intended to thwart health care monopolies, and to protect against shoddy care and fraudulent billing of patients or Medicare. Consumer advocates fear that the health care law could worsen some of the very problems it was meant to solve — by reducing competition, driving up costs and creating incentives for doctors and hospitals to stint on care, in order to retain their cost-saving bonuses. 'The new law is already encouraging a wave of mergers, joint ventures and alliances in the health care industry,' said Prof. Thomas L. Greaney, an expert on health and antitrust law at St. Louis University. 'The risk that dominant providers and dominant insurers may exercise their market power, individually or jointly, has never been greater.' </blockquote> Skeptical Liberals and Libertarians Amazingly, while ACOs seem to be supported by many left-wing policy wonks and right-wing health care executives, they have also rapidly engendered skepticism from both liberals on the left and libertarians on the right, and from within government and the private sector. For example, at the end of the NY Times article we find: <blockquote>Dr. Donald M. Berwick, the administrator of the Centers for Medicare and Medicaid Services, hails the benefits of 'integrated care.' But, Dr. Berwick said, “we need to assure both patients and society at large that destructive, exploitative and costly forms of collusion and monopolistic behaviors do not emerge and thrive, disguised as cooperation.” </blockquote> Dr Berwick is a well-known advocate of innovative approaches to improve the quality of care, but was tarred as a raving left-winger when he was nominated to his current position. On the other hand, in the New York Post was an <a href="http://www.nypost.com/p/news/opinion/opedcolumnists/health_reform_competition_crushers_f2dIEwqEdJYvA3tsNH37wM">op-ed </a>by Dr Scott Gottlieb: <blockquote>I warned that the creation of 'accountable care organizations,' which put hospitals in control of all the doctors in their outlying areas, would lead to concentrated power over the provision of medical care -- turning physicians into salaried employees and reducing consumer choices.</blockquote> Furthermore, he wrote: <blockquote>Since the ACOs will have local monopolies, they'll also have little incentive to compete for more patients in an open marketplace. Yet this is the only incentive that would spur an ACO to truly innovate and improve its delivery of medical care and offer better services. Private health plans vie to contract with the best doctors and hospitals, creating market prices for services and competition to improve outcomes. If the ACOs squeeze out this competition, the result will be a de facto 'single payer': Every market will be controlled by a single ACO,....</blockquote> Dr Gottlieb writes frequently about health care and policy issues, and is a "resident fellow at the American Enterprise Institute." Missing the Main Point: Doctors vs Business Executives as Leaders At least it did not take long this time for the fundamental flaws in the latest fashionable health care reform effort to get attention. It is really striking that this time around, skepticism is coming from both liberals and libertarians.  Maybe we all have learned something from the failures of managed care and of vertically integrated hospital systems. A Washington Post <a href="http://www.washingtonpost.com/wp-dyn/content/article/2010/11/23/AR2010112306194.html">op-ed </a>by Steven Pearlstein hinted at one fundamental problem with the ACO concept. <blockquote>Most reformers believe ...that the best way to deliver affordable quality care is through organizations such as the Mayo Clinic, which coordinate physician and hospital services under one roof and are paid not on the basis of how many procedures they do but on the quality of the care they provide. These organizations tend to rely on salaried doctors, make extensive use of electronic medical records and evidence-based 'best practices,' and, in effect, take on much of the risk traditionally borne by insurers. Several provisions of the new health-care reform law encourage the formation of such 'accountable care organizations.' </blockquote> Somehow, however, the supposed health care reformers seemed to have overlooked a crucial fact about the Mayo Clinic they are using as a model. The Mayo Clinic traditionally was basically a large physician group practice. It was run by physicians. Even <a href="http://www.mayoclinic.org/governance/leadership.html">now</a>, the Mayo Clinic's CEO is a physician (Dr John H. Noseworthy) who had a substantial clinical and academic career. The CAO is a nurse, and the three top Vice Presidents are physicians.  I submit the fact that the organization was run by physicians, physicians who once swore to put their patients' clinical care ahead of all other considerations, was crucial to the Clinic's success in taking care of patients as well as maintaining its finances. However, nearly all of the would-be ACOs we hear about now are centered on big hospital systems, run by business executives who have never taken care of patients, and never swore to put patient care ahead of anything. For example, the most advanced degree possessed by the CEO of Sutter Health is a Master's in Health Administration (see <a href="http://www.sutterhealth.org/about/ourteam/index.html">here</a>). Sutter Health does not make biographical information about its top executives particularly easy to find, but according to the most recent (2008) 990 form <a href="http://www.guidestar.org/FinDocuments/2008/942/788/2008-942788907-05747304-9.pdf">posted on Guidestar</a>, of its 19 top executives, only 2 had MD degrees. As we have <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">seen</a> time and again on Health Care Renewal, such executives have become extremely good at becoming rich in their jobs. (For example, according to the 2008 990 form, of those 19 executives, all had total compensation greater than $200,000, 16 had compensation greater than $500,000, and 9 had compensation greater than $1 million.) When things go wrong, these royally paid executives may take their golden parachutes and open the exit door, and jump on the slide. The advent of ACOs reminds me of the advent of managed care. The original managed care organizations, exemplified by Kaiser - Permanante, were also not-for-profit large group practices run by physicians. However, the "managed care organizations" that evolved out of the 1970s law, favored by our glorious former President Nixon, were for-profit corporations run by business executives. Somehow, when legislators seek to promote better health care, the legislation they right often get the crucial details wrong. The one good thing about ACOs seems to be that they have galvanized liberals and libertarians alike to worry about big, collective, bureaucratic health care organizations run by executives with no clear commitment to putting care of individual patients first. ADDENDUM (26 November, 2010) - See also comments <a href="http://www.healthbusinessblog.com/?p=4044">by David Williams</a> on the Health Business Blog.

ACO = Arrogant Clinical or Aggressive Care Oligopoly?

In the 1970s, it was managed care organizations. In the 1990s, it was vertically integrated health care systems. In the 2010s, the fashion...

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Of Drug Talks, Deception, and Denial

A month ago, we <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">discussed</a> a series of reports by Pro Publica and multiple other respected news organizations about payments by seven pharmaceutical companies to thousands of doctors.  Industry often claims that they only pay the best and the brightest physicians and academics to provide education relevant to their products.  However, the ProPublica et al report suggested that they mainly recruited physicians who already showed their favor to their products by prescribing them often, but soothed their consciences by dubbing them "thought leaders" or "key opinion leaders."  While some of the physicians were well-known academics, others had notably blemished records.  Since then, a series of local or regional news organizations have reported on physicians in their areas.  These reports (all listed below as "references" in somewhat chronological order ) further explained how these "drug talks" are just marketing exercises, and how some of the physicians involved rationalized making money hawking drugs. Physicians as Marketers Considered together, the articles documented how the drug talks served marketing rather than educational needs. Doctors are the Most Influential Speakers As noted previously, corporations and the doctors they hire chronically characterize the doctors' talks as educational. However, from New York City,(9) <blockquote>[Dr Stephen] Friedes said drug companies can’t use sales reps to give the same speeches. Instead, they need doctors to serve as speakers because the presentations are more believable when they come from an expert’s mouth. And that’s why companies will pay the biggest bucks to get the biggest experts to read their slides.</blockquote>Paying Doctors Who Already are Prolific Prescribers From Chattanooga, Tennessee(7), came pulmonologist Daniel Smith's acknowledgment that the corporations choose speakers who they already know favor their products: <blockquote>He emphasized that his use of GlaxoSmithKline's Advair inhaler began long before he started speaking for the company. 'The assumption is if the doctor didn't have the relationship, he wouldn't prescribe the medication,' he said.</blockquote>Also, as reported from Des Moines, Iowa(8): <blockquote>Several doctors said drug company representatives asked them to become paid speakers because sales records showed the physicians often prescribed the companies' products. 'They're like, 'We noticed you're using a lot of our drugs, would you mind telling other doctors why?' ' said [Sioux City internist Dr Mark] Carlson, who emphasized that he prescribes the medications he believes work best.</blockquote>Furthermore, from New York City(9) : <blockquote>First, the industry says it picks the doctors who are the most knowledgeable about the drugs. But [Dr Richard] Schloss said Pfizer first picked him because he was a high prescriber of Geodon. 'What they do is they get the pharmacy records, and they know who’s prescribing what,' said Schloss, 'and they can come in and say, ‘I see you’re prescribing, you know, a lot of, in this case, Geodon. What do you like about it?’ And you if say nice things, they say, ‘Will you be interested in speaking for us?’'</blockquote>Payments Influence Behavior Even though health care corporations may select speakers who already favor their products, probably to reinforce this pattern, that does not mean that such payments do not induce even more enthusiasm. From Chattanooga, Tennessee(7), obstetrician-gynecologist Kirk Brody <blockquote>said he hasn't actually spoken on behalf of a drug company for eight years or so. He quit after one year when he realized the drugs he lectured about ended up popping into his head when it came time to prescribe, he said. 'I felt like it was probably influencing my prescription habits,' he said. 'If you're out there singing the praises of something, you tend to believe it. It was just an ethical problem.'</blockquote>Also, from New York City(9): <blockquote>[Dr Richard] Schloss said he agreed to be a speaker because he genuinely believes in Geodon, and he enjoys teaching. But even he admitted the speaking has actually changed the way he prescribes. 'You know, I may use Geodon maybe 10 percent more than I did before I was a speaker,' said Schloss. 'I use it 10 percent more because I’ve spoken about it so many times....'</blockquote>"Push Poll" From New Hampshire(1), Dr. Leonard Korn, president of the New Hampshire Psychiatric Society, described how the drug talks resembled a "push poll" (biased poll meant to sell a viewpoint) <blockquote>'We sat there being educated by their people and they sent us a check,' he said, recalling the usual fee was about $500. The doctors would then give feedback about the positive and negative aspects of a particular medication and of drugs made by competitors. 'It was a bit like a focus group ... except a focus group is not really promoting its product,' he said. 'This is much more like a push poll.' His concern is that such events can influence doctors, even subconsciously, to choose that company's drug.</blockquote>Why Hide the "Education?" If the physicians' talks are educational, as some of the speakers and their corporate pay-masters assert, why should they be hidden from the media. However, as reported from Des Moines (Iowa)(8): <blockquote>The companies say they favor openness. 'We believe transparency is critical to rebuilding trust in our industry, and Lilly seeks to continue to be a leading voice and example in transparency efforts in the biopharmaceutical industry,' said J. Scott MacGregor, a spokesman for Eli Lilly. In that spirit, The Des Moines Register asked MacGregor and his counterparts at the other two leading companies to let a reporter observe one of their doctor-education sessions. All three declined. 'It would be inappropriate for you to attend an event,' AstraZeneca spokeswoman Katie Lubenow said. She said the sessions are open only to medical professionals.</blockquote>Also, from New York City(9): <blockquote>But for talks that are supposed to be purely educational, there seems to be a lot of secrecy. WNYC called the seven companies in the ProPublica database, and asked if it could observe a presentation. Each company declined. And none would send copies of their slides. [Columbia Unviersity urologist Franklin] Lowe wouldn’t provide a copy either. He said the slides were company property and he could get into trouble if he passed them out. </blockquote>Physicians' Rationalizations for Getting Paid to Give Pharmaceutical Talks  Denial: Industry Sponsored Talks are Educational Despite the evidence above and elsewhere that pharmaceutical companies pay physicians to give talks to market their products, not to altruistically provide unbiased education, many physicians asserted what they were doing is educational. Those providing the rationalizations included high ranking academics. For example, from New Hampshire(1): <blockquote>Dr. Craig L. Donnelly, chief of the child psychiatry section at Dartmouth-Hitchcock Medical Center, said he views such appearances as part of his mission to educate the next generation of physicians. Donnelly is the second-highest earner on Pro Publica's list for New Hampshire, earning $136,578 from Eli Lilly in 2009 and the first quarter of 2010. When he gives talks, Donnelly said in an e-mail, he advocates not for one particular drug but for a "full range of treatment options," including non-pharmacological ones. 'When I speak to colleagues, I am putting my reputation on the line,' he said. 'I genuinely believe that these talks provide educational value to my colleagues in primary care, above and beyond the informational component on the particular drug topic.' </blockquote> Denial:  Physicians are Not Chosen to Speak Because they Favor the Product Despite the evidence above and elsewhere that corporations pick physician speakers who already favor their products, from San Francisco, California(10), former Stanford faculty member psychiatrist Manoj Waikar said: <blockquote>he does not disclose what drugs he prescribes to pharmaceutical companies so they hire him for his expertise, not because of his prescribing patterns.</blockquote>He seemed unaware that the companies already have easy access to data about his prescribing habits. Rationalization: The Need for "Collaboration" Implies the Need to Get Paid for Marketing Furthermore, even academics who were uncomfortable with industry supported talks recited the mantra that academic-industrial "collaboration" is needed to provide "innovation." This begs the question of why such "collaboration" needs to include payments by industry to academia for marketing, or in fact any activities other than pure research. For example, from an article specifically about the Dartmouth-Hitchcock Medical Center in New Hampshire(2), Dr James L. Bernat, a DHMC neurologist and chairman of the bioethics committee, <blockquote>said the relationship between medicine and industry can be 'synergistic and useful' for both groups. But he said, 'There are potential conflicts of interest that can occur ... that need to be identified, mitigated and prevented.'</blockquote>Also, co-chair of the hospital's integrity and ethics task force Dr. Carl DeMatteo, an infectious-disease physician and chief quality and compliance officer, <blockquote>said academic physicians who share their research with pharmaceutical or medical-device companies 'can bring forward treatments and cures to the public that can make a real difference in people's lives.'</blockquote> The latter, of course, is mainly an argument for publication and dissemination of basic science research, not for academic physicians working with drug, device or other companies on evaluating the products those companies have a vested interest in, much less involving academics in marketing. Universities are always promoting academic-industrial collaboration, but never seem to explain why such collaboration requires academics to be paid to give talks, or for that matter, for ill-defined consulting work.  They talk about the benefits of research as a monolithic whole, rarely explaining why it is good for industry to sponsor and control human research meant to evaluate the products in which companies have vested interests. Reasoning from a Biased Sample: Multiple Conflicts as De-Biasing Physicians asserted that being paid by multiple corporations is reduces bias in favor of a particular drug, ignoring the possibilities that multiple conflicts of interest might bias in favor of expensive drugs vs generics, in favor of drug therapy vs other approaches, or even in favor of aggressive vs conservative therapy. For example, from Erie, Pennsylvania(3), a report quoted Dr Gurjaipal Kang, <blockquote>'I don't feel there is a conflict of interest,' Kang said. 'I speak for competing drug companies. I speak about some drugs that I don't often prescribe.' </blockquote>Also, from Vancouver, Washington(4), a quote from Dr Jeffrey L Hansen, psychiatrist: <blockquote>'I don’t believe it influences my prescribing practices because I work with a number of companies,' Hansen said. 'I want to make sure that no matter who’s sponsoring my speaking the message is the same.'</blockquote> Denial: Conflicts of Interest Do Not Influence Behavior Many doctors simply asserted that being paid to give a talk does not influence their prescribing. This begs the question of whether they were hired to speak to reinforce their pre-existing preference for the products of their employers. It also seems to simply deny that financial incentives matter, a position supported by common sense, and underlying essentially all of economics. For example, from Syracuse, New York(5), the chief of urology at Crouse Hospital, said <blockquote>'Morally my goal is to treat the patient with the best medications I know of,' Albala said. 'I find it hard to believe some people would write a (prescription for) a medication just because they are a speaker.' 'I would be happy to do these gratis,'.... </blockquote> Note, of course, that despite the last assertion, he was apparently even happier to get paid. Dr Albala was the top recipient of drug company honoraria in the Syracuse region, getting $180,200 from GlaxoSmithKline. False Dilemma: If It is Not Illegal, It Must be Good An old argument in politics and business is the assertion that one's behavior is good as long as one has not been convicted of a crime.  An analogous argument made by physicians is to claim that compliance with local administrative processes certifies one's actions as ethical. For example, from Durham, North Carolina)(6), Duke Medicine oncologist David Rizzieri, <blockquote>asked whether the substantial sums he has received from drug companies could lead to ethical issues, Rizzieri replied, 'I respect this concern and feel the multiple layers of oversight and conflict of interest management planning ... help assure appropriate application and presentation of the data.</blockquote>Rationalization: Entitlement Physicians may feel that because of the hardships they have endured, especially during training, they are entitled to be rewarded, apparently no matter what the circumstance. So, from Durham, North Carolina,(6) a medical student noted: <blockquote>There is certainly a sense that once you go through medical school and you go through residency, you're kind of entitled to these gifts from industry, or to be paid well enough for speaking </blockquote> Also, from Chattanooga, Tennesse(7), local pulmonologist Daniel Smith sarcastically asserted: <blockquote>We're considered experts in our field. I guess we're supposed to spend hours and hours of time educating other doctors for free</blockquote>This, of course, begs the question of who should be paying. Appeal to Common Practice: Pharmaceutical Paid Talks are Part of the Culture Some in the academic world seemed to assert that since the talks are common practice, they must continue.  From Durham, North Carolina(6), Ross McKinney, director of Duke's Trent Center for Bioethics, Humanities and History of Medicine, said <blockquote>the new policies will also have to consider the existing culture among doctors. 'It is hard to set restrictions when that is the existing culture. This isn't the Mayo Clinic where everybody is just a salaried employee,'.... </blockquote>Summary There is a growing body of evidence that pharmaceutical companies, and presumably other for-profit health care corporations, may pay physicians to give talks to help market their products, not to altruistically support unbiased education.  Physicians may command more respect than sales people.  The companies may choose those who are already known to favor their products.  While the speakers may influence other physicians, payments to them may reinforce, if not enhance their favorable stance towards the companies' products.  The setting of the talks may be designed to favor their marketing purpose.  Pharmaceutical companies and the physicians they pay may be wary of letting skeptics witness these talks because they have the above considerations to hide. However, it seems that many physicians who give the talks, and sometimes the academic institutions with which they are affiliated, are in denial about the nature of these talks.  They are quick to rationalize what they do, sometimes with the help of logical fallacies. I submit that physicians and health professionals should shun commercially sponsored talks as deceptive marketing.  Physicians who give such talks are at best naive, and at worst complicit in the deception.  Deceptive marketing is never good, but is particularly upsetting and dangerous when it is used to sell products that have serious health consequences.  ADDENDUM (24 November, 2010) - See this related <a href="http://brodyhooked.blogspot.com/2010/11/more-from-propublica-disciplined-docs.html">post</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog. References 1.  Wickham SE. Three Doctors paid $100,000-plus by drug companies. New Hampshire Union-Leader, Nov 8, 2010.  Link <a href="http://www.unionleader.com/article.aspx?headline=Three+doctors+paid+%24100%2C000-plus+by+drug+companies&articleId=c341476b-9ff4-4b62-88f6-ef5f1eac06a8">here</a>. 2. Wickham SE. Dartmouth-Hitchcock takes fresh look at such payments. New Hampshire Union Leader, Nov 8, 2010. Link <a href="http://www.unionleader.com/article.aspx?headline=Dartmouth-Hitchcock+takes+a+fresh+look+at+such+payments&articleId=860ca012-9415-47a7-8557-75c72560de49">here</a>. 3. Bruce D. Drug companies pay Erie doctors to speak about their drugs, devices. Erie (Pennsylvania) Times-News, Nov 8, 2010. Link <a href="http://www.goerie.com/apps/pbcs.dll/article?AID=/20101108/NEWS02/311059857/-1/news">here</a> 4. Lasher B. Pharmaceutical industry spends millions on doctors: Clark County doctors got $190,000 over 18 months. Vancouver (Washington) Columbian, Nov 7, 2010. Link <a href="http://www.columbian.com/news/2010/nov/07/pharmaceutical-industry-doctors-Clark-County/">here</a>. 5. Mulder JT. Drug makers pay 51 central New York doctors nearly $1 million to talk about their products. Syracuse (New York) Post-Standard, Nov 7, 2010. Link <a href="http://www.syracuse.com/news/index.ssf/2010/11/drug_makers_pay_51_central_new.html">here</a>. 6. Chen M. 'Dollars for Docs' hits home. Durham (North Carolina) Herald-Sun, Nov 13, 2010. Link <a href="http://www.heraldsun.com/view/full_story/10309768/article--Dollars-for-Docs--hits-home">here</a>. 7. Bregel E. Prescription for concern: pharmaceutical companies' payments to doctors raise questions amid soaring U. S. drug costs. Chattanooga (Tennessee) Times- Free Press. Nov 14, 2010. Link <a href="http://www.timesfreepress.com/news/2010/nov/14/prescription-for-concern-pharmaceutical-companies/">here</a>. 8. Leys T. 121 Iowa physicians collect from drug firms. Des Moines (Iowa) Register, November 14, 2010. Link <a href="http://www.desmoinesregister.com/article/20101114/NEWS/11140335/1001/121-Iowa-physicians-collect-from-drug-firms">here</a>. 9. Chang A. Physicians on pharma's payroll: educators or marketers? WNYC, November 18, 2010. Link <a href="http://www.wnyc.org/articles/wnyc-news/2010/nov/18/physicians-pharmas-payroll-educators-or-marketers/">here</a>. 10. Colliver V. Disciplined doctors receiving pharmaceutical funds. San Francisco (California) Chronicle. Nov 18, 2010. Link <a href="http://articles.sfgate.com/2010-11-18/news/24837724_1_drug-companies-drug-samples-pharmaceutical-companies">here</a>.

Of Drug Talks, Deception, and Denial

A month ago, we discussed a series of reports by Pro Publica and multiple other respected news organizations about payments by seven pharma...

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EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

Additional detailed answers to the questions I raised <a href="http://hcrenewal.blogspot.com/2010/11/ehreventorg-web-site-to-collect-ehr_15.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/11/emrevent-survey-amateurism-bias-or.html">here</a> about a new site EHRevent.org, for reporting of healthcare IT-related medical errors, can now be found at a HIStalk interview entitled "HIStalk Interviews Edward Fotsch MD, CEO, PDR Network (EHR Event)" <a href="http://histalk2.com/2010/11/22/histalk-interviews-edward-fotsch-md-ceo-pdr-network-ehr-event">at this link</a>. It is an interesting interview. I certainly find the recognition of need for an EHR/clinical IT problems reporting service a major cultural advancement in healthcare. It's still unclear to me how -- and why -- this organization originated with little to no public knowledge and involvement, especially considering the organization types mentioned below that participated, and how it will function in interactions with myriad healthcare IT stakeholders. Here's an explanation by Dr. Fotsch: <blockquote>... We work with a not-for-profit board called the iHealth Alliance. They Alliance is made up of medical society executives, professional liability carriers, and liaison representatives from the FDA. They govern some of the networks that we run, and in exchange for that, help us recruit physicians. Professional liability carriers, for example, promote our services that send drug alerts to doctors because that’s good and protective from a liability standpoint. In the course of our conversations with them roughly a year ago, when we were talking about adding some drug safety information into electronic health records, we came across the fact that there were concerns from the liability carriers that there was no central place for reporting adverse EHR events or near misses or potential problems or issues with electronic health records. [Translation: the carriers saw their losses potentially increasing as a result of litigation arising from EHR-related lawsuits, and decided to do something proactive- ed.] They were interested in creating a single place where they could promote to their insured physicians that they could report adverse EHR events. Then it turned out that medical societies had similar concerns. [That must have been one of the best-kept secrets on Earth considering the promotion EHR's have received as a miracle-working technology, and the lack of expression of concerns from those societies - ed.] Rather than have each of them create a system, the Alliance took on a role of orchestrating all of the interests, including some interest from the FDA and ONC in creating an electronic health record problem reporting system. That’s how it came into play. Our role in it, in addition to having a seat on the iHealth Alliance board, was really in network operations — in running the servers, if you will, which didn’t seem like a very complicated task. Since business partners we rely on for our core business were interested in it, it was easy to say yes. It frankly turned out to be somewhat more complicated than we originally thought [I predict they haven't seen anything yet; wait until they get knee deep into real world EHR issues - ed.], but now it’s up and available.</blockquote> While I find the recognition of need for an EHR/clinical IT reporting service a major advancement, I am nonetheless troubled by certain statements made by Dr. Fotsch. They seem at odds with the theoretic and empirical findings of medical informatics, social informatics, human-computer interaction and other fields relevant for health IT evaluation, and/or seem to demonstrate biases about HIT. My comments are in red italics: <blockquote>Fotsch: … Probably what we’re seeing more often than not, the real challenge with EHRs like any technology, turns out to be some form of user error. [What about contributory or causative designer error? – ed.] “I didn’t know it would do that" [Why did the user not know? Lack of training, poor manuals, or overly complex information systems lacking informative messages and consistency of control-action relationships, as an example? -ed] ... or “I didn’t know that it pre-populated that" [Why did it pre-populate? Was that inappropriate for the clinical context, such as <a style="font-style: italic; font-weight: bold;" href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_24.html">in this example</a>?] ... or “I didn’t know I shouldn’t cut and paste" [Then why did the software designers enable cut and paste, without some informative message on overuse, such as length of text cut and pasted?– ed.] ... or “I wasn’t paying attention to this" [Perhaps due to distractions from <a style="font-weight: bold;" href="http://www.tinyurl.com/hostileuserexper" rel="nofollow">mission hostile user interfaces</a>? -ed] ... or maybe the user interface was a little confusing [What is "a little confusing?" (Is that like "A little pregnant?) And why was it confusing? User intellectual inadequacy, or software design issues leading to cognitive overload? - ed.] Actual software errors appear to be the exception rather than the rule as it relates to EHR events. ["Actual software errors" are defined as, what, exactly--? Loss of database relational integrity as a result of a programming error, as apparently recently happened at Trinity Health, a large Catholic hospital chain as reported in HIStalk? Memory leaks from poor code? Buffer overflows? What?] That’s at least as I understand it. [Understand it from whom? Hopefully not from me or my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">extensive website</a> on the issues - ed.]</blockquote> In summary, a "blame the user" attitude seems apparent. There appears to be little acknowledgment of the concept of IT "errorgenicity" - the capacity of a badly designed or poorly implemented information system to facilitate error, and of the systemic nature of errors in complex organizations to which ill-done IT can contribute. These are concepts understood long ago in mission critical settings, as in this mid 1980's piece from the Air Force cited in my previously-linked <a href="http://www.tinyurl.com/hostileuserexper">eight part series on mission hostile health IT</a>: <blockquote> From "<a href="http://hcibib.org/sam/">GUIDELINES FOR DESIGNING USER INTERFACE SOFTWARE</a>" ESD-TR-86-278 August 1986 Sidney L. Smith and Jane N. Mosier The MITRE Corporation Prepared for Deputy Commander for Development Plans and Support Systems, Electronic Systems Division, AFSC, United States Air Force, Hanscom Air Force Base, Massachusetts.<a href="http://hcibib.org/sam/"></a> ... SIGNIFICANCE OF THE USER INTERFACEThe design of user interface software is not only expensive and time-consuming, but it is also critical for effective system performance. To be sure, users can sometimes compensate for poor design with extra effort. Probably no single user interface design flaw, in itself, will cause system failure. But there is a limit to how well users can adapt to a poorly designed interface. As one deficiency is added to another, the cumulative negative effects may eventually result in system failure, poor performance, and/or user complaints.Outright system failure can be seen in systems that are underused, where use is optional, or are abandoned entirely. There may be retention of (or reversion to) manual data handling procedures, with little use of automated capabilities. When a system fails in this way, the result is disrupted operation, wasted time, effort and money, and failure to achieve the potential benefits of automated information handling. In a constrained environment, such as that of many military and commercial information systems, users may have little choice but to make do with whatever interface design is provided. There the symptoms of poor user interface design may appear in degraded performance. Frequent and/or serious errors in data handling may result from confusing user interface design [in medicine, this often translates to reduced safety and reduced care quality - ed.] Tedious user procedures may slow data processing, resulting in longer queues at the checkout counter, the teller's window, the visa office, the truck dock, [the hospital floor or doctor's office - ed.] or any other workplace where the potential benefits of computer support are outweighed by an unintended increase in human effort. In situations where degradation in system performance is not so easily measured, symptoms of poor user interface design may appear as user complaints. The system may be described as hard to learn, or clumsy, tiring and slow to use [often heard in medicine, but too often blamed on "physician resistance" - ed.] The users' view of a system is conditioned chiefly by experience with its interface. If the user interface is unsatisfactory, the users' view of the system will be negative regardless of any niceties of internal computer processing. </blockquote><a href="http://hcibib.org/sam/"></a> I am not entirely happy when the CEO of an organization taking on the responsibility of being a central focus for EHR error reporting makes statements that are consistent with unfamiliarity with important HIT-relevant domains, as well as a possible pro-IT, anti-user biases. For that reason as well as the other questions raised at my prior posts (such as the onerous legal contract and apparent lack of ability of the public to easily view the actual report texts themselves), I cannot recommend use of their site for EHR problems reporting. I recommend the continued use of the FDA facilities until such time as a compelling argument exists to do otherwise. -- SSAddendum 11/28/10:This passage ends the main essay at my site "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties</a>" and is quite relevant here: <blockquote style="font-family: arial;"> ... An article worth reviewing is "Human error: models and management", James Reason (a fitting name!), BMJ 2000;320:768-770 (18 March), <a href="http://www.bmj.com/cgi/content/full/320/7237/768">http://www.bmj.com/cgi/content/full/320/7237/768</a>:Summary points: <ul><li>Two approaches to the problem of human fallibility exist: the person and the system approaches </li></ul><ul><li>The person approach focuses on the errors of individuals, blaming them for forgetfulness, inattention, or moral weakness </li></ul><ul><li>The system approach concentrates on the conditions under which individuals work and tries to build defenses to avert errors or mitigate their effects</li></ul><ul><li>High reliability organizations---which have less than their fair share of accidents---recognize that human variability is a force to harness in averting errors, but they work hard to focus that variability and are constantly preoccupied with the possibility of failure.</li></ul><o:p></o:p></blockquote>-- SS

EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

Additional detailed answers to the questions I raised here and here about a new site EHRevent.org , for reporting of healthcare IT-relate...

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Former KV Pharmaceutical CEO and Chairman Banned from Government Business

Early this year we <a href="http://hcrenewal.blogspot.com/2010/03/sacks-medical-kv-pharmaceutical-plead.html">noted</a> that a subsidiary of KV Pharmaceutical, Ethex, pleaded guilty to two felony counts, and paid a fine in response to charges "stemming from its failure to make and submit to the U.S. Food and Drug Administration a report on its discovery of undistributed pills that 'failed to meet product specifications,' ...."   At the time, we noted that this was yet another marcher in the parade of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements </a>affecting health care organizations.  In this case, as in many others, despite the acknowledgement that unethical actions, worse, crimes were committed, no person appeared to suffer any penalty or negative incentive.  As usual, we argued that settlements like this would be perceived by unscrupulous leaders as mere costs of doing business, and would not deter future bad behavior. That was then, and this is now.  Bloomberg just<a href="http://www.bloomberg.com/news/2010-11-17/kv-pharmaceutical-s-hermelin-resigns-after-u-s-ban-will-sell-stake.html"> reported</a>: <blockquote>KV Pharmaceutical Co. said Marc Hermelin resigned as a director and will sell his controlling interest after being banned from doing business with the U.S. government for two decades. KV rose in New York trading. Hermelin left the board on Nov. 10 and will sell his shares, said Catherine Biffignani, vice president of investor relations, in a telephone interview today. Hermelin, 68, had been fired as chairman and chief executive officer of Bridgeton, Missouri-based KV in December 2008. He held about a 52 percent voting stake, either in his own name or through trusts, according to a company filing on May 7. KV didn’t specify the timing of the stock sales. The ban takes effect tomorrow.</blockquote> This was really news. As the article noted: <blockquote>Hermelin will become the first drug-company owner or executive barred from doing business with the government in an antifraud push involving Medicare, the insurance program for seniors and the disabled, and Medicaid, the health program for the poor, according to the Health and Human Services Office of Inspector General’s website.</blockquote> We just <a href="http://hcrenewal.blogspot.com/2010/11/this-is-really-going-to-set-peoples.html">discussed</a> an indictment of a former GlaxoSmithKline executive. Now we have a KV Pharmaceutical executive banned from doing business with the government. So all of a sudden, it looks like the US government has realized that when health care organizations violate the law, their executives do not have complete impunity. Of course, things immediately became more complicated. The St Louis Post-Dispatch just <a href="http://www.stltoday.com/business/article_95b38ed5-a19d-57b3-9e78-9b1afa70be24.html">reported</a>: <blockquote>In yet another major shakeup, KV Pharmaceutical's board chairman, a member of its audit committee and its chief financial officer quit this week. The chairman and audit committee member charged that KV's newly elected board can't provide the independent oversight the company needs. The new board had been elected last Thursday. The CFO, John Stamp, quit on Monday and has not been replaced, the company said in a regulatory filing released Wednesday afternoon. KV also revealed that the new board had terminated interim CEO David A. Van Vliet. The company last week announced that Van Vliet had been replaced but gave no details.</blockquote> What seems to be going on here is resistance to the continued control of the company by the family of the now banned former CEO: <blockquote>In their resignation letters, board chairman Terry Hatfield and audit committee member John Sampson said they had 'serious concerns regarding the ability of the newly constituted board and senior management to provide the required independent oversight of KVs business during this critical time in the company's history.' They noted that only three of the board's seven nominees for board seats were elected at KV's annual meeting last Thursday. The remaining elected members were candidates proposed by shareholders. The family of the firm's founder, Victor Hermelin, retains 52 percent of the Class B shares, which have super voting rights, according to the company proxy issued in May. Among those re-elected to the board was Marc Hermelin, son of the founder, who was ousted as CEO in 2008. Also re-elected was David Hermelin, the son of Marc Hermelin and a former director of corporate strategy who retained his seat on the board. David Hermelin was among the board's nominees. Marc Hermelin was not.</blockquote> As soon as the government appears to get somewhat serious about imposing negative consequences for bad behavior in health care, one can expect that the leaders of organizations who have personally profited from bad behavior in the past will try to come up with work-arounds. Nonetheless, it may be that if health care leaders realize they do not have complete impunity, and they may be held responsible for the bad behavior of the organizations they lead, they may behave better. One can hope. One can also hope that increasing evidence about the bad behavior of leaders of health care organizations will lead to increased unwillingness by health care professionals to go along with, or at least ignore such bad behavior that compromises their own professional values.

Former KV Pharmaceutical CEO and Chairman Banned from Government Business

Early this year we noted that a subsidiary of KV Pharmaceutical, Ethex, pleaded guilty to two felony counts, and paid a fine in response to...

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