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"Unreasonably Dangerous" Heparin

It is time for an update on the case of the deadly contaminated heparin sold by Baxter International, which has received much less attention than seems warranted given its human costs (81 lives).  How the heparin was contaminated, and how the contaminated heparin ended up being sold as a US Food and Drug Administration approved American product are still unknown.  Despite the fact that the outcome of this case were so bad, it received disproportionately little attention when it was first made public, and now seems to have become nearly anechoic. Case Summary  Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.  (For a more detailed summary of the case, look <a href="http://hcrenewal.blogspot.com/2010/05/more-questions-no-answers-about-case-of.html">here</a>, and for all our posts on this topic, look <a href="http://hcrenewal.blogspot.com/search/label/heparin">here</a>.) Civil Cases Plod Forward If there is any ongoing official investigation of this case, it has not been made public.  Civil cases filed by patients allegedly injured by the heparin, or by relatives of patients who died allegedly from the heparin, seem to be proceeding at a glacial pace.  However, there is one development in one set of civil cases worthy of note.  As <a href="http://online.wsj.com/article/SB10001424052748703374304575623013312191090.html">reported</a> two weeks ago by Alicia Mundy in the Wall Street Journal: <blockquote>A state court in Illinois has granted a partial summary judgment to two plaintiffs suing Baxter International Inc. over contaminated blood thinner, saying that some of the company's heparin was 'unreasonably dangerous.' The suit involves tainted imported heparin ingredients from China that caused a public health crisis in 2008, and were linked to more than 80 deaths in the U.S. and many other serious allergic reactions. Some 300 cases nationwide against Baxter and its main ingredient supplier, Wisconsin-based Scientific Protein Laboratories LLC, were consolidated in Chicago in Cook County Circuit Court. Both companies have said that they weren't negligent and weren't responsible for the deadly reactions among patients. The Illinois judge's ruling, dated Wednesday, involved a motion for partial summary judgment that named only Baxter. The motion was filed on behalf of two plaintiffs in the consolidated cases, one of whom died. The ruling cites statements by Baxter's corporate quality vice president and the president of the company's medication delivery division that the heparin was defective. Baxter argued in its defense that a jury should address the question of whether a product is 'unreasonably dangerous.' The company noted that the two Baxter executives who agreed in depositions that the heparin was defective aren't doctors or scientists. However, Judge Jennifer Duncan-Brice wrote that the issue before her wasn't whether heparin actually caused the death or injury to the plaintiffs, but just whether the product was, as a matter of fact, contaminated. </blockquote>The most basic responsibility of a pharmaceutical company is to produce pure, unadulterated product.  As the current director of the US Food and Drug Administration <a href="http://healthpolicyandreform.nejm.org/?p=13270">wrote</a> in this week's New England Journal of Medicine, the agency's "modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law, more than a quarter of a century in the making, that prohibited interstate commerce in adulterated and misbranded food and drugs."  However, in the 21st century, drug companies are increasingly failing to produce unadulterated products, and the FDA is having increasing difficulty assuring patients that the drugs they take meet even the most basic safety standards.  I submit that corporate cultures increasingly influenced by the arrogant, greedy, amoral leadership of the financial services industry that lead us to the brink of another depression are also leading us to the brink of a poisonous era in health care.  Corporate leaders intent on cutting costs, and paying themselves as much of the resulting proceeds as possible, may see quality and safety as just another cost cutting target.  Corporate leaders brought up in the culture of finance, but untrained and inexperienced in engineering, science, and medicine find it all too easy to ignore quality and safety and focus on the bottom line.  (It is ironic that in the quote above, Baxter International's attorneys made light of the judgments of the company's own executives because they are not physicians or scientists.) Meanwhile, society seems to have been so mesmerized by the mantra that laissez faire capitalism will lead to miraculous "innovation" that we do not even attend to instances in which it lead instead to death. As we have said until being blue in the face, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them. To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large).

"Unreasonably Dangerous" Heparin

It is time for an update on the case of the deadly contaminated heparin sold by Baxter International, which has received much less attention...

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BLOGSCAN - This Book is Haunted

We have posted quite a bit about ghost-written articles, that is, ostensibly scholarly articles appearing in medical and health care journals with apparently prominent authors that were really written mainly by medical writers hired by companies to market particular products, usually drugs.  Now we hear of a case of a ghost-written book.  Our fellow bloggers have covered this well.  See posts <a href="http://www.margaretsoltan.com/?p=27749">here</a> and <a href="http://www.margaretsoltan.com/?p=27756">here</a> by Professor Margaret Soltan in University Diaries, and<a href="http://www.insidehighered.com/blogs/university_diaries/to_be_removed_before_submission"> here</a> on Inside Higher Ed; <a href="http://carlatpsychiatry.blogspot.com/2010/11/its-textbook-its-ad-its.html">here </a>by Dr Daniel Carlat on the Carlat Psychiatry Blog; <a href="http://brodyhooked.blogspot.com/2010/11/ghostwriting-from-journal-articles-to.html">here</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog; and <a href="http://alison-bass.blogspot.com/2010/12/government-oversight-agency-calls-on.html">here</a> by Alison Bass on the Alison Bass blog.  Ghost writing is often an important component of stealth marketing schemes, and serves not only to deceptively market products, but to deceptively increase the influence and prestige of the "key opinion leaders" who enable the practice.  Be skeptical about the medical literature, and particularly skeptical by any academic who seems to have written more articles than would be humanly possible. ADDENDUM (2 December, 2010) - As suggested by the comment below, see also posts <a href="http://1boringoldman.com/index.php/2010/11/30/a-quintessential-resource/">here</a> and  <a href="http://1boringoldman.com/index.php/2010/12/01/roaches/">here</a> on the 1BoringOld Man blog.  Also see an additional <a href="http://brodyhooked.blogspot.com/2010/12/more-on-recent-ghostwriting-allegations.html">post</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

BLOGSCAN - This Book is Haunted

We have posted quite a bit about ghost-written articles, that is, ostensibly scholarly articles appearing in medical and health care journal...

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American Medical Schools Are "Only In It for the Money" Say Their Faculty

We recently <a href="http://hcrenewal.blogspot.com/2010/11/who-you-gonna-call-how-should-young.html">discussed</a> the plight of young medical faculty.  It appears that their plight is even worse than we imagined. Last month, an <a href="https://www.aamc.org/download/154216/data/your_career_is_more_than_your_specialty_-_246.pdf">abstract</a> was presented at the <a href="https://www.aamc.org/meetings/2010_annualmtg/programs_by_sponsor/157094/rime_oral_abstracts.html">Annual  Conference on Research in Medical Education</a> at the Annual Meeting of the Association of American Medical Colleges, in a session entitled "Your Career is More than Your Specialty."  The citation would be: <a href="https://www.aamc.org/download/154216/data/your_career_is_more_than_your_specialty_-_246.pdf">Pololi L, Ash A, Krupat E.  Faculty Values in the Culture of Academic Medicine: Findings of a National Faculty Survey</a>. The authors described a large survey, of over 5000 faculty at 26 US nationally representative medical schools, done as part of the <a href="http://www.brandeis.edu/cchange/">National Initiative on Gender, Culture, and Leadership in Medicine</a> (known as C ‐ Change) project.  The overall response rate was good (53%).   Here are the striking results: <blockquote>51% agreed that 'the administration is only interested in me for the revenue I generate'; 31%; that 'the culture of my institution discourages altruism'; 31%, that other people have taken credit for my work'; and 30% that 'I am reluctant to express my opinion for fear of negative consequences.' Half perceived that the institution does not value teaching and 27% that it does not reward clinical excellence; Over half disagreed with the statement that their own values are aligned with those of the institution. Also, 30% had seriously considered leaving academic medicine and 46% their own institution, both in the prior year.</blockquote> These results show that US medical education is in moral crisis, and probably close to catastrophe.  These results should provoke shame and outrage, and cause widespread discussion. On the other hand, it is remarkable that they were allowed to see the light of day at all, given the persistent strength of the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>.  Pololi and colleagues obviously never got the message that one is never ever supposed to discuss such things in public. Instead of being about discovery and dissemination of knowledge, the fundamental mission of education, a majority of large sample of faculty surveyed says American medical schools are about making money.  Instead of putting teaching first, half of the faculty said their institutions explicitly do not value teaching. Instead of supporting free speech, free enquiry, and academic, a significant minority of faculty say that are afraid to speak out. It is no wonder that nearly half of the faculty are considering leaving. On Health Care Renewal, we have discussed evidence, mostly anecdotal, about the rot within the foundations of medicine and health care.  (Note, posts on conflicts of interest, often affecting medical school faculty and leadership, are <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">here</a>; we have posted about how academic medicine has often allowed <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> of research;  posts on excessive compensation of health care executives, including those of academic institutions, not based on upholding the academic mission are <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">here</a>.)  Now it appears that the rot is so severe that the whole edifice is about to fall down. Our foolish transformation of the calling and profession of medicine into a business (see posts <a href="http://hcrenewal.blogspot.com/2007/12/relman-in-jama-on-threats-to-physicians.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/06/why-did-us-physicians-give-up-their.html">here</a>)  at a time when businesses were taken over by the arrogance, greed, unscrupulousness, and amorality that lead to the global financial collapse will surely also lead to a global health care collapse if something is not done very soon. We need a new effort much bigger than but at least as influential as the <a href="http://www.carnegiefoundation.org/sites/default/files/elibrary/Carnegie_Flexner_Report.pdf">Flexner Report</a> to re-imagine academic medicine again as valuing teaching, learning, research and patient care, while regarding its financing only as the means to reach those ends. The <a href="http://www.carnegiefoundation.org/">Carnegie Foundation</a> sponsored the original Flexner Report, and the <a href="http://www.rockefellerfoundation.org/">Rockefeller Foundation</a> then hired Dr Flexner to reform medical education (see Mitka M.  he Flexner Report at the century mark:  a wake-up call for reforming medical education .  JAMA 2010; 303(15):1465-1466. Link <a href="http://jama.ama-assn.org/cgi/content/full/303/15/1465">here</a>.) Will anyone or any organization have the courage to sponsor a new, bigger, and likely much more contentious effort? Meanwhile, the academic leaders who have personally profited from and colluded with the transformation of the system into one that is only in it for the money should resign. The few remaining leaders will need to draw upon all their honesty, integrity, knowledge, and determination to rebuild the system. Finally, shame on all of us for letting us get to this place. With apologies to the late <a href="http://with%20apologies%20to%20the%20late%20frank%20zappa%20and%20the%20mothers%20of%20invention./">Frank Zappa and the Mothers of Invention</a>.

American Medical Schools Are "Only In It for the Money" Say Their Faculty

We recently discussed the plight of young medical faculty. It appears that their plight is even worse than we imagined. Last month, an abs...

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The Economist, Information Privacy, Microsoft, and Technological Determinism: An Online Debate

At <a href="http://www.economist.com/">The Economist</a>, an online "debate" entitled Health 2.0 has been posted (<a href="http://www.economist.com/debate/debates/overview/189">link</a>). It poses a debate between two experts. In this case, the debate is between Peter Neupert, Corporate vice-president, Microsoft Health Solutions Group, vs. Deborah Peel, MD, Founder, Patient Privacy Rights and leader of the Coalition for Patient Privacy. The readers are asked to vote upon whether they agree or disagree with this statement: <blockquote>This house believes that any loss of privacy from digitising health care will be more than compensated for by the welfare gains from increased efficiency.</blockquote>Note the phrase "will be." Readers are also permitted to post comments. My response was as follows: <div style="height: auto;" class="text"><blockquote>30/11/2010 19:16:26 pmDear Sir, The premise of this entire debate is logically fallacious, in fact begging the question. This statement implies proven or inevitable "gains" from health IT. This is far from certain. Health IT such as electronic medical records systems and computerized order entry systems (CPOE) remain highly experimental medical devices. They are unregulated devices as well. Their effects on medical care can be toxic, and patients are exposed to these effects without informed consent. The "gains" attributed to them are increasingly doubted in a growing body of literature. See "Common examples of healthcare IT difficulties" at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" rel="nofollow" title="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/</a> and "2009 a pivotal year in healthcare IT" at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009" rel="nofollow" title="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc...</a> for exposure to some of this literature. In essence, management information systems and other business computing-derived approaches, customs and traditions for software design, development and lifecycle have proven ill suited in healthcare. Clinical computing and business computing are conflated; yet, they are two fundamentally different subspecialties of computing. Further, medicine is a scientific discipline, yet the approach to IT in healthcare has been nearly devoid of science and critical thinking. Sacrificing privacy for a dream that may or may not be true is not good social policy. In the aftermath of the latest Wikileaks disclosures, a scientific approach - such as assertions about the beneficence of IT in healthcare not being made without strong, robust scientific evidence and without consideration of the downside evidence not being proferred so freely - would be a fine start. S. Silverstein, MD Drexel University College of Information Science and Technology Philadelphia, PA USA.</blockquote> </div> I found the position of Peter Neupert (Corporate vice-president, Microsoft Health Solutions Group) defending the motion particularly concerning: <blockquote>Consumers must trust that the organisations they are engaged with are accountable and will respect—and protect—the privacy of their data. </blockquote>"Must trust?" I find this remarkable in the context of repeated violations of "trust" I've noted at this blog such as at my posts: <ul><li>"<a href="http://hcrenewal.blogspot.com/2010/02/networked-emrs-and-healthcare.html">Networked EMR's and Healthcare Information Security: Practical When Massive IT Security Breaches Continue</a>?",</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/02/networked-interoperable-secure-national.html">Networked, Interoperable, Secure National Medical Records a Castle in the Sky?</a>",</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/01/it-flaws-and-coverups-of-same-why-i.html">Operation Aurora And a Widespread Reluctance to Discuss IT Flaws: Is Universal Healthcare IT Really a Good Idea in 2010?</a>",</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/10/medical-data-breach-of-week-but-your.html">Medical data breach of the week - but your EMR data is secure, trust us, we're IT experts</a>", </li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/11/insurers-test-data-profiles-to-identify.html">Insurers Test Data Profiles to Identify Risky Clients</a>",</li></ul><ul><li>and <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">others</a>.</li></ul> Neupert's view is especially paternalistic and naive in the context of Wikileaks repeatedly and recently leaking hundreds of thousands of supposedly secure documents, stolen from U.S. intelligence by at least one known person and probably others. If the Pentagon and U.S. intelligence cannot keep information secure, how can lowly hospital IT departments? The moderator's initial comments are also disturbing: <blockquote> ... Supporters argue that health information technologies have advanced to the point that such [security] concerns are vastly overblown. After all, do not financial data flow freely and with little incident over digital systems? On this argument, any loss of privacy will be more than offset by efficiency gains. In arguing for the motion, Peter Neupert of Microsoft, a software firm, insists that digital medicine must be centred on the patient—rather than, say, the doctor or the insurer, as is often the case today [this 'centered on the patient' meme sounds good, but what exactly does it mean? - ed.] —and that medical information must be as mobile as the patient. If that is the case, he argues, it is not merely the efficiency of health systems that will improve but also the value of health care—and perhaps health outcomes too. MR VIJAY V. VAITHEESWARAN Correspondent, The Economist </blockquote> Note the statements of absolute certainty - "will be more than offset by efficiency gains", "will improve", etc. They remind me of the statements made in the NEJM by the Director of ONC, Dr. David Blumenthal, as I wrote at "<a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">Science or Politics? The New England Journal and The 'Meaningful Use' Regulation for Electronic Health Records</a>": <blockquote>The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.</blockquote> On that I had commented: <blockquote>Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced. I note the lack of footnotes showing the source(s) of these statements.</blockquote> The meme of technological determinism, that computerization in medicine is synonymous with, and will deterministically provide "improvements", no matter what the evidence, is quite concerning coming from a company as profoundly large and influential as Microsoft. Further, the complete omission of consideration of the adverse clinical consequences (let alone mere information breaches) that may occur along the way to cybernetic utopia in healthcare is very disturbing. These are experimental medical devices, are unregulated, and are used without patient informed consent. Yet the IT industry seems to opine as if these systems are only to be used on experimental lab rats. These systems produce "legible gibberish" of no clinical use to clinicians, but take clinician time to generate through distracting "clickorrhea." For example, just the placement of an IV and fluid infusion generates a half page of nonsense: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhtByU1K1iP0RfJ3rbrjuRw0u3T8ZCBTTqAfXkBy90OI3zTdxJoluEtGYTitYSFoZ5LncrGI-TYMjttrvxyE4fXyqWIkIl2wioDf80CBKScT4w8zRTmykrrQfb6ccVkjsmcSRBkMIkKQR_6/s1600/ed1a.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5548339448503998978" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhtByU1K1iP0RfJ3rbrjuRw0u3T8ZCBTTqAfXkBy90OI3zTdxJoluEtGYTitYSFoZ5LncrGI-TYMjttrvxyE4fXyqWIkIl2wioDf80CBKScT4w8zRTmykrrQfb6ccVkjsmcSRBkMIkKQR_6/s320/ed1a.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 254px;" /></a>Actual "legible gibberish" from an ED EHR report, major health IT vendor. Half a page on how an IV was started and a saline infusion given. (How many distracting clinician mouse clicks did it take to produce this?) Click to enlarge. </div> Addendum 12/8/10 - From "<a href="http://www.medscape.com/viewarticle/589724">Hidden Malpractice Dangers in EMRs</a>", Steven I. Kern, Esq., Medscape.com:<h4></h4><blockquote><h4>Too Much Information</h4>... Pages of repetitive documentation can be more time-consuming to review than brief, handwritten notes. When important information is embedded in paragraphs of boilerplate, it can easily be overlooked. The chance of missing critical data increases.Overlooking important information is, of course, a significant cause of malpractice. A positive finding embedded in a string of negative findings can easily be missed. </blockquote> Ironically, my relative was injured as a result of EHR-related disruption not long ago. Further, just the initial two and a half weeks of hospitalization generated more than 2,800 laser printed pages of "legible gibberish" (which cost just under $1000 to obtain; Kinko's should only have it so good). A fellow physician I know well related: <blockquote style="margin-right: 0px;" dir="ltr"> <div dir="ltr">From: [redacted name of MD] </div> <div dir="ltr"> Good Lord! I am so sorry to see this and hope your Mom gets better. You must be furious. </div> <div dir="ltr"> May I add to the cacophony? My wife went to [another local hospital's] ER for emergency transfusion. Their Emr displayed someone else's info under her name & SSN. Had I not been there she would have received incorrect treatment. My wife went to [yet another hospital] for hip replacement. After surgery, while she slept off her anesthesia, a nurse came in and started injecting her. I asked and learned it was insulin. I stopped the nurse (with difficulty). My wife's not diabetic. Her screen showed someone else's orders. Had I not been there she might have died.</div> <div dir="ltr"> So keep up the good work... please! </div> <div dir="ltr"> </div> <div dir="ltr">[redacted name of MD]</div></blockquote> How many other patients have been injured or killed as a result of EHR's? In fact, we really don't know how many adverse events related to EHR's occur. As the Joint Commission itself admits in its Sentinel Events Alert #42, <a href="http://www.jointcommission.org/sentinel_event_alert_issue_42_safely_implementing_health_information_and_converging_technologies/">Safely implementing health information and converging technologies</a>: "There is a dearth of data on the incidence of adverse events directly caused by HIT overall." I further wrote on this issue in a paper "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">here</a>. Is this a proper environment for national rollout of these clearly experimental medical devices, one should ask? The memes of technological determinism and health IT "white-as-driven-snow" beneficence seem as difficult as vampires to eradicate. Yet if this technology is to achieve the benefits of which it is capable via remediation of current IT industry customs, traditions and practices, these memes must be challenged and defeated. Regarding health IT in the real world, reality matters. -- SS

The Economist, Information Privacy, Microsoft, and Technological Determinism: An Online Debate

At The Economist , an online "debate" entitled Health 2.0 has been posted ( link ). It poses a debate between two experts. In th...

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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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