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Two Opposing Views of EHR: InformaticMD vs. NextGen's Holder of "American Medical Informatics Certification for Health Information Technology"

The AMA's publication American Medical News recently quoted me following comments from IOM EHR Safety committee member Richard Cook in the Nov. 21, 2011 article "<a href="http://www.ama-assn.org/amednews/m/2011/11/21/psa1121.htm">IOM calls for monitoring and probe of health IT hazards</a>" by Kevin O'Reilly: <blockquote>... Not everyone on the panel agreed with delaying FDA regulation. [Per the IOM report on health IT safety released Nov. 10, 2011, see <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">here</a> - ed.] Committee member Richard I. Cook, MD, filed a dissent in the report in which he recommended that health IT systems be regulated as class III medical devices. "It is quite remarkable that we're in this situation," said Dr. Cook, associate professor of anesthesia and critical care at the University of Chicago Pritzker School of Medicine. [Also, an expert in Medical Informatics - ed.] "It's not surprising that such adverse events are being found related to health IT, and it's not surprising that those promoting these systems have neither looked for them nor anticipated them. To make large-scale investments in these systems and only now be looking at the impact on patient safety borders on recklessness."Scot M. Silverstein, MD, agreed. "The bone I have to pick with the IOM report is that the action agenda is weak," said Dr. Silverstein, a consultant in medical informatics at the Drexel University College of Information Science and Technology in Pennsylvania. It is unethical to expand health IT so dramatically without understanding the precise nature of the risks it poses to patients, Dr. Silverstein said.</blockquote> Ironically, right below my statement was the following from HIT industry figure Charles Jarvis, blaming the user: <blockquote>Users faulted Leaders in the health IT industry also had their share of objections to some of the IOM panel's conclusions. "We don't think there's a great deal of data to substantiate that there are major safety problems with the majority of electronic health records systems in use today," said Charlie Jarvis, executive committee vice chair of the EHR Assn., a trade group that represents 46 organizations that supply most of the EMR systems implemented in medical practices. "These products are safe, dependable, time-tested and display a lot of the safety features we think are necessary to prevent problems going forward." Jarvis, also a vice president at the health IT firm <a href="http://www.nextgen.com/">NextGen</a>, said vendors and the government should work to help physicians and other health professional users understand systems, take advantage of their safety features and avoid errors. [Charitable translation: computers are infallible, so medical errors due to HIT are the user's fault, <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">the Sept. 2011 National Institute of Standards and Technology (NIST) report on usability</a> be damned. Clinicians should spend their valuable time learning to compensate for and then actually wading through <a href="http://www.tinyurl.com/hostileuserexper">mission hostile user experiences</a>. If only those stupid doctors and nurses would use our cybernetic miracle tools the way we want, the members of the EHR Association could be making even more money. Oh, and by the way, the NIST's concept of "use error" [1] is nonsense. - ed.]</blockquote> I presume the "EHR Assn." is the <a href="http://www.himssehra.org/ASP/index.asp">HIMSS EHR Association</a>, with <a href="http://www.himss.org/ASP/index.asp">HIMSS</a> itself being a gargantuan "cause-based, not-for-profit organization exclusively focused on providing global leadership for the optimal use of information technology and management systems for the betterment of healthcare":<blockquote> The HIMSS Electronic Health Record (EHR) Association is a trade association of Electronic Health Record (EHR) companies, addressing national efforts to create interoperable EHRs in hospital and ambulatory care settings. The EHR Association operates on the premise that the rapid, widespread adoption of EHRs will help improve the quality of patient care as well as the productivity and sustainability of the healthcare system. </blockquote> I observe that there are no conflicts of interest here that could cause Mr. Jarvis' stated opinions to be skewed towards the rights of computers and away from the rights of patients ... right? First, Mr. Jarvis makes a logical error related to the error illustrated in my earlier post today "<a href="http://hcrenewal.blogspot.com/2011/11/magical-thinking-on-health-it-from.html">Magical Thinking on Health IT from ModernMedicine.com</a>." His error is that of "proof by lack of evidence" [2]. No need to actually study the issue rigorously, despite repeated risk management-relevant incident reports (as opposed to the industry's preferred and highly erroneous term "anecdotes"). Just one recent, highly alarming example of an "anecdote" affecting probably tens of thousands of patients due to programming malpractice and grossly negligent quality assurance, at both vendor and end user hospitals, is illustrated <a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">here</a>. Since it's an "anecdote", perhaps Mr. Jarvis would agree there's nothing to see there, so we should all move along. (See the Aug. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things</a>" which puts the misuse of the "anecdotes" label in its proper place - the garbage can.) Not only is "proof by lack of evidence" in the face of hair-raising incident and defects reports (e.g., as in <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">FDA's MAUDE database</a>) a prima facie logical fallacy unfitting in medicine, and in fact alien to medical ethics, but the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">IOM report</a> specifically stated in no uncertain terms that nobody really knows the magnitude of the risks. This is due in part to numerous inhibitory factors in evidence diffusion. From the IOM report: <blockquote>... Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.</blockquote> Imagine such a situation in, say, the pharmaceutical, automotive, aviation, or nuclear power industries. The responsible individuals would likely be hauled off to jail. However, this all may be irrelevant. After all, who can argue with the expert personal opinion of someone who holds "<a href="http://web.archive.org/web/20100103141103/http://nextgen.com/about-nextgen/leadership-structure.html#15">the American Medical Informatics Certification for Health Information Technology</a>?" That astonishing credential could conceivably elevate Mr. Jarvis' opinion over all others - even mine, with my meager background in the domain. I don't know if he still claims that credential, but he did as I described in my post about prior interactions with Mr. Jarvis and NextGen (dating back to 2004) in my Feb. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/02/nextgen-and-vendordoctor-dialog-yet.html">NextGen and Vendor/Doctor Dialog: Yet Another Patronizing EHR Company of Certified HIT Experts?</a>" I guess the fact I'd never heard of such a qualification represents my dearth of familiarity with the field of Medical Informatics and healthcare information technology. -- SS Notes: [1] “Use error” is a term used very specifically by NIST to refer to user interface designs that will engender users to make errors of commission or omission. It is true that users do make errors, but many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging, misuse of color-coding conventions, omission of information, etc. From "NISTIR 7804: Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records." It is available at <a href="http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf" rel="nofollow">http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf</a> (PDF). [2] Example of proof by lack of evidence, courtesy <a href="http://www.packetslut.co.uk/weblog/archives/00000053.htm">Scott Adams</a>: "I've never seen you drunk, so you must be one of those Amish people. " More on these issues is at the site "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties</a>."

Two Opposing Views of EHR: InformaticMD vs. NextGen's Holder of "American Medical Informatics Certification for Health Information Technology"

The AMA's publication American Medical News recently quoted me following comments from IOM EHR Safety committee member Richard Cook in ...

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Magical Thinking on Health IT from ModernMedicine.com

Annette M. Boyle, MBA has an article in the journal ModernMedicine.com that exhibits a severe form of fallacious thinking, approaching magical thinking. It's this type of thinking that gets patients injured and killed: <a href="http://www.modernmedicine.com/modernmedicine/article/articleDetail.jsp?id=749903&cid=PRAC"></a><blockquote><a style="font-weight: bold;" href="http://www.modernmedicine.com/modernmedicine/article/articleDetail.jsp?id=749903&cid=PRAC">Health information technology: Better in long term despite short-term safety risks</a> Publish date: Nov 23, 2011 By: <a href="http://www.modernmedicine.com/modernmedicine/author/authorInfo.jsp?id=55090">Annette M. Boyle, MBA</a> Responding <a href="http://books.nap.edu/openbook.php?record_id=13269&page=2" target="_blank">to a new report that says health information technology (HIT) is creating some short-term safety issues</a>, technology experts say physicians should remember one immutable fact: The new systems are far less dangerous than the old paper-based systems still in use in many practices. </blockquote>Consider that first paragraph in light of the second: <blockquote>Although the magnitude of the problem remains unknown, “serious errors involving these technologies—including medication dosing errors, failure to detect fatal illnesses, and treatment delays due to poor human-computer interactions or loss of data—have led to several reported patient deaths and injuries,” the <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=13269" target="_blank">Institute of Medicine (IOM) said in a news release</a>.</blockquote> So, "technology experts" proffer that a technology where the "magnitude of the problem remains unknown" are "far less dangerous than the old paper-based systems still in use in many practices." Because they say so, right? Wrong. This is why "technology experts" need to be kept on a very short leash. They cannot think logically, even regarding such a simple issue such as this. They claim as an "immutable fact" (that "physicians should remember") a comparison that has very little data underlying it? This is risible, shameful, patronizing in the extreme, insulting, and an example of the dangers of the invasion of medicine by computer technicians and salespeople. The only "immutable fact" is, if you don't know the magnitude of risk, because it's - ah - unknown, you cannot (or should not) make statements about that very magnitude of risk. (This is K-12 level logic, and more towards the "K" than the 12.) Actually, the evidence for significant risks beyond paper - far beyond paper - come from incidents like I've described on this blog. A very recent example is my Nov. 4, 2011 post "<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands - that, of course, caused no patient harm that they know of - yet</a>." Doctors are not in the habit of leaving off suffixes for slow release or long acting drugs (e.g., XR, SR), but a few lines of code can - and did - affect thousands at just one healthcare system. This was a potentially lethal error. Health IT can greatly amplify risk in a manner that paper simply cannot. People who proffer gross illogic in medicine need to do society a big favor and simply remove themselves from any roles that affect medical care, patients, and medical ethics. If they know better, and are simply spinning their statements to promote sales, the need for such individuals to be distanced from healthcare is even more acute. If they don't clean up their act, either way, they may find themselves on the defendant's witness stand, where such illogic will be ripped to shreds by plaintiff's attorneys. -- SS

Magical Thinking on Health IT from ModernMedicine.com

Annette M. Boyle, MBA has an article in the journal ModernMedicine.com that exhibits a severe form of fallacious thinking, approaching magic...

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John Wiley and Sons Director Apologizes for Pepper Spray - An Example of the Proximity of the One Percent to the Leaders of Academic Medicine

The title of this post has not been hacked.  All will be revealed soon. Review: the University of California - Davis Pepper Spray Incident We just <a href="http://hcrenewal.blogspot.com/2011/11/uc-davis-pepper-spray-case-as.html">discussed</a> the now infamous pepper spraying of peaceful student protesters at the University of California.  We noted our previous concerns about the leadership of the university Chancellor who presided over this incident because she had previously seemed disconnected from the prime mission of the university (but instead pushed its role as a developer and marketer of biotechnology) (see <a href="http://hcrenewal.blogspot.com/2009/08/university-leaders-goal-taking-new.html">this post</a>), and defended the nearly one million dollar compensation for the medical center CEO at a time when the university's finances became increasingly fragile (see <a href="http://hcrenewal.blogspot.com/2011/09/more-repeats-of-talking-points.html">this post</a>). Since then, the Chancellor, Linda P B Katehi, vaguely apologized for the incident at a student rally where many speakers called for her resignation (see, for example, <a href="http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2011/11/21/MNK71M2548.DTL">this story</a> in the San Francisco Chronicle). A University Chancellor in Proximity to the One Percent as Director of John Wiley and Sons There is a certain irony to all this.  While the overriding theme of the "occupy" movement has been to advocate for the "99 percent" of Americans who feel increasingly powerless, the original protest at UC-Davis was not so much against the plutocratic one percent, as against "tuition increases and state cuts in higher education," (per the Chronicle)   Yet the person who is now at the focus of the Occupy UC-Davis group's wrath is closer to the one percent than most protesters realized. A quick search on Google revealed that Chancellor Katehi started a new part time job in 2011.  She is now a member of the <a href="http://www.wiley.com/WileyCDA/Section/id-301709.html">board of directors of John Wiley and Sons, Inc</a>, a $2.8 billion market market capitalization "global  publisher of print and electronic products."  Note that this position on not listed on <a href="http://chancellor.ucdavis.edu/about/index.html">her official bio</a> on the UC - Davis web-site as of 23 November, 2011, nor on <a href="http://chancellor.ucdavis.edu/local_resources/pdfs/katehi_vita.10.29.2010.pdf">her official curriculum vita</a> (from 2010) available on that web-site.  As a board member, she can expect over $100,000 yearly as compensation, based on fees paid in 2010 reported in the <a href="http://www.wiley.com/about/corpnews/2011_proxy.pdf">2011 company proxy statement</a>.  Since last year, the board approved compensation for the five highest paid executives ranging from over $1.8 million to over $5.3 million.  So a position on the board certainly put Ms Katehi in the proximity of the one percent. Furthermore, as we have <a href="http://hcrenewal.blogspot.com/2011/06/managers-coup-how-hired-hands-got.html">noted</a> previously, compliant, if not crony board members have been blamed for the huge increase in the compensation of top corporate executives who now make up the majority of the "one percent."  Since most board members seem to be current or retired high-ranking executives, their enthusiasm for raising their fellow hired executives' compensation should not be surprising.  Note that Ms Katehi is effectively the "CEO" of UC- Davis. A Conflict of Interest In some cases, board members' disinclination to challenge the executives they are supposed to be supervising may arise from conflicts of interest.  Note regarding the current example that John Wiley and Sons is a leading publisher of text books and professional journals in medicine, the life sciences, and many other subjects relevant to the curriculum of many of the schools and departments at UC-Davis, and particularly to the medical school and academic medical center.  More importantly, as we noted here, John Wiley and Sons' Wiley-Blackwell subsidiary includes a medical education and communications unit.  On its website, this entity <a href="http://www.wiley.com/WileyCDA/Section/id-310320.html">promises</a>: <blockquote>Our Global Corporate Sales Team of more than 100 people is dedicated to serving the publishing and communication needs of your industry. Through our extensive range of clinical and professional publications, we can develop a customized communications plan to support your promotional strategy, maximizing the impact of your brand. Whether you are looking for global or localized campaigns, for strategic or tactical support, our publishing teams are knowledgeable at all levels and are easy to reach in your time zone by phone, email or in person. We provide an expert service, competitive pricing, dedicated project management and the flexibility to provide peer-reviewed support for your brand from pre-launch to maturity, achieving strong credibility.</blockquote>Among the services provided are "continuing professional development," including "conferences and training schemes," and establishing "advisory boards to provide direction on issues surrounding new products or developing brands. We draw on our close relationships with industry leaders...." Thus, like other <a href="http://hcrenewal.blogspot.com/search/label/medical%20education%20and%20communication%20companies">medical education and communication companies</a> (MECCs), this subsidiary can use a variety of tactics to infiltrate marketing messages into what appears to be medical education.  By accepting a position on the board of directors of an academic and medical publisher that also runs a MECC, Ms Katehi has taken on fiduciary responsibility for the company, and thus seems to have a potentially intense conflict of interest, particularly affecting her leadership of a medical school and academic medical center (see our first discussion of what then appeared to be a "new species" of conflict of interest due to academic medical leaders' membership on a board of a health care corporation <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">here</a>.)  Summary I can only speculate that proximity to the one per cent, and the conflict of interest induced by fiduciary responsibility for the stewardship of an academic and medical publisher and a medical education and communication company might have left Ms Katehi feeling distant from protesters who claimed "we are the 99 per cent," and hence more inclined to support clearing them from the campus by whatever means. In any case, it turns out that Occupy UC -Davis took on a more appropriate opponent than they realized.  This case illustrates how the complex web of relationships among the top leaders of society, including leaders of health acre organizations, is more sticky and pervasive than was heretofore apparent.  In any case, it underlines our repeated call....  To reform health care, we must reverse the managers' coup d'etat, and restore leadership of health care organizations that puts the mission, and the health of patients and the population first, and is accountable to corporate owners (when applicable) and to patients and the public.  But that will mean now going up against those who have made themselves the richest and most powerful people in the country and the world, who will not lightly give up their oligarchy.

John Wiley and Sons Director Apologizes for Pepper Spray - An Example of the Proximity of the One Percent to the Leaders of Academic Medicine

The title of this post has not been hacked. All will be revealed soon. Review: the University of California - Davis Pepper Spray Incident W...

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The UC-Davis Pepper-Spray Case as Illustrative of Problems with the Leadership of Health Care

The aggressive actions by University of California-Davis police against unarmed, peaceful student protesters turn out to be the latest illustration of the problems with leadership and governance we discuss on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>.  The University of California - Davis Pepper Spray Incident To summarize the current episode, I start with quotes about its background <a href="http://www.reuters.com/article/2011/11/19/us-protests-davis-pepperspray-idUSTRE7AI0ZA20111119">from Reuters</a>, <blockquote>Student protesters at Davis had set up an encampment in the university's quad area earlier this month as part of the nationwide Occupy movement against economic inequality and excesses of the financial system. Their demonstrations, which had been endorsed by a faculty association, included protests against tuition increases and what they viewed as police brutality on University of California campuses in response to recent protests. The students had set up roughly 25 tents in a quad area, but they had been asked not to stay overnight and were told they would not be able to stay during the weekend, due to a lack of university resources, [university Chancellor Linda] Katehi said. Some protesters took their tents down voluntarily while others stayed.</blockquote> Then, <blockquote>The pepper spray incident appeared to take place on Friday afternoon, when campus police moved in to forcibly evict the protesters.</blockquote> Then, as <a href="http://www.independent.co.uk/news/world/americas/outcry-over-chilling-campus-pepper-spray-use-6265203.html">per the (London, UK) Independent</a>, <blockquote>A police officer saunters up to a group of young protestors who are sat in a line on the ground, with their arms linked. Then he removes a canister of pepper spray from his belt, with a flourish, before casually proceeding to unload its contents into their faces. The demonstrators remain silent and motionless, with their heads bowed. So the policeman carries on, methodically covering them, from point blank range. By the time he’s finished, their heads and faces are covered in a thick layer of the toxic red liquid.</blockquote> The actual video is below: <iframe allowfullscreen="" frameborder="0" height="315" src="http://www.youtube.com/embed/WmJmmnMkuEM" width="560"></iframe> The UC-Davis Chancellor's Defense of the Police Actions The Independent's coverage emphasized that initially the leadership of the campus police defended the use of pepper spray on apparently unarmed, peaceful students: <blockquote>Annette Spicuzza, the head of the UC Davis Campus Police, who were responsible for Friday’s incident .... told reporters that her officers had been 'forced' to use the pepper spray, after demonstrators surrounded them. Lt Pike gave his victims sufficient warning of the impending attack, she added, and emptied the canister with a sweeping motion, in keeping with official procedures. 'When you are encircled by 200 individuals, I don’t know if I want to say ‘afraid,’ but I think they were quite concerned about their safety,' she said, regarding the circumstances her officers faced. 'There was no way out of that circle... It's a very volatile situation.'</blockquote> That coverage also made clear that the directive to clear the demonstrators came from the top: <blockquote>Linda Katehi, the Chancellor of UC Davis ... had asked the police to clear demonstrators from her campus, a couple of hours north of San Francisco. In the aftermath of the incident, she had initially joined Spicuzza in defending the force's methods, saying that they had 'no option' but to adopt a hard line.</blockquote> Ms Katehi later backed off, but only after her first response <blockquote>sparked immediate outrage, and within hours, the university’s Faculty Association, representing Ms Katehi’s employees, issued a statement called for her resignation, saying that her authorisation of 'excessive' force had amounted to a 'gross failure of leadership.' Nathan Brown, an assistant English professor who witnessed the incident, wrote in an open letter: 'Several of these students were hospitalized. Others are seriously injured. One of them, forty-five minutes after being pepper-sprayed down his throat, was still coughing up blood... You are responsible.'</blockquote> Other comments likened the police actions to something "coming from some riot-control unit in China, or in Syria," [<a href="http://www.theatlantic.com/national/archive/2011/11/pepper-spray-brutality-at-uc-davis/248764/">James Fallows in the Atlantic</a>] called them indicative of "a police state in its pure form," [<a href="http://www.salon.com/2011/11/20/the_roots_of_the_uc_davis_pepper_spraying/">Glenn Greenwald in Salon</a>], or otherwise denounced them as "outrageous" or "awful." (Clark McPhail, professor emeritus of sociology at the University of Illinois, and Greg Lukianoff, President of the Foundation for Individual Rights in Education, respectively, <a href="http://www.insidehighered.com/news/2011/11/21/experts-and-activists-question-use-pepper-spray-davis">via Inside Higher Ed</a>.) This aggressive, violent response to peaceful protest seems to be the latest example of the arrogance of some current leaders of our important organizations. Our Previous Discussion of the Chancellor in Health Care Renewal This case appears directly related to the problems in leadership and governance we discuss on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal </a>Ms Katehi has the distinction of having been already written up twice on Health Care Renewal for questions about her leadership. On her arrival at UC-Davis in 2009, she promised to "help UC Davis to become more aggressive in taking new biotechnology and agriculture products to market." This indicates at best ignorance of, at worst hostility to the fundamental university mission, which is hardly developing and particularly marketing products, but discovering and disseminating knowledge (see <a href="http://hcrenewal.blogspot.com/2009/08/university-leaders-goal-taking-new.html">this post</a>). At that time, I called this an example of "how the leaders of academic institutions seem to be forgetting or radically deconstructing their academic missions." In 2011, Ms Katehi defended the payment to the medical center CEO, whom she called a "great CEO,' of nearly a million dollars yearly in compensation. However, that CEO was part of a group of top university leaders demanding large increases in their pensions at a time when the university was under great financial distress. For that, some called them not great leaders, but greedy and "despicable." Thus, Ms Katehi seemed to stand up for top leaders' privilege and exceptionalism, including their entitlement to huge compensation whatever the circumstance, even in a time of financial travail (see <a href="http://hcrenewal.blogspot.com/2011/09/more-repeats-of-talking-points.html">this post</a>). I could not have predicted that Chancellor Katehi would preside over the pepper spraying unarmed students for peaceful, legitimate protest. However, it is not surprising that a leader who does not understand the fundamental academic mission and who supports executive privilege and exceptionalism would foster an authoritarian climate in which such an incident could happen. This example clearly illustrates the issues we have been discussing on Health Care Renewal for a long time. In particular, leaders who are more dedicated to their own and their fellow executives' privilege and exceptionalism than their organizations' missions are likely to end up promoting actions that threaten those  missions. The Moral of the Story Instead, as we have been preaching endlessly,... health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses. You heard it here first on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal </a>. Keep your eye on Health Care Renewal for continued discussion of parallels between problems in health care and in the larger political economy.

The UC-Davis Pepper-Spray Case as Illustrative of Problems with the Leadership of Health Care

The aggressive actions by University of California-Davis police against unarmed, peaceful student protesters turn out to be the latest illus...

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If gov't officials can't deal with bendy bananas, curvy cucumbers and water for hydration, how can they possibly consider issues with computers?

I present this story with almost no commentary except this post's title, the simple observation that keeping government out of many aspects of out lives is not a bad idea, and a few minor points: <blockquote>The Telegraph <a style="font-weight: bold;" href="http://www.telegraph.co.uk/news/worldnews/europe/eu/8897662/EU-bans-claim-that-water-can-prevent-dehydration.html">EU bans claim that water can prevent dehydration </a> Brussels bureaucrats were ridiculed yesterday after banning drink manufacturers from claiming that water can prevent dehydration. By Victoria Ward and Nick Collins <div>6:20AM GMT 18 Nov 2011 </div> <div class="firstPar"> EU officials concluded that, following a three-year investigation, there was no evidence to prove the previously undisputed fact. </div><div class="secondPar"> Producers of bottled water are now forbidden by law from making the claim and will face a two-year jail sentence if they defy the edict, which comes into force in the UK next month. </div><div class="thirdPar"> Last night, critics claimed the EU was at odds with both science and common sense. Conservative MEP Roger Helmer said: “This is stupidity writ large. </div><div class="fourthPar"> “The euro is burning, the EU is falling apart and yet here they are: highly-paid, highly-pensioned officials worrying about the obvious qualities of water and trying to deny us the right to say what is patently true. </div><div class="fifthPar"> “If ever there were an episode which demonstrates the folly of the great European project then this is it.” <div class="body"> NHS health guidelines state clearly that drinking water helps avoid dehydration, and that Britons should drink at least 1.2 litres per day. The Department for Health disputed the wisdom of the new law. A spokesman said: “Of course water hydrates. While we support the EU in preventing false claims about products, we need to exercise common sense as far as possible." German professors Dr Andreas Hahn and Dr Moritz Hagenmeyer, who advise food manufacturers on how to advertise their products, asked the European Commission if the claim could be made on labels. They compiled what they assumed was an uncontroversial statement in order to test new laws which allow products to claim they can reduce the risk of disease, subject to EU approval. They applied for the right to state that “regular consumption of significant amounts of water can reduce the risk of development of dehydration” as well as preventing a decrease in performance. However, last February, the European Food Standards Authority (EFSA) refused to approve the statement. A meeting of 21 scientists in Parma, Italy, concluded that reduced water content in the body was a symptom of dehydration and not something that drinking water could subsequently control. Now the EFSA verdict has been turned into an EU directive which was issued on Wednesday. Ukip MEP Paul Nuttall said the ruling made the “bendy banana law” look “positively sane”. He said: “I had to read this four or five times before I believed it. It is a perfect example of what Brussels does best. Spend three years, with 20 separate pieces of correspondence before summoning 21 professors to Parma where they decide with great solemnity that drinking water cannot be sold as a way to combat dehydration. “Then they make this judgment law and make it clear that if anybody dares sell water claiming that it is effective against dehydration they could get into serious legal bother. EU regulations, which aim to uphold food standards across member states, are frequently criticised. Rules banning bent bananas and curved cucumbers [what?? - ed.] were scrapped in 2008 after causing international ridicule. Prof Hahn, from the Institute for Food Science and Human Nutrition at Hanover Leibniz University, said the European Commission had made another mistake with its latest ruling. “What is our reaction to the outcome? Let us put it this way: We are neither surprised nor delighted. “The European Commission is wrong; it should have authorised the claim. That should be more than clear to anyone who has consumed water in the past, and who has not? We fear there is something wrong in the state of Europe.” Prof Brian Ratcliffe, spokesman for the Nutrition Society, said dehydration was usually caused by a clinical condition [like hot weather and low fluid intake? - ed.] and that one could remain adequately hydrated without drinking water. [As the study was done in Italy, perhaps they had something else in mind? - ed.] <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjyLZUalU-u6gFdQV7_ahHIuCl5rKWj8ISlHwobBq2rxIG5xST8aJTc3QH-j4-PWZgv0nPRDYLKvmex6boEjJR1FvSSNCexoD0-1iH0Dp966zlA_c25nbKYEBo7svDnBcVjGANMzNZQ_I-1/s1600/wine-bottles.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5676861099366478818" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjyLZUalU-u6gFdQV7_ahHIuCl5rKWj8ISlHwobBq2rxIG5xST8aJTc3QH-j4-PWZgv0nPRDYLKvmex6boEjJR1FvSSNCexoD0-1iH0Dp966zlA_c25nbKYEBo7svDnBcVjGANMzNZQ_I-1/s320/wine-bottles.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 189px; height: 189px;" /></a> Water? Where we're going, we don't need water. He said: “The EU is saying that this does not reduce the risk of dehydration and that is correct. “This claim is trying to imply that there is something special about bottled water which is not a reasonable claim.” </div></div><div class="storyHead"> </div> </blockquote>Hard as this is to believe, the ruling is no April Fool's joke. -- SS

If gov't officials can't deal with bendy bananas, curvy cucumbers and water for hydration, how can they possibly consider issues with computers?

I present this story with almost no commentary except this post's title, the simple observation that keeping government out of many aspe...

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Websites dedicated by patients to a physician in Illinois under fire essentially because he's "too slow" with an EMR

Stunning. Two websites dedicated by patients to a physician in Illinois under fire essentially because he's "too slow" with an EMR: <a href="http://kottemann.wordpress.com/" title="In Support of Dr. Steven Kottemann" rel="home"></a><blockquote>In Support of Dr. Steven Kottemann Testimonials submitted by the patients of Dr. Steven Kottemann, Lincoln, Illinois<hgroup></hgroup> <a href="http://kottemann.wordpress.com/">http://kottemann.wordpress.com/</a> </blockquote> And a corresponding Facebook page: <blockquote> Support Dr. Kottemann <a href="http://www.facebook.com/pages/Support-Dr-Kotteman/170060299745403">http://www.facebook.com/pages/Support-Dr-Kotteman/170060299745403</a></blockquote> The posts at these sites are well worth reading. For background, see "<a href="http://www.prairiestatereport.us/2011/10/26/beloved-springfield-doctor-benched-for-not-being-proficient-with-electronic-medical-records-system/">Beloved Springfield Doctor Benched For Not Being Proficient with Electronic Medical Records System</a>", The Prairie State Report, Oct. 26, 2011: <blockquote>... This situation brings into focus the problem of top-down medical solutions, calling into question the efficacy of healthcare by committee, not to mention Obmacare itself. Do we really want to sacrifice good doctors in favor of good followers of top-down rules? Do we want good users of computers or excellent doctors? The doctor, Steven Kottemann, 63, was placed on paid administrative leave in September because they felt he was not properly utilizing the new electronic medical records system that his employer, Family Medical Center, instituted.</blockquote> Which is more important, one needs to ask? A computer, or an excellent clinician? -- SS

Websites dedicated by patients to a physician in Illinois under fire essentially because he's "too slow" with an EMR

Stunning. Two websites dedicated by patients to a physician in Illinois under fire essentially because he's "too slow" with a...

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To Sir Andrew? With a Settlement - GlaxoSmithKline to Settle for $3 Billion, CEO Said to Pursue Knighthood

Two weeks ago, reports of the largest legal settlement involving a pharmaceutical company to date in the US appeared.  The $3 Billion Settlement In summary, <a href="http://articles.philly.com/2011-11-04/business/30359814_1_glaxo-diabetes-drug-medicaid-pricing">per the Philadelphia Inquirer</a>, <blockquote>In perhaps the largest penalty ever paid by a pharmaceutical company, GlaxoSmithKline said Thursday it had reached a tentative deal with the U.S. Justice Department to pay $3 billion to settle criminal and civil allegations of illegal marketing practices and pricing under a Medicaid program.</blockquote> Why the deal was announced this month is not clear. Neither are all its provisions: <blockquote>Glaxo said the deal would be made final in 2012, but it was unclear why it was announced now. A spokeswoman declined to say whether Glaxo would have to live by a corporate integrity agreement, which the government sometimes requires in such cases.</blockquote> The Inquirer listed some possible reasons for the settlement, <blockquote>As for Glaxo's latest situation, one investigation, started by the U.S. Attorney's Office in Colorado and later run on a national level by the U.S. Attorney's Office in Boston, looked at Glaxo's marketing practices related to nine of its best-selling drugs, including Paxil, Wellbutrin, and later Advair. In a second investigation, the Justice Department looked at Glaxo's possibly inappropriate use of rules exceptions when reporting prices charged for drugs for different situations in the marketplace. Under part of the Medicaid Rebate Program, drugmakers are supposed to report the lowest price they charge most organizations, which is then used to calculate the price that Medicaid ultimately pays for its drugs. The third investigation, also by the Justice Department, was over how Glaxo promoted the diabetes drug Avandia, which was pulled from European markets and severely restricted last fall by the Food and Drug Administration after it was shown to cause heart attacks.</blockquote> As commonly occurs in such cases, GSK and its CEO averred that all the sorts of conduct that lead to this settlement are old news: <blockquote>The company said in a statement that since 2008 it had 'established a new framework for compliance in the U.S., based on the company's values, policies and established industry codes of practices. It is supported by a larger compliance staff and strengthened training programs that require certification by employees.' The changes included new incentive formulas for sales representatives, eliminating sales targets for bonuses. 'This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today,' Glaxo chief executive officer Andrew Witty said in the statement. 'In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently.'</blockquote> As is also usual, none of the reports included any acceptance of responsibility for the bad conduct by GSK or any of its leaders, and certainly they did not mention any negative consequences for any persons who might have authorized, directed, or implemented the misbehavior, even giving, as is apparently true in this case, that some of the behavior was at least alleged to be criminal. A Settlement for a Knight? It was not clear why this settlement was announced this early in such a preliminary, and vague manner. However, a <a href="http://www.pharmalot.com/2011/11/your-majesty-may-i-present-sir-andrew/">post</a> on the PharmaLot blog suggested one motivation: <blockquote>As the calendar year draws to a close, the UK government is busy readying the next list of individuals who are to be honored as members of the Order of the British Empire. These honors are bestowed on people from all walks of life who have somehow made a difference in their community. And there are various types of awards, including knighthood, that recognize a different type of contribution. The list, however, is a closely guarded secret. Presumably, even Rupert Murdoch employees would have a hard time hacking into the treasured line up of nominees. But one name that may be under consideration is Andrew Witty, the ceo at GlaxoSmithKline. Our sources say that Glaxo minions have been encouraged to find ways to hone his image in hopes that he becomes Sir Andrew.</blockquote> So one could speculate that being able to clear up these "difficult, long-standing matters," could be touted as a task that only could be accomplished by a knight. That might have been plausible if Mr Witty recently rode into town on a white horse, and then dispatched these old legal demons. Some More History In fact, that is not what happened. Per his <a href="http://www.gsk.com/about/bio-witty-cet.htm">official GSK biography</a>, <blockquote>Andrew Witty became Chief Executive Officer of GlaxoSmithKline plc on 21 May 2008. He is a member of the Board and Corporate Executive Team. Andrew joined Glaxo in 1985 and held a variety of Sales and Marketing roles in the UK business. He has worked in the Company’s International New Products groups, both in the Respiratory and HIV/Infectious disease fields and has been involved in multiple new product development programmes. He has also worked in South Africa, The USA and Singapore where he led the Group’s operations as Senior Vice President, Asia Pacific. While in Singapore Andrew was a Board Member of the Singapore Economic Development Board, the Singapore Land Authority and in 2003 he was awarded the Public Service Medal by the Government of Singapore. In 2003 Andrew was appointed President of GSK Europe, and joined GSK’s Corporate Executive Team. </blockquote> So he has been with GSK a long time. However, the misbehavior that the current settlement is apparently designed to resolve has been going on for a long time. As we previously <a href="http://hcrenewal.blogspot.com/2010/10/glaxosmithkline-subsidiary-pleads.html">posted</a>, Paxil (Seroxat in the UK, or paroxetine), was the anti-depressant whose marketing lead GlaxoSmithKline (GSK) to settle allegations of fraud brought by then New York Attorney General Elliott Spitzer in 2004. That case included allegations of suppression and manipulation of clinical research, and was discussed in great detail in the book <a href="http://www.alison-bass.com/books.html">Side Effects</a> by Alison Bass. We posted about various aspects of this case, e.g., more recently <a href="http://hcrenewal.blogspot.com/2007/01/not-something-we-want-to-publicise-spin.html">here</a>, <a href="http://hcrenewal.blogspot.com/2008/03/british-government-concludes-gsk.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2008/09/brown-university-student-journalists.html">here</a>.  The case continues to echo to this day: see <a href="http://alison-bass.com/blog/2011/11/international-group-seeks-brown-universitys-help-in-getting-controversial-paxil-study-retracted">this post</a> by Alison Bass about attempts to have a questionable journal article that was used to market Paxil retracted.  Then there was Avandia (rosiglitazone), the anti-diabetic drug whose use was just restricted by the US Food and Drug Administration. This GlaxoSmithKline product inspired a <a href="http://hcrenewal.blogspot.com/2010/07/avandia-spin-cycle-continues-even-after.html">"spin cycle"</a> which provided us with endless grist for the Health Care Renewal mill. A good summary of the case appeared in September, 2010, in the British Medical Journal (Cohen D. Rosiglitazone: what went wrong: Brit Med J 2010; 341: 530-534. Link <a href="http://www.bmj.com/content/341/bmj.c4848.fu%20%20ll">here</a>) Once again, it appears that research was suppressed and manipulated (e.g., see <a href="http://hcrenewal.blogspot.com/2010/02/bring-back-dsi-avandia-case-as-spy.html">here</a>), Avandia critics were attacked by "experts" whose financial relationships with GSK were not always obvious (e.g., see <a href="http://hcrenewal.blogspot.com/2007/06/avandia-spin-cycle-continues.html">here</a>), and there were allegations that GSK executives tried to intimidate those who disagreed with them (e.g., see <a href="http://hcrenewal.blogspot.com/2010/02/bring-back-dsi-avandia-case-as-spy.html">here</a> and <a href="http://hcrenewal.blogspot.com/2007/11/more-about-who-called-dogs-out-on.html">here</a>).  All this about Avandia came out after Mr Witty became President of GSK Europe and joined the Corporate Executive Team.  While there is no reason to think he was directly responsible for any of it, as a member of this team, he ought to be accountable for the corporation's major actions, and misbehavior.  By the way, we <a href="http://hcrenewal.blogspot.com/2010/10/glaxosmithkline-subsidiary-pleads.html">posted</a> last year about another settlement by GSK, in which a GSK subsidiary pleaded guilty to criminal charges for selling adulterated drugs, including a version of Paxil. In the Washington Post <a href="http://www.washingtonpost.com/business/economy/3billion-settlement-expected-in-glaxosmithkline-drug-marketing-probe/2011/11/03/gIQAYf7sjM_story.html">report</a> of the $3 billion settlement, there is this quote from Dr Sidney Wolfe, <blockquote>'The size of the penalties, although large, are not as large as the money [the drug companies] make and so they keep doing it over again,' said Sidney M. Wolfe, director of Public Citizen’s health research group. 'The only way this is going to stop, or get reversed, is to greatly increase the size of the penalties or to start sending some of the executives to jail, if appropriate.'</blockquote>Summary I have no idea whether there is evidence supporting criminal charges for any executives in this case. However, GSK and its leadership have not covered themselves in glory recently as shown by now three major legal settlements. I am just an American and not very knowledgeable about how the UK decides to dub people knights. However, in my humble opinion, it would be grotesque to honor the current CEO of GlaxoSmithKline with a knighthood based how his company has been lead since he became a member of its Executive Team in 2003. I thus will end on my usual, repetitive note for such cases.... penalties that only appear to be (relatively small) costs of doing business are unlikely to deter future bad behavior. Until the people who actually authorized, directed and implemented the bad behavior have to suffer some negative consequences, expect the bad behavior to continue. When it comes to health care's leadership, society seems to have acceded to defining deviancy down. Until we start holding health care leaders to high standards, expect their organizations not to uphold high standards. Further, expect organizations that did not uphold high standards in one instance to fail to uphold them in other instances. ADDENDUM (18 November, 2011) -  See additional posts on attempts to have Study 329, a particularly questionable study of Paxil, withdrawn on <a href="http://loathingbioethics.blogspot.com/2011/11/fraud-what-fraud-brown-remains-silent.html">the Fear and Loathing in Bioethics blog</a>, <a href="http://brodyhooked.blogspot.com/2011/11/will-brown-university-investigate.html">the Hooked: Ethics, Medicine and Pharma blog</a>, and on <a href="http://www.margaretsoltan.com/?p=33573">the University Diaries blog</a>. ADDENDUM (21 November, 2011) - See also these posts on the call for the withdrawal of Study 329 on the <a href="http://alison-bass.com/blog/2011/11/international-group-seeks-brown-universitys-help-in-getting-controversial-paxil-study-retracted">Alison Bass blog</a>, and the <a href="http://1boringoldman.com/index.php/2011/11/20/a-walk-on-the-wrong-side-side-of-the-street">1BoringOldMan blog</a>.

To Sir Andrew? With a Settlement - GlaxoSmithKline to Settle for $3 Billion, CEO Said to Pursue Knighthood

Two weeks ago, reports of the largest legal settlement involving a pharmaceutical company to date in the US appeared. The $3 Billion Settle...

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