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BLOGSCAN - Attention to Medtronic's Payments to Spine Surgeons in the Main Stream Media

On the HealthBeat blog, Maggie Mahar <a href="http://www.healthbeatblog.com/2011/01/on-the-road-to-reform-the-mainstream-media-is-telling-the-story-of-waste-part-1.html">takes up</a> the case of huge royalty and consulting payments to spine surgeons by medical device company <a href="http://hcrenewal.blogspot.com/search/label/Medtronic">Medtronic</a>.  We had discussed the case recently <a href="http://hcrenewal.blogspot.com/2010/12/spine-surgeons-reticent-about.html">here</a>, followed by Howard Brody on the Hooked: Ethics, Medicine and Pharma blog (see link in <a href="http://hcrenewal.blogspot.com/2011/01/blogscan-on-device-companys-obfuscation.html">this post</a>).  Ms Mahar was notably optimistic because of the continued attention to this case by the main stream media.  She argued that the increased emphasis on aspects of health care dysfunction shown by the media means "health care reform is moving ahead on the ground."  I hope she is right, but I would feel more hopeful if ill-informed, mission-hostile, self-interested, conflicted, and corrupt health care leadership was less anechoic, if health care dysfunction actually got some attention in the medical/ health care/ health services research/ health care policy literature , and if I could identify at least one prominent politician or policy-maker who talks about these issues.

BLOGSCAN - Attention to Medtronic's Payments to Spine Surgeons in the Main Stream Media

On the HealthBeat blog, Maggie Mahar takes up the case of huge royalty and consulting payments to spine surgeons by medical device company ...

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KOL Phollywood

I have wondered many times about the proliferating offers I've received in increasing numbers in recent years for medical symposia, talks, conferences, etc. that appear either subtly or overtly geared to promote some treatment or product for a disease area. Roy Poses' post "<a href="http://hcrenewal.blogspot.com/2011/01/key-opinion-leader-services-companies.html">Key Opinion Leader Services Companies: the Creation of Useful Idiots and Usefully Idiotic Organization</a>" would appear to help explain this phenomenon. Worse: At my Aug. 2009 post "Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?" <a href="http://hcrenewal.blogspot.com/2009/08/has-ghostwriting-infected-experts-with.html">here</a> I wrote: <blockquote>... Will we ever be able to peel back all the layers of the ghostwriting onion to get to the core of impartial and objective scientific articles related to drugs and medical devices? Perhaps not, but the practice must stop going forward. Tainted literature creates tainted scientific knowledge, the carriers of which may then further taint the knowledge base (with the best of intentions and with firm belief in the fairness and accuracy of their activities, of course). Practitioners of evidence-based medicine may be unwittingly practicing "evidence-tainted medicine", or "pseudo-evidence based medicine" as described by others on this blog.</blockquote> We now learn that an entire industry exists to identify, catalog, index social networks, and do other data mining to quantify "KOL suitability factors", and then interact with pharma and surely other healthcare sectors to launch and "nurture" people so identified, as Hollywood might do to identify actors for a movie. It thus seems the situation with regard to medical science might be even worse than I thought. I ask: <ul><li>Can we ever fully trust information given at medical presentations, especially by "popular", even well-published physicians any more?</li></ul><ul><li>Can we truly trust any medical literature, period?</li></ul> Even worse - do pharmas and other healthcare sectors use these services not just to identify what might be called "positive" KOLS to be seduced and romanced and deployed to spread the company's charms, but also to identify "negative" KOLs (with messages not to the liking of the industry) to be marginalized? Finally, I coin a new term for this circle jerk of pharma KOL 'services companies' (a.k.a. KOL peddlers), KOL handlers and KOL promoters: "Phollywood." -- SS Jan 12, 2011 addendum: See the post "<a href="http://1boringoldman.com/index.php/2011/01/11/a-massive-cynical-effort/">A Massive Cynical Effort</a>" at the blog of <a href="http://1boringoldman.com/">1BoringOldMan</a> for interesting observations about these issues.

KOL Phollywood

I have wondered many times about the proliferating offers I've received in increasing numbers in recent years for medical symposia, talk...

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Key Opinion Leader Services Companies: the Creation of Useful Idiots and Usefully Idiotic Organizations

In researching the conflicts of interest of the University of California "36," I <a href="http://hcrenewal.blogspot.com/2011/01/why-would-directors-of-health-care.html">stumbled upon</a> a fascinating corner of the pharmaceutical/ biotechnology/ medical device marketing universe, the companies that find and manage<a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders"> key opinion leaders</a> (KOLs), also known as "thought leaders."  Reviewing their own marketing materials reveals how KOLs truly are health care corporate marketing's useful idiots. I found three companies which seem entirely devoted to the adoption, care and feeding of KOLs, plus numerous companies, including some medical education and communication companies (MECCs) that provide KOL-related products and services.  I will first describe the companies briefly, then draw upon their marketing materials to underline what KOLs are really about. Leadership in Medicine Inc This is the company I <a href="http://hcrenewal.blogspot.com/2011/01/why-would-directors-of-health-care.html">found first</a>, because one of its directors is a member of the UC 36, the group of top university leaders who threatened to sue the university to increase their already generous pensions. Leadership in Medicine Inc's <a href="http://www.leadershipinmedicine.com/">web-site </a>describes its reason for being thus: <blockquote>IF YOU NEED TO KNOW who are the most prominent, admired, and influential actors in healthcare, how they are interconnected, and why, you need our expertise. Given how vastly complex are the relationships among providers, researchers, and other significant actors in healthcare, it is vital to focus on key opinion leaders (KOLs) at local, regional, and global levels, and to understand the ties among them. </blockquote> Its <a href="http://www.leadershipinmedicine.com/company.htm">clients</a> are: <blockquote>Over 80 client companies * All of the top 15 largest pharmaceuticals * 8 of the 10 largest biotechs * 5 of the 10 largest medical device companies</blockquote> A graphic on its <a href="http://www.leadershipinmedicine.com/experience.htm">"experience" page </a>listed the following companies: Baxter, Wyeth, Lilly, Roche, Gilead, GlaxoSmithKline, Pfizer, Abbott Laboratories, Genzyme, Bristol-Myers-Squibb, Medtronic, Johnson and Johnson, Genentech, and Covidien. KOL LLC <a href="http://www.kolonline.com/">Company description</a>: <blockquote>As our name implies, we are a company devoted to providing Key Opinion Leader software and Key Opinion Leader Management services for pharmaceutical, biotechnology and device companies. </blockquote> The company's <a href="http://www.kolonline.com/about-clients.asp">graphic client list </a>included: Cephalon, Scios, Novartis, Schering-Plough King Pharmaceuticals, Pfizer, Genentech, Reliant Pharmaceuticals, McNeil (division of Johnson and Johnson, Jazz Pharmaceuticals, Endo Pharmaceuticals, Cytogen, Health Products Research, Shire, Reckitt Benckiser, Protein Design Labs, and Odyssey Pharmaceuticals. Thought Leader Select The relevant parts of the <a href="http://www.thoughtleaderselect.com/about/">company description</a>: <blockquote>Thought Leader Select is a Chapel Hill, NC-based private research and consulting firm serving the biopharmaceutical and healthcare industries.</blockquote>and <blockquote>We serve these industries and the medical community at large by assessing medical experts (known as 'thought leaders' and 'key opinion leaders')....</blockquote> Perusal of the materials used by these companies, and other companies which market KOL or thought leader related services makes the nature of the relationship between KOLs and commercial health care firms, and the purpose of employing KOLs clear. KOLs are Employed by Marketing Departments to do Marketing The best example comes from a description of a KOL information technology application sold <a href="http://www.nagarro.com/Documents/Nagarro_Casestudy_KOL.pdf">by Nagarro</a>: <blockquote>A web-based application was developed by Nagarro to help the marketing department of a global pharmaceutical company exploit Key Opinion Leader (KOL) information in order to promote products and remain ahead of its competition. Problem Description In today s fast-paced competitive environment, pharmaceutical companies cannot solely rely on superior products to succeed. Well organized marketing departments help sales departments reach goals and give companies an edge over competition, but without access to valuable resources, like KOLs, they are ineffective. KOLs influence the medical community and ultimately the end users of pharmaceutical products.</blockquote><blockquote>Pharmaceutical companies that are able to identify and work with KOLs will be better positioned to compete.... Benefits [include] Creation of market intelligence from highly specialized and customizable reports containing previously unavailable aggregate data.... Ability to group KOLs by product knowledge and associations in order to better promote products Ability to maximize ROI from KOL related events Enhanced sales and marketing productivity through streamlining of complex multi-source information</blockquote> That makes it crystal clear that marketers use KOLs to market, to sell products. While at times KOLs might actually be used to advise health care corporations about clinical or scientific issues, that is hardly their major point. KOLs are almost always hired to market by marketing departments. In case someone might argue that this is only one example, let us look at materials from the other companies. KOL LLC <a href="http://www.kolonline.com/services-development.asp">described</a> the usefulness of KOLs thus: <blockquote>Everyone recognizes the value of opinion leaders (OL), or thought leaders. While national level OLs may not write many prescriptions they influence thousands of prescribers and hence prescriptions through their research, lectures, publications and their participation on advisory boards, committees, editorial boards, professional societies and guidelines/consensus document development. Regional level OLs are often involved in state societies or legislative initiatives in addition to their speaking and publications. While local level OLs may not publish, they provide advice to local colleagues and may speak at grand rounds. And who are the ‘rising stars’ in your therapeutic area? It is imperative that you know the OLs in your market at a national, regional and local influence level as well as those ‘rising stars’.</blockquote> This is a bit more indirect, but it is clear that the goal is to "influence prescribers" to prescribe, not provide scientific or clinical advice to the company. Leadership in Medicine Inc's materials also continually emphasized the point of KOLs is to influence, for example, they boasted of pioneering analyses "to assess paths of influence in healthcare," developed a particular tool called "Centrality Ranking" to "provide fine-grained ratings of KOLs' influence," and claimed to "have identified, profiled, and mapped the influence of tens of thousands of individual KOLs...." The clear implication is that KOLs' influence is the central consideration, and what else is this influence good for other than to sell products, and perhaps advocate for corporations in general? When KOLs are Involved, Many Activities that Appear to be Educational or Scientific Really Are For Marketing Strikingly, KOL LLC claimed its role in <a href="http://www.kolonline.com/services-guidlines.asp">guideline development</a>: <blockquote>Guidelines produced by national societies are optimal, but often can be a slow, painful and expensive process to develop. KOL, L.L.C. can provide a faster alternative. We have experience convening a panel of experts in a therapeutic area. We serve a project management role to ensure the timelines and deliverables are met. We have access to a medical writing team of 25 healthcare professionals who can write the initial drafts, as our experience tells us it is easier for experts to edit, than to write from scratch.</blockquote> There has been growing realization that <a href="http://hcrenewal.blogspot.com/search/label/guidelines">guidelines</a> may be biased by commercial sponsorship and by the participation by individuals with conflicts of interest. The KOL LLC marketing materials suggest, however, that guidelines have become purpose-built marketing vehicles through the participation of selected KOLs with allegiances to drug, device and biotechnology companies. As an aside, note that guideline-development services includes the participation of a team of <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">ghost-writers</a> who will write the first drafts, a function that naive academics might have thought should be that of clinical and scientific experts. For another example, KOL LLC asserted it could manage <a href="http://www.kolonline.com/services-investigator.asp">"investigator meetings," </a>: <blockquote>We’ll help you better plan to maximize the communication of the trial results through targeted abstracts, posters, publications and lectures.</blockquote>so <blockquote>Due to the time constraints placed on Clinical Research Departments, many times ‘research mills’ are selected as the trial sites. This is fine, but who is going to publish the results and stand up and present the results at national, regional and local meetings. We can provide you advice and counsel about how to involve your KOLs effectively, while maintaining your aggressive timelines.</blockquote> The goal of KOL management here is for the company to control how the research is disseminated. Note also the cynical view of "research mills," which likely refers to <a href="http://hcrenewal.blogspot.com/search/label/contract%20research%20organizations">contract research organizations</a>. Do we really think that CROs are used by commercial firms because they do better research? Key Leading Organizations A bonus from reading through the offerings on KOL management was to discover another related business that has not been subject of polite conversation before. Leadership in Medicine Inc put it this way: <blockquote>Equally essential is recognizing the roles played by key leading organizations (KLOs) such as medical institutions, payers, professional organizations, patient groups, government entities, and journals in structuring KOL activities and relationships, since those are the stages on which KOLs perform. </blockquote> Key Leading Organizations (KLOs) apparently include influential organizations, e.g., academic medical institutions, medical societies, and patient advocacy groups that can be deliberately turned into organizations of useful idiots for marketing purposes. Note that we and others have discussed how <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional conflicts of interest</a> and <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> affecting leaders of of such organizations can lead to bias in favor of commercial interests. But what Leadership in Medicine Inc has written suggests that such organizations can be deliberately taken over to function as industry's fellow travelers. Similarly, Thought Leader Select advertised services to manage organizations to support "thought leadership": <blockquote>Through Centers, all of our research and assessment skills culminate in our evaluation of universities, influential clinics, and research foundations for a holistic approach to thought leadership in the medical community. With centers of excellence assessments we take a drill-down approach, starting at the academic medical centers, then moving into affiliated hospitals and clinics....</blockquote> Summary Industry spokespeople and key opinion leaders tout themselves as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There are documented instances (e.g., see posts <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post <a href="http://hcrenewal.blogspot.com/2010/11/of-drug-talks-deception-and-denial.html">here</a>).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a> about marketing of Lexapro, and <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a> about Neurontin). However, the marketing materials used by KOL service companies (for lack of a better name) show that KOLs are largely meant to be stealth marketers, and hired for that purpose, that KOLs participate as marketers in the sorts of activities that to the naive appear to be educational or scientific, and that marketers try to recruit whole organizations, such as medical schools, research organizations, medical societies, and patient advocacy groups as disguised sales organizations. This goes beyond the problem of bias of physicians, or individual health professionals due to their financial relationships.  It goes beyond the problem of bias of organizations due to their sources of financial support or the financial relationships of their leaders.  It looks like there has been a massive campaign by health care corporate marketers to make useful idiots out of possibly a majority of medical academics and academic, professional, and supposedly patient-centered organizations.  This appears to be a massive, cynical effort to hollow out our once respected health care institutions and professionals in the service of marketing. A final word to any individuals reading this who are paid by corporate marketers to be KOLs.  If you think that you are paid for educational or scientific purposes, you likely have been made into a chump.  The people who did this to you were likely not acting in your best interests, or those of society, but to cynically market their product and increase their own earnings.  If you doubt this, look at the materials cited above.  You really don't want to continue being chumps, do you?

Key Opinion Leader Services Companies: the Creation of Useful Idiots and Usefully Idiotic Organizations

In researching the conflicts of interest of the University of California "36," I stumbled upon a fascinating corner of the pharma...

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Why Would Directors of Health Care Corporations Push for Bigger Pensions for Academic Administrators?

We recently <a href="http://hcrenewal.blogspot.com/2011/01/some-call-it-tyranny-top-leaders-of.html">posted</a> about 36 well-paid top executives in the University of California system, including leaders of medical schools, academic medical centers, and public health, who threatened a lawsuit if their pensions were not increased according to what they claim was a promise made to them in 1999. Riddle me this: why would a group of directors of for-profit corporations that provide health care goods and services. plus a director of a leading biotechnology trade group, and the director of a leading mutual fund family band together to support this demand, thus to push for bigger pensions for these top managers of the University of California system? Here is a list of the directors, and their corporations: -  Mark R Laret, director of <a href="http://investors.varian.com/file.php/2678/Proxy+Statement+2010.pdf">Varian Medical Systems</a> and <a href="http://services.corporate-ir.net/SEC/Document.Service?id=P3VybD1odHRwOi8vaXIuaW50Lndlc3RsYXdidXNpbmVzcy5jb20vZG9jdW1lbnQvdjEvMDAwMDk1MDEyMy0xMC0xMTE4NjkvZG9jL051YW5jZUNvbW11bmljYXRpb25zSW5jLnBkZiZ0eXBlPTImZm49TnVhbmNlQ29tbXVuaWNhdGlvbnNJbmMucGRm">Nuance Communications Inc</a>, which provides numerous <a href="http://www.nuance.com/for-healthcare/index.htm">health care products </a> - Dr David Feinberg, director of <a href="http://investors.osi-systems.com/directors.cfm">OSI Systems</a>, whose <a href="http://osi-systems.com/bus_spacelabs.asp">Spacelabs Healthcare</a> subsidiary manufactures medical devices - Steven C Currall, <a href="http://www.gsm.ucdavis.edu/currall/">director of Leadership in Medicine Inc</a>, which <a href="http://www.leadershipinmedicine.com/">claims</a> to be a leading provider of intelligence about <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders</a> (KOLs) in medicine and health care.  Its web-site asserts, "IF YOU NEED TO KNOW who are the most prominent, admired, and influential actors in healthcare, how they are interconnected, and why, you need our expertise.  Given how vastly complex are the relationships among providers, researchers, and other significant actors in healthcare, it is vital to focus on key opinion leaders (KOLs) at local, regional, and global levels, and to understand the ties among them."  (Note that we have often <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">discussed</a> how KOLs function as stealth marketers for pharmaceuticals and devices.) They joined: -  Robert S Sullivan, PhD - <a href="http://www.biocom.org/about_biocom/biocom_board_of_directors/">director of BIOCOM</a>, whose web-site <a href="http://www.biocom.org/about_biocom/">asserts</a> it is the" largest regional life science association in the world, representing more than 550 member companies in Southern California." -  Richard K Lyons, <a href="http://www2.haas.berkeley.edu/Faculty/lyons_rich.aspx">director of iShares</a>, a leading <a href="http://us.ishares.com/home.htm">provider of mutual funds</a>. The answer is simple.  All the corporate directors listed above are also members of the group of 36 litigious executives.  See their name on the list of 36 <a href="http://articles.sfgate.com/2010-12-29/news/26349177_1_uc-employees-uc-system-higher-pensions">here</a> in the San Francisco Chronicle. - Mark R Laret, director of Varian Medical Systems and Nuance Communications Inc, which provides numerous health care products, is also CEO of UCSF Medical Center. - Dr David Feinberg, director of OSI Systems, whose Spacelabs Healthcare subsidiary manufactures medical devices, is also CEO of the UCLA Hospital System - Steven C Currall, director of Leadership in Medicine Inc, which claims to be a leading provider of intelligence about key opinion leaders (KOLs) in medicine and health care, is also Dean, and Professor of Management of the University of California - Davis Graduate School of Management. Robert S Sullivan, PhD - director of BIOCOM, whose web-site asserts it is the" largest regional life science association in the world, representing more than 550 member companies in Southern California, is also Dean of the University of California - San Diego Rady School of Management. - Richard K Lyons, director of iShares, a leading provider of mutual funds, is also Bank of America Dean and Professor of Business, University of California - Berkeley Haas School of Business. Their inclusion within the larger group seems ironic, at best.  As corporate directors, they have outside income and have accumulated assets that will likely keep them out of poverty in their old age.  For example, Mr Laret had accumulated the equivalent of 37,168 shares of Varian, and was paid $267,300 a year for his services according to the company's <a href="http://investors.varian.com/file.php/2678/Proxy+Statement+2010.pdf">2010 proxy statement</a>. Furthermore, for those who directly lead health care institutions, Mr Laret and Dr Feinberg, their memberships on the boards of health care corporations, which imply fiduciary responsibilities to the companies and their stock-holders, conflict with their duties as leaders of academic health care to uphold teaching, research and patient care.  Dean Currall's responsibilities to an organization which seems entirely dedicated to helping drug, device, and biotechnology companies turn health care professionals and academics into stealth marketers at least seems unseemly given that his school is part of a university which also includes a medical school and academic medical center.  Since our earlier post, it appears that the University of California president will not accede to the demands of the 36, as <a href="http://www.sfgate.com/cgi-bin/article.cgi?f=%2Fc%2Fa%2F2011%2F01%2F04%2FBAF71H3L67.DTL">noted</a> in the San Francisco Chronicle.  Their demands have continued to provoke outrage.  A recent <a href="http://www.insidehighered.com/news/2011/01/05/california_pension_fight_politically_tough_for_yudof">discussion</a> in Inside Higher Ed interviewed Emeritus Professor Helen Henry, a member of the University's Academic Senate, who posited: <blockquote>the debate as part of a fundamental philosophical disagreement within the university. The signatories to the letter, many of whom are based in medicine or management, have a different view of the university than faculty from other disciplines, she said. 'I don’t think there’s any question but that there are these two different mindsets that are fighting for what the university should be. It’s transparent in this letter,' said Henry, a professor emeritus of biochemistry at the Riverside campus. 'They are running businesses. But there are those of us that don’t feel this is what the university should be.' 'This is absolutely a manifestation of that clash between the people who see UC as their business … and the people who see UC’s mission as teaching, and research and service to the state. That’s a dual personality that the university always has to live with.'</blockquote> Five of the university leaders demanding higher pensions for themselves have responsibilities as directors of corporations that may conflict with their academic institutions' missions, while these corporate positions ought to insulate them from financial concerns about their retirement. This corroborates Prof Henry's notion that they see themselves as businesspeople whose role is separate from, and not necessarily supportive of the university mission. I disagree, however, with Prof Henry's implication that the University has to live with such a split among its leadership. People who lead academic institutions have a primary responsibility to support the academic mission. Their goals should not be to maximize profits, much less to enrich themselves. Letting academia, and academic medicine be lead by leaders out to make money and line their own pockets will lead to just that, but hardly better teaching, research, and patient care.

Why Would Directors of Health Care Corporations Push for Bigger Pensions for Academic Administrators?

We recently posted about 36 well-paid top executives in the University of California system, including leaders of medical schools, academic...

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Blast from the Anechoic Past: Former UCI Fertility Doctor Arrested in Mexico

Soon after we started Health Care Renewal, we ran a <a href="http://hcrenewal.blogspot.com/search/label/UCI">series of posts</a> about the University of California-Irvine (UCI) medical school and medical center, featuring stories of mismanagement of major programs, especially those involving organ transplantation (liver, kidney, and bone marrow) while the top executives who presided over the mess received generous compensation, sometimes in strikingly irregular ways, and while at least one whistle-blower alleged he lost his job for complaining about safety issues.  Some of the stories went back another 10 years, to 1995.  One particularly striking story involved the UCI infertility program.  Three physicians were accused of stealing ova from some women to implant in others.  One physician was convicted, and two fled the country (see post <a href="http://hcrenewal.blogspot.com/2006/02/more-trouble-but-also-little-hope-in.html">here</a>). One of those physicians just turned up.  As <a href="http://abcnews.go.com/Health/ReproductiveHealth/fugitive-fertility-doctor-ricardo-asch-arrested-mexico/story?id=12492575">reported</a> by ABC News at the end of 2010: <blockquote>U.S. authorities are working to extradite one of the doctors accused of being behind of the biggest fertility scandals in history. Mexican authorities arrested Dr. Ricardo Asch last month. Back in the 1990s, Asch and another fertility doctor, Jose Balmaceda, were charged with stealing embryos and eggs belonging to dozens of women who sought treatment at the University of California-Irvine Center for Reproductive Health and implanting them into other women. They are also accused of not reporting more than $1 million in earnings, and fleeing the country to avoid prosecution. Marla McCutcheon is one of the women who says she was victimized by Asch. She was one of his patients until she decided to switch physicians because she said she found him 'uncaring.' McCutcheon, from Irvine, Calif., says she found out years later that after she'd left Asch's care that there were leftover eggs she didn't know about. To this day, she doesn't know what happened to those eggs. 'I would have done anything for those eggs at that time. It's still hard for me to grasp that there might be something to my eggs. Someone may have been able to get pregnant from them,' McCutcheon said. At the time of the scandal, ABC News saw documents showing that more than 60 other women who were patients at the fertility center had eggs taken from them without their consent. Asch, however, said he knew nothing about it. During the time the incidents occurred, it was not illegal to transfer human tissue without consent. </blockquote> The case had major repercussions for how fertility clinics operate: <blockquote>The scandal allegedly involving Asch, Balmaceda and another doctor, Sergio Stone, rocked the field of reproductive medicine, and doctors say they still feel its effects. 'Reproductive medicine is very new. It's come a long way and we've made tremendous progress, but because of scientific advances, it's very high-profile,' said Dr. Jani Jensen, a Mayo Clinic reproductive endocrinologist in Rochester, Minn. 'Whenever there are publicized incidents like this that involve ethical issues, it's sometimes difficult to engender the public's trust.' Dr. Howard Zacur, director of the Division of Reproductive Endocrinology and Infertility at the Johns Hopkins Fertility Center in Baltimore, Md., said patients still want reassurance their eggs and embryos will be protected from these types of incidents. It is now against the law in California to take eggs from a woman without her consent. </blockquote> Note that the disconnect between problematic quality of care at UCI and the generous compensation afforded its top leaders continued through 2010, as <a href="http://hcrenewal.blogspot.com/2010/01/uci-medical-center-fails-inspection-uci.html">this post </a>discussed. Aside from its colorfulness, there are other reasons to recall the story of the stolen ova and the subsequent troubles at UCI.  First, the list of problems over 15 years discussed in our series of posts suggests an institution whose leadership culture is seriously disturbed.  I cannot view the institution from a distance and figure out what the fundamental problems are with its leadership and governance, but there must be some.  (Note that per a <a href="http://hcrenewal.blogspot.com/2006/02/mismanagement-in-oc-report-on-uci.html">2006 post</a>, an internal report did fault lack of accountability, leadership by people with no medical background, absence of clear reporting lines, and the overlooking of whistleblowers, but these are just descriptions of bad management and governance, not explanations of them.  Furthermore, it is not clear whether there have been any fundamental changes in leadership or governance since then.  If there readers know there is more to this, please let me know in the comments section below.) Second, this case illustrates how the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a> has decreased recognition that the problems at UCI may be part of more systemic problems.  Despite the number of problems that occurred, their vividness, and their coverage in local media, the troubles at UCI have not gotten national media attention, nor as far as I can tell, have they ever been discussed in the medical, health care, health services research, or health policy literature.  (I have tried multiple Google scholar searches using the institution's name, and keywords including "scandal," and the names of some of the physicians most prominently named in our series of posts, and have found nothing relevant.)  The 15 year history has produced almost no echoes, and hence now has become as striking a black hole in the annals of bad health care leadership and governance as was the case of the fall of the <a href="http://hcrenewal.blogspot.com/search/label/AHERF">Allegheny Health Education and Research Foundation</a> (AHERF).  Certain issues that we discuss on Health Care Renewal have become less anechoic, in particular, conflicts of interest caused by academic physicians financial ties to the drug, biotechnology and device industries.  However, the larger issues of mismanagement by lavishly compensated, and hence perversely incentivized executives remains relatively anechoic.  I am not sure how big a scandal it will take to remove the taboo from discussing it.

Blast from the Anechoic Past: Former UCI Fertility Doctor Arrested in Mexico

Soon after we started Health Care Renewal, we ran a series of posts about the University of California-Irvine (UCI) medical school and medi...

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Institute of Medicine Committee on Patient Safety and Health Information Technology, and Thoughts on Social Aspects of Health IT Evaluation

<div style="text-align: center;">March 2011 addendum: also see my thoughts on Meeting two of the Committee on Patient Safety and Health Information Technology <a href="http://hcrenewal.blogspot.com/2011/03/committee-on-patient-safety-and-health.html">at this link</a>. </div> The U.S. National Research Council of the <a href="http://www.nationalacademies.org/">National Academy of Sciences</a> issued a report in early 2009 on the state of health IT. That study's report, led in part by pioneers in Medical Informatics G. Octo Barnett and William Stead, was entitled "Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions" (pre-publication PDF available free at <a href="http://www.nlm.nih.gov/pubs/reports/comptech_prepub.pdf">this link</a>). The report was announced under the following header: <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572"> </a><blockquote><a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">CURRENT APPROACHES TO U.S. HEALTH CARE INFORMATION TECHNOLOGY ARE INSUFFICIENT </a></blockquote> The insufficiencies were largely in the areas of difficulties with data sharing and integration, deployment of new IT capabilities, large-scale data management, and lack of cognitive support by health IT for busy clinicians. One might reasonably conclude such deficits could affect patient safety. Recently the <a href="http://www.iom.edu/About-IOM.aspx">Institute of Medicine</a> (the health arm of the National Academy of Sciences) formed a Committee to study health IT safety. It held its first meeting on Dec. 14, 2010 (quite a few years late in my opinion, and only after tens of billions of dollars have been earmarked for health IT, but better late than never): <blockquote> The <a href="http://www.iom.edu/Activities/Quality/PatientSafetyHIT.aspx" style="font-weight: bold;">Institute of Medicine Committee on Patient Safety and Health Information Technology</a> is holding its first meeting on December 14-15, 2010. The first day, December 14, 2010 beginning at 10:30 am, is open to the public to observe the committee proceedings. The committee will hear presentations by the Office of the National Coordinator and other invited guests. There will also be an opportunity for members of the public and representatives of interested organizations to make a brief statement before the committee. Prior registration is requested for attendees and required for those wishing to make a statement.</blockquote> Participant lists and materials from that first meeting are available at <a href="http://www.iom.edu/Activities/Quality/PatientSafetyHIT/2010-DEC-14.aspx">this link</a>. This brings to mind some thoughts on the social aspects of health IT evaluation. At a website by Dr. David Healy (<a href="http://www.healyprozac.com/">link</a>) on mass over-promotion and clinical trial data irregularities regarding SSRI's, academic abuses towards critical thinkers, and related affairs, I note an interesting observation in the preface. The author states: <blockquote>"On the face of it, the investigation of possible hazards posed by SSRIs does not seem to have followed the conventional dynamics of science, where anomalies in the data are supposed to spur further investigation. In this case, debate has been closed down rather than opened up. Journals that might have been thought to be independent of pharmaceutical company influence have “managed” not to publish articles and the appropriate scientific forums have “managed” not to debate the issues."</blockquote> This sounds eerily familiar with regard to another domain in biomedicine - health IT. Allow me to substitute a few words: <blockquote>"On the face of it, the investigation of possible hazards posed by clinical information technology does not seem to have followed the conventional dynamics of science, where anomalies in the data are supposed to spur further investigation. In this case, debate has been closed down rather than opened up. Journals that might have been thought to be independent of information technology company influence have “managed” not to publish articles and the appropriate scientific forums have “managed” not to debate the issues."</blockquote> Only recently do I note this phenomenon starting to lift. I've aggregated a number of reports and articles of recent years that take a critical-thinking attitude about health IT safety, efficacy, and sociopolitical matters such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=other">here</a>. I intend to broaden and deepen this aggregation to make it more comprehensive in the coming months. This is a somewhat personal exercise as my relative was severely injured in 2010 by health IT interference with clinician communications. However, it's also a professional endeavor. I will be presenting at a regional health care attorney's meeting in a few months on health IT risks. In my talk I will undoubtedly recommend aggressive litigation when HIT is implicated in patient injury, and investigations of potential contributions of health IT to medical malpractice when not readily apparent. I am not alone in this stance. Several weeks ago I also asked the IOM Committee on Patient Safety and Health Information Technology to be allowed to present my mother's case at some point, a tragic and ironic example of a family member of a physician and Medical Informatics specialist (not just a layperson) injured as a result of health IT. I have not yet received a reply. Evaluation of health IT will likely become more than an academic endeavor in the next few years. Those engaged in it might find themselves called as expert witnesses - or as defendants. I see a legal storm approaching in health IT. This is a domain I am somewhat familiar with, as pre-informatics I was a medical officer in public transit making safety-related medical decisions on transit authority/DOT-related matters, at a time when nationally-mandated random drug testing in the industry had recently begun. The legal implications of such work can be quite unexpected - and profound, especially when interfered with by outside sources with conflict of interest (e.g., labor unions). Train wrecks - literally, accompanied by litigation through the roof. To those involved in health IT, this is not a scientific opinion, and thus feel free to ignore it. At your own peril IMO. -- SS

Institute of Medicine Committee on Patient Safety and Health Information Technology, and Thoughts on Social Aspects of Health IT Evaluation

March 2011 addendum: also see my thoughts on Meeting two of the Committee on Patient Safety and Health Information Technology at this link ...

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Some Call it "Tyranny" - Top Leaders of University of California (Including Leaders of Academic Medicine) Demand Bigger Pensions for Themselves

The state of California, and its flagship university system, the University of California, have been under extreme financial pressure lately.  The 36 Executives' Demands However, that apparently has not decreased the University's hired managers' and executives' sense of entitlement.  They are threatening to sue if their pensions are not increased.  As reported <a href="http://articles.sfgate.com/2010-12-29/news/26349177_1_uc-employees-uc-system-higher-pensions">by the San Francisco Chronicle</a>, <blockquote>Three dozen of the University of California's highest-paid executives are threatening to sue unless UC agrees to spend tens of millions of dollars to dramatically increase retirement benefits for employees earning more than $245,000. 'We believe it is the University's legal, moral and ethical obligation' to increase the benefits, the executives wrote the Board of Regents in a Dec. 9 letter and position paper obtained by The Chronicle. 'Failure to do so will likely result in a costly and unsuccessful legal confrontation,' they wrote, using capital letters to emphasize that they were writing 'URGENTLY.' Their demand comes as UC is trying to eliminate a vast, $21.6 billion unfunded pension obligation by reducing benefits for future employees, raising the retirement age, requiring employees to pay more into UC's pension fund and boosting tuition. The fatter executive retirement benefits the employees are seeking would add $5.5 million a year to the pension liability, UC has estimated, plus $51 million more to make the changes retroactive to 2007, as the executives are demanding. The executives fashioned their demand as a direct challenge to UC President Mark Yudof, who opposes the increase. 'Forcing resolution in the courts will put 200 of the University's most senior, most visible current and former executives and faculty leaders in public contention with the President and the Board,' they wrote. </blockquote> Background to the Case Here is the relevant background: <blockquote>The roots of the pension dispute go back to 1999, five years after the IRS limited how much compensation could be included in retirement package calculations. But even after the IRS granted UC's waiver in 2007, nothing changed. University executives were having troubles of their own that year. President Robert Dynes resigned in 2007 after it was discovered that UC was awarding secret bonuses, perks and extra pay to executives. State auditors also found that UC's compensation practices were riddled with errors and policy violations. UC officials also had become aware of another big problem: UC's pension obligations were about to outstrip its ability to pay retirees. Neither UC nor its employees had paid into the fund since 1990. It took until this year for UC to act. In September, a retirement task force offered Yudof several options for closing the $21.6 billion gap - and one to widen it: increasing executive pensions.</blockquote>Health Care Executives Included Note that in addition to a bunch of finance officers and portfolio and asset managers, the demanding executives included quite a few leaders of the medical schools, and academic medical centers, including: <blockquote>UC System's Central Office Dr. Jack Stobo, senior vice president, health services and affairs UCSF Dr. Sam Hawgood, vice chancellor and dean, School of Medicine Ken Jones, chief operating officer, medical center Mark Laret, CEO, medical center Larry Lotenero chief information officer, medical center John Plotts, senior vice chancellor UC Davis William McGowan, CFO, health system Dr. Claire Pomeroy, CEO health system, vice chancellor/dean, School of Medicine Ann Madden Rice, CEO Medical Center UCLA Dr. David Feinberg, CEO of the hospital system; associate vice chancellor Dr. Gerald Levey, dean emeritus Virginia McFerran, chief information officer of the health system Amir Dan Rubin, chief operating officer of the hospital system Dr. J. Thomas Rosenthal, chief medical officer of the hospital system; associate vice chancellor Paul Staton, chief financial officer of the hospital system UC San Diego Dr. David Brenner, vice chancellor for health sciences; dean of the School of Medicine Tom Jackiewicz, CEO, associate vice chancellor of the health system Dr. Thomas McAfee, dean for clinical affairs UC Irvine Terry Belmont, CEO, Medical Center</blockquote>The Outraged Reaction The executives' demands sparked anger on campus. <blockquote>Dissenting members of the task force said it would be unseemly' to expand executive pensions. Tuition had just been increased by 32 percent this fall, and the regents were poised to raise it another 8 percent for fall 2011. They also voted to shift more money into the retirement fund from employees' pockets, as low-wage workers worried about retiring into poverty. 'I think it's pretty outrageous that this group of highly compensated administrators of a public university are challenging the president and the chair of the Board of Regents, said Daniel Simmons, chairman of UC's Academic Senate and a law professor at UC Davis. 'What outrages me the most is that these 36 people are blind to the fact that this is a public entity in dire straits,' said Simmons, who also served on the retirement task force and opposed the higher pensions.</blockquote> The demands prompted outrage from politicians and editorialists. A few choice samples: - The executives are "tarnishing the university's name with greed," <a href="http://www.dailybruin.com/index.php/article/2011/01/with_the_uc_in_crisis_senior_executives_should_be_helping_to_fix_the_budget_instead_of_demanding_a_f">editorial (UCLA) Daily Bruin</a>. - "Very out of touch," by Governor Elect Jerry Brown; "truly living in an ivory tower...." while "people are suffering in the rest of the state and losing their homes," by Assemblyman Jerry Hill, D- San Mateo (<a href="http://articles.sfgate.com/2010-12-30/bay-area/26350890_1_uc-system-higher-pensions-uc-execs">per the San Francisco Chronicle</a>) - "Uncaring and divisive," "undercuts public support for one of California's most treasured institutions," "sending out its own special-interest message: what's in it for me," - <a href="http://articles.sfgate.com/2010-12-30/bay-area/26350890_1_uc-system-higher-pensions-uc-execs">editorial, San Francisco Chronicle</a>. - "despicable threat," the California Regents (UC board of trustees) should not "claim that lavish pension may be needed to recruit good people to UC. Good people don't threaten lawsuits against a cash-strapped sate to enrich themselves." <a href="http://www.sacbee.com/2011/01/02/3290033/editorial-uc-executives-offer.html">editorial, Sacramento Bee</a>. - Governor-Elect B4rown should issue an executive order "to eliminate any position in the University of California system paying $245,000 a year or more," (thus effectively firing all the 36 complaining executives); "free taxpayers and students alike from the tyranny of those whose main objective during any time - tough or otherwise - is to keep milking the state for every penny the can squeeze out," <a href="http://www.mantecabulletin.com/news/article/19725/">editorial, Manteca Bulletin</a>. Summary We have posted frequently about hired managers and executives of health care organizations receiving <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">compensation</a> and <a href="http://hcrenewal.blogspot.com/search/label/executive%20life%20style">benefits</a> out of all proportion to their apparent performance. The case of the demanding University of California executives is just one of many. However, what is really remarkable about this case is the reaction to it. We are hearing top leaders, including many of the top leaders of the state's medical schools and academic medical centers, called uncaring, greedy, and despicable by well-known politicians and in newspaper editorials, and we are hearing calls that they be fired, en masse. Maybe we are at a tipping point. Of course, hired health care managers and executives are not entitled to line their own pockets while patients and their other constituencies suffer during the great recession. They are not entitled to continually drive health care costs up while they enrich themselves. However, apathy,<a href="http://hcrenewal.blogspot.com/search/label/learned%20helplessness"> learned helplessness</a>, and the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a> have let them promote themselves into a de facto new aristocracy (just like the hired managers and executives of some other non-profit organizations, for-profit corporations, and especially financial service corporations have turned themselves into the rest of that aristocracy.) If we do not reclaim health care from these new oligarchs, we will all end up not just with expensive, difficult to access, mediocre health care, but under their tyranny. Post-Script This is just the latest example of the sense of entitlement displayed by the hired managers and executives of the University of California. Outrageous pay and benefits unjustified by any measure of performance for University of California's hired managers and executives has been grist for the Health Care Renewal mill since 2005.  A few samples: -  The ranks of those paid more than $200 K rose much faster than those paid less, while lower paid employees endured a pay freeze, and the university cut its budget.  Managers got bonuses for extra work, while faculty did not.  Managers got housing allowances, and other perks.  (<a href="http://hcrenewal.blogspot.com/2005/11/leadership-living-large-at-university.html">November, 2005</a>)  - UC-Irvine managers were paid lavishly while presiding over debacles involving transplant services  (liver transplants, <a href="http://hcrenewal.blogspot.com/2005/11/university-of-california-irvine-shuts.html">November, 2005</a>; bone marrow transplants, <a href="http://hcrenewal.blogspot.com/2006/01/even-more-trouble-in-oc-uci-bone.html">January, 2006</a>; kidney transplants, <a href="http://hcrenewal.blogspot.com/2006/01/california-bad-dreamin-more-troubles.html">January, 2006</a>) - UC - San Diego Chancellor was paid $359 K plus a bonus of $248 K for supposed full time work while serving on ten for-profit corporate and non-profit boards, including directorships of for-profit health care corporations that were conflicts of interest with her role overseeing the medical school and medical center.  This was the first case of what we later called the "new species of conflicts of interest" posted on the blog.  (<a href="http://hcrenewal.blogspot.com/2006/01/california-nightmares-more-troubles-at.html">January, 2006</a>) - UC - Irvine managers got bonuses while its medical center failed an inspection (<a href="http://hcrenewal.blogspot.com/2010/01/uci-medical-center-fails-inspection-uci.html">January, 2010</a>), as did managers at other UC campuses (<a href="http://hcrenewal.blogspot.com/2010/01/more-california-medical-centers-plagued.html">January, 2010</a>). Maybe if these older stories produced more outraged, the current situation would not have occurred. You heard it first on Health Care Renewal Hat tip to Prof Margaret Soltan <a href="http://www.margaretsoltan.com/?p=28524">on the University Diaries blog</a>.

Some Call it "Tyranny" - Top Leaders of University of California (Including Leaders of Academic Medicine) Demand Bigger Pensions for Themselves

The state of California, and its flagship university system, the University of California, have been under extreme financial pressure lately...

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