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If a Medical School is Just Part of the "Biomedical Industry," Who Will Do Medical Education?

A little while ago, we <a href="http://hcrenewal.blogspot.com/2011/09/director-of-bristol-myers-squibb-to-run.html">discussed</a> questions raised by the pre-existing financial relationships of Dr Laurie Glimcher, the new incoming Dean of Weill Cornell Medical School. Dr Glimcher is also the longest serving director of Bristol-Myers-Squibb, and has a number of other financial relationships with drug and device companies. A new interview with Dr Glimcher suggested that what is most interesting about the coverage of her ascension to the Cornell Deanship is what it did not mention, especially whether she has any goals other than promote relationships with and do product development for corporate health care. So let me review what has been made public about the interests and goals of Weill Cornell Medical College's new Dean. The New York Times: To Develop "Research Capacity" and a "New High-Tech Campus" The New York Times <a href="http://www.nytimes.com/2011/09/08/nyregion/laurie-h-glimcher-named-dean-of-weill-cornell-medical-college.html">article</a> focused on the new Dean's conflicts of interests, but found no doubts about these conflicts among the university leadership to whom the new Dean would report. Instead, <blockquote>Cornell University’s president, Dr. David J. Skorton, said he believed Dr. Glimcher had the skills to carry out the medical school’s plan to double its research capacity and to help the university compete to develop a new high-tech campus proposed by the Bloomberg administration.</blockquote> However, while it emphasized how university leaders defended Dr Glimcher's conflicts of interest, the New York Times article said nothing about the university leadership's educational or clinical expectations for Dr Glimcher. The Cornell Sun: To "Strengthen its Relationship with Biotechnology and Pharmaceutical Companies" Similarly, <a href="http://cornellsun.com/section/news/content/2011/09/08/glimcher-chosen-new-dean-cornell-medical-college">according to </a>the Cornell Daily Sun, the university leadership regarded the new Dean's relationships with industry as strengths, not weaknesses, <blockquote>As the longest-standing member of the corporate board of biopharmaceutical company Bristol-Myers Squibb, [Dr Laurie] Glimcher has 'extensive experience' in corporate finance, governance and management, according to a University press release. </blockquote> So, <blockquote>Under Glimcher’s leadership, Weill hopes to strengthen its relationship with biotechnology and pharmaceutical companies, develop innovative cures and bolster research, the University stated.</blockquote> The Sun did briefly note, <blockquote>In a press release, [Cornell University President David J] Skorton said he was 'honored and delighted' that Glimcher accepted the position. 'Her passion for accomplishment and her many research and clinical strengths make her ideally suited to build on Tony Gotto’s strong foundation and lead Weill Cornell’s bright future in clinical care, education and translational research,' Skorton said.</blockquote> However, there were no further details about what Dr Glimcher would do for clinical care or education. The Cornell Press Release: To Achieve "Preeminence in the Biomedical Sciences" This <a href="http://www.pressoffice.cornell.edu/presskits/New-WCMC-dean.cfm">press release </a>emphasized Dr Glimcher's corporate skills even more than did the Times or Sun articles, <blockquote>Her service with the biopharmaceutical company Bristol-Myers Squibb, where she is the longest-standing member of the corporate board of directors and of its audit committee, has afforded her extensive experience in management oversight, corporate governance, corporate finance, accountability, leadership and the practical aspects of running a business and bringing therapeutics to the marketplace. 'This is great news for the medical school and for the city,' said Sanford I. Weill, chairman of the medical college's board of overseers and a member of the board of trustees of Cornell University. 'With her thorough appreciation of the management and financial challenges of complex organizations, I am confident she will lead the college with the same creativity and acumen she demonstrated when she pioneered the establishment of Bristol-Myers' science and technology committee, which is widely credited for transforming its stake in research. With a state-of-the-art biomedical research facility under construction and Dr. Glimcher at the helm, Weill Cornell and New York are on course to achieve a preeminence in the biomedical sciences that has already been achieved in clinical medicine and first-rate medical education.' </blockquote> However, it said nothing substantive about Dr Glimcher's educational or clinical goals or interests. (Perhaps, because Mr Weill thought that the school had already achieved preeminence in these areas, he also thought no further goals in these areas are needed.) Crain's New York Business: "Critical that the Pharmaceutical Industry has Input from the Biomedical Industry" Now Crain's New York Business just published <a href="http://www.crainsnewyork.com/article/20111030/SUB/310309989">an interview</a> with Dr Laurie Glimcher, the Dean to be of the Weill Cornell Medical College with a singular emphasis.  It introduced Dr Glimcher thus, <blockquote>She is the longest-serving member of the board at Bristol-Myers Squibb and has been a big earner from her work with drug companies. Snaring Dr. Glimcher is a coup for Cornell University, which is using her status to bolster its proposal to build a science and engineering campus on Roosevelt Island.</blockquote> The interviewer asked, can New York become "a more competitive research hub?"  Dr Glimcher opined, <blockquote>I think New York City is going to be the next greatest center for biomedical research.</blockquote> Then, with an instructive tilt, why are you so comfortable taking research funding from drug makers?  Her answer included the usual rationale, but with a twist: <blockquote>I think it's critical that the pharmaceutical industry has input from the biomedical industry. I believe it is essential to have partnerships to accomplish our goals.</blockquote>The implication, and the twist is that she apparently sees herself as leading not a medical college, but an entity within the "biomedical industry." The next question was, does this mean that more collaboration with drug companies are ahead for Weill Cornell?  Her answer was no surprise, <blockquote>Harvard probably has more ties to pharmaceutical companies than Weill Cornell, but Weill Cornell definitely has connections that I hope we can leverage.</blockquote> At this point, it should be no surprise that this interview of this erstwhile leader of "biomedical industry" mentioned nothing substantive about clinical care or medical education. Summary: Education and Patient Care Disappear into the Maw of the "Biomedical Industry" In summary, so far, all the hoopla about the new Dean of Weill Cornell Medical College has been about her anticipated ability to align the school with the pharmaceutical and biotechnology industry. Amidst the hoopla, neither the new Dean nor anyone within the Cornell leadership has said anything about her interests, goals, or positions relevant to education or clinical care. Yet education is the most fundamental mission of a medical school and of academic medicine. Instead, on one occasion, the new Dean suggested that she would be leading not a medical school, but part of the "biomedical industry." So it appears that the brave new version of the Weill Cornell Medical College is not merely more focused on doing product development for industry than on its traditional mission of education, research more broadly defined, (e.g., which also may include basic biomedical research, clinical research, and epidemiological and public health research), and patient care. It appears that applied research for product development has become its only important goal. How else should one interpret what the new Dean and her supervisors have said? Not one of them has said anything about education or patient care other than to acknowledge that these endeavors exist.  (Also, not one of them discussed the other kinds of research that medical schools and academic medical centers have traditionally done.) If Cornell's Board Chairman, President, and Medical College Dean are only interested in being part of the "biomedical industry," why should anyone want to attend what is still called their "Medical College?" Why should anyone want to serve as a house officer in one of the "Medical College's" hospitals? Why should anyone want to attend one of the "Medical College's" continuing medical education courses? If Cornell's Board Chairman, President, and Medical College Dean are only interested in being part of the "biomedical industry," that is, doing applied research for product development, why would any patient want to go to their hospital,s clinics, and other facilities? We now see not merely academic medical leadership chosen because of, not despite their conflicts of interest with health care corporations. We now also see academic medical leadership who appear only interested in corporate product development, and not even interested in talking about education or patient care (or traditional biomedical, clinical, and epidemiological research.) Of course, all this discussion is based only what has been published so far about the new leadership of Weill Cornell. Maybe the publications have been woefully incomplete and full of errors. I eagerly hope that to be the case (nooffense intended to the journalists involved.) But I fear that we are seeing the final common pathway for the corporate academic medical center, its transformation into the "Biomedical Industry." If academic medical leaders no longer care about education or patient care, the downward spiral of our health care system has only just begun.

If a Medical School is Just Part of the "Biomedical Industry," Who Will Do Medical Education?

A little while ago, we discussed questions raised by the pre-existing financial relationships of Dr Laurie Glimcher, the new incoming Dean ...

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Dr. Scott Monteith: On a New Wonder "Drug" on the Market

I've posted several guest posts by Dr. Scott Monteith, a psychiatrist/informaticist, at Healthcare Renewal. These include the Mar. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/03/dr-scot-monteith-on-best-compromise-on.html">On 'The Best Compromise' on Physicians and Use of Troublesome Health IT</a>", the Jan. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/01/dr-monteith-hit-testimony-to-hhs.html">Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith</a>" and the Dec. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/12/meaningful-use-and-devil-in-details.html">Meaningful Use and the Devil in the Details: A Reader's View</a>". Here's a new guest post from Dr. Monteith regarding a new "Wonder Drug" on the market: <blockquote>New Drug on the market! This new drug claims to be incredibly effective. It’s very expensive, but the sellers assure us that it’s worth it! Using the drug is complicated, and the health care team will likely experience side effects including frustration, reduced efficiency, fatigue, lack of attention, confusion, and cognitive dissonance (as the drug often “appears” not to work -- but it really does work and we know because the manufacturers consistently tell us it does). By the way, the sellers of this new drug say that side effects are the fault of the people who use the drug, not the drug itself. The drug isn’t proven to work, but its investors view it as promising and tell us that this small detail can be ignored. Besides, it would be costly to prove that it’s effective (remember, it’s already a very expensive drug). And there are case studies showing that it appears to work. Some people reportedly really like it (these people, in fact, often become drug salesmen). Never mind that there are also large numbers of case studies indicating that it’s ineffective and dangerous, and can even kill people. [Of course, cases of success are scientifically robust and universally valid; cases of adverse events are <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">merely anecdotal (link)</a> - ed.] Nor do we have clear best practices related to correct dosages and when to take it, but the drug’s producers tell us that more of the drug is generally better than less. Everyone will have to figure out these minor details on their own. It’s recommended that you hire experts to help you with this detail. No problem – there are experts around every corner (they’re called “consultants”). Please join the manufacturers in their campaign to use and promote this new drug – the government has! Uncle Sam will pay you an incentive to use this new experimental drug over the next few years. If you refuse to use it, however, beware! Uncle Sam will penalize caregivers who refuse to use the drug by reducing their payments by 1% in the first year, and then accelerating these reductions in years 2-5. We also need to work hard to keep groups of citizens from regulating it, or asking inconvenient questions like “can you please prove that it works before we take it and risk side effects and spend large amounts of money on it?” (You know, the same kind of nasty questions that we ask of other health care interventions.) Almost forgot…once you start the drug, it’s very hard to quit to using it. No, it’s not heroin. Don’t be silly! Finally, we’re working hard to keep the manufacturers safe from any liability associated with the drug. Yes, yes, I know – they claim it’s safe and works and all problems are related to the people who take it. But these “safe harbors” (whether through government intervention or strong user agreements) are necessary ... just in case ... By now I’m sure that you want to run out to your pharmacy to buy this wonderful new drug. You may also want to invest in its maker as well. So here are the details… The generic name is “HIT.” The trade name is “EHR.” It’s stock symbol is ONC. </blockquote> I think the point is very well made. -- SS

Dr. Scott Monteith: On a New Wonder "Drug" on the Market

I've posted several guest posts by Dr. Scott Monteith, a psychiatrist/informaticist, at Healthcare Renewal. These include the Mar. 2011 ...

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Cybernetik Über Alles: Computers Have More Rights Than Patients?

<div style="text-align: center;">[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.]</div> What medical devices are shielded from liability? Are there other examples of legislation seeking legal protections for wide-scale use of medical devices that even the device's trade group leadership admits are <a href="http://hcrenewal.blogspot.com/2010/07/barry-chaiken-md-mph-lets-be-patient.html">not ready, and are experimental</a>? Here we have a proposal from a member of the U.S. Congress to shield health IT software, a medical device (per <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">FDA's Director of CDRH - the Center for Device and Radiological Health</a> and <a href="http://hcrenewal.blogspot.com/2009/06/improving-patient-safety-in-eu-hit.html">others</a>), and its users from liability through an apparently unique special accommodation. This from iHealthBeat.org: <div class="date"></div><blockquote><div class="date">Thursday, October 27, 2011 </div><div class="date"><a href="http://www.ihealthbeat.org/articles/2011/10/27/bill-would-establish-new-legal-protections-for-ehr-adopters.aspx">Bill Would Establish New Legal Protections for EHR Adopter</a><a href="http://www.ihealthbeat.org/articles/2011/10/27/bill-would-establish-new-legal-protections-for-ehr-adopters.aspx">s</a></div>On Wednesday, Rep. Tom Marino (R-Penn.) introduced legislation (<a href="http://thomas.loc.gov/cgi-bin/bdquery/z?d112:h.r.3239:" target="_blank">HR 3239</a>) that would create certain legal protections for Medicare and Medicaid providers who have implemented electronic health record systems, the <a href="http://www.timesleader.com/news/Marino__Bill_offers_safeguards_for_electronic_records_10-26-2011.html" target="_blank">Wilkes-Barre Times Leader</a> reports. The bill -- called the Safeguarding Access for Every Medicare Patient Act -- would create a system for reporting potential medical errors that occur when using EHRs, but it would not allow such information to be used as legal admission of wrongdoing. The bill would cover certain physicians and hospitals that serve Medicare and Medicaid beneficiaries. It also would cover participants and users of health information exchanges. Marino, who is a member of the House Judiciary Committee, said that offering the new legal protections to health care providers would promote greater use of EHRs and encourage Medicare and Medicaid providers to continue serving beneficiaries. [As if they could not do so without EHR's? - ed.] He said, "Many providers are reluctant to use [EHRs] because they believe the practice will make them more vulnerable to unnecessary legal action," [unnecessary? How about real and necessary, as per the White Paper <a href="http://www.acgroup.org/images/2011_White_Paper_-_Do_EHRs_Increase_Liability.pdf">Do EHR's Increase Liability</a><a href="http://www.acgroup.org/images/2011_White_Paper_-_Do_EHRs_Increase_Liability.pdf">?</a> - ed] adding, "This [bill] protects access for seniors in the Medicare and Medicaid programs" (Riskind, Wilkes-Barre Times Leader, 10/27). <div id="articlebody"></div></blockquote><div id="articlebody"></div> From Rep. Marino's <a href="http://marino.house.gov/press-release/bill-would-protect-access-medicare">website</a> (my comments are in [bracketed red italics]): <blockquote><div align="center">Marino Introduces Safeguarding Access For Every Medicare Patient Act</div><div align="center">FOR IMMEDIATE RELEASE Oct. 26, 2011 </div>WASHINGTON -- U.S. Rep. Tom Marino, PA-10, has introduced legislation that offers limited legal protection to Medicare and Medicaid providers who use electronic records. [Which, I fear, could effectively act as, or mutate into, absolute protection in the environs of the legal system - ed.] HR3239, the Safeguarding Access For Every Medicare Patient Act, would ensure patient access to Medicare and Medicaid providers; reduce health care costs [really? That's not what <a href="http://hcrenewal.blogspot.com/2009/06/wharton-on-healthcare-it-can-i-go-home.html">Wharton</a> and <a href="http://hcrenewal.blogspot.com/2010/03/hospitals-under-knife-sacrificing.html">others</a> write - ed.]; guarantee incentives to providers to remain in the Medicare and Medicaid programs; and promote participation in health information technology. Providers will eventually be required to participate in electronic recordkeeping or face a reduction in payments. Marino said the bill offers incentive in the form of legal protection to providers who may be reluctant to remain in the Medicare and Medicaid programs due to low reimbursement rates which are constantly being targeted for further reductions. [I imagine the known risks of health IT such as these at "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">MAUDE and HIT Risks: What in God's Name is Going on Here?</a>" are a minor consideration if you receive legal immunity - ed.] HR3239 would create a system for reporting potential errors that occur when using electronic records without the threat of that information being used as an admission of guilt. [Even if the physician or nurse is guilty of EHR-caused or aggravated, i.e., "<a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">use error</a>" per NIST, malpractice - ed.] It also prevents electronic records from being used as an easy source for “fishing expeditions,’’ [like <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html">this case</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">this case</a>, <a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html">this case</a> and <a href="http://hcrenewal.blogspot.com/2011/03/thanks-to-wonders-of-ehr-this-premature.html">this case</a> where patients died? - ed.] while making sure that parties responsible for errors are held accountable [how? -ed]. The proposal allows for providers who use electronic records to take remedial measures without having those actions be used to establish guilt [even though remediation may be very relevant to malpractice, patient injury and death prior to the remediation, and the remediation is informed by the error - ed.]; places time limits on the filing of lawsuits; and offers protection against libel and slander lawsuits. [If this provision were to allow clinicians to speak publicly about HIT flaws without legal retaliation or <a href="http://www.aapsonline.org/peerreview/epidemic.php">sham peer review</a>, I'd be all for it - ed.] “Many providers are reluctant to use electronic records because they believe the practice will make them more vulnerable to unnecessary legal action,” Marino said. [I think it's much more likely they are reluctant to use them due to the aforementioned hair-raising MAUDE reports and literature such as <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">here</a>, <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> - ed.] and “Every time a doctor or hospital chooses not to participate because of these fears, our seniors lose another provider. This protects access for seniors in the Medicare and Medicaid programs.” Marino said HR3239 is a two-pronged attack against rising health care costs: It provides legal protection to providers while encouraging the use of health information technology which has been shown to reduce costs. [See above links on that issue - ed.] “Best of all, passage of this bill would require no new spending,” Marino said. [Besides the hundreds of billions to be spent on the IT itself - ed.]</blockquote> This sounds like a healthcare IT vendor marketing piece, with claims refuted repeatedly here at HC Renewal, usually via the biomedical literature. It's slick, purporting to "protect Medicare access" while actually promoting health IT sales. Did Rep. Marino get snowed by the health IT lobby? (See "<a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">The Machinery Behind Healthcare Reform</a>" in the Washington Post.) A major question is: What are the patients and their rights to redress for injuries that occur due to EHR's? Chopped liver? Isn't this bill really saying that patients are experimental subjects with limited rights? In other words, that improving EHR's should be at the expense of the unfortunate patients treated under its auspices? That the computers have more rights than the patients? That line of thinking about what in reality is unconsented medical experimentation (i.e., "First, let's experiment" as opposed to "First, do no harm") has led to some very dark places in medicine, and not just in ancient history (e.g., see "<a href="http://hcrenewal.blogspot.com/2011/09/bioethics-panel-blasts-late-u.html">Bioethics panel blasts late U. Pittsburgh professor</a>"). See <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">this reading list</a> for more on these issues. Also see the many other posts on this blog about health IT quality, usability, efficacy, risk (and that the levels of that risk are admittedly unknown), lack of informed consent, and other issues via query links such as <a href="http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20dangers" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20failure" style="font-weight: bold;">here</a> and <a href="http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20defects" style="font-weight: bold;">here</a> - and the hyperlinks within those lists of posts - to more fully understand this perspective. The text of the proposed legislation is <a href="http://thomas.loc.gov/cgi-bin/query/z?c112:H.R.3239:">here</a>. While not all bad, it raises a number of concerns. Excerpts are as follows: <h3></h3><blockquote><h3 style="font-weight: normal;">H. R. 3239</h3><h3 style="font-weight: normal;">To provide certain legal safe harbors to Medicare and Medicaid providers who participate in the EHR meaningful use program or otherwise demonstrate use of certified health information technology.</h3><h3>... SEC. 4. RULES RELATING TO E-DISCOVERY.</h3><ul> In any health care lawsuit against a covered entity that is related to an EHR-related adverse event, with respect to certified EHR technology used or provided by the covered entity, electronic discovery shall be limited to--</ul> <ul><ul>[I'm not sure what "certification" has to do with litigation, since "certification" of health IT has nothing to do with safety or usability; see note below - ed.] (1) information that is related to [what does that mean? - ed.] such EHR-related adverse event; and</ul></ul><ul><ul> (2) information from the period in which such EHR-related adverse event occurred. [eDiscovery related to EHR-related adverse events is already difficult, e.g., obtaining complete metadata. What these provisions would do is likely to increase the complications through legal maneuvers on terms such as"related to", "period" etc. - ed.]</ul></ul><h3>SEC. 5. LEGAL PROTECTIONS FOR COVERED ENTITIES.</h3><ul> (a) General- For a covered entity described in section 2, the following protections apply:</ul><ul><ul> (1) ENCOURAGING SPEEDY RESOLUTION OF CLAIMS-</ul></ul><ul><ul><ul> (A) GENERAL- A claimant may not commence a health care lawsuit against a covered entity on any date that is 3 years after the date of manifestation of injury or 1 year after the claimant discovers, or through the use of reasonable diligence should have discovered, the injury, whichever occurs first. This limitation shall be tolled to the extent that the claimant is able to prove--</ul></ul></ul><ul><ul><ul><ul> (i) fraud;</ul></ul></ul></ul><ul><ul><ul><ul> (ii) intentional concealment; or</ul></ul></ul></ul><ul><ul><ul><ul> (iii) the presence of a foreign body, which has no therapeutic or diagnostic purpose or effect, in the person of the injured person.</ul></ul></ul></ul><ul><ul> ... (2) EQUITABLE ASSIGNMENT OF RESPONSIBILITY- In any health care lawsuit against a covered entity--</ul></ul><ul><ul><ul> (A) each party to the lawsuit other than the claimant that is such a covered entity shall be liable for that party's several share of any damages only and not for the share of any other person and such several share shall be in direct proportion to that party's proportion of responsibility for the injury, as determined under clause (iii);</ul></ul></ul><ul><ul><ul> (B) whenever a judgment of liability is rendered as to any such party, a separate judgment shall be rendered against each such party for the amount allocated to such party [does that include the IT vendor? - ed.] ; and</ul></ul></ul><ul><ul><ul> (C) for purposes of this paragraph, the trier of fact shall determine the proportion of responsibility of each such party for the claimant's harm.</ul></ul></ul><ul><ul> (3) SUBSEQUENT REMEDIAL MEASURES- Evidence of subsequent remedial measures to an EHR-related adverse event with respect to certified EHR technology used or provided by the covered entity (including changes to the certified EHR system, additional training requirements, or changes to standard operating procedures) by a covered entity shall not be admissible in health care lawsuits. [This in and of itself seems to give special accommodation to health IT, since remediation helps make the case for the presence of problems to begin with - ed.]</ul></ul><ul><ul> (4) INCREASED BURDEN OF PROOF PROTECTION FOR COVERED ENTITIES- Punitive damages may, if otherwise permitted by applicable State or Federal law, be awarded against any covered entity in a health care lawsuit only if it is proven by clear and convincing evidence that such entity acted with reckless disregard for the health or safety of the claimant. In any such health care lawsuit where no judgment for compensatory damages is rendered against such entity, no punitive damages may be awarded with respect to the claim in such lawsuit. [Would that apply to a case such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">this?</a> Does it apply to the health IT vendors and their often cavalier software development and quality practices, if patients become injured, such as <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">here</a>, "A Study of an Enterprise Health Information System?" How about to <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit">this case</a>, "A Lawsuit Over Healthcare IT Whistleblowing?" - ed.]</ul></ul> <ul><ul> (5) PROTECTION FROM LIBEL OR SLANDER- Covered entities and employees, agents and representatives of covered entities are immune from civil action for libel or slander arising from information or entries made in certified EHR technology and for the transfer of such information to another eligible provider, hospital or health information exchange, if the information, transfer of information, or entries were made in good faith and without malice. [Does that include defects reports? - ed.]</ul></ul></blockquote><ul><ul></ul></ul> From an ethical perspective, when you know a technology can be unsafe, but you don't know the levels of risk it creates, and the literature is conflicting on the benefits (prima facie evidence the technology is still experimental), you do not promote its wide-scale use in medicine and offer special accommodations to the technology's producers and users. Period. This is especially true without explicit patient informed consent and opportunity for opt-out. To promote such technology is not ethical. Note: I believe the misunderstanding of "certification" of health IT contributes to the problems with such proposals. "Certification" of HIT has little if anything to do with safety, reliability, usability, etc. (e.g,, see <a href="http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html" rel="nofollow">http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html</a>). "Certification" of health IT is not validation of safety, usability, efficacy, etc., but a pre-flight checklist of features, interoperability, security and the like. The certifiers admit this explicitly. See the <a href="http://www.cchit.org/about">CCHIT web pages</a> for example. ("CCHIT Certified®, an independently developed certification that includes a rigorous inspection of an EHR’s integrated functionality, interoperability and security.") Health IT "certification" is not like <a href="http://www.ul.com/global/eng/pages/">Underwriters Laboratories (UL) certification of appliances</a>. ("Independent, not-for-profit product safety testing and certification organization ... With more than a 116-year proven track record, UL has been defining safety from the public adoption of electricity to new breakthroughs that help protect our future. UL employees are committed to safeguarding people, places and products in new and innovative ways for today’s borderless world.") -- SS 10/28/11 Addendum: This Representative seems to represent <a href="http://marino.house.gov/our-district">districts in Pennsylvania served by the Geisinger </a>healthcare system, including <a href="http://maps.google.com/maps?client=firefox-a&rls=org.mozilla:en-US:official&channel=s&hl=en&biw=1920&bih=887&q=danville+pa&um=1&ie=UTF-8&hq=&hnear=0x89cf6538e03a582d:0xceea3df3d7837f38,Danville,+PA&gl=us&ei=TiarToSNGMrs0gG29oWCDw&sa=X&oi=geocode_result&ct=image&resnum=2&ved=0CD0Q8gEwAQ">Danville, PA</a> where their <a href="http://www.geisinger.org/locations/index.html">main campus</a> is located. His legislative assistant on healthcare represented Geisinger to me in a conversation today in glowing terms. However, I suggest that Geisinger does not have a perfect track record, e.g., see the post "<a href="http://hcrenewal.blogspot.com/2011/08/safe-technology-factors-contributing-to.html">A 'safe' technology? Factors contributing to an increase in duplicate medication order errors after CPOE implementation</a>" and its reader comments and links. 10/30/11 Addendum: It occurred to me that in the post "<a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html">Is Healthcare IT a Solution to the Wrong Problem?</a>" referencing a study published in the Nov. 25, 2010 New England Journal of Medicine entitled "<a href="http://www.nejm.org/doi/full/10.1056/NEJMsa1004404">Temporal Trends in Rates of Patient Harm Resulting from Medical Care</a>" [Landrigan N Engl J Med 363;22] I pointed out that the abilities of health IT to "reduce medical error" may be significantly less than imagined. This is because most medical errors have little to do with record keeping, but instead with human factors. See the post at <a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html">http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html</a>. -- SS

Cybernetik Über Alles: Computers Have More Rights Than Patients?

[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.] What medical devices are sh...

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Doctor Placed on Administrative Leave ("Railroaded?") Because He "Fell Behind on Handling Electronic Records For His Patients"

This story is tragic and appalling: <a href="http://www.sj-r.com/top-stories/x268461054/Physician-Memorial-Health-at-odds-over-electronic-records"> </a><blockquote><a href="http://www.sj-r.com/top-stories/x268461054/Physician-Memorial-Health-at-odds-over-electronic-records">Lincoln doctor, Memorial Health clash over electronic records</a> By DEAN OLSEN The State Journal-Register Posted Oct 19, 2011 @ 11:00 PM Last update Oct 20, 2011 @ 06:37 AM LINCOLN — A Lincoln doctor who was removed from his job a month ago says his bosses in Springfield failed to train him properly on a new electronic medical-records system. An official with Memorial Health System disputes the doctor’s claims.<a href="https://www.almh.org/Physician-Profiles/Physician-Details.aspx?i=73206">Dr. Steven Kottemann</a>, 63, who was placed on paid administrative leave Sept. 16 by Springfield-based Memorial Health System, wants to return to his $100,000-a-year position as a family physician at <a href="https://www.memorialmd.com/Physician-Profiles/Physicians-List.aspx">Family Medical Center of Lincoln</a>, 515 N. College St. Kotteman said he had “no computer skills” before Memorial turned on an all-electronic medical-records system Jan. 12, and he fell behind on handling electronic records for his patients. He said he was accused by Memorial of creating “a liability for the clinic.”</blockquote> I think it appropriate to question whether an EHR <a href="http://www.tinyurl.com/hostileuserexper">mission hostile user experience</a> may be creating a liability for the clinic. Also see the semi-rhetorical question-titled White Paper "<a href="http://www.acgroup.org/images/2011_White_Paper_-_Do_EHRs_Increase_Liability.pdf">Do EHR's Increase Liability?</a>" (PDF). <blockquote>“They did this to me,” Kottemann told The State Journal-Register from his home in Lincoln. “They bought a lousy system. [I would like to know the vendor - ed.] They caused everything, as far as I’m concerned, and I resent the fact that they’re trying to make me look bad.”Memorial’s chief medical officer, Dr. Rajesh Govindaiah, said Kottemann has been treated fairly. Though Govindaiah wouldn’t go into specifics, he said concerns about Kottemann’s performance go beyond his proficiency with electronic medical records.</blockquote> Was this <a href="http://www.aapsonline.org/peerreview/epidemic.php">Sham Peer Review</a>? <blockquote> “Dr. Kottemann is aware of the issues,” Govindaiah said. “He knows more than I’m allowed to tell you, and he knows that this is related to more than just the electronic medical record. It has to do with performance and ensuring a safe environment for our patients.”</blockquote> That sounds like an excuse, considering the patient testimonials in the article and on the linked Facebook page mentioned below. In the meantime, NIST is just now studying poor health IT usability (see my post "<a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">NIST on the EHR Mission Hostile User Experience: Blame the User?</a>", and IOM is just now studying safety of electronic medical records (see my post "<a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">Cart before the horse, again: IOM to study HIT patient safety for ONC</a>.") FDA chimes in that<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html"> injuries and deaths are reported</a>, but the magnitude is not known; however they won't regulate a technology that is a "<a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">political hot potat</a><a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">o</a>."Looking at FDA's MAUDE database on just about the only health IT vendor who reports there (it's voluntary) makes my hair stand on end. See "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">MAUDE and HIT Risks: What in God's Name is Going on Here?</a>" Further, the literature is conflicting on benefits of EMR's (see my post "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">An Updated Reading List on Health IT</a>"). Who, exactly, is promoting patient safety? <blockquote> Kottemann said Govindaiah’s “vague innuendos” amount to an “administrative snow job.”</blockquote> "Railroading" seems like a better term. <blockquote> Patients ask why Kottemann, who grew up in the Chicago area, moved to Lincoln in 1977. He has practiced in Lincoln his entire career and says he is the oldest practicing physician in the Logan County seat. But he has no plans to retire. His patients have come to his defense, creating a <a href="http://tinyurl.com/kottemann">Facebook page</a> and sending letters to Memorial officials.“This man is very genuine,” longtime patient and Lincoln resident Jonette Tibbs said. “He is just the greatest. He’s on that upper crust. Why would you like to get rid of a doctor like that?”Another patient, Fern Donnan of Beason, said Memorial officials should be more understanding.“Technology is a learning curve, and you need to allow for that and support that,” she said. Donnan said she and her family members will avoid Memorial health-care providers unless Kottemann is reinstated.“I don’t know why they’re pushing him out,” she said.</blockquote> Perhaps because he just won't cave in using the health IT that has been forced upon him, and upon his patients (without their informed consent, I might add). See my post "<a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">Draft Patient Rights Statement and Informed Consent on Use of HIT</a>." It gets worse: <blockquote> Stroke in 2008 Kottemann said he fell behind because the new system wouldn’t accept his dictated notes after he saw patients in the office. The system’s computers were supposed to accept dictation, he said. But he said he learned after several weeks that the system was mistakenly deleting dictations. [See Informatics expert Dr. Jon Patrick's <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">forensic analysis of a major EHR system</a>, especially part 7 "The Integrated Assessment" for why that might be so - ed.] He said he told his supervisors about the problem, but when there was no response [because it's the user's fault - ed.], he was faced with the other main option — typing notes into the system while he sat with patients in exam rooms. A minor stroke in 2008 makes it hard for Kottemann to write or type for sustained periods of time. He also believed that typing would detract from his communication with patients. [It often does, even for good typists. See my later link to a post on Scribes - ed.] </blockquote> It sounds like there may be a disability lawsuit as well as a sham peer review lawsuit brewing here... <blockquote>As a result, he decided not to attempt to type during patient visits. With dictation not an option, Kottemann for several months would go to the office before regular business hours and stay after the office closed in order to type in his notes. “It got to the point where I was going in seven days a week to keep up,” he said. </blockquote> The doctor was serving the computer; it became his master. <blockquote> Memorial sookesman Michael Leathers said no other doctor in the Lincoln clinic who used the new system’s dictation option lost any dictations. Kottemann said a Memorial official put him on administrative leave without warning last month. Govindaiah, however, said Memorial officials were working with Kottemann “to address some performance concerns … well in advance of Sept. 16.”Govindaiah said “mutually agreed-upon targets for performance” weren’t being met. Memorial placed Kottemann on a “paid leave of absence in order to address our concerns and to identify why we weren’t making any progress,” Govindaiah said.</blockquote> Again, was this sham peer review, or was full and fair due process being followed? <blockquote>At an impasse Kottemann said he knows his slowness on the system eventually could have compromised the care of his patients, but he wouldn’t have gotten behind if he had been better trained and if the dictation system had worked.</blockquote> It is well known that hospitals skimp on training. <blockquote>Govindaiah said Memorial did provide additional training and scribes to help him keep up. But Kottemann said the scribes lacked medical knowledge, so he couldn’t rely on them.</blockquote> Indeed. See my post <a href="http://hcrenewal.blogspot.com/2010/09/ultimate-workaround-to-mission-hostile.html">"The Ultimate Workaround To Mission Hostile Health IT: Humans (a.k.a. "Scribes"</a>). <blockquote>After being put on leave, Kottemann said he was cleared to return to work by a Bloomington psychologist and a Springfield occupational-medicine specialist. Those evaluations were requested by Memorial, he said. After those evaluations, Kottemann said Memorial also wanted him checked out by a neuropsychologist. Kottemann said he has refused this evaluation because he now believes Memorial officials are trying to have him declared impaired so they can fire him.</blockquote> Could this be a case of <a href="http://en.wikipedia.org/wiki/Constructive_dismissal">constructive discharge</a> as well? <blockquote> Kottemann said he scored among the top 1 percent of family medicine specialists in the 2009 exam he took to renew his board certification.</blockquote> But, the computer doesn't like him, so out he goes? <blockquote>... Kottemann said he doesn’t know what will happen next, but he has secured legal representation when dealing with Memorial in the future.“I want to see my patients, and they want to see me,” he said.</blockquote> But the computer doesn't want to see you. You're just not adapting to its deficiencies properly.Here's a passage that is really stunning: <blockquote>Doctors need to adapt, Medical Society president says Electronic medical-record systems aren’t perfect, and questions about whether they improve patient care and save money haven’t been answered conclusively, but doctors must try to adapt to the systems, the president of the Illinois State Medical Society says.“This is going to be the future, and we need to work on that,” said Dr. Wayne Polek, 57, an anesthesiologist who practices in the Chicago suburb of Geneva. “Like any technology, it has a lot of promise, but the devil’s in the details.”</blockquote> IT designers and implementers need to first adapt to doctors, not the other way around, I say to the Medical Society President. And it's OK for technology to be bedeviled by details...when the subjects are lab rats, not unconsenting human subjects, I say to the anesthesiologist. Hospitals are not IT beta testing and development shops. <blockquote>Doctors’ everyday use of electronic records is important for clinics and hospitals to qualify for millions of dollars in federal incentive payments and to avoid financial penalties in the future. But Polek said it shouldn’t be surprising that some doctors find the transition difficult.</blockquote> This is an experimental technology. Let me repeat: THIS - IS - AN - EXPERIMENTAL - TECHNOLOGY. Perhaps Polek should read what the major trade organization for HIT, <a href="http://www.himss.org/">HIMSS</a>, and the National Research Council say. From my post "<a href="http://hcrenewal.blogspot.com/2010/12/unintended-errors-with-ehr-based-result.html">Unintended errors with EHR-based result management: a case series, and a special pleading for health IT</a>": <div dir="ltr" style="font-family:arial;"> <div dir="ltr"> </div><blockquote><div dir="ltr">HIMSS's former Chairman of the Board admits the <a href="http://hcrenewal.blogspot.com/2010/07/barry-chaiken-md-mph-lets-be-patient.html" target="_blank">technology remains experimental</a>: </div> <blockquote style="margin-right: 0px;" dir="ltr"> <div dir="ltr">... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better; </div></blockquote> <div dir="ltr">While HIMSS itself admits <a href="http://www.himss.org/content/files/himss_definingandtestingemrusability.pdf" target="_blank">in this 2009 PDF</a> that </div> <blockquote style="margin-right: 0px;" dir="ltr"> <div dir="ltr">"Electronic medical record (EMR) adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available"; </div></blockquote> <div dir="ltr">While the National Research Council (the highest scientific authority in the U.S.) in 2009 <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572" target="_blank">reported that</a>: </div> <blockquote style="margin-right: 0px;" dir="ltr"> <div dir="ltr">"Current Approaches to U.S. Health Care Information Technology are Insufficient" and that the technology "does not support clinicians' cognitive needs." The study was chaired by Medical Informatics pioneers Octo Barnett (Harvard/MGH) and William Stead (Vanderbilt).</div></blockquote></blockquote><blockquote style="margin-right: 0px;" dir="ltr"><div dir="ltr"> </div></blockquote></div> <div dir="ltr" style="font-family:arial;"> </div> EHR's also may facilitate record spoliation and make upcoding/overbilling easier. See my posts "<a href="http://hcrenewal.blogspot.com/2011/09/stroud-v-abington-memorial-hospital-is.html">Stroud v. Abington Memorial Hospital: Is This Why Chart Alteration Might Be Appealing?</a>" on the former issue, and "<a href="http://hcrenewal.blogspot.com/2011/02/does-emr-facilitated-upcoding-formely_15.html">Does EHR-Incited Upcoding (Also Known as "Fraud") Need Investigation by CMS, And Could it Explain HIT Irrational Exuberance?</a>" on the latter. <blockquote>“A lot of us, even if we’re doctors, have problems programming a VCR,” he said. </blockquote> Perhaps the user experience of the VCR, like that of many EHR's, CPOE's etc., is <a href="http://www.tinyurl.com/hostileuserexper">mission hostile</a>. <blockquote>‘Not so hard’Dr. Gayle Woodson, 61, a surgeon who is president of the Sangamon County Medical Society, said she is convinced electronic records can improve patient care by making information more accessibly and, in some cases, helping physicians avoid errors.</blockquote> And what about the errors they promote? <blockquote>“It’s always a pain to do something different, but it’s not so hard,” she said.</blockquote> Really? How is that you speak for everyone regarding use of clinical IT and the cognitive issues, distractions, and difficulties it creates for many? E.g., see my post "<a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">An Honest Physician Survey on EHR's</a>." <blockquote>Springfield Clinic deploys a group of nurses specializing in “clinical informatics” who help doctors with the clinic’s electronic record system, chief clinical officer Mary Stewart said.</blockquote> What is their formal training in the field? Why no physicians specializing in Medical Informatics, such as those postdoctorally trained in the field? Too expensive, perhaps? See my post "<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html">ONC Defines a Taxonomy of Robust Healthcare IT Leadership.</a>" <blockquote>Hospital Sisters Health System, which operates St. John’s Hospital, finds that some doctors have more difficulty than others in the transition to electronic records, spokesman Brian Reardon said.“Doctors who are older need more attention,” Reardon said.</blockquote> Welcome to the legions of the Masters of the Obvious. - Or, have EHR's become a form of medical age discrimination, to root out those "old docs" who adhere to all those quaint relics of yesteryear (such as the Hippocratic Oath)? I believe Dr. Kotteman should defend himself vigorously on the issues I bring forth in this post. He should also demand data on near misses, patient injuries, and even patient deaths caused by the EMR he is being coerced to use, whether within his center or at other customer sites. Let the IT adapt to the doctors, and let the patients consent to its use in their care after being made fully aware of the downsides (as at my reading list). -- SS

Doctor Placed on Administrative Leave ("Railroaded?") Because He "Fell Behind on Handling Electronic Records For His Patients"

This story is tragic and appalling: Lincoln doctor, Memorial Health clash over electronic records By DEAN OLSEN The State Journal-Register P...

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Former US Secretary of Health and Human Services Saunters Through Revolving Door, Ends Up as Director of Medtronic

There they go again.  Another US government health care leader, this time the top health care leader at the end of the previous George W Bush administration, has wound up in a leadership position in a big, for-profit health care corporation.  As per the press release <a href="http://www.bizjournals.com/twincities/news/2011/10/17/medtronic-board-leavitt-fda.html">published</a> in the Minneapolis-St Paul Business journal, <blockquote>Mike Leavitt, the former Governor of Utah who also oversaw the Food and Drug Administration for four years, has been elected to the board of Medtronic Inc. Leavitt is the founder and chairman of Leavitt Partners, which advices clients in the healthcare and food safety sectors, according to a news release from Fridley-based Medtronic (NYSE: MDT). He served as governor of Utah from 1993 through 2003. Former President George W. Bush appointed Leavitt administrator of the Environmental Protection Agency in late 2003 and secretary of Health and Human Services in January 2005. Leavitt served in that position into January 2009. At Health and Human Services, he oversaw the FDA and the Center for Medicare and Medicaid Services — two agencies that are important to Medtronic, which makes medical devices.</blockquote> Mr Leavitt's full-time job is to chair <a href="http://leavittpartners.com/">Leavitt Partners</a>, which advertises that it "advises clients that invest in health care and food safety." It does not publicize its client list, but that list apparently includes Alliance Health Networks, whose press release noted that Leavitt Partners "will help it expand its presence in the US health industry and beyond "(look <a href="http://www.healthcareitnews.com/news/alliance-health-networks-gets-boost-leavitt-partners">here</a>); and Connextions, Inc, whose press release noted that it would work with Leavitt Partners to " refine existing health insurance exchange models for federal and state governments, as well as private sector organizations that are navigating health care reform law," (look <a href="http://www.businesswire.com/news/home/20110614005331/en/Connextions-Leavitt-Partners-Enter-Agreement-Bring-Health">here.</a>) Note that Mr Leavitt's official Department of Health and Human Services <a href="http://www.hhs.gov/secretary/dhhssec.html">biography</a> listed no training or experience in direct health care (or in biomedical sciences or the engineering of health care devices, for that matter.) Before he was Secretary of HHS, he was Governor of Utah, and before then, he was the CEO of an insurance company.  Since I very much doubt Mr Leavitt is a large Medtronic shareholder, it would appear that the rationale for his position on its board is his conectedness with other powerful health care insiders. Summary: the Revolving Door Mr Leavitt did not transit the revolving door as quickly as did other health care leaders from that administration.  We <a href="http://hcrenewal.blogspot.com/2010/12/former-nih-director-spins-trhough.html">noted</a> in 2010 that the leaders of the US Food and Drug Administration (FDA), US National Institute of Health (NIH), and US Centers for Disease Control (CDC) at the end of the Bush administration had already gotten powerful positions in the health care corporate world.  Mr Leavitt is not the first recent former Secretary of HHS to become the director of a big health care corporation whose fortunes may be affected by what HHS does.  We <a href="http://hcrenewal.blogspot.com/2011/06/embedded-networks-of-influence-in.html">noted</a> in 2011 how rapidly the Secretary of HHS at the end of the William Clinton administration, Donna Shalala, signed up as a director for UnitedHealth.  We have also noted a variety of <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">other examples</a> of the revolving door phenomenon. These examples suggest how the leaders of government health care agencies and health care corporations are becoming interchangeable, forming a giant embedded network of influence.  Furthermore, they suggest how top government health care leaders can now expect a cushy corporate position to open up as soon as they can legally accept it.  Whether government leaders who expect such future job opportunities will avoid offending possible corporate employers while in office, even if giving such offense would be good for patients' or the public's health, is an open question.  The answer, I fear, may be obvious.    These examples suggest that the US is becoming increasingly corporatist, a country dominated by an unholy alliance between top leaders of government and of large corporations, who are becoming increasingly interchangeable.  Another way of putting it is the country is increasingly dominated by an insider elite that manipulates the system for its own benefit.  A recent <a href="http://www.theatlantic.com/politics/archive/2011/10/can-an-overpaid-ceo-and-2-sleazy-union-lobbyists-unite-us/247302/">article</a> in the Atlantic juxtaposed two cases, one that of a CEO given a golden retirement package after presiding over the decline of his media company, and two union lobbyists who gamed the system to get outsized pensions.  While the first example would commonly draw condemnation from the left wing, and the second from the right, they are similar, and similar to those of  revolving doors we have discussed.   Author Conor Friedersdorf summarized the cases thus <blockquote>neither the CEO nor the lobbyists were paid what they earned, nor were they compensated in a way that made the relevant stakeholders better off. Instead they were taken care of in a way that reflected their elite insider status and their ability to take advantage of wrinkles in the system while breaking no laws. In both cases, less politically connected people -- other Gannett employees, Gannett shareholders, readers of Gannett newspapers, Illinois school teachers, and Illinois taxpayers -- were unjustly made worse off by what transpired. And isn't the overlapping ethic that guided the behavior of these people a big part of what's wrong with America? Behavior like theirs is one reason Americans on the right and left have recently taken to the streets. Ours is a society that has always tolerated inequality of wealth; and so long as some imperfect degree of fairness is maintained in the getting of material goods, the system functions smoothly. But if people feel that wealth they struggled to earn is being taken from them to pad the nest eggs of dishonorable union lobbyists; or that they're at risk of being fired from their $14 an hour job if they're ten minutes late, whereas their ultimate boss retires with an eight-figure package after presiding over plummeting stock prices and massive layoffs; people put in situations like that eventually revolt, if they've concluded that injustice is the norm rather than an aberration. </blockquote> I would propose that the fundamental injustice of having an insider elite run health care so as to put their self-interest first is the basis of what has gone wrong with health care (and the rest of the country, and maybe the world.) If we do not have the courage to first say this out loud, and then restore some rationality and justice to the structure and leadership of health care, the spiral will continue downward. Additional Thought I expect if any of the insider elite's defenders bother to read this, one argument they might propose is it was always thus.  How can one expect people who work as government leaders for a short time not to take advantage of the best possible job offers when they leave?  My answer is that an admittedly cursory look at history suggests it has not always been thus.  Using Wikipedia as an imperfect but quick source, I found that <a href="http://en.wikipedia.org/wiki/Joseph_A._Califano,_Jr.">Joseph A Califano Jr</a>, the last Secretary of Health, Education and Welfare under President Carter worked at a law firm, founded the National Center for Addiction and Substance Abuse, and wrote books after he left office.  He did serve on a corporate board (CBS), but not for a health care corporation.  <a href="http://en.wikipedia.org/wiki/Patricia_Roberts_Harris">Patricia Roberts Harris</a>, the first Secretary of HHS under President Carter, became a law professor.  <a href="http://en.wikipedia.org/wiki/Otis_R._Bowen">Dr Otis R Bowen</a>, the last Secretary of HHS under President Reagan, retired after that, but served on some non-profit boards and government committees.

Former US Secretary of Health and Human Services Saunters Through Revolving Door, Ends Up as Director of Medtronic

There they go again. Another US government health care leader, this time the top health care leader at the end of the previous George W Bus...

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What the Pfizer (V)? - Few Consequences of a Long History of Bad Behavior

The recent in-depth <a href="http://features.blogs.fortune.cnn.com/2011/07/28/pfizer-jeff-kindler-shakeup/">investigation</a> by Fortune reporters of 10 years of dysfunctional leadership at <a href="http://www.pfizer.com/">Pfizer</a>, the "world's largest research-based pharmaceutical company," raised many issues about leadership and governance in health care (see our post <a href="http://hcrenewal.blogspot.com/2011/08/10-years-of-pfizer-leadership-saga-of.html">here</a>).  In a series of posts, we then discussed lack of transparency in Pfizer's communication about management performance <a href="http://hcrenewal.blogspot.com/2011/08/what-pfizer-ii-lack-of-transparency.html">here</a>, how bad management was rewarded with outsize compensation <a href="http://hcrenewal.blogspot.com/2011/08/what-pfizer-iii-enormous-pay-for-poor.html">here</a>, and how a board of directors dominated by members of the "CEOs union," with a number of apparent conflicts of interests and multiple ties to the financial firms that brought us the "great recession," seemed happy to continually reward poor executive performance <a href="http://hcrenewal.blogspot.com/2011/09/what-pfizer-iv-one-board-to-rule-them.html">here</a>. The Latest Settlement A recent article also serves as a reminder that Pfizer's dysfunctional leadership and stewardship coincided with an amazing series of ethical missteps.  Just the latest legal settlement by Pfizer appeared <a href="http://www.washingtonpost.com/business/pfizer-agrees-to-pay-145m-to-settle-latest-government-charges-of-illegal-drug-marketing/2011/10/21/gIQAQZmZ3L_story.html">in the Washington Post</a> (from the AP). <blockquote>The drugmaker Pfizer Inc. has agreed to pay the government $14.5 million to settle charges it illegally marketed its drug for a condition called overactive bladder. The settlement disclosed Friday resolves the last of 10 whistleblower lawsuits, dating back to 2003, that claimed Pfizer marketed a number of its prescription medicines for unapproved uses. Pfizer agreed to pay $2.3 billion in September 2009 to settle both criminal charges and civil claims in many of those cases. The rest were dismissed. In the final case, Pfizer was accused of marketing overactive bladder drug Detrol for men with enlarged prostates and related conditions including bladder obstruction. The drug wasn’t approved for those uses.</blockquote> As usual, <blockquote>New York-based Pfizer, the world’s biggest drugmaker by revenue, said in a statement it denies all allegations of wrongdoing and that the 'settlement allows Pfizer to avoid the cost and distraction of litigation.'</blockquote> Maybe the company will stay out of trouble for a little while. Its statement noted, <blockquote>the company has put 'numerous controls and oversight mechanisms in place to ensure compliance with state and federal laws,' including a corporate compliance committee.</blockquote>A History of Misbehavior Based on recent history, it seems unlikely that the company will be able to stay out of trouble.  This settlement is just the latest chapter in a long story of misbehavior. Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post <a href="http://hcrenewal.blogspot.com/2009/09/pfour-legal-settlements-for-pfizer-why.html">here</a>).  Pfizer was involved in three other major cases from then to early 2010, including two involving settlements of fraud charges, and one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post <a href="http://hcrenewal.blogspot.com/2010/03/settlement-and-conviction-round-up.html">here</a>).  The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post <a href="http://hcrenewal.blogspot.com/2010/12/drug-companies-are-now-no-1-when-it.html">here</a>).  Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post <a href="http://hcrenewal.blogspot.com/2011/02/pharmacia-or-maybe-pfizer-settles-only.html">here</a>).   In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see <a href="http://www.bloomberg.com/news/2011-03-22/pfizer-reaches-asbestos-settlement-that-may-end-quigley-unit-s-bankruptcy.html">this story</a> in Bloomberg). And going back a little further, <a href="http://articles.philly.com/2009-09-03/business/25267571_1_pfizer-employee-pfizer-sales-representatives-zyvox">from the Philadelphia Inquirer</a>, <blockquote>Repeat Offender: Previous Pfizer Settlements April 2007: Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug. May 2004: Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000. October 2002: Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor. </blockquote>By my count, Pfizer made nine separate settlements from 2002 to 2011.  Some other bad behavior by Pfizer that did not necessarily result in legal action can be found under our label <a href="http://hcrenewal.blogspot.com/search/label/Pfizer">"Pfizer."</a> Summary Looking at a summary of this bad behavior, it seems remarkable that no individual in a leadership position at Pfizer has suffered any obvious negative consequence of these events, that Pfizer's whole leadership has not been forced to reorganize, maybe even that the company is still in business. Naively, one might ask why trust a company with such a track record? Why is there not so much mistrust of this organization that it could no longer continue business as usual? Yet, while as noted in previous posts, Pfizer has not had the best financial results, and has gone through several CEOs, the company has made no fundamental changes in its leadership or governance despite this sorry history. Perhaps one reason for the lack of response to these events is that they have not previously been presented together so that their pattern is evident, as we did above on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>.  It is true that in 2009, then Pfizer CEO Jeffrey Kindler acknowledged the company has had ethical lapses, and called on government and industry leaders in general to face up to ethical breaches or else the people would find a way to force changes upon them (see post <a href="http://hcrenewal.blogspot.com/2009/12/pfizer-ceo-now-acknowledges-we-need-to.html">here</a>.) However, not even then did Kindler detail Pfizer's own troubled history, and he did not last much longer as CEO. I have not found any other publication that puts together the list of bad behaviors that appears above. Most publications in business sections of the news media focus on only the most recent lapses. The medical, and health care/ services/ policy research literature generally ignores these issues entirely. So here is the tragedy of the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>. Because it is still simply not done to talk about the poor stewardship, bad leadership, and ethical misadventures of big health care organizations, the dysfunction just continues. As long as we fear to even talk about what has gone wrong with the leadership and governance of health care, how are we ever going to make any real improvements?

What the Pfizer (V)? - Few Consequences of a Long History of Bad Behavior

The recent in-depth investigation by Fortune reporters of 10 years of dysfunctional leadership at Pfizer , the "world's largest re...

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NIST on the EHR Mission Hostile User Experience: Blame the User? Nyet...

I have often had to respond to those who claim that EHR's don't cause medical errors, users do. That subset of the health IT irrationally exuberant seem common in the health IT industry and pundit channels. <a href="http://www.nist.gov/index.html">NIST</a> (The U.S. National Institute of Standards and Technology) has recently issued a draft report "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). The report is quite negative concerning the low usability of today's commercial health IT, and recommends significant improvements that have been standard practice in other mission- and life-critical IT sectors for decades. I will have more to write about this report, but I found a passage and footnote early in the report striking. Of note, from the new NIST draft report: This passage, from page 10: <blockquote>The EUP (EHR usability protocol) emphasis should be on ensuring that necessary and sufficient usability validation and remediation has been conducted so that use error [3] is minimized. [3] “Use error” is a term used very specifically 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 [or lack of messaging, e.g., no warnings of potentially dangerous actions - ed.], misuse of color-coding conventions, omission of information, etc. </blockquote>This passage describes what I have termed a <a href="http://www.tinyurl.com/hostileuserexper">mission hostile user experience</a>. "Blame the user" as the default, reflex reply to clinical IT-related medical errors, and the "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda">hold vendor harmless for defects</a>" clauses that facilitate this excuse are now heading to the junkpile - in the clinic, hospital, and courtroom. It is my hope that the the Wild West, free-for-all, cavalier, get out of jail free days of the health IT industry are coming to a close. Hint to health IT industry: you may actually need to invest in people who know what they're doing, instead of hiring the cheapest labor possible. (See, for example, my Aug. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html">EPIC's outrageous recommendations on healthcare IT project staffing</a>" for more on that issue.) -- SS Oct. 25, 2011 Addendum: <a href="http://histalk2.com/2011/10/24/thoughts-on-nists-ehr-usability-document-102411/#comment-17581"> This comment</a> (#5, October 25th, 2011 at 12:38 pm) by "a practicing front-end designer and application developer" over at HIStalk is quite interesting. The writer points out the differences between designers and developers, and opines that: <blockquote>If you’re going to improve vendor design, it has to begin with an internal commitment to value designers and what they contribute to the product development process. They can not be an afterthought. There are very few companies with this mindset. Almost all HIT companies are developer-driven, so the first thought, and one that is promoted in this report, is to turn developers into designers. This will not work! A developer and a designer require two fundamentally different skill sets that are not easily transposed. Developers are trained to think rationally and analytically; design requires empathy for the user. </blockquote> In health IT, empathy for the patient as well, I might add. -- SS

NIST on the EHR Mission Hostile User Experience: Blame the User? Nyet...

I have often had to respond to those who claim that EHR's don't cause medical errors, users do. That subset of the health IT irrati...

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