healthy4u: conflict of interest

Citizen's Council for Health Freedom: "The Truth about Electronic Health Records"

The Citizen's Council for Health Freedom (CCHF) is an independent 501(c)3 non-profit organization with a mission "to protect health care choices and patient privacy" (<a href="http://www.cchfreedom.org/about.php">www.cchfreedom.org/about.php</a>). Its president, Twila Brase, wrote this piece about Electronic Health Records in the CCHF newsletter of June 18, 2014, observing some "inconvenient truths" and highlighting one of the most asinine statements I've ever seen about computers made by (of course) a venture capital official who happened to play a significant role in formulating the Affordable Care Act a.k.a. "Obamacare": <blockquote class="tr_bq"><a href="http://healthenews.cchfreedom.org/newsletter.php/148">http://healthenews.cchfreedom.org/newsletter.php/148</a> The Truth about Electronic Health Records Propaganda only works for so long. Pretty soon truth catches up to it. This is exactly what's happening with electronic health records. If you're a doctor you know how bad the government-mandated electronic health record (EHR) is. But if you're a patient, you may not realize that EHRs are endangering your life and jeopardizing medical excellence. The EHR is nothing like what Big Government, Big Data, and Big Health said it would be. They promised convenience, coordinated care, fewer medical errors, more efficient medical practice, and portable medical records. They never meant it and it hasn't happened. These data systems were created for billing, data collection and government control of doctors, not patient care.</blockquote> From all I have seen over the years, I must agree with the last two sentences above. The pioneers who explored this technology back to the 1950's warned against the nightmare that exists today, but I don't think they believed we would ever get to where we are in 2014. Further, while Politico did not explicitly mention risk to life and limb caused by these systems, Twila Brase did.  "EHRs are endangering your life" is the elephant in the living room that the industry and its well-captured (and perhaps lubricated?) "regulators" simply will not address in a serious manner. It has been my belief this reflects self-serving willful blindness, gross negligence and/or pecuniary motives, but I also believe that a fundamental malevolence on the part of people and organizations who know better increasingly needs to be considered as a contributor to the recklessness in the health IT sector.  These are experimental technologies of admittedly (by the regulators) definite but unknown risk, due to impediments to that knowledge.  Demanding their rapid diffusion under threat of penalty while knowing about the risks, and the uncertainty about magnitude, certainly does not reflect a benevolent disposition. For more on the above points see my April 9, 2014 post "FDA on health IT risk: reckless, or another GM-like political coverup?" (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>) and its 11 points and hyperlinks.  This post and its linked brethren represents an indictment of sorts against the health IT hyperenthusiast culture and the unprecedented regulatory accommodation enjoyed by this sector. <blockquote class="tr_bq">Arthur Allen at POLITICO Pro eHealth (<a href="http://www.politico.com/story/2014/06/health-care-electronic-records-107881.html">http://www.politico.com/story/2014/06/health-care-electronic-records-107881.html</a>) says government-imposed EHRs are: <ul><li>Driving doctors to distraction </li></ul><ul><li>Igniting nurse protests </li></ul><ul><li>Crushing hospitals under debt</li></ul>"In short," he writes, "the current generation of electronic health records has about as many fans in medicine as Barack Obama at a tea party convention."</blockquote> I guess that's  Politco's way of saying "not very many at all." <blockquote class="tr_bq">Doctors forced to use these EHRs say: </blockquote><blockquote class="tr_bq"><ul><li>"They slow us down and distract us from taking care of patients."</li></ul><ul><li>"We're basically key-punch operators, transcriptionists having to input the data ourselves. It has essentially tripled the time to complete a medical record."</li></ul><ul><li>"That's why I'm retiring."</li></ul><ul><li>"Before I took notes, wrote what I wanted to say. Now I write and I click. If you just click, the person who reads the record gets no idea of what the patient was going through, your thought process."</li></ul><ul><li>"Anything that in a normal world would take at most two clicks, here it takes four or five."</li></ul></blockquote> In fact, doctors and nurses forced to use this technology say far worse (e.g., see my posts on candid clinician feedback at <a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html</a> , <a href="http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html">http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html</a> , <a href="http://hcrenewal.blogspot.com/2014/02/ehrs-real-story-sobering-assessment.html">http://hcrenewal.blogspot.com/2014/02/ehrs-real-story-sobering-assessment.html</a> , and <a href="http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html">http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html</a>). <blockquote class="tr_bq"> Proponents falsely promised privacy. The real goal of Big Government, Big Data and Big Health was NO privacy. Data is valued as a tool of control and a means to profit. And today, 2.2 million entities today have legal access to your medical records without your consent because of the so-called HIPAA "privacy rule" and the 2009 HITECH Act. In addition, untold numbers of computer thieves, identity thieves and hackers have illegal access.</blockquote> Not only that, but our data is sold in, in essence, data broker "back alleys" (e.g., see "Health IT Vendors Trafficking in Patient Data?" at <a href="http://hcrenewal.blogspot.com/2009/10/health-it-vendors-trafficking-in.html">http://hcrenewal.blogspot.com/2009/10/health-it-vendors-trafficking-in.html</a> ). Worse, the phenomenon of mismanagement of the "sales" is international in scope (e.g., see "NHS slammed for MAJOR data blunders as scale of patient info sell-off is revealed" at <a href="http://www.theregister.co.uk/2014/06/17/nhs_blamed_for_major_data_blunders_with_sale_of_patient_info_to_private_outfits/">http://www.theregister.co.uk/2014/06/17/nhs_blamed_for_major_data_blunders_with_sale_of_patient_info_to_private_outfits/</a>). <blockquote class="tr_bq">Every doctor and hospital must use EHRs by January 1, 2015 or face financial penalties. This was part of Obama's 2009 Recovery Act, and the foundation of Obamacare. The sheer cost of the mandate has forced many doctors to shut down private clinics and become health system employees, susceptible to being told by outsiders how to practice medicine.</blockquote> Regarding "crushing hospitals under debt", the EHR "mania" has led medical centers such as the University of Arizona Health System, about to undergo the stresses of mass immigration of South American children no less, to sink $30 million into the red in large part in trying to fix EHR bugs (see my June 2, 2014 post "In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red" at <a href="http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html">http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html</a>). As another example of madness, the mania -- plus bad health IT -- led a  medical system based in Rhode Island to spend $100 million to replace Siemens health IT that caused thousands of potentially harmful prescription errors (<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html</a>) with Epic, and in doing so, eroding the cash flow and bond rating of the state's largest health system (<a href="http://www.modernhealthcare.com/article/20140606/NEWS/306069948">http://www.modernhealthcare.com/article/20140606/NEWS/306069948</a>). Next Ms. Brase reveals a stunning fact about one of the architects of that 2009 Economic Recovery Act: <blockquote class="tr_bq">The arrogance of some EHR supporters is unpardonable. Bob Kocher helped write Obamacare, was trained as a doctor and is employed as a Venrock venture capitalist in health IT, but his credentials are those of a bureaucrat and profiteer (<a href="http://www.venrock.com/teammember/bob-kocher/">http://www.venrock.com/teammember/bob-kocher/</a>). </blockquote> Unpardonable arrogance indeed.  In other words, a speculator and profiteer in the health IT sector helped in the formulation of laws that pushed the technology onto physicians, nurses and hospitals with CMS penalties for non-adopters of "certified" systems.   It would be interesting to know just how far such a potential conflict of interest went in the crafting of the ACA and HITECH itself. Beyond that issue, this venture cap issues the following perverse statement, as cited by Politico and CCHF: <blockquote class="tr_bq">Per Politico pro eHealth, he says, "The reason so many [computers] are inefficient is that doctors are inefficient. If they redesigned their workflows, computers would work better."</blockquote> Readers of this blog are familiar with perversity in health IT, but that statement is literally stunning.  It would make for a funny Saturday Night Live or Rowan and Martin's Laugh-In (to us 60's folks) skit if the topic were not so serious. If they [doctors] redesigned their workflows, computers would work better? Where, exactly, is the evidence for that assertion?   Exactly how should doctors "redesign" their workflows, considering the poorly bounded, conflicted, highly variable, uncertain, and high-tempo nature of the field? [1] How can one even have a well-defined and unvarying "workflow" in such a domain that would "make computers work better?" Answer:  it's impossible. (Perhaps patients should adjust the unpredictable nature of their illnesses and symptoms to make the computers work better, too?) What Dr. Kocher seems to turn on its head is the recognition that:  "The reason so many [computers in healthcare] are inefficient is that they are grossly misdesigned for a domain like medicine.  They are unfit for purpose.  If they [the IT companies] redesigned their entire process in HIT production (from conception, design, implementation, marketing, and support) to be consistent with the needs of the field of clinical medicine and of clinicians, computers would work better." - Silverstein The reality is that if the healthcare IT industry actually fired its ossified business-IT-oriented leaders (since business computing and clinical computing are two highly different fields, e.g., see <a href="http://hcrenewal.blogspot.com/2008/06/business-v-clinical-computing.html">http://hcrenewal.blogspot.com/2008/06/business-v-clinical-computing.html</a>), or relegated them to managing accounting systems, and embraced the teaching of 50+ years of Medical Informatics in building good health IT (see definitions of good and bad health IT at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a>), then we might actually get significant value and better safety from the technology. Mr. Kocher, that's an idea to consider.  As I wrote at that 2008 post on business v. clinical computing: <blockquote class="tr_bq">... The prevalent belief in MIS [management information systems a.k.a. business computing] seems to be that medicine is another area of transactional business subject to conventional modeling by generalists, to be followed by "business process re-engineering" and traditional information systems development processes and methodologies. However, the belief that one could employ conventional business-oriented "analysis" in the clinical world always seemed to me to be oversimplistic, overoptimistic, and in fact not infrequently harmful to medical practice as a result of the simplistic assumptions. It is a belief that does not perform well even in the conventional business world where significant cost overruns, project difficulties, and project failures are commonplace, let alone in the unforgiving environments of medicine. </blockquote> My fear is that many in business computing may lack the mental flexibility and capability to understand issues like that, that conflict directly with their linear-flow, business-oriented worldview. <blockquote class="tr_bq">In other words, Mr. Kocher wants doctors to practice according to the computer systems he helped impose, not the doctor's patients. We must never let his agenda for medical practice prevail. State legislatures must act now to restore patient privacy rights and use Tenth Amendment powers to undo the EHR mandate.</blockquote> Exactly.  It's certainly the simple way to big profits, and injured and dead patients be damned.  Building good health IT is far more resource intensive. <blockquote class="tr_bq"> Working to sustain an ethical patient-doctor relationship, Twila Brase President and Co-founder</blockquote> Thank heaven someone is working towards those ends. Notes: [1]  Per Medical Informatics researchers Nemeth and Cook's "Hiding in plain sight: What Koppel et al. tell us about healthcare IT", Journal of Biomedical Informatics 38 (2005) 262–263 available at <a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf">http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf</a>)

Citizen's Council for Health Freedom: "The Truth about Electronic Health Records"

The Citizen's Council for Health Freedom (CCHF) is an independent 501(c)3 non-profit organization with a mission "to protect health care choices and patient privacy" (www.cchfreedom.org/about.php).Its…

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19 Jun 2014

Insurers' diversification creating monopoly power and conflict of interest - quoted in the Washington Post

I am quoted in a Washington Post article today on potential conflicts of interest when medical payers/insurers acquire the firms that hospitals and doctors use to challenge medical payment denials: <blockquote class="tr_bq"> <a href="http://www.washingtonpost.com/health-insurance-companies-push-to-diversify-raises-concerns/2012/04/27/gIQAWoSkoT_story.html" target="_blank">"Health insurers’ push to diversify raises ethical concerns" </a> Washington Post Jay Hancock, Sunday, April 29 Like hospitals and doctors everywhere, Banner Health fights a daily battle to get paid by insurance companies and government agencies for the care it delivers.  So the hospital system hired a company called Executive Health Resources to fight back against the likes of Medicare and UnitedHealthcare when they deny claims or pay bills for less than what Banner thinks it is owed.</blockquote> Fair enough. <blockquote class="tr_bq">But Banner executives began to worry about EHR’s independence when the firm was acquired in 2010 by UnitedHealth Group, UnitedHealthcare’s parent. </blockquote> Issues can get a bit sticky under such an arrangement. I put it this way: <blockquote class="tr_bq"> Critics call United’s ownership of EHR a troubling conflict of interest that could give it confidential information about rivals as well as patients and limit EHR’s power to demand payment from its much larger corporate sister. “How is that ownership going to affect the mission of a company whose business is to extract more money from payers?” said Scot Silverstein, a physician and specialist in medical software and patient records at Drexel University. “Imagine going to a plaintiff’s lawyer to take your malpractice case and not knowing that plaintiff’s lawyer actually works for the hospital that you’re suing.”</blockquote> When payers acquire those who would challenge their payment denials, I worry about the consolidation of power being too great for the public good. As we learn, the relationship is somewhat stealthy: <blockquote class="tr_bq">... There is no mention of EHR’s ownership in the “Corporate Overview” section of its Web site or elsewhere on the site. Nor did the American Hospital Association identify EHR as a United subsidiary in September when it renewed its exclusive endorsement of EHR’s denial-fighting services. EHR pays the hospital association a fee for the endorsement. The group declined to disclose the amount.  </blockquote> The plot thickens: <blockquote class="tr_bq">Claims consultants such as EHR typically gain access to millions of patient records and confidential contracts between hospitals and insurers, industry officials say. If UnitedHealthcare, United’s insurance wing, gained access to that data, it would obtain “a huge business advantage” over insurance rivals as well as the hospitals, Kofman said.</blockquote> In today's healthcare business environment, "if" seems to me to be optimistic. Hancock goes further in the article: <blockquote class="tr_bq"> As insurers eager to add revenue streams convert themselves into diversified health-services companies, they often buy traditional business adversaries, including physician groups and hospital consultants such as EHR. They’re also buying technology companies and research firms that serve medical-care providers, raising questions not only about independence but about the privacy of patient information. </blockquote> A Georgetown professor, formerly a state insurance superintendent, gets to the heart of the matter, using United as but one example: <blockquote class="tr_bq"> “I am not convinced that, even with proper disclosure, that an entity owned by United could aggressively advocate against United’s interests,” said Mila Kofman, a Georgetown professor who was Maine’s insurance superintendent.</blockquote> This factoid is eye-opening: <blockquote class="tr_bq"> Appealing claims denials has become a huge, high-tech business, reflected in the more than $1 billion that United reportedly paid for EHR [Executive Health Resources].</blockquote> You might think there were better things to do with $1 billion besides administrative bloat - such as taking care of patients. We probably need new laws to catch up with the flurry of M&A's going on in healthcare between payers, the healthcare delivery sector, and the "referees" that mediate between them when disputes arise. Read the entire article at the WaPo link above.  The examples get even more convoluted. -- SS Addendum: Roy Poses notes: <blockquote class="tr_bq">This appears to be a newly recognized type of conflict of interest that contributes to the concentration of power in the US commercialized health care system.  While many people tout how our health care system is "competitive" and a "free market," it is ever more dominated by a decreasing number of enlarging organizations.  True health care reform would break up health care oligopolies. </blockquote> -- SS

Insurers' diversification creating monopoly power and conflict of interest - quoted in the Washington Post

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29 Apr 2012

Wikipedia page on EHR's: ==Disadvantages== material seems to keep disappearing

It's interesting how most of the information below seems to have a hard time "staying put" on the Wikipedia page for "Electronic Health Record" at <a href="http://en.wikipedia.org/wiki/Electronic_health_record">http://en.wikipedia.org/wiki/Electronic_health_record</a> The information is presented in a neutral fashion from impeccable sources. Yet several Wikipedia "editors" take issue with it and, rather then editing it or refuting it (and stating their rationale and sources!), they keep deleting it. (The most recent <a href="http://en.wikipedia.org/w/index.php?title=Electronic_health_record&action=edit">edit history comments</a> follow this "disappearing" information, at the bottom of this post): <blockquote style="font-family: arial;font-family:arial;">==Disadvantages== <ref name="cbo2008/"></ref> <ref></ref>===Software quality and usability deficiencies=== EHR software is unregulated, unlike computer systems used both in the development and production of, and as a part of pharmaceutical products, medical devices, food, blood establishments, tissue establishments, and clinical trials.<ref>http://en.wikipedia.org/wiki/Validation_%28drug_manufacture%29</ref> Other life-critical industries also have strict software validation and testing standards, e.g., Federal Aviation Administration, NASA.<ref>http://www.faa.gov/regulations_policies/advisory_circulars/index.cfm/go/document.information/documentID/1019261</ref><ref>http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf</ref>. As a result, EHR software quality and usability is often suboptimal. For example, in "A study of an Enterprise Health information System", March 2011, a Medical Informatics researcher at [[University of Sydney]] in Australia found that a major EHR system for Emergency Departments slated for deployment in the public hospitals of [[New South Wales]] has serious deficiencies in software architecture and fit with clinician workflow. These deficiencies make it difficult to use and unreliable in terms of data integrity and loss, in one of the most demanding of clinical environments .<ref>http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146</ref> The [[Healthcare Information and Management Systems Society]] (HIMSS), a very large U.S. healthcare IT industry trade group, observed that EHR 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."<ref>http://www.himss.org/content/files/HIMSS_DefiningandTestingEMRUsability.pdf</ref> Serious reliability and usability problems with the U.S. Department of Defense’s [[AHLTA]] EHR system have been reported to the Congress.<ref>http://www.usmedicine.com/articles/electronic-records-system-unreliable-difficult-to-use-service-officials-tell-congress.html</ref> The U.S. [[National Institute of Standards and Technology]] (NIST) issued a Sept. 2011 report on deficient usability of current EHR systems, with recommendations for usability evaluation, testing and validation.<ref>http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf</ref> ===Unintended adverse consequences=== EHRs can introduce new unintended consequences, compared to paper records, and adverse outcomes, including patient injury and death, according to regualtory and governmental agencies, researchers, and others; for example, in an internal 2009 FDA memorandum<ref>http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf</ref> of Feb. 23, 2010 obtained and released by the Huffington Post Investigative Fund<ref>http://web.archive.org/web/20110425002322/http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight</ref>, EHR-related medical errors are categorized as: errors of commission (EOC), errors of omission or transmission (EOT), errors in data analysis (EDA), and incompatibility between multi-vendor software applications or systems (ISMA). The [[National Health Service]] (NHS) in the UK reports specific examples of EHR-caused patient harms in a 2009 document on guidance on the management of clinical risk relating to the deployment and use of health software, Annex A "Examples of potential harm presented by health software."<ref>http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009/0160182009specification.pdf</ref>. Also, in "Research in Ambulatory Patient Safety 2000–2010: A 10-year review", Dec. 2011<ref>http://www.ama-assn.org/resources/doc/ethics/research-ambulatory-patient-safety.pdf</ref>, the American Medical Association reports: <blockquote>:While health IT may confer benefits, some research has also suggested that health IT systems can create new issues or exacerbate existing problems. Wachter noted that, “[i]n both professional and lay publications, concerns have been raised that today’s electronic health records promote the copying and pasting of clinical information, instead of its thoughtful analysis; foster a focus on completing computerized checklists and templates rather than detailed probing of the patient’s history, and support less thoughtful diagnostic reasoning and more automatic behavior on the part of caregivers." Research indicates that a great deal depends on the design of the health information technology system, with poorly designed systems contributing to instances of errors (Ash et al). Where user interface designs are cumbersome to use and do not fit into the clinician’s natural work context, some have noted the potential for “cognitive overload,” among other reactions, and ultimately the possibility of increasing errors in data entry and retrieval as well as errors in the process of communication and coordination (Ash et al, Singh et al).</blockquote> In the U.S., FDA's MAUDE (Manufacturer and User Facility Device Experience) database<ref>http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM</ref>reveals many reported EHR problems, some of which could result in patient injury or death <ref>http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html</ref>. Both FDA (in the 2010 memo referenced above) and the [[Institute of Medicine]] of the National Academies in a 2011 study <ref>http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF</ref> reveal that EHR-related injuries and deaths are real, but the true extent is likely understated, they report, due to numerous factors impeding diffusion of knowledge such as contractual gag and hold harmless clauses<ref>http://jama.ama-assn.org/content/301/12/1276.extract</ref> and lack of familiarity by users of where to report EHR-related adverse events (per aforementioned 2009 FDA internal memo). A Medical Informatics researcher in the U.S. has compiled a well-referenced teaching site that covers unintended consequences of EHRs, health IT project difficulties and failure and related issues<ref>{{cite web | last=Silverstein| first=Scot| year=2012 | url=http://www.ischool.drexel.edu/faculty/ssilverstein/cases/ | title=Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties| publisher=Drexel University |accessdate=2012-01-26}}</ref>. The literature is conflicting on benefits and harms of EHRs <ref>http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html</ref>, and as in the Jan. 2009 U.S. National Academies study "COMPUTATIONAL TECHNOLOGY FOR EFFECTIVE HEALTH CARE: IMMEDIATE STEPS AND STRATEGIC DIRECTIONS", EHR's ultimate success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.<ref>http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572</ref> ===Regulatory controversy=== FDA's Jeffrey Shuren, MD JD, Director of the [[Center for Devices and Radiological Health]] (CDRH), has explicitly declared EHRs are a medical device.<ref>http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11673_910717_0_0_18/3Shuren_Testimony022510.pdf</ref> So has the [[Medical Products Agency (Sweden)]]; Swedish law for medical devices is based on EU Directives.<ref>http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf</ref>. In medicine, legal and ethical standards such as the NIH Guidelines for Conduct of Research Involving Human Subjects<ref>http://ohsr.od.nih.gov/guidelines/index.html</ref> and the World Medical Association Declaration Of Helsinki<ref>http://ohsr.od.nih.gov/guidelines/helsinki.html</ref> restrict introduction of new drugs and medical devices without informed consent, and without extensive preclinical and clinical testing and post-marketing surveillance, especially when risks of the technology are unknown. As in the 2011 U.S. [[Institute of Medicine]] study "Health IT and Patient Safety: Building Safer Systems for Better Care"<ref>http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF</ref>, there are calls for formal governmental regulation of the technology. </blockquote> The edit-history comments are quite interesting, where a poster who uses the ID "Barek" keeps deleting all or most of the information on EHR disadvantages, despite indications the material is impeccably sourced and does not draw its own conclusions. Read from bottom to top: <blockquote style="font-family: arial;font-family:arial;">17:29, 27 January 2012‎ Ohnoitsjamie (talk | contribs)‎ (67,826 bytes) (please discuss on talk page, as you are approaching WP:3RR) 17:28, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,232 bytes) (clarifying that information comes from the cited sources.) 17:26, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,137 bytes) (→Unintended adverse consequences) 17:24, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,151 bytes) (If you have factual disageements, let them be known and document the source of your information.) 17:23, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,137 bytes) (If you have factual disageements, let them be known and document the source of your information.) 17:18, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,122 bytes) (Undid revision 473542684 by Barek (talk). Barek may have a conflict of interest regarding exposure of health IT difficulties.) 17:14, 27 January 2012‎ Barek (talk | contribs)‎ m (67,826 bytes) (Reverted edits by InformaticsMD (talk) to last version by Barek) 17:14, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,122 bytes) (→Regulatory controversy) 17:12, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,217 bytes) (The added information is factual, well-referenced from impeccable sources, and does not draw conclusions.) 17:08, 27 January 2012‎ Barek (talk | contribs)‎ (67,826 bytes) (→Disadvantages: restore some content after purging WP:SYNTH material) 17:06, 27 January 2012‎ Ohnoitsjamie (talk | contribs)‎ (65,826 bytes) (rv per WP:SYNTH) 17:01, 27 January 2012‎ 108.16.62.235 (talk)‎ (76,341 bytes) (Undid revision 473539844 by Barek (talk)) 16:57, 27 January 2012‎ Barek (talk | contribs)‎ (65,826 bytes) (rv - some of that content is usable - but most is pure WP:SYNTH, attempting to draw conclusions rather than simply stating what's in the sources - requires a total re-write to be encyclopedic) ... 20:22, 26 January 2012‎ SarekOfVulcan (talk | contribs)‎ (65,058 bytes) (→Unintended Adverse Consequences: actually, remove whole section - BAD HANDWRITING can result in patient injury and death) 20:21, 26 January 2012‎ SarekOfVulcan (talk | contribs)‎ (65,860 bytes) (→Unintended Adverse Consequences: If it's unknown, we don't need to report it. If it's not a RS, we don't need to report its conclusions. And "a researcher says" isn't notable enough to mention without establishing authority in the subject) (undo) </blockquote> I note that the logically fallacious "Bad handwriting can cause patient injury and death, so remove whole EHR Unintended Adverse Consequences section" and "if it's unknown, we don't need to report it" [regarding the referenced FDA and IOM observations that the true extent of EHR adverse consequences is unknown -- which is on its face a matter critical to public health and policy - ed.], coming from an editor who ironically calls him/herself "Sarek of Vulcan", offers a prime example of how the utopian concept of tapping "community wisdom" can fall flat on its face. WP:SYNTH is Wikipedia-talk for "Synthesis of published material that advances a position", i.e., "drawing conclusions." Apparently, when it comes to EHR, citing the work of governmental regulatory and healthcare agencies, expert researchers, etc. is "drawing conclusions."Wikipedia is essentially open to all, including the HIT industry and its pundits. It is possible that the Wikipedia editors who keep deleting the material could have some sort of conflict of interest. COI could cause them to find easily-verifiable information from impeccable sources on the Wikipedia EHR page (viewed 22924 times in the last 30 days as of this morning) that refutes common cybernetic legends to be "inconvenient." We've certainly seen that type of person before (<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html">link</a>).This affair may also be another example of the "<a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>", the notion we discuss often on this blog that certain topics in medicine and health care 'just aren't talked about', in action. The 'disadvantages' material, revised, will be re-posted again soon, after my being blocked (for 'reverting', i.e., restoring the material three times in 24 hrs.) expires tomorrow. It will be revised to have as neutral a tone as possible, with exact page numbers where possible, in accordance with written Wikipedia examples. If the additions still disappear, that will be revelatory. -- SS

Wikipedia page on EHR's: ==Disadvantages== material seems to keep disappearing

It's interesting how most of the information below seems to have a hard time "staying put" on the Wikipedia page for "Electronic Health Record" at http://en.wikipedia.org/wiki/Electronic_health_record…

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27 Jan 2012

A comment posted to the website "Doctors Helping Doctors Transform Healthcare", Peter Basch, William Bria et al.

A new website has appeared that purports to be: <blockquote>A collaborative effort led primarily by doctors for doctors to provide a "trusted resource" for physicians as they work to transform health care - initially through the use of health IT.</blockquote> The site is entitled "Doctors Helping Doctors Transform Health Care" and is at <a href="http://doctorshelpingdoctorstransformhealthcare.org/">this link</a>. (I note that when one encounters such platitudinous and potentially highly ideological titles, one should ask "transform how, and into what, exactly?" I presume "transform" means, in part, to reduce risk and improve safety and outcomes - while protecting patient and physician rights.) The site has a significant number of people on their advisory board (<a href="http://doctorshelpingdoctorstransformhealthcare.org/leadership/">link</a>), but no information on compensation. I note there are industry people involved, representing a potential conflict of interest. According to one of the principals, <a href="http://doctorshelpingdoctorstransformhealthcare.org/author/pbasch/">Peter Basch, MD</a>, Medical Director, Ambulatory EHR and Health Information Technology Policy, MedStar Health, Washington, DC, <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/">on funding:</a> <blockquote>A Few Words About Our Supporters It takes resources to create and maintain this site, to make the work of Doctors Helping Doctors possible. We have solicited unrestricted contributions from individuals and organizations who believe in our mission and are able to support its work. In particular, we wish to thank Patrick Soon-Shiong of the Chan Soon-Shiong Family Foundation, John Glaser of Siemens Health Services; and Andy Slavitt of Optum’s Institute for Sustainable Health.</blockquote> To my knowledge, I've never met Dr. Basch, but at meetings I have met one of the other principals of the new website, <a href="http://doctorshelpingdoctorstransformhealthcare.org/author/wbria/">William Bria, III, MD</a>, Chief Medical Information Officer, Shriners Hospitals for Children; President and Co-Founder, Association of Medical Directors of Information Systems (AMDIS), St. Petersburg, FL. Dr. Basch's writing has appeared at Healthcare Renewal before, such as at the Jan. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/01/throwing-national-research-council.html">Throwing The National Research Council Report On Health IT Under The Bus, Part 1: MedStar Health</a>." In the new site, Dr. Basch states that: <blockquote>As early adopters, EHR implementers, and practicing physicians, we have seen the “bad and the ugly” as well as the promise of health IT. We understand how health IT can and should be used to make care better, safer, and more value-laden. As such, we believe that unnecessarily harsh criticism of Meaningful Use—which we have heard from some quarters—and uncritical cheerleading—which we have also heard—are equally unhelpful. We see physician “extremism” essentially marginalizing what is needed now more than ever—a clear and constructive physician voice, articulating not for compliance with Meaningful Use, but rather leveraging the opportunity that Meaningful Use presents, and consistently inserting the highest ideals that led us all to choose a career in medicine.</blockquote> While on the surface this is not an unreasonable position, I fear the word "extremism" is used as a metaphor for those who express genuinely critical appraisals of the state of health IT as it now exists, on issues regarding safety, efficacy, usability, need for regulation, vendor, buyer and user liability, and other "unpleasant" topics. I do note precious little on the site about educating physicians on the considerable downsides of health IT as it currently exists, nor on the scientific literature expressing doubts about its safety, efficacy, usability, ROI and other issues (such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">here</a>). There is, it would seem obvious, no ethical excuse for introducing medical devices and other technology of unknown benefit and of unknown risk magnitude (as recently reported by the IOM, see <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">this post</a>), that is <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">unregulated</a>, into life-critical domains such as medicine without explicit acknowledgement of experimentation. Human subjects experimentation requires, of course, explicit informed consent under the <a href="http://grants.nih.gov/grants/policy/hs/ethical_guidelines.htm">many guidelines</a> formulated as a result of past systemic abuses. Also, users need to be fully aware of the risks. Such informed consent cannot be accomplished, and awareness attained by physicians regarding the dangers of use of health IT in its present form, through simple "best practices" protagonism. For instance, health IT can be inherently defective and/or <a href="http://www.tinyurl.com/hostileuserexper">mission hostile</a> (worse, the industry is unregulated), and can injure or kill. Several illustrative examples just off the top of my head are at: <ul><li>"<a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html">FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death</a>";</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">Lifespan (Rhode Island): Yet another health IT 'glitch' affecting thousands</a>";</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html">FDA MAUDE Database: Patient Outcome - Death</a>" and "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">FDA Manufacturer and User Facility Device Experience (MAUDE) database - case reports of EHR defects</a>";</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/12/ecri-healthcare-it-in-top-ten-health.html">ECRI: Healthcare IT In Top Ten Health Technology Threats to Patient Safety</a>";</li></ul><ul><li>"<a href="http://iig.umit.at/efmi/badinformatics.htm">Bad Health Informatics Can Kill</a>" [European Federation for Medical Informatics]; </li></ul><ul><li> "<a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">A Study of an Enterprise Health information System</a>" [Australia - severe deficiencies in software engineering noted in major U.S. vendor ED EHR system that cause user confusion as well as data corruption/loss];</li></ul><ul><li>"<a href="http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009/0160182009specification.pdf">Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software</a>" [ISO/UK NHS - with an accounting of EHR-related medical errors in Annex A]; </li></ul><ul><li> and a personal account "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">A Diary of EHR-Initiated Tragedy</a>."</li></ul> Not even including privacy and confidentiality issues (see <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">this query link</a> on those issues), should physicians, nurses, patients and other stakeholders not be explicitly educated on the issues of risk, that can be greatly replicated/amplified across hundreds or thousands of patients by EHRs as opposed to paper, and on actual injuries and deaths that have occured? If not, why not? Are not these issues and the issue of the <a href="http://hcrenewal.blogspot.com/2010/08/health-it-via-observation-and-research.html">lack of a culture of safety in the health IT field</a> at least as important, if not more important for clinicians, patients, healthcare executives and other stakeholders to be strongly aware of than "best practices" and "meaningful use?" (I note that the "negative reports are mere anecdotes" argument commonly used by health IT pundits only shows, as in the Aug. 2011 essay by a senior clinician in Australia "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things</a>", that those making that argument need to attend revision courses in research methodology and risk management.) In consideration of the "Doctors Helping Doctors" site's seemingly uncritical pro-HIT advocacy, I have posted the following note at the end of Dr. Basch's introductory essay. The comment appears <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/#comment-20">at this link</a> and is awaiting moderation. The comment's remaining online would be a sign that the site is not another attempt to "<a href="http://hcrenewal.blogspot.com/2011/03/how-lousy-health-it-gets-pushed-on.html">control the channel</a>", and is truly serious about being "trusted." It would be a sign of a site truly concerned with "physicians helping physicians transform health care" while not sacrificing patients as unconsenting test subjects of unregulated, experimental <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">software-based medical devices</a> in the process. <cite class="fn"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" rel="external nofollow" class="url"></a></cite><blockquote><cite class="fn"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" rel="external nofollow" class="url">S Silverstein MD</a></cite> says: <div class="comment-meta commentmetadata"> <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/#comment-20">December 17, 2011 at 10:29 pm</a> </div> Doctors, One way to help doctors transform healthcare would be to educate them on the downsides of information technology in healthcare, how to avoid them, and the conflicting literature on benefits (e.g., as at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglis">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist</a>). I do not see such information here yet. I do expect some such information will follow. Sincerely, Scot Silverstein --------------------------------------------------- Scot M. Silverstein, MD Consultant/Independent Expert Witness in Healthcare Informatics (May 2010-present) Adjunct faculty in Healthcare Informatics and IT (Sept. 2007-present) Assistant Professor of Healthcare Informatics and IT, and Director, Institute for Healthcare Informatics (2005-7) Drexel University College of Information Science and Technology 3141 Chestnut St., Philadelphia, PA 19104-2875 Email: sms88 AT drexel DOT e-d-u Bio: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm</a> Common Examples of Healthcare IT Difficulties: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/ </a> Note: I am cross-posting this comment on Healthcare Renewal blog under the title "A comment posted to the website 'Doctors Helping Doctors Transform Healthcare, Peter Basch, William Bria et al.'"</blockquote> It is my hope the comment stays, and receives a reasoned reply. -- SS Dec. 23, 2011 addendum: My comment appears to have disappeared. I leave it to the reader to determine what that means about the site "Doctors Helping Doctors Transform Healthcare." -- SS

A comment posted to the website "Doctors Helping Doctors Transform Healthcare", Peter Basch, William Bria et al.

A new website has appeared that purports to be:A collaborative effort led primarily by doctors for doctors to provide a "trusted resource" for physicians as they work to transform health care - initia…

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17 Dec 2011

Quis Custodiet Ipsos Custodes? Redux

Revised HHS Rules for Conflict of Interest Fall Short This morning NIH Director Dr. Francis Collins announced <a href="http://freepdfhosting.com/3dde31520d.pdf">revisions</a> to the existing 1995 regulations on objectivity in research that is funded by the Public Health Service. The focus is on significant financial interests (SFI) and on financial conflicts of interest (FCOI). The regulations illustrate the 3-way dance involving academic institutions (the grantees), NIH (the grantor) and academic scientists (the investigators). Thanks to Senator Grassley (R-Iowa) and his investigator Paul Thacker, headlined revelations in recent years about unacceptable management of FCOI at places like Stanford (Alan Schatzberg), Emory (Charles Nemeroff) and Harvard (Joseph Biederman) forced these revisions of the NIH regulations. The general initial reaction to the new rules has been critical – <a href="http://www.pharmalot.com/2011/08/nih-issues-new-conflict-of-interest-rules/">here</a> and <a href="http://pogoblog.typepad.com/pogo/2011/08/the-national-institutes-of-health-new-ethics-rules-a-swing-and-a-miss.html">here</a>, for instance. Many stakeholders had urged the NIH to require that institutions make the disclosed FCOI of their investigators available on a public website. Dr. Collins had intimated that we could expect to see this change, so there is consternation that it somehow became derailed by institutional lobbying in recent months. The stated concern was that institutions would feel burdened by the need to maintain these data bases. Instead, if citizens wish to inquire about FCOI involving PHS-derived research funding, they will need to write to the institution, which is obliged to respond within 5 days. That’s not exactly user friendly. POGO today made the smart <a href="http://pogoblog.typepad.com/pogo/2011/08/the-national-institutes-of-health-new-ethics-rules-a-swing-and-a-miss.html">suggestion</a> that the data could easily be attached to information about awarded funds on the <a href="http://projectreporter.nih.gov/reporter.cfm">NIH RePORTER</a> website, that already exists. A second failing is that the revised regulations do not close the regulatory loophole through which Charles Nemeroff strolled when he moved from Emory to the University of Miami. We covered that incident <a href="http://hcrenewal.blogspot.com/#uds-search-results">several times</a> on this blog last year. Though Nemeroff was under a 2-year sanction and banned from participating in NIH-funded research at Emory, his friend Thomas Insel, Director of NIMH, assured the dean of the medical school at Miami that Nemeroff was in good standing to apply for NIH funding when he moved from Emory. To underline the point, Insel displayed the bad judgment of appointing Nemeroff to 2 new NIMH review committees. Do today’s revised regulations prevent a repeat of this administrative travesty? No, they don’t. There is some mention of ensuring oversight if a sanctioned investigator wishes to transfer a grant to a new institution, but nothing to prevent the Nemeroff-Insel dance from being repeated. Here is the relevant section of today’s <a href="http://freepdfhosting.com/3dde31520d.pdf">announcement</a> (page 89): We did, however, agree with one respondent that it would be helpful to clarify, in the grants context in particular, that institutional sanctions against an Investigator can travel with the Investigator upon his or her transfer to another Institution. Specifically, we have revised 42 CFR 50.606, paragraph (a), as follows: “If the failure of an Investigator to comply with an Institution’s financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Institution shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS-funded research project. The PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.” This revision is intended to reference the range of options for the PHS Awarding Component to consider, depending on the specific circumstances at issue. For example, PHS may decide to initiate government-wide suspension or debarment of the Investigator under 2 CFR Part 376; or to use enforcement measures under 45 CFR 74.62, e.g., perhaps to make the approval of a transfer contingent upon the former Institution’s disclosure of the corrective action- including the specific sanctions against the Investigator- to the new Institution; and/or to use special award conditions under 45 CFR 74.14, e.g., perhaps to make the new Institution agree to take the same or similar action against that Investigator or explain to the PHS Awarding Component in writing why such action was not taken and what alternative measures will be used to ensure compliance. What’s wrong here? Everything is optional; everything is discretionary; everything is contextual – that is a formula for NIH and the academic institutions to just look the other way. And if a Nemeroff decides just to relocate without transferring a grant then he is free to start reapplying again right away. Miami would not be required to continue applying the Emory sanction banning him for 2 years from involvement in federal grants. The PHS Awarding Component (NIMH in this case) may or may not get involved, or it may pass the buck to the new institution. So what has changed? If it is left up to compromised federal bureaucrats like Thomas Insel, and institutional administrators like Pascal Goldschmidt at Miami, then nothing has changed. It's business as usual, folks. Dr. Collins, you have not done what you set out to do. Too bad.

Quis Custodiet Ipsos Custodes? Redux

Revised HHS Rules for Conflict of Interest Fall Short This morning NIH Director Dr. Francis Collins announced revisions to the existing 1995 regulations on objectivity in research that is funded by th…

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23 Aug 2011

WHO YOU GONNA BELIEVE?

WHO YOU GONNA BELIEVE? Ghostwriting Charges and Stonewalling at the American Psychiatric Association The American Psychiatric Association came under a searchlight this past December over allegations of ghostwriting. The story originated with a public <a href="http://www.pogo.org/pogo-files/letters/public-health/ph-iis-20101129.html">letter</a> from Project on Government Oversight (POGO) to the Director of NIH, and it was picked up by Duff Wilson writing in the <a href="http://www.nytimes.com/2010/11/30/business/30drug.html?_r=3">New York Times</a>. The book was Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. The named authors were Charles Nemeroff, now chairman of psychiatry at the University of Miami, and Alan Schatzberg, formerly chairman of psychiatry at Stanford University. Both are well known for ethical controversy – see <a href="http://hcrenewal.blogspot.com/search?q=Nemeroff">here</a> and <a href="http://hcrenewal.blogspot.com/search?q=Schatzberg">here</a>. Soon, these allegations were being dissected in the blogosphere, with stellar contributions from <a href="http://carlatpsychiatry.blogspot.com/2010/11/its-textbook-its-ad-its.html">Daniel Carlat</a>, <a href="http://1boringoldman.com/index.php/2011/01/21/when-charlie-met-sally/">1boringoldman</a>, <a href="http://www.pharmalot.com/2010/11/ghostwriting-from-medical-journals-to-entire-books/">Ed Silverman</a>, and <a href="http://alison-bass.blogspot.com/2010/12/government-oversight-agency-calls-on.html">Alison Bass</a>. The APA and its publishing arm, known as American Psychiatric Press, Inc. or APPI, came to the defense of the two prominent academic authors over the ghostwriting charge. In particular, an APA employee named Mark Moran authored a <a href="http://pn.psychiatryonline.org/content/46/2/1.1.full">denial </a>of the charge in the January 2011 issue of the APA news magazine, Psychiatric News. As the controversy played out, letters from attorneys demanded retractions, and partial qualifications of the original story appeared in the New York Times and on the POGO weblog. There was never any doubt that the heavy lifting was done by a pair of professional writers employed by a medical communications company under a financial grant from a drug company. Nemeroff defended his role by averring that he ‘scrutinized’ the work product of the professional writers. Threatening letters from lawyers for Nemeroff and Schatzberg were publicized, and the APA weighed in. The coup de grâce was administered by blogger Daniel Carlat’s withering <a href="http://carlatpsychiatry.blogspot.com/2010/12/nemeroff-and-schatzbergs-textbook.html">review</a> of the book’s artful construction to highlight the use of the sponsoring company’s antidepressant and anti-anxiety drug in primary care, while muting important information about the drug’s liabilities. Nevertheless, the APA held to its legalistic stance in defense of the ‘authors.’ This behavior is counterproductive for professional medical organizations, as I have discussed <a href="http://hcrenewal.blogspot.com/2010/12/impeachment-its-about-institution-not.html">before</a>, because it misses the ethical forest for the legal trees. Now comes the good part. In response to the piece by Mark Moran in Psychiatric News, Leemon McHenry prevailed on Robert Rubin and myself to write with him to the magazine’s editors. Leemon is a faculty member in the Department of Philosophy at California State University, Northridge. He also has experience evaluating legal documents arising in litigation over antidepressant drugs. Robert Rubin has partnered with me in outing several notable ethics compromises involving Nemeroff and Schatzberg, going back as far as 2002, though we always call ourselves equal opportunity critics. Our letter sent in late January to Dr. Carolyn Robinowitz, the Interim Editor of Psychiatric News, has been <a href="http://pogoblog.typepad.com/pogo/letter-to-apa-20110128.html">posted</a> today on the POGO site. In our letter, we challenged much of Mr. Moran’s defense, and we called attention to what WASN’T in the public domain, despite all the claims and counterclaims. Essentially, the partial qualifications of the original reports that appeared in The New York Times and in the letter to NIH from POGO resulted from the inconclusiveness of some of the documents. We called on the APA to come clean with the release of all relevant materials, in the interest of transparency. For instance, what WASN’T known were the specifics of the contract involving the corporation, the (ahem) authors, the publisher (APPI), and the medical communications company. Or the money flow to the ‘authors’ from the contract in addition to their royalties. Or the legal release form transferring ownership of the work product to the ‘authors’ and APPI. Or the corporation’s planned marketing activities, given that the corporation ordered 10,000 copies of the book. Or the correspondence among all parties that might reveal who actually did what. Leemon McHenry’s perspective is that this hidden layer of documents may well be available if they could be unsealed in pending litigation. Naturally, corporations and their attorneys strive to keep the information hidden. But our general point is that the APA has a different duty – which is to transparency rather than to stonewalling. Did the APA do that? Sadly, no, they did not. Here is the curt <a href="http://pogoblog.typepad.com/pogo/apa-response-20110322.html">reply</a> from the Executive Editor Catherine Brown denying publication of our letter after a delay of almost 8 weeks. Now that’s what I call stonewalling.

WHO YOU GONNA BELIEVE?

WHO YOU GONNA BELIEVE? Ghostwriting Charges and Stonewalling at the American Psychiatric Association The American Psychiatric Association came under a searchlight this past December over allegations o…

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04 Apr 2011

DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

DR. PANGLOSS AS NIH INSTITUTE DIRECTOR JAMA is out today with a <a href="http://jama.ama-assn.org/cgi/content/extract/303/12/1192">Commentary</a> by Dr. Thomas Insel, Director of the National Institute of Mental Health. Using indirection, Dr. Insel has risen to the defense of seven academic psychiatrists on whom an ethical searchlight has been trained for the past several years by Senator Grassley and others. With ludicrous optimism and a series of straw man discussions, Dr. Insel makes the case that things are not really as bad as they seemed to be or, if they were, then other specialty physicians were doing much the same things. Dr. Insel needs to recalibrate his ethical compass. Why is an NIH Institute Director issuing this apologia for the corruption of academic psychiatry? Does he not have better things to do, such as ensuring that longstanding NIH regulations on conflict of interest are enforced? Why does an NIH Institute Director presume to speak for academic psychiatry? Where are the leaders of the major professional and scientific organizations like the American Psychiatric Association, the American College of Psychiatrists, the American College of Neuropsychopharmacology, and the Society of Biological Psychiatry? Why are they not stepping up publicly to the plate? Perhaps they are confounded by the awkward fact that some of the seven individuals are current and past presidents of these very organizations. Even the Institute of Medicine of the National Academy of Sciences has not sanctioned those of the seven who are Institute members. Why is an NIH Institute Director downplaying the gravity of the ethical controversies surrounding these compromised individuals like Charles Nemeroff at Emory (now at Miami), and Alan Schatzberg at Stanford? To hear Dr. Insel tell it, all they did was fail to disclose income from pharmaceutical companies. That is not the half of it. Readers can look <a href="http://hcrenewal.blogspot.com/search?q=Nemeroff">here</a> and <a href="http://hcrenewal.blogspot.com/search?q=Schatzberg">here</a> for much more detail on the activities of Nemeroff and Schatzberg. If Dr. Insel chose to remain ignorant of or to overlook the history of false claims on behalf of pharmaceutical corporations or the concealment of consulting relationships or the complaisance with ghostwriting or the patently misleading “educational” presentations or the cashing in through stock sales or the editorial self dealing, then Dr. Insel’s fitness to serve as an NIH Institute Director needs to be reviewed. Surely Dr. Insel knows that Nemeroff and the others worked mainly with the marketing personnel within pharmaceutical companies. Nemeroff’s staggering schedule of promotional talks for GlaxoSmithKline, released by Senator Grassley, is testament to that. So is Nemeroff’s record of priming the pump for himself with GSK by giving the corporation unpublished research data from NIMH-funded projects at Emory. In turn, GSK and its medical education communications company, Scientific Therapeutics Information, Inc., incorporated Nemeroff’s privileged material in the training manual for PsychNet – a speaker program designed to build advocacy for GSK’s antidepressant drug Paxil. These issues go well beyond just failing to report income. They signify the corruption of academic psychiatry. Doesn’t Dr. Insel understand that? In his Commentary, Dr. Insel reported no financial disclosures. This is a good example of the problem that Dr. Insel doesn’t see. Many readers will interpret this Commentary from the Director of NIMH as the opening move in the attempted rehabilitation of Charles Nemeroff by his friends and cronies. Though Dr. Insel spoke in platitudes about the need for transparency as a solution, the spirit of transparency did not move him to disclose that Nemeroff is his former boss at Emory; that Nemeroff found a position for him when Insel was departing the intramural research program at NIMH; that Nemeroff lobbied for Insel’s appointment as NIMH Director; and that Insel appointed Nemeroff as an advisor soon after he moved to NIMH. These are pertinent conflicts of interest that readers of JAMA deserve to know about. Quis custodiet ipsos custodes? Maybe Dr. Insel should stick to his knitting and resist the impulse to speak for academic psychiatry as a whole. A good place for him to start looking hard would be at the productivity and accounting of the once vaunted Emory-GSK-NIMH Collaborative Mood Disorders Initiative (Principal Investigator Charles B. Nemeroff; 5U19MH069056). One never knows what one will find when the rocks are turned over.

DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

DR. PANGLOSS AS NIH INSTITUTE DIRECTORJAMA is out today with a Commentary by Dr. Thomas Insel, Director of the National Institute of Mental Health. Using indirection, Dr. Insel has risen to the defens…

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23 Mar 2010

Study: Researchers with Glaxo ties favored Avandia

As mentioned in my previous post on the MIT controversy surrounding an economist's testifying to Congress on healthcare policy without revealing possible economic conflicts of interest that could affect his views, frequently expressed on this blog are concerns about undisclosed conflicts of interest and their corrosive effects upon healthcare (<a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">query link</a>). One major question that arises is the degree to which conflicts of interest can affect the integrity of the scientific literature. Answering this question is more a matter of social science research rather than biomedical inquiry. One internal medicine resident at the Mayo Clinic took on this challenge and published such a study, a systematic review, in the British Medical Journal. It is entitled "<a style="font-weight: bold;" href="http://www.bmj.com/cgi/content/full/340/mar18_1/c1344">Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review</a>" (BMJ 2010;340:c1344). Mayo Clinical researchers led by the resident, Amy Wang, examined more than 200 articles that appeared after an analysis in the NEJM linked Avandia to a 43 percent increased risk of heart attacks, and a subsequent clinical trial found no greater danger of heart disease. The results are fascinating. From a summary in the <a href="http://www.philly.com/inquirer/business/homepage/20100320_Study__Researchers_with_Glaxo_ties_favored_Avandia.html">Philadelphia Inquirer</a>:<blockquote> "We aimed to determine whether financial conflicts of interest with pharmaceutical manufacturers could be fueling this fire," wrote the researchers, led by Amy Wang, a resident in internal medicine at the Mayo Clinic in Rochester, Minn. "From our findings, it appears that the answer is yes.</blockquote> From the BMJ article itself, free full text available as of this writing at link above: <blockquote>For each article, we sought information about the authors’ financial conflicts of interest in the report itself and elsewhere (that is, in all publications within two years of the original publication and online). Two reviewers blinded to the authors’ financial relationships independently classified each article as presenting a favourable (that is, rosiglitazone does not increase the risk of myocardial infarction), neutral, or unfavourable view on the risk of myocardial infarction with rosiglitazone and on recommendations on the use of the drug.</blockquote> The "and elsewhere" can be a valuable addition to the capabilities of today's researchers, often enabled via the internet (e.g., non-literature based resources such as conference brochures, personal web pages, corporate and other financial disclosures. etc.) when articles themselves prove unrevealing. Overall, this is a straightforward methodology, and while potentially subject to bias and expertise issues, nonetheless seems an excellent new contribution to the needed social research on undisclosed COI's. As to results (see the full article for statistical details I am omitting here): <blockquote> Of the 202 included articles, 108 (53%) had a conflict of interest statement. Ninety authors (45%) had financial conflicts of interest. Authors who had a favourable view of the risk of myocardial infarction with rosiglitazone were more likely to have financial conflicts of interest with manufacturers of antihyperglycaemic agents in general, and with rosiglitazone manufacturers in particular, than authors who had an unfavourable view. There was likewise a strong association between favourable recommendations on the use of rosiglitazone and financial conflicts of interest. These links persisted when articles rather than authors were used as the unit of analysis, when the analysis was restricted to opinion articles or to articles in which the rosiglitazone controversy was the main focus, and both in articles published before and after the Food and Drug Administration issued a safety warning for rosiglitazone.</blockquote> While causality is not proven, these results are still stunning. Per the Inquirer's summary: <blockquote>... Almost 90 percent of scientists who wrote positive articles, reviews, or commentaries about Avandia had financial ties to London-based Glaxo, the study published in the British Medical Journal found. Almost three of every four authors who expressed negative views of the drug had no financial ties to manufacturers of diabetes medicines, while just 6 percent of those with positive opinions of the drug received no funding or fees from industry.</blockquote> The authors cite prior literature also demonstrating an associations of COI with pro-industry views (references 2-6; #2 is regarding the mid 1990's calcium channel blocker controversy). The authors observe that: <blockquote>In the past decade, research and policy has focused on this association [between COI and pro-industry views - ed.], leading to important progress in policies to manage and encourage disclosure of such financial conflicts of interest. </blockquote> Their findings about the effects of this "progress" was particularly disappointing, that only about half of the articles carried conflict-of-interest statements: <blockquote> Of the 202 eligible studies (10 reported original research, 91 were letters, editorials, or commentaries, and 101 were reviews, meta-analyses, or guidelines), 108 articles (53%) included a conflict of interest statement. [The other 47% did not - ed.] </blockquote>One wonders about the publishers of the articles themselves omitting COI statements, either acknowledging possible COI's or confirming that no COI's exist. <blockquote>... A total of 90 (45%) of the 202 articles were authored by individuals who had financial conflicts of interest. Of the 90 studies with conflicts of interest, 69 (77%) had a statement disclosing the conflict of interest in the article itself. The other 21 studies with financial conflicts of interest (23%) did not disclose these relationships, which were discovered through searching other publications by the same author or the internet. Three (14%) of these 21 studies published a statement declaring no conflicts of interest. [Oops - ed.]</blockquote> So, almost one quarter of articles with author COI did not disclose that fact, and several misrepresented the issue. Finally, the pharmaceutical company's view, also published in the Inquirer article cited above: <blockquote>A Glaxo spokeswoman said the company posted information and results from all its clinical trials on its Web site. "It's vital that people have trust in the way we do research and the way it's made public," Jo Revill, Glaxo spokeswoman, said yesterday. "Part of that is sharing data. What we have done is develop policies that will have disclosure and encourage disclosure." </blockquote> "Encouraging" disclosure of COI's is far too weak a stand for a pharmaceutical company to take on such a critical issue, in my view. The Mayo researchers wisely conclude: <blockquote> Disclosure rates for financial conflicts of interest were unexpectedly low, and there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies. Although these findings do not necessarily indicate a causal link between the position taken on the cardiac risk of rosiglitazone in patients with diabetes and the authors’ financial conflicts of interest, they underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted.</blockquote> Finally, I add that these findings are not too surprising. It's human nature not to bite the hand that feeds you. Money is also a powerful stimulant to the brain's rationalization (as opposed to rational) centers. We as a culture do truly need to understand the potential corrosive effects on the scientific literature of dysfunctions such as ghostwriting, financial and other conflicts of interest, publish-or-perish pressures of academia, and other such social issues. These practices also simply need to be abolished, for as I have written before on these pages ("<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2009/08/has-ghostwriting-infected-experts-with.html">Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?</a>"), once a "critical mass" of faux knowledge is put into circulation via the scientific literature, even the ostensibly impartial experts' views can become tainted, dependent as they are on that very same scientific literature. Even worse, we don't know what that critical mass is - or whether we've reached it already. -- SS

Study: Researchers with Glaxo ties favored Avandia

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20 Mar 2010

Is Someone at Jefferson Regional Medical Center Lying About EHR Safety?

This curious story appeared about apparent clinician health IT safety concerns at <a href="http://www.jeffersonregional.com/">Jefferson Regional Medical Center</a> near Pittsburgh: <div class="headline"></div><blockquote><div class="headline"><a href="http://www.pittsburghlive.com/x/pittsburghtrib/news/s_650606.html">Switch to electronic records alarms Jefferson Regional physicians</a> By Walter F. Roche Jr. PITTSBURGH TRIBUNE-REVIEW Friday, October 30, 2009 Jefferson Regional Medical Center's attempts to convert to electronic medical records have some doctors concerned about patient safety. </div> In a memo issued this month, the hospital's Health Information Technology Committee announced the 373-bed facility in Jefferson Hills would revert to printed versions of patients' consultant reports "due to patient safety concerns from the majority of physicians." Jefferson executives downplayed the memo and said they found no evidence that patient safety has been impacted, arguing a small group of physicians expressed concerns and not a majority, as the memo claimed. "It was a very small number that were concerned. It wasn't the majority," said Dr. Richard F. Collins, Jefferson's vice president for medical affairs. "To this point, we haven't identified any issue of patient safety."</blockquote> Now, one or the other must be true. Either a majority of physicians expressed concerns, or a small number did. Both cannot be true. Assuming the account in the Pittsburgh Tribune Review is accurate, someone is lying. I should point out that the numbers ultimately do not matter - patient safety issues should never be determined via a headcount, and in fact hospital governance obligations under the Joint Commission and their own fiduciary responsibilities mandate the utmost conservatism and due diligence on safety concerns. Perhaps the executives did find "no evidence" of safety issues. Regardless, I raise the following questions: <ul><li>How was such a study performed, how were physicians and other clinicians involved in the study, and was it a rigorous study using validated methodologies, or cursory?</li></ul><ul><li>Who is most motivated to find an HIT system "safe", the HIT Committee and clinicians, or the administration?</li></ul> I have served on HIT Committees; led them, in fact. Those committees "have the pulse" of clinician sentiment, even when they do not conduct formal surveys. In hospitals, the walls have ears, and the clinicians on HIT Committees understand what their colleagues are feeling - usually via direct and sometimes confrontational conversations. HIT Committees charged with making HIT successful do not generally pull back from HIT projects without very good reason. On the other hand, hospital executives who have signed off on investments of millions or tens of millions of dollars in IT investments do have a strong motive to ensure all goes well - either in reality or in the narrative they proffer. This is especially true when conflicts of interest exist. <blockquote>According to [VP for Medical Affairs] Collins and James Witenske, Jefferson's chief information officer, the transition [to EHR] began about a year ago and was completed in May. The hospital uses a system developed by Siemens, Collins said. He declined to disclose the cost.</blockquote> I find this an interesting finding. After a short Google search, the following appeared: <blockquote>Western Pennsylvania Hospital News<a href="http://www.wpahospitalnews.com/archives/default.asp?page=18&articleID=486">20 Years of Hospital Information Technology</a> by John Fries (December 2005) ... James Witenske is chief information officer at Jefferson Regional Medical Center, having left Arthur Andersen four years ago to accept the position. Before working at the Big Eight firm, he served as chief information officer at UPMC Health System. At Jefferson, IT takes place a bit differently that at other healthcare institutions. Where most hospitals have an IT department with staff, Witenske works almost exclusively with outside experts, one of whom is Ron Forys, a Siemens site executive who is based at Jefferson. It’s a complementary relationship – Witenske’s role is strategic and Forys’ is operational. Both are longtime technology professionals who have seen huge changes take place during the past two decades. </blockquote> The hospital had/has its own vendor representative in a front line role, and apparently shied away from having its own IT staff. A person who comes from a consulting firm uses consultants whose loyalty is to the vendor, not the hospital, one of them as his operations guy. This raises a number of questions: <ul><li>Who paid/pays the Siemens Site Executive? The hospital, the vendor, or both?</li><li>Who did/does the Site Executive report to?</li><li>Did/does not the Site Executive have a conflict of interest with regard to physician opposition to the vendor's system?</li><li>What was/is the financial relationship between hospital executive leadership and the Site Executive? Between hospital executive leadership and the vendor?</li></ul> These type of arrangements do raise my eyebrows, and the discrepancy between the HIT Committee's memo and the hospital executive's account, both of which cannot be true, could certainly be a symptom of conflicts of interest. I have noted that a <a href="http://hcrenewal.blogspot.com/2009/10/washington-post-emrs-no-cure-all-sen.html">Congressional investigation of the health IT industry</a> is now underway. This would not be a good time for hospital governance to downplay physician concerns about HIT, overruling their own HIT committee. For if a patient is injured or dies as a result of physician HIT concerns that were ignored, the executives could likely find themselves in a very unpleasant situation - and not just from malpractice attorneys. <blockquote> Collins and other hospital officials who support the conversion say that once adopted and accepted, electronic records will increase patient safety and efficiency, and eliminate "piles of paper."</blockquote> He apparently forgot the word "perfected." HIT in an experimental medical device. This VP for Medical Affairs makes no mention of the unintended consequences of poorly designed or implemented HIT. He either doesn't know about them (i.e., is dyscompetent regarding HIT) or is suffering the syndrome of inappropriate overconfidence in computers in the face of what seems like his own staff's concerns. This is typical of the Wild West environment of Health IT. -- SS

Is Someone at Jefferson Regional Medical Center Lying About EHR Safety?

This curious story appeared about apparent clinician health IT safety concerns at Jefferson Regional Medical Center near Pittsburgh:Switch to electronic records alarms Jefferson Regional physiciansBy …

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05 Nov 2009

STOSSEL and ACRE: WHERE'S the BEEF?

STOSSEL and ACRE – WHERE’S the BEEF? Thomas Stossel from Harvard is at it again. As Daniel Carlat has humorously <a href="http://carlatpsychiatry.blogspot.com/2009/07/acre-academics-craving-reimbursement.html">described</a>, Stossel is planning the inaugural meeting next week of a group to counter those he calls pharmascolds. The group is named ACRE – Association of Clinical Researchers and Educators. Here is its website: <a href="http://www.acreonline.org/">http://www.acreonline.org/</a> For months, Stossel has been warning of the dire negative consequences that will result from tightened conflict of interest policies, but he has not presented any persuasive examples of damage to “productive relationships between industry and physicians involved in clinical research and educational outreach.” At the same time, Dr. Stossel has conveniently overlooked the shenanigans of the bad actors whom Senator Grassley exposed. Dr. Stossel is a blowhard, as I have described here <a href="http://hcrenewal.blogspot.com/2008/02/dr-stossel-sounds-off.html">before</a>. But wait! ACRE has found something! A News item in the July 2009 issue of Nature Medicine (“Conflict of interest rules seen by some as too stringent”) quoted one of the participants in the upcoming ACRE conference. Avi Markowitz, chief of oncology at UT Medical Branch, Galveston, came up with this example: Patients taking a Sanofi Aventis chemotherapy product may experience peripheral neuropathy, which can cause unpleasant sensations in the hands and feet. ‘Sanofi Aventis had been providing Markowitz and his UTMB colleagues with free blankets and gloves for those patients. Last fall, however, the university adopted stricter rules banning industry freebies. Now, Markowitz can’t even accept the unbranded blankets and gloves that Sanofi Aventis has offered to provide.’ Reading between the lines, it is a good bet that these items originally were branded. Whatever. And never mind that the patients receiving chemotherapy at UTMB are doubtless billed a hefty facility fee that must include comfort items like blankets and gloves. Since when does a chief of oncology need to beg for these basic patient care provisions from drug companies? Is this all that ACRE can come up with? The ACRE homepage warned sternly of “restrictive conflict of interest policies that often sever productive relationships between industry and physicians involved in clinical research and educational outreach.” Does Thomas Stossel’s whining and catastrophizing through ACRE come down to piffling items like blankets and gloves for chemotherapy patients? That’s it? Where’s the beef? At least ACRE has the good sense not to include on its program the smooth operators whom Senator Grassley outed – like Nemeroff at Emory, Schatzberg at Stanford, Kuklo at Walter Reed, Keller at Brown, Biederman at Harvard. Not even Stossel has been brazen enough to try to defend them. The Nature Medicine News item does close on a helpful note: 'Stossel would like to see abuses involving financial conflicts of interest treated more like cases of scientific misconduct. Rather than forcing everyone to abide by prohibitive rules, he says administrators should focus on weeding out those who misbehave.' I say Amen to that, even if it is a day late and a dollar short. We have arrived at our present state of discomfiture because the leaders of academic institutions and professional societies looked the other way for too long. They failed to do their job of reining in the ethical outliers. Grassley had to do it for them. As a result, the rest of us will be burdened with new regulations for years to come. Those who did speak up years ago were ignored or demonized. As the saying goes, every group gets the leadership it deserves. Those in academic medicine had better not count on Stossel and ACRE to lead them out of the wilderness. Bernard Carroll.

STOSSEL and ACRE: WHERE'S the BEEF?

STOSSEL and ACRE – WHERE’S the BEEF?Thomas Stossel from Harvard is at it again. As Daniel Carlat has humorously described, Stossel is planning the inaugural meeting next week of a group to counter tho…

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18 Jul 2009

Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-"Certified" HIT

A remarkable Bill (ASSEMBLY, <a href="http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM">No. 3934</a>, STATE OF NEW JERSEY, 213th LEGISLATURE) has appeared in NJ that would prohibit the sale or use of healthcare IT not "certified" (i.e., feature-qualified) by the industry-founded and connected group "Certification Commission for Healthcare Information Technology" (CCHIT). The Bill calls for monetary <a href="http://en.wikipedia.org/wiki/Civil_penalty">civil penalties</a> for such sale or use: <blockquote>A civil penalty or civil fine is a term used to describe when a state entity or a governmental agency seeks monetary relief against an individual as restitution for wrongdoing by the individual. </blockquote> I previously wrote about CCHIT in a series of linked posts that start here: <a href="http://hcrenewal.blogspot.com/2009/02/very-troubling-post-about-cchit.html">A very troubling post about the CCHIT (Certification Commission for Healthcare Information Technology)</a>. I have now written the following open letter to Mark Leavitt, MD, PhD, Chairman, Certification Commission for Healthcare Information Technology. <blockquote>To: <a class="Addr" title="Create new mail memo with this address" href="javascript:noop()" onclick="BuK('%22Mark%20Leavitt%22%20%3Cmleavitt%40cchit.org%3E')">"Mark Leavitt"</a> <script> if (window.s_IsEditPrint && window.s_IsEditPrint == "1") wM(window.s_DocCreated);else wM(window.s_DisplayDate);</script>Date: Sunday, June 07, 2009 02:10PM<a class="Addr" title="Create new mail memo with this address" href="javascript:noop()" onclick="BuK('%22Mark%20Leavitt%22%20%3Cmleavitt%40cchit.org%3E')"><mleavitt@cchit.org></mleavitt@cchit.org></a> Cc: Robert O'Harrow, Jr., Washington Post, and various AMIA working group mailing lists (CIS - clinical info systems, POI - people & organizational issues, OS - Open Source, and ELSI - Ethics, Legal & Social Issues) June 7, 2009 Mark Leavitt, MD, PhD Chairman, Certification Commission for Healthcare Information Technology www.cchit.org [6/8/09 - contact info from www.markleavitt.com removed per critique in response below -ed.] <div style="margin-left: 40px;">Re: NJ HIT Bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM by Assemblyman Harb Conaway, Jr., District 7, and Upendra Chivukula, District 17 </div> Dear Mark, The NJ Bill at <a target="blank" href="http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM">http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM </a> by Assemblyman Harb Conaway, Jr., District 7, and Upendra Chivukula, District 17, calls for making it a violation of law to sell HIT not "certified" by CCHIT . Penalties are called for. The bill states: <div style="margin-left: 40px;">... No person or entity, either directly or indirectly, shall sell, offer for sale, give, furnish, or otherwise distribute to any person or entity in this State a health information technology product that has not been certified by the Certification Commission for Healthcare Information Technology. </div> As used in this section, "health information technology product" means a system, program, application, or other product that is based upon technology which is used to electronically collect, store, retrieve, and transfer clinical, administrative, and financial health information. b. A person or entity that violates the provisions of subsection a. of this section shall be liable to a civil penalty of not less than $1,000 for the first violation, not less than $2,500 for the second violation, and $5,000 for the third and each subsequent violation, to be collected pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.). I and others find this bill remarkable. It really calls into focus the HIT community's concerns about CCHIT and its political connections, especially pursuant to the article " <a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">The Machinery Behind Healthcare Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records </a>" of May 16, 2009 in the Washington Post by Robert O'Harrow Jr. I therefore seek answers to the following questions: 1. Do you approve of the proposals in the bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM ? 2. Did you, or anyone in a governance or leadership position at CCHIT, play a role in sponsorhip of this bill, through financial contributions, lobbying, advocacy for its proposals, and/or other means to prohibit sale of non-CCHIT certified HIT? 3. Did anyone with governance or leadership roles in CCHIT's founding or affiliated organizations (e.g,, HIMSS, CITL, and others) or business associates of such people, play a role in the bill's sponsorhip, through financial contributions, lobbying, advocacy for its proposals, and/or other means to prohibit sale of non-CCHIT certified HIT? 4. Did anyone (person or company) in the HIT industry, broadly speaking, who could directly profit from such a bill becoming law play a role in sponsorhip of, or advocacy for this bill? I believe candid and transparent answers to these questions are important in giving the HIT community confidence that CCHIT primarily serves the public interest, not interests of an HIT lobby. </blockquote> -- SS 6/8/09 Dr. Leavitt has candidly responded. I take his word on these issues at face value, having done business with him a bit over a decade ago (supporting the purchase of his company's EHR, Logician, for Christiana Care over the opposition of the IT department which preferred another vendor): <blockquote> From: "Mark Leavitt" <mleavitt@cchit.org> Date: 06/08/2009 02:51AM cc: cis-wg@mailman.amia.org, poi-wg@mailman.amia.org, os-wg@mailman.amia.org, els-wg@mailman.amia.org, oharrowr@washpost.com,sreber@cchit.org<cis-wg@mailman.amia.org><poi-wg@mailman.amia.org><os-wg@mailman.amia.org><els-wg@mailman.amia.org><oharrowr@washpost.com><sreber@cchit.org> Subject: RE: Bill to make illegal the sale or use of non-CCHIT "certified" systems </sreber@cchit.org></oharrowr@washpost.com></els-wg@mailman.amia.org></os-wg@mailman.amia.org></poi-wg@mailman.amia.org></cis-wg@mailman.amia.org></mleavitt@cchit.org><div dir="ltr" align="left">Scot, </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">Here are the answers to your questions: </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">1. No, I do not approve of this legislation -- which I'm reading for the first time in your email. Our goal, stated in almost every presentation I've given, and to which I've adhered in my leadership of the Commission, has always been to unlock positive incentives for health IT adoption. The bill does not fit that model at all, and it is a bad idea. </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">2. Neither I personally, nor CCHIT as an organization, have lobbied, advocated, sponsored, or had anything to do with that bill. We were unaware of it until it started showing up on listserves Friday. The bill has never been mentioned in any of our Trustee, Commission, or staff meetings. </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">3. Trustees, Commissioners, and Work Group members serve in a volunteer capacity at CCHIT. We require disclosure of conflicts of interest, but we do not monitor all activities in their 'day jobs' or other volunteer roles. "HIMSS, CITL, etc" are not affiliated with CCHIT, and we don't know about all their advocacy activities. I'm not privy to the information you seek. </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">4. This question presumes that I would know everything that "anyone in the HIT industry, broadly speaking" has done regarding the bill. Naturally I do not have that knowledge either. </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">Now that I've responded, the AMIA listserve members can stop reading here, while I go on to chat with Scot. </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">Scot, in 15 years of medical training and practice followed by 25 years of healthcare informatics, I've encountered very few people -- and certainly no university professors -- who acted so disrespectfully toward me. Being a veteran of health IT, it's easy to find people who have worked with me or know me well, and to ask them about my integrity. Or to talk to some of the other 50 or so Commissioners who've served or the hundreds of work group volunteers. Shouldn't an informatics scientist do a modicum of research before undertaking a potentially harmful procedure such as attacking a person's or organization's reputation? Reading a news article by Mr O'Harrow does not qualify as due diligence. Would you let your informatics students get away with that before recommending a major, potentially disruptive or destructive IT project? </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">From your own blogging I see that your "early medical mentor, cardiothoracic surgery pioneer Victor P Satinsky, MD, believed in public embarrassment as a tool to fight bureaucracy and discrimination ." Well, that helps me understand. And your blogging about your frustration when you sought employment with a commercial EHR vendor <a href="http://hcrenewal.blogspot.com/2009/02/nextgen-and-vendordoctor-dialog-yet.html">http://hcrenewal.blogspot.com/2009/02/nextgen-and-vendordoctor-dialog-yet.html </a> explains even more. Knowing that, I forgive you for your tone and for inappropriately disclosing my home address and cell phone to everyone on these lists. I would be pleased to engage in a civil, rational debate with you along the lines of "EHRs -- do the benefits outweigh the risks?" C'mon out to the farm here sometime -- you know the address, and the dog's friendly -- or we could do it on the web. </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">Finally, my apologies to everyone on the mailing lists that Dr. Silverstein chose to include in his investigative journalism broadcast. If you object to his use of AMIA mailing lists for this kind of activity, you could let him know. </div> <div> </div> <div>Mark Leavitt, MD, PhD Chairman, CCHIT </div></blockquote> My response was simple: <blockquote>To: "Mark Leavitt" <mleavitt@cchit.org> Date: 06/08/2009 05:24PM cc: <cis-wg@mailman.amia.org>cis-wg@mailman.amia.org, poi-wg@mailman.amia.org, os-wg@mailman.amia.org, els-wg@mailman.amia.org, oharrowr@washpost.com,sreber@cchit.org<poi-wg@mailman.amia.org><os-wg@mailman.amia.org><els-wg@mailman.amia.org><oharrowr@washpost.com><sreber@cchit.org> Subject: RE: Bill to make illegal the sale or use of non-CCHIT "certified" systems Mark, I thank you for the answers to my questions. > Knowing that, I forgive you for your tone and for inappropriately disclosing my home address and cell phone to everyone on these lists. Mark, that information came from your page at <a href="http://www.markleavitt.com/">http://www.markleavitt.com/</a> which I found on a google seach for "Mark Leavitt." Image attached. I believed that to be your professional contact info. As to the rest of your response, you appear to attempt to discredit my arguments through ad hominem. I refer you to this page: <a target="blank" href="http://www.nizkor.org/features/fallacies/ad-hominem.html">http://www.nizkor.org/features/fallacies/ad-hominem.html </a> <div style="margin-left: 40px;">Translated from Latin to English , "Ad Hominem" means "against the man " or "against the person." An Ad Hominem is a general category of fallacies in which a claim or argument is rejected on the basis of some irrelevant fact about the author of or the person presenting <input name="IL_MARKER" type="hidden">the claim or argument. Typically, this fallacy involves two steps. First, an attack against the character of person making <input name="IL_MARKER" type="hidden">the claim , her circumstances, or her actions is made (or the character, circumstances, or actions of the person reporting the claim ). Second, this attack is taken to be evidence against <input name="IL_MARKER" type="hidden">the claim or argument the person in question is making (or presenting). This type of "argument" has the following form: </div><ol style="margin-left: 40px;"><li>Person A makes claim X. </li><li>Person B makes an attack on person A. </li><li>Therefore A's claim is false. </li></ol> The reason why an Ad Hominem (of any kind) is a fallacy is that the character, circumstances, or actions of a person do not (in most cases) have a bearing on the truth or falsity of <input name="IL_MARKER" type="hidden">the claim being made (or the quality of the argument being made). Ad hominem, sadly, is not debate. Neither is <a target="blank" href="http://www.nizkor.org/features/fallacies/appeal-to-authority.html">appeal to authority </a>. Scot</sreber@cchit.org></oharrowr@washpost.com></els-wg@mailman.amia.org></os-wg@mailman.amia.org></poi-wg@mailman.amia.org></cis-wg@mailman.amia.org></mleavitt@cchit.org></blockquote> Truth be told, I actually offered no arguments in my email message. I was asking very probing questions with concern they would be ignored, or responded to with "spin" as <a href="http://www.hcrenewal.blogspot.com/2009/02/cchit-dissolved-involuntarily-in-april.html">here</a>, and their tone offended him. Fair enough. I was a bit disappointed, however, by the "<a href="http://www.quotationspage.com/quote/25317.html">The lady doth protest too much, methinks</a>" ad hominem embellishments to an otherwise candid and convincing response. Such are the risks of directness and <a href="http://hcrenewal.blogspot.com/2009/03/disruptive-innovators-at-healthcare.html">disruptive innovation</a>, however. -- SS 6/9 Addendum: Additional views on the NJ Bill are at ePatients.net at "<a href="http://e-patients.net/archives/2009/05/david-kibbe-mark-leavitt-openness-vs-opacity.html">David Kibbe & Mark Leavitt:Openness vs. Opacity</a>" and "<a href="http://e-patients.net/archives/2009/06/dossia-microsoft-healthvault-google-healthillegal-in-nj.html">Dossia, Microsoft HealthVault & Google Health: Illegal in NJ?</a>". There are some now-familiar themes regarding CCHIT civility in those posts. 6/10 Addendum: As a result of a link sent by a commenter, I am adding the post "<a href="http://www.hcplive.com/mdnglive/The_HIT_Realist/Kibbe_Leavitt">The Kibbe/Leavitt Rumble in the High Tech Jungle!</a>" to the list of interesting views in the 6/9 addendum above.

Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-"Certified" HIT

A remarkable Bill (ASSEMBLY, No. 3934, STATE OF NEW JERSEY, 213th LEGISLATURE) has appeared in NJ that would prohibit the sale or use of healthcare IT not "certified" (i.e., feature-qualified) by the…

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07 Jun 2009

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