Old Mystery Solved? Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety

At my Dec. 2005 post "<a href="http://hcrenewal.blogspot.com/2005/12/report-life-science-manufacturers.html" target="_blank">Report: Life Science Manufacturers Adapt to Industry Transition</a>" I wrote:<br /><br /><blockquote class="tr_bq">... The recognition of a gap in formally-trained medical informatics-trained personnel in the pharmaceutical industry [by Gartner Group] is welcome. For example, from my own experience:<br /><br />I recall an interview I had last year with the head of the Drug Surveillance & Adverse Events department at Merck Research Labs in a rehire situation [after a 2003 layoff]. I came highly recommended by an Executive Director in the department, to whom I had shown my prior work. This included well-accepted, novel human-computer interaction designs I'd developed for use by busy biomedical researchers for a large clinical study in the Middle East, as well as my work modeling invasive cardiology and leading the development and implementation of a <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/scotsilv/invascard.htm" target="_blank">comprehensive information system</a> to detect new device and treatment modality risks in a regional center performing more than 6,000 procedures/year. In addition, I'd worked with the wife of the Executive Director in years prior, when she ran the E.R. of the hospital where I was director of occupational medicine.<br /><br />Despite all this in my favor, the Executive Director's boss, himself a former FDA adverse events official <i style="color: red;"><b>[a former deputy director of CDER’s office of drug safety, who'd recently moved to the pharma industry he once regulated - ed.]</b></i>, <b>dismissed me in five minutes as I was showing him the cardiology project, saying flatly "we don't need a medical informatics person here." </b>I had driven 80 miles to Rahway for this interview to save the executive a trip to Pennsylvania, where I was originally scheduled to come for the interview, since the executive's father was ill in the hospital. In an instance of profound social ineptness, my effort was not even acknowledged. Perhaps he was in a bad frame of mind, but the dismissal under the circumstances was all the more disappointing.</blockquote><br />I recall this was one of the most puzzling hiring debacles I'd ever experienced, as all the senior people in his dept. had recommended he hire me - I was really only there for his approval and signoff - and the work I'd shown him had improved care, saved lives, and saved money.<br /><br />I may not need to be puzzled any longer.  This story just appeared:<br /><br /><blockquote class="tr_bq"><span style="font-size: small;"><b><a href="http://truth-out.org/news/item/10524-former-fda-reviewer-speaks-out-about-intimidation-retaliation-and-marginalizing-of-safety" target="_blank">Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety</a></b></span><br />By Martha Rosenberg, <a href="http://truth-out.org/" target="_blank">Truthout </a><br />July 29, 2012 <br /><br />The Food and Drug Administration (FDA) is often accused of serving industry at the expense of consumers. But even FDA defenders are shocked by reports this week of an institutionalized FDA spying program on its own scientists, lawmakers, reporters and academics that included an enemies list of "actors" and collaborators <br /><br />... Ronald Kavanagh [FDA drug reviewer from 1998 to 2008]:  ... In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices,<b> the honest employee fears the dishonest employee</b>. There is also irrefutable evidence that <b>managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drug ... </b>While I was at FDA, drug reviewers were clearly told not to question drug companies and that <b>our job was to approve drugs.</b></blockquote><br /><span class="itemAuthor">Read the entire story at the link.  I won't cover it more here, except to say it's certainly possible to believe certain FDA officials don't want serious people around -- who in addition to being MD's can write serious software to detect drug and device problems -- whose work can get in the way of drug approvals.</span><br /><br />-- SS

Old Mystery Solved? Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety

At my Dec. 2005 post " Report: Life Science Manufacturers Adapt to Industry Transition " I wrote: ... The recognition of a gap in ...

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A Bonus for Bankruptcy? - KV Pharmaceutical Reveals CEO's Bonus, then Declares Bankruptcy

The latest example of the disconnect between compensation for leaders of health care organizations and their and their organizations' performance comes from a <a href="http://www.bizjournals.com/stlouis/news/2012/07/26/kv-pharmaceutical-ceo-divis-pay-more.html">report</a> in the St Louis Business Journal.  <br /><br /><strong>Executive Compensation and KV Pharmaceutical</strong><br /><br />Its essence was:<br /><blockquote><em>KV Pharmaceutical Co. President and CEO Gregory Divis Jr. earned <strong>$976,270</strong> in the fiscal year<strong> ended March 31</strong></em>, more than double the $385,102 he was paid in fiscal 2011, according to a proxy statement the company filed Thursday with the Securities and Exchange Commission.<br /><br /><em>His 2012 earnings were comprised of a $638,750 salary, a <strong>$130,000 bonus, $204,189 in option awards</strong> and $3,331 in other compensation</em>, which includes a $2,909 car allowance, a 401(k) match and group term life insurance.<br /><br />The total pay for other top executives was as follows:<br /><br />Treasurer and Chief Financial Officer Thomas McHugh earned $506,615 in fiscal 2012, including a $65,000 bonus. Hit total comp in fiscal 2011 was $320,950.<br />Vice President, General Counsel and Secretary Patrick Christmas earned $530,604 in fiscal 2012. He joined the company in June 2011.</blockquote><br />Admittedly, compensation of just under $1 million a year does not seem that high for the CEO of a pharmaceutical company in this day and age. Furthermore, as <a href="http://www.forbes.com/sites/edsilverman/2012/07/30/kv-pharma-ceo-gets-hefty-raise-despite-all-the-problems">noted</a> in Forbes, Mr Divis' compensation is less than that of his predecessor:<br /><blockquote>who was interim ceo and president, received $1.25 million before Divis succeeded him, and so the ceo is now being compensated at a lower amount. </blockquote><br /><strong>The Troubled History of the Company</strong><br /><br />However, first consider that the company was not exactly in the best financial health at the time Mr Divis was getting his pay, as per the St Louis Business Journal:<br /><blockquote>KV Pharmaceutical Co. officials said July 20 that the company has been <em>notified by the New York Stock Exchange that it is below listing standard criteria</em> due to the company’s average market capitalization being less than $50 million over a 30-day trading period and its stockholder’s equity being less than $50 million.<br /><br /><em>After years of missteps, mismanagement and mounting losses, KV Pharmaceutical’s ability to survive is in question</em>. <em>The company itself raised doubts as to its ability to continue as a going concern in its quarterly filing<strong> Feb. 9</strong></em> with the Securities and Exchange Commission. [Note that this filing occurred during the same fiscal year in which the CEO received the compensation noted above - Ed.]</blockquote><br />In fact, as we discussed <a href="http://hcrenewal.blogspot.com/2010/11/former-kv-pharmaceutical-ceo-and.html">here</a> in 2010, a former KV Pharmaceutical CEO and Chairman is one of the very few for-profit health care corporate leaders who actually received personal punishment due to a US government prosecution. Former CEO and Chairman Marc Harmelin was banned from doing business with the US government for 20 years after a fraud prosecution that lead to "a KV subsidiary's conviction on criminal charges earlier this year for shipping oversize morphine tablets" <a href="http://www.stltoday.com/business/kv-s-hermelin-is-banned-from-federal-health-care-programs/article_f51abe32-a767-5f3b-bf55-4978db665cab.html">per</a> the St Louis Post-Dispatch.<br /><br /><strong>The Failed Strategy to Get a License for a Previously Generic Drug, and Increase its Price by Ten Thousand Percent (10,000%)</strong><br /><br />Then consider the direction company leadership took after that setback.  As described in an August, 2012, St Louis Post-Dispatch <a href="http://www.stltoday.com/business/local/kv-pharmaceutical-files-for-bankruptcy/article_4a26c62c-dfde-11e1-9ffb-0019bb30f31a.html">article</a>, the company's main strategy was based on a license to sell Makena, an injectable form of hydroxyprogesterone. Hydroxyprogesterone had first been approved in the 1950s. In 2003, a National Institute of Health funded study showed that injecting it reduced the risk of premature birth [Meis PJ, Klebanoff M, Thom E et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med 2003; 348: 2379. Link <a href="http://www.nejm.org/doi/pdf/10.1056/nejmoa035140">here</a>.]. Somehow, with funding from KV Pharmaceutical, "the FDA granted the approval to Hologic, which presented the application and argued for the drug based on medical research sponsored by the National Institutes of Health." After that, while "KV neither invented nor patented Makena, but agreed to pay Hologic nearly $200 million for 'orphan drug' status – and seven years of market exclusivity – for the rights to sell the branded drug." I cannot figure out why either company should have been granted an exclusive right to sell this drug under these circumstances. Nonetheless, once KV Pharmaceutical obtained the rights, <br /><blockquote>Makena sparked a national controversy over <em>its sky-high price – a 100-fold increase over the average cost – about $15</em> – <em>for an already widely available non-branded version</em> of the drug produced by compounding pharmacies.<br /><br />Leading national medical organizations and advocacy groups, including the March of Dimes and two U.S. senators, publicly blasted the pricing.<br /><br />On March 30, 2011, the FDA announced that it would not enforce KV’s market exclusivity because of concerns that the drug would be unaffordable to many women. Hours later, the federal Centers for Medicare and Medicaid Services indicated that states could purchase the compounded version, called 17P, from specialty pharmacies.<br /><br />The resistance prompted KV executives to dramatically lower Makena’s cost, but the move failed to forestall the backlash. As a result, KV’s ambitious sales projections for its latest drug failed to materialize.</blockquote><br /><strong>Bankruptcy</strong><br /><br />That sealed the company's fate, and the same article reported,<br /><blockquote>KV Pharmaceutical Co., once among the St. Louis region’s strongest public companies, now faces yet another survival struggle after filing for bankruptcy.</blockquote><br /><strong>Summary: A Bonus for Bankruptcy</strong><br /><br />So a company that suffered a criminal conviction for selling morphine tables whose dose was twice what was on their label, whose former CEO was banned from the pharmaceutical industry, which based its survival on a scheme to game the regulations to allow it to sell a previous $15 drug for $1500, then paid its CEO nearly $1 million, including over $330,000 in cash bonus and stock options just before it filed for bankruptcy.  Note that the CEO "earned" that compensation over a time period during which the company revealed doubts that it could survive as a "going concern."<br /><br />This is a simple, relatively small, but especially graphic example of how leaders of health care organizations are not simply overpaid, but seem to personally profit from their organizations' mismanagement, poor financial results, and last but not least, exploitation of patients. Describing these incentives as perverse seems euphemistic.<br /><br />Economists seem to like to justify outsized executive compensation by citing shareholder value they create, realistically defined as short-term stock price (look <a href="http://hcrenewal.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">here</a>).  One could argue that companies that sell health care products or provide health care directly should measure performance in terms of effects on patients' and the public's health.  Putting this aside, however, in this case, the executives seemed to be receiving bonuses not based on shareholder value, or stock price, but for continuing a course that resulted in the complete destruction of shareholder value.  (Stock shares lose essentially all their value when a company goes bankrupt.)  <br /><br />In this case, and in others we have <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">discussed</a>, executive compensation seems to be based on the ability of executives to control their own pay, which seems more like what economists like to call "rent-seeking," as <a href="http://en.wikipedia.org/wiki/Rent-seeking">defined</a> by Wikipedia, gaining from "manipulating the social or political environment in which economic activities occur, rather than by creating new wealth."  <br /><br />Clearly, as long as health care leaders can personally profit however bad their performance is, or even due to their poor performance, we can expect nothing other than worsening performance.  Health care will become continually more dysfunctional until true reform makes health care leaders accountable for their actions, and all their effects, on stockholders, but also on patients' and the public's health.

A Bonus for Bankruptcy? - KV Pharmaceutical Reveals CEO's Bonus, then Declares Bankruptcy

The latest example of the disconnect between compensation for leaders of health care organizations and their and their organizations' pe...

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My Presentation to the Health Informatics Society Of Australia: "Critical Thinking on Building Trusted, Transformative Medical Information: Improving Health IT as the First Step"

In early 2011 I was invited to present at the annual convention of the <a href="http://www.hisa.org.au/" target="_blank">Health Informatics Society of Australia </a>(HISA) by its CEO, Louise Schaper, PhD.  HISA was aware of my writings and thought a presentation at their conference would be of interest to the Australian informatics and healthcare governance community.<br /><br />Dr. Schaper wrote:<br /><br /><blockquote class="tr_bq">From: Louise Schaper <br />Sent: Thursday, March 24, 2011 10:50 AM<br />To: Scot Silverstein<br />Subject: HIC invitation to deliver a keynote presentation<br /><br />Hi Scot,<br /><br />I trust this email finds you well and I hope spring is bringing you some warmer weather and cheer.<br /><br />I wanted to let you know that the Health Informatics Conference committee met recently and expressed a high level of interest in having you deliver a keynote address at HIC and also to form part of a panel presentation.  <br /><br />I know you may not be able to make a commitment to come to Australia in August, but I wanted to let you know what we would love to have you, if circumstances permit you being here.  I’m confident we could have your trip sponsored (providing you don’t mind spending some face-time with the sponsoring organisation) and generate some media coverage around your visit.<br /><br />The preliminary program will be advertised in the next few weeks and at the moment I’m leaving a ‘spot’ for you in the hope that you may be able to join us.  <b>I know you are in difficult and upsetting circumstances so please know that I’m not intending to add to any pressure – I just wanted to let you know that we would be honoured if you are able to deliver an address at HIC this year and I will keep a speaking spot reserved for you if you think you may be able to accept our invitation.</b><br /><br />Thanks for your time Scot.  I look forward to hearing from you.<br /><br />Kindest regards,<br /><br />Louise</blockquote><br />Sadly, the "difficult and upsetting circumstances" she mentioned were my involvement in caring for my mother, seriously injured in May 2010 in a healthcare information technology-related medical misadventure and, by this time, dying.<br /><br />I was thus unable to attend.<br /><br />My mother<a href="http://www.findagrave.com/cgi-bin/fg.cgi?page=gr&GRid=88446972" target="_blank"></a> <a href="http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html" target="_blank">passed away</a> June 6, 2011 of her injuries.<br /><br />In January 2012, Dr. Schaper was gracious enough to re-invite me to the annual 2012 conference in Sydney.  I accepted.<br /><br />I attended <a href="http://www.hisa.org.au/page/hic2012/" target="_blank">HIC 2012</a>, held in the Darling Harbour Convention Centre in Sydney 30 July - 2 August 2012. <br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiWaQumA9bnkpcHhBU8MKD0wQmepK_Ff_pkUrwUn5RsdzU6gMtDCcSComDCL6LM-_3OhVxpFBfzQj3aBVvMmAHgLL_ZOqnnELJcKyAcpMq6FHbg6Q8trfGKOsJWChvkQWypa6bmqOxAEJRV/s1600/sydney_IMG_1099a.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="300" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiWaQumA9bnkpcHhBU8MKD0wQmepK_Ff_pkUrwUn5RsdzU6gMtDCcSComDCL6LM-_3OhVxpFBfzQj3aBVvMmAHgLL_ZOqnnELJcKyAcpMq6FHbg6Q8trfGKOsJWChvkQWypa6bmqOxAEJRV/s400/sydney_IMG_1099a.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">I enjoyed taking pictures like this with my trusty (and portable) Canon SX110 IS.  Click to enlarge.  More photos <a href="http://www.facebook.com/media/set/?set=a.4025347084034.2161136.1592238231&type=3&l=a25989ee6e" target="_blank">here</a>.</td></tr></tbody></table><br />My powerpoint slides for the presentation entitled "<b>Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step</b>" are <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/HISA2012_Final.ppt" target="_blank">at this link</a>.<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEinCZFwCFISDK3ycGg0vjvj5b9c863NRP159A_d8cAi_rtzPyjh66R6knd8UFRf-tGAng31fM5hmjWu8Y6UZXuhoLYDUEcmpbWYzpWFF6cSmj8_4Tv0-wY76MVrD1MhjArEpCn_mNO4J9r9/s1600/convention_center_0729121059-00.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="300" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEinCZFwCFISDK3ycGg0vjvj5b9c863NRP159A_d8cAi_rtzPyjh66R6knd8UFRf-tGAng31fM5hmjWu8Y6UZXuhoLYDUEcmpbWYzpWFF6cSmj8_4Tv0-wY76MVrD1MhjArEpCn_mNO4J9r9/s400/convention_center_0729121059-00.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Darling Harbour Convention Centre, Sydney, Australia. Click to enlarge.</td></tr></tbody></table><br />Australia has embarked on a national <a href="http://www.nehta.gov.au/ehealth-implementation/what-is-a-pcher" target="_blank">Personally Controlled Electronic Health Record (PCEHR) project</a> under the auspices of Nehta, the <a href="http://www.nehta.gov.au/" target="_blank">National E-Health Transition Authority</a>.  I find this an interesting approach to national health IT; unlike the U.S., whose project is top-down (centrally controlled records), Australia seems to have learned from our mistakes and is initiating health IT as a bottom-up (patient-controlled) initiative.<br /><br />At the conference last week, I delivered a keynote address on the theme of improving health IT as an essential step in leveraging the capabilities of the technology.<br /><br />Being that I am anti-"bad IT" and pro-"good IT", implicit in my address was the issue of the technology's untrustworthiness in 2012, largely due to the unregulated free-for-all its market represents and the poor engineering that is the result.<br /><br />I also participated in a Panel Discussion led by Australian investigative journalist and popular political TV program host <a href="http://www.abc.net.au/tv/qanda/" target="_blank">Tony Jones</a>.  Mr. Jones hosts the Australian Broadcasting Corporation's "Q&A - Adventures in Democracy."<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhSeK96cHUjMoamPlGqBBh34-upflUg4XEjcvrsQhxtLKeQj_pL73pgvfQI6h_F9LsSehtv58g4zsMcyVOVHgqSLLmnvbpuGZSn-_qA77q1T76bu-NjlU9ec7xSG0h4sgNtpLI9u6DB9PuC/s1600/scot_panel.JPG" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="300" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhSeK96cHUjMoamPlGqBBh34-upflUg4XEjcvrsQhxtLKeQj_pL73pgvfQI6h_F9LsSehtv58g4zsMcyVOVHgqSLLmnvbpuGZSn-_qA77q1T76bu-NjlU9ec7xSG0h4sgNtpLI9u6DB9PuC/s400/scot_panel.JPG" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Panel discussion moderated by Australian political commentator Tony Jones, who hosts the show "Q&A" on the Australian Broadcasting Corporation.  Click to enlarge.</td></tr></tbody></table><br /><br />I will highlight several key points I made in my keynote and on the panel:<br /><br /><ul><li>Critical thinking is essential at all times in healthcare ... or your patient's dead.</li><li>Critical thinking is not mindless criticism; on the contrary, it is reflective, inquisitive, logical thinking that is focused on deciding what to believe or do.</li><li>Health IT must be trusted by users and patients [and be free of major downsides] - as a primary step before HIT can optimally benefit healthcare </li><li>I pointed out I am not suggesting anything new and that, in fact, I am suggesting something old:  "First, do no harm."</li><li>I pointed out the "revolutions" usually have downsides, and IT always produces winners...and losers (per the empirical research of <a href="http://rkcsi.indiana.edu/" target="_blank">Social Informatics</a>). </li></ul><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgPv_7EmRu2YtyP9cxNypfcaChsqerNMmjCXd-uI09od0RJU_Zktp0xI9EunbKc2LDOuBNh8Goc7viOA4MRC5LlZf0MLk0A9bYC_YS80j0l5_hSnRNZtoMavZ_eEWydN4H4u7Dk6BgjXWG_/s1600/me_presenting_1.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="291" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgPv_7EmRu2YtyP9cxNypfcaChsqerNMmjCXd-uI09od0RJU_Zktp0xI9EunbKc2LDOuBNh8Goc7viOA4MRC5LlZf0MLk0A9bYC_YS80j0l5_hSnRNZtoMavZ_eEWydN4H4u7Dk6BgjXWG_/s400/me_presenting_1.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Me presenting my keynote, driving home the point that IT on its own won't "revolutionize" healthcare; it is a tool <b>to facilitate the true enablers of healthcare</b> - <b>clinicians</b> - a point that should never be forgotten.  Click to enlarge. <span class="hasCaption">From the excellent multimedia piece on the conference <a href="http://www.youtube.com/watch?v=DZg_46wY0E0" target="_blank">at this link</a>.<a href="http://www.youtube.com/watch?v=DZg_46wY0E0" rel="nofollow nofollow" target="_blank"><wbr></wbr></a></span></td></tr></tbody></table><br /><br />I then posed a series of questions of great relevance to understanding health IT realities.  Click to enlarge:<br /><br /><br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh-uFWvUdZ7PTw56nSsNDqoOIzOKbQMTNSkCWnge6Jw5jy9AOfTMdThxjDyse4rBY7U4pj8f7LIy4qeY47qG6b3D_9obbuPx-64XZ_R3At5AjaQ2eJtpmGGRIau2IsxpfpmO4WKw0r-g0QT/s1600/slide1.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="300" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh-uFWvUdZ7PTw56nSsNDqoOIzOKbQMTNSkCWnge6Jw5jy9AOfTMdThxjDyse4rBY7U4pj8f7LIy4qeY47qG6b3D_9obbuPx-64XZ_R3At5AjaQ2eJtpmGGRIau2IsxpfpmO4WKw0r-g0QT/s400/slide1.jpg" width="400" /></a></div><br /><br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEguSttqZabxxoQiCzP7yl_9FMlW4rnT3ZUx8twTf_sbazNcDGy1VvW5AD2QVpiB9d7Rxutxc9EThK9yudU0GIgnu8pj87tk5xTGuQ8uekuXnqhnD997iwv2No8GIPQZ_ChffLyWFSXdV5yG/s1600/slide2.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEguSttqZabxxoQiCzP7yl_9FMlW4rnT3ZUx8twTf_sbazNcDGy1VvW5AD2QVpiB9d7Rxutxc9EThK9yudU0GIgnu8pj87tk5xTGuQ8uekuXnqhnD997iwv2No8GIPQZ_ChffLyWFSXdV5yG/s400/slide2.jpg" width="400" /> </a> </div><div class="separator" style="clear: both; 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margin-right: 1em;"><img border="0" height="300" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhFj5OyTIR1JrS5wAhg3S8L1upwQVP-0gcC41xQDZij5-4-Gdies1yLqqrvUmSYSeof8FOelUBTIumhMCTQTSceMp88svBZ_i9wDAWMvIaW2utox0lBIhyphenhyphenzFHVIC1tFsQFtjQUuEJJAyFZP/s400/slide4.jpg" width="400" /></a></div><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpCb_UzFD6Zxw7EECp2tTOj_AGFsBGuWOUNE0IH4dwDhDV0DKBRZEoiw4NdAuwtdsg6X4XBlu9X9LxELJ3UnXPJPRSaXnkRZrLnecHBBYPostxJpYoeCKszw4-s3-Qs0DdAt9eePf1W6Ay/s1600/slide5.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpCb_UzFD6Zxw7EECp2tTOj_AGFsBGuWOUNE0IH4dwDhDV0DKBRZEoiw4NdAuwtdsg6X4XBlu9X9LxELJ3UnXPJPRSaXnkRZrLnecHBBYPostxJpYoeCKszw4-s3-Qs0DdAt9eePf1W6Ay/s400/slide5.jpg" width="400" /></a></div><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEitCex1mQm8nkOlg7pSBqCoEqn6CRp4NMqum4pm8vWLFyj2jJMLSMRQSrs7w3zGw5yg34KkpLGP10uBexfKCHNfczJkYEzGmwKms7eQP0yX-ylLWr777G4n40FpZKS1VYBI2Lymyz8F2DG-/s1600/slide6.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEitCex1mQm8nkOlg7pSBqCoEqn6CRp4NMqum4pm8vWLFyj2jJMLSMRQSrs7w3zGw5yg34KkpLGP10uBexfKCHNfczJkYEzGmwKms7eQP0yX-ylLWr777G4n40FpZKS1VYBI2Lymyz8F2DG-/s400/slide6.jpg" width="400" /></a></div><div class="separator" style="clear: both; text-align: center;"><br /></div><br />I left it to the audience to answer these questions. <br /><br />I then posed the question "Is health IT being done well?"<br /><br />I provided links to various evidence that it was not, such as the <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572" target="_blank">National Research Council 2009 report</a> on health IT; AMIA's report on its <a href="http://hcrenewal.blogspot.com/2009/03/health-it-project-success-and-failure.html" target="_blank">workshop on healthcare IT failure</a>, the 2012 U.S. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf" target="_blank">IOM report on safety</a>, the 2012 U.S. <a href="http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf" target="_blank">NIST report on usability</a>, work by <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146" target="_blank">Australian Professor Jon Patrick of U. Sydney</a> on health IT defects, and other sources as aggregated <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">at this link</a>.<br /><br />Again, I did not impose views on the audience.  I didn't need to, as that corpus speaks for itself.<br /><br />I also clarified terminology that reduces essential caution, such as the terms "electronic medical record" (EMR) and "electronic health record" (EHR) - a source of endless, wasted contention on definitions of which is which - being anachronisms from an earlier age of IT.  I pointed out that in 2012 what these innocuous terms somewhat deceptively and disarmingly represent are in reality <b>complex enterprise clinical resource management and clinician workflow control systems</b> – where many, many things can go wrong.<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhZumc0y9_28FXWfsMcfOZqyJHKP9kdpAvJtKu8gq5MYqMOko6WQ3rD5TH_C0OiNEi9JTfP7ELdGbN_PllfwHjkE1kgDP1xEoti46ZeQ_xLs0tw3IQI5x4FK4o8Y-nmfvl_FxRgJncN0KpR/s1600/slide7.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="300" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhZumc0y9_28FXWfsMcfOZqyJHKP9kdpAvJtKu8gq5MYqMOko6WQ3rD5TH_C0OiNEi9JTfP7ELdGbN_PllfwHjkE1kgDP1xEoti46ZeQ_xLs0tw3IQI5x4FK4o8Y-nmfvl_FxRgJncN0KpR/s400/slide7.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">"EHR":  an innocuous "file cabinet" for records, or something else entirely?  Click to enlarge.</td></tr></tbody></table><br /><br />I asked if case reports of health IT unintended consequences (UC’s) were “anecdotal” and to be played down, while studies of health IT benefits to date solid science.  I then asked if the reality might be that studies of health IT benefits to date were mostly anecdotal (e.g., in specialized settings; weak observational studies vs. randomized clinical trials) while reports of UC’s <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html" target="_blank">are risk management-relevant incident report “red flags”</a> pointing to possible systemic problems.<br /><br />I pointed out the common seller marketing memes of beneficence and deterministic efficacy, and asked if these were realistic.  I also pointed out the need for <b>transparency </b>about HIT risks, and the impediments to this transparency.<br /><br />Finally, I indicated what was the likely problem affecting all countries involved in EHR projects: that the <b>rigor, ethics and skepticism of medical science itself not applied in the domain of health IT.</b><br /><br /><b>I suggested a simple solution:  a paradigm shift in thinking about health IT as another medical device, </b>that needed to be subject to the same methodologies and ethical considerations applicable for decades (or more) in the healthcare delivery sector such as medical devices, pharmaceuticals, and research (and other risk-prone industries e.g., aviation and automotive).<br /><br />My goal was to provoke thinking about these issues, to circumvent blank, uncritical acceptance of industry and industry-supporter memes.<br /><br />I believe I succeeded.  Feedback I received was that the audience, including government officials, found many new things to consider as they embark on their national health IT projects.<br /><br />I also heard that some HIT seller representatives were squirming a bit.  That was not unexpected.  I was taking "control of their message" away from them.<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhGiHKiF08nosKVU7uTAYFAuZg0tzy09D_tVjFrfb2sJmv6LrJlm_Pv-vazJeH5joFN8HbBEAGFJRgS9EIIr5grSxultREvX8Uycje6Tgf0cYzN6BfLqgbHbKFxor9o14guSy_qimQdUwou/s1600/jon_IMG_1038a.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="300" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhGiHKiF08nosKVU7uTAYFAuZg0tzy09D_tVjFrfb2sJmv6LrJlm_Pv-vazJeH5joFN8HbBEAGFJRgS9EIIr5grSxultREvX8Uycje6Tgf0cYzN6BfLqgbHbKFxor9o14guSy_qimQdUwou/s400/jon_IMG_1038a.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">University of Sydney Professor Jon Patrick presenting on computational linguistics.   Jon is the author of a treatise on health IT defects (at <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146" target="_blank">this link</a>), mentioned numerous times on this blog.  Dr. Patrick graciously hosted me at his Sydney home for several days after the conference and he and his wife gave me a wonderful tour of the city.  Click to enlarge.</td></tr></tbody></table><br />Finally, I had a question from the audience, from fellow blogger <a href="http://thehealthcareblog.com/blog/category/matthew-holt/" target="_blank">Matthew Holt of the Health Care Blog</a>.  (I've had some online debate with him before, such as in the comment thread at my April 2012 post <a href="http://hcrenewal.blogspot.com/2012/04/allscripts-shares-plunge-on-weak.html" target="_blank">here</a>.)<br /><br />Matthew asked me a somewhat hostile question (perhaps in retaliation for the thrashing he received at the end of my May 2009 post on the WaPo's HIT Lobby article <a href="http://hcrenewal.blogspot.com/2009/05/machinery-behind-healthcare-reform-how.html" target="_blank">here</a>), that I was well prepared for, expecting a question along these lines from the seller community, actually.  The question was preceded by a bit of a soliloquy of the "You're trying to stop innovation through regulation" type, with a tad of Merck/VIOXX ad hominem thrown in (I ran Merck Research Labs' Biomedical libraries and IT group in 2000-2003).<br /><br />His question was along the lines of - you were at Merck; VIOXX was bad; health IT allowed discovery of the VIOXX problem by Kaiser several years before anyone else; you're trying to halt IT innovation via demanding regulation of the technology thus harming such capabilities and other innovations.<br /><br />The audience was visibly unsettled.  Someone even hollered out their disapproval of the question.<br /><br />My response was along the lines that:<br /><br /><ul><li>VIOXX was certainly not Merck at its best, but regulation didn't stop Merck from "revolutionizing" asthma and osteoporosis via Singulair and Fosamax;</li><li>That I'm certainly not against innovation; I'm highly pro-innovation;</li><li>That our definitions of "innovation" in medicine might differ, in that innovation without adherence to medical ethics is not really innovation.  It is <i>exploitation</i>.</li></ul><br />(I forgot to mention that I gave an invited presentation to Merck's Drug Surveillance department in 2006, PPT <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/silverstein_merck_informatics_nov2006.ppt" target="_blank">here</a>, long after I was their employee, on the potential use of EHR data to detect drug adverse events sooner than traditional phase IV studies or ad-hoc reporting allowed.)<br /><br />When I spoke of medical innovation requiring ethics, nearly the full audience at my keynote address - hundreds of people - broke out in applause.<br /><br /><div class="O"><div style="mso-char-wrap: 1; mso-kinsoku-overflow: 1; mso-line-spacing: "100 20 0"; mso-margin-left-alt: 216;"><span style="font-family: Calibri; font-size: 178%;"><span style="font-family: Arial; left: -3.74%; mso-special-format: bullet; position: absolute;">•</span></span><span style="font-family: Calibri; font-size: 32pt; mso-ascii-font-family: Calibri; mso-hansi-font-family: Calibri;"></span><span style="font-family: Calibri; font-size: 32pt; mso-ascii-font-family: Calibri; mso-hansi-font-family: Calibri;"></span></div></div>I knew at that point that my talk was a success.<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhEK2U60to_tB_kXJTSf-Qe5ZaNpx9W1QcfYdeVVUzfgg9vdWregrtDUXPVsD6jdwSqMw_stc3jSUIQBxskqnK83HsNBcQ5WgC1MKocdAnrl_OABrk9RSJ4PXDJOcgG_gprdRB3kiIItMRb/s1600/Louise_Scot_HIC2012_080212.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhEK2U60to_tB_kXJTSf-Qe5ZaNpx9W1QcfYdeVVUzfgg9vdWregrtDUXPVsD6jdwSqMw_stc3jSUIQBxskqnK83HsNBcQ5WgC1MKocdAnrl_OABrk9RSJ4PXDJOcgG_gprdRB3kiIItMRb/s320/Louise_Scot_HIC2012_080212.jpg" width="240" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">This author with HISA CEO Louise Schaper , PhD. Click to enlarge.</td></tr></tbody></table><br />More photos of my trip are <a href="http://www.facebook.com/media/set/?set=a.4025347084034.2161136.1592238231&type=3&l=a25989ee6e" target="_blank">here</a>. <br /><br />-- SS<br /><br /><b>Addendum:  </b>Another added pleasure in my visit Down Under. As Australia and the U.S. respect each other's amateur radio licenses, I was able to operate my handheld radio as "KU3E portable Victor-Kilo." VK is the international radio prefix for Oz.  Contacting Australia from the U.S. is considered a "holy grail" of ham radio.  It was interesting to hear amateur radio "from the other end."<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgLNBtEIJGKFAAofrv5VhAkUXCgQjPqCfV3aD9E1JI5XmIPE-TwuVC09JJB_Eat7S0tMY3QgeDD2gNiKu1XtJn2lNSrjn91D6BURD6nhahGjbh3HVWTs0XoESuw-9Pr1tuX88OeL_XLNTlK/s1600/vx3.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgLNBtEIJGKFAAofrv5VhAkUXCgQjPqCfV3aD9E1JI5XmIPE-TwuVC09JJB_Eat7S0tMY3QgeDD2gNiKu1XtJn2lNSrjn91D6BURD6nhahGjbh3HVWTs0XoESuw-9Pr1tuX88OeL_XLNTlK/s200/vx3.jpg" width="110" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Yaesu VX-3 Multiband Transceiver</td></tr></tbody></table><br />-- SS<br /><br /><b>Aug. 11, 2012 Addendum:</b><br /><br />An excellent multimedia video of HIC 2012 produced as the conference proceeded has been posted on YouTube at <a href="http://www.youtube.com/watch?v=DZg_46wY0E0">http://www.youtube.com/watch?v=DZg_46wY0E0</a>.  It was finished and shown immediately after the conference's conclusion.<br /><br />-- SS

My Presentation to the Health Informatics Society Of Australia: "Critical Thinking on Building Trusted, Transformative Medical Information: Improving Health IT as the First Step"

In early 2011 I was invited to present at the annual convention of the Health Informatics Society of Australia (HISA) by its CEO, Louise Sch...

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Defense Attorney Lies Under Oath In Sworn Filing to Protect Hospital's Health IT

At my Aug. 7. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/08/pa-attorney-puts-onc-approved-hit.html">Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?"</a> I wrote:<br /><br /><blockquote class="tr_bq"> ... I returned to the U.S. to find that the defense attorney for the hospital where my mother was severely injured, and then died as a result, is once again raising an absurd issue in objections to the medical malpractice Complaint that was refiled within the Statute of Limitations for technical reasons.   The President Judge of the county where the case is filed had dismissed this complaint (among many others) some time ago: </blockquote><br /><blockquote class="tr_bq"><blockquote class="tr_bq"><b>(ii) Plaintiffs Software Design Defect Claims are Preempted by the Federal HITECH Act</b><br /><br />... To the extent Plaintiff attempts to bring a common law product liability claim against [name redacted] Hospital <b>for required use of EMR software</b> <b><i style="color: red;">[see addendum below - ed.]</i></b>, such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.C. 201, 300, et seq.<br /><br />Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a <b>highly regulated industry </b>under the jurisdiction of the Department of Health and Human Services (HHS). <b>The HHS draws its statutory authority to design and certify EMR as safe and effective </b>under the HITECH act as amended. Id.<br /><br />The Supremacy Clause of the United States Constitution, article VI, clause 2, <b>preempts any state law that conflicts with the exercise of federal power. </b>Fid. Fed. Say. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 102 S. Ct. 3014 (1982). “Pre-emption may be either express or implied, and ‘is compelled whether Congress’ command is explicitly stated in the statute’s language or implicitly contained in its structure and purpose.” Matter of Calun Elec. Power Co-op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.s. 519, 525 (1977).<br /><br />In this case, to impose common law liability upon [name redacted] Hospital for <b>using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology</b>, would directly conflict with Congress’ statutory scheme for fostering and promoting the implementation and use of EHR<span style="background-color: white;"></span>  <i style="color: red;"><b><br /></b></i></blockquote><br />I really don't think Congress intended HIT to maim and kill patients with impunity.  In any case, this assertion was thrown out in its entirety several months ago, but<i> here it is again in a new set of objections.  </i>I find its reappearance remarkable.  I also wonder if the industry is behind it.</blockquote><br />What I didn't post is the reply to this nonsense that was presented to the court by Plaintiff (me), via Plaintiff's counsel after my analysis of this passage, in a Memorandum of Law to the court Dec. 5, 2011:<br /><br /><blockquote class="tr_bq">... HHS does not regulate the design, manufacture, specification, certification, and sale of EMRs or any other clinical information technology. The HITECH Act itself does not establish standards and certification criteria for health information technology, but instead establishes the HIT Standards Committee to implement such specifications and standards for certification. HITECH Act § 3003, 42 U.S.C. § 300jj-13. <br /><br /><b>The initial set of standards specifications and certification criteria were not published until July 28, 2010, approximately 2 months after Mrs. Silverstein entered [name redacted] Hospital. </b>Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 75 Fed. Reg. 44589 (July 28, 2010). <b>Therefore, it would have been impossible for [name redacted] Hospital’s EMR system “to be in compliance with federal law and regulations for Health Information Technology” during the time of Mrs. Silverstein’s admission. </b></blockquote><br />These facts were filed with the Court and delivered to the defense on Dec. 5, 2011 regarding health IT certification.  An Affidavit/Certificate of Service to the defendants was also filed with the Response and Memorandum of Law as is customary, and are noted on the Prothontary website.  No "I didn't receive it" excuse is possible...<br /><br />The facts about health IT "certification" are trivial to verify.  <br /><br />As the hospital admission where my mother was injured, and the injury itself, were in May 2010, "<b>using certified EHR technology</b> <b>in compliance with federal law and regulations for Health Information Technology</b>" was <i>not possible at that time</i>.  (Not to mention the facilities' EHR's were not actually "certified" until December 2010 via the ONC database of certified systems.)<br /><br />Thus, the defense attorney by re-issuing this claim in August 2012 (to the new judge overseeing the case re-filing) is now <i>knowingly lying to the Court in sworn filings</i>, in order to harass, cause unnecessary delays in litigation, and needlessly increase the cost of litigation while collecting hourly fees for production of frivolous and untrue assertions.<br /><br />The attorney is also making a mockery of the court system in the locality where the case is being heard, and also insulting the judges' intelligence. <br /><br />These are the lengths to which hospitals and defense attorneys seem to be willing to go in defense of health IT.  I find this remarkable (but not surprising).<br /><br />It will be interesting to see how the judge responds to an attorney knowingly trying to blow smoke up his behind.<br /><br />-- SS<br /><br /><b>Addendum:  </b>Also pointed out in earlier filings was the fact that use of EMR's is not "required."   It seems the defense attorney, besides being a liar, has a thick skull.<br /><br />-- SS<br /><br />

Defense Attorney Lies Under Oath In Sworn Filing to Protect Hospital's Health IT

At my Aug. 7. 2012 post " Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?...

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Needed: A Webcast on Disruptive and Criminal Hospital Executives

I received this, unsolicited, via email:<br /><br /><blockquote class="tr_bq"><b>Webcast:  Managing Disruptive Docs in a New Era of Hospital-Physician Relations </b><br /><br />If you haven't already purchased this live Webcast, don't miss out! Left unchecked, disruptive physicians do more than just create a negative work environment; they endanger patient care and can lead to million-dollar lawsuits and bad publicity.  Our top experts will show you early intervention techniques and a range of effective resources that can help you reduce behavioral problems, retain star physicians, create a healthier workplace and save millions in potential lawsuits.<br /><br />The agenda includes:<br /><br />    Defining and identifying causes of disruptive behavior<br />    Economic consequences of disruptive behavior<br />    Overcoming disruptive physician problems<br /><br />This program will be guided by your questions, so register now and ask away! </blockquote><blockquote class="tr_bq">Your instructors:<br /><br />Alan Rosenstein, MD, MBA<br />Medical Director of Physician Wellness Services<br /><br />David Danielson, JD, CPA<br />Senior Vice President, Clinical Risk Management, Sanford Health<br /><br />Scott Hurst<br />Former Director of Physician Alignment and Recruitment, CHRISTUS Spohn Health System<br /><br />Managing Disruptive Docs in a New Era of Hospital-Physician Relations is designed to help CEOs, COOs, CMOs, group practice administrators, HR leaders, and physicians learn strategies and tactics to prevent, reduce, and limit the severity of disruptive physician incidents.</blockquote><br />"Disruptive physician" is a vague term subject to enormous abuse, leading to <a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/" target="_blank">sham peer review</a> among other totalitarian tactics.   It reminds me of the old Soviet Union's politics.<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiaZGkgvYub9OiuiXN2A_9Y57CTEJFCv8iKNfY4K7pA4HQW3dkVL-lHxHWLXPsFN4cplq0kC4fe42SsNySpr5W3e1WBLtbuuSyFgzbNL_OS9kiRFL5kidQezG61bXRNwk2iNoA23fTkqvcV/s1600/poster-06.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="219" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiaZGkgvYub9OiuiXN2A_9Y57CTEJFCv8iKNfY4K7pA4HQW3dkVL-lHxHWLXPsFN4cplq0kC4fe42SsNySpr5W3e1WBLtbuuSyFgzbNL_OS9kiRFL5kidQezG61bXRNwk2iNoA23fTkqvcV/s320/poster-06.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">You have been deemed a Disruptive Physician, Comrade.  You will be given a fair trial, then shot</td></tr></tbody></table><br /><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiaZGkgvYub9OiuiXN2A_9Y57CTEJFCv8iKNfY4K7pA4HQW3dkVL-lHxHWLXPsFN4cplq0kC4fe42SsNySpr5W3e1WBLtbuuSyFgzbNL_OS9kiRFL5kidQezG61bXRNwk2iNoA23fTkqvcV/s1600/poster-06.jpg" style="margin-left: 1em; margin-right: 1em;"></a><br />In particular, this label can be used to suppress clinician concerns about care quality in an era of cost cutting and care manipulation through electronic workflow control systems (e.g., EHR's CPOE, CDS etc.)<br /><br />The potential of being labelled as "disruptive" may be one reason why physician outcry against the very low quality of healthcare IT systems and dangers posed by them is relatively uncommon.<br /><br />Patients - you - ultimately suffer when your physicians fear being your outspoken advocates. <br /><br />As the many stories of healthcare executive malfeasance and profiteering at the expense of patients on this blog indicate, what is really needed for true healthcare reform are webcasts on:<br /><br /><b>MANAGING DISRUPTIVE AND CRIMINAL HOSPITAL EXECUTIVES IN AN ERA OF RAMPANT CORPORATIZATION OF MEDICINE.</b><br /><br />-- SS<br /><br />Addendum:  here are additional resources on the “Disruptive Physician”:<br /><br /><b>Abuse of the “Disruptive Physician” Clause</b>,<a href="http://www.jpands.org/vol9no3/huntoon.pdf" target="_blank"> http://www.jpands.org/vol9no3/huntoon.pdf</a><br /><b><br />The Insulting Physician “Code of Conduct”</b>,<a href="http://www.jpands.org/vol13no1/huntoon.pdf" target="_blank"> http://www.jpands.org/vol13no1/huntoon.pdf</a> <br /><br />In the latter article, Lawrence Huntoon MD PhD, and expert on abuses of this label, notes:<br /><br /><blockquote class="tr_bq">... The typical physician code of conduct is initiated by a hospital administration. Its wording is curiously similar from one hospital to the next, suggesting that a template is being circulated.<br /><br />... The physician code of conduct is intentionally insulting, demeaning, and degrading to physicians, and reduces physicians to being treated like juvenile delinquents at a reform school. It assumes that all physicians, like juvenile delinquents, need to be subjected to a long list of prohibited behaviors because, in the hospital administration’s view, physicians are predisposed to such things as theft, destruction of property, and physical and sexual assault. <b>Conspicuous by its absence is any mention of “disruptive” or “abusive” hospital administrators, or any similar code of conduct applicable to a hospital administration.</b></blockquote><br />Dr. Huntoon then goes on to make a recommendation, a "hospital administration’s code of conduct":<br /><br /><blockquote class="tr_bq">... The term “disruptive hospital administrator” and/or “abusive hospital administrator” should be incorporated into the hospital administration’s code of conduct and should be defined as anyone in the hospital administration who, in the view of the medical staff (as determined by majority vote), <b>interferes with the ability of physicians to provide safe and high-quality care to patients in the hospital.</b></blockquote><br />His detailed criteria for “disruptive hospital administrator” in the latter article are worth reading in their entirety.<br /><br />-- SS<br /><span style="font-size: small;"><b><span style="color: #343434;"><span style="font-family: Verdana,Arial,sans-serif;"></span></span></b></span>

Needed: A Webcast on Disruptive and Criminal Hospital Executives

I received this, unsolicited, via email: Webcast:  Managing Disruptive Docs in a New Era of Hospital-Physician Relations If you haven't ...

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ONC and Misdirection Regarding Mass Healthcare IT Failure

In my keynote address to the Health Informatics Society of Australia in Sydney recently, I cautioned attendees including those in government to be wary of <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">healthcare IT hyper-enthusiast</a> misdirection and logical fallacy (a.k.a. public relations).<br /><br />In the LA Times story "<a href="http://www.latimes.com/business/la-fi-hospital-data-outage-20120803,0,5302779.story?track=rss&cid=dlvr.it&dlvrit=52116" target="_blank">Patient data outage exposes risks of electronic medical records</a>" on the Cerner EHR outage I wrote of in my post "<a href="http://hcrenewal.blogspot.com/2012/08/massive-health-it-outage-but-of-course.html" target="_blank">Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised</a>" (the title, of course, being satirical), Jacob Reider, acting chief medical officer at the federal Office of the National Coordinator for Health Information Technology is quoted.  He said:<br /><br /><blockquote class="tr_bq">"These types of outages are quite rare and there's no way to completely eliminate human error." </blockquote><br />This is precisely the type of political spin and hyper-enthusiast misdirection I cautioned the Australian health authorities to evaluate critically.<br /><br />As comedian Scott Adams <a href="http://www.leany.com/logic/Adams.html" target="_blank">humorously noted</a> regarding irrelevancy, a hundred dollars is a good price for a toaster, compared to buying a Ferrari. <br /><br />Further, when you're the patient harmed or killed, or the victim is a family member, you really don't care how "rare" the outages are.<br /><br /><i><b>Airline crashes are "rare", too.   </b></i>So, shall they just be tolerated as a "cost of doing business" and spun away?<br /><br />(As I once wrote, the asteroid colliding with Earth that caused the extinction of the dinosaurs was a truly "rare" event.) <br /><b><br /></b>It seems absurd for me to have to point out that paper, unless there is a mass outbreak of use of disappearing ink, or <i>locally hosted</i> clinical IT, <b>do not go blank en masse across multiple states and countries for any length of time,</b><b> raising risk across multiple hospitals </b><b>greatly, </b><b>acutely and simultaneously.   </b>Yet, I have to point out this obvious fact in the face of misdirection.<br /><br />Locally hosted health IT, of course, can only cause "local" chart disappearances.  "Local" is a relative term, however, depending on HC organization size, as in the example of a Dec. 2011 regional University of Pittsburgh Medical Center (UPMC) 14-hour outage affecting thousands <a href="http://hcrenewal.blogspot.com/2011/12/yet-another-glitch-affecting-thousands.html" target="_blank">here</a>.<br /><br />Further, EHR's and other clinical IT, whether hosted locally or afar, had better offer truly <i><b>major</b></i> advantages, <i><b>without</b></i> major risks and disadvantages, over older medical records technologies before exposing large numbers of patients to an invasive IT industry and the largest unconsented human subjects experiment in history.<br /><br />Unfortunately, those basic criteria are not yet apparent with today's systems (see for instance this <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">reading list</a>).<br /><br />EHR's and other clinical IT, forming in reality an <i><b>enterprise clinical resource management and clinician workflow control apparatus</b></i>, have introduced new risk modes including mass <a href="http://hcrenewal.blogspot.com/2012/06/more-electronic-medical-record-breaches.html" target="_blank">chart theft</a> (sometimes tens of thousands in the blink of an eye); also, mass chart disappearances as in this case - all not possible with paper.<br /><br />At the very least, if hospitals want enterprise clinical resource management and clinician workflow control systems, these should not be relegated to a distant third party.<b>  Patients are not guinea pigs upon whom to test the <a href="http://en.wikipedia.org/wiki/Application_service_provider" target="_blank">ASP software model</a> ("software as a service") that, upon failure for any reason, threatens their lives.</b><br /><br />Finally, these complications are a further example why this industry cannot go on without meaningful oversight.  The unprecedented special medical device regulatory accommodations must end.<br /><br />-- SS

ONC and Misdirection Regarding Mass Healthcare IT Failure

In my keynote address to the Health Informatics Society of Australia in Sydney recently, I cautioned attendees including those in government...

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Joint Commission Should Be Named As Defendant If Patients Harmed by EHR "Outages"

At my recent post "<a href="http://hcrenewal.blogspot.com/2012/08/massive-health-it-outage-but-of-course.html">Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised</a>" over a massive, outrageous Cerner outage to hospitals contracting their clinical IT via an <a href="http://en.wikipedia.org/wiki/Application_service_provider" target="_blank">ASP model</a> (that is, 'software as a service'), I observed:<br /><br /><blockquote class="tr_bq">... The Joint Commission, for example, likely issued its stamp of approval for the affected hospitals, hospitals who had outsourced their crucial medical records functions to an outside party that sometimes went mute.  If someone was injured or died due to this outage, they would not care very much about the supposed advantages.</blockquote><br />From the JC's page "<a href="http://www.jointcommission.org/about_us/about_the_joint_commission_main.aspx" target="_blank">About the Joint Commission</a>":<br /><br /><blockquote class="tr_bq"><b>An independent, not-for-profit organization</b>, The Joint Commission accredits and certifies more than 19,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is <b>recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.</b></blockquote><br />It's time to up the ante regarding this accreditation body, fully aware of health IT risks (e.g., the Dec 2008 <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html" target="_blank">Sentinel Events Alert on Health IT</a>) but to date having done little about them.  Through my legal work and my speaking to Plaintiff's attorneys, I am becoming increasingly aware of medical malpractice cases that  involve an EHR or related clinical IT systems at JC-accredited organizations.<br /><br />In effect, the JC has accredited hospitals whose entire clinical command-and-control structure (the term EHR is an anachronism; these systems are in reality <b>enterprise clinical resource management and clinician workflow control devices</b>)<b> </b>can disappear in the blink of an eye, without warning, raising risk to patients greatly.<br /><br />If I discover that a patient was harmed or killed as a result of, or related to, this massive recent outage of outsourced medical records/workflow control  infrastructure, I will be recommending that the Joint Commission, including its leadership, which likely certified the hospital(s) involved for safe operations in areas such as Information Management, <i><b>be named </b></i><i><b>as defendants.</b></i><br /><br />I have informed the JC leadership by email<i><b>.</b></i><br /><i><b> </b></i> <br />-- SS

Joint Commission Should Be Named As Defendant If Patients Harmed by EHR "Outages"

At my recent post " Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised " over a massive, outrageous Cer...

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