Fourth Time is the (Anti)Charm? - UK NICE Highlights "Uncertainties in the Evidence Base" About Sovaldi

As we have discussed, (<a href="http://hcrenewal.blogspot.com/2014/04/knee-deep-in-hoopla-triumph-of-medical.html">here</a>, <a href="http://hcrenewal.blogspot.com/2014/05/some-authoritative-skepticism-about.html">here</a> and <a href="http://hcrenewal.blogspot.com/2014/05/sovaldi-revolution-in-clinical-care-or.html">here</a>), while anger continues to build about the $1000/ pill price sought by Gilead for its new antiviral drug for hepatitis C, Sovaldi (sofosbuvir), almost all public discussion still treats the drug as miraculous.  However, my reading of some key trials, and reviews by three groups of evidence-based medicine experts, suggested that the evidence supporting the drug is actually weak and unclear, and hardly suggests it is miraculous.<br /><br /><b>NICE Weighs In </b><br /><br />Now, as first noted by the indomitable Ed Silverman in his revived PharmaLot blog, the National Institute for Health and Care Excellence in the UK is also skeptical.    <br /><br /><blockquote class="tr_bq"> the U.K.’s National Institute for Health and Care Excellence, otherwise known as NICE, has <i>declined to endorse the use of Sovaldi, at least for now</i>, until Gilead supplies further evidence of the medication works in certain subgroups of patients. In announcing the move, NICE officials wrote there are '<i>substantial uncertainties' in the evidence from the drug maker</i>. In <a data-ls-seen="1" href="http://www.nice.org.uk/newsroom/pressreleases/NICEOnDraftGuidanceForSofosbuvirSovaldiDrugHepatitisC.jsp">a statement</a> issued about a draft guidance, NICE wrote that the agency 'is minded not to recommend' that the U.K.’s National Health Service cover the cost of Sovaldi,</blockquote><br />The actual <a href="http://www.nice.org.uk/newsroom/pressreleases/NICEOnDraftGuidanceForSofosbuvirSovaldiDrugHepatitisC.jsp">statement</a> said,<br /><br /><blockquote class="tr_bq"> The available evidence shows that sofosbuvir is an effective treatment for chronic hepatitis C in certain patients. However, evidence is lacking for some subgroups of patients with chronic hepatitis C, and there are also substantial uncertainties in the evidence base presented by the manufacturer. The Committee has therefore requested further information from the manufacturer before it can decide whether sofosbuvir is a cost-effective use of NHS resources.</blockquote><br />In the US, the only other news source that covered the NICE statement was <a href="http://www.businessweek.com/news/2014-06-16/u-dot-k-dot-cost-regulator-may-reject-gilead-s-sovaldi-treatment">Bloomberg</a>.<br /><br /><b>The Problems with the Evidence</b><br /><br />As we discussed in our previous posts, the problems with the evidence underlying Sovaldi include:<br />- Lack of a randomized controlled trial comparing Sovaldi to the previously most recommended treatment regimen<br />- The only trial trial to compare an antiviral regimen containing Sovaldi to one without it  (Sovaldi plus ribavirn versus peg-interferon plus ribavirin) used a lower dose of ribavirin in the comparator regimen, seemingly handicapping it; had a highly selected patient population whose results would be unlikely to generalize to many patients in the real world; had issues with randomization of patients; only assessed short-term "sustained" virologic response, but not any clinical outcomes; even so, did not show that the sofosbuvir containing regimen produced a better SVR than did the comparator; and appeared to show that the sofosbuvir containing regimen produced more severe adverse effects, and perhaps a higher death rate than the comparator regimen<br />-  So far, the other published trials included one versus placebo, and multiple trials that compared only sofosbuvir containing regimens to each other, and hence were effectively just case series of patients receiving sofosbuvir.  These case-series all had highly selected patient populations results from whom would be unlikely to generalize to real world patients.<br /><br />The severe problems with the evidence have now also been noted by<br />-  the <a href="https://www.iqwig.de/en/press/press_releases/press_releases/sofosbuvir_indication_of_added_benefit_for_specific_patients.6099.html">German Institute for Quality and Efficiency in Healthcare</a> (IQWiG)<br />-  the US Institute for Clinical and Economic Review (look <a href="http://archinte.jamanetwork.com/article.aspx?articleid=1867174">here</a>)<br />-  the US Center for Evidence-Based Policy (look <a href="http://hcrenewal.blogspot.com/2014/05/sovaldi-revolution-in-clinical-care-or.html">here</a>) <br />-  the<a href="http://www.nice.org.uk/newsroom/pressreleases/NICEOnDraftGuidanceForSofosbuvirSovaldiDrugHepatitisC.jsp"> UK National Institute for Health and Care Excellence</a> (NICE)<br /><br /><b>Summary - Why Does the Evidence, or Lack Thereof, Remain Anechoic? </b><br /><br />Yet none of these reviews have gotten any significant attention in the US media or medical and health care literature, and the idea that Sovaldi has hardly been proven to be a miracle drug, or even better than older drugs for hepatitis C has not informed the US debate and the US outrage about its price.  Examples of the most recent outrage include <a href="http://www.forbes.com/sites/theapothecary/2014/06/17/the-sovaldi-tax-gilead-cant-justify-the-price-its-asking-americans-to-pay/">this in Forbes</a>,<br /> <br /><br /><blockquote class="tr_bq">A cure for hepatitis C is within reach for 170 million people around the world — thanks to the charitable efforts of poor and sick Americans who are picking up the tab by paying <i>outrageous prices</i> for their own treatment. It’s like Robin Hood in reverse. </blockquote><br />Also, <br /><br /><blockquote class="tr_bq"> It also took a complete lack of self-awareness — and <i>unmitigated gall</i> — to price Sovaldi the way Gilead has.</blockquote><br />Furthermore, Democrats in the US House of Representatives are calling for an investigation (which their Republican "colleagues" will doubtless block), <a href="http://www.bloomberg.com/news/2014-06-19/democrats-want-gilead-to-explain-84-000-cost-for-therapy.html">according to Bloomberg</a>,<br /><br /><blockquote class="tr_bq">The company 'did not provide a compelling justification for the high price they are charging for most patients,' Waxman and DeGette wrote  </blockquote><br /><br />If the price is outrageous for a miracle drug, it would be even more outrageous for a drug that has not been proven to be better than previously available treatments.<br /><br />The fact that skepticism about all the hype for Sovaldi has hardly touched the public discussion in the US is a prime example that the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a> lives.  (The only skepticism from an expert could [probably only] be <a href="http://blogs.wsj.com/pharmalot/2014/06/12/will-oregon-restrict-coverage-for-a-pricey-gilead-pill-for-hepatitis-c/">found again in PharmaLot</a>, and came from one of the authors of the Center for Evidence Based Policy report [see above]). <br /><br /><blockquote class="tr_bq">'For most patients with hepatitis C, they have time to make those decisions,' Valerie King, one of the physicians at the center who worked on the Sovaldi review, tells OregonLive. 'I’m certainly not saying that this is a bad drug. I’m just saying that we don’t know that it is a good drug.' [<strong>UPDATE</strong>: King later called us to say that 'the research hasn't been extensive enough or transparent enough to tell us it is a good drug or bad drug, or has limited application.' This was based solely on assessing clinical research, not cost issue.]</blockquote><br />We have endlessly discussed the anechoic effect, that information and ideas that challenge the powers that be in health care, and particularly that challenge the ability of health care leaders and well-connected insiders to personally profit, often to a tremendous extent - the CEO of Gilead, John Martin, was <a href="http://www.fiercepharma.com/special-reports/biopharma-ceos-2013-john-martin-gilead">listed by FiercePharma </a>as the eighth highest paid biotech CEO in 2013, with total compensation of $15.45 million, before sales of Sovaldi really increased -  are considered recent unpleasantness that are just not to be discussed.  However, without open honest discussion of truths, however inconvenient or unpleasant, and the ideas that they suggest, health care will continue to degenerate into a plutocratically run, often corrupt swamp with ever increasing costs, and ever worsening access and quality, causing increasing suffering of patients and worsening of public health. <br /><br />A good place to start true health care reform might be honest discussion of the evidence about sofosbuvir.    <br /><br />

Fourth Time is the (Anti)Charm? - UK NICE Highlights "Uncertainties in the Evidence Base" About Sovaldi

As we have discussed, (here, here and here), while anger continues to build about the $1000/ pill price sought by Gilead for its new antiviral drug for hepatitis C, Sovaldi (sofosbuvir), almost all pu…

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Yet another EHR "glitch" - insulin decreased per protocol, oops, I meant heparin

Yet another EHR "glitch" (<a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>):<br /><br /><blockquote class="tr_bq"><a href="http://www.labornotes.org/2013/07/electronic-medical-records-friend-or-foe">http://www.labornotes.org/2013/07/electronic-medical-records-friend-or-foe</a><br /><br />An emergency room nurse described her frustrating experience trying to accurately document a dose of <b>heparin</b>, a blood thinner for patients with chest pain. “The doctor stated he wanted 4000 units bolus [all at once] and then a 1000 unit per hour infusion,” she wrote. “The order in Paragon stated 5000 units of <u><b>heparin</b></u>. I was given the option to decrease the dose, which I manually changed.<br /><br />“However, I had to pick a reason why I decreased the dose. There was a drop-down box, and the only option was <b>‘<u>Insulin</u> decreased per protocol.’”</b></blockquote><br />In the unregulated world of health IT, there's no pre-market evaluation or QC process to find little "glitches" like this that make it onto floors of live patients.  <br /><blockquote class="tr_bq"><br />The drug was heparin, not insulin. What was she supposed to do? “I contacted the pharmacy and spoke to three different people, and the final response was,<b> ‘snapshot the screen and give it to your manager.’ </b>This was a nine-minute conversation.”</blockquote><br />That's really not very helpful to the patient needing heparin urgently.<br /><blockquote class="tr_bq"><br />The manager finally advised her to <i>select the given option for insulin</i>, <b>then separately document that heparin, not insulin, was given.</b></blockquote><br />No future mistakes are possible due to this little glitch "workaround", right?<br /><br /><blockquote class="tr_bq">That’s <b>nine extra minutes away from the bedside</b>, just to document one medication—<b>and to document it inaccurately, to boot.</b> Multiply that times the many different tasks and patients a nurse juggles every day, and you start to see the problem. </blockquote><br />I point out that this order would have taken exactly ten seconds with a pen and paper.<br /><br />I hear stories like this - odd "glitches" and "gotchas" - from medical colleagues at least weekly, and sometimes daily. <br /><br />-- SS

Yet another EHR "glitch" - insulin decreased per protocol, oops, I meant heparin

Yet another EHR "glitch" (http://hcrenewal.blogspot.com/search/label/glitch):http://www.labornotes.org/2013/07/electronic-medical-records-friend-or-foeAn emergency room nurse described her frustrating…

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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>).<br /><br />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":<br /><br /><blockquote class="tr_bq"><a href="http://healthenews.cchfreedom.org/newsletter.php/148">http://healthenews.cchfreedom.org/newsletter.php/148</a><br /><br />The Truth about Electronic Health Records<br /><br />Propaganda only works for so long. Pretty soon truth catches up to it. This is exactly what's happening with electronic health records.<br /><br />If you're a doctor you know how bad the government-mandated electronic health record (EHR) is. <b>But if you're a patient, you may not realize that EHRs are endangering your life</b> and jeopardizing medical excellence.<br /><br />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. <b>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.</b></blockquote><br />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.<br /><br />Further, while Politico did not explicitly mention risk to life and limb caused by these systems, Twila Brase did.  <b>"EHRs are endangering your life" </b>is the elephant in the living room that the industry and its well-captured (and perhaps lubricated?) "regulators"<b> simply will not address in a serious manner.</b><br /><br />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.<b> </b><br /><br />For more on the above points see my April 9, 2014 post <b>"FDA on health IT risk: reckless, or another GM-like political coverup?"</b> (<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.<b><br /></b><br /><br /><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:<br /><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, "<b>the current generation of electronic health records has about as many fans in medicine as Barack Obama at a tea party convention.</b>"</blockquote><br />I guess that's  Politco's way of saying "not very many at all."<br /><br /><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><br />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>).<br /><blockquote class="tr_bq"><br />Proponents falsely promised privacy. The real goal of Big Government, Big Data and Big Health was NO privacy. Data is valued <b>as a tool of control and a means to profit. </b>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><br />Not only that, but our data is sold in, in essence, data broker "back alleys" (e.g., see <b>"Health IT Vendors Trafficking in Patient Data?"</b> 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> ).<br /><br />Worse, the phenomenon of mismanagement of the "sales" is international in scope (e.g., see "<b>NHS slammed for MAJOR data blunders as scale of patient info sell-off is revealed"</b> 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>).<br /><br /><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><br />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 <i>trying to fix EHR bugs</i> (see my June 2, 2014 post <b>"In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red"</b> 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>).<br /><br />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 <i><b>thousands of potentially harmful prescription errors </b></i>(<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>).<br /><br />Next Ms. Brase reveals a stunning fact about one of the architects of that 2009 Economic Recovery Act:<br /><br /><blockquote class="tr_bq">The arrogance of some EHR supporters is unpardonable. <b>Bob Kocher helped write Obamacare</b>, was trained as a doctor and <b>is employed as a Venrock venture capitalist in health IT</b>, 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><br />Unpardonable arrogance indeed.  <br /><br />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.<br /><br />Beyond that issue, this venture cap issues the following perverse statement, as cited by Politico and CCHF:<br /><br /><blockquote class="tr_bq">Per Politico pro eHealth, he says, <b>"The reason so many [computers] are inefficient is that doctors are inefficient. If they redesigned their workflows, computers would work better."</b></blockquote><br />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.<br /><br /><b>If they [doctors] redesigned their workflows, computers would work better?</b><br /><br />Where, exactly, is the evidence for that assertion? <b>  Exactly how should doctors "redesign" their workflows, </b>considering the poorly bounded, conflicted, highly variable, uncertain, and high-tempo nature of the field? [1]<br /><br />How can one even have a well-defined and unvarying "workflow" in such a domain that would "make computers work better?" <br /><br />Answer:  it's impossible.<br /><br />(Perhaps<span data-ft="{"tn":"K"}" data-reactid=".u.1:3:1:$comment10203787041178410_10203787453188710:0.0.$right.0.$left.0.0.1:$comment-body"><span class="UFICommentBody" data-reactid=".u.1:3:1:$comment10203787041178410_10203787453188710:0.0.$right.0.$left.0.0.1:$comment-body.0"><span data-reactid=".u.1:3:1:$comment10203787041178410_10203787453188710:0.0.$right.0.$left.0.0.1:$comment-body.0.$text0:0:$0:0"> patients should adjust the unpredictable nature of their illnesses and symptoms to make the computers work better, too?)</span></span></span><br /><br />What Dr. Kocher seems to turn on its head is the recognition that:<b> </b><br /><br /><b>"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." </b>- Silverstein<br /><br />The reality is that if the healthcare IT industry actually <i>fired its ossified business-IT-oriented leaders</i> (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.<br /><br />Mr. Kocher, that's an idea to consider.  <br /><br />As I wrote at that 2008 post on business v. clinical computing:<br /><br /><blockquote class="tr_bq"><span style="font-family: inherit;"><span style="font-size: small;">... The prevalent belief in MIS [management information systems a.k.a. business computing] seems to be that <b>medicine is another area of transactional business subject to conventional modeling by generalists</b>, to be followed by "business process re-engineering" and traditional information systems development processes and methodologies.<br /><br />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. </span></span></blockquote><br />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.<br /><br /><blockquote class="tr_bq">In other words, Mr. Kocher <b>wants doctors to practice according to the computer systems he helped impose, not the doctor's patients</b>. 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><br />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.<br /><blockquote class="tr_bq"><br /><b>Working to sustain an ethical patient-doctor relationship,</b><br /><br />Twila Brase<br />President and Co-founder</blockquote><br />Thank heaven someone is working towards those ends.<br /><br />Notes: <br /><br /><span style="font-size: x-small;">[1]  Per Medical Informatics researchers Nemeth and Cook's "<b>Hiding in plain sight: What Koppel et al. tell us about healthcare IT"</b>, 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>)  </span><b><br /></b>

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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On the EHR-related term "cognitive overload"

I often use the term "cognitive overload" when writing about EHR and related information technology systems that present a needlessly complex user experience to clinicians.  This affects the care they deliver in negative ways.<br /><br /><span class="fbPhotosPhotoCaption" id="fbPhotoSnowliftCaption" tabindex="0"><span class="hasCaption">Physicians and nurses are presented with too much complexity for the hard, fast, unpredictable work they have to perform.</span></span> <br /><br />This picture of a B36J cockpit illustrates the concept of cognitive overload instantly:<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/AVvXsEgkfRgIgQaT3726kKEcp1vjalSZDBn_zGe8_v8032FqvccpsdAztXtBp_BMfea5bldaCr8dxdvi4dFckdNFESSHRHr3mEirIexqKUp5XaduQjQjnYOHgvYnHd1DfH-y4hMaiGNGaOMK5G92/s1600/b36cockpit.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="190" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgkfRgIgQaT3726kKEcp1vjalSZDBn_zGe8_v8032FqvccpsdAztXtBp_BMfea5bldaCr8dxdvi4dFckdNFESSHRHr3mEirIexqKUp5XaduQjQjnYOHgvYnHd1DfH-y4hMaiGNGaOMK5G92/s1600/b36cockpit.bmp" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">(Click to enlarge)</td></tr></tbody></table><br />A 360-degree "virtual tour" is at <a href="http://www.nmusafvirtualtour.com/media/062/B-36J%20Engineer.html">http://www.nmusafvirtualtour.com/media/062/B-36J%20Engineer.htm</a>.  Scroll around the cockpit to see more. <br /><br />Any questions?<br /><br />-- SS

On the EHR-related term "cognitive overload"

I often use the term "cognitive overload" when writing about EHR and related information technology systems that present a needlessly complex user experience to clinicians.  This affects the care they…

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At Merck's Urging, a Federal Judge Threatens to Sanction a Lone Professor for Trying to Reveal Evidence about Vioxx

We have written often, and most recently<a href="http://hcrenewal.blogspot.com/2014/06/justice-delayed-is-justice-denied.html"> this week,</a> about the limp posture taken by US law enforcement and regulatory agencies in the face of misbehavior by large health care organizations.  At best, official action often results in<a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements"> legal settlements</a> which let companies pay fines, sometimes large, while the individuals who profited most from the alleged wrongdoing do not suffer any negative consequences.  Worse, the legal settlements often allow the companies to continue to deny any culpability, and the legal evidence underlying the settlement, which might let the public at least estimate culpability, is often kept sealed, or confidential.  As Judge Rakoff wrote in turning down such a settlement involving a financial, not health care company, sealing evidence hides "<i>any proven or admitted facts upon which to exercise even a modest degree of independent judgment,"  </i>and prevents courts and presumably anyone else from trying to determine whether the government endorsement of such a settlement serves any public purpose (look <a href="http://hcrenewal.blogspot.com/2011/11/will-citigroup-ruling-challenge-health.html">here</a>).<br /><br /><b>Keeping Evidence from the Latest Vioxx Case Secret </b><br /><br />But Ed Silverman, <a href="http://blogs.wsj.com/pharmalot/2014/06/16/merck-seeks-sanctions-against-expert-witness-for-talking-to-a-journalist/">posting</a> to the revived PharmaLot blog, found an example of how far big health care organizations will go to try to keep secret evidence uncovered during litigation that lead to legal settlements, and how judges other than Judge Rakoff may let them do so.<br /><br /><blockquote class="tr_bq">A federal judge <i>may sanction a physician who served as an expert witness</i> in the ongoing litigation over the Vioxx painkiller for describing confidential documents to The Wall Street Journal.<br /><br />Earlier this month, U.S. District Court Judge Eldon Fallon issued a <a data-ls-seen="1" href="http://freepdfhosting.com/56538c8069.pdf">restraining order</a> saying David Egilman, who is a Brown University clinical professor of family medicine, 'may have acted in derogation of his responsibilities.'  Egilman was an expert witness with access to documents in litigation over the Merck pill that took place in various courts around the country. Vioxx was withdrawn a decade ago over links to heart attacks and strokes.<br /><br />Fallon, who presides over Vioxx litigation that was consolidated in federal court in New Orleans, had <i>issued an order in 2005 that marked swaths of documents as confidential. Much of the documentation was filed as evidence in litigation in both state and federal courts.</i></blockquote><br /><b>The Nature of the Information to be Kept Secret </b><br /><br />The post is vague about what secret information Dr Egilman was accused of making public.  Apparently, it had to do with his work as<br /><br /><blockquote class="tr_bq">a paid expert witness for plaintiffs in a lawsuit that had been filed by the Kentucky Attorney General, who<i> alleged Merck violated consumer protection laws by failing to disclose to doctors and patients that taking Vioxx significantly raised the risk of a heart attack.</i> The lawsuit was settled last November for $23 million, although the drug maker did not admit to any wrongdoing.<br /><br /><i>Egilman maintains that some documents demonstrated a failure to properly inform research subjects of side effects and risks, and thus he believes the information should be publicly available.</i><br /><br />'In general, <i>there’s information on the toxicity of the drug that’s not been previously published by Merck and there is information that Merck published that misrepresents the health effects of the drug</i>,' he told us three months ago, which prompted the drug maker to complain to the federal judge.</blockquote><br />So apparently the information had to do with the possibility that Merck withheld or misrepresented information about the toxicity and health effects of Vioxx.  Also, apparently another judge thought that there was at least an argument that this evidence should be public.<br /><br /><b>What About the Public's Interest?</b> <br /><br /><blockquote class="tr_bq">Three months ago, though, a Kentucky state judge permitted Egilman to challenge the confidentiality of the documents, since he had standing as an expert witness which gave him previous access to the materials. <a data-ls-seen="1" href="http://blogs.wsj.com/corporate-intelligence/2014/03/26/more-disclosure-coming-in-mercks-decade-long-vioxx-nightmare/?KEYWORDS=silverman+egilman">As we noted at the time</a>, the judge wrote that '<i>important public policy questions regarding consumer protection and public health have been raised. The public has an interest in evaluating Dr. Egilman’s opinions and the documents on which they were based</i>.'</blockquote><br />Merck appears to be squirming in response to the prospect that this information could become public, and that the public might have an interest, in any sense, in it.<br /><br /><blockquote class="tr_bq"> Merck continues to decline comment about the content of the documents and the legal fight with Egilman. But the drug maker argued at a recent hearing that, by virtue of describing the documents to The Wall Street Journal, Egilman violated the 2005 protective order. Moreover, <i><a data-ls-seen="1" href="http://freepdfhosting.com/359c9a7427.pdf">the drug maker maintained</a> that it would be harmed if the documents were disclosed</i>, and Fallon agreed.</blockquote><br />While the judge seemed very concerned that Merck somehow might be harmed were to truth to be revealed, it is not obvious either the judge or Merck were at all concerned about the public interest in this truth, if for no other reason than it would say something about what appointed and elected government law enforcement officials are willing to keep secret.  Nor did the judge seem concerned about the imbalance for forces obvious when a huge drug company and US law enforcement are on one side, and a single physician is on the other. <br /><br /><b>Merck's Track Record Vis a Vis Vioxx </b><br /><br />By the way, while past results do not guarantee future performance, as financial reports are wont to say, past results suggest that Merck was up to no good on a grand scale in its promotion of Vioxx.<br /><br />As we noted <a href="http://hcrenewal.blogspot.com/2011/12/merck-admits-little-while-settling.html">here</a>, all these settlements  arose out of what was called the "Vioxx scandal." In summary, Vioxx (rofecoxib, Merck) a Cox-2 inhibitor non-steroidal anti-inflammatory drug used for pain, and touted for its ostensibly low risk of gastrointestinal side-effects, was withdrawn from the market in 2004 because of its cardiac risks.  The Vioxx case is flush with examples of how the company used deception to market a very profitable drug without regard to its risks to patients.  <br /><br />There is evidence is that the company knew about these effects since 2000, but suppressed the clinical research evidence until 2003.(1)  In particular, in 2005, the editors of the New England Journal of Medicine raised concerns that an article published in that journal in 2000 about the results of the VIGOR study of rofecoxib sponsored by Merck failed to report data that would have suggested that the drug caused excess cardiovascular risks.(2) In 2007, the company paid more than $4.9 billion to settle patient lawsuits alleging harm due to Vioxx.(3)  Also in 2008, the company made a $58 million settlement of claims its advertising of Vioxx deceptively minimized its risks.(4) In 2008, it became clear that at least one apparently clinical trial of Vioxx, the ADVANTAGE trial, was merely a "seeding trial,' that is, a marketing exercise.(5) <br /><br />On Health Care Renewal, we starting <a href="http://hcrenewal.blogspot.com/search/label/Vioxx">writing about Vioxx</a> in 2005, including, <br />- <a href="http://hcrenewal.blogspot.com/2005/04/more-evidence-of-ghostwriting.html">here</a> about ghost-writing of a Vioxx research publication;<br />- <a href="http://hcrenewal.blogspot.com/2005/06/allegations-that-merck-threatened.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2005/12/more-allegations-that-merck-executives.html">here</a> about allegations that Merck executives tried to intimidate Vioxx critics;<br />- <a href="http://hcrenewal.blogspot.com/2007/03/drug-crazy.html">here</a> about how advocates of an extreme laissez faire approach to regulation of health care corporations used illogical arguments about the Vioxx case;<br />- <a href="http://hcrenewal.blogspot.com/2008/08/article-in-annals-of-internal-medicine.html">here</a> about the ADVANTAGE "seeding trial," that is, a study really meant to recruit supposed physician-researchers as prescribers; and<br />- <a href="http://hcrenewal.blogspot.com/2010/01/physician-pleads-guilty-to-fraud-for.html">here</a> about how one once prominent Vioxx researcher pleaded guilty to fraud in connection with his research on other drugs.<br />-  <a href="http://hcrenewal.blogspot.com/2010/02/merck-settles-another-vioxx-case.html">here</a> about how in settling a shareholder lawsuit Merck vowed to improve its scientific and academic integrity, and refrain from manipulating and suppressing clinical research.<br /><br />In 2010, we <a href="http://hcrenewal.blogspot.com/2010/02/merck-settles-another-vioxx-case.html">summarized </a>the Vioxx case thus, " the Vioxx case provides a <i>good lesson about some of the tactics used to deceptively and unethically promote health care products</i> (pharmaceuticals in this case)."  <br /><br />In case there are any doubts about the harms patients suffered as a result of using Vioxx as a pain reliever, in 2004, a cumulative meta-analysis of published trials of Vioxx known by then estimated the risk of myocardial infarction (heart attack) due to Vioxx compared with placebo or other non-steroidal anti-inflammatory drugs was 2.3 times the baseline rate.(6)  That analysis suggested that there was data by 2000 that Vioxx increased the risk of bad cardiovascular events.  A cumulative meta-analysis from 2009 suggested that the risk of death due to Vioxx was 1.7 times the baseline rate.(7)   That analysis suggested there was data by 2001 that Vioxx increased the risk of bad cardiovascular events.  Graham and colleagues' nested case-control study of Vioxx use in a large managed care organization lead them to estimate that "88 000 - 140 000 excess cases of serious coronary heart disease probably occurred in the USA over the market-life of rofecoxib."(8).<br /><br />Yet after all that, Merck is still trying to hide evidence from Vioxx litigation, and a federal judge and apparently federal prosecutors are willing to go along, opposed only by Dr David Egilman <br /><br /><b> Summary</b><br /><br />We have long talked about what we have called the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, how inconvenient truths that might reflect badly on the current health care status quo and especially those insiders who are making so much money from it are treated as recent unpleasantness that one just should not talk about.  The anechoic effect does not arise merely from politeness, or desire not to discomfit the powerful, but from active measures the powerful take to keep dissent down.  Here we have an example of a huge drug company, apparently helped by US law enforcement and US courts trying to keep truths about how it marketed a drug out of the public eye, even after so much information suggesting that its marketing was deceptive and unethical, and lead to patients dying has come out.<br /><br />As we have said endlessly, until health care professionals, policy makers, and the public can obtain and openly discuss information about health care dysfunction, even if that information and its discussion may threaten those who lead health care and make so much money doing so, health care dysfunction will continue.  True health care reform would improve transparency and put an end to the anechoic effect.<br /><br /><b>Disclosure</b><br /><br />Note that both Dr Egilman and I are voluntary faculty at Brown, although we do not directly work together.<br /><br /> <b>References</b><br /><br />1. Topol EJ. Failing the public health - rofecoxib, Merck and the FDA. N Engl J Med 2004; 351: 1707-1709.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMp048286">here</a>.<br />2. Curfman GD, Morrisey S, Drazen JM et al.  Expression of concern reaffirmed. N Engl J Med <span class="citation"><span style="font-size: xx-small;">2006; 354:1193</span></span>. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMe068054">here</a>.<br />3. Charatan F. Merck to pay $5bn in rofecoxib claims. Brit Med J 2007; 335: 1011. Link <a href="http://www.bmj.com/content/335/7628/1011.1.full">here</a>.<br />4. Charatan F. Merck to pay $58m in settlements over rofecoxib advertising. Brit Med J 2008; 336: 1208-1209. Link <a href="http://www.bmj.com/content/336/7655/1208.2.full">here</a>.<br />5. Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE seeding trial: a review of internal documents. Ann Int Med 2008; 149: 251-258. Link<a href="http://www.annals.org/content/149/4/251.full"> here</a>.<br />6.  Juni P, Nartey L, Reichenbach S et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis.  Lancet 2004; 364: 2021-2029.  Link <a href="http://www.sciencedirect.com/science/article/pii/S0140673604175144">here</a>.<br />7.  Ross JS, Madigan D, Hill KP et al.  Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance.  Arch Intern Med 2009; 169: 1976-1984.  Link <a href="http://archinte.ama-assn.org/cgi/content/full/169/21/1976">here</a>.<br />8.  Graham DM, Campen D, Hui R et al.  Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study.  Lancet 2005; 365: 475-481.  Link <a href="http://www.sciencedirect.com/science/article/pii/S0140673605178647">here</a>. <br /><br />ADDENDUM (19 June, 2014) - See also <a href="http://1boringoldman.com/index.php/2014/06/19/first-order-solution/">comments</a> on the 1BoringOldMan blog. <br /><br /><br />

At Merck's Urging, a Federal Judge Threatens to Sanction a Lone Professor for Trying to Reveal Evidence about Vioxx

We have written often, and most recently this week, about the limp posture taken by US law enforcement and regulatory agencies in the face of misbehavior by large health care organizations.  At best, …

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Justice Delayed is Justice Denied? - Another Neurontin Settlement by Pfizer 20 Years After the Alleged Events

We have argued repeatedly against the strategy used by US government authorities to address allegations of bad behavior in health care (and elsewhere) by pursuing monetary <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">settlements</a> against the companies involved, rather than trying to impose penalties on the people who may have done wrong.  There are many apparent things wrong with this approach (which we will rant about again below), but one aspect that deserves more attention is its slowness.<br /><br /><b>The Latest Pfizer Settlement </b><br /><br />For example, Bloomberg <a href="http://www.bloomberg.com/news/2014-06-02/pfizer-agrees-to-325-million-settlment-over-neurontin.html">reported</a> in early June about yet another settlement by Pfizer of allegations about the marketing of the drug Neurontin (gabapentin, made by its Parke-Davis subsidiary):<br /><br /><blockquote class="tr_bq">Pfizer Inc agreed to pay $325 million to settle a lawsuit brought by health-care benefit providers who claimed the drugmaker marketed the epilepsy drug Neurontin for unapproved uses.<br /><br />The settlement, which needs approval from a federal judge in Boston<a href="http://topics.bloomberg.com/boston/"></a>, would end a case over <i>claims that the company’s Parke-Davis unit schemed to market the drug for unapproved conditions <b>as early as 1994. </b></i></blockquote><br />Thus this settlement occurred 20 years after the first actions were alleged to have occurred.<br /><br /><b>Officially, "Pfizer Didn't Admit Wrongdoing" Despite Allegations of Kickbacks </b><br /><br />Otherwise, this particular settlement appears unremarkable.  As is typical, the federal authorities and the judge allowed a settlement which obscures what really happened, because,<br /><br /><blockquote class="tr_bq">The Boston accord will resolve 'all third-party payer claims regarding off-label promotion' and state antitrust claims over Neurontin sales, Steve Danehy, a company spokesman, said in a statement. <i>Pfizer didn’t admit wrongdoing</i>, he said. </blockquote><br />Nonetheless, the allegations were about kickbacks to physicians, a behavior that ought to concern ethical health care professionals.<br /><br /><br /><blockquote class="tr_bq">The companies alleged that Parke-Davis, part of Warner-Lambert Co., <i>paid kickbacks to doctors to encourage them to prescribe the anti-seizure drug for unapproved uses such as bipolar and panic disorders. </i><br /> <br />Pfizer acquired Warner-Lambert in 2000 and 'deliberately expanded the promotion of off-label uses,' lawyers for the benefits firms said in an amended complaint filed in 2011. </blockquote><br /><b>So Why Pay $325 Million? </b><br /><br />So Pfizer appears to have paid another $325 million to allow the company to claim again that these allegations were never proven.  Yet if these allegations were really entirely false, one might think it would have cost the company less than that to take the case to trial?<br /><br />As Judge Rakoff noted in rejecting a settlement between the US Department of Justice and Citigroup of allegations of financial misbehavior (look <a href="http://hcrenewal.blogspot.com/2011/11/will-citigroup-ruling-challenge-health.html">here</a>),<br /><br /><blockquote class="tr_bq">As for common experience, <em><strong>a consent judgment that does not involve any admissions and that results in only very modest penalties is just as frequently viewed, particularly in the business community, as a cost of doing business imposed by having to maintain a working relationship with a regulatory agency</strong></em>, rather than as any indication of where the real truth lies.</blockquote><br />Yet the latest Pfizer Neurontin settlement, occurring 20 years after the events in question, officially gives no indication of where the real truth lies.<br /><br /><b>No Admitted Wrongdoing, Despite Past Evidence, Including a RICO Conviction </b><br /><br />These very late denials of admission of wrongdoing seem hollow when they are compared to the revelations that have appeared over the years from various legal actions about Neurontin marketing.  As we have discussed <a href="http://hcrenewal.blogspot.com/search/label/Neurontin">here</a>, documents revealed by previous Neurontin litigation have uncovered a catalog of deceptive marketing practices, including <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of clinical research</a>, including its design and the analysis and dissemination of its results,  (look <a href="http://hcrenewal.blogspot.com/2012/10/when-clinical-trials-are-meant-for.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/11/editorial-that-wasnt-evidence-for.html">here</a>), the <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of clinical research</a> (look <a href="http://hcrenewal.blogspot.com/2008/10/did-pfizer-marketers-suppress-and.html">here</a>), and <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing">stealth marketing campaigns</a>, including manipulation of <a href="http://hcrenewal.blogspot.com/search/label/CME">continuing medical education</a> through "unrestricted educational grants," captive speakers bureaus, docile and well-paid academics and physicians on advisory boards and consultants, the use of <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders</a> as marketers, and publications strategies including <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">ghost writing</a> (look <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a>).   <br /><br /><br />Note also that this is only the latest chapter in the long saga of Neurontin, for whose mismarketing Pfizer has already shelled out a lot of money (for the most recent example look <a href="http://hcrenewal.blogspot.com/2014/04/the-pervasiveness-of-health-care.html">here</a>, then see<a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html"> this post</a>, and look <a href="http://hcrenewal.blogspot.com/search/label/Neurontin">here</a> for the collection).  Pfizer has an amazing record of bad behavior on view <a href="http://hcrenewal.blogspot.com/search/label/Pfizer">here</a>.  In fact, it has had a conviction as a Racketeering Influenced Corrupt Organization (RICO) on the basis of its previous marketing of Neurontin (look <a href="http://hcrenewal.blogspot.com/2013/12/blogscan-us-supreme-court-turns-down.html">here</a>), which was recently upheld on appeal (look <a href="http://hcrenewal.blogspot.com/2013/12/blogscan-us-supreme-court-turns-down.html">here</a>).   Yet Pfizer, convicted as a racketeering influenced corrupt organization, gets to officially deny wrong-doing once again.  And through all this, no Pfizer executive who authorized or directed any of this conduct, or who got a big bonus based on Neurontin revenues hiked by deception, has apparently had to suffer any negative consequences.<br /><br /><b>Summary: the Usual Rant </b><br /><br />So here we go again,...  The failure of the current limp legal efforts against such corruption is evident by how many corporations have become ethical repeat offenders.  Pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction.  So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue.<br /><br />True health care reform would include much more vigorous enforcement of existing laws to make sure health care organizations and their leaders actually put health, rather than personal enrichment, first. 

Justice Delayed is Justice Denied? - Another Neurontin Settlement by Pfizer 20 Years After the Alleged Events

We have argued repeatedly against the strategy used by US government authorities to address allegations of bad behavior in health care (and elsewhere) by pursuing monetary settlements against the comp…

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Full Moon Friday the 13th: Computers down at Vermont's largest hospital

A health IT "glitch" hit in Vermont on Full Moon Friday the 13th (have some werewolf with your bad luck!)<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/AVvXsEjV_zdKebiTKhfRJ6uNpkvPKcEBO6KdRLFaX9I2jr_774V1kxcEclGioScEsgplQzaD5ewqWC5zNQeqq2L4uEd62Qt4Hth98npdNSWR5lBv7f_BXtr0hnEZim77eHA10BZwaHDmZ8JjPTaU/s1600/werewolf.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="160" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjV_zdKebiTKhfRJ6uNpkvPKcEBO6KdRLFaX9I2jr_774V1kxcEclGioScEsgplQzaD5ewqWC5zNQeqq2L4uEd62Qt4Hth98npdNSWR5lBv7f_BXtr0hnEZim77eHA10BZwaHDmZ8JjPTaU/s1600/werewolf.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Dark Shadows' Quentin Collins (David Selby) in a foul full-moon mood.</td></tr></tbody></table><br />Note, however, that "bad luck" has little or nothing to do with mission-critical healthcare IT mass outages.  Mismanagement often does:<br /><br /><blockquote class="tr_bq"><a href="http://www.wcax.com/story/25773022/computers-down-at-vermonts-largest-hospital">http://www.wcax.com/story/25773022/computers-down-at-vermonts-largest-hospital</a><br /><div id="WNStoryHeader"><h3 class="">Computers down at Vermont's largest hospital</h3><i class="wnDate">Posted: Jun 13, 2014 4:12 PM EST </i><i class="wnDate">Updated: Jun 13, 2014 4:12 PM EST </i><br /><div id="WNStoryByline"><div class="byline">By WCAX News</div></div></div></blockquote><div class=" withRelated right" id="WNStoryBody"><blockquote><span id="WNStoryDateline">BURLINGTON, Vt. - </span><br />A major, systemwide computer problem at Fletcher Allen Health Care in Burlington Friday.<br /><br />The hospital says the computer system went down at 9:45 a.m. <b>The glitch</b> means doctors and nurses could not enter patient information into computers.</blockquote><br /><b>"Glitch"</b> is an unfortunate euphemism for potentially harmful or deadly computer malfunctions, often due to mismanagement of that technology. See query link <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>.<br /><br /><blockquote class="tr_bq">Hospital spokesperson Mike Noble says information is now being recorded manually <span style="color: red;"><i><b>[i.e., on paper - ed.] </b></i></span>Noble says the staff continues to provide the same care as normal and no surgeries were canceled because of the computer issue.<br /><br />Noble says the issue appears to be an internal problem and not something from an outside computer provider.<br /><br /><b>It’s not known when the problem will be corrected.</b></blockquote><br />This is yet another "the systems that revolutionize healthcare against all of paper's ills have all gone down, we don't know when they will be fixed, but patient care has not been compromised because we are resorting to paper" story (more at query link <a href="http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised">http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised</a>).  <br /><br />-- SS</div>

Full Moon Friday the 13th: Computers down at Vermont's largest hospital

A health IT "glitch" hit in Vermont on Full Moon Friday the 13th (have some werewolf with your bad luck!)Dark Shadows' Quentin Collins (David Selby) in a foul full-moon mood.Note, however, that "bad l…

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