There They Go Again - Merck Threatened Legal Action Against Italian Doctor who Criticized Zetia

It seems that when confronted with unfavorable facts or opinions, Merck executives like to threaten legal action, rather than just argue their side of the case.  Last month we <a href="http://hcrenewal.blogspot.com/2014/06/at-mercks-urging-federal-judge.html">discussed</a> how Merck officials used the US court system to try to prevent a physician from publicizing evidence uncovered in prior litigation that suggested Merck employees had concealed the risks of Vioxx from research subjects.<br /><br /><b>Legal Threats to Shut Up a Critic</b> <br /><br />Recently, a <a href="http://www.bmj.com/content/349/bmj.g4441">British Medical Journal news article</a> explained how Merck tried to shut up an Italian physician who dared criticize another of its drugs, Zetia (ezetimibe).<br /><br /><blockquote class="tr_bq"><div id="p-1">The Italian branch of the drug company Merck Sharp and Dohme (MSD) has stopped a leading public health doctor and administrator from circulating texts to GPs advising them about the use of one of the company’s drugs. </div><div id="p-1"><br /></div><div id="p-2">In the texts, Alberto Donzelli—the head of education, appropriateness, and evidence based medicine at the public health authority of Milan (Milan Healthcare)—had analysed the published evidence on the cholesterol lowering drug ezetimibe and discouraged its prescription in addition to statins.</div><br /><i>A letter telling Donzelli to 'cease and desist' was sent in February by MSD’s medical director, Patrizia Nardini,</i> and was cosigned by the company’s director of legal affairs. They accused Donzelli of serious misconduct and a breach of medical ethics and threatened to sue him and Milan Healthcare for as much as €1.3m (£1m; $1.78m).</blockquote><br />Dr Donzelli was defended by Dr Roberto Carlo Rossi, the Director of the Order of Physicians of Milan, the local regulatory body,<br /><br /><blockquote class="tr_bq"> Rossi replied in April, declaring that the medical commission had analysed and discussed the issue in depth and concluding that there was no reason to object on ethical grounds to Donzelli’s behaviour.</blockquote><br />But,<br /><br /><blockquote class="tr_bq">in late May the company sent <i>a second 'cease and desist' letter to Donzelli </i></blockquote><br />So,<br /><br /><blockquote class="tr_bq">In mid-June, Donzelli bowed to the request and removed the relevant material from his website....</blockquote><br /><br /><b>The Anechoic Effect Trumped </b><br /><br />Up to then, the story line was familiar.  We have often noted the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, that facts or ideas that offend the rich and powerful in health care often get little circulation, have few echoes.  Health care professionals' may fear that speaking out may lead to great unpleasantness.  Self-censorship may be reinforced by knowledge that the pervasiveness of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> in health care means that one's friends, colleagues, family members, or more particularly supervisors are likely to have financial relationships with big health care corporations.  Similarly, those in the media and in the medical and health care scholarly literature may have similar fears, knowing that advertising revenue often comes from health care corporations, and their executives and boards may have their own conflicts of interest.<br /><br />But in this case, Dr Donzelli was not cowed at first.  Furthermore, neither was the BMJ, and then some people in the media.  Instead of quieting the issue, Merck's legal threats resulted in the BMJ news article.  Then, in short order, the story was picked up by Larry Husten <a href="http://www.forbes.com/sites/larryhusten/2014/07/06/merck-uses-legal-threats-to-stifle-negative-advice-about-zetia-and-vytorin-in-italy/">blogging for Forbes</a>, and by Ed Silverman's <a href="http://blogs.wsj.com/pharmalot/2014/07/07/merck-threatened-to-sue-doc-over-prescribing-advice/">PharmaLot blog</a> for the Wall Street Journal.  Amazingly, this time it only took Merck one day after this negative publicity to change its position.  Per Matthew Herper, again <a href="http://www.forbes.com/sites/matthewherper/2014/07/07/merck-says-it-regrets-strong-arming-italian-researcher/">in Forbes</a>,<br /><br /><blockquote class="tr_bq"><i>Merck says that it 'regrets' using legal threats</i> to push a leading Italian researcher to muffle his public critiques of one of the company’s cholesterol drugs.</blockquote><br />Herper was able to get confirmation from Merck spokesman Steve Cragle who said<br /><br /><blockquote class="tr_bq">the physician would be able to post his arguments about the drug, ezetimibe, on his web site again without fear of legal reprisal coming from Merck.</blockquote>So in this case, sunlight was an effective disinfectant.  Perhaps if some of  the health care professionals who have silently acquiesced to pressure to maintain the anechoic effect decided they would not take it any more, there could be a lot more disinfection.<br /><br />Note that Merck seems to have a chronic problem with honest discussion about Zetia (as well as Vioxx).  In 2007, we first <a href="http://hcrenewal.blogspot.com/2007/12/data-about-ezetimibe-adverse-effects.html">blogged</a> about reports that Merck had suppressed results of clinical research that showed the drug could cause adverse effects on the liver.  Eventually in 2013, a Reuters article that somehow got by us at the time, but was<a href="http://www.fiercepharma.com/story/merck-attacks-italian-critic-cholesterol-fighter-zetia-then-backs/2014-07-08"> summarized in FiercePharma</a>, announced that Merck would "<span id="articleText"><span class="focusParagraph"><span class="articleLocatio</span>n">pay $688 million to settle two U.S. class-action lawsuits by shareholders who said they lost money <i>because the company concealed the poor results of a clinical trial of the anti-cholesterol drug Vytorin</i> [a combination drug that included ezetimibe]."  Although, "</span></span></span><span id="articleText">the settlements include no admission of liability or wrongdoing.  '</span><span id="articleText"><span id="articleText">There's probably some merit (to the claims) or they wouldn't have settled for such a large amount,' Judson Clark, a health care analyst with Edward Jones,</span>..."  </span><br /><br /><span id="articleText">Merck managers, like many other health care leaders, got away with making facts and opinions they did not like taboo as topics of conversation for a long time.  Maybe if the health care leaders who are used to producing the anechoic effect for their own benefit saw that doing so will not be so easy in the future, the fog that obscures honest discussion of health care dysfunction might start to lift.  True health care reform would enable such honest discussion, no matter who among the powerful it might offend.  </span><br /><br /><span id="articleText">ADDENDUM (8 July, 2014) - See also comments <a href="http://shearlingsplowed.blogspot.com/2014/07/is-sanity-making-comeback-matt-herper.html">in the Shearlings Got Plowed blog</a>.   </span><br /><span id="articleText"><br /></span>

There They Go Again - Merck Threatened Legal Action Against Italian Doctor who Criticized Zetia

It seems that when confronted with unfavorable facts or opinions, Merck executives like to threaten legal action, rather than just argue their side of the case.  Last month we discussed how Merck offi…

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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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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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Is this Any Way to Discuss Health Care Policy? - Television Advertising about US Health Care Reform Cost $445 Million from 2010 -2014

Every now and then, we get an anonymous comment criticizing our "lack of balance" or words to that effect, maybe because we criticized some action by a big, often but not always for-profit, health care organization.  We usually respond that we have no obligation to be balanced, since<br />- We publish opinion, not hard news<br />-  It is questionable that even hard news reporters must report all opinions on an issue, if some of those opinions are demonstrably less credible<br />-  There are far more voices extolling the wonderful "innovations" provided by our current "best health care system in the world," than providing our sorts of criticism.<br /><br />To expand on that last point - a recent news item suggests how much of the health care policy debate is paid marketing and public relations, rather than individual voices of citizens, health care professionals, or even health care policy experts.<br /><br />From the AP, <a href="http://www.seattlepi.com/news/article/Study-Political-TV-ads-on-health-law-total-445M-5483653.php">via the Seattle Post -Intelligencer</a>,<br /><br /><blockquote class="tr_bq">A new analysis finds the nation's health care overhaul deserves a place in advertising history as the focus of extraordinarily high spending on negative political TV ads that have gone largely unanswered by the law's supporters.<br /><br />The report, released Friday by nonpartisan analysts Kantar Media CMAG<a href="http://www.seattlepi.com/?controllerName=search&action=search&channel=news%2Fpolitics&search=1&inlineLink=1&query=%22Kantar+Media+CMAG%22"></a>, estimates <i><b>$445 million</b> was spent on political TV ads mentioning the law since the enactment of the Affordable Care Act in 2010</i>. Spending on negative ads outpaced positive ones by more than 15 to 1.</blockquote><br />In particular,<br /><br /><blockquote class="tr_bq">In the 2014 congressional races, 85 percent of the anti-Obama ads were also anti-'Obamacare' ads, the analysis found. In some competitive races, 100 percent of the pro-Republican TV ads aimed at Democrats contained anti-health law messages.<br /><br />Over the four years,<i> an estimated $418 million was spent on 880,000 negative TV spots focusing on the law, compared to $27 million on 58,000 positive spots</i>, according to the analysis. Nearly all of the spending was on local TV stations, in races ranging from state offices such as treasurer and governor to Congress and the presidential election.</blockquote><br />That is just amazing. <br /><br />My concern is not so much that much of this advertising is against "Obamacare."  We have not often written about the Affordable Care Act (ACA), aka "Obamacare," and what we wrote at best was mild praise.  As I <a href="http://hcrenewal.blogspot.com/2010/03/health-care-reform-bill-and-health-care.html">posted</a> back in 2009, very little of the law had anything to do with the issues we discuss on Health Care Renewal.  In my humble opinion, since the law went into effect, it has increased access to health insurance, especially for certain groups of people that commercial health care insurers previously spurned, e.g., older people and people with pre-existing diseases.  It also contained provisions that might increase disclosure of conflicts of interest, and foster comparative effectiveness research.  On the other hand, the law has done nothing to reduce <a href="http://hcrenewal.blogspot.com/search/label/concentration%20of%20power">concentration of power</a> in health care.  It has done nothing to make health care leaders more <a href="http://hcrenewal.blogspot.com/search/label/accountability">accountable</a>, especially for their organization's unethical or even <a href="http://hcrenewal.blogspot.com/search/label/crime">criminal</a> behavior, decrease their ability to <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">line their pockets</a> regardless of such behavior, and thus reduce their <a href="http://hcrenewal.blogspot.com/search/label/impunity">impunity.</a>  It will not obviously decrease <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest </a>affecting those who make decisions about patient care or health policy, lock the <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving door</a> between government and the health care industry, end <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of clinical research</a> to serve vested interests, or <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of research</a> whose results offend such interests, etc, etc.  So there is plenty to discuss about health care reform and related matters of health care policy.<br /><br />Yet a major venue of US public discussion about health care policy, at least having to do with health care reform legislation, appears to be 15 -60 second paid television advertisements.  Often who pays for these ads are obscure, as certainly are the identities of the advertising or public relations firms that actually craft them.  Certainly, the ads do not explain who might profit were what they urge be implemented. The ads may appeal to emotion, or engage in logical fallacies.  And they appear in millions of peoples homes day in and day out.<br /><br />Such advertising, added to all the other billions of dollars worth of <a href="http://hcrenewal.blogspot.com/search/label/marketing">marketing</a> and <a href="http://hcrenewal.blogspot.com/search/label/public%20relations">public relations</a> that swirl around health care, make any sort of intelligent discussion very difficult.  The advertising frenzy renders the voices of individual citizens, health care professionals, and even health policy experts  whispers in comparison.<br /><br />While there are ostensible free speech advocates who defend these advertisements, and maybe who promote the free speech rights of corporations as the same as those of human citizens (without, of course, many of the responsibilities of citizens), none of these vocal self-proclaimed civil libertarians seem to be doing anything to defend the audibility of the voices of individuals in the health care policy debate.<br /><br />So we will continue to do what we can to bring some healthy skepticism about loud proclamations in health care made by people who stand to gain financially from their effects.  But is it any wonder that our voices create <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">so few echoes</a>? <br /><br />

Is this Any Way to Discuss Health Care Policy? - Television Advertising about US Health Care Reform Cost $445 Million from 2010 -2014

Every now and then, we get an anonymous comment criticizing our "lack of balance" or words to that effect, maybe because we criticized some action by a big, often but not always for-profit, health car…

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Abort, Retry, Fail? - Lancet Avoided Much Recent Unpleasantness in Reporting on New Gates Foundation CEO (Including Her Defense of $55,000 a Year for Bevacizumab)

The April 26, 2014 issue of the prestigious journal Lancet used two full pages and two separate articles by the same author to discuss the ascension of the Gates Foundation new CEO, Dr Susan Desmond-Hellmann.(1-2)<br /><br /><b>Two Somewhat Redundant Lancet Articles </b><br /><br />Dr Desmond-Hellmann trained as an oncologist, spent time working on AIDS and Kaposi's Sarcoma in Uganda, but then spent much of her career as a pharmaceutical/ biotechnology executive, as described in the first article,(1)<br /><br /><blockquote class="tr_bq">After returning from Uganda, Desmond-Hellmann <i>joined the nascent Taxol development programme at Bristol-Myers Squibb</i>, before being poached by Arthur Levinson, the then Head of Research and Development at Genentech. Levinson was convinced Genentech had a strong pipeline of anticancer therapies, and brought Desmond-Hellmann on board to help guide them through to approval. The <i>pipeline went stratospheric</i>, and <i>took Desmond-Hellmann with it</i>. By 2009 she had been <i>promoted to President of Product Development</i>, having overseen the introduction of two of the first gene-targeted therapies for cancer, bevacizumab and trastuzumab.</blockquote><br />After Genentech was bought out by Roche, Dr Desmond-Hellmann became Chancellor of the University of California, San Francisco,<br /><br /><blockquote class="tr_bq">Over the next 5 years, Desmond-Hellmann <i>instituted wide-ranging reforms</i> at UCSF, including aggressively cutting administrative waste and putting a greater emphasis on partnerships with the biotech and pharmaceutical sectors, coming in for some criticism in the process. 'Some of the press suggested one of Sue's goals was to take UCSF out of the public system', says [current UCSF interim Chancellor Sam] Hawgood. 'Nothing could be further form the truth. She was very proud of the public mission of UCSF, and had no intent to alter that.' Mindful of how damaging perceived conflicts of interest could have been to her credibility during her time at UCSF, Desmond-Hellmann says she '<i>specifically avoided being on pharma and biotech boards'</i>.</blockquote><br />The article suggested we should expect nothing but great things from Dr Desmond-Hellmann at the Gates Foundation,<br /><br /><blockquote class="tr_bq">it is Desmond-Hellmann's ability to forge partnerships and her wide network of contacts, rather than her knack for cutting administrative overheads, that will have seemed most attractive to the Gates Foundation as it looks to speed up the process of translating research into results.</blockquote><br />The second article used remarkably similar wording(2), e.g., regarding her career in the pharmaceutical business,<br /><br /><blockquote class="tr_bq">Soon after joining the Taxol team, Desmond-Hellmann was leading it; the kind of progress that was bound to catch the eye of Genentech's then Head of Research and Development Arthur Levinson. What happened next is <i>part of pharmaceutical folklore</i>, as Desmond-Hellmann helped to mastermind<i> one of the most profitable drug-development pipelines in history</i>, including the approval of two of the first targeted cancer therapies, for Genentech.</blockquote><br />Also, regarding her career at UCSF,(2)<br /><br /><blockquote class="tr_bq"> Desmond-Hellmann from embarking on a <i>programme of structural reforms</i> to cut administrative inefficiency and forge closer links with private industry, something that still stirs up controversy. 'There definitely were concerns, and there remain<i> concerns in academia, about conflicts of interest, privatisation</i>. I think what helped most was that I was clear in my actions that I did and do value that UCSF is a public institution, and I think my actions spoke and speak for themselves', she says. But Desmond-Hellmann is robust in her defence of the <i>importance of public—private partnerships</i> for driving innovations that ultimately benefit society.</blockquote><br />Finally, regarding expectations for her performance in the future,<br /><br /><blockquote class="tr_bq">'There are a lot of people who are looking to the foundation, and in the world of philanthropy there's a lot of visibility to the Bill & Melinda Gates Foundation, so I certainly feel accountable and responsible for doing a good job.' But, she asserts, 'I'm up for it'. With a track record that ranges from clinical research, global health, and the sharp end of commercial drug development, <i>she seems to be made for it.</i></blockquote><br />So Lancet, a very well known journal which normally is very parsimonious about its use of the printed page, used two full pages for two very similar articles about the new Gates Foundation CEO.  Both articles made the same points,<br />-  Dr Desmond-Hellmann had a brilliant career in the pharmaceutical/ biotechnology business, and was responsible for the development of several important cancer drugs<br />-  Dr Desmond-Hellmann made major reforms at UCSF, including pushing for some sort of privatization, and for public-private partnerships, while dismissing concerns about any resulting conflicts of interest<br /> -  Dr Desmond-Hellmann is likely to be very successful as Gates Foundation CEO.<br /><br /><b>What the Articles Did Not Say</b><br /><br />When Dr Desmond-Hellmann's appointment as Chancellor of UCSF was announced in 2009, I <a href="http://hcrenewal.blogspot.com/2009/05/bio-tech-u.html">suggested</a> that she was a very unusual choice because of aspects of her track record in the pharmaceutical/ biotechnology business.  Yet the Lancet's two articles on her prospects as new Gates Foundation CEO ignored these considerations, and ignored or downplayed aspects of her track record as UCSF Chancellor.  In particular,<br /><br /><u>Defending $55,000/ Year Bevacizumab</u><br /><br />As I noted in 2009, Dr Desmond-Hellmann's defense as a Genentech executive of the sky high prices the company was charging for its new drugs was well documented in an article in the Journal of the National Cancer Institute)(3)<br /><br /><blockquote class="tr_bq"><i><b>And cancer biologics, though among the most costly drugs, are still only a tiny fraction of total GDP, said Genentech's Susan Desmond-Hellmann, president for product development,</b></i> at AACR.<br /><br /><i><b>Hellmann and others argue that with these drugs’ potential to alleviate the huge societal burden of cancer, biologics are worth the cost</b></i>.<br /><br />The industry has responded to concerns about costs by putting more resources into patient assistance programs. When Genentech received U.S. Food and Drug Administration approval for bevacizumab in lung cancer last October, it also announced a cap on expenditures for the drug for patients with family incomes less than $100,000 a year. In 2005, the median household income was $46,326.<br /><br /><i>Originally announced as $55,000, the cap actually doesn't kick in until after a patient has received 10,000 mg. At the wholesale acquisition cost, 10,000 mg is about $55,000, </i>said Genentech spokesperson Edward Lang.<br /><br /><i>What the companies have not done so far is reduce prices. The reason, industry representatives say, is the need to recoup massive research and development costs, including high manufacturing costs for biologics. <b>These costs have long kept biotech companies from making much of a profit overall, Hellmann said. She noted that profit levels of publicly held biotech firms have 'hovered close to zero' throughout the life of the industry.</b></i></blockquote><br />Whatever the company's nominal profit levels, its executives, including Dr Desmond-Hellmann, have made extremely good money.   According to <a href="http://www.sec.gov/Archives/edgar/data/318771/000095013408004633/0000950134-08-004633-index.htm">Genentech's 2008 proxy statement</a>, (the last available, since the company has been bought out by Roche), Dr Desmond-Hellmann's <i><b>total compensation was $8,361,348 in 2007 and $7,820,142 in 2006</b></i>. In 2007, her <i><b>total compensation was equal to 0.3% of the firm's total net income</b></i>.<br /><br />Of course, since 2007, and especially since 2009, the problem of hugely expensive pharmaceuticals as a driver of health care costs, especially in the US, has become all too apparent.  The Lancet articles were completely silent about this aspect of Dr Desmond-Hellmann's track record, and what implications it might have for her new role of a foundation that spends $3 billion a year, mainly ostensibly to improve the health of poor people. <br /><br />Since she began as Chancellor of UCSF in 2009, other aspects of Dr Desmond-Hellmann's track record came to light that might have a bearing on how she will conduct herself as Gates Foundation CEO.  <br /><br /><u>Investments in Tobacco Stocks</u><br /><br />As I <a href="http://hcrenewal.blogspot.com/2010/06/smoke-detector-medical-center-leader.html">posted</a> in 2010, then NY Times reporter Duff Wilson discovered that Dr Desmond-Hellmann and her husband (also a physician), had stock holdings in Altria, the parent company of tobacco company Phillip Morris USA, worth between $100,000 and $1,000,000.  When this made public, they abruptly sold the stock.  The head of the UCSF tobacco control center then said,  “I do find that <i>kind of shocking</i>, but at least she got rid of it,...”<br /><br />The goals of tobacco companies seem completely antithetical to those of a medical school, especially one with a tobacco control center, and incidentally seem antithetical to those of the Gates Foundation, which has a <a href="http://www.gatesfoundation.org/What-We-Do/Global-Policy/Tobacco-Control">tobacco control initiative</a>, with a stated goal:<br /><br /><blockquote class="tr_bq">to reduce tobacco-related death and disease in developing countries by preventing the initiation of new smokers, decreasing overall tobacco use, and reducing exposure to secondhand smoke. </blockquote><br />The Lancet articles were silent on this issue.   <br /><br /><u>Questions Whether Industry Partnerships Threaten the University Mission</u><br /><br />In 2011, I <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">posted</a> about Dr Desmond-Hellmann's vigorous push to create public-private partnerships, which seemed meant to turn UCSF into a de facto drug company research and development contract shop.  At the time, I noted that many of her arguments seemed to be based on logical fallacies, and that she never provided any good evidence for her claims of marvelous new "innovations" that would result from such supposed partnerships.  The Lancet articles did not mention any substantive concerns about this issue.<br /><br /><u>Dismissing Concerns about Conflicts of Interest</u><br /><br />In 2012, I <a href="http://hcrenewal.blogspot.com/2012/02/logical-fallacies-in-defense-of.html">posted</a> about how Dr Desmond-Hellmann also dismissed concerns that public-private partnerships could lead to damaging conflicts of interest, again employing several logical fallacies.  In particular, she implied that medical academics should no longer just do research to advance knowledge, but had become responsible for getting their "discoveries to society," and therefore would have to "<i>start a company or work with a company to commercialize a product."  </i>She did not seem to acknowledge the possibility that academics could make discoveries, but perhaps other people would be better at turning these discoveries into useful products.  The Lancet articles were silent on these issues.<br /><br /><u>Minimizing Concerns about Conflicts of Interest due to Membership on the Board of Corporations with Health Care Agendas</u><br /><br />As noted above, Dr Desmond-Hellmann stated that she demonstrated her sensitivity to the issue of conflicts of interest affecting academic health care by avoiding membership on boards of directors of "pharma or biotech" companies.  These, of course are not the only sorts of for-profit corporations who have health care agendas.  This statement appears to have been carefully worded to avoid dealing with Dr Desmond-Hellmann's membership since 2010 on the board of directors of Procter & Gamble (see the company's <a href="http://www.pginvestor.com/file.aspx?IID=4004124&FID=19227491&O=3&OSID=9">2013 proxy statement</a>.)   While Procter & Gamble is no longer a major pharmaceutical company, it has a <a href="http://www.pg.com/en_US/brands/global_health_grooming/index.shtml">Global Health and Grooming unit</a>, whose products include over the counter pharmaceuticals (e.g., Pepto-Bismal, Metamucil, Prilosec OTC).  Also, while Procter & Gamble does not make it very obvious, it has also owned MDVIP, a company that employs physicians to provide concierge medical services, since 2010, although as Cincinnati.com just <a href="http://www.cincinnati.com/story/money/business/2014/05/02/pg-sells-concierge-medicine-unit/8622903/">reported</a>, it will soon sell this unit to private equity.   So while perhaps Dr Desmond-Hellmann could claim that while she was UCSF Chancellor she was not on the board of directors of any pure pharmaceutical or biotechnology company, she was certainly on the board of a major international company that sells pharmaceuticals and other health care related products, and employs physicians to provide direct patient care.  (Presumably, she will be staying on the P&G board while she is Gates Foundation CEO.)  The Lancet did not mention this issue.  <br /><br /><u>Privatizing UCSF</u><br /><br />Also, the Lancet articles seemed to contradict other reports that Dr Desmond-Hellmann made a serious attempt to privatize at least some aspects of UCSF, but that this effort failed. (Note that quote by Dr Hawgood from the first article above.)     <br /><br />However, in 2012, I posted about a prevalent conspiracy theory that University of California managers were trying to take the university private.  However, it seemed to be more of a theory, because at least one news report included statements that Dr Desmond-Hellmann wanted to take UCSF out of the state university system.  This week, an <a href="http://www.bizjournals.com/sanfrancisco/blog/2014/04/university-of-california-uc-ucsf-janet-napolitano.html">article</a> in the San Francisco Business Times suggested that this was a serious plan, in that Dr Desmond-Hellmann<br /><br /><blockquote class="tr_bq">ran into opposition when she  <a href="http://pubads.g.doubleclick.net/pagead/adview?ai=B46LUcTVlU4KNFIrUkwT0tYG4DYnY2pwFAAAAEAEgADgAWJmX6YiuAWDJvriM1KSoEIIBF2NhLXB1Yi05NzM2MDkyNjA0Njc3NTE2sgETd3d3LmJpempvdXJuYWxzLmNvbboBCWdmcF9pbWFnZcgBCdoBa2h0dHA6Ly93d3cuYml6am91cm5hbHMuY29tL3NhbmZyYW5jaXNjby9ibG9nLzIwMTQvMDQvdW5pdmVyc2l0eS1vZi1jYWxpZm9ybmlhLXVjLXVjc2YtamFuZXQtbmFwb2xpdGFuby5odG1smALohAHAAgLgAgDqAiI0NjM1L2J6ai5zYW5mcmFuY2lzY28vYXJ0aWNsZV9wYWdl-AL00R6QA-ADmAPgA6gDAeAEAZIFCwgHEAEYByDp888YoAYg&sigh=t4VXjjLVbHw&adurl=http://pagead2.googlesyndication.com/pagead/imgad?id=CICAgKCNn-yIxgEQARgBMggPKtH7CIiUnA%26t%3D10%26cT%3Dhttp%253A//bizjournals.com%26l%3Dhttp%253A//www.bizjournals.com/sanfrancisco/blog/2012/01/susan-desmond-hellmann-ucsf-uc.html">proposed in early 2012 that some of UCSF's functions be separated from the rest of the UC system</a>.<br /><br />The<i> autonomy coming from the separation, Desmond-Hellmann argued at the time,</i> would have meant that the sole graduate-level-only campus in the 10-campus UC system would no longer subsidize UC undergrad programs. It also would have translated into UCSF having more control over the money it generates from its medical center and other operations.</blockquote><br />However, the same article noted that the current University of California President,<br /><br /><blockquote class="tr_bq">dismissed as 'loose talk' <i>a more than two-year-old plan for UCSF to weaken its ties to the larger UC system</i>. 'UCSF is firmly part of the system and will remain so,...' </blockquote>The current president seemed to thus acknowledge that this plan existed, however "loose" it may have been.  Clearly, the Lancet articles suggested rather that Dr Desmond-Hellmann did not have any privatization plans, whatever the criticisms people could have made of them.   <br /><br /><b>Summary</b><br /><br />We have often discussed the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, how it seems taboo to discuss certain unpleasant facts and issues relevant to the health care system, especially those that might lead to questions about the abilities of the current leadership of large health care organizations.  This taboo seems to particularly affect public discourse within the health care system, such as is found in medical and other scholarly health care journals.<br /><br />The Lancet is one of the largest circulation and most prestigious medical journals.  The Gates Foundation is one of the biggest foundations working in the health care sphere.  In their <a href="http://www.gatesfoundation.org/Who-We-Are/General-Information/Letter-from-Bill-and-Melinda-Gates">latest letter</a>, Bill and Melinda Gates stated,<br /><br /><blockquote class="tr_bq">Our foundation is teaming up with partners around the world to take on some tough challenges: extreme poverty and <i>poor health in developing countries</i>, and the failures of America’s education system.</blockquote><br />Yet when the Lancet devoted two full pages to often repetitive discussion of the new leader of the Gates Foundation, it avoided discussion of several issues that might have lead to questions about whether her future leadership would really be about challenging "poor health in developing countries," rather than promoting the interests of large pharmaceutical/ biotechnology and other health care related companies, as she had apparently tried to do before.  That such an important medical journal would publish such incomplete health news reporting suggests the operation of the anechoic effect. <br /><br />I hope the questions that ought to be raised about Dr Desmond-Hellmann's priorities as CEO of the Gates Foundation will eventually be put to rest.  It would be more reassuring, however, if they could be confronted directly rather than obfuscated.  As long as big health care journals remain so deferential to big health care leaders, concerns we have raised before about whether health care is now primarily lead by a small in-group of executives and managers who may put private interests ahead of entrusted responsibilities remain acute.<br /><br />As we have said many, many times, true health care reform would ensure that leaders of big health care organizations really put patients' and the public's health ahead of private interests.  <br /><br /><br /><b>References</b><br /><br />1.  Holmes D. New CEO takes the reins at the Gates Foundation.  Lancet 2014; 383: 1440.  Link <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2960702-9/fulltext">here</a>. <br />2.  Holmes D. Susan Desmond-Hellmann taking charge at the Gates Foundation.  Lancet 2014; 383: 1455.  Link<a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2960706-6/fulltext"> here</a>.<br />3.  McNeil C. Sticker shock sharpens focus on biologics.  J Nat Cancer Instit 2007; 99: 910-914.  Link <a href="http://jnci.oxfordjournals.org/content/99/12/910.extract">here</a>.<br /><br />ADDENDUM - Material about MDVIP as subsidiary of Procter & Gamble added 5 May, 2014 PM. 

Abort, Retry, Fail? - Lancet Avoided Much Recent Unpleasantness in Reporting on New Gates Foundation CEO (Including Her Defense of $55,000 a Year for Bevacizumab)

The April 26, 2014 issue of the prestigious journal Lancet used two full pages and two separate articles by the same author to discuss the ascension of the Gates Foundation new CEO, Dr Susan Desmond-H…

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Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life.<br /><br />Even self-stated human rights advocates in healthcare won't seem to broach the topic of <b>EHR-related harms</b> and<b> lack of informed consent processes</b> regarding their use in a patient's care, even when authors openly state their concerns for patient and human rights.<br /><br />This is despite known harms at potentially alarming levels as indicated by organizations including the IOM, FDA, ECRI Institute, AHRQ, Harvard Med Mal insurer CRICO, The Joint Commission, NHS in the UK, and others.<br /><br />Forbes contributor Nicole Fisher (<a href="http://www.forbes.com/sites/nicolefisher/">http://www.forbes.com/sites/nicolefisher/</a>) published an article in Forbes dated 3/18/2014 and entitled <b>"Electronic Health Records - Expensive, Disruptive And Here To Stay</b>" (<a href="http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/">http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/</a>).<br /><br />You can read the article at the above link.  It focuses on physician distraction and dissatisfaction, poor usability and usefulness, expense, and related issues.  Of course, quotes from HHS figure prominently.<br /><br />Nowhere, however, is mention of EHR-related harms to patients, such as reported by the aforementioned organizations mentioned - as in this very small sample list of posts, which contain links to source:<br /><br /><blockquote class="tr_bq"><b>Patient Safety & Quality Healthcare: "CRICO Malpractice Claims Analysis Confirms Risks in EHRs"</b><br /><a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a><br /><br /><b>Peering Underneath the Iceberg's Water Level: ECRI "Deep Dive" Study of Health IT "Events"</b><br /><a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a><br /><br /><b>Internal FDA memorandum on HIT risks</b><br /><a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a><br /><br /><b>IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care"</b><br /><a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a><br /><br /><b>EHRs and Deadly glitches</b><br /><a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> (multiple posts)<br /><br /><b>Not to forget issues of breach of privacy:</b>  <br /><a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a> (multiple posts)</blockquote><br />Nor are mentioned the issues of the experimental, unregulated nature of this technology, and the lack of any informed consent process regarding patient's rights to decide whether or not to have these systems used in their care.<br /><br />The only mention of "<b>unintended consequences</b>" links to "<a href="http://www.emrandhipaa.com/guest/2014/03/11/unintended-icd-10-consequences-inadequate-clinical-documentation-can-negatively-impact-physician-profiles-icd-10-tuesdays/">Unintended ICD-10 Consequences: Inadequate Clinical Documentation Can Negatively Impact Physician Profiles</a>." <br /><br />This is in my view disappointing, and seems to be yet another extraordinary healthcare IT industry accommodation, remarkable for an author with the following bio (emphases mine):<br /><br /><blockquote class="tr_bq"><a href="http://www.forbes.com/sites/nicolefisher/">http://www.forbes.com/sites/nicolefisher/</a><br /><br />Nicole Fisher is the Founder and Principal at HHR Strategies, <b>a health care and human rights focused advising firm.</b> Additionally, she is a Senior Policy Advisor and health policy expert on health economic analyses mainly focusing on Medicare, Medicaid and health reform, <b>specifically as they impact women and children</b>. Nicole runs a Health Innovation and Policy page at Forbes.com highlighting and advising companies, ideas and people that are changing the health care landscape. She is also currently pursuing her PhD at the University of North Carolina in the Health Policy and Management Department. Her writing has appeared in other publications such as Health Affairs, Wall Street Journal, Washington Post, Centers for Medicare & Medicaid Services Journal, Wright on Health, The Health Care Blog and Health Services Research. Before pursuing her PhD in health policy, Nicole earned her Master’s degree in Public Policy from the University of Chicago and her undergraduate degree from the University of Missouri. Her health care and policy work at those institutions <b>had an emphasis on underserved populations, women's and children’s issues</b>. She presides on several Boards for domestic and international health organizations and <b>frequently speaks on health reform and human rights.</b></blockquote><br />One might conclude the computer has more rights than the patient and the clinician via this Forbes piece.<br /><br />Finally, although I am a domain specialist (<a href="http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx">http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx</a>), I am getting rather tired of having to point out the obvious to major media outlets and writers, in essence doing their homework for them.  I'm sure other bloggers feel the same way.  <br /><br />The title of the Forbes piece should have been "<b>Electronic Health Records - Expensive, Disruptive, Deadly."</b><br /><br />To the author of the Forbes piece and other HIT writers, here is the face (and gravestone) of someone injured by this "disruptive" technology.  <b> </b><a href="http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html">http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html</a><br /><b><br /></b>A few babies too:  <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a><b></b><br /><b><br /></b>A family man:  <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html">http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html</a><br /><br />I know of others from my legal work supporting the EHR-related injured and deceased that I cannot mention.  And I am but one person.<br /><br />If health IT were causing rapes** and child abuse, rather then merely causing mundane severe injuries and equally mundane deaths, would the media would pay more attention? <br /><br />-- SS<br /><br />** I sadly note that EHR's without proper security measures in force actually did enable rape-like behavior in 2011, as at <b>"EHR as Molestation Candidate Selector: What was this Resident looking for in the EHR before 'examining' female patients?"</b> at <a href="http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html">http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html</a>.<br /><br />

Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life.Even self-stated human rights advocates in healthcare won't seem to broach the topic of EHR-related harms and lack of informed consent processes regarding t…

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CA Supreme Court upholds "whistleblower" protection for Modesto physician - and on replacing the abuser-favoring connotations of "whistleblower" with "Corporate Integrity Advocate"

"Whistleblower" is a term commonly used to refer to insiders in an organization who do not "go along to get along" or look the other way with regard to corruption and malfeasance.<br /><br />The connotation, of course, is that these individuals are "snitches" and "non-team players", in other words, the "bad guys."  They are then punished for their good deeds.<br /><br />(More on the term "whistleblower" below.)<br /><br />Here's one "whistleblower" who punished back:<br /><br /><blockquote class="tr_bq"><b>California Supreme Court upholds whistleblower protection for Modesto physician</b><br /><br />By Ken Carlson<br />February 20, 2014 <br /><a href="http://www.modbee.com/2014/02/20/3201156/california-supreme-court-upholds.html">http://www.modbee.com/2014/02/20/3201156/california-supreme-court-upholds.html</a><br /><br />The California Supreme Court ruled Thursday that a Modesto physician who challenged the termination of his hospital privileges has whistleblower protections.<br /><br />Dr. Mark Fahlen, a kidney specialist, filed a March 2011 whistleblower lawsuit in Stanislaus County Superior Court after Sacramento-based Sutter Health <b>canceled his privileges to care for patients at Memorial Medical Center.</b><br /><br />Fahlen’s lawsuit claims that Sutter Central Valley Hospitals and Steve Mitchell, then the chief operating officer of Memorial, persuaded the Sutter Gould medical group to fire him and terminated his hospital privileges <b>because of his complaints about insubordination and substandard care by hospital nurses.</b></blockquote><br />At least they didn't threaten to plaster his complaints to his forehead as occurred in Ohio (<a href="http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html">http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html</a>).<br /><br /><blockquote class="tr_bq">His attorney said the court decision guarantees that physicians have the same protections as hospital employees if they report problems that threaten to harm patients.</blockquote><br />That "<b>guarantees protections</b>" and "<b>report problems that threaten to harm patients</b>" have to appear in the same sentence at all is symptomatic of the most severe form of patient-be-damned dysfunction in this industry. <br /><br /><blockquote class="tr_bq">It’s “the biggest victory for patient rights since California’s health care whistleblower law was adopted in 1999,” said attorney Stephen Schear of Oakland. “In a hospital environment dominated by corporate giants too often more focused on protecting their marketing and brand name than patient health, <b>today’s ruling will finally unshackle doctors from fear of retribution so they can protect patients.”</b></blockquote><br />Ditto my prior comment.<br /><br /><blockquote class="tr_bq">In a case closely watched by the hospital industry, the American Medical Association supported Fahlen with a “friend of the court” brief. <b>The California Hospital Association and groups such as Kaiser Foundation Hospitals, Scripps Health and Dignity Health filed briefs on behalf of the defendants.</b></blockquote><br />That is rather indicative of the mindsets of those who filed briefs on behalf of the defendants.<br /><br /><blockquote class="tr_bq">... After he was given staff privileges at Memorial in 2004, Fahlen complained to administrators that nurses refused or failed to follow his patient care instructions. According to facts in the case, Fahlen had six clashes with nurses about patient care from August 2007 to April 2008. He told supervisors and administrators that nurses were insubordinate and that their care was substandard.<br /><br />One complaint was regarding <b>a nurse’s refusal to transfer a patient to intensive care, delaying for five hours the appropriate level of care for the patient,</b> the doctor said.</blockquote><br />What if the patient had died, I ask?<br /><br /><blockquote class="tr_bq">Mitchell, the chief operating officer, <b>blamed Fahlen for his conflicts with nursing staff</b> and contacted Sutter Gould’s medical director about Fahlen’s conduct. Sutter Gould cut ties with Fahlen in May 2008, causing his malpractice insurance to be canceled. Fahlen decided to start his own practice and arranged a meeting with Mitchell to talk about his hospital privileges.<br /><br />Mitchell wrote in an email to Memorial’s chief executive officer that <b>Fahlen “does not get it,” </b>meaning that he was going to lose his privileges. The CEO replied that it “looks like we need to have the medical staff take some action on his MedQuals!!! (or medical qualifications). Soon!”<br /><br />According to the lawsuit, Mitchell told Fahlen at the meeting t<b>hat he should resign and leave town, or the hospital would report him to the Medical Board of California</b>. Fahlen charged that a subsequent in-house investigation, and an executive committee decision not to renew his privileges, occurred in retaliation for his complaints about patient care.</blockquote><br />In other words, the doctor was a "disruptive physician" - a bad schoolboy who needed to be spanked - which was, of course, more important to the executives than maimed or dead patients.<br /><br /><blockquote class="tr_bq">Fahlen asked for a hearing, resulting in an October 2009 to May 2010 review by a six-physician committee at Memorial. The panel concluded that the evidence did not show he was incompetent or that his behavior had endangered patients. [But] <b>Memorial’s board of trustees overruled the panel in early 2011.  <span style="color: red;"><i>[It's not hard to imagine that few if any on that board were themselves medical professionals - ed.]</i></span></b></blockquote><br />It's more likely in my view that this physician was ultra-competent.<br /><blockquote class="tr_bq"><br />Sutter attorneys argued that the doctor first needed to exhaust other legal remedies before bringing the whistleblower lawsuit. <b>The Supreme Court dismissed a previous expectation that doctors exhaust other remedies before filing suit with claims of retaliation. </b>Such conditions would “<b>seriously undermine the Legislature’s purpose to afford a whistleblower on a hospital medical staff the right to sue</b>,” the Supreme Court’s opinion said.</blockquote><br />Next, a typical circular argument:<br /><blockquote class="tr_bq"><br />Attorney Lowell Brown, who handles physician disciplinary cases for hospitals, said Thursday’s ruling will “change the rules of the game,” though additional court decisions will be needed to clarify issues. He predicted doctors will be reluctant to serve on hospital panels that review the competency or behavior of physicians.<br /><br />“The doctor can claim the action is being taken because he or she is whistleblowing,” Brown said. “<b>No one ever produces evidence that a sham peer review has taken place. </b>What we will see is sham whistleblower complaints about peer reviews.”</blockquote><br />Since <b>sham peer review</b> (see more at <a href="http://hcrenewal.blogspot.com/2009/10/sham-peer-review-could-this-bad-faith.html">http://hcrenewal.blogspot.com/2009/10/sham-peer-review-could-this-bad-faith.html</a>) is done secretly and behind closed doors, with protections, it's pretty hard to produce "evidence" of the type required in court.<br /><br /><blockquote class="tr_bq">... Fahlen said the ruling means that “<b>doctors no longer have to choose between speaking out for their patients or continuing with their careers</b>.”</blockquote><br />Again, this is an absolutely perverse choice foisted upon clinicians by corporatized, financialized medicine and its leadership.<br /><br />------------ <br /><br />More on the term "whistleblower" itself.<br /><br />My attitude about that term is clear - the people who use it are attempting an ad hominem attack in one word.  It is a bad term, with bad connotations, and does not actually describe what the individual is attempting to accomplish.<br /><br />AHIMA's  Kim Baldwin Stried-Reich has a similar view, and a suggestion for replacement of that term with a more descriptive and non-abusable term:<br /><br /><blockquote class="tr_bq"><b>"Changing Perception of ‘Whistleblowers’"</b></blockquote><blockquote>From  <a href="http://journal.ahima.org/2014/03/01/hipaa-whistleblower-protections-promote-information-governance/">http://journal.ahima.org/2014/03/01/hipaa-whistleblower-protections-promote-information-governance/</a><br /><br />... According to <b>Kim Baldwin Stried-Reich</b>, the former Speaker of the AHIMA House of Delegates, the new amendment to the HITECH-HIPAA Omnibus rule demonstrates both the increasing importance and value HIM professionals have today in ensuring both integrity and compliance with rules, regulations, and laws governing access and disclosure of health information within their organizations. Baldwin Stried-Reich is a privacy and compliance officer with the Lake County Physicians Association, in Waukegan, IL.<br /><br />She notes that while the new provision provides specific protections against disclosures reported to an oversight agency by whistleblowers and workforce members who are victims of a crime, <b>she’s not so sure this new rule will encourage individuals, such as HIM professionals to speak-up and speak-out when or if they see evidence of systematic and ongoing non-compliance with federal mandates.</b><br /><br />One reason for this is the widespread use of the word “whistleblower,”<b> which often carries negative connotations. </b>She prefers the term <b>“corporate integrity advocate.”</b></blockquote><br /><b>"Corporate Integrity Advocate"</b> clearly and unequivocally describes what the individuals - including those who write for blogs such as this one - are trying to accomplish.<br /><br />It is also a term that is rather hard for malfeasance-doers to use as ad hominem..<br /><br /><blockquote class="tr_bq">“Perhaps if Health and Human Services had utilized another term, such as ‘corporate integrity advocate’ more individuals would understand what the intent of this new law is and that it is meant as <b>an avenue individuals can choose to pursue if their professional integrity and ethics are not in alignment with the corporation’s</b> any longer,” Baldwin Stried-Reich says.</blockquote><br /><br />"Not in alignment with the <i>lack</i> of the corporation's integrity and ethics" is a more direct, and likely more accurate, way to put it.<br /><br /><blockquote class="tr_bq">A relevant example of this is evident in the settlement that Shasta Regional Medical Center (SRMC) entered into with the Department of Health and Human Services (HHS) following an investigation concerning the breach of PHI after senior-level executives intentionally disclosed protected information to the media on at least three separate occasions.<br /><br />The Shasta case demonstrates how and why corporate integrity advocates or whistleblowers are needed to facilitate change within their organizations when it is warranted, Baldwin Stried-Reich explains.</blockquote><br />That example is but the tip of the iceberg.  There are many posts on this blog alone dealing with the issues of <s><span style="mso-bidi-font-weight: bold;">whistleblowers</span></s><span style="mso-bidi-font-weight: bold;"> Corporate Integrity Advocates</span> (see the query link <a href="http://hcrenewal.blogspot.com/search/label/whistle-blowers">http://hcrenewal.blogspot.com/search/label/whistle-blowers</a>).<!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument></xml><![endif]--><br /><br />The term "whistleblower" needs to be retired ASAP.<br /><br />-- SS

CA Supreme Court upholds "whistleblower" protection for Modesto physician - and on replacing the abuser-favoring connotations of "whistleblower" with "Corporate Integrity Advocate"

"Whistleblower" is a term commonly used to refer to insiders in an organization who do not "go along to get along" or look the other way with regard to corruption and malfeasance.The connotation, of c…

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Medical Malpractice Insurer CRICO Challenges "EMR Complacency" - Or Do They?

In my Feb. 28, 2014 post "<b>Malpractice Claims Analysis Confirms Risks in EHRs</b>" (<a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a>) I pointed out that the annual medical malpractice claims related to health IT received by the insurer for the Harvard medical community, one of the world's best users of health IT, might represent a significant percentage of the annual med mal claims in the state of Massachusetts.  Many involved serious injury.<br /><br />I also pointed out that the claims themselves represent only a small fraction of total incidents of med mal-related harms (including due to IT), due to the economic realities of med malpractice litigation.<br /><br />In the press release reproduced below, CRICO writes of poor integration and "design deficiencies" - <b>bad health IT</b> - and that "there has been <b>no apparent leader in this field</b> making a concerted effort to design the next generation of EMRs <b>with the physician in mind</b>", and that they hear "<b>significant frustration from physicians related to their experience with EMRs."  </b><br /><br />However, CRICO does not write of the reasons<b> why</b> these issues are as prevalent as they are.<br /><br />Their claim appears to be, in essence, that these problems will be solved through dialog and "conversation" - in other words, appeals to corporate altruism.<br /><br />Why this industry receives special accommodation even from those who have to pay for their mistakes is beyond me: <br /><br /><blockquote class="tr_bq"><b><span style="font-size: small;"><span style="font-family: inherit;">CRICO Challenges EMR Complacency</span></span></b><span style="font-size: small;"><span style="font-family: inherit;"> </span></span><br /><span style="font-size: small;"><span style="font-family: inherit;"><a href="http://www.rmf.harvard.edu/EMR">http://www.rmf.harvard.edu/EMR</a></span></span><span style="font-size: small;"><span style="font-family: inherit;"> </span></span><br /><b><span style="font-size: small;"><span style="font-family: inherit;">February 6, 2013</span></span></b><br /><br />In a recently released video, CRICO offers a vision of how EMRs of the future might improve health care safety for both patient and physician.<b> </b><br /><br /><b>Press Release:  Cambridge, MA —</b> CRICO, the patient safety and medical professional liability company serving the Harvard medical community, has produced a video that puts forth a future vision of how Electronic Medical Records (EMRs) might be embedded into the physician workflow in a manner that would improve health care delivery. CRICO has based the dramatization on real malpractice cases. Through combined analysis of how harm can come to patients from flawed encounters with providers, and conversations with medical and technological visionaries across the country, the video integrates various scenarios into an idealized patient/physician encounter.<b> </b><br /><br /><b>Hearing significant frustration from physicians related to their experience with EMRs</b>, CRICO was inspired to envision a way in which they might be better integrated into  the clinical workflow. This would allow the EMR to offer some relief to physicians and nurses who face seemingly insurmountable challenges of time and data management.<br /><br />Luke Sato, MD, chief medical officer and senior vice president for CRICO said, “The impetus behind this video was to facilitate a dialogue among health care professionals—physicians, IT, hospital administrators—about why we aren’t making better progress in the development of EMRs.  Through analysis of medical malpractice claims, we have line of sight to <b>design deficiencies in the EMR that contribute to claims.</b> The best technological design is one that is integrated seamlessly into one’s workflow. The current EMR is passive—the physician has to actively look for data instead of the technology anticipating what the physician needs to act on.”<br /><br />Opinions within the health care industry are diverse about EMRs but <b>there has been no apparent leader in this field making a concerted effort to design the next generation of EMRs with the physician in mind.</b> In addition to a need for standards across systems, <b>the manual data entry of today’s EMRs adds to the burden of already time-pressed physicians.</b><br /><br />The film was created as a collaborative effort between CRICO’s Luke Sato, MD and David Ting, MD, associate medical director for information systems at Massachusetts General Physicians Organization, who acted as an expert resource for script development and video production. Ting said, “<b>The actual purpose of the video is to ask whether we might intelligently prioritize today’s choices to move our institutions toward improved patient care and improve provider and practice work-life experience.”</b><br /><br />While most of the technology that is used in this dramatization is available today, other elements are further out. CRICO’s future vision, as depicted in the video, is meant as a launching pad <b>to begin the conversation </b>about how new technologies can provide a way to enable EMRs to enhance, streamline, and make safer the patient-physician encounter.<br /><br />Dr. Ting has encouraged his colleagues at MGH to view the video and share their feedback. The physician reaction has elicited a variety of reactions and diverse feedback ranging from “cool, efficient, saves time, and improves outcomes” to “I don’t want voices interfering with my patient interactions.”  The video is available for viewing on the CRICO website, <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=boV17iId5ky3j-AH7i-8UbFkSFsPF9EI1dNj1bsYgpqo6Y-wxui_17h2gLlU68Tga7gAZSNP4So.&URL=https%3a%2f%2fwww.rmf.harvard.edu%2fEMR" target="_blank">www.rmf.harvard.edu/EMR</a>.<b> </b><br /><br /><b>ABOUT CRICO</b><br /><br />For more than 30 years, CRICO has been the patient safety and medical professional liability company owned by and serving the Harvard medical community.<br /><br />CRICO is an internationally renowned leader in evidence-based risk management, proudly serving more than 12,000 physicians (including residents and fellows), 22 hospitals, and nearly 209 other health care organizations.</blockquote><br />They see the problems but do not engage the human reasons for the problems, including generic leadership, conflicts of interest, incompetence, territoriality, profit motive, and the other ills that we write of till our faces turn blue at Healthcare Renewal.<br /><br />In other words, their "challenge to EHR complacency" is about as powerful as our challenges have been to Vladimir Putin regarding Crimea and Ukraine. <br /><br />Perhaps when the payouts become even more severe, insurers will think it a good idea to stop 'making nice' with an intrusive and unregulated industry that has invaded clinical affairs <i>like a bull in a china shop.</i><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/AVvXsEgaWP3zIvzuW2hnbvndLEoTuKD54nAHbQjth4Rgxipxag7L7yracMBpy_ofQ_pUn719eiqRvGFanSAjZ8P2B8UrlbYmkLvElRI7-rSujvgY05Q_XCD7ms5qQqwg5w0kCPUB5_MEapO7uGJn/s1600/bull.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="243" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgaWP3zIvzuW2hnbvndLEoTuKD54nAHbQjth4Rgxipxag7L7yracMBpy_ofQ_pUn719eiqRvGFanSAjZ8P2B8UrlbYmkLvElRI7-rSujvgY05Q_XCD7ms5qQqwg5w0kCPUB5_MEapO7uGJn/s1600/bull.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Can we please, pretty please dialog for a bit about your breaking the dishes?</td></tr></tbody></table><br />-- SS

Medical Malpractice Insurer CRICO Challenges "EMR Complacency" - Or Do They?

In my Feb. 28, 2014 post "Malpractice Claims Analysis Confirms Risks in EHRs" (http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html) I pointed out that the annual medical malpr…

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Patient Safety & Quality Healthcare: "Malpractice Claims Analysis Confirms Risks in EHRs"

Two "<i>EHR beneficence is not exactly as advertised</i>" stories in one day.  It's hard to keep up:<br /><br />After my earlier post today <a href="http://hcrenewal.blogspot.com/2014/02/ehrs-real-story-sobering-assessment.html">"EHRs: The Real Story" - Sobering assessment from Medical Economics</a>, now there's this.<br /><br />From the journal "Patient Safety & Quality Healthcare" (<a href="http://www.psqh.com/%E2%80%8E">PSQH</a>):<br /><br /><b>Malpractice Claims Analysis Confirms Risks in EHRs</b><br /><b>Jan/Feb 2014 </b><br /><br />Article available at <a href="http://www.cci.drexel.edu/faculty/ssilverstein/PSQH_MalpractClaimsAnalyConfirRisksEHR.pdf">this link</a>.<br /><br /><blockquote class="tr_bq">[Short header on several EHR-related care foul ups]<br /><br />... Distressing situations like those described above are happening around the country as healthcare organizations adopt electronic health records (EHRs) in growing numbers. Although these systems promise to reduce costs and improve quality and safety, they’ve also ushered in unintended consequences as a result of human error, design flaws, and technology glitches.<br /><br />Recognizing these emerging risks, CRICO—the patient safety and medical malpractice insurer for the Harvard medical community— is taking action. The Massachusetts-based company has expanded its proprietary coding system to capture EHR-related problems that have contributed to patient harm, and to guide the hospitals, physicians, and other providers it serves toward addressing vulnerabilities in their systems. </blockquote><br />I had previously written about another Med Mal insurer who had noted these problems at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal">http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal</a>.<br /><br /><blockquote class="tr_bq">... CRICO recently analyzed a year’s worth of medical malpractice claims in its comparative database and found <b>147 cases in which EHRs were a contributing factor</b>. Computer systems that don’t “talk” to each other, test results that aren’t routed properly, and mistakes caused by faulty data entry or copying and pasting <b>were among the EHR-related problems found in the claims, which represented $61 million in direct payments and legal expenses.</b></blockquote><br />The article notes this:<br /><blockquote class="tr_bq"><br />... Half of the 147 cases resulted in severe injury.</blockquote><br /><b>Patient deaths were a likely result, too, </b>I note.<br /><br />Note that this is just one insurer's data and assuming a good number of them were local to Massachusetts, could represent a significant percentage of the annual medical malpractice lawsuits in the state (Pennsylvania, a much larger state, has about 1500 med mal lawsuits filed annually).  <br /><br />Note also that most cases of harm <b>never make it to litigation</b> due to the harsh economics of medical malpractice.<br /><br />Numbers such as this will be going up as implementation, driven by HITECH incentives and penalties, accelerates in coming years.  This is especially true as medical centers and physician practices with far less clinical IT expertise and savvy than Harvard's become HIT users, and as the ability to capture such events increases.<br /><br />The ECRI Institute "Deep Dive" study of health IT risk also speaks to a rise in numbers, with its finding of <b>171 health IT "events" in just 36 hospitals over 9 weeks</b> voluntarily reported (i.e., just a fraction of the total), with <b>8 injuries and 3 possible deaths as a result</b> (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>).<br /><br /><blockquote class="tr_bq">... The team asked its CRICO and Strategies members, “What vulnerabilities are you seeing? What are your risk managers worried about? What are your doctors complaining about?”<br /><br />It used that feedback to draft a set of EHR-specific codes and then tested them in three datasets: CRICO (Harvard users) and two of Strategies’ larger clients, !e Doctors Company and Princeton Insurance. Based on those results, CRICO revised and approved 15 new EHR codes that went “live” in January 2013.<br /><br />That means CRICO’s cadre of nurse coders can now identify EHR as a contributing factor to a malpractice claim, instead of using one of the less specific factors available in the past. <span style="color: red;"><i><b>[It's about time for a dose of transparency in the health IT sector - ed.]</b></i></span>  And they can flag whether the problem involved user issues, system/technology issues, or both. “In some cases,” Sato points out, “<b>the system design sets up humans to make errors.”<i> </i></b></blockquote><br />This should all be no surprise to any reader of this blog.  Read the whole article.<b> </b><br /><br />A more comprehensive list of "EHR harm modes" are at my posts "<b>Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide</b>" (<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a>) and "<b>Cart Before the Horse, Part 3: AHRQ's Health IT Hazard Manager</b>" (<a href="http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html">http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html</a>).<br /><br />The actual Hazards Manager report is at <span style="font-size: small;"><a href="https://www.blogger.com/null"></a><a href="http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf">http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf</a>. It contains this summary of known hazards:</span><br /><span style="font-size: small;"><br /></span><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/AVvXsEjBfqMe89ZhrHPmZk_4tCcymGkvz0t0XEm8VSOMumbHa-U2WrdKJeZaZDUb8iQMEr5Y2ZwleIsSrYDanYk9nGbP9UOERnVYtIDNu0dhTodoua_1sfR6nHyVk_98F0eyq2xOjnBa_bjUejjX/s1600/hazman.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="247" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjBfqMe89ZhrHPmZk_4tCcymGkvz0t0XEm8VSOMumbHa-U2WrdKJeZaZDUb8iQMEr5Y2ZwleIsSrYDanYk9nGbP9UOERnVYtIDNu0dhTodoua_1sfR6nHyVk_98F0eyq2xOjnBa_bjUejjX/s1600/hazman.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">AHRQ's taxonomy of health IT hazards.  <b>Click to enlarge.</b></td></tr></tbody></table><br />------------------- <br /><br />Having written on these issues since 1998 as a "health IT iconoclast" (<a href="http://rtg.cis.upenn.edu/MDCPS/Posters/IT%20Iconoclasts.pdf">http://rtg.cis.upenn.edu/MDCPS/Posters/IT%20Iconoclasts.pdf</a>) and having been largely ignored by the <i>cognoscenti</i>, can I now say <b>"I told you so?"</b><br /><br /><span style="font-size: small;">-- SS</span>

Patient Safety & Quality Healthcare: "Malpractice Claims Analysis Confirms Risks in EHRs"

Two "EHR beneficence is not exactly as advertised" stories in one day.  It's hard to keep up:After my earlier post today "EHRs: The Real Story" - Sobering assessment from Medical Economics, now there'…

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To Die in Texas - Dr Mahmood's Apparently Fatal Stealth Hospital System Collapses Nearly Anechoically

I would bet that most people in the US still think our health care system is highly regulated.  Some may thus conclude that the system is basically safe, because, for example, drugs have to be proven safe and effective to be approved by the government, and hospitals must be licensed and run by competent people who are thoroughly vetted.  Of course, some people still think that the US has, or had until recently, the best health care system in the world (look <a href="http://www.nbcnews.com/health/health-care/best-health-care-system-really-john-boehner-f2D11598594">here</a>).<br /><br />Furthermore, the view that less regulation is always better is no quite popular in the US and elsewhere.  For example, after the chemical spill threatened water supplies in the capitol of West Virginia, the Dallas News <a href="http://www.dallasnews.com/news/west-explosion/headlines/20131221-despite-crises-from-salmonella-outbreak-to-west-blast-rick-perry-s-pushed-freer-rein-for-business.ece">reviewed</a> Texas Governor Rick Perry's consistent attacks on government regulation.    <br /><br /><blockquote class="tr_bq">'American business in general, and American agriculture specifically, have <i>had enough of bureaucracy at both the federal and state levels,</i> but especially bureaucracy out of Washington,' Perry said at a congressional hearing. 'The men and women who feed and clothe this nation are suffocating under the weight of mounting federal regulations.'<br /><br />That was back in 1993, when Perry was Texas’ agriculture commissioner. Now Texas’ longest-serving governor, Perry has remained <i>steadfast in his opposition to government regulations. </i></blockquote><br />Some who take such a neoliberal stance may say the health care system is over-regulated, and thus is inefficient and not innovative, leading to our high costs and poor access.<br /><br />However, an amazing case out of Governor Perry's Texas that was made public last year, and I regret I just heard about recently, suggests how little health care may be regulated, and how unregulated health care, whether or not it is efficient, may be deadly. <br /><br />As <a href="http://www.dallasnews.com/investigations/patient-safety/headlines/20130713-patients-died-amid-federal-state-regulatory-inaction.ece">reported</a> in the Dallas News, July, 2013, in the last few years there seems to have been an epidemic of quality problems in a number of seemingly unrelated small rural Texas hospitals.  The report focused first on one hospital, <br /><br /><b>Renaissance Hospital Terrell</b><br /><br />After for-profit hospital corporation Renaissance Healthcare declared bankruptcy in 2008 (look <a href="http://www.bizjournals.com/houston/stories/2008/09/08/story6.html">here</a>), it sold its hospital in Terrell, Texas to RH Terrell Management LLC owned by one Dr Tariq Mahmood.  Almost immediately, however, there was trouble.  First Edwina Henry, the quality director, spied a doctor making questionable entries in patients' charts:<br /><br /><blockquote class="tr_bq">from her office, she had a clear view of doctors’ foot traffic through the medical records department.<br /><br />When she saw [Dr Tariq] Mahmood jotting in patient charts, she <i>knew he wasn’t seeing patients. Mahmood himself had not been credentialed to treat patients</i> — a process in which management vets backgrounds and competencies of doctors. Part of Henry’s job was tracking such evaluations. She also knew it was a breach of privacy laws to review patients’ medical records.<br /><br />'I immediately questioned some of the clerks and [insurance billing] coders,' she said. They were deeply concerned, saying <i>he was altering the patients’ records to help boost reimbursements for insurance claims,</i> Henry said.</blockquote><br />When Ms Henry complained, things did not go well, <br /><br /><blockquote class="tr_bq">Henry made her confidential call to the bankruptcy court in early November 2008, alleging potential fraud and threats to patient care that were eluding government notice [Ed - note that the hospital was going through bankruptcy proceedings and had just been acquired by a new owner]. The court forwarded her complaint to the U.S. Justice Department, the Texas attorney general’s office and the state health department, officials confirmed.<br /><br />Later that month, the state health department sent an inspector to the hospital. However, the visit was brief, Henry said, and the inspector didn’t interview her or seek her help in obtaining records.<br /><br />Williams, the health department spokeswoman, told <i>The News</i> her agency’s records show the inspector was unable to substantiate violations at the time.<br /><br /><i>Henry was terminated from Renaissance </i>as part of a 'restructuring'.... </blockquote>Then the hospital was cited for turning patients away from the emergency department,<br /><blockquote class="tr_bq">At Renaissance, <i>two women in labor, one bleeding, were refused treatment</i>. The inspection reports don’t reveal whether the women suffered complications because of the delays.<br /><br />A Renaissance employee told one of the women that if she 'could stand there and have a conversation with them then (she) wasn’t about to have a baby,' reports say.</blockquote><br />Then there were problems with infection control,<br /><br /><blockquote class="tr_bq">At Renaissance, <i>no supervision over infection control could be found</i>. For three months in the summer of 2010, no one was in charge of tracking infectious diseases or preventing their spread.</blockquote><br />The next year, the problem was blood transfusions<br /><br /><blockquote class="tr_bq">Inspectors returned to Renaissance in September 2011 to investigate a botched blood transfusion procedure. They found that <i>a registered nurse had not supervised the patient’s care</i>. In another case, an inspector witnessed an unsupervised vocational nurse administering blood to a patient, despite no evidence that she was competent to do so — another violation.</blockquote><br />In 2012,<br /><br /><blockquote class="tr_bq">During the summer, the Texas secretary of state had <i>revoked Renaissance’s business charter for failure to pay franchise taxes.</i><br /><br />That office didn’t share the information with the health department; it isn’t required to do so.<br /><br />In September, state health regulators notified Renaissance that they were proposing a $35,050 fine for 13 violations, including the nursing supervision failures, dating as far back as 2010.<br /><br />Williams, the health department spokeswoman, could not explain why the fine process took nearly two years since the first violation. </blockquote><br />Finally, in 2013, patients started to die,<br /><br /><blockquote class="tr_bq">In January of this year, when state inspectors returned to Renaissance, they found nursing supervision failures yet again.<br /><br />This time, <i>the failures had led to three deaths: All ER patients. All with severe breathing difficulties. All receiving little to no intervention as their conditions worsened.</i></blockquote><br />In particular,<br /><br /><blockquote class="tr_bq">[Eve] McCallum sought her own care after complaining of shortness of breath during a family dinner.<br /><br />McCallum had chronic obstructive pulmonary disease. When she was admitted, nurses were ordered to monitor her vital signs and oxygen levels. Her breathing soon improved, said her niece, Lou Ann Sims.<br /><br />'We were fully expecting to pick her up the next morning,' Sims said.<br /><br />Instead, they watched helplessly as her condition deteriorated. On Christmas Day, a physician explained to McCallum’s family that she had to be transferred to the intensive care unit.<br /><br />Later, Sims witnessed a scene she can’t let go of: Her aunt lay connected to a ventilator while a nurse stood smoking a cigarette just outside the door. The nurse had propped open the door with an IV pole.<br /><br />The family immediately <i>sought to have McCallum transferred to another hospital</i>. But hospital officials told them '<i>this would be a lateral move and was not allowed</i>,' according to a transcript of an interview the family later conducted with state officials.<br /><br />McCallum died two days later.<br /><br />Inspectors wrote that a licensed vocational nurse had been left in charge of her treatment, <i>without a registered nurse’s oversight</i>. There was no evidence an RN had assessed her condition on admission or was watching over her in the ICU.<br /><br />They could find <i>no doctor orders to place her on oxygen, no order for medications administered to her, 'nor evidence of communication with the M.D</i>.'<br /><br />Suspecting more than just care breakdowns at Renaissance, McCallum’s family reported her death to the Texas attorney general’s fraud-control unit.</blockquote><br /><br />So partially in response to this egregious case, <br /><br /><blockquote class="tr_bq">By February, the state health department had moved to <i>revoke Renaissance’s operating license</i>, and <i>CMS had ordered its federal funding terminated</i> — only the ninth time nationally in the last three years CMS had taken such a step.</blockquote><br />Even those steps could not shut down the hospital, but city officials took that last step due to the failure to pay taxes.<br /><br /><b>Other Hospitals</b><br /><br />Dallas News reporter Miles Moffeit found several other cases of severe problems at small hospitals owned by Dr Mahmood, with at least one patient death apparently resulting, .<br /><br /><br /><u>Shelby Regional Medical Center</u><br /><br />This hospital was owned by Tenet Healthcare, but was sold to another of Dr Mahmood's companies, Shelby Medical Holdings, in 2007 (look <a href="http://www.beckershospitalreview.com/hospital-management-administration/shelby-regional-medical-center-in-texas-closes-its-doors.html">here</a>).  <br /><br />In 2009, this hospital was also cited for providing insufficient treatment in the emergency department. <br /><br />In 2012, things were really falling apart,<br /><br /><blockquote class="tr_bq">In October 2012, inspectors were at Shelby chronicling dirty, clogged air-conditioners and failures to prevent <i>ceiling plaster 'from falling into the patient food service line and contaminating food</i>.' Those problems put patients’ safety in 'immediate jeopardy,' they wrote.<br /><br />As inspectors roamed Shelby’s halls in December, <i>the power suddenly went out</i> in four buildings, though not in the main hospital facility itself. The <i>electric bill hadn’t been paid</i>. They found other debts stacking up, too — as much as $190,442 owed to as many as 79 service providers.<br /><br />Signs of neglect were everywhere. <i>Only three of 20 patient rooms inspected were 'fully functional for patient care,' </i>they wrote. They found holes in walls, dirty and tattered curtains, and patients complaining of heat pouring from the faulty A/C system.</blockquote><br />Finally, in 2013, another patient died,<br /><br /><blockquote class="tr_bq">On Wednesday, <i>CMS cut off federal funding to ... Shelby Regional Medical Center</i> in Center in East Texas after regulators said <i>a patient rushed there by ambulance never received treatment from a doctor</i>.<br /><br />The ER physician wouldn’t leave his 'sleep room,' the inspection report said, resulting in the patient’s death. Regulators also cited the hospital for failing to vet backgrounds of doctors and nurses.<br /><br /></blockquote>Apparently soon thereafter Dr Mahmood shut the hospital down due to "legal issues that ... [he] is facing," <a href="http://lightandchampion.com/article/003856-mahmood-closes-shelby-regional-medical-center-staff-volunteers-time-until-doors-shut">per</a> the Shelby Light and Champion. <br /><br /><br /><u>Lake Whitney Medical Center </u><br /><br />Dr Mahmood apparently purchased this hospital from a struggling local hospital authority in 2007.   <br /><br />In 2009, it was cited for inadequate care in the emergency department,<br /><br /><blockquote class="tr_bq">At Lake Whitney, a nurse acknowledged to inspectors that she had <i>shredded records of a patient who was denied care following a fall</i>, according to a report. The 'patient wasn’t going to pay anyway,' the nurse was quoted as saying in the document.</blockquote><br />In 2010, there was evidence of major infrastructure problems,<br /><br /><blockquote class="tr_bq">At Lake Whitney, patients were served food on <i>rusty 'over-the-bed tables that were a source of possible infections for open wounds.' </i>Bulging ceiling tiles exposed pipes. Pavement outside a main hospital door was 'cracked and unlevel,' putting patients at risk of injury. </blockquote>As Dr Mahmood's legal troubles mounted, the hospital was sold to Frontier Hospitals Inc (look <a href="http://watchdogblog.dallasnews.com/2013/08/florida-company-takes-over-lake-whitney-medical-center-effectively-dissolving-embattled-owners-troubled-chain.html/">here</a>). <br /><br /><br /><u>Cozby-Germany Hospital </u><br /><br />I have been unable to discover when Dr Mahmood purchased this hospital.  <br /><br />In 2010, it became apparent that the hospital was not properly licensed, <br /><br /><blockquote class="tr_bq">'The administrator reported the new owner had not notified (CMS) … and <i>has not applied for hospital licensure </i>with the state licensing agency,' a report said. [The owner] ... also was found to have <i>appointed his own employees to the hospital’s governing board of directors, instead of independent outsiders</i>.</blockquote><br />And there were more severe problems with credentialing,<br /><br /><blockquote class="tr_bq">At Cozby-Germany hospital, hospital inspectors discovered that the <i>chief of staff and another doctor had expired medical licenses.</i> There were no 'functional' nurse and doctor credentialing processes, and clinical policies had not been updated since 2008, they said. The hospital pledged reforms.</blockquote><br />But in May 2011, records show, Cozby hired one of Texas’ most notorious doctors, Rolando Arafiles.<br /><br /><blockquote class="tr_bq">At the time, Arafiles had been placed on <i>probation by the medical board for allegations of harming nine patients, overbilling and improper coding </i>at a Winkler, Texas, facility, according the board. He also was <i>disciplined for intimidating the Winkler nurses </i>who blew the whistle on his practices.<br /><br />In November, Arafiles would be <i>convicted of two felonies linked to the retaliation and would surrender his license.</i></blockquote><br />In 2013, two local doctors purchased the hospital.<br /><br /><b>The Vanishing Owner</b><br /><br />What made this series of cases all the more amazing is that it was really one interlinked case.  All these hospitals, plus a few more, had the same owner.  Yet no one, especially  no one in state or federal government knew that until 2013 when the facts were uncovered by Mr Moffeit.<br /><br /><blockquote class="tr_bq">[Dr Tariq] Mahmood, a Pakistan-trained doctor, obtained his Texas medical license in 1978. Since 2008, he has practiced medicine only at his Central Texas Hospital in Cameron, south of Waco, records with the Texas Medical Board show. Older documentation is not available.<br /><br />Over the last two decades, <i>he has purchased at least six hospital companies and two home-health care agencies</i>, according to filings with the Texas secretary of state. He also has invested his money outside health care, acquiring the historic Hotel Lawrence in downtown Dallas, property records show.<br /><br />In addition to Renaissance, Shelby and Central Texas Hospital, Mahmood owns the Lake Whitney Medical Center in Whitney and Cozby-Germany Hospital in Grand Saline. He sold Community General Hospital in Dilley around the time of his arrest in April.<br /><br />The hospitals have <i>no common corporate identity</i> and little or no website presence, making it difficult for anyone to know they are owned by Mahmood or are part of a chain.</blockquote><br /><br />However, much bout Dr Mahmood was mysterious, and the deliberate cultivation of mystery might have slowed the response to this case. <br /><br /><blockquote class="tr_bq">Mahmood is rarely seen in the communities where his hospitals are located, say business associates and city officials. Sometimes they catch a glimpse of him passing by in a chauffeur-driven car.<br /><br />'He’s almost impossible to track down' to discuss business matters, said Tom Elliott, a director for a nonprofit company that owns the hospital building in Grand Saline. 'He lets his people do the talking.'<br /><br />Mahmood is a mystery to many of his own employees. He works almost entirely behind the scenes, they say, focusing largely on the business side of his operations. He often is traveling or spending time at his 10,000-square-foot gated estate in Cedar Hill, they say.<br /><br />'We see him maybe once a year,' said one of his hospital physicians. 'The employees say he doesn’t like confrontation. I say he just doesn’t like to communicate. He seems to live in a different world.'</blockquote><br /><b>Aftermath</b><br /><br /> At some point, the shadowy Dr Mahmood may have to answer for all this, at least to some extent, <br /><br /><blockquote class="tr_bq">In April, federal authorities charged the 62-year-old Cedar Hill resident with <i>defrauding Medicare and Medicaid programs through $1.1 million in false billings.</i><br /><br />Mahmood is accused of directing employees at his Central Texas Hospital in Cameron to alter underlying information in insurance claims from his other hospitals. 'In many cases,' the indictment alleges, these were 'for patients he had never seen.' Mahmood pleaded not guilty, and his attorney said he denies all charges. He has declined repeated interview requests from <i>The Dallas Morning News</i>. </blockquote><br />Note, however, that these are charges of financial fraud.  They do not obviously have to do with poor quality care, risks to patients' safety, or the deaths of at least three patients as discussed above.<br /><br />This case was so bad that even the current Governor of Texas, Rick Perry, a politician known for taking a small government, minimal regulation stance, at least said he was going to take some action, as <a href="http://www.dallasnews.com/investigations/patient-safety/headlines/20130719-perry-orders-investigation-into-oversight-of-troubled-rural-hospital-chain.ece">reported</a> again in the Dallas News,<br /><br /><blockquote class="tr_bq">The governor’s office has ordered a 'deep and comprehensive look' at health care facilities owned by Dr. Tariq Mahmood, whose chain of rural Texas hospitals avoided serious regulatory action despite years of endangering patients.<br /><br />The inspector general for the state Health and Human Services Commission and one of the agencies it oversees, the state health department, will conduct separate investigations, officials said Friday.</blockquote><br />And in February, 2014, the Dallas News <a href="http://www.dallasnews.com/investigations/20140206-texas-hospitals-chief-faces-fraud-charges-over-use-of-stimulus-grants.ece">reported</a> that the chief financial officer of the Dr Mahmood's stealth hospital chain was also in hot water,<br /><br /><blockquote class="tr_bq">The top administrator of a chain of hospitals that collapsed under the ownership of a North Texas physician faces charges that he defrauded the federal government of nearly $800,000 in stimulus funds.<br /><br />Joe White of Cameron <i>rose from maintenance man to head administrator and chief financial officer</i> over hospitals once owned by Dr. Tariq Mahmood. Now he joins Mahmood in facing the possibility of prison time.<br /><br />Like Mahmood, who pleaded not guilty, White is accused of identify theft and bilking the federal government of health care dollars. White has yet to enter a plea.</blockquote><br />Note that the CFO and apparently COO was not even a professional generic manager.  He was a former maintenance man  and operator of a Radio Shack store..  <br /><br />Dr Mahmood has not yet come to trial.  Many questions about the case remain unanswered:<br /> -  Did Mahmood the only person besides his CFO cum maintenance man in charge of all this, or did he have other backers,  cronies, associates?<br />-  What happened to the rigorous state investigation promised by Rick Perry?<br />-  Given that what went on harmed patients, and hence was not just financial manipulation, are there any civil lawsuits pending?  Are there any other criminal investigations?\<br /><br />Furthermore, despite its egregious nature, this case was amazingly <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>  The only national recognition I could find was i<a href="http://runningahospital.blogspot.com/2013/07/hospital-slumlord.html">n Paul Levy's Not Running a Hospital blog.</a>  Seven months later, I could find nothing in the national media, nothing in medical and health care literature.  Despite the amazingly poor quality of care in evidence, despite the fact that patients died, I could find no cries of outrage from those who proclaim to support quality health care or patient safety.  <br /><br /><br /><b>Summary</b><br /><br />Dr Mahmood and his chief operating and financial officer collectively displayed leadership that was ill-informed (the COO/ CFO was a former maintenance man), incompetent (see the egregious health quality problems listed above), self-interested (note the size of Dr Mahmood's mansion versus how little was obviously spent on his hospitals), opaque and dishonest (note how Dr Mahmood's ownership of the hospitals was obscured), and allegedly criminal.  This leadership persisted over at least eight years until it culminated in cases of apparently needless patient deaths.   <br /><br />The amazing case of the stealth for-profit hospital system run by Dr Mahmood, and how its combined problems failed for so long to get systemic regulatory notice hardly suggest that our health care system is heavily regulated, or that current regulation can be relied upon to reassure patients that all is well and that the system is safe.<br /><br />In fact, in the case of Dr Mahmood, government regulators did not seem to even want to know too much about hospital ownership,<br /><br /><blockquote class="tr_bq">Top health regulators weren’t even aware Mahmood owned several hospitals until <i>The News</i> sought information about them earlier this year. <i>Regulatory agencies aren’t set up to track problem hospital owners or hold them accountable. Nor do they look for patterns of care breakdowns inside hospital chains.</i><br /><br /><i>'We just don’t have that authority,'</i> said David Wright, deputy regional administrator for CMS. The federal agency oversees the state health department’s inspections of federally funded hospitals. 'We can only address problems in stand-alone facilities.'</blockquote><br /><br />Furthermore, it appears that modern regulators have decided to become hospital managers' and owners' best friends,<br /><br /><blockquote class="tr_bq">The process allows hospitals to <i>avoid sanctions if they cooperate</i>. Hospitals submit “corrective action plans” to remedy failures. It can take months for state regulators to bring penalties such as fines against a facility. In the case of Renaissance, it took years.<br /><br />'We want to do what’s in the best interest of the patients, and our regulatory philosophy is <i>to get hospitals into compliance,</i>' said Carrie Williams, spokeswoman for the Texas Department of State Health Services. '<i>We’re not in the business of shutting down hospitals. We will give them some leeway and work with them.'</i></blockquote><br />Of course, this minimalist, light touch regulatory methodology may have made some sense in an earlier era when nearly all hospitals were small community not-for-profit organizations, non-profit academic institutions, or were run by local governments.  It seems quaint, and hopelessly out of date in an era when most hospitals are part of <a href="http://hcrenewal.blogspot.com/search/label/hospital%20systems">ever larger systems,</a> now often owned for-profit corporations, and when hospital system CEOs who are professional, and thus <a href="http://hcrenewal.blogspot.com/search/label/generic%20managers">generic managers</a>, not health care professionals, in an era of <a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a> and "maximizing shareholder value," that is, making short-term revenue the most important outcome.<br /><br />Instead, the current minimalist regulatory system seems insufficient to prevent patients from dying of poor care allowed by poor leadership of health care organizations.  Much of the content of this blog has been about bad health care leadership, i.e., leadership that is <a href="http://hcrenewal.blogspot.com/search/label/ill-informed%20management">ill-informed</a>, incompetent, unsympathetic or <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">hostile to health care professionals' values</a>, self-interested, <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicted</a>, dishonest, or even <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">corrupt</a>.  In my humble opinion, health care regulation ought to be sufficient to promote competent, caring, unconflicted, honest leadership that is accountable for putting patients' interests ahead of self-interest.  Regulation needs to be more intense, and much smarter, geared to the reality of a health care system that is now largely for-profit in an era when management dogma puts revenue ahead of all other concerns.<br /><br />Maybe the deaths of some patients in Dr Mahmood's Texas hospital will finally let the air out of the mindlessly anti-regulatory bubble, and start some discussion of intelligent regulation to improve patient safety.<br /><br />However, that cannot happen if this case remains anechoic.  I regret it took me so long to find it, but now I have done my part to start some echoes.  But where are the media, where are the journal editors, and where are those who so loudly proclaim their interest in patient safety and health care quality?<br /><br />In particular, there are several prominent organizations that claim to promote health care quality and patient safety.  These organizations make these claims- <br /><br /><a href="http://www.jointcommission.org/topics/patient_safety.aspx">Joint Commission</a><br /><br /><blockquote class="tr_bq"> For more than 60 years, The Joint Commission has been a <i>champion of patient safety</i> by helping health care organizations to improve the quality and safety of the care they provide. </blockquote><br /><a href="http://www.leapfroggroup.org/about_leapfrog">Leapfrog Group</a><br /><br /><blockquote class="tr_bq"> The Leapfrog Group is a voluntary program aimed at mobilizing employer purchasing power to alert America’s health industry that <i>big leaps in health care safety, quality</i> and customer value will be recognized and rewarded.</blockquote><br /><a href="http://www.qualityforum.org/who_we_are.aspx">National Quality Forum</a><br /><br /><blockquote class="tr_bq"> <i>Transforming our healthcare system to be safe</i>, equitable, and of the highest value will take time and the work of many, but the potential rewards are great. The National Quality Forum (NQF) is a nonprofit, nonpartisan, public service organization committed to this transformation. </blockquote><br /><a href="http://www.rwjf.org/en/about-rwjf/our-mission.html">Robert Wood Johnson Foundation</a><br /><br /><blockquote class="tr_bq">Our efforts focus on improving both the health of everyone in America and their health care—how it's delivered, how it's paid for, and <i>how well it does for patients and their families. </i></blockquote><br />These  organizations should the ones to start the conversation about improving rather than forever shrinking regulation.   I have not heard anything from them about the deadly hospitals of Dr Mahmood.  Are they listening now?  Will we ever hear from them?  Time will tell....  <br /><br /> Note: the entire Dallas News series on the Mahmood hospitals can be found <a href="http://res.dallasnews.com/interactives/collapseofcare/">here</a>.  <br /><br />

To Die in Texas - Dr Mahmood's Apparently Fatal Stealth Hospital System Collapses Nearly Anechoically

I would bet that most people in the US still think our health care system is highly regulated.  Some may thus conclude that the system is basically safe, because, for example, drugs have to be proven …

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