healthy4u

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 "any proven or admitted facts upon which to exercise even a modest degree of independent judgment,"  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>). Keeping Evidence from the Latest Vioxx Case Secret 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. <blockquote class="tr_bq">A federal judge may sanction a physician who served as an expert witness in the ongoing litigation over the Vioxx painkiller for describing confidential documents to The Wall Street Journal. 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. Fallon, who presides over Vioxx litigation that was consolidated in federal court in New Orleans, had 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.</blockquote> The Nature of the Information to be Kept Secret The post is vague about what secret information Dr Egilman was accused of making public.  Apparently, it had to do with his work as <blockquote class="tr_bq">a paid expert witness for plaintiffs in a lawsuit that had been filed by the Kentucky Attorney General, who 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. The lawsuit was settled last November for $23 million, although the drug maker did not admit to any wrongdoing. 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. 'In general, 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,' he told us three months ago, which prompted the drug maker to complain to the federal judge.</blockquote> 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. What About the Public's Interest? <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 '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.'</blockquote> 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. <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, <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, and Fallon agreed.</blockquote> 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. Merck's Track Record Vis a Vis Vioxx 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. 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.  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) On Health Care Renewal, we starting <a href="http://hcrenewal.blogspot.com/search/label/Vioxx">writing about Vioxx</a> in 2005, including, - <a href="http://hcrenewal.blogspot.com/2005/04/more-evidence-of-ghostwriting.html">here</a> about ghost-writing of a Vioxx research publication; - <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; - <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; - <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 - <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. -  <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. 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 good lesson about some of the tactics used to deceptively and unethically promote health care products (pharmaceuticals in this case)."  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). 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  Summary 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. 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. Disclosure Note that both Dr Egilman and I are voluntary faculty at Brown, although we do not directly work together.  References 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>. 2. Curfman GD, Morrisey S, Drazen JM et al.  Expression of concern reaffirmed. N Engl J Med 2006; 354:1193. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMe068054">here</a>. 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>. 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>. 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>. 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>. 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>. 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>. 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.

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...

Đọc thêm »

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

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

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

We have argued repeatedly against the strategy used by US government authorities to address allegations of bad behavior in health care (and ...

Đọc thêm »

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

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

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

A health IT "glitch" hit in Vermont on Full Moon Friday the 13th (have some werewolf with your bad luck!) Dark Shadows' Quenti...

Đọc thêm »

Masters of the Obvious at Athens Regional Medical Center: Lack of clinician input, training, common sense created problems with Athens Regional electronic records system - but mostly lack of common sense

<div style="text-align: center;">(Note: also see my earlier May 26, 2014 post at <a href="http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html">http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html</a>)</div> My early medical mentor, Dr. Victor P. Satinsky, had disdain for those whom he called "Masters of the Obvious", who proffered profound words of wisdom that were in fact common-sensical or well-accepted, as if they'd invented those words personally. I think it's fair to say that after countless publications dating back decades, pointing out the essential role of clinical leadership in the development of clinical tools such as healthcare information technology systems, that such involvement is now a standard of care that reasonable hospital leadership would mandate when spending tens of millions of dollars on potentially injurious or lethal systems. Yet the physician revolt at Athens Regional Medical Center appears to be a result of its most senior leadership not keeping IT leadership on an appropriately short leash (a phenomenon that falls under the topical heading of "severe mismanagement"): <blockquote class="tr_bq"><a href="http://onlineathens.com/local-news/2014-06-14/lack-input-training-created-problems-athens-regional-electronic-records-system">http://onlineathens.com/local-news/2014-06-14/lack-input-training-created-problems-athens-regional-electronic-records-system</a>  Lack of input, training created problems with Athens Regional electronic records system By Kelsey Cochran Athens Banner-Herald Updated Sunday, June 15, 2014  More input in the way Athens Regional Health Systems’ electronic health records system was implemented should have come from the clinicians who use it every day, and fewer decisions should have been made by the hospital’s information technology department, a top hospital administrator and two vice presidents of system vendor Cerner Corp. said this week, in the wake of criticism of the system by a number of physicians. ... Although some daily users of the system were involved in the planning and design process from the beginning, Cerner Vice President Michael Robin, who has worked closely with ARMC since the deal was first made, said his team noticed midway through its implementation that the hospital system’s IT team was leading the project, which is "atypical" of Cerner clients like ARMC, he said. </blockquote> First, I don't think that IT team control of health IT projects is all that unusual.   Clinicians, even medical informaticists with cross-disciplinary expertise, rarely are more than "internal consultants" who may be ignored, as opposed to true leaders with executive presence and authority (e.g., control of budgets, grants of authority, and IT staff performance evaluation, hire and fire authority). Second, where was the Board of Directors?  They were ultimately responsible for allowing the IT leadership in at a level beyond their collective heads. Third, it's just a bit odd that the leader of the (failed) $20 billion National Programme for IT in the NHS, Richard Granger, said almost exactly the same thing about listening to end-users ca. 2007 (see <a href="http://hcrenewal.blogspot.com/2007/07/clinical-it-mayhem-is-good-for-it.html">http://hcrenewal.blogspot.com/2007/07/clinical-it-mayhem-is-good-for-it.html</a>).  I as well as numerous other authors had similar observations, in some cases dating to the 1960's.  For example,  see my essays, some dating to the late 1990s at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases">http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases</a>, and Dr. Donald Lindberg's quotes from 1969 at the page below from Morris Collen's book "A History of Medical Informatics in the United States 1950-1990." <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/AVvXsEgcn4aLX1NGS_wG4FsSop81xaYmy9OeDKeiW-6qndwAvRWTmR6Sa4pwXyBuG02j4jKhifXdjSbcCcLcFngrkv6lYcip-V6DQvXzAsPCHdqMity4UopLN1lptK4OjgvBQIMUurTDLVb4l7Jr/s1600/collen168.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgcn4aLX1NGS_wG4FsSop81xaYmy9OeDKeiW-6qndwAvRWTmR6Sa4pwXyBuG02j4jKhifXdjSbcCcLcFngrkv6lYcip-V6DQvXzAsPCHdqMity4UopLN1lptK4OjgvBQIMUurTDLVb4l7Jr/s1600/collen168.jpg" width="210" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">EHR pioneer Dr. Donald A.B. Lindberg (<a href="http://www.nlm.nih.gov/od/roster/lindberg.html">http://www.nlm.nih.gov/od/roster/lindberg.html</a>), 1969:  "Computer engineering experts per se have virtually no idea of the real problems of medical or even of hospital practice, and furthermore have consistently underestimated the complexity of the problems ... in no cases can these jobs be done, simply because they have not been defined with a physician as the continuing major contributor and user of the information." (Click to enlarge)</td></tr></tbody></table> The essential nature of clinicians actually having input (and at a leadership level) into the design and implementation of clinical tools such as health IT is patently obvious.  Only in the perverse control-mentality of business information technology (a.k.a. MIS or management information systems, see <a href="http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html">http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html</a> for the possible pre-electronic computer, tabulator-based roots of that culture) could such a precept even be questioned, let alone ignored. <blockquote class="tr_bq"> ... Moore, who took over as administrative lead on the electronic health record system after Thaw resigned, said some of the issues outlined in the physicians’ letter were real, and some were “theoretical.”</blockquote> Translation: some of the complaints were accidents waiting to happen. <blockquote class="tr_bq">..."To the best of our knowledge, there was not patient harm or patient death.” </blockquote> In other words, this is yet another story where the common, feel-good and ignorant refrain "but patient care has not been compromised" has reared its ugly head.  (I've made this type of claim a topical header at this blog.  See query link <a href="http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised">http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised</a> for others.) Assuming that's true - note that the impact of bad health IT can be delayed due to delayed effects of bad or missing information - this statement is, let me be impolite, vacuous on its face. <div class="headword" id="headword"><blockquote class="tr_bq"><h2>vac·u·ous (<a href="http://www.merriam-webster.com/dictionary/vacuous">http://www.merriam-webster.com/dictionary/vacuous</a>)</h2>adjective \ˈva-kyə-wəs\ </blockquote><div class="ld_on_collegiate"><blockquote><div class="bottom_entry">: having or showing a lack of intelligence or serious thought : lacking meaning, importance, or substance</div></blockquote></div></div> It seems some simple facts apparently need to be explained to these geniuses.   I'll put it in caps just to make sure they understand some basic issues: <ul><li>A HOSPITAL IS NOT A PLACE FOR RISKY INFORMATION TECHNOLOGY EXPERIMENTATION.   UNNECESSARY RISK IN HEALTHCARE IS A VERY, VERY BAD THING. </li></ul><ul><li>THE GOAL OF HOSPITALS IS NOT TO SUBJECT PATIENTS TO RISK VIA MISMANAGEMENT OF HEALTHCARE IT, AND THEN PROCLAIM "NOBODY WAS INJURED OR KILLED" AFTER THE PERPETRATORS OF THE MISMANAGEMENT ARE UPROOTED. </li></ul><ul><li>CLINICIANS DO NOT TOIL IN HOSPITALS TAKING CARE OF SICK PATIENTS SO THAT INFORMATION TECHNOLOGY PERSONNEL CAN HAVE COMFY JOBS AND COOL COMPUTERS.</li></ul> One wonders if these points might be above the intellectual pay grade of those running hospitals - including boards - in 2014. If nobody was injured or killed, it was due to happenstance, not due to appropriate due diligence and adherence to the standards of care essential in this healthcare sector - that is, healthcare information technology. Depending on happenstance is not a good healthcare management strategy. -- SS

Masters of the Obvious at Athens Regional Medical Center: Lack of clinician input, training, common sense created problems with Athens Regional electronic records system - but mostly lack of common sense

(Note: also see my earlier May 26, 2014 post at http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html ) My early me...

Đọc thêm »

Sham Peer Review Issue Goes Mainstream. WaPo: VA Physicians Fear Sham Peer Review

The paper's words this time, not mine: From the Washington Post, "VA docs concerned about retaliation", June 12, 2014, <a href="http://www.washingtonpost.com/blogs/federal-eye/wp/2014/06/12/va-docs-concerned-about-retaliation/">http://www.washingtonpost.com/blogs/federal-eye/wp/2014/06/12/va-docs-concerned-about-retaliation/</a>: <blockquote class="tr_bq">Retaliation from management is a real concern among <a href="http://www.va.gov/">Department of Veteran Affairs </a>(VA)  employees ...  James Martin, a physician and a representative of the American Federation of Government Employees National VA Council, told the gathering  that sham peer reviews are a problem in the department. In a later interview, he elaborated, saying, “orchestration of facts” related to issues involving contact with patients [in other words, fabricating stories about substandard patient treatment by physicians, cherry-picking minor incidents and exaggerating them, etc. - ed.] is an issue at some facilities.” Sham reviews, he explained, can be used when management wants to replace or punish a doctor. Retaliation against employee whistleblowers was again the subject of discussion during Thursday’s <a href="http://veterans.house.gov/hearing/an-examination-of-bureaucratic-barriers-to-care-for-veterans">hearing</a> of the House Veterans Affairs Committee.</blockquote> Further amplifying the point: <blockquote class="tr_bq"> ... During the hearing, Republicans Jeff Miller (Fla.) and Dan Benishek (Mich.), both of whom spoke to the NAVAPD conference, asked Robert L. Jesse, the department’s acting under secretary for health, about reports that VA employees were instructed not to talk with members of Congress. Benishek, a physician and former VA employee, said agency doctors have told him they are “reprimanded and have this retribution if they try to change the system.” </blockquote> Read the whole article at the link above. Then, read more on sham peer review at the American Association of Physicians and Surgeons (AAPS) resource site at <a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/</a>. A typical scenario is described like this: A conscientious doctor reports a quality care problem or patient safety problem to the hospital administration. This might be anything from an anesthesiologist falling asleep during surgery to a malfunctioning piece of equipment which places patients at risk for harm. <blockquote class="tr_bq">Instead of fixing the problem, some hospitals misuse the peer review process to attack and silence the physician whistleblower. The hospital administration and unethical physician collaborators then search for some pretext upon which to attack the physician whistleblower. This might involve the hospital bringing trumped up charges against the physician or it might involve bringing totally false and/or fabricated charges against the physician. The truth and the facts do not matter in a sham peer review in the hospital since the hospital controls the entire process. The hospital then goes through the motions of providing a hearing to the accused physician, which they call “fair,” yet the outcome of the hearing is predetermined. The physician’s due process rights are often utterly trampled. At the conclusion of the process, the physician’s privileges to practice at the hospital are terminated. The physician is reported to the National Practitioner Data Bank, and the physician’s career is essentially over. Once a physician receives a negative report in the National Practitioner Data Bank, it is unlikely that physician will ever work in any hospital again anywhere in the nation. </blockquote> Sham peer view affects all physicians, not just public-sector ones. It does not help patients when physicians, their supposed advocates, are cowering in fear over destruction of their careers for being "whistleblowers" (for which a better term might be "corporate integrity agents"). Finally, I think this fear helps explain the relatively low levels of complaints about bad health IT, on which hospital executives invest billions of dollars and their reputations. -- SS

Sham Peer Review Issue Goes Mainstream. WaPo: VA Physicians Fear Sham Peer Review

The paper's words this time, not mine: From the Washington Post, "VA docs concerned about retaliation", June 12, 2014, http://...

Đọc thêm »

Canada: Province-wide electronic medical record computer system 'glitch' causing patients to be turned away from care

This story describes a very bad scenario for sick Canadians.  I offer just a few pithy comments, as not much more than that is needed: <blockquote class="tr_bq"><a href="http://medicinehatnews.com/news/local-news/2014/06/10/system-failure-has-docs-patients-upset/">http://medicinehatnews.com/news/local-news/2014/06/10/system-failure-has-docs-patients-upset/</a></blockquote><blockquote>System failure has docs, patients upset By Gillian Slade on June 10, 2014 Many patients were turned away from their doctor’s office Monday because a province-wide electronic medical record computer system had collapsed.</blockquote> Province-wide.  Stunning.  A very big argument against centralization of EHR resources. <blockquote class="tr_bq">“This is the third straight week of issues with the TELUS Wolf system,” said Dr. Donovan Nunweiler at Southlands Medical Clinic. “We feel we were encouraged by government to switch to Wolf and now it’s not working.”</blockquote> I wonder when someone in the Canadian government is  going to issue that now-famous slogan "but patient safety has not been compromised"... <blockquote class="tr_bq">A year ago 202 physician clinics across Alberta using TELUS Wolf were unable to access patient records for most of the day.</blockquote> More than 200 physician clinics are blind, deaf and dumb?  Wonder what happens to acute patients on days like that. <blockquote class="tr_bq">On Monday patients arrived only to be told the electronic patient files were not accessible making it impossible to see test results, past medical history and medications.</blockquote> Paper never goes on strike.  Perhaps elimination of paper completely is not such a good idea? <blockquote class="tr_bq">“This is affecting me big time and affecting my income,” said Ken Hoeppner, a patient at HealthWORX Medical clinic, who had waited 15 days for his appointment. “Every time government touches something they wreck it. Our health care used to be good here before Alberta Health Services took over.”</blockquote> No comment. <blockquote class="tr_bq">At HealthWORX, office manager Carel Liebenberg said the office was doing what it could to reschedule people. One patient had driven three hours to be there for his appointment early Monday.</blockquote> It's just a "glitch", sir or madam.  Stop complaining. (<a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>) At Health Matters Medical Clinic, staff confirmed they too were dealing with no access to patients’ records on TELUS’s Wolf system. <blockquote class="tr_bq">Originally to encourage physicians to move to electronic medical records, the government gave a monetary incentive. Alberta Health selected TELUS Health Solutions Wolf EMR after a request for proposals in 2008. There was a requirement for the service to be available 99.9 per cent of the time between 6 a.m. and midnight with financial penalties for failure to do so. “There is no longer any government support,” said Nunweiler. “We (Southlands Medical Clinic) pay $2,000 a month for this. Who is going to hold TELUS accountable now? The government has abandoned us. Cost and issues switching patient data, when systems are not compatible, prevents us from going somewhere else.”</blockquote> Seems to be this TELUS:  <a href="https://www.telushealth.com/health-solutions/electronic-health-records-%28ehr%29">https://www.telushealth.com/health-solutions/electronic-health-records-%28ehr%29</a>.  Sounds like a monopoly to me. On that page: <blockquote class="tr_bq"><h4>TELUS Electronic Health Records (EHR) provides a better way to share, access and consolidate information.</h4>Without quick, secure access to complete and reliable information, healthcare provision can be inefficient, preventing patients from receiving the best care possible.</blockquote> How ironic. <blockquote class="tr_bq">Liebenberg reached TELUS at 9 a.m. Monday. “They said they had just become aware of the issue and that their data technicians were in a meeting discussing the problem,” said Liebenberg. “Last week the system was extremely slow, taking 15 minutes for a physician to simply renew a prescription.”</blockquote> Data technicians were in a meeting?  Sounds like a fantastic way to respond to a Province-wide medical emergency. <blockquote class="tr_bq"> Nunweiler said he’d made notes on paper as he struggled to manage the snail’s pace of the system last week. Monday he would be adding to those notes and envisaged several hours at night entering the data to make it current.</blockquote> Paper never goes on strike. <blockquote class="tr_bq">Liebenberg said the need to re-schedule appointments reflects badly on the clinic and some patients don’t understand it’s a system failure beyond the clinic’s.</blockquote> That's just great for patient-physician relations. <blockquote class="tr_bq">Dr. Franz Yonker said HealthWORX had been using JonokeMed but the government endorsed TELUS Wolf and physicians were encouraged to switch. “I think this is really bad for a government-backed system,” said Yonker.</blockquote> "Wolf" is a somewhat humorous name considering these problems.  As in, a predatory EHR ... one wonders just how much better the others are. <blockquote class="tr_bq">Becky Nelson arrived for her appointment to refill prescriptions and was concerned about how long it would take to get another appointment. “The government needs to get this on track. We are suffering the consequences,” said Nelson.</blockquote> I wonder if any patients will suffer the ultimate consequence.  (Hint to Canadians:  never become too dependent on the Government.  Stuff like this happens.) <blockquote class="tr_bq">Donna Schneider brought her mother Vernie Ferguson in for results of some tests. Ferguson said she was not at all well. “There is nowhere else to go and get my test results,” said Ferguson.</blockquote> Held medical hostage to bad health IT.  How horrible. <blockquote class="tr_bq">The News requested an interview with TELUS but there was no response on Monday afternoon. The News requested information from Alberta Health but that was not available on Monday. </blockquote> Perhaps they're busy, in meetings discussing how to fix the problem. -- SS

Canada: Province-wide electronic medical record computer system 'glitch' causing patients to be turned away from care

This story describes a very bad scenario for sick Canadians. I offer just a few pithy comments, as not much more than that is needed: http:...

Đọc thêm »

The Return of PharmaLot

After an unfortunate hiatus (see<a href="http://hcrenewal.blogspot.com/2014/01/pharmalot-sent-down-memory-hole.html"> this post</a>), <a href="http://blogs.wsj.com/pharmalot/">PharmaLot</a> is back.  PharmaLot was one of the premier sources of incisive information on the pharmaceutical industry, is back.  PharmaLot was and now is run by Ed Silverman, and is known for publishing important, but sometimes unpleasant truths. Ed Silverman provided unbiased, insightful reporting.  Notably for the <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> audience, he was not afraid to report on the good, the bad, and the ugly. He was no friend of marketing and public relations smarm.  Often he was first to break stories involving legal settlements, guilty pleas, and miscellaneous misconduct, and in some cases was one of the few to document such stories. For example, when PharmaLot last disappeared, I noted that it provided one of the few accounts of a $21 million fine imposed on Merck by French antitrust regulators (here is the brief <a href="http://www.reuters.com/article/2013/12/19/us-france-fine-idUSBRE9BI0Q420131219">Reuters version</a>.)  PharmaLot reported on a judgement against Actelion for anti-competitive practices in support of its drug for pulmonary artery hypertension.  The only other media report on this was <a href="http://www.sfgate.com/business/article/Actelion-loses-appeal-in-lung-drug-case-5079481.php">in the San Francisco Chronicle</a>, and it was less detailed.  As we have noted endlessly, bad behavior by large health care organizations, including pharmaceutical and biotechnology companies and the various organizations with which they interact, like <a href="http://hcrenewal.blogspot.com/search/label/contract%20research%20organizations">contract research organizations</a>, <a href="http://hcrenewal.blogspot.com/search/label/medical%20education%20and%20communication%20companies">medical education and communication companies (MECCs)</a>, etc has often been <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>.  If one likes to get along by going along, it is not a good idea to make too much of a fuss about such issues and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of clinical research</a>, <a href="http://hcrenewal.blogspot.com/search/label/deception">deception</a> in  <a href="http://hcrenewal.blogspot.com/search/label/marketing">marketing</a>, and <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a> including the creation of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interests</a>, much less outright <a href="http://hcrenewal.blogspot.com/search/label/crime">crime </a>and <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">corruption</a>.  Ed Silverman was known to fuss about such issues. So the return of his fearless reporting, and willingness to post controversial interviews and editorials, is a rare ray of light in the gloom.  PharmaLot has just been added back to our blog roll.  Welcome back! PS - It may be too much to hope that the back archives of older versions of PharmaLot can be restored to public view.  We wait with baited breath.  Hat tips to <a href="http://1boringoldman.com/index.php/2014/06/04/oh-how-weve-missed-our-pharmalot/">1BoringOldMan</a>, <a href="http://loathingbioethics.blogspot.com/2014/06/pharmalot-is-back.html">Fear and Loathing in Bioethics</a>

The Return of PharmaLot

After an unfortunate hiatus (see this post ), PharmaLot is back. PharmaLot was one of the premier sources of incisive information on the ...

Đọc thêm »