healthy4u

WellCare "Did Not Contest" that its Political Contributions Violated State Law

From a <a href="http://blogs.tampabay.com/buzz/2009/08/huge-fine-levied-over-dubious-campaign-donations.html">report</a> in the St Petersburg (Florida) Times: <blockquote> WellCare Health Plans on Wednesday admitted to making 129 'questionable' contributions to Florida politicians over four years ending in 2007. In a consent order with the Florida Elections Commission, the Tampa-based managed-care company agreed to pay a $120,000 fine and did not contest the commission's finding of probable cause that the contributions violated state law. The Associated Press reported in February that WellCare, its subsidiaries and executives spent $2.4 million in political contributions in the 2004 and 2006 elections. More than 95 percent went to Republicans, who pushed a plan to send more state and federal Medicaid spending through private companies like WellCare. </blockquote> In May, 2009 we <a href="http://hcrenewal.blogspot.com/2009/05/wellcare-settles-accepts-deferred.html">posted</a> about WellCare's submission to a deferred prosecution agreemeent based on charges that it defrauded state programs by inflating its expenses. In 2007, we <a href="http://hcrenewal.blogspot.com/2007/11/health-plans-programs-cancelled-for.html">posted</a> about how the state of Connecticut stopped WellCare from running a plan for poor children after the company refused to reveal what it was paying physicians, and why it was failing to pay for particular services. So WellCare has paid three penalties for three different kinds of unethical behavior in the last two years. WellCare is one of numerous health care organizations which seem to be serial violators of reasonable ethical norms. Usually, however, the penalties paid for these behaviors are trivial, given the financial capacities of the offending organizations. Furthermore, rarely are the individuals who made the decisions that caused the behaviors identified, much less subjected to negative consequences. Given our continued permissiveness towards all sorts of deception, dishonesty, cheating, and even outright fraud, bribery, and corruption, is it any wonder that the unethical behavior continues? Such behavior doubtless directly drives up costs. Furthermore, leaders focused on their personal power and enrichment may not lead well, and demoralize employees and professionals who want to do the right thing, leading to further cost increases, access decrements, and threats to health care quality. I submit that to truly reform health care, and have a chance at improving cost, quality, and access, we cannot continue to shrug off these sorts of ethical violations. A postscript - as we have noted before, one member of the <a href="http://ir.wellcare.com/phoenix.zhtml?c=176521&p=irol-govboard">WellCare board of directors </a>is Regina Herzlinger, a well known and prolific health policy expert, and holds the <a href="http://drfd.hbs.edu/fit/public/facultyInfo.do?facInfo=bio&facEmId=rherzlinger">Nancy R. McPherson Professor of Business Administration Chair of the Harvard Business School</a>. As far as I know, Prof Herzlinger is one of the many health policy experts who avoids discussing the sorts of problems with the accountability, integrity, and transparency of health care leadership which is grist for the mill here at Health Care Renewal. Perhaps, Prof Herzlinger, like many other main stream health policy experts, should learn to acknowledge that health care leadership may be unaccountable, opaque, dishonest, and sometimes flagrantly corrupt. Furthermore, Prof Herzlinger, like many other well-paid board members of health care organization, should pay a bit more attention to the mischief being committed by those who answer to her.

WellCare "Did Not Contest" that its Political Contributions Violated State Law

From a report in the St Petersburg (Florida) Times: WellCare Health Plans on Wednesday admitted to making 129 'questionable' contri...

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Another Haunting Tale

Halloween is more than two months away, but the ghost stories just keep on coming. The latest version was <a href="http://www.google.com/hostednews/ap/article/ALeqM5iUKEK0btRTAsKW5IDK5GtDQz_DWQD9A669802">reported</a> by the Associated Press (with a hat tip to Prof Margaret Soltan <a href="http://www.margaretsoltan.com/?p=16497">on the University Diaries blog</a>). To quickly summarize, <blockquote> Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press. An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug. Known as the CASPPER program, the paper explains how the company can help physicians with everything from 'developing a topic,' to 'submitting the manuscript for publication.' </blockquote> The actual document is now available from the PharmaGossip blog <a href="http://pharmagossip.blogspot.com/2009/08/gsk-paxil-caspper-read-file-for.html">here</a>. Reviewing that document suggests that the CASPPER program was a bit different from other ghost-writing schemes (for example, see previous posts <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">here</a>.) A typical ghost-writing scheme would entail ghost-writers employed by a medical education and communications company (MECC) drafting manuscripts of a scholarly-appearing review articles. The articles would be written to support the marketing of a product made by the (usually pharmaceutical) company which hired the MECC. Then, the MECC would recruit well-known medical academics as (guest) authors for the articles. The guest authors might make some minor revisions in the draft manuscripts, which would then be submitted to scholarly journals. The MECCs would handle the submission process, while maintaining the pretense that the articles were the work of the guest academic authors. The ultimate purpose of such schemes apparently would be to market the product in the guise of scholarly publication. CASSPER, on the other hand, was meant to produce more modest articles, ostensibly written by practicing, rather than purely academic physicians. Review of the CASSPER document leads to some interesting conclusions about the project - The project was purely a marketing project. "The objectives of CASSPER, from a publication standpoint, are to strengthen the product positioning and overcome competitive issues." The document clearly was written by marketers, and directed to pharmaceutical representatives ("drug reps.") It did not mention any involvement by GSK scientific or medical personnel. The closest it came to making a pretense about any scientific or clinical usefulness of the project was, "publication of such articles will benefit the sales force by expanding the database of published data to support PAXIL." - It was as much about promoting closer relationships among pharmaceutical representatives ("drug reps") and doctors as about publishing articles. The project was to be implemented by drug reps, and "your participation will establish and/or strengthen your relationships with key physicians and thought leaders in the psychiatric field." The drug reps would handle, and presumably shape all communications between their physicians and the MECC. - Articles were to arise from instigation by the drug reps, rather than from physicians' initiatives. For example, a scenario for recruiting authors began, "a physician tells you that he or she has had treatment success with PAXIL in certain indications or difficult-to-treat patient populations." Then, "ask the physician if any consideration has been given to publishing a case study based on this clinical experience." - Although the document is somewhat ambiguous about the role of the putative author in the process, an extensive list of services available from the MECC (Complete Healthcare Communications [CHC] ) would have left little for the author to do. "The full range of editorial assistance that CASSPER can offer contributing physicians includes: developing a topic, coordinating the editorial review process, submitting to the target journal." The company's role would include "coordinating" manuscript preparation, which was defined as "development of an outline and first draft, editorial reviews, and revisions." The company would make available "published literature, available internal support, literature search results, and a database of journal submission criteria." Also, "the numerous details that CHC is prepared to coordinate ... [include] copy editing and proofreading, production of tables and graphics, preparation of the submission package, and follow-up." So CASSPER seems to be a not really so friendly example of a newly recognized species of ghost-writing, targeted more at promoting relationships among drug reps and physicians than at producing ostensibly scholarly articles. Nonetheless, this example of the haunting of medicine is as fundamentally deceptive as previously described ghost-writing schemes. In the CASSPER project, physicians would be reduced to little more than ectoplasm, goaded by drug reps into token involvement in a writing process exclusively handled by the MECC, and mediated by the friendly appearing drug reps. I wonder whether physicians who participated escaped with any psychological independence from the drug reps who magically turned them into acclaimed "published authors?" In any case, the disclosure of CASSPER, a ghost who was friendly only in appearance, adds more evidence about how deception and dishonesty now haunts our health care system. To achieve real health care reform, we will have to find a new group of ghost-busters. Who you gonnna call? ADDENDUM (25 August, 2009) - See also<a href="http://brodyhooked.blogspot.com/2009/08/friendly-ghosts-why-should-academic.html"> comments </a>by Dr Howard Brody in the Hooked: Ethics, Medicine and Pharma Blog.

Another Haunting Tale

Halloween is more than two months away, but the ghost stories just keep on coming. The latest version was reported by the Associated Press ...

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Why Siemens Healthcare Fails

I have written <a href="http://hcrenewal.blogspot.com/search?q=don%27t+need+informatics">numerous times on this blog</a> about the blind-man ignorance displayed by many healthcare IT and biomedical companies regarding Medical Informatics expertise. As a graduate and postdoctoral-level <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases">Medical Informatics educator</a> with considerable applied expertise, as well as talent management experience, I teach students of a variety of healthcare backgrounds that the only way to overcome the sociotechnical complexities (i.e., issues at the intersection of people and their interaction with technology) of HIT is via education and considerable experience. Once students become aware of the nuances and complexities of HIT in real-world clinical settings (if not already enmeshed in such environments), they find the lessons learned from substantial and rigorous immersion into a wide corpus of literature, overseen by someone with expertise, profoundly important towards advising their own organizations in avoiding pitfalls and achieving success. I note that I used to admire German engineering rigor, but after seeing ill conceived, misguided position ads like the following from Siemens Healthcare, I am having sincere doubts about that country's current prowess in that domain. I refer to a recent ad (<a href="https://careers.peopleclick.com/careerscp/client_siemens/external/jobDetails.do?functionName=getJobDetail&jobPostId=288315&localeCode=en-us&source=Indeed&sourceType=PREMIUM_POST_SITE">here</a> at the moment) for a Physician Consultant: <blockquote>Job Description Siemens Medical Solutions is the industry leader in Healthcare IT technology and Clinical workflow solutions. We are seeking to hire an experienced Physician for our Professional Consulting Services Organization. In this highly visibly position, you will support the implementation of Siemens products (such as Soarian ) in hospitals nationwide. To be considered for this position, qualified candidates must have the following credentials and experience: • U.S. based Medical degree with at least five years of post-residency experience in large multi-specialty practice or hospital-based facility in the United States. • Currently practicing medicine, or must have practiced at least 1 week per month within the last 3 years • Leadership experience with at least one CPOE implementation in a large, multi-facility health system, Integrated Delivery Network (IDN) setting • Extensive public-speaking and executive presentation experience • Medical informatics credentials or advanced degree preferred, but not required [Medical Informatics not required? - ed.] • Prefer some experience in public-health related projects</blockquote> Here are the obvious major problems: One CPOE implementation or even several does not by any means qualify a person to counsel other medical organizations and clinicians as a representative of a company citing itself as "the industry leader in Healthcare IT technology." Further, the criteria "Medical informatics credentials or advanced degree preferred, but not required" suggests the crafters knows little about Medical Informatics, or hold it at a low level of esteem, considering it an optional "gift" that might add slight extra value to the incumbent's ability to travel the country and give good advice and support in clinical IT implementation. What might substitute for such knowledge and expertise? This J.D. might better be described as "glorified salesperson." It might be a good exit route for a "techie doc" (usually, someone who knows just enough about HIT to be destructive) who hates the current practice environment. It might also be good for managers who don't want knowledgeable experts pointing out their bad decisions and mismanagement, but I think a global company like Siemens should be setting its sights higher in such a crucial area as electronic medical records and clinical IT consultants. I would not want such a physician advising or supporting complex HIT projects at my organization. I spent time at Siemens Healthcare headquarters in Erlangen in 2000, and was offered gracious hospitality and a position overseeing the Soarian cardiology suite. The people I met in Erlangen then seemed extremely competent and informatics-savvy, but I turned the offer down through no fault of Siemens. I'd received a near-simultaneous offer (FAXed to my hotel in Erlangen, in fact) from pharma that involved a much stronger management role. I understand through conversations over the past few years with current and ex-Siemens personnel that most of the Siemens personnel I'd met in Germany in 2000 are no longer with the company. I was told they'd performed suboptimally after the acquisition/merger with Shared Medical Systems (SMS) in Malvern, PA. (I do not find that credible, and would find it far easier to accept that the problems were on the American side, but that is a personal opinion.) Questions raised by these observations: <ul><li>What manner of ideology about education and expertise does this job description represent?</li></ul><ul><li>Is there nobody left in Germany with a realistic sense of the education and expertise required to advise on and support HIT implementations in a competent manner, I ask? </li></ul> Allow me to answer question #1. It represents the IT designer-centric, data processing and <a href="http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html">tabulator punch card culture-based</a> (and antithetical to medicine and science) view that with enough generalists and sufficient "process", any problem can be solved. By this logic, Bach and Beethoven would have had symphonies written for them by low level musicians in the name of "efficiency" and cost savings. <div style="TEXT-ALIGN: center"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEix2PJZV6Lvz941B1K1MCZDOWpErm3UXImudOHfJVWl5yuX37hFPCy8cN8OlzhDqFnkSyN-g1ERPUCryj_HrM6HT1IB7bHzS5IowuLcYMSWtcAJMDZ-Loyp9s2R8SDwrUijd9Yq2ZqICcv1/s1600-h/Beethoven.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5373145108395395298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEix2PJZV6Lvz941B1K1MCZDOWpErm3UXImudOHfJVWl5yuX37hFPCy8cN8OlzhDqFnkSyN-g1ERPUCryj_HrM6HT1IB7bHzS5IowuLcYMSWtcAJMDZ-Loyp9s2R8SDwrUijd9Yq2ZqICcv1/s320/Beethoven.jpg" style="DISPLAY: block; MARGIN: 0px auto 10px; WIDTH: 129px; CURSOR: pointer; HEIGHT: 156px; TEXT-ALIGN: center" /></a> Wanted: consultants to write my Ninth Symphony, according to the Acme Symphony-Writing Process Manual. Musical experience not essential. Must be team players. </div> Shareholders, take note. I emailed this post to the Siemens Healthcare CEO Hermann Requardt, who I note (almost predictably) <a href="http://w1.siemens.com/about/en/management-structure.htm">lacks a biomedical background</a> other than having been a research assistant for aviation medicine once, and having worked on MRI: <div class="p clearfix"></div><blockquote><div class="p clearfix">Education </div><div class="list"><ul class="bullet-list-orange"><li>Secondary school (baccalaureate)</li><li>Studied physics at the Technical University of Darmstadt and University of Frankfurt (Dr. phil. nat., Dipl.-Phys.)</li></ul></div></blockquote><div class="list"> A lack of response is therefore not surprising. </div>-- SS

Why Siemens Healthcare Fails

I have written numerous times on this blog about the blind-man ignorance displayed by many healthcare IT and biomedical companies regarding...

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A new website for the rapid sharing of influenza research

[From time to time we invite guests to blog about initiatives of interest, and we are very pleased to have Harold Varmus join us here. Harold is the Chairman and Co-Founder of the <a href="http://www.plos.org/">Public Library of Science</a>, a non-profit publisher of <a href="http://www.openaccessweek.org/about-the-oa-movement/">open access</a> journals committed to making scientific and medical research literature a freely accessible public resource. <a href="http://www.plos.org/cms/node/480">This announcement</a> is also posted on the Public Library of Science <a href="http://www.plos.org/">website</a>. – Ed.] The successful development of <a href="http://www.plos.org/oa/index.html">open access publishing</a> by organizations including the <a href="http://www.plos.org/">Public Library of Science</a> (PLoS) in recent years is a dramatic illustration of how the Internet is revolutionizing scientific communication. Today, after several months of work, I’m delighted to announce that PLoS is launching PLoS Currents (Beta) — a new and experimental website for the rapid communication of research results and ideas. In response to the recent worldwide H1N1 influenza outbreak, the first PLoS Currents research theme is influenza. <a href="http://knol.google.com/k/plos/plos-currents-influenza/28qm4w0q65e4w/1">PLoS Currents: Influenza</a>, which we are launching today, is built on three key components: a small expert research community that PLoS is working with to run the website; <a href="http://knol.google.com/k/">Google Knol</a> with new features that allow content to be gathered together in collections after being vetted by expert moderators; and a new, independent database at the National Center for Biotechnology Information (NCBI) called <a href="http://www.ncbi.nlm.nih.gov/rrn">Rapid Research Notes</a>, where research targeted for rapid communication, such as the content in PLoS Currents: Influenza will be freely and permanently accessible. To ensure that researchers are properly credited for their work, PLoS Currents content will also be given a unique identifier by the NCBI so that it is citable. PLoS Currents: Influenza welcomes contributions covering any and all aspects of research into influenza: influenza virology, genetics, immunity, structural biology, genomics, epidemiology, modeling, evolution, policy and control. Contributions might take the form of new datasets, preliminary analyses or entire manuscripts. The launch site already features new findings from some outstanding influenza researchers. To enable contributions to PLoS Currents: Influenza to be shared as rapidly as possible, they will not be subject to in-depth peer review; however, unsuitable submissions will be screened out by a board of expert moderators led by <a href="http://www.cidd.psu.edu/people/ech15">Eddie Holmes</a> (Center for Infectious Disease Dynamics, Pennsylvania State University) and <a href="http://www.mountsinai.org/Research/Centers%20Laboratories%20and%20Programs/Palese%20Laboratory?citype=Physician&ciid=Palese%20Peter%200606446">Peter Palese</a> (Department of Microbiology, Mount Sinai School of Medicine). The key goal of PLoS Currents is to accelerate scientific discovery by allowing researchers to share their latest findings and ideas immediately with the world’s scientific and medical communities. Google Knol’s features for community interaction, comment and discussion will enable commentary and conversations to develop around these findings. Given that the contributions to PLoS Currents are not peer-reviewed in detail, however, the results and conclusions must be regarded as preliminary. In time, it is therefore likely that PLoS Currents contributors will submit their work for publication in a formal journal, and the <a href="http://www.plos.org/journals/index.php">PLoS Journals</a> will welcome these submissions. PLoS Currents: Influenza is an experiment and a prototype for further PLoS Currents sites. It reflects our commitment to using online tools to the fullest extent possible for the open sharing of research results. As with any new project, we will be listening carefully to the reactions within and beyond the scientific and medical communities and welcoming suggestions for improvements. Posted by Harold Varmus, Chairman and Co-Founder, Public Library of Science

A new website for the rapid sharing of influenza research

[From time to time we invite guests to blog about initiatives of interest, and we are very pleased to have Harold Varmus join us here. Harol...

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On HIT Vendor Nondisclosure of Nondisclosure Agreements

Seen at the HIStalk blog in <a href="http://histalk2.com/2009/08/18/news-81909/">News of 8/19/09</a>: <blockquote> A couple of readers wisely suggested that I not consider running nondisclosure language from vendor contracts. Reasons: (a) it might identify the client since terms are often customized; (b) it might violate vendor privacy requirements and get a client or me in trouble; (c) clients might not want to share anyway since they may like the idea of being prohibited from sharing patient safety information. A couple of vendors e-mailed to say they don’t include such terms. I’d be very surprised if Cerner and Epic don’t based on my limited history with them. </blockquote>My response to the HISTalk blog owner, Tim, and other interested parties: <blockquote> <table class="w100" cellpadding="0" cellspacing="0"><tbody><tr><td><table class="msgHd" cellpadding="0" cellspacing="0"><tbody><tr><td class="hdtxt">Sent: </td> <td class="hdtxnr"> Thursday, August 20, 2009 7:32 AM </td> </tr> <tr> <td class="hdtxt"> To: </td> <td class="hdtxnr"> <div id="divTo" class="rwWRO"><a href="https://exchangeweb.drexel.edu/owa/?ae=Item&t=IPM.Note&a=New&to=mr_histalk%40yahoo.com&nm=mr_histalk%40yahoo.com" class="emadr">mr_histalk@yahoo.com</a></div> </td> </tr> <tr> <td class="hdtxt"> Cc: </td> <td class="hdtxnr"> <div id="divCc" class="rwWRO"><a href="https://exchangeweb.drexel.edu/owa/?ae=Item&t=IPM.Note&a=New&to=david.kreda%40gmail.com&nm=david.kreda%40gmail.com" class="emadr">david.kreda@gmail.com</a>; <a href="https://exchangeweb.drexel.edu/owa/?ae=Item&t=IPM.Note&a=New&to=rkoppel%40sas.upenn.edu&nm=rkoppel%40sas.upenn.edu" class="emadr">rkoppel@sas.upenn.edu</a>; <a href="https://exchangeweb.drexel.edu/owa/?ae=Item&t=IPM.Note&a=New&to=Emilia_DiSanto%40finance-rep.senate.gov&nm=Emilia_DiSanto%40finance-rep.senate.gov" class="emadr">Emilia_DiSanto@finance-rep.senate.gov</a>; <a href="https://exchangeweb.drexel.edu/owa/?ae=Item&t=IPM.Note&a=New&to=MChassin%40jointcommission.org&nm=MChassin%40jointcommission.org" class="emadr">MChassin@jointcommission.org</a>; <a href="https://exchangeweb.drexel.edu/owa/?ae=Item&t=IPM.Note&a=New&to=pschyve%40jointcommission.org&nm=pschyve%40jointcommission.org" class="emadr">pschyve@jointcommission.org</a></div> </td> </tr> <tr style="display: none;" id="trAtt"> <td class="hdtxt"> Attachments: </td> <td id="tdAtt" style="display: none;" class="hdtxnr"></td> </tr> </tbody></table> </td> </tr> <tr> <td class="clp"><table class="w100" cellpadding="0" cellspacing="0"><tbody><tr><td colspan="2"> </td></tr></tbody></table></td> </tr> <tr> <td class="bdy"> <div class="bdy"> <div class="BodyFragment"> <div class="PlainText">To: HISTalk blog Re: nondisclosure of nondisclosure agreements by HIT vendors Tim, Those who've written advising you *not* to post the language of HIT nondisclosure agreements are in fact correct: As per Koppel and Kreda's March 2009 <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">"Hold Harmless" article</a> in JAMA and my <a href="http://hcrenewal.blogspot.com/2009/07/health-care-information-technology.html">July 21 JAMA letter</a> to the editor commenting on it, nondisclosure and hold harmless agreements stifle HIT innovation, put patients at risk, and cause healthcare executives to violate their Joint Commission and fiduciary responsibilities to protect patients and workers from undue physical or legal jeopardy. You and other bloggers should *not* be the ones to clandestinely obtain and post such language. The HIT vendors themselves, in an atmosphere of transparency and in deference to patients safety and to hospital governance, should gladly and transparently do so if such language exists in their contracts. This assumes, of course, that HIT vendors hold patient safety and practitioners' rights as a high priority. S.S. </div></div></div></td></tr></tbody></table></blockquote><table class="w100" cellpadding="0" cellspacing="0"><tbody><tr><td class="bdy"><div class="bdy"><div class="BodyFragment"><div class="PlainText"></div></div></div> </td></tr></tbody></table>I think that says what needs to be said. -- SS

On HIT Vendor Nondisclosure of Nondisclosure Agreements

Seen at the HIStalk blog in News of 8/19/09 : A couple of readers wisely suggested that I not consider running nondisclosure language from v...

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High Costs and Poor Outcomes - A Lesson About the Suppression of Research

Last week, blogger Alison Bass was one of the few to<a href="http://alison-bass.blogspot.com/2009/08/study-confirms-that-antidepressants.html"> comment </a>on a new article on the risks of antidepressant medications published electronically last week by the British Medical Journal.[1] The article adds to the clinical evidence about these specific drugs. However, it also should remind us about why our health care costs seem to continue to inflate disproportionate to any improvements in health care outcomes. Background - Why Don't Doctors Diagnose and Treat Depression According to the Evidence? Here is the background. Since the early 1990s, based on numerous published clinical trials that showed that the newer (mainly SSRI, that is, selective serotonin reuptake inhibitor) antidepressants seemed to be quite safe and effective, authoritative guidelines have urged physicians to screen patients for depression, and have a low threshold for beginning treatment, particularly with these then new drugs. (For example, see the 1993 AHCPR guidelines,[2] and the Ambulatory Care Quality Alliance Recommended Starter Set[3].) Such guidelines targeted primary care physicians as well as psychiatrists. As a primary care physician, I often felt guilty that I didn't screen all patients, including those who did not outwardly appear depressed, for depression, and was reluctant to be the primary prescriber of antidepressants for depressed patients. I was not alone. There was evidence that many primary care physicians failed to follow these apparently evidence-based guidelines. Suspicions that SSRIs Were Not as Effective or Safe as Thought However, in 2004, internal documents from one drug company (Glaxo Smith Kline), published by the Canadian Medical Association Journal, suggested that the company had suppressed a study which failed to show its SSRI was effective for adolescent patients.[4] Also, then New York state attorney general Elliot Spitzer sued the company alleging it had suppressed such data.[5] Considerable anecdotal information thereafter came to light suggesting that drug companies may have suppressed data from clinical research (that is, studies done on patients, not in the laboratory) which tended to show the drugs were less effective, or more dangerous than previously thought. Many began to suspect that the drugs increased the risk of suicidal thoughts or behavior, even though one would think that if they were effective in treating depression, they should decrease such risks. How Does Uncovering Suppressed Trials Change the Evidence About the Benefits and Harms of SSRIs? Then, an analysis of trials of SSRIs given to adolescent patients, which included unpublished as well as published trials, did show they increased the risk of suicide.[6] But what about adult patients? In 2008, Erick Turner and colleagues published a meta-analysis that included numerous trials of SSRIs and other antidepressants given to adult patients that had never been published, but whose results had been submitted to the US Food and Drug Administration (FDA).[7] When those trials were included in the analysis, the drugs seemed less effective than was previously believed. The new meta-analyis by Stone et al[1] suggested how adding evidence from the suppressed trials improves our knowledge about the possible harms of these drugs. Stone et al specifically addressed whether the drugs increased the risk of suicidal thoughts or actions for adult patients. It was based on data from 372 trials that included 99,231 patients. "Most of the studies were unpublished; those that had been published in some form seldom contained information concerning suicidality in the publication." Its main result was that SSRI drugs approximately doubled the risk of suicidal behavior for patients less than 25 years old, but decreased the risk for older patients. Suppressing Trials Distorted the Evidence-Base Thus, the combined results of several meta-analyses suggests that SSRIs are neither as safe nor as effective for adult patients as they were previously touted to be. The drugs used to appear to be more safe and effective because the drug companies that sponsored (paid for) clinical trials of their own products suppressed the publication of studies whose results did not show their products in a favorable light. The guidelines once thought to be so authoritative are probably much to enthusiastic about the use of drugs to treat depression. It may be that those physicians who resisted pressure from these guidelines and other efforts by would-be quality improvers to diagnose more depressed patients and treat them with SSRIs weren't so dumb. Health Policy Implications The recently published meta-analysis of the risk of suicidal ideation or behavior due to SSRIs for adult patients[1] adds not just to the clinical evidence about the treatment of depression, but to the evidence that suppression of research by those with vested interests in its results may not be rare. There is no reason to think that suppression of research about other medical interventions used for other clinical problems does not occur just as often. This underscores why we as a society should not have handed over control of how new drugs and devices are evaluated to the companies that stand to profit by selling them. The apparent benefits and safety of most drugs and devices brought to the market in recent years may have been exaggerated by the ability of the corporations who sponsored the research to suppress those studies that were least favorable to their products. Thus, it is very likely that doctors have over prescribed newer (and more expensive) drugs and devices based on erroneous beliefs about their safety and effectiveness, beliefs supported by an evidence base which was distorted by suppression of studies whose results did not show the results their commercial sponsors wanted to see. Furthermore, we have likely collectively paid too much for these drugs and devices based on these same erroneous beliefs. Thus, the distortion of the clinical evidence base caused by putting the makers of medical products in charge of their evaluation has likely led to increased costs and worse outcomes for patients. Health care reformers serious about wanting to improve patient outcomes and reduce costs ought to be at the forefront of a movement to make clinical research more honest. All clinical trials completed and submitted to government regulators ought to be published in some form, so that the data they contain is available to guide clinical decisions. Going forward, all studies should be published in some form in a timely manner to prevent future research suppression. There ought to be better regulation of research sponsored, and de facto run by companies who have vested interests in the results being favorable to their products. It would not be unreasonable to prevent companies with such vested interests from running or otherwise directly influencing clinical research meant to evaluate their own products. But here in the States, we are probably too diverted by yelling at each other about whether a "public option" is vital or nefarious to worry about such issues.. Meanwhile, expect our health care to continue to get more expensive, less accessible, and less good for patients. ADDENDUM (25 August, 2009) - Also, see the <a href="http://brodyhooked.blogspot.com/2009/08/sifting-through-garbage-to-find-science.html">comments</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma Blog References 1. Stone M, Laughren T, Jones ML et al. Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration. Brit Med J 2009; 339: b2880. Link <a href="http://www.bmj.com/cgi/content/full/339/aug11_2/b2880">here</a>. 2. Depression Guideline Panel. Depression in Primary Care: Volume 2 - Treatment of Major Depression. Rockville, MD: US Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research, 1993. Link <a href="http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat6.chapter.15593">here</a>. 3. Ambulatory Care Quality Alliance. Recommended Starter Set: Clinical Performance Measures for Ambulatory Care. <a href="http://www.ahrq.gov/qual/aqastart.htm">http://www.ahrq.gov/qual/aqastart.htm</a> 4. Kondro W. Drug company experts advised staff to withhold data about SSRI use in children. Can Med Assoc J 2004; 170: 783. Link <a href="http://www.cmaj.ca/cgi/content/full/170/5/783">here</a>. 5. Wadman M. Sptizer sues drug giant for deceiving doctors. Nature 2004; 429: 589. Link <a href="http://www.nature.com/nature/journal/v429/n6992/full/429589a.html">here</a>. 6. Hammad T, Laughren T, Racoosin JA. Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry 2006;63:332-9. Link <a href="http://archpsyc.ama-assn.org/cgi/content/full/63/3/332">here</a>. 7. Turner EH, Matthews AM, Linardatos E et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008; 358: 252-260. Link <a href="http://content.nejm.org/cgi/content/full/358/3/252">here</a>.

High Costs and Poor Outcomes - A Lesson About the Suppression of Research

Last week, blogger Alison Bass was one of the few to comment on a new article on the risks of antidepressant medications published electron...

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Getting connected Side-by-Side with enterprise search

People use search to find what they need, and the same holds true in the business world. We want searching your company intranet to be comparable to searching on Google.com, and the <a href="http://google.com/gsa">Google Search Appliance (GSA)</a> to have the most relevant, high quality results possible. That's why today we're announcing two new tools for Google Enterprise Search: Side-by-Side search comparison and new connectors for the GSA, both in <a href="http://google.com/enterprise/labs">Enterprise Labs</a>. Enterprise Labs is where you can find the latest-and-greatest tips and tools for better enterprise searching — tools like Side-by-Side. Side-by-Side lets employees test and rate results from two different search queries on the same body of data, to see which gives better results. In the example below, the admin has set up two different GSA configurations to search [google]. <a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjTqyKe9AOXxpsKvQP4uye13r_7_Iw97k8nFlS-LO5AvkkNhE8cf9BPg1XKYXfGmJYq27ABpgy70-0OJfPgWAQiPWpCY0VwXFFQbbtmuB7g3j66_ZCv6O-J6t2ch6OcKUmkgbcY6WmeOjKT/s1600-h/side_by_side.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5371454967711952418" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjTqyKe9AOXxpsKvQP4uye13r_7_Iw97k8nFlS-LO5AvkkNhE8cf9BPg1XKYXfGmJYq27ABpgy70-0OJfPgWAQiPWpCY0VwXFFQbbtmuB7g3j66_ZCv6O-J6t2ch6OcKUmkgbcY6WmeOjKT/s400/side_by_side.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 305px; height: 400px;" /></a> Employees can then vote on their preferred results, by choosing the Policy A or B buttons, and the administrator can then use that information to choose and set up the right search solution for the business. Product manager (and Enterprise Labs guru) Cyrus Mistry explains more: <object height="340" width="560"><param name="movie" value="http://www.youtube.com/v/XeG3-n9u-3c&hl=en&fs=1&"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/XeG3-n9u-3c&hl=en&fs=1&" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" height="340" width="560"></embed></object> In the enterprise, search engines crawl more than just the Internet — they're also searching across all sorts of data stores and offline content. Today we're also announcing GSA connector updates to the major content management systems, as well as a cool new GSA connector for <a href="http://www.salesforce.com/">Salesforce</a> data, so the GSA can search and provide employees access to the internal Salesforce info they need in search results. Connectors integrate data from all different kinds of file and content systems (like SharePoint, FileNet, Documentum) so an employee searching their company intranet can see a single, unified search results page, even if the results are drawn from a wide variety of company data systems. Enterprise search is about the fundamentals: organizing information so that people can do their jobs more easily. You can read more about today's launches on the <a href="http://googleenterprise.blogspot.com/">Google Enterprise Blog</a>, and download Side-by-Side and other search tools in <a href="http://www.google.com/enterprise/labs/">Google Enterprise Labs</a>. Posted by Michael Parker and Salmaan Rashid, Engineering team

Getting connected Side-by-Side with enterprise search

People use search to find what they need, and the same holds true in the business world. We want searching your company intranet to be compa...

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