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...

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Know-Nothing, or Industry Shill? You Be The Judge.

I have not been writing much the past few weeks due to other concerns, and will probably not write much this summer.<br /><br />However, I have been commenting on various posts on other blogs.  One resultant thread stands out as yet another example of a likely industry shill or sockpuppet defending the state of health IT, oddly at a blog on pharma (same blog as was the topic of tmy post "<a href="http://hcrenewal.blogspot.com/2012/04/more-youre-too-negtive-and-you-dont.html" target="_blank">More 'You're Too Negative, And You Don't Provide The Solution To The Problems You Critique', This Time re: Pharma</a>").<br /><br />Industry-sponsored sockpuppetry is a form of stealth marketing or lobbying, through discreditation of detractors, although in a perverse form.<br /><br />The following exchanges meet the sockpuppetry criteria once pointed out by business professional and HC Renewal reader Steve Lucas in 2010 in a post about an industry sockpuppet caught red-handed through IP forensics <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html" target="_blank">here</a>:<br /><br /><blockquote class="tr_bq">... In reading this thread of comments I have to believe [anonymous commenter moniker] "IT Guy" is a salesperson. My only question is: <span style="font-weight: bold;">Were you assigned this blog or did you choose it? </span>We had this problem a number of years ago<span style="font-weight: bold;"> where a salesperson was assigned a number of blogs with the intent of using up valuable time in trying to discredit the postings.</span><br /><br />In my very first sales class we learned to focus on <span style="font-weight: bold;">irrelevant points, constantly shift the discussion, and generally try to distract criticism.</span> I would say that HCR is creating heat for IT Guy’s employer and the industry in general.<br /><br />I find it sad that a company would allow an employee to attack anyone in an open forum. IT Guy needs to check with his superiors to find out if they approve of this use of his time, and I hope he is not using a company computer, unless once again this attack is company sanctioned. </blockquote><br />In the hopes that continued exposure of this nonsense can educate and thus help immunize against its effects, I present this: <br /><br />At <b>"In the Pipeline"</b>, a blog on medicinal chemistry (the science of drug making) and other pharma topics, a rebuttal to a claim that over 500,000 people (not 50K) might have died due to VIOXX was posted entitled "<a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php" target="_blank">500,000 Excess Deaths From Vioxx? Where?</a>"<br /><br />That 500K possibility appeared on a UK site <b>'THE WEEK With the FirstPost'</b> at "<a href="http://www.theweek.co.uk/us/46535/when-half-million-americans-died-and-nobody-noticed" target="_blank">When half a million Americans died and nobody noticed</a>."  The author of the FirstPost piece started out by raising the point made by publisher Ron Unz that life in China might be more valued than that in the U.S., where major pharma problems and scandals generally meet what this blog calls "<a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect" target="_blank">the anechoic effect</a>."  (In China, Unz noted, perpetrators of scandalous drug practices actually get arrested and suffer career repercussions.)<br /><br />FirstPost notes: <br /><br /><blockquote class="tr_bq">ARE American lives cheaper than those of the Chinese? It's a question raised by Ron Unz, publisher of <a href="http://www.theamericanconservative.com/blog/chinese-melamine-and-american-vioxx-a-comparison/%20" target="_blank">The American Conservative</a>, who has produced a compelling comparison between the way the Chinese dealt with one of their drug scandals – melamine in baby formula - and how the US handled the Vioxx aspirin-substitute disaster ... (Unz) "The inescapable conclusion is that in today's world and in the opinion of our own media, American lives are quite cheap, unlike those in China."  </blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />Not to argue to merits of the order of magnitude-expanded VIOXX claim, which I disagree with, but having concern for the general state of ethics in biomedicine in the U.S., I posted the following comment at the comment thread of the rebuttal post at <i>"<b>In the Pipeline</b>"</i> <a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#973935" target="_blank">at this link</a>:<br /><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq"><div class="commentsbody"><span class="commentnumber"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#973935">6. </a></span><span style="color: #003366;">MIMD </span>on May 30, 2012 11:38 AM writes...</div><br />While I agree the VIOXX numbers here are likely erroneous, the point of the cheapening of the value of American life is depressingly accurate.<br /><br />For instance, look how readily companies lay people off, ruining them, and perhaps forcing them out of the workforce forever.<br /><br />Also, currently being pushed by HHS is a medical device for rapid national implementation known to cause injury and death. The government is partially financing it to the tune of tens of billions of dollars, probably with Chinese money no less.  <i style="color: red;"><b>[Either that, or with freshly-printed money adding to the trillions of $ in our deficit - ed.]</b></i><br /><br />There are financial penalties for medical refuseniks (non-adopters).<br /><br />However, FDA, the Institute of Medicine and others readily admit in publication thay have no idea of the magnitude of the harm because of lack of data collection, impediments to information diffusion and even legal censorship of the harms data. In effect, we don't even know if the benefits exceed the harms, and FDA and IOM admit it. FDA in fact refers to the known injuries and deaths from this device as "likely the tip of the iceberg."<br /><br />Perhaps to some it's no longer a big deal if people are injured and/or die in data gathering for this medical enterprise.<br /><br />E.g., see "<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">FDA Internal Memo on H-IT Risks</a>", and the Inst. of Medicine report in the same issues <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">here</a>. </blockquote><blockquote class="tr_bq">It's all for the greater social good, they might say.</blockquote>  </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">The following anonymous reply ensued:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq"><div class="commentsbody"><span class="commentnumber"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#974103">10. </a></span><span style="color: #003366;">Watson </span>on May 30, 2012 1:47 PM writes...</div><br />@6 You keep using that word - "device" - I do not think it means what you think it means</blockquote>  </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">I replied:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><blockquote class="tr_bq"><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><span class="commentnumber"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#974232">11. </a></span><span style="color: #003366;">MIMD </span> on May 30, 2012 3:48 PM writes...</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> #10<br /><br />'medical device' is the term chosen by FDA and SMPA (EU).<br />But that's a distraction from the points I raise in the linked post about the experiment.</div></blockquote><br />To which this confused misdirection came forth from the ether:<br /><br /><blockquote class="tr_bq"><div class="commentsbody"><span class="commentnumber"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#974290">12. </a></span><span style="color: #003366;">Watson </span>on May 30, 2012 4:46 PM writes...</div><div class="commentsbody"><br /></div>The linked article is discussing the poor state of "medical device records" because of a lack of uniform specifications with respect to Health Information Technology, i.e. how these technologies code data and the challenges of making the data obtained uniform across a wide variety of implementations and vendors. <i style="color: red;"><b>[Erroneous, incomplete misdirection - ed.]</b></i><br /><br />It seems that the concern, far from being that Health Information Technology is "killing" people, is that the <b>Medical Device Records may contain duplicate reports for adverse health events because of health care providers encoding the data more than once for each event.  <i style="color: red;">[What in the world? - ed.] </i></b>This problem with replication exists because there are different health record systems where this data needs to be input, and perhaps the same patient uses different physicians who have different systems, but all of which are required to report adverse events. <i style="color: red;"><b>[I have little idea what this even means - ed.] </b></i></blockquote><blockquote class="tr_bq">In other words, "Health Information Technology" is not some monolithic "device", and your conflation of "HIT" which is more properly an abstract term with the "devices" which are used to generate some forms of patient data is in my view <b>the real distraction</b>. <i style="color: red;"><b>[The "real" distraction from the ethical issues of the HIT experiment is terminology about medical devices?  Misdirection again from the ethical issue, and of a perverse nature - ed.]</b></i><br /><br />Yes, some of the "devices" (a blood pressure monitor for example) may have underlying issues, which the FDA regulations for "medical device records" are designed to identify. <b>The FDA, as a governmental entity has no constitutional power to mandate certain devices or implementations are to be used.  <i style="color: red;">[Now we're in la-la land of misinformation and distraction- ed.]</i></b> The power that the FDA does have is to inspect that the manufacturer of a device keeps appropriate medical device records (e.g. a lot of syringes, or a batch of formulated drug) and addresses any complaints about the device to the satisfaction of the FDA.</blockquote><br />My replies:<br /><br /><blockquote class="tr_bq"><span class="commentnumber"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#976431">17. </a></span><span style="color: #003366;">MIMD </span> on May 31, 2012 8:51 PM writes... <br /><br />#12<br /><br /><i>It seems that the concern, far from being that Health Information Technology is "killing" people, is that the Medical Device Records may contain duplicate reports for adverse health events because of health care providers encoding the data more than once for each event </i><br /><br />Yes, fix just that little problem and then the problems with clinical IT are solved! (Actually,I'm not even sure what you're referring to, but the evidence is that fixing it as you suggest is the cure.)  <i style="color: red;"><b>[Sarcasm - ed.]</b></i><br /><br /><i>The FDA, as a governmental entity has no constitutional power to mandate certain devices or implementations are to be used.</i><br /><br />You are also right about FDA. They were completely toothless even <a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html" rel="nofollow">in this situation</a>.  <i style="color: red;"><b>[Sarcasm again - ed.]</b></i><br /><br /><span class="commentnumber"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#976453">18. </a></span><span style="color: #003366;">MIMD </span> on May 31, 2012 9:10 PM writes... <br /><br />#12 <br /><br /><i>In other words, "Health Information Technology" is not some monolithic "device", and your conflation of "HIT" which is more properly an abstract term with the "devices" which are used to generate some forms of patient data is in my view the real distraction.</i><br /><br />Those who conducted the Tuskegee experiments probably felt the same way. <br /><br />It's all about definitions, not ethics, and not data - which FDA as well as IOM or the National Academies, our highest scientific body, among others, admits, as in the linked posts in #6, is quantitatively and structurally lacking on risks and harms. <br /><br />I don't really mean to laugh at you, not knowing how little you really know about the Medical Informatics domain, but you bring to mind this Scott Adams adage on logical fallacy:<br /><br />FAILURE TO RECOGNIZE WHAT’S IMPORTANT<br />Example: My house is on fire! Quick, call the post office and tell them to hold my mail!<br /><br />And with that, I move on, letting others enjoy the risible comments from surely to follow! :-)</blockquote><br /><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">I could not have been more correct.<br /><br />In typical industry shill/sockpuppet fashion comes this, with clear evidence of a not-so-clever liar which I've bolded:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><blockquote class="tr_bq"><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><span class="commentnumber"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#976731">19. </a></span><span style="color: #003366;">Watson </span> on June 1, 2012 12:35 AM writes... <br />@18<br /><br />I read the articles you originally linked to, and my comments were based upon trying to interpret your meaning from those selections. I worked in the industry and had to deal with GMP, and had to make sure to follow all of the guidelines with respect to medical device manufacturing and electronic records. I understand the terminology very well. Luckily, I never had to deal with "health IT", <b>but I did have to pore over enough pages of Federal Register legalese to know that what is sufficient is not necessarily what is best.  <i style="color: red;">[Right.  See below - ed.]</i></b><br /><br />Is that risible enough for you?<br /><br />The link that you provided in @17 was a much more concrete example, and if you had referenced it in your original post, would have cleared up much of the confusion that I (and I assume @9) faced in understanding what it was you were trying to convey. It would have been useful if you had explained which device or devices you were talking about. If you had more than conjecture to back up the Chinese money trail, and if you had provided an example of a company that has been damaged by being a refusenik, those would have supported your argument as well. <i style="color: red;"><b>[Continuing haphazardly with the irrelevant as a distraction in an attempt to shift the focus from the ethical issue of nationally implementing HIT in a relative risk-information vacuum, having weakly conceded the main argument's been lost - ed.]</b></i><br /><br />Straw man and ad hominem fallacies are pretty transparent around here, and I wish you the best with both. <i style="color: red;"><b>[Another attempt at diversion - ed.]</b></i><br /><br />I assure you that I recognize what's important, that I have ethics, and that I care about people having reliable healthcare.<i style="color: red;"> <b>[This seems a form of post-argument-lost attempt to seize the moral high ground - ed.]</b></i></div></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><table border="0" cellpadding="0" cellspacing="0" id="content"><tbody><tr><td valign="top" width="100%"><br />I then point out the nature of what is likely a bold-faced lie.  Someone who's read the Federal Register in depth would likely know FDA's authority is not a "Constitutional power", as bolded below:<br /><br /><blockquote class="tr_bq"><span class="commentnumber"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#977304">20. </a></span><span style="color: #003366;">MIMD </span> on June 1, 2012 6:44 AM writes... <br /><br />@19<br /><br />The FDA taxonomy of HIT safety issues in the leaked Feb. 2010 "for internal use only" document "H-IT Safety Issues" available at the link in my post #6 is quite clear:<br />- errors of commission<br />- errors of omission or transmission<br />- errors in data analysis<br />- incompatibility between multi-vendor software applications or systems<br /><br />This is further broken down in Appendices B and C, with actual examples. <br /><br />Both this FDA internal report and the public IOM report of 2011 (as well as Joint Commission Sentinel Events Alert on health IT of a few years ago, and others) make it abundantly clear there is a dearth of data on the harms, due to multiple cultural, structural and legal impediments to information diffusion. <br /><br />Yes, it's in the linked IOM report at #6 entitled "Health IT and Patient Safety: Building Safer Systems for Better Care". See for instance the summary pg. S-2 where IOM states about limited[ed] transparency on H-IT risk that "these barriers to generating evidence pose unacceptable risks to safety."<br /><br />Argue with them, not me.<br /><br />Back to my original point: national rollout of this medical device (whatever you call it is irrelevant to my point, but see Jeff Shuren's statement to that effect <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" rel="nofollow">here</a>) under admitted conditions of informational scarcity regarding risks and harms represents a cheapening of the value of patient's lives. Cybernetics Over All.<br /><br /><b>As to your other misdirection, spare me the lecture. It's not ad hominem to call statements like "The FDA, as a governmental entity has no constitutional power to mandate certain devices or implementations are to be used" for what they are - laughable (and I am being generous). </b><br /><br /><b>FDA's authority is statutory, not written in the Constitution. Same with their parent, HHS. To get quite specific, on human subjects experimentation, which the H-IT national experiment is, the statutory authority for HHS research subject protections regulations derives from 5 U.S.C. 301; 42 U.S.C. 300v-1(b); and 42 U.S.C. 28. </b><b><i style="color: red;">[</i><i style="color: red;">The USC or United States Code is the codification by subject matter of the general and permanent laws of the United States.  </i></b><b><i style="color: red;">HHS revised and expanded its regulations for the protection of human subjects in the late 1970s and early 1980s. The HHS regulations on human research subjects protections themselves are codified at 45 CFR (Code of Federal Regulations, aka Federal Register) part 46, subparts A through D. </i></b><b><i style="color: red;">See </i><i><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/">http://www.hhs.gov/ohrp/humansubjects/guidance/</a></i></b><b><i>. <span style="color: red;">- ed.]</span></i></b><br /><br />A real scientist would have known things like this before posting, or have made it their business to know. </blockquote><blockquote class="tr_bq">Tell me: are you in sales? Not to point fingers, but with your dubious evasion of the ethical issue that was the sole purpose of my post, and your other postings using misdirection and logical fallacy to distract, you fit that mindset.<br /><br />You certainly don't sound like a scientist. Any med chemist worth their salt (pun intendend) would have absorbed the linked reports and ethical issues accurately, the first time.</blockquote><br />I then pointed out I've moved this 'discussion' to the HC Renewal Blog, as it is not relevant per se to pharma, the major concern of <i>In the Pipeline</i>.<br /><br />Industry shill/sockpuppet (as in the perverse example at <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html" target="_blank">this link</a>) or just a dull, ill-informed but opinionated person who happens to read blogs for medicinal chemists, where layoffs have been rampant in recent years, takes issue with my attacks on those practices, and defends health IT like a shill?<br /><br />You be the judge.<br /><br />Whether a shill or know-nothing contributed the cited comments, it is my hope this post contributes to an understanding of pro-industry sockpuppetry.<br /><br />-- SS<br /><br /></td><td valign="top" width="100%"><br /></td><td valign="top" width="100%"><br /></td><td valign="top" width="100%"><br /></td><td valign="top" width="100%"><br /></td><td valign="top" width="100%"><br /></td><td valign="top" width="100%"><br /></td><td valign="top" width="100%"><br /></td><td valign="top" width="100%"><br /></td><td valign="top" width="100%"><br /></td><td valign="top" width="100%"><br /></td></tr></tbody></table></div><span class="printemail"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#zemail"></a></span>

Know-Nothing, or Industry Shill? You Be The Judge.

I have not been writing much the past few weeks due to other concerns, and will probably not write much this summer. However, I have been co...

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Merck Admits Little While Settling the Vioxx Case

A week ago, another legal settlement with some noteworthy aspects came marching along.  As <a href="http://online.wsj.com/article/SB10001424052970204531404577054472253737682.html">reported</a> by the Wall Street Journal, here are the details.<br /><br /><strong>A Guilty Plea to "Misbranding"</strong><br /><br />First, there was a guilty plea (to a misdemeanor):<br /><blockquote>Merck & Co. <em>agreed to pay $950 million and plead guilty to a criminal misdemeanor charge to resolve government allegations that the company illegally promoted its former painkiller Vioxx and deceived the government about the drug's safety</em>.</blockquote><br />In particular,<br /><blockquote>The Justice Department said Merck illegally promoted Vioxx for rheumatoid arthritis before that use was approved by the Food and Drug Administration in 2002. The drug was initially approved in 1999 to treat certain types of pain. Drug companies are barred from promoting drugs for unauthorized, or 'off label,' uses, though doctors may prescribe off-label uses.<br /><br /><em>Merck agreed to plead guilty to introducing a 'misbranded' Vioxx into interstate commerce, which is a misdemeanor violation of the Food, Drug and Cosmetic Act, and to pay a $321.6 million criminal fine.</em></blockquote><br />So the company actually admitted to violating the law in the form of a misdemeanor, selling a drug for unapproved uses. The importance of this sort of activity has been frequently challenged, especially by those who claim that corporations have free speech rights that allow them to promote practically anything they want.<br /><br />However, this was not the only issue apparently resolved.<br /><br /><strong>A Civil Settlement </strong><br /><br /><blockquote>The company agreed to pay $628.4 million to settle civil allegations.</blockquote><br />What were these allegations?<br /><blockquote>The government also made allegations against Merck in parallel civil litigation related to Vioxx in addition to the criminal charges. <br /><br /><em>According to the government, Merck representatives made inaccurate, unsupported or misleading statements about Vioxx's cardiovascular safety, in order to increase sales of the drug.</em> The government also said Merck made false statements to state Medicaid agencies about the drug's safety. </blockquote><br />However,<br /><blockquote><em>Merck isn't admitting liability or wrongdoing in the civil aspect of the settlement. Mr. Rogers said Merck expressly denies the civil allegations.</em><br /><br />'We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx,' said Merck General Counsel Bruce Kuhlik in a statement.</blockquote><br />So this is yet another example of a legal settlement made by a health care organization involving that organization paying a fine, but not admitting it did anything wrong. <br /><br /><strong>The Parallel with the Citigroup Settlement</strong><br /><br />Last week, we <a href="http://hcrenewal.blogspot.com/2011/11/will-citigroup-ruling-challenge-health.html">wrote</a> about how one US federal judge refused to accept a settlement (in a case of alleged financial misbehavior involving Citigroup) which did not require the company to admit wrongdoing. The judge noted that this presented the logically incomprehensible situation of a company apparently being punished for a reason that is unknown. At that point, one (admittedly outspoken) critic wrote, "This has essentially created a parallel or secret criminal justice system, in which both crime and punishment are adjudicated behind closed doors." Furthermore, these<br /><blockquote>settlements have evolved into a kind of cheap payoff system, in which crimes may be committed over and over again, and the ... [government's] only role is to take a bribe each time the offenders slip up and get caught.<br /><br />If you never have to worry about serious punishments, or court findings of criminal guilt (which would leave you exposed to crippling lawsuits), then there’s simply no incentive to stop committing fraud. These SEC settlements simply become part of the cost of doing business....</blockquote><br /><strong>What No One Had to Admit</strong><br />In the case of the current Merck settlement, we do know something about the activities that lead to the settlement.  The settlement 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 <em>good lesson about some of the tactics used to deceptively and unethically promote health care products</em> (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 despite all the evidence of deceptive practices used to market Vioxx as a first-line pain reliever, and all the evidence that Vioxx may have lead to a large number of myocardial infarctions and premature deaths, the US government's settlement with the maker of Vioxx allowed it to deny that its marketers concealed the dangers of the drug.  This shows that the US regulation of health care organizations has been reduced to Kabuki theatre, detached from reality, and in this case, from what appears to be very clear clinical epidemiological evidence.  <br /><br />As noted above, and by us frequently in the past, as long as the only punishments for bad behavior are fines (paid by the entire organization, not those who authorized, directed or implemented the bad behavior), such "punishments" only modestly add to the cost of doing business, and do not deter future bad behavior.  The continuing bad behavior, indicated in part in the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade of legal settlements</a> we have documented, doubtless leads to much of our health care problems, particularly high costs, poor access, poor quality, and demoralized health care professionals.<br /><br />Like a broken record (for anyone who remembers what that means), I repeat...   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. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich. <br /><br /><br /><strong><span style="font-size: x-small;">References</span></strong><br /><span style="font-size: x-small;"><br /></span><br /><span style="font-size: x-small;">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>.</span><br /><span style="font-size: x-small;">2. Curfman GD, Morrisey S, Drazen JM et al.  Expression of concern reaffirmed. N Engl J Med <span class="citation"><span style="font-size: x-small;">2006; 354:1193</span></span>. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMe068054">here</a>.</span><br /><span style="font-size: x-small;">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>.</span><br /><span style="font-size: x-small;">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>.</span><br /><span style="font-size: x-small;">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>.</span><br /><span style="font-size: x-small;">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>.</span><br /><span style="font-size: x-small;">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>.</span><br /><span style="font-size: x-small;">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>. </span>

Merck Admits Little While Settling the Vioxx Case

A week ago, another legal settlement with some noteworthy aspects came marching along.  As reported by the Wall Street Journal, here are th...

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Do Health Care Leaders Realize They Do Not Practice What They Preach?

When we began Health Care Renewal in late 2004, we focused on "concentration and abuse of power" as a driver of dysfunction in the health system.  We have frequently discussed how problems with the leaders of health care organizations, who may be uninformed, incompetent, self-interested, conflicted, or even corrupt, may be a major cause of rising costs, declining access, and poor quality.  This week, the news reminded us how unsustainable US health care costs have become.  The average cost of health care insurance for those fortunate enough to have it provided by employers exceeded $15,000 last year (look <a href="http://www.nytimes.com/2011/09/28/business/28insure.html">here</a>), a year in which median house-hold income fell under $50,000 (look <a href="http://www.census.gov/newsroom/releases/archives/income_wealth/cb11-157.html">here</a>).  Yet there is no evidence that the country with the world's most expensive health care has anything approaching the world's best health care.  <br /><br /><strong>From the Harvard Business School, a Call to Rethink Management's Conventional Wisdom</strong><br /><br />So it was with some hope that I read about a call to change the fundamental beliefs of corporate leaders, particularly corporate health care leaders.  An adjunct faculty member at the august Harvard Business School, Raymond V Gilmartin, <a href="http://blogs.hbr.org/hbsfaculty/2011/09/ceos-need-a-new-set-of-beliefs.html">posting on the school's blog</a> first summarized the conventional wisdom of corporate leaders:<br /><blockquote>Most CEOs and corporate board members would agree that the theories and beliefs listed below drive their decision-making on how best to meet the challenges they face:<br /><br />- The focus of the CEO and the board should be on <em>maximizing shareholder value</em>.<br />- The stock market is short-term-oriented.<br />- <em>Stock-based incentive compensation aligns the self-interest of management with shareholders, and a performance-based pay system increases employee motivation</em>.<br />- <em>Societal concerns should be addressed through corporate social responsibility programs</em>.<br />- <em>The 'best athlete' from inside or outside the company should be chosen as the successor to the CEO.</em><br /><br />In my experience,<em> these beliefs have led managers and boards to take actions that have had unintended, destructive consequences</em>.</blockquote><br />Some of these issues seemed to overlap those we have discussed. We have written about the harmful effects of some of these aspects of the conventional wisdom of health care leaders, particularly the <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives </a>supplied by excess <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive compensation</a> that seems unrelated to how his or her or the organization's performance affects patients' and the public's health, that health care leaders seem to <a href="http://hcrenewal.blogspot.com/search/label/mission-ignorant%20management">care little</a> about the organization's health care mission, if they are not actively <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">hostile to it</a>, and that leaders often seem to be chosen because of their perceived ability as <a href="http://hcrenewal.blogspot.com/search/label/generic%20managers">generic managers</a>, not their knowledge of health care or their understanding of its values.  <br /><br />Furthermore, Mr Gilmartin advocated for a new set of guiding beliefs that also were at least somewhat resonant:<br /><blockquote>Shareholders benefit most when CEOs and boards <em>maximize value for society and act as agents of society rather than shareholders. </em></blockquote><blockquote><em>Actions to address societal issues should be an integral part of strategy</em>, and operations and should not be isolated as a separate activity under the heading of corporate social responsibility. </blockquote><br />Thus Mr Gilmartin seemed to be supporting the notion that health care corporations should focus on providing products and services that actually improve health care, and should operate in ways that support health care's core values.<br /><br />Also,<br /><blockquote><em>Purpose, meaning, and recognition are more powerful motivators than economic self-interest, and large external rewards can reduce intrinsic motivation.</em></blockquote><br />Here Mr Gilmartin seemed to be calling for less extravagant monetary rewards within health care corporations, and perhaps implying that awards should be aligned with health care outcomes and values rather than financial goals.<br /><br /><strong>Did He Practice What He Preached?</strong><br /><br />Long-time readers of Health Care Renewal know that we often base our arguments about how health care should be renewed on demonstrations of the internal contradictions within the current dysfunctional system. So for those of you wondering if this is one of our rare upbeat posts about the message getting out, it is time to demonstrate the paradoxical aspects of Mr Gilmartin's apparently reformist views.<br /><br />If you did not recognize his name right away, Mr Gilmartin, besides being a current adjunct faculty member at Harvard, was the CEO and Chairman of Merck from 1994 to 2005 (see <a href="http://www.microsoft.com/presspass/bod/rgilmartin/">here</a>). When he proclaimed his beliefs above, he did not assert they were new revelations, but rather his guiding beliefs since before he became the leader of Merck:<br /><blockquote>Listed below are an alternative set of beliefs <em>that guided me when I was the CEO of Merck</em> and Becton Dickinson. I strongly feel that they have greater validity, are more effective in meeting today's management challenges, will lead to superior outcomes, and will help restore public faith in business and its leaders. </blockquote><br />However, his record as leader of Merck, a <a href="http://hcrenewal.blogspot.com/search/label/Merck">record that supplied considerable grist to the Health Care Renewal mill since 2005</a>, stands in stark contrast to these stated beliefs.<br /><br /><strong>CEOs should "maximize value for society and act as agents of society"</strong><br /><br />Mr Gilmartin presided over what became known as the Vioxx scandal, one so big that it was actually eventually well-documented in medical journals, thus escaping the anechoic effect.<br /><br />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 <em>good lesson about some of the tactics used to deceptively and unethically promote health care products</em> (pharmaceuticals in this case)."<br /><br />The widespread deceptions of the Vioxx case, which likely fooled many patients into taking and physicians into prescribing a drug whose harms greatly outweighed its benefits, seem to be the antithesis of "maximizing value for society."<br /><br /><strong>"Purpose, meaning, and recognition are more powerful motivators than economic self-interest"</strong><br /><br />Yet Mr Gilmartin embraced compensation that greatly boosted his economic self-interest even as the scope of the Vioxx case became well-known. <br /><br />In 2005, we <a href="http://hcrenewal.blogspot.com/2005/04/after-vioxx-withdrawal-how-did-merck.html">noted </a>that Merck CEO and Chairman Raymond V Gilmartin got a 2004 salary of US $1.6 million, plus a $1.4 million bonus, and stock options worth $19.2 million. Also, he exercised other stock options that year, gaining a further $34.8 million.  All this he received soon after the withdrawal of Vioxx, and  despite Merck's stock 30% drop after this withdrawal.<br /><br /><strong>Lack of Insight</strong><br /><br />We have occasionally discussed evidence that a significant proportion of organizational leaders, including health care leaders, are <a href="http://hcrenewal.blogspot.com/2006/06/snakes-in-suits-book.html">"snakes in suits,"</a> that is, sociopaths who only care about their own self-interest. However, it is likely that the majority of leaders are certainly not sociopathic. <br /><br />Why, then, do so many health care leaders preside over, if not directly authorize, direct or implement actions they ought to have known were wrong?  The stark contrast between Mr Gilmartin's stated beliefs and the history of Vioxx case which occurred on his watch suggest a failure of insight about his own actions.  He did not seem to realize that what he practiced appeared at odds with the beliefs he now says he espouses. <br /><br />We constantly hear that our health care organizational leaders, particularly the CEOs of large health care organizations, are the "best and the brightest," especially when their enormous compensation needs justification (for example, look <a href="http://hcrenewal.blogspot.com/2011/09/highly-paid-skilled-executives-and.html">here</a> for a recent example, and <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">here</a> for more.)  A reasonable assumption would be that the "best and the brightest" have some insight into their own actions, and the extent their actions live up to their principles and beliefs. <br /><br />This new extension of the Vioxx case suggests that an important reason that health care leaders continue to appear ill-informed, incompetent, self-interested, conflicted, or even corrupt is that they lack insight into how their actions might make them seem such. If their mental model of their own actions tells them they well-informed, competent, devoted to the mission of their organization, and honest, regardless of any evidence to the contrary, this faulty insight will allow them to continue actions that make them appear otherwise.<br /><br />The challenge then is to somehow provide real feedback to health care leaders when their actions appear ill-informed, incompetent, self-interested, conflicted or corrupt. Some reasonable hypotheses would be:<br />- CEOs and other top leaders must be removed from their bubbles, must relinquish their <a href="http://hcrenewal.blogspot.com/search/label/imperial%20CEO">"imperial"</a> status. They must not be too sheltered from the vicissitudes of daily life, or shielded from criticism or disagreement.<br />- We must end the perverse incentives that reward CEOs for doing wrong, particularly for making short-term revenue, or even the illusion thereof, their primary benchmark.<br />In other words, as we have said before, health care leaders must become accountable for what they do, particularly for the effects of what they do on patient's and the public's health.<br /><br />Maybe if health care leaders can begin to see themselves as others see them, they will start to act to benefit patient's and the public's health, and we might see some improvement in our drastically expensive, inaccessible, and poor quality health care system. <br /><br />Hat tip to Ed Silverman <a href="http://www.pharmalot.com/2011/09/former-merck-ceo-says-execs-need-new-beliefs/">on the PharmaLot blog</a>.<br /><br /><strong><span style="font-size: x-small;">References</span></strong><br /><span style="font-size: x-small;"><br /></span><br /><span style="font-size: x-small;">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>.</span><br /><span style="font-size: x-small;">2. Curfman GD, Morrisey S, Drazen JM et al.  Expression of concern reaffirmed. N Engl J Med <span class="citation"><span style="font-size: x-small;">2006; 354:1193</span></span>. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMe068054">here</a>.</span><br /><span style="font-size: x-small;">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>.</span><br /><span style="font-size: x-small;">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>.</span><br /><span style="font-size: x-small;">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>.</span>

Do Health Care Leaders Realize They Do Not Practice What They Preach?

When we began Health Care Renewal in late 2004, we focused on "concentration and abuse of power" as a driver of dysfunction in the...

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Merck Settles Another Vioxx Case

All the shenanigans that went on in the course of Merck's marketing of the now withdrawn Cox-2 inhibitor non-steroidal anti-inflammatory drug Vioxx have provided grist for the <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> mill since 2005.  For example, see these posts:<br /><br />- <a href="http://hcrenewal.blogspot.com/2005/04/more-evidence-of-ghostwriting.html">here</a> about <em>ghost-writing</em> 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 <em>intimidate</em> 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 how an apparently major clinical trial of Vioxx turned out to be a "<em>seeding trial</em>," 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 <em>fraud</em> in connection with his research on other drugs.  <br /><br />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).<br /><br />Merck just announced just the latest settlement of Vioxx related legal actions, as <a href="http://www.businessweek.com/news/2010-02-10/merck-changes-safety-procedures-pays-in-vioxx-suits-update1-.html">reported by Business Week</a>:<br /><blockquote>Merck & Co. agreed to settle shareholder lawsuits over the withdrawn Vioxx painkiller by strengthening its drug-safety procedures, appointing a new chief medical officer and paying $12.2 million in legal fees.<br /><br />Merck would <em>appoint one committee to address risks that require immediate action and another to monitor the safety of drugs,</em> the company said in a regulatory filing. Merck would also <em>amend its code of conduct to <strong>promote scientific and academic integrity</strong> as well <strong>'honest communication' with doctors</strong></em><strong>.</strong><br /><br />'In all research endeavors that are sponsored by Merck, we <em><strong>will refrain from attempting to influence inappropriately the results and conclusions of such research</strong></em>,' according to the amended code. 'We strive for all <em><strong>communications with the medical community to be accurate, truthful </strong></em>and consistent with labeling.'</blockquote><br />Also, <br /><blockquote>The company will be required to make corporate governance changes and “supplement existing policies and procedures,” ... [a Merck spokesperson] said.</blockquote><blockquote>Merck would <em>submit results of clinical trials to a public registry</em>, with its compliance overseen by an independent third party.<br /><br />The chief medical officer will have an 'executive voice' on product safety issues independent of Merck Research Laboratories. </blockquote>Note that this settlement is only of one type of lawsuit, as described in <a href="http://online.wsj.com/article/SB10001424052748704140104575057231552987908.html">a Wall Street Journal article</a>,<br /><blockquote>The pact, which is pending final court approval, would resolve state and federal shareholder 'derivative' complaints (which are brought by shareholders on behalf of a company) alleging that current and former Merck officers and directors breached their fiduciary duties in handling Vioxx. </blockquote>Merck had already settled thousands of lawsuits,<br /><blockquote>Since the Vioxx controversy erupted, about 27,000 personal-injury lawsuits have been filed, the company says. Merck has been challenging all of the cases and settled many of them. Most notably, it agreed to a pay $4.85 billion to settle personal-injury claims of more than 40,000 people. In another settlement, the company will pay $80 million to resolve 190 claims filed by drug-benefit plans seeking to recover costs of paying for Vioxx use.</blockquote>Merck has lots of other legal actions to go through,<br /><blockquote>The Vioxx litigation remains far from over. The U.S. Supreme Court is weighing a separate shareholder case, seeking billions of dollars in damages from the company. Merck disclosed last year the U.S. Attorney's office in Boston was conducting a grand-jury investigation of Merck's handling of Vioxx. The claims of some 310 plaintiff groups are outstanding in courts in the U.S., according to the securities filing. There are also cases overseas, including Australia and Turkey.</blockquote>So the parade of legal actions and settlements thereof continues.  We believe that the scope of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">this parade</a> provides some sort of index of bad behavior by the health care organizations needing to make such settlements.  Most of these legal results are reported on in the business media, and rarely appear in any medical, health care research, or health policy journals.  I submit that were health care professionals, health care researchers, and health policy makers more systematically aware of these cases, they might realize that unethical and sometimes illegal behavior, often generated by bad leadership unrestrained by poor organizational governance, is a major cause of the current, seemingly intractable health care crisis.<br /><br />One notable attribute of the current Vioxx settlement is that it does mandate some changes in Merck's governance and leadership meant to prevent future cases similar to this one.  These include developing leadership structures and changing the company's code of conduct to emphasize the need for "truthful" communication, and the need to refrain from "inappropriately" influencing research.  <br /><br />On <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> we have discussed numerous examples of deceptive practices by health care organizations, often affecting marketing, and of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> of research.  It is a small step forward for one company to commit to honest communications and to not manipulate research.  A better code of conduct may at least be a start towards an <a href="http://hcrenewal.blogspot.com/2009/10/organisational-ethics-policies-primer.html">organizational ethics policy</a>, which in turn may have the potential to actually improve behavior.  <br /><br />On the other hand, typical settlements that involve only monetary damages paid by the organization seem to have little deterrent effect on future bad behavior. Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts suffers any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior. Until the people who approve, direct, and perform unethical or illegal acts pay some penalties, expect such acts to continue, at best deterred only slightly by written policies that condemn them. I again suggest that to truly reform health care, we need rigorous regulation of health care organizations that has the power to deter unethical behavior that may risk patients' health

Merck Settles Another Vioxx Case

All the shenanigans that went on in the course of Merck's marketing of the now withdrawn Cox-2 inhibitor non-steroidal anti-inflammatory...

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Physician Pleads Guilty to Fraud for Fabricating Celebrex (and Other) Study Data

As reported <a href="http://www.masslive.com/chicopeeholyoke/republican/index.ssf?/base/news-25/1263545132168150.xml&coll=1">by the Springfield, MA, Republican</a>:<br /><blockquote>A former chief of acute pain at Baystate Medical Center has <em>agreed to plead guilty to falsifying medical research</em> and must pay $420,000 in restitution to pharmaceutical companies, federal court records show.<br /><br />Dr. Scott S. Reuben, of Longmeadow, was charged on Thursday with health care fraud. <em>He signed a plea agreement with prosecutors a week earlier.</em><br /><br />Reuben prompted a furor in the medical community in March, when he was accused of making up research results in at least 21 published studies and inventing patients in certain instances. <br /></blockquote><br />In one notable instance,<br /><blockquote>In 2005, Reuben received a $74,000 research grant from pharmaceutical giant Pfizer, agreeing to test Celebrex as a component of the multimodal therapy. He claimed to have treated 200 patients, 100 with Pfizer's product and 100 with a placebo.<br /><br />'In fact, <em>Reuben had not enrolled any patients into that study and the results reported both to Pfizer and to the Anesthesia and Analgesia Journal and in turn to the public were wholly made up by Reuben</em>,' the charge states.<br /><br />Albert said the fabrications were <em>discovered by medical staff within the hospital during a routine review at the hospital's 'research week</em>,' when clinicians design poster displays of their studies. <br /></blockquote><br />A <a href="http://www.theday.com/article/20100116/BIZ02/301169909/1044">report </a>in the New London, CT, Day indicated the scope of Reuben's fake research:<br /><blockquote>Anesthesia & Analgesia later <em>had to retract 10 papers</em> authored by Reuben, and medical experts at the time said at least<em> 21 journal articles by the anesthesiologist appeared to have been fabricated.</em><br /><br />The agreement calls for Reuben to pay restitution of $296,557 to Pfizer and $16,000 to Wyeth Pharmaceuticals, two companies that merged last fall. Merck & Co. would receive $49,375 from the agreement, according to documents.<br /><br />In addition to his fabricated Celebrex studies, <em>Reuben had pretended to do research that backed the effectiveness of other pain drugs, including Pfizer's Bextra and Merck's Vioxx</em>, according to prosecutors. Bextra and Vioxx later were pulled from the market because studies showed they increased the risk of death from heart attacks and strokes.<br /><br />In addition, <em>Reuben published data showing that Pfizer's antidepressant Effexor had exhibited painkilling properties.</em><br /><br />Reuben's studies had been <em>considered pioneering</em> at the time they were published. <em>His data had supported the use of two of Pfizer's major products - Celebrex and Lyrica - in combination</em> to treat certain types of post-operative pain.<br /><br />Reuben <em>'was a regular on the medical lecturing circuit</em>,' according to court documents, and 'had become a well known figure in the anesthesia and pain management medical communities.'<br /><br /><em>Pfizer said previously that it had supported five of Reuben's research initiatives</em>. Pfizer, which declined at the time to reveal how much it paid Reuben over the years to be part of its speakers' bureau, said the company played no part in the fraud.<br /><br />Asked for a comment Friday, Pfizer was not able to provide a timely response.<br /></blockquote><br />Note that we usually do not post about stories of individual's clinical research misconduct, not because it is unimportant, but because individual misconduct may be related more to an individual's motives and character than to concentration and abuse of power in health care.<br /><br />However, in this case it appears that Dr Reubens was enabled, at least in the psychological and logistical senses, by pharmaceutical companies happy to sponsor research which suggested the effectiveness of their products.  Since Dr Reubens apparently fabricated most of his data, notice that he apparently deliberately fabricated data that made Pfizer's Celebrex, Bextra, Lyrica, and Effexor, and Merck's Vioxx look good.  Perhaps there was careerism here.  Positive studies about "innovative" effective drugs are more likely to get published than negative studies or studies of old drugs.  However, we have <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">noted before</a> that pharmaceutical (and biotechnology and device) companies like to sponsor studies with results that make their products look good.  <br /><br />One bit of good news in this story is that Reuben's colleagues at the hospital apparently were able to uncover the fabrications when they had an opportunity to critically look at data from several of his studies.<br /><br />Certainly some Pfizer employees had easy access to the same data.  But perhaps they would not have thought to look at it critically as long as it was so unrelentingly positive about their company's products.  <br /><br />As we have said before, health care professionals, policy makers and patients ought to be extremely skeptical of clinical studies sponsored (and often deeply influenced) by those with vested interests in the studies' turning out in certain ways.  We ought to reconsider national research policies that have turned over sponsorship of the majority of clinical research to those with such vested interests.<br /><br />Hat tip to Prof Margaret Soltan <a href="http://www.margaretsoltan.com/?p=20778">on the University Diaries blog</a>.<br /><br />ADDENDUM (19 January, 2010) - see also <a href="http://alison-bass.blogspot.com/2010/01/why-fda-is-more-pro-business-than-ever.html">comments</a> on the Alison Bass Blog.

Physician Pleads Guilty to Fraud for Fabricating Celebrex (and Other) Study Data

As reported by the Springfield, MA, Republican : A former chief of acute pain at Baystate Medical Center has agreed to plead guilty to falsi...

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BLOGSCAN - Merck Hired Elsevier to Create Fake Peer-Reviewed Medical Journal

<span style="color:#006600;">You just can't make this stuff up. </span><a href="http://scienceblogs.com/insolence/2009/05/when_big_pharma_pays_a_publisher_to_publ.php"><span style="color:#006600;">On the Respectful Insolence blog</span></a><span style="color:#006600;">, Orac recounted how pharmaceutical giant Merck hired medical publishing giant Elsevier to create what appeared to be a peer-reviewed journal, but theAustralasian Journal of Bone and Joint Medicine really was just a marketing outlet. The goal was to market Fosamax and Vioxx. This is another bizarre variant on the stealth marketing theme, taken to quite an extreme. And the pharmaceutical companies wonder why people don't trust them? </span><br /><span style="color:#006600;"></span><br /><span style="color:#006600;">ADDENDUM (4 May, 2009) - Dr Aubrey Blumsohn is <a href="http://scientific-misconduct.blogspot.com/2009/04/fake-editorial-board-of-mercks-fake.html">back online </a>on his Scientific Misconduct Blog, and noted the academic luminaries who were willing to serve on the editorial board of this fake peer-reviewed journal.</span><br /><span style="color:#006600;"></span><br /><span style="color:#006600;">ADDENDUM (11 May, 2009) - See also <a href="http://laikaspoetnik.wordpress.com/2009/05/08/mercks-ghostwriters-haunted-papers-and-fake-elsevier-journals/">comments</a> on Laika's MedLibBlog.</span>

BLOGSCAN - Merck Hired Elsevier to Create Fake Peer-Reviewed Medical Journal

You just can't make this stuff up. On the Respectful Insolence blog , Orac recounted how pharmaceutical giant Merck hired medical publis...

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Caught in the Cross-Fire: Merck Tried to "Neutralize" Vioxx Opponents

Here is a new kind of example of how physicians have been caught in cross-fires between competing interests.<br />The <a href="http://www.nytimes.com/2005/02/11/business/11merck.html">NY Times reported </a>today about some newly obtained documents about how Merck marketed Vioxx. Particularly striking were references in them to the need to "neutralize" physicians who Merck marketers perceived were Vioxx opponents. To quote the Times, <em>"In the 'neutralize' documents written by a Merck marketing executive, company officials identified dozens of influential but 'problem' physicians whom [sic] the company believed had either a negative view of Merck or Vioxx or were active boosters of Celebrex. To win them over, the documents show, Merck officials planned to offer them carrots like clinical trials, posts as consultants, or give them grants."</em> A form that Merck used internally to request payments for doctors asked for "<em>Expected Outcome/ Return on Investment</em>."<br />When I first read the headline, I feared "neutralization" meant something even more sinister. But the reality was bad enough. This is a vivid case of how when physicians are caught between powerful organizations, here, competing drug companies, the patients' interests seem to come last.

Caught in the Cross-Fire: Merck Tried to "Neutralize" Vioxx Opponents

Here is a new kind of example of how physicians have been caught in cross-fires between competing interests. The NY Times reported today abo...

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The Managed Care View on the Vioxx Mess

On <a href="http://www.medrants.com/index.php">MedRants</a>, a commentator expressed this "managed care" view of the Vioxx mess:<br /><br /><blockquote><p>Payers are frustrated that MDs are prescribing drugs patients don’t need, driving up short term costs with no attendant benefit to patients. Meanwhile, these decisions may very well lead to additional costs, as patients suffering cardiovascular events who also took COX-2s for WC injuries seek compensation from their WC payer.<br />The net - payers see MD prescribing behavior as abdicating responsibility, and increasing payer costs. Frustration is rampant.</p></blockquote>I think there is plenty of blame to spread around for the Vioxx debacle. Physicians' enthuisiasm for Vioxx and other Cox-2 inhibitors clearly went beyond the evidence. And I think some physicians believed that Cox-2 inhibitors are actually more effective than regular non-steroidal anti-inflammatory drugs (NSAIDS), without evidence to support this belief.<br />However, before 2004, it would have taken some digging to find evidence that suggested Cox-2 inhibitors were actually dangerous. The published VIGOR trial data did show heart attack risk was higher in the Vioxx group, but this could have been due to chance alone.[1] Although the most evidence-based discussions of Cox-2 inhibitors did raise questions about cardiac risk, they offered no definitive conlusions (see the Cochrane Review[2] and ACP Journal Club[3] from 2002.)<br />Furthermore, even the most evidence-based physician would have had a hard time discouraging a patient absolutely determined to get a Cox-2 inhibitor before 2004, especially in the context of the typical 15 minute visit during which Cox-2 may have been only one of many issues raised. Such patients were not rare, due to vigorous direct to consumer (DTC) advertisements.<br />Managed care, of course, has to accept some blame for deluging physicians with paper-work and bureaucracy, while cutting reimbursements for office visits, thus making it financially disadvantageous for physicians to spend enough time with patients to discuss benefits and harms of treatments. Managed care, of course, likes to talk about "evidence-based medicine," but has provided little real support for clinical trials, systematic reviews, or educating physicians about evidence-based medicine. And managed care did nothing to counter all those fancy pharamaceutical DTC advertising campaigns that down-played the adverse effects of drugs, including Cox-2 inhibitors.<br />If managed care organizations really want patients to get the best possible care based on the best possible evidence, they should provide support and incentives for physicians to take enough time with patients, and for physicians to understand, have access to, and be able to use the tools of evidence-based medicine.<br />References<br />[1] Bombardier C et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000; 343: 1520-8.<br />[2] Garner S et al. Rofecoxib for the treatment of rheumatoid arthritis. Cochrane Database Syst Rev 2002; CD003685.<br />[3] Meyerhoff J. Rofecoxib, 25 md/d, was more effective than rofecoxib, 12.5 md/d, or acetaminophen in osteoarthritis of the knee. ACP Journal Club 2002; 137: 26.

The Managed Care View on the Vioxx Mess

On MedRants , a commentator expressed this "managed care" view of the Vioxx mess: Payers are frustrated that MDs are prescribing d...

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