healthy4u

Giant GSK Settlement Provides Reminder of the Pervasiveness of Stealth Marketing

The latest  and biggest legal settlement involving health care to hit the news, that of GlaxoSmithKline (GSK) and the US government, has many familiar elements. As <a href="http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html">summarized by the New York Times</a>, <blockquote>In the largest settlement involving a pharmaceutical company, the British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug, federal prosecutors announced Monday. The agreement also includes civil penalties for improper marketing of a half-dozen other drugs. </blockquote> As was the case for nearly every other <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlement</a> we have discussed, <blockquote>No individuals have been charged in any of these cases.</blockquote>Thus, how well even such a large settlement will deter future wrong-doing is not clear. Nonetheless, the documents released with it provide good documentation about how pervasive systematic, deceptive stealth marketing campaigns have become in health care.  In particular, the <a href="http://www.justice.gov/opa/documents/gsk/us-complaint.pdf">official "complaint" filed by the US Department of Justice</a> emphasized all these elements in the stealth marketing of paroxetine (Paxil, Seroxat in the UK) to adolescents. Manipulation of Clinical Research We have frequently discussed how health care corporations, particularly pharmaceutical, biotechnology and device companies, now sponsor  the majority of clinical research.  Their control of the design, implementation, analysis and dissemination of clinical research allows <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> that increases the likelihood that the results will be favorable to their vested interests, usually the products and services they sell.  We have previously discussed the manipulation of Study 329 to promote the marketing of Paxil (look <a href="http://hcrenewal.blogspot.com/2008/04/selective-reporting-of-study-329.html">here </a>and <a href="http://hcrenewal.blogspot.com/2008/09/brown-university-student-journalists.html">here</a>).  However, the US DOJ document makes these concerns more official.  It included: Manipulation of Study Endpoints Study 329 was a randomized controlled trial of Paxil vs imipramine vs placebo for depression in adolescents. The two primary endpoints pre-specified to the US Food and Drug Administration were "the degree to which a patient's Hamilton Rating Scale for Depression ('HAM-D') total score changed from baseline"; and "the patient's 'response' to medication, as defined as (a) a 50% or greater reduction in the patient's HAMD-D score, or (b) a HAM-D score of less than or equal to 8." However, initial analysis by GSK failed to show that Paxil improved either of these two end-points. The company concluded "it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of [Paxil]." So the analysis emphasized secondary outcomes, the "Study 329 investigators later added several additional efficacy measures not specified in the protocol. Paxil separate statistically from placebo on certain of these measures." Adding numerous post-hoc measures increased the likelihood of finding a difference on at least one due to chance alone. Manipulation of Data Initial analysis of the data suggested that patients given Paxil experienced 11 serious adverse events, including five that appeared related to suicidal ideation or action. When the FDA later reexamined the data, "upon closer examination the number of possible suicide-related events among the Study 329 Paxil patients increased beyond the five patients GSK described in the JACAAP article as having 'emotional lability.' While collecting saftey information for the FDA, GSK admitted that there were four more possible suicide-related events among Paxil patients in Study 329. In addition the FDA later identified yet another possible suicide-related event in the Study 329 Paxil patients, which was also not among the 11 serious advents listed in the JAACAP article. Thus, altogether, 10 of the 93 Paxil patients in Study 329 experienced a possible suicidal event, compared to one in 87 patients on placebo. This is a fundamentally different picture of Paxil's pediatric safety profile than the one painted by the JAACAP article...."  Manipulation of Dissemination The report describing the results of Study 329 (Keller MB, Ryan ND, Strober M et al.  Efficacy of paroxetine in the treatment of adolescent major depression: a randomized controlled trial.  J Am Acad Child Adolescent Psychiatry 2001; 40: 762-772.  Link <a href="http://www.justice.gov/opa/documents/gsk/complaint-ex2.pdf">here</a>. ) was written under the control of GSK. "In April 1998, GSK hired Scientific Therapeutics Information, Inc (STI) to prepare a journal article about Study 329. GSK worked closely with STI on the article by providing a draft clinical report to 'serve as a template for the proposed publication.'" The published report of Study 329 "mischaracterized the results." "Although the ... article identified the study's two primary endpoints in the abstract, the article did not explicitly state that Paxil failed to show superiority to placebo on either of the primary efficacy measures." Also, "the article did not explicitly identify the two protocol-specified primary outcome measures - or that Paxil failed to show superiority to placebo on these two measures. Instead the article claimed that there were eight efficacy measures and that Paxil was statistically superior to placebo on four of them." In addition, "while the article listed the five protocol-defined secondary endpoints, the text of the article omitted any discussion regarding three of the secondary measures on which Paxil failed to statistically demonstrate its superiority to placebo and instead focused on the five secondary measures that GSK added belatedly and never incorporated into the Study 329 protocol. The article claimed that these finve secondary measures had been identified 'a priori,' therefore incorrectly suggesting that all secondary endpoints had been part of the original study protocol." In other words, the final published articles contained multiple outright falsehoods about the drug's efficacy that exaggerated that efficacy. Furthermore, initial analysis showed that patients given Paxil had more serious adverse events than others. An initial draft of the study article stated, "serious adverse events occurred in 11 patients in the paroxetine group, 5 in the imipramine group, and 2 in the placebo group." These included "headache during down-titration(1 patient), and various psychiatric events (10 patients): worsening depression (2); emotional lability (e.g., suicidal ideation/ gestures, overdoses), (5); conduct problems or hostility (e.g., aggressiveness, behavioral disturbance in school) (2); and mania (1)." As noted above, the number of suicide related events was actually double that noted in this draft as "emotional lability."  However, the published version of the report "falsely state[d] that only one of the 11 serious adverse events in Paxil patients was considered related to treatment...."  Nor did it mention the true number of events related to suicidal ideation or action. The article only "listed at most five possibly suicidal events among Paxil patients, brushed those off as unrelated to Paxil, and conclude that treating children with Paxil was safe." Later, GSK marketing materials described the results of the study thus, <blockquote>This 'cutting-edge,' landmark study is the first to compare efficacy of an SSRI and a TCA with placebo in the treatment of major depression in adolescents. Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression."</blockquote>Thus the conrol exerted by GSK over the published article, despite its apparent academic authorship, enabled it to promote a drug that was not efficacious and had major adverse events as remarkably safe and effective, a totally deceptive result that would mislead any health care professional who used the article to guide clinical practice.  Suppression of Clinical Research GSK sponsored two other studies of Paxil in pediatric populations, Studies 377 and 701. As stated in the Department of Justice's Criminal Complaint against GSK, <blockquote>GSK Did Not Publicize the Results of Studies 377 and 701 43. GSK learned the results of Study 377 in 1998 and the results of Study 701 in 2001. Paxil failed to demonstrate efficacy on any of the endpoints of either study. 44. GSK did not hire a contractor to help write medical articles about the results of Studies 377 and 701, as it had with Study 329. 45. GSK did not inform its sales representatives about the results of Studies 377 and 701.</blockquote>Thus, GSK managed to conceal the fact that the majority of the studies it sponsored about Paxil used for adolescent patients showed no evidence that the drug worked, again seriously distorting the evidence-base on which clinicians made decisions, and doubtless leading to the use of a dangerous, ineffective drug by numerous vulnerable patients. Bribing Physicians to Prescribe <blockquote>GSK's sales representative reflected in their call notes their use of money, gifts, entertainment and other kickbacks to induct doctors to prescribe GSK drugs.... </blockquote> One really creative way to pay physicians to be exposed to marketing: <blockquote>For example, in or about 2000 or 2001, GSK used 'Reprint Mastery Training Programs' or 'RMTS' to further promote drugs by purporting to pay physicians to train sales representative to review reprints of studies. Although the training was purportedly for the representatives, in fact, the sales force was already familiar with the materials. GSK typically paid physicians $250 to $500 to review the reprints.</blockquote>Thus GSK simply paid physicians to use its drug, a practice characterized as kickbacks in the official complaint.  An <a href="http://www.guardian.co.uk/business/2012/jul/03/glaxosmithkline-fined-bribing-doctors-pharmaceuticals">article in the Guardian </a>noted that the US Attorney involved in the case put it even more bluntly, <blockquote>The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts.</blockquote> Use of Key Opinion Leaders as Disguised Marketers <blockquote>GSK also created a group of national 'key opinion leaders' ('KOLs') who were paid generous consulting fees. GSK selected many of these physicians based on their prescribing habits and influence within the community and used the speaker fees paid to these physicians to induce and reward prescribing of GSK's products. GSK used these individual to communicate marketing messages focused on the drug's marketing campaigns at the time, including off-label uses. Some physicians on GSK's speaker's board have been paid more than a million dollars for speaking on behalf of the company and recommending its drugs.</blockquote> Thus key opinion leaders were paid specifically to market drugs, and as a reward, a bribe for prescribing drugs. Consulting Fees as Kickbacks In general, <blockquote>In order to induce physicians to prescribe and recommend its drugs, GSK paid kickbacks to health professionals in various forms, including speaking or consulting fees, travel, entertainment, gifts, grants, and sham advisory boards, training,....</blockquote> In particular, <blockquote>During 2000 and 2001 at least, GSK also utilized events termed 'advisory boards' or consultant meetings and forums to disseminate its promotional message. Although these boards were purportedly composed of 'thought leaders' for the purpose of obtaining advice from the physicians, in fact, the 'advisory boards' were little more than promotional events coupled with financial inducement to prescribing and influential physicians.</blockquote> Also, <blockquote>GSK typically paid the physician between $250 and $750 to attend each local 'advisory' meeting. The payments did not reflect the value of services. The physician was not required to do anything but show up. GSK had no legitimate business reason to hire thousands of 'advisors' to 'consult' with the company about a single drug. </blockquote> Manipulation of Continuing Medical Education <blockquote>GSK also used so-called CME and CME Express programs and other sham training for marketing purposes, and to promote off-labe uses for the GSK prescription drugs.</blockquote> Furthermore, <blockquote>These CME programs purported to be independent eduaction free of company influence, but in fact functioned as GSK promotional programs disguised as medical education. GSK maintained control and influence over the purportedly independent CME programs through speaker selection, and influence over content and audience, among other things. Although third party vendors were usually also involved, they served only as artificial 'firewalls' that did not insulate the program from GSK's influence.</blockquote> Summary The legal documentation of the GSK settlement demonstrated how one drug company used an integrated, systematic campaign incorporating deception and bribery to sell drugs. Its elements included manipulation and suppression of the clinical research it sponsored, paying key opinion leaders to be disguised drug marketers, outright payments to physicians to prescribe drugs, and manipulation, again using payments to physicians, of supposedly independent continuing medical education.  Note that while I summarized the elements of the stealth marketing campaign to sell Paxil, particularly for use in pediatric patients, the US government complaint also documents similar activities used to sell other drugs.  Furthermore, other <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing">stealth marketing campaigns</a> have come to light through legal action, and many other instances 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 clinical research, use of <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">KOLs</a> as disguised marketers, <a href="http://hcrenewal.blogspot.com/search/label/kickbacks">kickbacks</a> and bribes, and manipulation of <a href="http://hcrenewal.blogspot.com/search/label/continuing%20medical%20education">CME</a> have been documented. This means that any claims that: - commercially sponsored clinical research provides clear, unbiased data that should drive clinical decisions - health care professionals and academics paid as consultants by commercial health care firms are not influenced by these payments, and can provide clear, unbiased opinions - commercially sponsored medical education provides clear, unbiased teaching unfortunately must be viewed with extreme skepticism. This is particularly unfortunate given that most clinical research is now supported by commercial sponsors, and the majority of influential academics in medicine get some form of payments from the health care industry (look <a href="http://hcrenewal.blogspot.com/2007/10/medical-school-leaders-conflicts-of.html">here</a>). Of course, there are some physicians who consult for commercial firms who actually provide clinical or scientific advice or assistance, and some commercially sponsored activities are honest. But we must wonder what garden path all those advocates for increasing industry "collaboration" to promote "innovation," and who regard conflicts of interest as "inevitable" and "manageable" are taking us down (e.g., look <a href="http://hcrenewal.blogspot.com/2012/02/logical-fallacies-in-defense-of.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/11/if-medical-school-is-just-part-of.html">here</a>). Although the current settlement will require a huge payment, as I have said many times before (as early as 2008, <a href="http://hcrenewal.blogspot.com/2008/07/amerigroup-settles.html">here</a>), do not expect such settlements to deter future bad behavior like that listed above.  The cost of the settlement will actually be spread among all company shareholders, all company employees, and likely patients and taxpayers.  However, the settlement will entail no specific negative consequences to the people who authorized, directed, or implemented the bad behavior.  In particular, executives whose remuneration was swollen by proceeds from the sales of affected drugs, and the health care professionals who willingly accepted what the US Attorney called bribes will not pay any sort of penalty.  The bad behavior listed above was doubtless personally very profitable for some people.  Unless people who indulge in such behavior face the possibility of penalties worse than their expected gains, expect such bad behavior to continue. In fact, as the New York Times reported, <blockquote>critics argue that even large fines are not enough to deter drug companies from unlawful behavior. Only when prosecutors single out individual executives for punishment, they say, will practices begin to change. 'What we’re learning is that money doesn’t deter corporate malfeasance,' said Eliot Spitzer, who, as New York’s attorney general, sued GlaxoSmithKline in 2004 over similar accusations involving Paxil. 'The only thing that will work in my view is C.E.O.’s and officials being forced to resign and individual culpability being enforced.' </blockquote> True health care reform would strive to eliminate important conflicts of interest affecting clinical research and medical education.  Specifically, it would prevent corporations that sell health care products or services from controlling clinical research meant to evaluate these products or services.  It would seek to eliminate serious conflicts of interest affecting health care professionals.  Finally, it would prevent vested interests from controlling medical education.  Not that I expect any such reform in the near future, it would be too threatening to those who have personally benefited from the current system. Hat tip to Dr Howard Brody whose Hooked: Ethics, Medicine and Pharma blog <a href="http://brodyhooked.blogspot.com/2012/07/inside-paxil-study-329-courtesy-justice.html">scooped me </a>on the details of the settlement relevant to study 329. ADDENDUM (11 July, 2012) - see also <a href="http://1boringoldman.com/index.php/2012/07/06/another-shot/">this post</a> on the 1BoringOldMan blog.

Giant GSK Settlement Provides Reminder of the Pervasiveness of Stealth Marketing

The latest and biggest legal settlement involving health care to hit the news, that of GlaxoSmithKline (GSK) and the US government, has man...

Đọc thêm »

Fool Us Once, Shame on You, Fool Us Twice, Shame on Us - The Untrustworthy Pronouncements of Aetna's Former CEOs

A small tempest in the larger US health care reform teapot was produced a few weeks ago when Ron Williams, former CEO of Aetna, declared in a <a href="http://online.wsj.com/article/SB10001424052702303734204577464713182634028.html">Wall Street Journal op-ed</a> that he no longer supported the health insurance mandate.  The "mandate" for all US citizens to buy health insurance, actually a relatively small tax that would be imposed on people without health insurance, was the central point of contention in the lawsuit before the US Supreme Court challenging the Affordable Care Act (ACA).  Immediate Past-CEO of Aetna Ron Williams' Abrupt Change of Mind on the Individual Mandate Williams wrote, <blockquote>Soon the U.S. Supreme Court will rule on the constitutionality of the Affordable Care Act. I am not a lawyer, or an expert on the Constitution. But as the chairman and CEO of a major health plan, I had a ringside seat to the entire health-care reform process. After much reflection, I have concluded that the federal individual mandate, which requires all Americans to purchase health insurance starting in 2014, will not be upheld. </blockquote> On this, Williams was soon proven wrong. The Supreme Court upheld the law. However, the tempest was not due just to Williams' reversal of his former opinion, but the role he actually played in pushing his former opinion into the passage of the law, which was really far more than being a "ringside" spectator. In an August 24, 2009 <a href="http://www.forbes.com/forbes/2009/0824/outfront-insurance-premiums-aetna-ron-williams-health-reform.html">article</a>, "Aetna's Ron Williams on Health Reform," Forbes' Dan Whelan noted, <blockquote>Williams, 59, is taking a surprisingly visible role in arguing for change in the health care system. He has met with Obama a half-dozen times (he shrugs off the surname gaffe), has testified four times in front of Senate committees this year and participates in shindigs set up by the many trade groups for which he's a director. Williams' position echoes that of the HMO industry generally: He's against a government-run plan but favors universal coverage and forcing insurers to take all comers.</blockquote> As Wendell Potter, the former head of public relations for large health for-profit health insurance company Cigna, who is now a strong industry critic, put it on <a href="http://wendellpotter.com/2012/06/flip-flop-on-healh-care-refrom-casts-president-as-modern-day-julius-caesar">his blog</a>, <blockquote>Ron Williams who possibly more than anyone else had persuaded the President to reconsider his campaign pledge to enact reform without making people buy coverage from a private insurer. Candidate Obama’s reform platform differed from those of Hillary Clinton’s and John Edwards’ in only one significant way: both Clinton and Edwards embraced the mandate, which Williams was championing, first behind the scenes and then publicly, on behalf of the insurance industry. Candidate Obama said he didn’t believe it was right for people to be forced to buy something they couldn’t afford. Williams was the industry’s most visible CEO on Capitol Hill during the debate on reform. He testified at numerous congressional hearings about how essential it was to move the millions of uninsured Americans into private health insurance plans and how an individual mandate was necessary to make that happen. He also never missed an opportunity to trash the idea of a 'public option' to compete with private insurance companies, which candidate Obama had said was essential 'to keep private insurers honest.' Capitol Hill was not the only place Williams was frequenting during the reform debate. In an August 2009 article in Forbes, Williams was quoted as saying that he already had met with the President six times. When I called the White House to confirm that, a top aide told me it was true Williams had been there many times, adding, 'We’ve found him to be one of the more reasonable ones.' </blockquote> Williams' recent seeming disavowal of the individual mandate raises the question of why anyone, much less President Obama, trusted him in the first place. After all, he was CEO of Aetna. 2001 Aetna CEO John Rowe Blamed Everyone Else for Health Care Problems In fact, perusal of my memory, and a few file folders suggested several previous cases in which Aetna CEOs issued pronouncements that should not have been trusted. First I recalled a meeting in 2001 at Brown during which the then Aetna CEO was honored by giving the Paul Levinger Lecture on "Good Health: Can We Afford It?" (See original Brown news release <a href="http://brown.edu/Administration/News_Bureau/2001-02/01-056.html">here</a>.) My memory is that of Dr Rowe blaming just about everybody other than the for-profit health care insurance companies for health care's ills. A Brown Daily Herald article (not currently on line, Baskin B. Health care getting harder to afford, Aetna chief tells Brown U. Brown Daily Herald, November 30, 2001) recounted him blaming "cost inflation," (presumably due to doctors and hospitals), and employers, for whom "quality doesn't matter." He only allowed that insurers were to blame for not giving "better service," but not either rising costs or poor quality. I also recall Dr Rowe being treated with great respect by the audience. After all, this was a prestigious lecture. However, his talk seemed just the least bit self-serving. If the audience had been aware of his record at the time, maybe we would have been more skeptical. Mount Sinai CEO Dr John Rowe Extolled Merger with New York University, Jumped to Become Aetna CEO as Merger Began to Fail By 1993, Dr Rowe was CEO of Mount Sinai Medical Center, and was seemingly at the vanguard of the movement for health care CEOs to be paid a lot. The New York Times <a href="http://www.nytimes.com/1993/04/05/us/top-charity-executives-earn-6-figures.html">reported</a> that the 1993 Chronicle of Philanthropy survey showed him to be the country's best paid non-profit CEO, bringing in total compensation of over $800,000 in 1993 dollars. By 1998, Dr Rowe's big project was pushing concentration of power in health care in the form of a proposed merger between New York University Medical Center and Mount Sinai. <a href="http://www.nytimes.com/1998/01/25/nyregion/after-earlier-failure-nyu-and-mount-sinai-medical-centers-to-merge.html">According to the New York Times</a>, the plan would be for Dr Rowe to become CEO of the combined entity. At the time, he said, <blockquote>The advantages of merging hospitals are so great, they far outweigh any hypothetical potential negative impact.</blockquote> The bond issue needed to finance the merger, however, ran into trouble by early 2000.  Soon after that, Dr Rowe seemingly demonstrated his lack of faith in it by jumping to the leadership of Aetna. It turned out, <a href="http://articles.courant.com/2000-10-19/business/0010191503_1_aetna-mount-sinai-nyu-health-quarterly-dividend">according to the Hartford Courant</a>, Aetna's offer was just to rich to turn down. <blockquote>Rowe got a $2 million sign-on bonus to leave Mount Sinai NYU Health and become chief executive of Aetna's health business, the document says. He will also get a $1.4 million retention bonus on July 3, 2001. Both bonuses are designed to replace money that Rowe forfeited by leaving the giant New York hospital system, Aetna spokeswoman Joyce Oberdorf said. In addition, Rowe will get an annual salary of at least $1 million and an annual bonus of $1 million to $3 million, depending on how well goals are met, under a three-year employment agreement with two possible one-year extensions. Rowe, who already received 25,000 shares of restricted Aetna stock and options on 500,000 shares, will get another 100,000 options. The new options will be granted when Aetna spins off its health business to shareholders, or on Jan. 1, 2001 -- whichever comes first. The exercise price will be about $72.73, or whatever price Aetna stock is trading at the time if it's higher than that.</blockquote> By 2001, the New York Times <a href="http://www.nytimes.com/2001/12/02/nyregion/celebrated-hospital-merger-a-union-in-name-only.html">referred</a> to the merger as existing "in name only." That year, the campuses resumed separate administration. The merger was officially terminated in 2008. Its failure was documented in an Academic Medicine article. (Kastor JA. Failure of the merger of the Mount Sinai and New York University hospitals and medical schools: part 2. Acad Med 2010; 85: 1828-32. Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/20856095">here</a>.) If the Brown audience had known that the merger Dr Rowe extolled with such confidence was already failing, but that he was able to leverage his role in its development to go from the country's best paid non-profit CEO to a multi-million dollar a year insurance CEO, maybe we would have felt less guilt about our responsibility for health care's high cost, low access and poor quality. Aetna CEO Richard Huber's Failure to "Walk the Walk" In fact, searching through the files showed an even earlier example of an Aetna CEO talking out of two sides of his mouth. By 1998, an <a href="http://www.ama-assn.org/amednews/1998/amn_98/summ1109.htm">American Medical News article </a>documented the "rocky relations" between Aetna and physicians. By early 2000, Aetna CEO Richard Huber was known as "the managed care executive physicians love to hate," <a href="http://www.ama-assn.org/amednews/2000/03/13/mksb0313.htm">per the American Medical News</a>. His departure was <a href="http://www.ama-assn.org/amednews/2000/03/13/mkca0313.htm">characterized by then American Medical News Street Smarts columnist Dr Scott Gottlieb</a>, as partly due to how <blockquote>Huber talked out of one side of his mouth about his company's obsessive quest for 'quality' health care -- while out of the other he was screaming at doctors, hospitals and drug firms about controlling costs. Yet Aetna's medical costs were still creeping up. As Richard Huber learned, you can't talk the talk if you don't walk the walk. </blockquote> Summary So the unreliability of recent Aetna CEO Ron Williams' advocacy of the "patient mandate," was presaged by similarly untrustworthy pronouncement by two former Aetna CEOs. In each case, the remarks of the particular CEO seemed more designed to promote his immediate self-interest than to provide trustworthy opinion or policy advice. By the way, this summary should not be viewed as particularly an indictment of Aetna. I am sure I could find equally untrustworthy but self-serving pronouncements from the leaders of many other health care organizations. (Recall the visionary pronouncements of the failed and ultimately jailed CEO of the now vanished Allegheny Health Education and Research Foundation, see post <a href="http://hcrenewal.blogspot.com/2008/07/10-years-later-eerie-echo-of-fall-of.html">here</a>.) The recent Ron Williams reversal should serve, however, as a stark reminder that we, meaning physicians, other health care professionals, those who study health care and health policy, policy makers, and the public at large, should be very, very skeptical about any pronouncements about health policy by top executives of health care organizations. They as a group have shown themselves to be remarkably good at doing whatever it takes to buttress their immediate self-interest, including making apparently oracular but ultimately foolish policy pronouncements. The real question is why these pronouncements continue to be treated with reverence, if not as "visionaries,"  by health care professionals, health care and policy researchers, the news media, health care and medical journals, policy makers, politicians, and the public at large? Why has hardly anyone, besides yours truly, gone back to check the accuracy of their previous pontifications before swooning over their latest ones? Why has hardly anyone examined the accuracy of their predecessors' opinions, given that most executives these days seem to be subject to the same incentives to make things look good in the short term, and never mind the consequences?

Fool Us Once, Shame on You, Fool Us Twice, Shame on Us - The Untrustworthy Pronouncements of Aetna's Former CEOs

A small tempest in the larger US health care reform teapot was produced a few weeks ago when Ron Williams, former CEO of Aetna, declared in ...

Đọc thêm »

Health Care (Insurance) Reform Upheld, but Concentration and Abuse of Power Remain Largely Unaddressed

This may seem like sour grapes, but...  Numerous media reports say that the US Supreme Court has upheld the massive US health care "reform" law (look here for <a href="http://www.reuters.com/article/2012/06/28/us-usa-healthcare-court-idUSBRE85R06420120628">Reuters coverage</a> today, and here, for <a href="http://www.latimes.com/news/politics/la-pn-justice-roberts-leads-supreme-court-support-of-healthcare-law-20120628,0,3606595.story">the Los Angeles Times</a>, for example).  In my humble opinion, the law will likely increase acess to commercial health care insurance, although will likely not reduce the expense of such insurance, or address the misbehavior of many large insurance companies (for example, see our series of posts on <a href="http://hcrenewal.blogspot.com/search/label/Aetna">Aetna</a>, <a href="http://hcrenewal.blogspot.com/search/label/UnitedHealth">UnitedHealth</a>, <a href="http://hcrenewal.blogspot.com/search/label/WellPoint">WellPoint</a>, and the <a href="http://hcrenewal.blogspot.com/search/label/health%20insurance">insurance industry in general</a>, etc, etc). The law, as we summarized <a href="http://hcrenewal.blogspot.com/2010/03/health-care-reform-bill-and-health-care.html">here</a>, does contain a few provisions relevant to the concerns we raise on Health Care Renewal.  These include measures to improve disclosure of certain kinds of conflicts of interest affecting individual physicians and health care academics, and improved funding for comparative effectiveness research.  We hoped that the law would lead to a more rational way to fix payments to physicians that might supplant the secretive, procedure-happy RUC, but so far that hope remains unfulfilled.  However, as we wrote in 2010, the legislation will leave most of the other problems we discuss on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> untouched. We thus have one or two small steps for mankind in the US, but no reason for complacency. The news is not bad.  We are probably on balance somewhat better off with some health care insurance reform than none.  However, we are still a long way from meaningfully addressing concentration and abuse of power in health care. There will be no rest for the weary bloggers of <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>.

Health Care (Insurance) Reform Upheld, but Concentration and Abuse of Power Remain Largely Unaddressed

This may seem like sour grapes, but... Numerous media reports say that the US Supreme Court has upheld the massive US health care "ref...

Đọc thêm »

FDA Safety and Innovation Act: To contain an "Appropriate, risk-based regulatory framework pertaining to health information technology"

Congress has just released an an Act "to amend the <a href="http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm" target="_blank">Federal Food, Drug, and Cosmetic (FD&C) Act</a> to revise and extend the user-fee programs for prescription drugs and medical devices, to establish userfee programs for generic drugs and biosimilars, and for other purposes."  Health IT provisions are included. This Act, S. 3187, is entitled the ‘‘Food and Drug Administration Safety and Innovation Act.’’  PDF fulltext is located at this link:  <a href="http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf">http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf</a> With regard to health IT, the Act states the following.  A risk-based regulatory framework pertaining to health IT is to be developed (emphases mine): <blockquote class="tr_bq"> <div align="left" style="font-family: Arial,Helvetica,sans-serif;">SEC. 618. HEALTH INFORMATION TECHNOLOGY.</div><div style="font-family: Arial,Helvetica,sans-serif;"></div><div align="left" style="font-family: Arial,Helvetica,sans-serif;"> </div> <div align="left" style="font-family: Arial,Helvetica,sans-serif;">(a) REPORT.—Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), acting through the Commissioner of Food and Drugs, and in consultation with the National Coordinator for Health Information Technology and the Chairman of the Federal Communications Commission, shall post on the Internet Web sites of the Food and Drug Administration, the Federal Communications Commission, and the Office of the National Coordinator for Health Information Technology, a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.</div><div style="font-family: Arial,Helvetica,sans-serif;"></div><div style="font-family: Arial,Helvetica,sans-serif;"> </div> <div align="left" style="font-family: Arial,Helvetica,sans-serif;"> </div><div align="left" style="font-family: Arial,Helvetica,sans-serif;">(b) WORKING GROUP.—</div><div align="left" style="font-family: Arial,Helvetica,sans-serif;"> </div><div style="font-family: Arial,Helvetica,sans-serif;"></div><blockquote dir="ltr" style="margin-right: 0px;"><div style="font-family: Arial,Helvetica,sans-serif;"></div><div align="left" style="font-family: Arial,Helvetica,sans-serif;">(1) IN GENERAL.—In carrying out subsection (a), the Secretary may convene a working group of external stakeholders and experts to provide appropriate input on the strategy and recommendations required for the report under subsection (a).</div><div style="font-family: Arial,Helvetica,sans-serif;"></div><div style="font-family: Arial,Helvetica,sans-serif;"> </div> <div align="left" style="font-family: Arial,Helvetica,sans-serif;">(2) REPRESENTATIVES.—If the Secretary convenes the working group under paragraph (1), the Secretary, in consultation with the Commissioner of Food and Drugs, the National Coordinator for Health Information Technology, and the Chairman of the Federal Communications Commission, shall determine the number of representatives participating in the working group, and shall, to the extent practicable, ensure that the working group is geographically diverse and includes representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary.</div> </blockquote></blockquote> While a welcome development, it is to be determined if the Working Group representatives will include critical thinkers without conflict of interest, whose contributions to the health IT debate in this country are needed a lot more than the traditional <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">hyper-enthusiasts</a>, industry courtiers and opportunists. I am actually not hopeful. The "promotes innovation" and "avoids regulatory duplication" phrases are of especially great concern.  As I've written before, "innovation" that involves non-consented experimentation is not innovation at all, it is exploitation, and "regulatory duplication" can become an excuse for milquetoast regulation by the conflicted (e.g., regulatory capture) or poorly qualified. I also note that this Act, while welcome, is long overdue - another example of putting the cart before the horse (<a href="http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html" target="_blank">link</a>), with a national project (including CMS penalties for non-adopters) now several years underway. Final thought:  if health IT were safe as has been claimed now for decades, or had been made safe through proper development and clinical trials-based testing, we would not need health IT provisions in a  "Food and Drug Administration Safety and Innovation Act" in 2012. -- SS

FDA Safety and Innovation Act: To contain an "Appropriate, risk-based regulatory framework pertaining to health information technology"

Congress has just released an an Act "to amend the Federal Food, Drug, and Cosmetic (FD&C) Act to revise and extend the user-fee p...

Đọc thêm »

The Revolving Door's Bearings Overheat - Two Examples of the Health Care Insiders Who Keep it Spinning

Two recent stories illustrate a kind of conflict of interest affecting government health care policy. Note that neither story appeared in any one media outlet, but had to be pieced together from several sources, not all contemporaneous. The Peripetatic Architect of Health Care Reform Implementation Here is the story of Steve Larsen's latest career move, <a href="http://online.wsj.com/article/SB10001424052702303822204577468680618029466.html">per the Wall Street Journal</a>, <blockquote>A top official in charge of implementing the federal health-care overhaul said Friday he would step down in mid-July, shortly after the Supreme Court is expected to rule on the fate of the law. The official, Steve Larsen, heads the office at the Centers for Medicare and Medicaid Services that oversees most of the insurance provisions in the 2010 law. Those include setting up exchanges for consumers to shop for plans and obtain subsidies for premiums, establishing rules on how much money insurers must spend on medical benefits, and administering a federal program to provide insurance for consumers with pre-existing conditions. Mr. Larsen said in an interview that his departure was '100% for personal and family reasons,' and that he hadn't considered the timing of the court decision. He cited his need to pay tuition for his college-bound children,... </blockquote> The Wall Street Journal coverage made it sound like Mr Larsen was fleeing his post to avoid dealing with how the Supreme Court's decision on the Obama administration's health care reform law might complicate future functions of his office, <blockquote>Mr. Larsen's departure highlights the challenges the administration will face once the Supreme Court rules. If the court upholds the law, the administration has a 2014 deadline to put it in place, including persuading states to set up the exchanges or establishing them on states' behalf. If the court strikes down the law's key requirement, that most individuals purchase insurance or pay a fine, federal officials will have to establish whether they can make the remaining insurance elements of the law work, which would face stiff opposition from insurance companies and from Republican lawmakers who have pledged to overturn the law. If the court voids the law entirely, officials will have to start undoing hundreds of its requirements that are set up to take effect or are, in many cases, already in place. </blockquote> It only briefly mentioned where Mr Larsen was going, ostensibly in hopes that a better salary would aid in his tuition payments, <blockquote>[he] said he would be working at a health-services business unit of UnitedHealth Group, an insurer</blockquote> On the other hand, a <a href="http://www.bna.com/cciio-director-steve-n12884910135/">report from Bloomberg </a>suggested that UnitedHealth thought he would be well worth his salary, <blockquote>Larsen will be executive vice president at Optum, a health services and information technology company that is part of UnitedHealth Group Inc., of Minnetonka, Minn., the company confirmed. UnitedHealth Group is the parent company of UnitedHealthcare, the largest health insurer in the United States in terms of policyholders and revenues. 'We are excited to welcome Steve Larsen to Optum,' company spokesman Matthew Stearns told BNA in an email. 'Steve's extensive, broad-based experience in health care will further enhance the support Optum provides to the health system and consumers in a rapidly evolving environment.'</blockquote>It is funny how that experience seemed to be about crafting the regulations under which Optum, or at least its parent corporation would have to operate. But wait, there is more. Bloomberg also mentioned that Mr Larsen had previously gone from a state government health policy position to the insurance industry before he wound up at the CCIIO. <blockquote>Prior to joining the Obama administration to implement PPACA, Larsen served in a number of capacities at Amerigroup Corp., a public managed care company serving Medicaid and Medicare beneficiaries, according to his biography on the CCIIO website. Larsen also was Maryland insurance commissioner for six years, chairman of the Maryland Public Service Commission for Gov. Martin O'Malley (D),... </blockquote>To clarify, Amerigroup is a publicly-held, Fortune 500 for-profit corporation (look <a href="http://phx.corporate-ir.net/phoenix.zhtml?c=122199&p=irol-IRHome">here</a>). So in summary, and in chronological order, as best as I can establish it, Mr Larsen went from a Maryland state government policy position that affected health (and other insurance) companies, to a health insurance company (Amerigroup), to a US government policy position that affected health insurance, and now to another health insurance company (UnitedHealth). The Peripatetic Legislative Policy Director Brett Roper moved in the opposite direction, to government from industry, and to the Republican legislative majority, not the executive branch now controlled by the Democrats. Early in June, <a href="http://www.republicreport.org/2012/brett-loper-boehner/">on the Republic Report</a>, <blockquote>In late 2010, as Congressman John Boehner (R-OH) prepared to take the gavel as Speaker, he hired a lobbyist named Brett Loper as his new policy chief. Loper left his job at the Advanced Medical Technology Association, a lobby group for medical device-makers, to join Boehner.</blockquote> The Association did not seem to sad to see him go, <blockquote>Republic Report reviewed ethics forms disclosed filed with the House clerk’s office, and noticed that Loper actually received a $100,147 bonus in 2011 for leaving his medical device lobbying group and becoming a public servant.</blockquote> But wait, there is more. Loper also previously made more than one transition between government and industry. As <a href="http://www.politico.com/news/stories/1210/46211.html">Politico reported </a>in 2010, before Loper worked for the Advanced Medical Technology Association, <blockquote>Loper worked in senior positions for then House Majority Leader Tom DeLay and as the House Ways and Means Committee Republican staff director under then-ranking member Rep. Jim McCrery of Louisiana</blockquote> But wait, there is still more. In 2011, the <a href="http://www.theatlantic.com/politics/archive/2011/04/corruption-watch-john-boehners-abramoff-connection/73396">Atlantic reported</a>, <blockquote>In December, Boehner hired Brett Loper to be his policy director. At the time, articles focused on Loper's previous job as a lobbyist for the Advanced Medical Technology, where Loper vigorously resisted attempts to reduce the deficit by fighting cuts in fees to his clients proposed by the Obama administration. That is part of the story. But missing from the pieces about Loper have been his connection to the Abramoff scandal and knowledge of how to use government money to 'nfluence'legislators. Sometimes a picture is worth a thousand words. Here is a photo of Loper (far right), basking in the tropical sun of the Marianas Islands, with Michael Scanlon (center), Jack Abramoff's partner in crime. What is Loper doing in the Marianas? As a staff member for Tom Delay, Loper was part of a mission to deliver money from the "favor factory," otherwise known as the Appropriations Committee of Congress, to two legislators in the Marianas, Norm Palacios and Alejo Mendiola (between Scanlon and Loper, above). In exchange for money for their two pet projects, Palacios and Mendiola agreed to switch their votes and support Abramoff's key ally in the Marianas, Benigno Fitial, in his bid to become Speaker of the House there. The gambit worked. Fitial won. Abramoff -- whose lobbying contract to the Marianas had been canceled -- was re-hired by the Marianas. In that capacity, Abramoff resumed lobbying for the continuation of abusive labor practices in the islands. (For more on this, see my film, 'Casino Jack and the United States of Money.') Abramoff also continued to make sure that the grateful garment factory owners flowed campaign cash to key mainland Republican legislators, including Tom Delay. </blockquote> Note that according to the <a href="http://www.washingtonpost.com/wp-dyn/content/linkset/2005/06/22/LI2005062200936.html">Washington Post web-page on the Abramoff scandal</a>, <blockquote>Former Republican lobbyist Jack Abramoff was sentenced to five years and 10 months in prison on March 29, after pleading guilty to fraud, tax evasion and conspiracy to bribe public officials in a deal that requires him to cooperate in an investigation into his relationshps with members of Congress. Sources familiar with the federal probe have told The Post that half a dozen lawmakers are under scrutiny, along with Hill aides, former business associates and government officials. The scandal prompted Rep. Tom DeLay (R-Tex.) and Rep. Robert Ney (R-Ohio) to give up their leadership posts,...</blockquote> So Mr Larsen went from Republican senior legislative staff positions, during which time he associated with the now admittedly guilty Abramoff, to an industry trade association, and then back to a Republican senior legislative staff position. Summary So here are two recent good examples of a particular type of conflict of interest involving government and health care corporations. Both cases are of people who have made multiple transitions through the "revolving door" between the health care corporate world, and government agencies and organizations that are involved in policies that affect that world. These transitions' multiplicity appears to represent a conflict of interest because these peoples' frequent revolutions through the door might diminish any sense that they ever have a primary interest on behalf of any immediate employer when another employer on the other side of the supposed arms' length government-industry relationship is always beckoning. Thus the people involved appear to have become members of a peculiar class always in transition, and hence more attuned to self-interest than to promoting the health of patients and the population (which ought to have been the primary concern for government leaders.) As Matt Kelley <a href="http://www.complianceweek.com/as-the-revolving-regulatory-door-turns/article/246085">on the Compliance Week blog </a>wrote in response to the Larsen story, <blockquote>if you ever wonder why so many Americans feel like their country is slipping away from them, the revolving door—the sense that a private club of success exists in this country, and most Americans don't get to go through it, but merely live with the dictates of those who do—is a big reason why.</blockquote>As we wrote before health policy in the US, in particular, has become an insiders' game. Unless it is redirected to reflect patients' and the public's health, facilitated by the knowledge of unbiased clinical and policy experts rather than corporate public relations, expect our efforts at health care reform to just increase health care dysfunction. Physicians, public health advocates, whatever unbiased health policy experts remain must educate the public about how health policy has been turned into a corporate sandbox. We must try to somehow activate the public to call for health care policy of the people, by the people, and for the people.

The Revolving Door's Bearings Overheat - Two Examples of the Health Care Insiders Who Keep it Spinning

Two recent stories illustrate a kind of conflict of interest affecting government health care policy. Note that neither story appeared in an...

Đọc thêm »

Banking as the Standard Healthcare Should Look Up To On Medical Information Security?

At past posts "<a href="http://hcrenewal.blogspot.com/2012/03/at-my-oct.html" target="_blank">Don't Worry, Your Electronic Medical Records Are Getting Safer With Every Passing Day</a>", "<a href="http://hcrenewal.blogspot.com/2011/09/another-episode-of-dont-worry-your.html" target="_blank">Another Episode of "But Don't Worry, Your Records are Safe...</a>" and "<a href="http://hcrenewal.blogspot.com/2011/10/still-more-ehr-chaos-pandemonium-bedlam.html">Still More Electronic Medical Data Chaos, Pandemonium, Bedlam, Tumult and Maelstrom: But Don't Worry, Your Data is Secure</a>", "<a href="http://hcrenewal.blogspot.com/2012/04/dont-worry-your-records-are-safe-part.html" target="_blank">Don't Worry, Your Records are Safe - Part IV</a>" and others, I wrote on the issue of medical record security. Banking has been held as the standard as to which medicine has been compared, with medicine being called archaic and behind the times for its reliance on paper.  Banking security is cited as a reason why electronic medical records can also be secured. There's this: <blockquote class="tr_bq"><a href="http://news.sky.com/story/952931/fraud-ring-in-hacking-attack-on-60-banks" target="_blank">Fraud Ring In Hacking Attack On 60 Banks</a>  June 27, 2012 Some 60m euro is stolen from bank accounts in a massive cyber raid, after fraudsters raid dozens of banks around the world. By Pete Norman, Sky News Online Sixty million euro has been stolen from bank accounts in a massive cyber bank raid after fraudsters raided dozens of financial institutions around the world. According to a joint report by software security firm McAfee and Guardian Analytics, more than 60 firms have suffered from what it has called an "insider level of understanding". "The fraudsters' objective in these attacks is to siphon large amounts from high balance accounts, hence the name chosen for this research - Operation High Roller," the report said. "If all of the attempted fraud campaigns were as successful as the Netherlands example we describe in this report, the total attempted fraud could be as high as 2bn euro (£1.6bn)." The automated malicious software programme was discovered to use servers to process thousands of attempted thefts from both commercial firms and private individuals. The stolen money was then sent to so-called mule accounts in caches of a few hundreds and 100,000 euro (£80,000) at a time. Credit unions, large multinational banks and regional banks have all been attacked. Sky News defence and security editor Sam Kiley said: "It does include British financial institutions and has jumped over to North America and South America. "What they have done differently from routine attacks is that they have got into the bank servers and constructed software that is automated. "It can get around some of the mechanisms that alert the banking system to abnormal activity." The details of the global fraud come just a day after the MI5 boss warned of the new cyber security threat to UK business. McAfee researchers have been able to track the global fraud, which still continues, across countries and continents. "They have identified 60 different servers, many of them in Russia, and they have identified one alone that has been used to steal 60m euro," Kiley said. "There are dozens of servers still grinding away at this fraud – in effect stealing money."</blockquote> That's all very reassuring.   Let's put all of our personal medical secrets online ASAP.  Don't worry, your information's safe and secure. -- SS

Banking as the Standard Healthcare Should Look Up To On Medical Information Security?

At past posts " Don't Worry, Your Electronic Medical Records Are Getting Safer With Every Passing Day ", " Another Episod...

Đọc thêm »

"More Marketing Than Science" - An Anonymous Confession About Deceptive Marketing Published in the British Medical Journal

The British Medical Journal just published an anonymous article by a pharmaceutical company insider that explained once again how pharmaceutical companies turn research studies, apparently scholarly articles, and medical education into stealth marketing efforts.  (See Anonymous.  Post-marketing observational studies: my experience in the drug industry.  Brit Med J 2012; 344: 28.  Link <a href="http://www.bmj.com/content/344/bmj.e3990">here</a>.) We have previously discussed examples of health care corporate insiders confessing their individual efforts to turn medical research and education into marketing.  For example, peruse <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">this</a>.  We have also discussed how documents made public through litigation have revealed marketing plans for specific drugs that used apparently academic, educational, or scholarly publications and venues to market without revealing this transformation.  For example, see the Neurontin marketing plan (see post <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a>), and the Lexapro marketing plan (see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a>).  We have also discussed numerous examples of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of particular research studies</a> by those with vested interests, and outright <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of studies</a> whose results did not favor such vested interests. Yet I suspect majorities of health care academics and professionals, health care policy makers, and the public at large do not realize, or would not admit that the evidence base for making health care decisions, and the general academic and professional discourse has been so corrupted.  So it is worthwhile to review once again how an insider summarized this corruption. Research Studies Designed Primarily as Marketing Vehicles In general, the anonymous author suggested that at least some studies were done for marketing, not scientific purposes: <blockquote>some of the studies I worked on were not designed to determine the overall risk:benefit balance of the drug in the general population. They were designed to support and disseminate a marketing message. Whether it was to highlight a questionable advantage over a 'me-too' competitor drug or to increase disease awareness among the medical community (particularly in so called invented diseases) and in turn increase product penetration in the market, the truth is that these studies had more marketing than science behind them.</blockquote> Furthermore, the studies were supervised not by physicians or scientists, but by marketers in the marketing department, <blockquote>Although the medical department developed the publication plans, designed the study, performed the statistical analysis, and wrote the final paper (which when published was passed on to marketing and sales to be used as marketing material), the marketing team responsible for that product were directly involved in all stages. They also closely supervised the content of other educational 'scientific' materials produced in the medical department and intended for potential prescribers. Instructions from marketing to the medical staff involved were clear: to ensure that the benefits of the drug were emphasised and the disadvantages were minimised where possible.</blockquote> Manipulation of Research Design, Implementation, or Analysis The author described how the marketers manipulated research studies so they would produce the results desired from a marketing perspective, regardless of their underlying truth, <blockquote>Since marketing claims needed to be backed-up scientifically, we occasionally resorted to 'playing' with the data that had originally failed to show the expected result. This was done by altering the statistical method until any statistical significance was found. Such a result might not have supported the marketing claim, but it was always worth giving it a go to see what results you could produce. And it was possible because the protocols of post-marketing studies were lax, and it was not a requirement to specify any statistical methodology in detail. On the other hand, the studies were hypothesis testing (such as cohort studies, case-control studies) rather than hypothesis generating (such as case reports or adverse events reports), so playing with the data felt uncomfortable. Other practices to ensure the marketing message was clear in the final publication included omission of negative results, usually in secondary outcome measures that had not been specified in the protocol, or inflating the importance of secondary outcome measures if they were positive when the primary measure was not.</blockquote> So to summarize, the marketers would control the statistical analyses, promoting multiple analyses to attempt to come up with the "right" result that would support the marketing message (although the more kinds of analyses one tries, the more likely one is likely to come up with false results by chance alone). Presumably the marketers did not care whether or not the results were really true, which is perhaps why even they felt "uncomfortable" in some circumstances. They would also foster the suppression of negative results, and the dredging of data for extra outcome measures when analysis showed no advantage in terms of the real primary outcomes. Suppression of negative results could be viewed as plain lying. Deliberate analysis of multiple end-points again risks identifying random error as true results. The Role of Key Opinion Leaders The author described how key opinion leaders, that is, health care professionals thought to be especially influential on practice or policy, were hired to become marketers presumably without revealing this intention. <blockquote>Every big international observational study had a large advisory board. This was critical since the success of a newly launched drug in the market would depend on how many key opinion leaders were part of the study. Not only would they add credibility to the results, but they would also be key in influencing decision makers and other prescribers. In regional studies with thousands of patients, the study’s advisory board was formed by at least one key opinion leader from each country in that region, ensuring that areas important in terms of possible sales were covered. The contributions of the key opinion leaders to the study were always positive, but in my experience more directed towards designing new studies to answer their specific clinical questions rather than critically appraising our results and conclusions. In general, the relationship was amicable. We took them to the best hotels and restaurants during our advisory board meetings, and they appeared as authors in our research. Later, they would act as the company’s 'ambassadors,' giving conferences, teaching doctors, or talking to the media about the benefits of the drug.</blockquote> Note that even the anonymous author could not bring him or herself to call the key opinion leaders salespeople, or marketers, but used the ambiguous wterm "ambassadors." Nonetheless, the role of key opinion leaders described would clearly be that of marketers or salespeople. However, it is extremely doubtful that any of these KOLs felt they had to declare that they were paid salespeople when presenting at conferences, teaching doctors, or talking about the media. I would suggest that their actions would therefore fit <a href="http://www.transparency.org/whoweare/organisation/faqs_on_corruption">Transparency International's definition</a> of ethical corruption, "abuse of entrusted power for private gain." The KOLs are entrusted to be professional, and in many cases, scholarly. Using a professional or scholarly guise to act as a salesperson appears to be abuse of that entrusted power, in my humble opinion. In nearly every case, KOLs are paid, often handsomely, by the companies whose products they are selling. Thus, key opinion leaders acting as described by the anonymous author appear to be ethically corrupt. Summary The evidence of unethical marketing practices by commercial health care firms is mounting. Although I am most familiar with evidence from the US, there is mounting evidence that these practices are global, often done by companies that are not US based, and meant to influence practice and policy world-wide. As the evidence mounts, it becomes increasingly clear that many such marketing practices are corrupt, at least in an ethical sense. Whether they may break laws in particular countries is a question for someone else. The latest BMJ article is a reminder how skeptical the shrinking group of health care professionals who do not have conflicts of interest, are not biased in favor of particular products, and who put patients' interests first must be about ALL published research, scholarly publications, and apparently educational activities. Advocates of true evidence-based medicine must be extremely careful to try to use the least biased and manipulated parts of the evidence-base. The mounting evidence suggests that at a minimum, all research reports, scholarly articles, media reports, conferences, and educational programs should provide full, detailed disclosure of all conflicts of interest. Perhaps having to make a declaration like "I am paid 50,000 Euros a year by the marketing department of company X to help market drug Y" before a supposedly educational talk would make some health care professionals think twice about such relationships. However, even such detailed disclosure may not be sufficient to hamper marketing practices that now appear overtly corrupt. In my humble opinion, it is time to consider a global ban on the funding or influencing of human research by companies and other organizations which stand to gain financially according to the results of the research, or whose products and services are subject of such research. It is also time to consider a global ban on the funding or influencing of health care education by such organizations. However, so many people are making so much money from the current practices that I doubt such proposals would get much support, or even public notice beyond this humble blog.

"More Marketing Than Science" - An Anonymous Confession About Deceptive Marketing Published in the British Medical Journal

The British Medical Journal just published an anonymous article by a pharmaceutical company insider that explained once again how pharmaceut...

Đọc thêm »