Forwarded message from "veracare" <[email protected]> [ Subject: Doctors Without Borders: Don't Trust Medical Journals [ From: "veracare" <[email protected]> [ NNTP-Posting-Host: 220.127.116.11 [ Date: 15 Apr 2004 00:24:43 -0500 ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and full disclosure http://www.ahrp.org FYI Doctors Without Borders in the Washington Monthly (excerpt below), looks at the intricate web of collaborating players in medicine who are financially tied one and all-like cogs in a wheel--to the pharmaceutical industry. Shannon Brownlee tells the story of how medicine has been diverted, in blatant and subtle ways, from its traditional focus of treating patients and exchanging information freely (from clinical practice and research) about what works, what doesn't. Within the last twenty years or so, the culture of medicine has radically shifted. When the university embraced corporate financial incentives those corporate sponsors gained inordinate influence over the funding of both private and public research. Industry sets the research agenda, short circuiting accepted ethical safeguards, and inserting bias into the scientific literature. Demonstrably the peer-review system for ferreting out bias and scientifically questionable reports from scientific journals has failed utterly because the journals have grown accustomed to industry's copious advertising dollars. Brownlee writes: "That means that the studies published in scientific journals like Nature and The New England Journal of Medicine [and The Journal of the American Medical Association]--those critical reference points for thousands of clinicians deciding what drugs to prescribe patients, as well as for individuals trying to educate themselves about conditions and science reporters from the popular media who will publicize the findings--are increasingly likely to be designed, controlled, and sometimes even ghost-written by marketing departments, rather than academic scientists." A prime example of industry's insidious influence is the indiscriminate prescribing of SSRI antidepressants for children--the result of the collaborative efforts of industry, the media, and the academic based psychiatric and pediatric establishment that promulgated a myth about these drug' safety and efficacy. For example, a recent report in JAMA, accompanied by an editorial by a prominent Harvard psychiatrist, pronounced the antidepressant drug, Zoloft, to be "effective and well tolerated for children and adolescents." See: Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder: two randomized controlled trials by Wagner KD, Ambrosini P, Rynn M, Wohlberg C, Yang R, Greenbaum MS, Childress A, Donnelly C, Deas D; Sertraline Pediatric Depression Study Group. JAMA. 2003 Aug 27;290(8):1033-41 However, an examination of the actual data refutes those JAMA backed claims. Recently, even FDA officials acknowledged that pediatric SSRI studies that were reported in medical journals as positive, were in fact negative. See, for example: FDA Background Memorandum on Suicidality Associated with Antidepressant Drug Treatment, by Thomas Laughren to Members of PDAC and Peds AC, January 5, 2004. http://www.fda.gov/ohrms/dockets/ac/04/briefing/4006B1_03_Background Memo% 2001-05-04.htm When previously concealed evidence was publicly disclosed in the UK, several antidepressant drug manufacturers issued warnings about the drugs' risks of harm, acknowledging that antidepressants have not demonstrated a benefit for children but present a two-to-three fold increased risk of suicidal behavior in children. See GlaxoSmithKline letter: http://www.ahrp.org/risks/PaxilRisks0603.html See Wyeth letter: http://www.ahrp.org/risks/effexorLtr082203.html See Eli Lilly's revised Prozac UK label (Dec. 2003) stating that Prozac is NOT RECOMMENDED FOR CHILDREN. http://www.ahrp.org/infomail/03/12/19.html Unless the entire medical research community claims professional incompetence, one can only conclude that the psychiatric / medical research establishment has been complicit in concealing vital safety information from prescribing doctors and the public. The motive is no mystery: public disclosure about these drugs' hazards will negatively impact on sales. *Of particular note* As a source of information for the Brownlee article, I know that it was originally written at the request of a major national news magazine only to be canned. An obvious question arises: did the editors of that news magazine reject the article because its content conflicts with the interests of the publication's advertisers? Contact: Vera Hassner Sharav Tel: 212-595-8974 e-mail: [email protected] http://www.washingtonmonthly.com/features/2004/0404.brownlee.html Washington Monthly, April 2004 Doctors Without Borders Why you can't trust medical journals anymore. By Shannon Brownlee With financial ties to nearly two dozen drug and biotech companies, Dr. Charles B. Nemeroff may hold some sort of record among academic clinicians for the most conflicts of interest. A psychiatrist, a prominent researcher, and chairman of the department of psychiatry and behavioral science at Emory University in Atlanta, Nemeroff receives funding for his academic research from Eli Lilly, AstraZeneca, Pfizer, Wyeth-Ayerst--indeed from virtually every pharmaceutical house that manufactures a drug to treat mental illness. He also serves as a consultant to drug and biotech companies, owns their stocks, and is a member of several speakers' bureaus, delivering talks--for a fee--to other physicians on behalf of the companies' products. But it was just three of Nemeroff's many financial entanglements that caught the eye of Dr. Bernard J. Carroll last spring while reading a paper by the Emory doctor in the prominent scientific journal, Nature Neuroscience. In that article, Nemeroff and a co-author reviewed roughly two dozen experimental treatments for psychiatric disorders, opining that some of the new treatments were disappointing, while others showed great promise in relieving symptoms. What struck Carroll, a psychiatrist in Carmel, Calif., was that three of the experimental treatments praised in the article were ones that Nemeroff stood to profit from--including a transdermal patch for the drug lithium, for which Nemeroff holds the patent. Carroll and a colleague, Dr. Robert T. Rubin, wrote to the editor of Nature Neuroscience, which is just one of a family of journals owned by the British firm, Nature Publishing Group, pointing out the journal's failure to disclose Nemeroff's interests in the products he praised. They asked the editor to publish their letter, so that readers could decide for themselves whether or not the author's financial relationships might have tainted his opinion. After waiting five months for their letter to appear, the doctors went to The New York Times with their story--a move that sparked a furor in academic circles, and offered the public yet another glimpse into conflict of interest, one of the most contentious and bitter debates in medicine. In his defense, Nemeroff told the Times he would have been happy to list his (many) relationships with private industry--if only the journal had asked. "If there is a fault here," he said, "it is with the journal's policy," which did not require authors of review articles to disclose their conflicts of interest. And that is pretty much where the debate over conflict of interest in medical journals stands: Should research scientists who have financial stakes in the products they are writing about be forced to disclose those ties? To which the average person might reasonably respond, of course they should. But the more pertinent question is why scientists with financial stakes in the outcome of scientific studies are allowed anywhere near those studies, much less reviewing them in elite journals. The answer to that question is at once both predictable and shocking: For the past two decades, medical research has been quietly corrupted by cash from private industry. Most doctors and academic researchers aren't corrupt in the sense of intending to defraud the public or harm patients, but rather, more insidiously, guilty of allowing the pharmaceutical and biotech industries to manipulate medical science through financial relationships, in effect tainting the system that is supposed to further the understanding of disease and protect patients from ineffective or dangerous drugs. More than 60 percent of clinical studies--those involving human subjects--are now funded not by the federal government, but by the pharmaceutical and biotech industries. That means that the studies published in scientific journals like Nature and The New England Journal of Medicine--those critical reference points for thousands of clinicians deciding what drugs to prescribe patients, as well as for individuals trying to educate themselves about conditions and science reporters from the popular media who will publicize the findings--are increasingly likely to be designed, controlled, and sometimes even ghost-written by marketing departments, rather than academic scientists. Companies routinely delay or prevent the publication of data that show their drugs are ineffective. The majority of studies that found such popular antidepressants as Prozac and Zoloft to be no better than placebos, for instance, never saw print in medical journals, a fact that is coming to light only now that the Food and Drug Administration has launched a reexamination of those drugs. Today, private industry has unprecedented leverage to dictate what doctors and patients know--and don't know--about the $160 billion worth of pharmaceuticals Americans consume each year. This is an unsettling charge that many (if not a majority) of doctors and academic researchers don't want to acknowledge. Once grasped, however, the full scope and consequences of medical conflict of interest beget grave doubts about the veracity of wide swaths of medical science. As Dr. Drummond Rennie, deputy editor of The Journal of the American Medical Association (JAMA), puts it, "This is all about bypassing science. Medicine is becoming a sort of Cloud Cuckoo Land, where doctors don't know what papers they can trust in the journals, and the public doesn't know what to believe." Clinical trial and error How did we get to this point? What effect is industry influence having on the treatment of patients? And why are the medical journals not more vigilant to weed out papers that have been distorted by conflict of interest? The answers to these questions begin, oddly enough, with an amendment to U.S. patent law called the Bayh-Dole Act. Passed in 1980, Bayh-Dole for the first time permitted universities to commercialize products and inventions without losing their federal research funding, the seed money for innovative research. The brainchild of George Keyworth II, President Reagan's science advisor, who was watching the United States get beaten in world markets by the Japanese, Bayh-Dole was intended to stimulate advanced technological invention and speed its transfer from university labs into private industry, where it could be put to work spurring U.S. productivity. It seemed like a win-win proposition. Indeed, Bayh-Dole has helped launch the biotech industry and has propelled several life-saving products to market. The basic research behind Gleevec, for instance, an incredibly effective new anti-cancer drug, was done by a university scientist. The drug's manufacturer, Novartis, stepped in and provided additional funding for development. In 1984, private companies contributed a mere $26 million to university research budgets. By 2000, they were ponying up $2.3 billion, an increase of 9,000 percent that provided much needed funds to universities at a time when the cost of doing medical research was skyrocketing. That's the upside. The downside is that Bayh-Dole has also fostered increasingly cozy relationships between the academics upon whom the nation depends for unbiased medical information and Big Pharma, private companies whose main goal, let's face it, is making a profit. And we're talking serious money here. In addition to the salaries built into company-sponsored research grants, academic clinicians at medical schools can pad their already decent incomes with $1,000-a-day consulting contracts with pharmaceutical companies, patent royalties, licensing fees, and big-payoff stock options. Nemeroff stood to reap as much as $1 million in stock from a company that manufactured one of the products in his Nature Neuroscience paper. At many of the top research universities and medical schools around the country, a substantial percentage of the faculty enjoys the perks of industry relationships. At MIT, 31 percent of the science and engineering faculty has outside income; at Stanford Medical School, it's 20 percent. What's in it for the pharmaceutical companies? Simple economics. It's Marketing 101. By penetrating the wall that once existed around academic researchers, drug companies have gained access to the "thought leaders" in medicine, the big names whose good opinion of an idea or a product carries enormous weight with other physicians. Companies target academic KOLs, or Key Opinion Leaders, in the lexicon of marketing, and woo them with invitations to sit on scientific advisory committees, or to serve as members of speakers' bureaus, which offer hefty fees for lending their prestige to a company and touting its products at scientific meetings and continuing medical education conferences. Of course, KOLs must be convinced of their own impartiality, says Carl Elliott, a moral philosopher at the University of Minnesota and author of Better Than Well: American Medicine Meets the American Dream. "If they understood that they were being used as industry mouthpieces, they would probably pull the plug on the whole enterprise." Drug companies encourage their KOLs to consult for multiple companies so the appearance of objectivity can be maintained. But the drug industry's most powerful means of boosting the bottom line is funding research, which allows companies to control, or at least influence, a great deal of what gets published in the medical journals, effectively turning supposedly objective science into a marketing tool. "These are not benign people who are interested in helping people with their new wonder drugs," says Drummond Rennie. "The drug companies are run by hard-nosed marketers, not by the physicians and the scientists. They use what works, and money works." Rennie, who has a thatch of unkempt white hair and remnants of the accent of his native Leeds, England, got a clear picture of the extent to which drug companies will go to control the results of studies they fund in 1993, when a colleague at University of California San Francisco tried to publish a paper in JAMA in 1993 on the metabolic activity of four different forms of thyroid hormone. Betty J. Dong, a pharmacologist, had been contracted in 1987 by Flint Laboratories to run a clinical trial comparing Synthroid, Flint's synthetic version of thyroid hormone, to that of three competing formulations. At the time, Synthroid was the market leader and the most expensive drug in its class. Dong and Flint signed a lengthy agreement detailing the design of the study, and both sides fully expected the results would show that Synthroid was superior. But all four drugs turned out to be essentially equivalent. In 1990, as Dong prepared a paper for JAMA, the company that was at first so eager to solicit her help, launched a vigorous campaign to discredit the study. Flint then rushed its own paper into press at a less prestigious journal, concluding--surprise!--that Synthroid was superior. After numerous attempts to address the company's criticisms, Dong finally submitted her paper to JAMA, only to withdraw it three months later when the firm threatened to sue for breach of contract. It took the FDA and U.S. Department of Health and Human Services to get the company to back down. Dong's paper did not see print in JAMA until 1997. Xxx cut xxx When industry has penetrated every level of medicine from the lab bench to the FDA advisory panels, from the pages of the medical journals to your doctor's prescription pad, how are physicians to make decisions about treating their patients? How are they to know whether or not expensive calcium channel blockers are really better than over-the-counter diuretics for high blood pressure? (They're not.) Should you take a mildly depressed teenager to a psychotherapist, or put him on an antidepressant and risk sending him into a suicidal tailspin? Maybe a cholesterol-lowering statin drug will prevent this patient from suffering a heart attack, as the studies claim. Then again, maybe it will simply cause her muscles to break down and destroy her kidneys, one of the drug's side effects. .cut.. Shannon Brownlee is a fellow at the New America Foundation. FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. 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