Discussion in 'Health and medical' started by Dr. Jai Maharaj, Apr 18, 2004.

  1. Forwarded message from "veracare" <[email protected]>

    [ Subject: Doctors Without Borders: Don't Trust Medical Journals
    [ From: "veracare" <[email protected]>
    [ NNTP-Posting-Host:
    [ Date: 15 Apr 2004 00:24:43 -0500


    Promoting openness and full disclosure


    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

    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. Memo%

    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:
    See Wyeth letter:
    See Eli Lilly's revised Prozac UK label (Dec. 2003) stating that Prozac is

    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]

    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.

    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

    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.

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    End of forwarded message from "veracare" <[email protected]>

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