Medicine becoming cloud cuckoo land--JAMA deputy ed.

Discussion in 'Health and medical' started by Zee, Apr 8, 2004.

  1. Zee

    Zee Guest

    "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." Dr. Drummond
    Rennie, deputy editor of The Journal of the American
    Medical Association (JAMA),

    Washington Monthly, April 2004 <http://www.washingtonmonthl-
    y.com/features/2004/0404.brownlee.html>

    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
    Ds. 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.

    In this case, it might seem as if the only real harm to the
    public during the seven years that elapsed from the time
    Dong completed her study to its publication was higher
    prices to patients and insurers. To Rennie's way of
    thinking, the Dong imbroglio and others like it have a more
    insidious effect by sending a chilling message to
    scientists, namely, don't bite the hand that feeds you. In a
    recent survey of clinical researchers, nearly 20 percent of
    respondents admitted to delaying publication of their
    results by more than six months at least once in the last
    three years to allow for patent application, protect their
    scientific lead, or to slow the dissemination of results
    that would hurt sales of their sponsor's product--often
    without overt pressure from the company. "If you're getting
    a lot of money from a corporate sponsor, it's easy to get
    the impression that you'll get even more for future research
    if you don't write up the negative results," says Rennie--
    and that your funds will dry up if you do.

    The bottom line is that articles appearing in medical
    journals contain a lot of happy talk about medical products.
    At least eight studies have shown that industry-sponsored
    research that gets published tends to produce pro-industry
    conclusions, according to a review by Yale University
    researchers that appeared last year in JAMA. By reanalyzing
    data from eight separate studies of the effect of conflict
    of interest on 1,140 published scientific papers, the
    researchers found that papers based on industry-sponsored
    research are significantly more likely to reflect favorably
    on a sponsoring company's drug or device than research that
    is supported by a non-profit entity or the federal
    government.

    How can this be? Isn't science, well, scientific, an
    objective search for the truth? That's what many academic
    clinicians, especially those who are mixed up with corporate
    sponsors, would have the public believe. A typical comment
    comes from Niels Reimers, an early promoter of industry-
    university ties, who told the Hartford Courant, "You may
    think I'm a Pollyanna or something, but most people are
    honest. It's sort of the ethos of academic research." Here's
    Dr. Irwin Goldstein, a Boston University urologist who has
    consulted for at least seven companies developing impotence
    therapies: "Science is science. It comes down to the bottom
    line. What the data shows, the data shows."

    Such statements reflect the ideal of science, not the
    reality, says
    Dt. Marcia Angell, former editor in chief of The New England
    Journal of Medicine. Public protestations aside, she
    says, "Clinicians know privately that results can be
    jiggered. You can design studies to come out the way you
    want them to. You can control what data you look at,
    control the analysis, and then shade your interpretation
    of the results." Even the most careful research can be
    fraught with murky results that require sifting and
    weighing, a measure of judgment that the researcher
    hopes will bring him closer to the truth. Was this
    patient's headache caused by the antibiotic you gave
    her, or does she have a history of migraines? Is that
    patient's depression lifting because of the drug you are
    testing, or because a kindly doctor is actually
    listening to him?

    Sometimes there isn't much that journal editors can do to
    separate good science from that which has been weighed,
    sifted, and jiggered according to a corporate sponsor's
    needs. Increasing numbers of studies that get published are
    actually written by PR firms, "medical communications"
    specialists, who then go out and recruit an academic willing
    to put his name on the paper, for a fee. Other studies
    simply omit data that detract from the sponsor's message. In
    September 2000, for example, JAMA published a paper
    comparing the prescription painkiller Celebrex to over-the-
    counter ibuprofen. The manufacturer of the prescription
    drug, known as a selective Cox-2 inhibitor, launched the
    study in order to show that Cox-2 inhibitors, a class that
    also includes the prescription drug Vioxx and was already
    worth $3.5 billion a year, cause fewer instances of bleeding
    in the stomach and intestine than either aspirin or
    ibuprofen. The huge study, which looked at six months of
    data from more than 8,000 patients, produced unambiguous
    results: There were fewer side effects among patients on the
    Cox-2 drug.

    A year later, news surfaced that patients had actually been
    followed for 12-15 months at the time the JAMA paper came
    out, not six, and that during the second half of the study,
    the group taking the Cox-2 drug suffered higher rates of
    gastrointestinal side-effects than patients on the over-the-
    counter painkiller. To make matters worse, patients on the
    Cox-2 developed serious heart problems three times more
    often than those on ibuprofen. The authors of the paper--all
    of them either consultants to the manufacturer or
    employees"defended their decision to report only the first,
    positive, half of their study, saying several patients who
    weren't taking the Cox-2 drugs dropped out after six months,
    making the statistics more difficult to analyze. But Dr.
    Catherine D. DeAngelis, JAMA's editor in chief, told The
    Washington Post: "I am disheartened. We are functioning on a
    level of trust that was, perhaps, broken."

    Disheartened? Not furious? No, because DeAngelis could not
    know for certain whether or not the authors held back half
    the data in order to make their sponsor's drug look
    better"no matter how likely that explanation may seem. When
    researchers submit papers to a journal, the editor has
    little choice but to trust the authors have employed a
    ruthless skepticism when viewing their own results, that
    they have bent over backwards to minimize self-delusion.
    Editors and peer reviewers can ferret out sloppy reasoning,
    look at how an author has designed and executed a study, and
    correct faulty statistics, but as Angell remarked, "We don't
    put bamboo slivers under their nails. If they wanted to lie,
    they could lie."

    Articles of faith

    Du. Arnold Relman began worrying about this problem way back
    in 1977, when he became editor-in-chief of The New
    England Journal. That year, Relman got a call from a
    reporter about a paper that was due to appear in the
    next issue, discussing serious side effects--including
    lowering a man's testosterone and sperm counts--of a
    popular antacid. The reporter wanted to know what Relman
    intended to do about the fact that Wall Street analysts
    had acquired early copies of the paper and now the stock
    of the company that made the drug was falling.

    Relman, who began practicing medicine in the 1950s and
    calls himself a "relic," says before that reporter's call,
    it had never occurred to him that medical research could
    have financial consequences for industry. But the more he
    thought about it, he told me recently, "The more I became
    convinced that the commercialization of medical practice
    and medical research, and the use of the information for
    commercial purposes, was a major threat to the integrity of
    the whole system." He recognized that medical researchers,
    being only human, would have trouble applying that ruthless
    skepticism that was so necessary to good science when there
    was money at stake.

    The obvious solution to Relman and Angell, who was by then a
    deputy editor at The New England Journal of Medicine, was
    disclosure. Forcing authors to tell the world they were
    taking industry money, the editors reasoned, would prompt a
    little soul-searching among researchers who might otherwise
    be inclined to turn a blind eye to negative results or shade
    conclusions in favor of a corporate sponsor. It would put
    them on notice that readers would be watching. The editors
    also figured that disclosure would help readers judge the
    validity of an author's conclusions. "They could evaluate
    the data for themselves," Relman told me recently. "But the
    discussion, the interpretation by the author can be slanted
    . . . it was still important for readers to know when
    articles were sponsored by industry." JAMA, largely at
    Rennie's urging, followed suit soon after.

    Six years later, Relman upped the ante by barring
    researchers with conflicts of interest from writing
    editorials or review articles--like the one penned in Nature
    Neuroscience by Charles Nemeroff"because they carry great
    weight with doctors in private practice. Angell explains
    their decision like this: "Imagine a judge who has before
    him a case involving two companies suing each other--and he
    owns one of the companies. And he says, 'Not to worry. I'm a
    judge and I learned how to evaluate things in a
    dispassionate way.' He'd be laughed out of court." She and
    Relman argued that just as judges must recuse themselves
    from cases in which they have financial ties to a litigant,
    editorialists and review authors with conflicts of interest
    should refrain from offering medical opinions.

    Angell was still defending that decision a decade later, as
    editor in chief at the Journal, when she wrote in 2000 that
    disclosure was not sufficient to preserve the integrity of
    the science that appeared in her journal's pages: "We
    believe that a policy of caveat emptor is not enough for
    readers who depend on the opinion of editorialists." Why was
    it necessary to defend the Journal's policies? Partly
    because authors were ignoring them. In 1997, when Sheldon
    Krimsky, a professor of public policy at Tufts University,
    surveyed 61,134 articles in some 181 journals, he found that
    only 0.5 percent disclosed a conflict of interest related to
    the topic of the article, an impossibly low number given the
    fact that a quarter of biomedical researchers at the time
    were receiving funding from industry. The reason for this
    low rate of disclosure, as Krimsky notes dryly in his book,
    Science in the Private Interest, is that "author compliance
    is not especially high."

    "Lots of eminent people took great offense at being accused
    of being influenced," Relman told me recently. "'What an
    insulting thing to say. I value my reputation; doctors and
    scientists know best. Trust us.' I spent the first 25 years
    of my career doing clinical research and being one of them,
    and I know the feeling." As Harvey Lodish, professor of
    biology at MIT, huffed to Technology Review in 1984, when
    Relman first required disclosure at the Journal, "Scientists
    have all kinds of private consulting arrangements with
    biotechnology companies and many own stock in these
    companies, but that's nobody's business. It has nothing to
    do with the quality of their research."

    "They actually believe that they aren't influenced," says
    Angell. Aside from the fact that it's not in physicians' self-
    interest to acknowledge the effects of corporate money, they
    may have a hard time seeing the problem for the same reason
    fish don't know they're swimming in water: Doctors are
    surrounded by conflicts of interest almost from the moment
    they arrive at medical school. Pharmaceutical companies
    begin wooing young doctors with small tokens at first, pens
    and coffee mugs emblazoned with drug logos, then escalating
    to pizza night for medical residents, dinners at expensive
    restaurants and tickets to sporting events. Most schools
    offer a class in medical ethics, but there's no requirement
    that they discuss conflict of interest. Besides, a few
    lectures can't outweigh the message young doctors absorb
    every day, as they watch the icons in their profession--
    their professors, visiting lecturers, heads of departments--
    taking gifts, speaking on behalf of companies, flying first-
    class to medical meetings in Paris and Honolulu. By the time
    medical residents enter private practice or the lab, the
    gifts from industry no longer seem like gifts, but
    entitlements"just another way to be compensated for all
    those brutal, slogging years of lousy pay and long nights.

    A journalist friend of mine recently told me about the day
    his then-girlfriend, who was a neurosurgeon, received a
    check for several hundred dollars in the mail, along with a
    note from a drug company representative. It seemed his
    girlfriend had made favorable mention of a particular drug
    during a lecture she delivered a few days earlier, and the
    money was just a little thank you from the manufacturer.
    When my friend told her she could not in good conscience
    cash the check--that it was a conflict of interest--she
    looked at him, he said, as if he were speaking in some
    unintelligible language.

    This deafness to the power of money to corrupt medical
    science leads physicians and scientists to display an
    arrogance and a remarkable naïvete, both of which were very
    much in evidence in a snippy editorial entitled, "Avoid
    Financial 'Correctness,'" written in 1997 by the editors at
    Nature. They derided disclosure as a waste of time, writing,
    "This journal will persist in its stubborn belief that the
    research as we publish it is indeed research, not business."
    The Nemeroff case has not changed the editors' view
    substantially, although they did alter their policy after it
    broke. Nature Publishing now requires editorial and review
    writers, along with the authors of original research papers,
    to inform readers whether or not they have conflicts of
    interest, or to say they decline to declare. Charles
    Jennings, executive editor of Nature, says they have no
    intention of following the New England Journal in barring
    editorialists who have conflicts. "I flatly disagree with
    that policy," he told me. "That would exclude many of the
    leading experts. You don't want a policy that prevents
    Thomas Edison from writing about the future of electricity.
    Our position is for readers to decide for themselves about
    whether an author is biased."

    Of course, most readers, especially practicing physicians,
    don't have the expertise or the resources to decide for themselves--
    to know how the studies might have been constructed
    differently, whether the conclusions have been shaded to
    favor the author's sponsor, or which data the author decided
    conveniently to leave out of the article. Knowing that an
    author might be biased doesn't aid in determining the extent
    and nature of the bias. It's not as though there will be two
    articles, one by a biased writer and one by an unbiased
    writer, published side by side to allow readers to identify
    the differences. Besides, conflicts of interest are now so
    pervasive, says Rennie, many readers scarcely take note,
    even when they're disclosed.

    Race for the cure?

    It's tempting to wonder what medical research would look
    like if universities and medical associations and editors of
    journals stopped talking about how to manage conflict of
    interest and started thinking about how to expunge it. Just
    say no. Proponents of Bayh-Dole will object, claiming the
    pace of medical advances will slow to a crawl, but bear with
    me for a moment and just imagine a different universe. Let's
    start with the medical schools"those temples of higher
    learning. They would be the first to cast out the drug
    merchants. Hospitals would pay their medical residents a
    decent wage so they can afford to buy their own beer and
    pizza. FDA advisory panelists who have a financial stake in
    the drug being considered would not be allowed to vote. And
    if the journals stopped publishing papers and editorials
    penned by academic clinicians with conflicts of interest,
    authors would be forced to choose between taking scientific
    credit and taking the money.

    Of course, that's not going to happen unless academic
    clinicians somehow decide there's something wrong with the
    status quo. In Sheldon Krimsky's view, the only way to deter
    conflict of interest is for academics to feel shame. Maybe
    so, but as a journalist who has spent a decade and a half
    peering at medicine from the outside, nose pressed to the
    glass, I'm struck more than anything by the apparent lack of
    shame among clinicians when it comes to this issue.

    Here's a little thought experiment. Imagine that a
    medical journalist"me, for instance"makes a tidy sum
    writing press releases

    maybe just enough to cover a year's tuition for my son's
    private high school. And let's say for the sake of argument
    I also buy a few dozen Pfizer shares. Then I turn around and
    write a story for The New York Times about several new drugs
    for treating erectile dysfunction.

    What would you think, dear reader, should my financial
    relationship with the pharmaceutical company that makes one
    of the drugs featured in my story come to light? Would you
    have reason to doubt its objectivity and accuracy? Of course
    you would. Not only that, I would be ashamed to show my face
    in any newsroom, and I would not be writing for the Times
    again. I'm not trying to claim that journalists are paragons
    of virtue, but we have no illusions about our ability to
    withstand temptation and avoid shading what we say when
    faced with a wad of cash.

    Not so in medical research. In that world, the author of a
    review article can have direct financial relationships with
    the manufacturers of drugs he is critiquing and still argue
    he has done nothing unsavory. What that suggests is a sense
    of fiduciary responsibility is not built into the
    professional code of medicine, a doctor's internal compass
    of right and wrong.

    And of course there are also pecuniary reasons not to
    acknowledge the power of money. The fact is, universities
    and doctors have become so dependent on industry largesse
    they can't even imagine disentangling themselves. Repeal the
    Bayh-Dole Act? Not on your life. Kick the drug
    representatives who wheel their little carts filled with
    sample packets of drugs out of your office? Who would pay
    for all those trips to medical meetings in exotic locales?

    Company line

    And so they try to manage it. About half of universities
    require that faculty disclose their conflicts of interest. A
    scant 19 percent set limits on the outside financial
    interests faculty may hold. Harvard University, long
    considered a paragon of scientific virtue, is now
    considering relaxing its rules governing industry
    collaborations. Now that Angell is gone, even the once-
    starchy New England Journal has loosened its restrictions on
    editorialists and review writers, who are now free to enjoy
    some corporate largesse, just not too much. "They think it's
    possible to be virtuous and rich at the same time, to take
    money from companies and then manage it," says Angell. "They
    come up with rules that are so complicated in order to give
    the appearance of worrying about this, when what they are
    really worried about is the money might go away."

    All their managing doesn't seem to be working, and we are
    the ones who will suffer the consequences. In March 2000,
    the FDA yanked a diabetes drug called Rezulin off the market
    after it had been linked to at least 90 cases of liver
    failure and 63 deaths. The withdrawal came three years after
    the agency had approved the drug to great fanfare. Articles
    in the popular media quoted diabetes experts who praised
    Rezulin, calling it "a truly novel approach," and the
    manufacturer, Warner-Lambert, enjoyed a spectacular 144
    percent rise in its stock price.

    By the fall of 1997, however, the FDA had already begun to
    receive reports of patients on Rezulin suffering liver
    failure, a side-effect that the agency's advisory panel
    glossed over during its deliberations. A paper published
    in the New England Journal also made scant reference to
    liver toxicity, saying the drug was "well tolerated, and
    most adverse events were considered to be related to the
    underlying diabetes." Several clinicians with ties to the
    company subsequently urged the FDA not to withdraw the
    drug, even as the body count was rising. According to a
    Los Angeles Times investigation, at least 12 of 22
    scientists who played a central role in the federally-
    funded study of Rezulin received research funding or other
    compensation from Warner Lambert, while four of the 12
    voting members of the FDA advisory panel that approved
    Rezulin, and kept it on the market an extra 30 months, had
    financial ties to the company.

    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.

    And what about us patients? What are we to do with the
    knowledge that much of what passes as science in medicine is
    little more than gussied-up marketing? There isn't much we
    can do. And so, I say if you're ill, if you are ailing, or
    just sick at heart, go find a doctor who listens, who holds
    your hand. Just make sure you find a doctor who looks at
    evidence, not opinion, and when she pulls out the
    prescription pad, start asking a lot of questions.
     
    Tags:


  2. Sonos

    Sonos Guest

    On 8-Apr-2004, [email protected] (Zee) wrote:

    > "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." Dr. Drummond
    > Rennie, deputy editor of The Journal of the American
    > Medical Association (JAMA),

    usenet is not so bad after all. : )

    --
    Winning against heart attack and stroke
    http://www.sonoscore.com
     
  3. Zee wrote:

    > "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." Dr. Drummond
    > Rennie, deputy editor of The Journal of the American
    > Medical Association (JAMA),
    >
    > Washington Monthly, April 2004 <http://www.washingtonmont-
    > hly.com/features/2004/0404.brownlee.html>

    This is when the PhD training comes in *very* handy.

    God's gift of truth discernment is also very helpful here.

    Servant to the humblest person in the universe,

    Andrew

    --
    Dr. Andrew B. Chung, MD/PhD
    Board-Certified Cardiologist
    http://www.heartmdphd.com/

    **
    Who is the humblest person in the universe?
    http://makeashorterlink.com/?W1F522557

    What is all this about?
    http://makeashorterlink.com/?J2DB148A7

    Is this spam?
    http://makeashorterlink.com/?N69721867
     
  4. Sonos wrote:

    > On 8-Apr-2004, [email protected] (Zee) wrote:
    >
    > > "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." Dr.
    > > Drummond Rennie, deputy editor of The Journal of the
    > > American Medical Association (JAMA),
    >
    > usenet is not so bad after all. : )
    >

    Especially here at SMC with God's blessing :)

    Servant to the humblest person in the universe,

    Andrew

    --
    Dr. Andrew B. Chung, MD/PhD
    Board-Certified Cardiologist
    http://www.heartmdphd.com/

    **
    Who is the humblest person in the universe?
    http://makeashorterlink.com/?W1F522557

    What is all this about?
    http://makeashorterlink.com/?J2DB148A7

    Is this spam?
    http://makeashorterlink.com/?N69721867
     
  5. In article <[email protected]>,
    [email protected] (Zee) wrote:

    > "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." Dr. Drummond
    > Rennie, deputy editor of The Journal of the American
    > Medical Association (JAMA),

    Whew, I just saved this and will look at a paragraph every
    few days. I'm sometimes stuck by the notion that Medical
    science is/was a medical art. Some snake placed on a on a
    structure comes as an image.

    Thanks Zee!

    Aside

    I have two sons with Stargardts disease. AKA premature
    macular degeneration. Though not perfect
    http://www.ocutech.com/ offers a device for about $1500 that
    my 20 something son's will use. It helps.

    I am not with those folks .

    Bill

    --
    Zone 5 In South Jersey USA Shade Consider Hearing all sorts
    of music at http://xpn.org/ "No Progress without contraries"
    William Blake
     
  6. Zee

    Zee Guest

    William Wagner <[email protected]> wrote in message news:<[email protected]>...
    > In article
    > <[email protected]>,
    > [email protected] (Zee) wrote:
    >
    > > "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." Dr.
    > > Drummond Rennie, deputy editor of The Journal of the
    > > American Medical Association (JAMA),
    >
    > Whew, I just saved this and will look at a paragraph every
    > few days. I'm sometimes stuck by the notion that Medical
    > science is/was a medical art. Some snake placed on a on a
    > structure comes as an image.
    >
    > Thanks Zee!
    >
    > Aside
    >
    > I have two sons with Stargardts disease. AKA premature
    > macular degeneration. Though not perfect
    > http://www.ocutech.com/ offers a device for about $1500
    > that my 20 something son's will use. It helps.
    >
    > I am not with those folks .
    >
    > Bill

    I had no idea it could strike in youth. It is genetic? I
    know someone with this who is in her 40s. I too would be
    happy to have an option such as you describe if this
    affected me or my family.

    Regarding Shannon Brownlee. She is superb is she not? More
    of her work is at www.newamerica.net.

    B'adant
     
  7. Sonos

    Sonos Guest

  8. In article <[email protected]>,
    [email protected] (Zee) wrote:

    > I had no idea it could strike in youth. It is genetic? I
    > know someone with this who is in her 40s. I too would be
    > happy to have an option such as you describe if this
    > affected me or my family.
    >
    > Regarding Shannon Brownlee. She is superb is she not? More
    > of her work is at www.newamerica.net.
    >
    > B'adant

    Yes it is genetic. No one on either side of our family's
    ever had eye problems. My son's if married won't pass it on
    either. Seems a bit of me and a bit of my wife enabled this
    retina disease. It's a recessive gene that was just
    identified in the last few years. Some folks notice the
    problem in early teens. Center vision goes making catching a
    baseball very difficult. Reading is difficult too and for
    young folks no driving really matters. Legally blind.

    The Ocutech device has some short comings but it was the
    only device that brought a smile to my eldest son when he
    first tried it.

    http://www.ocutech.com/

    --
    Zone 5 In South Jersey USA Shade Consider Hearing all sorts
    of music at http://xpn.org/ "No Progress without contraries"
    William Blake
     
  9. Zee

    Zee Guest

    "Sonos" <[email protected]> wrote in message news:<[email protected]>...
    > On 8-Apr-2004, [email protected] (Zee) wrote:
    >
    > > "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." Dr.
    > > Drummond Rennie, deputy editor of The Journal of the
    > > American Medical Association (JAMA),
    >
    > usenet is not so bad after all. : )

    You're right on that Sonos and Andrew. Not so bad after all--
    and this article is what I am about: changing the system.

    So that medicine is for people, not for profit.

    Health care, not stockholders share.

    Science, not marketing.

    B'adant
     
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