Monday, September 27, 2010

Medicine, Trials, Conflict of Interest, Disclosures

Just a bunch of links -- mostly from the US -- that paint give us a troubling picture of the state of ethics in biomedical fields:

  • Adriane J. Fugh-Berman in PLoS Medicine: The Haunting of Medical Journals: How Ghostwriting Sold “HRT”. Here are the summary points:

    • Some 1500 documents revealed in litigation provide unprecedented insights into how pharmaceutical companies promote drugs, including the use of vendors to produce ghostwritten manuscripts and place them into medical journals.

    • Dozens of ghostwritten reviews and commentaries published in medical journals and supplements were used to promote unproven benefits and downplay harms of menopausal hormone therapy (HT), and to cast raloxifene and other competing therapies in a negative light.

    • Specifically, the pharmaceutical company Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with HT, to defend the unsupported cardiovascular “benefits” of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson's disease, vision problems, and wrinkles.

    • Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted.

    See also a related NYTimes report -- Menopause, as Brought to You by Big Pharma by Natasha Singer and Duff Wilson -- from December 2009.

  • Duff Wilson reports in the NYTimes: Medical Industry Ties Often Undisclosed in Journals:

    Twenty-five out of 32 highly paid consultants to medical device companies in 2007, or their publishers, failed to reveal the financial connections in journal articles the following year, according to a [recent] study.

    The study compared major payments to consultants by orthopedic device companies with financial disclosures the consultants later made in medical journal articles, and found them lacking in public transparency.

    “We found a massive, dramatic system failure,” said David J. Rothman, a professor and president of the Institute on Medicine as a Profession at Columbia University, who wrote the study with two other Columbia researchers, Susan Chimonas and Zachary Frosch.

  • Carl Elliot in The Chronicle of Higher Educations: The Secret Lives of Big Pharma's 'Thought Leaders':

    ... Pharmaceutical companies hire KOL's [Key Opinion Leaders] to consult for them, to give lectures, to conduct clinical trials, and occasionally to make presentations on their behalf at regulatory meetings or hearings.

    The KOL is a combination of celebrity spokesperson, neighborhood gossip, and the popular kid in high school. KOL's do not exactly endorse drugs, at least not in ways that are too obvious, but their opinions can be used to market them—sometimes by word of mouth, but more often by quasi-academic activities, such as grand-rounds lectures, sponsored symposia, or articles in medical journals (which may be ghostwritten by hired medical writers). While pharmaceutical companies seek out high-status KOL's with impressive academic appointments, status is only one determinant of a KOL's influence. Just as important is the fact that a KOL is, at least in theory, independent. [...]