Friday, December 31, 2010

Another Year of Opacity and Ghostwriting for the Drug Industry

Interests in Conflict
By MARTHA ROSENBERG

At the annual American Psychiatric Association meeting in New Orleans this summer, 200 protestors chanted "no conflicts of interest" and held up photos of individual doctors outside the convention center. Inside the hall, their charges were verified.

The meeting's Daily Bulletin disclosed that the APA president himself, Alan Schatzberg, has 15 links to drug companies including stock ownership and serving on a speakers bureau.

Doctors on other speaker bureaus like Shire's Ann Childress and Wyeth's Claudio Soares gave presentations and workshops that -- surprise! -- extolled company drugs.

And signing books, side by side, was the duo now accused of penning an entire book for the drug industry: Alan Schatzberg and Charles Nemeroff.

This month ProPublica and the New York Times report that Schatzberg and Nemeroff's book, Recognition and Treatment of Psychiatric Disorders: A Pharmacology Handbook for Primary Care, may be the first entirely drug industry-approved textbook ever. Published in 1999, the book's preface says it was funded by an unrestricted education grant to Scientific Therapeutics Information through London-based GlaxoSmithKline (GSK). Scientific Therapeutics Information of Springfield, NJ is the same medical publishing company that spun Vioxx.

Schatzberg was investigated by the Senate in 2008 which found "a lack of consistency" between what he earned from drug companies and what he reported to Stanford where he continues to head the psychiatry department. He owns $6 million of stock in a company he co-founded, Corcept Therapeutics, which sought FDA approval for a psychiatric drug despite Schatzberg's APA position.

Nemeroff, for his part, left Emory University in disgrace after a 2008 Congressional investigation unearthed $1.2 million in drug industry income, his $9 million NIH grant was terminated (a rare occurrence) and he was banned from further NIH grants for two years. But he resurfaced as head of the psychiatry department at the University of Miami in 2009 after the medical school dean, Pascal Goldschmidt, was assured by crony Thomas Insel, director of the National Institute of Mental Health (NIMH), that Nemeroff could still draw NIH money, according to the Chronicle of Higher Education. It was payback for when Nemeroff got Insel a job, say observers. Nemeroff still sits on NIH scientific panels reviewing others' grant applications, ensuring further cronyism.

Ghostwriting, of course, solves the "Company-Says-Company's-Product-Is-Great" problem and increases the chance of a paper's publication in a journal. It helps "authors"' careers and may even spur their individual prescribing habits since studies show doctors prescribe more of a drug they are paid to promote.

But the consumer version, unbranded advertising, is also effective: radio and TV commercials posing as public service announcements that push "awareness" of diseases like ADHD, Irritable Bowel Syndrome (IBS), Restless Legs Syndrome (RLS) or Excessive Sleepiness (ES) and drive worriers to sites where they can self-diagnose with simple quizzes.

Meanwhile, the consumer version of bought doctors is "Astroturf" or patient front groups like the "grassroots" National Alliance on Mental Illness (NAMI), investigated by Congress for drug industry links. These bought patients flash mob the FDA with sob stories when an expensive drug is up for approval and lobby Medicaid to not substitute less expensive drugs, inflating entitlement program and insurance premium costs for industry's benefit.

In the war against drug industry duplicity, company employees are increasingly reporting misdeeds thanks to provisions that entitle whistleblowers to 15 and even 30 percent of fraud settlement sums, in some cases. And last month the Justice Department filed the first criminal, not civil, charges against a the drug industry operative, Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. But as long as politicians like former Louisiana Rep. Billy Tauzin, who headed the industry trade group PhRMA, and former CDC director Julie Gerberding, now head of Merck vaccines, are willing to parlay a career's worth of knowledge and relationships to sell product, the government is essentially fighting itself.

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