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Just the Cost of Doing (Drug) Business

Continued drug company payouts prompt questions about who's minding medicine.

Last week the Justice Department announced that drug company Eli Lilly had agreed to pay $1.42 billion to settle criminal and civil charges that it had illegally marketed its blockbuster antipsychotic drug Zyprexa. The case accused company sales reps of promoting the drug for conditions beyond its narrow FDA-approved use of treating schizophrenia and symptoms of bipolar disorder, and for populations (children and the elderly) for whom its known side effects are particularly risky. The New York Times report indicates that claims and evidence in the case were similar to a California state lawsuit which alleged that company studies of the drug circulated among its sales force were "Lilly's thinly veiled marketing of Zyprexa as an effective chemical restraint for demanding, vulnerable and needy patients."

While the settlement was the largest amount paid by a single defendant in the history of the US department of Justice, it is dwarfed by the $39 billion in sales Zyprexa has generated since its approval in 1996, and is less than half of its $3.5 billion in sales in the first nine months of 2008.

This most recent case adds to the already sordid backdrop to Marcia Angell's scathing indictment of drug companies and the physicians, medical schools, and professional organizations happy to collude with them published in the latest New York Review of Books. Angell, the Senior Lecturer in the Department of Social Medicine at Harvard Medical School who served as editor-in-chief for the New England Journal of Medicine for two decades, believes these massive payouts are "just the cost of doing business" and "well worth it" for drug companies so long as the drug continues to rake in billions.

In Angell's telling, the particular offenses reported in the government Zyprexa case represent only a fraction of drug company improprieties, a discouraging litany she candidly rehearses. Yet without countenancing or minimizing their contributions to a corrupt system, she reserves her sharpest rebuke for her colluding peers.

It is easy to fault drug companies for this situation, and they certainly deserve a great deal of blame...Still, apologists might argue that the pharmaceutical industry is merely trying to do its primary job - further the interests of its investors - and sometimes it goes a little too far.

Physicians, medical schools, and professional organizations have no such excuse, since their only fiduciary responsibility is to patients. The mission of medical schools and teaching hospitals - and what justifies their tax-exempt status - is to educate the next generation of physicians, carry out scientifically important research, and care for the sickest members of society. It is not to enter into lucrative commercial alliances with the pharmaceutical industry.

Angell is concerned that unless the medical profession reasserts its independence by sharply breaking its improper financial dependence on the pharmaceutical industry, the integrity of its work will continue to decline, and with it, the trust of the public.

And no payout, however staggering, can buy that back.

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