Friday, September 5, 2008

Angell: Stop Asking Pharma To Fund Clinical Trials

The September 3 issue of JAMA (subscription required) contains three commentaries on the drug industry, providing updates on medicine's relationships. The most newsworthy of them is probably Marcia Angell's (former editor of the New England Journal) analysis of the "broken system" of industry-sponsored clinical research. Dr. Angell concludes that we can no longer allow what most national academic-medicine organizations and leaders persist in assuming to be the bottom line-- that the drug industry will go on funding the clinical trials by which its own products are tested (and that the academic medical center can continue to rake in the resulting research grants plus whatever extras it can scarf up).

Things were not so bad, she recalls, before the 1980s. Then, the industry gave research grants to university investigators who planned and conducted the studies, had control over all the data, and decided on publication. The investigators, or their institutions, seldom had any financial relations with the industry apart from the research grant. Today, by contrast, investigators and their universities are both heavily in bed with the industry, investigators seldom even see the data in their entirety, and the industry staunchly defends a business model in which all data they pay for is their proprietary possession. Dr. Angell also identifies competition from commercial contract research organizations (CROs) and academic centers aping CROs to get the grants (see latest post on UNC selling its School of Public Health to the largest commercial CRO). The result: the problem of bias in research, with companies routinely suppressing data they do not like or else respinning negative studies to make them sound positive, and investigators meekly going along.

The only meaningful solution, says Dr. Angell, is to take the funding of clinical trials needed to assess new drugs out of industry hands, and create a new NIH institute to fund these trials. She repeats this recommendation from her book, The Truth About the Drug Companies, which I cited in giving the same recommendation in HOOKED. If anything, the accumulated data since her book first appeared in 2004 completely reinforce the need for this drastic step.

Though I agree with the recommendation to disconnect trial funding from individual drug companies, Dr. Angell might have said a bit more about what universities and academic leaders can do while waiting for this reform to happen. She seems to view the cozy financial relationships with industry as simply a given in today's world, though she does have some choice words to say about Stanford and its apparent willingness to look the other way as its chair of psychiatry, Dr. Alan Schatzberg, racked up more financial conflicts of interests per square centimeter than any academic in recent memory. (As Dr. Angell notes, when Stanford more recently announced that it had replaced Dr. Schatzberg as PI on his NIMH study of a drug in which he controlled $6M in stock, it claimed that it did so "to eliminate any misunderstanding"-- rather than because his being PI was an unacceptable conflict of interest and violated NIMH rules.) I would have liked to have heard some suggestions as to what the academic medical center could do today to start to better police this industry gravy train.

Angell M. Industry-sponsored clinical research: a broken system. JAMA 300:1069-1071, 2008.

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