Pharmaceutical Conflict of Interest Laws

Doctors Fret On Behalf Pharma: Pro Bono For What? No Free Lunch?

Vermont and Massachusetts recently passed strict conflict of interest laws that require certain drug and medical-device manufacturers to inform state health officials of gifts made to doctors. At least half a dozen states have similar laws. Pharmaceutical companies spent $2.93 million on marketing in Vermont in 12 months. Payments and gifts to some Vermont psychiatrists totaled more than $100 thousand dollars a year. Nationwide, pharmaceutical companies spend between $20 billion and "$57 billion per year" on marketing per year.

The majority of Americans approve of the measures. In a survey of the public opinion, 64% of Americans think it's important to know their physician's financial ties to pharmaceutical companies and 68% support legislation requiring pharmaceutical companies to disclose gifts to doctors according to the results of a Prescription Project survey.

The regulations aim to bar some gifts from industry to doctors and researchers and more closely monitor which doctors and researchers pharma pays. The Vermont Medical Society supported the new regulations, noting that trust is necessary to build doctor patient relationships. The president of the physicians group commented: "Gifts from the pharmaceutical industry can create at least the appearance of conflict of interest, so in our minds that has a negative impact on our relationship with patients."

Just Don't Say "Corrupt"

However, opposing the conflict of interest regulation is the Association of Clinical Researchers and Educators (ACRE), a group of 100 physicians led by Harvard hematologist Thomas Stossel.1 ACRE acknowledges that some physicians or researchers may take too much money from industry but argues that regulation of conflict of interest is not the answer. ACRE says that regulation will encroach on the free give and take between industry, physicians, and researchers that has yielded great research and medical progress. Nature reported frustration on the part of physicians who attended ACRE's July 23rd meeting:

"One attendee complained that he couldn't buy a $12 hamburger for a consultant who had agreed to speak for free. 'They're giving us a pro bono service and we're going to ask them to pay for their own lunch?' he lamented." 2

Really? Should free consulting from a pharma representative or consultant raise feelings of obligatory angst in attendees? If a pro-bono talk motivates such laments, what guilt do free samples provoke? What about a vacation trip? Will a $12 dollar hamburger fulfill the obligation? Or perhaps just a few prescriptions orders for patients?

ACRE's Stossel objects to the gift ban because it suggests that physicians have "'have a corruption problem'". In Marcia Angell's January, 2009 NY Review of Books article, "Drug Companies & Doctors: A Story of Corruption", the author reviewed three books on pharmaceutical corruption.3,4 The books were published after the congressional inquiry into drug company payments that uncovered quantities of drug money flowing into psychiatry doctors' pockets.

A Senate investigation led by Chuck Grassley (R-IA) (pdf!), uncovered payments to three Harvard psychiatrists who received over a million dollars each over a several year period. One psychiatrist at Stanford and one at Emory also received payments of over a million dollars.

A study in 2007 by Columbia University researchers showed that doctors don't feel that their personal integrity is compromised by taking gifts or money from pharmaceutical companies. But they do feel that other doctors would be compromised by such gifts. Chimonas et al concluded: "Our findings suggest that voluntary guidelines, like those proposed by most major medical societies, are inadequate. It may be that only the prohibition of physician-detailer interactions will be effective."

Marcia Angell points out that although the cases highlighted by the media tend to be more extreme, most physicians (94%) do have some relationship with drug companies. And certainly many of these payments are inconsequential and/or don't sway research or influence prescribing patterns. But clearly many do, or else pharmaceutical companies wouldn't be spending tens of billions of dollars on doctors and research.

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1 The group is now supported by membership fees, according to Nature and the organization website. However in 2008, according to a note accompanying a British Medical Journal article, Stossel was on the boards of several pharmaceuticals, and received fees for speaking to corporations and other organizations about conflict of interest.

2 Willard, Cassandra, "Physicians fight back against disclosure rules" Nature 460, 556-557 (2009) | doi:10.1038/460556b. Also published in Nature Medicine.

3 The NY Review of Books received a letter from the legal representative of one of the doctors covered in her article, complaining about the use of the word "corruption" in the headline and text of Angell's review, because it inferred the doctor had been engaged in "bribery" or "similar dishonest dealings". The weekly disagreed.

4 The three books are: Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial by Alison Bass (Algonquin Books of Chapel Hill); Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs by Melody Petersen (Sarah Crichton/Farrar, Straus and Giroux); and Shyness: How Normal Behavior Became a Sickness by Christopher Lane, (Yale University Press).

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