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Editor: Katharine Van Tassel
Akron Univ. School of Law

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Sunday, April 13, 2008

Drug Companies and their New Disclosures

The Associated Press reports on some new disclosures by pharmaceutical companies concerning gifts and payments made to physicians.  Kevin Freking writes,

For years, the nation's largest drug and medical device manufacturers have courted doctors with consulting fees, free trips to exotic locales and by sponsoring the educational conferences that physicians attend.  Those financial ties don't have to be disclosed in most cases and can lead to arrangements that some say improperly influence medical care.

Now, under the threat of regulation from Congress, the two industries promise to be more forthcoming about their spending. A dozen of the nation's leading drug and device makers have told Sen. Charles Grassley, R-Iowa, that they have plans or are working on plans to publicly disclose grants to outside groups. The details will be provided on each company's Web sites. Watchdog groups say the companies are trying to head off legislation that would require public disclosure of their giving. "If they were doing this out of the goodness of their heart, they would have done so decades ago," said Dr. Peter Lurie of the consumer group Public Citizen.

Of particular interest to Grassley is the money that companies spend on continuing medical education. Physicians go to such conferences to fulfill their license requirements and to keep up to date with the latest treatment trends. Professional associations and companies frequently ask drug and device makers to help pay for the conferences. Recently, Grassley asked 15 companies whether they planned to follow the lead of Eli Lilly & Co., which now discloses its grants to such programs. . . .

The responses are in. They are wide-ranging, but mostly what the senator wanted to hear. Indeed, many of the companies said they would go beyond disclosing grants for medical education. Some companies said they would also disclose payments to patient advocacy groups such as the American Heart Association or the American Diabetes Association. Boston Scientific said it was developing a system that even discloses certain payments to physicians. . . .

If all of the companies follow through with their commitments to Grassley, there also would be widespread disclosure of how much money they give patient advocacy groups. The groups rely on industry for much of their financing. For example, the American Heart Association said donations from the pharmaceutical and device industry make up about 6 percent of its annual income, and totaled $48.3 million in the organization's latest fiscal year. . . .

"Donations from corporations, including the pharmaceutical and device industry, allow us to further enhance our programs and outreach, and to bring objective science and the highest quality of public education and information to more people," said Maggie Francis, the association's communications manager.

Grassley and Sen. Herb Kohl, D-Wis., have introduced legislation that would require drug and device makers to disclose anything of value given to physicians, such as payments, gifts or travel.  The disclosure of medical education grants is an extension of that concept. Last year, the staff for the Senate Finance Committee issued a report that said the drug industry may be using the "medical education industry to deliver favorable messages about off-label uses that the drug companies cannot legally deliver on their own."

The committee report noted that Warner-Lambert, now owned by Pfizer Inc. (PFE), paid $430 million to settle claims that medical conferences it sponsored were used to illegally promote off-label uses of the anti-seizure drug Neurontin. Serono-Laboratories paid $704 million to settle a similar claim concerning the AIDS drug Serostim.

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