Eli Lilly posted an online report of its educational funding for the first quarter of 2007, becoming the first drug firm to pledge full public disclosure of CME grants and other contributions.
The report shows $11.8 million in funding given in the first three months of the year, including grants to for-profit medical education and communication companies, medical societies, academic centers, patient groups and non-profit institutions. The names of grantees, amounts and a description of intended use are included, and Lilly says it will update the information quarterly at www.lillygrantoffice.com.
Pri-Med received the most of any MECC, according to the Lilly registry. The Boston-based company secured a total of $976,285 for several activities on erectile dysfunction, depression and pain and diabetes. The largest single grant, $825,000, went to Massachusetts General Hospital for an educational program.
Lilly CEO Sidney Taurel said in a statement that the firm is “addressing head-on questions regarding the nature of the relationships between our company and the organizations we support.”
Commercially supported education has been criticized for having an influence on physicians, despite stiff ACCME conflict of interest rules that are designed to keep activities independent. Last week, in a report stemming from a two-year probe into medical education grants, Sens. Max Baucus (D-MT) and Chuck Grassley (R-IA) cited a 24% noncompliance rate with ACCME's Standards for Commercial Support, based on responses from 23 top pharma companies.
In response to Lilly’s online grant registry, Sen. Grassley told The Wall Street Journal, “Eli Lilly’s action is a positive step, and I hope other drug companies will do the same thing.”
In their report, the senators, who lead the Senate Finance Committee charged with Medicare and Medicaid oversight, praised drug companies for taking steps to shelter grant-making from sales and marketing but said further unspecified steps are needed.
The report said that “it appears the manufacturers have implemented policies meant to rein in [the use of CME for off-label promotion]. The companies have taken steps to separate the grant-making process for educational programs from their marketing efforts. In addition, various industry groups and government agencies have created guidelines for educational grants to reduce the potential for abuse. Drug companies, however, are not mandated to follow the guidelines and a significant gray area continues to exist regarding the use of educational grants to serve marketing purposes.”
Committee researchers based their findings on company reports and a review of HHS and PhRMA guidelines regarding CME. The report says that in addition to the danger of companies using CME for off-label marketing, the committee found potential for abuse in the form of kickbacks, veiled advertising and bias in clinical protocols. Moreover, the report repeatedly returns to the assertion that companies would not be writing grants but for a profit motive.
“Continuing medical education has developed into a multi-billion dollar a year industry, much of which is funded by pharmaceutical manufacturers,” said the report. “It seems unlikely that this sophisticated industry would spend such large sums on an enterprise but for the expectation that the expenditures will be recouped by increased sales.”
In a statement, Baucus said: “This report shows some separation between medical education and marketing efforts, but this process isn’t clean enough. As long as drug companies’ medical education efforts can influence Medicare and Medicaid spending, the Finance Committee has to insist that there be more improvement.”
“They’re at least opening the door for FDA involvement,” said Stephen Lewis, president of Medical Education Collaborative and a former Senate staffer. “I think they want to work within the existing structure, but if they can establish a clear link between CME and product messages, it gives them an entry point for FDA to be involved in an oversight capacity.”
John Kamp, executive director of the Coalition for Healthcare Communication, said the committee’s demonization of off-label usage was misguided. He noted that independent CME is authorized by the FDA, and that all the specific abuses cited in the report occurred before PhRMA and ACCME enacted their current guidelines.
“I’m a diabetic, and I take eight medications,” said Kamp. “Six of them are off-label, and I don’t want Sen. Grassley hanging over my doctor’s shoulder limiting what she prescribes.”
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