Medical Device, Drug Makers Seek to Head Off Regulation by Disclosing CME Grants, Other Donations

<"http://www.yourlawyer.com/practice_areas/defective_medical_devices">Medical device makers and <"http://www.yourlawyer.com/practice_areas/defective_drugs">drug companies, facing increasing scrutiny from Congress, have decided to come clean about donations and grants they provide to fund medical education programs, patient advocacy organizations and other groups. Drug maker Eli Lilly already has such a program, and , Medtronic Inc., a maker of among other things, implantable defibrillators and defibrillator components, has announced it will disclose such funding on its website starting May 1. Other drug and medical device makers recently told one lawmaker they intend to start similar disclosure programs. While some patient advocates have praised such plans, others fear that the proposed disclosure efforts are simply an attempt by drug and device makers to end a push in Congress towards legislation that would require public disclosure of their giving.

The move to be more forthcoming about funding efforts comes on the heels of a letter written in February by Sen. Charles Grassley (R-Iowa) to 15 of the nation’s biggest drug and device companies. Grassley asked if the companies planned to start publishing grant information on their websites, in the way Eli Lilly began last year. Grassley, a member of the Senate Finance Committee, said he was particularly interested in grants the companies used to fund Continuing Medical Education (CME) programs for physicians.

Physicians must attend CME conferences in order to keep their licenses, and many drug and medical device makers “generously” fund such events. In fact, in 2006, pharmaceutical companies alone spent over $1 billion on CME courses. Unfortunately many of these courses are thinly disguised marketing ploys. Last summer, a Finance Committee found that drug companies were actually using CMEs to influence clinical practice guidelines and Medicaid formularies.

The Accreditation Council for Continuing Medical Education (ACCME) has rules spelling out who is allowed to pay for CME courses, and drug companies and device makers are not allowed to directly fund such programs. But “directly” is the operative word here. There is nothing in the rules that prohibits the manufacturers from paying a third party to design and promote courses. And that’s exactly what they do. Very often, the course materials designed by consultants for these programs exaggerate the benefits of the sponsoring company’s products, and downplay side effects and other safety issues. And it is not unusual for these conferences to include information on off-label uses of drugs and devices, something which manufacturers are legally barred from doing directly.

Congress has recently been threatening to legislate disclosure requirements for drug and device makers. In his February letter, Grassley wrote, “If your company does not yet have any efforts or plans in place, please explain why not.” The answers have been positive, with most agreeing to disclose CME funding, and many volunteering to publicize payments to patient advocacy groups such as the American Heart Association. In addition to Medtronic, AstraZeneca has plans to start posting its funding efforts to its website by August 1. Merck, Amgen and Abbot Labs all said they are working on developing plans to disclose funding programs,. Only Schering-Plough rebuffed Senator Grassley, saying “We do not publish or have plans at the moment to publish a list of charitable contributions or educational grants that medical organizations have received from us.”

While Grassley said he was happy with the results of his letter writing campaign, others were more cautions. Dr. Peter Lurie of the consumer group Public Citizen told the Associated Press that drug and device makers’ voluntary disclosure efforts could be little more than an effort to ward off legislation that would require more comprehensive disclosure. “If they were doing this out of the goodness of their heart, they would have done so decades ago,” Lurie said.

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