Settlement funds grants about drug marketing

Physicians and other health professionals can expect to see more continuing medical education and research activities aimed at improving prescribing practices thanks to $9.4 million in grants from a settlement with drugmaker Warner-Lambert, a division of Pfizer.

This spring, attorneys general from 50 states and the District of Columbia announced that the company would fund 24 projects at 23 institutions with grants ranging from $329,000 to $400,000 apiece.

Grantees' projects include developing a curriculum on safe pediatric prescribing, creating a course on sensible prescribing decisions during office visits and providing education aimed at reducing unnecessary use of heavily marketed medicines.

The grants are the result of a 2004 consumer protection settlement the attorneys general reached with Warner-Lambert that resolved allegations of deceptive "off-label" marketing of Neurontin, (gabapentin), which won Food and Drug Administration approval in 1994 as an add-on treatment for epilepsy. The drug also was promoted as effective for unapproved uses including migraines, bipolar disorder, and drug and alcohol withdrawal symptoms. Parent company Pfizer pleaded guilty to illegal promotion of unapproved uses for the drug and paid a total of $430 million in fines.

"The pharmaceutical industry spends billions to influence consumers and doctors," said John Santa, MD, MPH, the grant program's administrator at the Oregon Health & Science University Center for Evidence-Based Policy. "These investigators are trying to tell the other side of the story."

Principal investigators receiving grants have agreed not to accept any honoraria, gifts, grants or expense payments from pharmaceutical companies. Also, all the resulting educational curricula and research data will be made available to the public.

Randall Tackett, PhD, professor in clinical and administrative pharmaceuticals at the University of Georgia, is the principal investigator for a project that will create CME modules for physicians on how the FDA drug approval process works and how physicians can report adverse drug effects to the FDA. "We will survey 100 or so physicians regarding their prescribing practices for some of these high-profile, heavily marketed drugs," Dr. Tackett said.

His team aims to show physicians the strength and weaknesses of the drug approval process and explain nuances they may be unfamiliar with, such as how the contents of drug labels and package inserts often change.

"We want them to understand these issues so they can prescribe safely and effectively," he said.

His team will track these physicians' prescribing patterns before and after they take a series of CME modules, which are expected to run around 30 to 40 minutes. The modules will be available on the Internet and downloadable via personal or handheld computers and cell phones.

The American Medical Association is among the grantees as well. It will collaborate with academic medical centers at Stanford University in Palo Alto, Calif., University of Texas Medical School at Houston and New York University to develop a wide spectrum of curricula for medical students, residents and practicing physicians, including Web-based, specialty-specific modules for practicing physicians and a standardized patient module for students in which the patient requests a heavily marketed drug.

This summer, applications will be accepted for grants to create education for consumers on drug marketing and the impact on prescribing. The consumer- and prescriber-oriented grant awards are a one-time event.