Unbiased, comprehensive analysis of drug research from new web site

Apr 17 2008

Physicians and consumers who want fair and balanced information about the most appropriate uses for prescription medications can now find it using a Web-based resource that provides easily accessible, science-based research about drug uses free from pharmaceutical industry influence.

Prescribing for Better Outcomes, a Web-based educational campaign designed to provide accurate information about the uses of anti-epileptic drugs for the treatment of bipolar disorder, grew out of a global effort to promote evidence-based research and counter the practice of "off-label marketing," in which drug companies promote uses of their medications that may not be supported by science or approved by the U.S. Food and Drug Administration.

"All patients have unique needs. Sometimes, prescribing a drug for an off-label use is the best option," said Dr. John Oldham, M.D., a psychiatrist and Chief of Staff at The Menninger Clinic and the editor of the Journal of Psychiatric Practice. "But when decisions about off-label prescribing are influenced by explicit and deceptive marketing tactics, it lessens our ability as medical professionals to find the best treatment for individual patients."

Prescribing for Better Outcomes (http://prescribingforbetteroutcomes.org/) was launched in direct response to a 2004 lawsuit brought by 50 state attorneys general against pharmaceutical manufacturer Pfizer and its subsidiary, Warner-Lambert. The drug company had been charged with using deceptive marketing tactics to promote off-label sales of its anti-epileptic drug, Neurontin, the brand name for gabapentin. The pervasiveness of Warner-Lambert's off-label marketing techniques was found to increase the likelihood that physicians would prescribe gabapentin for the treatment of bipolar disorder, even though evidence-based research demonstrated that this treatment was largely ineffective.

The Prescribing for Better Outcomes campaign is funded by a portion of the settlement from that landmark case. In addition to the tools and information available at PrescribingforBetterOutcomes.org, the program includes resources for clinical practice and a forthcoming continuing medical education module.

"Deceptive, off-label marketing hurts the public and makes it harder for physicians and other practitioners to give their patients appropriate medical care because they're making decisions based on faulty information," said Tim Carey, M.D., M.P.H., Director of The Cecil G. Sheps Center for Health Services Research at the University of North Carolina at Chapel Hill. "Unfortunately, experience indicates that the practice of off-label marketing extends beyond gabapentin. We hope that Prescribing for Better Outcomes will help physicians to become more aware of the sources and quality of information used to guide patient care."

The Web-based resource PrescribingforBetterOutcomes.org was launched by The Sheps Center. The site will help clinicians and consumers better understand what the research actually shows regarding the efficacy of various antiepileptic drugs, including gabapentin, by providing an unbiased comprehensive analysis of the published research on this class of drugs. The site will later be expanded to include information about other prescription drugs.

"It is unrealistic to expect that medical professionals have time to carefully dissect all of the published research on prescription medication," said Cathy Melvin, Principal Investigator and Director of Child Health Services Research at The Sheps Center. "With access to information that the Prescribing for Better Outcomes program provides, medical professionals will be better informed as they make decisions about patient treatment. The site will also help the public better understand the drugs that have been prescribed to them and allow for a mutually beneficial doctor-patient relationship."