CHANGES IN OVERSIGHT OF OFF-LABEL USE NECESSARY, JOURNAL ARTICLE SAYS
The FDA and other regulatory agencies must step up to stem the tide of unscrupulous drug marketing practices, an Aug. 15 article in the Annals of Internal Medicine says. But former agency officials challenge the constitutionality of the recommendations and whether the government is in the best position to police the system.
Pfizer subsidiary Parke-Davis instituted a wide-ranging strategy to promote off-label drug use in the 1990s, which is indicative of fundamental ethical problems with industry marketing, the authors wrote. The study also illustrates the failings of physicians, professional organizations and the pharmaceutical industry to police such practices, they said.
However, three of the article's authors, Michael Steinman, Mary-Margaret Chren and C. Seth Landefeld, worked as expert witnesses in a lawsuit against Parke-Davis concerning that off-label use. Also, the data used in the article was obtained from a database set up by the attorney representing the whistleblower plaintiff in that case, the report's disclosures show.
According to the study, "Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents," the company used advisory boards, consultants' meetings and accredited medical education events to get doctors to prescribe its drug Neurontin (gabapentin), an anti-seizure medication, for off-label use. These efforts, along with recruiting doctors to influence other physicians and developing research solely to boost market share of the drug, were done without proper disclosure, they said. For example, the company's involvement in clinical trials, medical journal research and reviews, educational grants and continuing medical education was not provided, they allege.
These findings signal a need for change, the authors said. "There is widespread agreement that commercial interests should not influence the clinical decisions that physicians make on behalf of their patients." To address this, a complex system has developed involving disclosure and self-regulation by doctors, professional organizations and industry. However, these efforts have been "largely ineffective," as illustrated by Parke-Davis' promotion of Gabapentin, the study said.
Incremental changes will fail because "marketing is so deeply embedded" and "the borders between research, education and promotion are more porous than is commonly recognized," the study added. Instead, new approaches are needed, including "rigorous regulatory oversight, strict sequestration of commercial and scientific activities and a fundamental internal reevaluation of the interactions between individual physicians, professional organizations and industry."
Consumer advocates agree that changes are necessary. There is a growth in off-label use, many times based on little or no scientific support, according to William Vaughan, senior policy analyst for Consumers Union. "Fixing this problem has to be a major priority," he said. In particular, the FDA must take a stronger oversight role of off-label use.
But Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, disagreed. The FDA does not have the legal authority to restrict the dissemination of scientific information because doing so would be an unconstitutional restriction on First Amendment free speech protections, he said. In 1998, the Washington Legal Foundation successfully challenged the constitutionality of FDA restrictions on speech regarding off-label uses of FDA-approved products. This is a "closed issue," he said.