US drugmaker critics' challenged over conflict of interest

Three authors of an article in the Annals of Internal Medicine, a USA-based journal, who called for tighter regulations against off-label marketing by drug firms, failed to disclose their personal interest in the issue, according to a US think-tank.

Michael Steinman, Mary-Margaret Chren and C Seth Landerfield were expert witnesses in a law suit against Parke-Davis, a subsidiary of global giant Pfizer, concerning off-label use of Neurontin (gabapentin). The case saw Pfizer settle out of court with a $430.0 million payment to the US Department of Health and Human Services. In their article, the campaigners claim that, because "the borders between research, education and promotion are more porous than is commonly recognized," new regulatory approaches are required. Peter Pitts, director of the New York, USA-based think-tank the Center for Medicine in the Public Interest, accused the trio of lack of transparency and pointed to a 1998 court ruling that the US Food and Drug Administration does not have the constitutional right to prohibit the dissemination of data about potential off-label benefits of drugs. He said this is "a closed issue."

Referring to the journal authors' backgrounds, Mr Pitts described their links with plaintiffs in the Parke-Davis case "extremely suspicious." He told the Marketletter that, "just as industry members on advisory boards must have their industry connections scrutinized, industry critics should also face the same standards."