U.S. joins whistleblower suit against Pfizer for drug marketing

The Wall Street Journal: "The Justice Department is trying to take the lead in a lawsuit accusing Pfizer Inc.'s Wyeth unit of improperly promoting an organ-transplant drug for unauthorized uses and paying illegal kickbacks to doctors. The lawsuit was filed by two former Wyeth sales representatives who were responsible for promoting Rapamune, an immunosuppressant used to prevent the body's rejection of transplanted kidneys. … The lawsuit, first filed confidentially in 2005, alleges that Wyeth promoted Rapamune for off-label uses, or those not consistent with the prescribing label approved by the Food and Drug Administration. The suit alleges Wyeth promoted the drug for use in lung-transplant patients, for instance" (Loftus, 9/21).

The Philadelphia Inquirer: "Among the suit's allegations are claims that Wyeth targeted African American transplant patients, and that Wyeth used speaking fees and grants to reward doctors who prescribed the drug for unapproved uses, such as liver, lung, and heart transplants. … While doctors are permitted to use drugs for treatments beyond those approved by the FDA, drug makers are barred from promoting such uses" (Hepp, 9/22).

The New York Times: "Reuben A. Guttman, lawyer for two former Wyeth employees, predicted that the government action could result in recovery of hundreds of millions of dollars in inappropriate billings to public health programs. Nineteen states, including New York, and the District of Columbia also joined the filing. ... Pfizer also disclosed in February that there was a criminal investigation into the marketing. ... The filing continued a crackdown on drug industry fraud. Over the last three years, the government has also settled false claims suits against Bristol-Myers Squibb for $515 million, AstraZeneca for $520 million, Eli Lilly for $1.4 billion, and last week, a unit of Forest Laboratories for $313 million" (Wilson, 9/21).

Modern Healthcare: "Pfizer issued a written statement noting that the company previously disclosed it was cooperating with a government investigation involving Rapamune. 'Our labeling information includes the appropriate caveats about treatment areas where safety and efficacy have not been established,' the company said in the statement" (Blesch, 9/21).