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HGH: Court Rules in Favor of Pfizer on Off-Label Marketing Allegations

17 Sep

On September 14, the United States District Court for the District of Massachusetts issued a ruling that effectively ended a whistleblower’s attempts to bring attention to the off-label marketing of human growth hormone for anti-aging and other non-approved uses. Former Pfizer executive Peter Rost filed the qui tam claim in 2003, and I wrote about it in Selling the Fountain of Youth. In short, Rost alleged that Pfizer improperly promoted its HGH drug Genotropin by providing kickbacks to physicians, including all-expense-paid trips to medical conferences in exotic locations.

Rost wasn’t exactly Mr. Popular at Pfizer. After he filed his qui tam, the company started dismantling his 60-person team, moving everybody but Rost from their New Jersey office to New York City. Then men in hardhats showed up and started knocking down the walls around him. Rost ultimately lost his job.

In 2005, the U.S. Dept. of Justice declined to join Rost in his suit and instead investigated Pfizer on its own. Two years later, in a settlement with the government, Pfizer paid a fine of $15 million and admitted that the unit that made Genotropin, Pharmacia, had promoted it for off-label uses such as anti-aging. (The company paid an additional $19.7 million fine related to a separate charge.) In an online posting, Rost dismissed the settlement as “equivalent to a speeding ticket”–a reference to the fact that Pfizer’s profit the previous year had been $11 billion.

Rost continued to fight his whistleblower claim, but it was a struggle. In 2008, a judge ruled that he could proceed as long as he focused only on allegations related to the promotion of HGH for the treatment of short children. His dream of exposing off-label use of HGH in anti-aging clinics was dead.

And now this latest ruling. It states that Rost failed to show that Pfizer’s promotion of HGH violated the False Claims Act. In other words, those activities did not result in improper claims being made to state Medicaid programs, as Rost alleged in his amended complaint. The ruling was made partially on the judge’s determination that the pharmacies that filled the prescriptions were “third parties” who were not knowledgeable about the marketing of the drug. If the pharmacy does not know that the prescription was written because a doctor was induced by the drugmaker to write it, she said, then there is no illegal false claim.

Jim Edwards, a blogger for BNET who mentioned my book in his posting about the case, concluded that this ruling “has made it easier for drug companies to bribe doctors with cash and gifts to prescribe their products.” I’m not sure I would go that far. But I will say this: Rost’s long and dramatic whistleblower story has come to a rather deflating end.

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