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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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Posted in HGH


Botox: A Marketing Dispute Over an Anti-Aging Drug

04 Sep

On Sept. 1, drugmaker Allergan agreed to pay $600 million to the feds to settle charges that it improperly marketed wrinkle-eraser Botox for uses not approved by the FDA, such as relieving headaches. It caught my eye,  because I’m being asked quite frequently these days to explain why regulators aren’t more attuned to the improper use of anti-aging drugs.

Drug companies are prohibited by law from marketing their products “off label”–that is for uses not cleared by the FDA.

Botox is approved by the FDA to erase wrinkles and treat some muscle disorders. But Allergan has been testing the drug for other purposes, including treating migraines. And last October, it became the first drug company to sue the federal government over the ban on off-label marketing, arguing that the law violated its first-amendment rights to commercial free speech.

As part of this settlement, Allergan agreed to drop that suit. And that pretty much settles it: Drug companies will not be permitted under the laws of this country to market their drugs off-label.

Off-label marketing is a particularly touchy subject when it comes to human growth hormone, another drug commonly prescribed in the anti-aging industry. HGH is in a special legal class, because it’s not only illegal for the drug companies that make it to market it off-label (i.e. for anti-aging), but it’s also illegal for doctors to prescribe it off-label. Normally, physicians can use their discretion and prescribe drugs for uses not approvecd by the FDA. That’s not the case with HGH.

As I explain in Selling the Fountain of Youth, regulators have had only a modest amount of success prosecuting HGH cases. In 2007, Pharmacia (a unit of Pfizer) admitted to improperly marketing its popular HGH drug, Genotropin, but only had  to pay the federal government a fine of $15 million.

Some physicians have faced charges, as well, though most of the prosecutions have been levied against doctors found prescribing HGH to professional athletes.

The government has long vowed to step up its monitoring of off-label marketing, and after the Allergan settlement was announced, Tony West, assistant attorney general for the Justice Department’s civil division, told reporters, “These cases are cases that we will continue to aggressively pursue.”

The point of cases such as this is to dissuade drug companies–and in the case of HGH, doctors–from engaging in improper marketing of any drug. I’ll be interested, however, to see if it actually works.

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Posted in Lifestyle