Big Money, Big Fines – It’s All Hormonal

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Big pharma is being taken to task for illegal marketing of human growth hormone

MACLEANS – February 27, 2006

By DANYLO HAWALESHKA

Once regulators approve a prescription drug, it can be used to treat just about anything, within reason. But this so-called “off-label” use has to be generally recognized as acceptable by the medical community. It can get tricky — take the roughly US$2-billion global trade in human growth hormone. The Internet is crawling with sites that hawk HGH-based remedies against aging, despite a dearth of supporting evidence. A one-month course of treatment can cost US$1,000, says Dr. Peter Rost, who formerly oversaw the marketing of Genotropin, Pfizer Inc.’s brand of growth hormone. Rost, a vocal Pfizer critic who was fired by the company in December, says some anti-aging cocktails contain Genotropin worth about US$200, plus a few other inexpensive generic hormones. “It’s a very good markup for these docs,” says Rost, but “it’s quackery.”

Most human growth hormone is supposed to go to children suffering from a narrow set of conditions that include deficient growth due to inadequate hormone production. But according to a study published last fall in the Journal of the American Medical Association, three-quarters of HGH prescriptions in 2004 were for adults 20 and older, and 44 per cent were for people 40 to 59. In addition to its purported anti-aging qualities, HGH remains popular among cheating athletes looking for a performance edge. The natural hormone is produced by the pea-sized pituitary gland at the base of the brain. But for 20 years now, scientists have been able to genetically engineer the protein in the lab.

With the supply-side problem solved, drug companies ramped up production. But in the U.S. (unlike in Canada and most other parts of the world), off-label use of HGH is actually illegal, and pushing it has gotten some firms into expensive trouble. In 1999, San Francisco-based Genentech Inc. was fined US$50 million for illegally marketing its HGH brand, Protropin. Then, last October, Serono S.A., a Swiss-based corporation, was fined US$704 million for illegally promoting Serostim — an HGH used to treat AIDS patients with profound weight loss. Serono pleaded guilty to offering U.S. physicians an all-expenses-paid trip to Cannes. In exchange, the doctors would agree to write as many as 30 new prescriptions for Serostim, worth US$630,000.

Rost is currently suing Pfizer, the world’s largest drug company, and its subsidiary, Pharmacia Corp., over what he claims was the illegal promotion of Genotropin for anti-aging treatments. After failing to get Pfizer to take action, he says, in 2003 he filed a qui tam, a provision of the False Claims Act that allows citizens to sue in the name of the U.S. government (plaintiffs are awarded a substantial share of fines, potentially worth millions). Last November, the U.S. Justice Department declined to participate in the civil action, a move some observers interpreted as a repudiation of Rost’s case. But lawyer Kenneth Nolan, a Florida-based authority on whistle-blower suits, says just because the government declines a case does not mean it isn’t worth pursuing. “There are plenty of meritorious cases that are declined each year.” In fact, Nolan says, U.S. authorities often lack the resources to pursue a qui tam, and prefer to let private citizens do the legal legwork.

Rost’s suit alleges that — starting about 1997 and continuing into 2003 — Pharmacia illegally promoted Genotropin for off-label uses such as anti-aging treatments, as well as a growth aid for children who were simply short but otherwise healthy. Pfizer spokesman Paul Fitzhenry did not respond to a request for an interview. But Pfizer recently filed a motion to dismiss Rost’s suit, alleging his complaint was filed after the company had already disclosed Pharmacia’s marketing practices to the government. Pfizer also says Rost’s claims do not meet the requirements of a qui tam. Clearly, Pfizer does not want a repeat of its 2004 experience with Neurontin, an anti-seizure medication marketed by Warner-Lambert, which Pfizer acquired in 2000. The Justice Department did not initially join in a suit, brought by a former employee, alleging the drug was being marketed for off-label treatments. (Off-label use of Neurontin, unlike HGH, is legal, but marketing for those uses isn’t.) In the end, Justice did join, and Warner-Lambert paid more than US$430 million to resolve the case.

Rost is hoping for a similar outcome, although he acknowledges that, in 2003, Pfizer did accept most of his recommendations and stopped distributing Genotropin to doctors who used it in anti-aging treatments. Still, the global anti-aging business continues to go gangbusters. “This is a disservice to patients,” Rost says. “But most doctors in this country are businessmen first — and doctors second.”