Genentech was prosecuted under the FCA and paid $50 million to settle the case.
Since then, the government has used the FCA in 15 cases that were settled out of court, but according to Taxpayers Against Fraud, a non-profit advocacy group that assists whistleblowers, 150 more cases are currently pending.
The FCA has become effective in large part due to the reward for whistleblowers who can receive between 15% and 30% of the amount recovered in the lawsuit with the average award being $120,000, according to Taxpayers Against Fraud.
"Growth hormone is different from any other drug," Dr Rost explains, "distributing the drug for off-label purposes is a crime."
"Not even a doctor is allowed to prescribe growth hormone for off-label use," he says.
The Controlled Substances Act states in part: "...whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services ... and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison.
"None of us who became employed by Pharmacia asked to be put into an incriminating situation," Dr Rost points out.
The criminal penalties were a result of the 1988 and 1990 amendments to the Food, Drug and Cosmetic Act, that made off-label sale of human growth hormone to treat age-associated illnesses illegal, according to a report in the October 26, 2005 Journal of the American Medical Association.
In the JAMA article, authors Dr Thomas Perls, director of the New England Centenarian Study at Boston Medical Center; Dr Neal Reisman, clinical professor of plastic surgery at Baylor College of Medicine, who is also an attorney; and S. Jay Olshansky, professor of epidemiology at the University of Illinois at Chicago School of Public Health discuss the little known law.
According to the article, human growth hormone can be legally prescribed for only 3 conditions: HGH deficiency-related syndromes that cause short stature in children, adult deficiency due to rare pituitary tumors and their treatment, and muscle-wasting disease associated with HIV/AIDS.
According to Dr Olshansky, "off-label use for many drugs is a normal and accepted practice in medicine, but that is not true for growth hormone. According to laws instituted by Congress more than 10 years ago, HGH can only be distributed for indications specifically authorized by the Secretary of Health and Human Services, and aging and its related disorders are not among them."
"The use of HGH as an alleged anti-aging intervention is a major public health concern not just because it is illegal," Dr Olshansky explains, "but also because its provision for anti-aging is not supported by science and it is potentially harmful."
People are spending a fortune on HGH under the belief that it reverses aging. "On the contrary, responsibly conducted and peer-reviewed science indicates that HGH could in fact accelerate aging and shorten lifespan," according to Dr Perls.
"It is associated with very high rates of serious adverse effects," he advised, "and long-term use could increase one's risk of cancer."
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