Pharmacies that once risked prosecution for using unauthorized, foreign HGH _ improperly labeled as raw pharmaceutical ingredients and smuggled across the border _ now simply dispense name brands, often for the same banned uses. And usually with impunity.
Eight companies have been granted permission to market HGH by the U.S. Food and Drug Administration, which reviews the benefits and risks of new drug products. By contrast, three companies are approved for the diabetes drug insulin.
The No. 1 maker, Roche subsidiary Genentech, had nearly $400 million in HGH sales in the U.S. last year, up an inflation-adjusted two-thirds from 2005. Pfizer and Eli Lilly were second and third with $300 million and $220 million in sales, respectively, according to IMS Health. Pfizer now gets more revenue from its HGH brand, Genotropin, than from Zoloft, its well-known depression medicine that lost patent protection.
On their face, the numbers make no sense to the recognized hormone doctors known as endocrinologists who provide legitimate HGH treatment to a small number of patients.
Endocrinologists estimate there are fewer than 45,000 U.S. patients who might legitimately take HGH. They would be expected to use roughly 180,000 prescriptions or refills each year, given that typical patients get three months’ worth of HGH at a time, according to doctors and distributors.
Yet U.S. pharmacies last year supplied almost twice that much HGH _ 340,000 orders _ according to AP’s analysis of IMS Health data.
While doctors say more than 90 percent of legitimate patients are children with stunted growth, 40 percent of 442 U.S. side-effect cases tied to HGH over the last year involved people age 18 or older, according to an AP analysis of FDA data. The average adult’s age in those cases was 53, far beyond the prime age for sports. The oldest patients were in their 80s.
Some of these medical records even give explicit hints of use to combat aging, justifying treatment with reasons like fatigue, bone thinning and “off-label,” which means treatment of an unapproved condition. In other cases, the drug was used “for an unknown indication,” meaning that the reason for treatment wasn’t clear.
Even Medicare, the government health program for older Americans, allowed 22,169 HGH prescriptions in 2010, a five-year increase of 78 percent, according to data released by the Centers for Medicare and Medicaid Services in response to an AP public records request. And nearly half the increase came in one year: 2007.
“There’s no question: a lot gets out,” said hormone specialist Dr. Mark Molitch of Northwestern University, who helped write medical standards meant to limit HGH treatment to legitimate patients.
And those figures don’t include HGH sold directly by doctors without prescriptions at scores of anti-aging medical practices and clinics around the country. Those numbers could only be tallied by drug makers, who have declined to say how many patients they supply and for what conditions.
The AP approached every U.S.-authorized manufacturer to ask what efforts they make to market responsibly and prevent abuse. Only one HGH supplier, Novo Nordisk, agreed to an interview.
“We’re doing our level best to make sure that the right patients are getting the right medicine at the right time,” said company spokesman Ken Inchausti.
He said the company is aware of the abuse issue. He said if patients apply for assistance from the company’s patient-support hub, prescriptions will be flagged for review if they are missing the most rigorous test or an endocrinologist’s signature. He said the company won’t sell HGH directly to doctors accused of bad practices and does not deal with anti-aging clinics.
Representatives of other FDA-approved HGH makers insist they do not encourage use by bodybuilders or athletes or wealthy baby boomers trying to recapture their youth. But some said they are largely powerless to control who uses their medications or why.
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