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FDA and HGH

By Marc Kaufman Washington Post Staff Writer
Saturday, July 26, 2003

FDA Approves Wider Use of Human Growth Hormone (continued)

The approval could significantly increase the number of children who receive the expensive treatment, which doctors say can cost $30,000 to $40,000 a year, because it will put pressure on insurance companies to cover it. The drug's manufacturer says it would cost less. But the FDA said that the maker of Humatrope, Eli Lilly & Co., has agreed not to advertise it directly to consumers; that can greatly increase demand for a medication. The company estimates that 400,000 children would fit the new category, but that only about 10 percent will get treatment. The medical profession is split on whether expanding the use of human growth hormone is good. "We really don't have enough information to know how effective it will be and how widely it should be used," said Naomi D. Neufeld, a Los Angeles pediatric endocrinologist who is a board member of the American Association of Clinical Endocrinologists. "Some doctors think it can be very helpful, but we also have a small but very loud group that says, 'Don't do it.' " she said. "Clearly, this is a treatment that has to be considered on a case-by-case basis and that involves a major family decision." She said that doctors are debating whether it makes sense to recommend the medication when it costs so much and has limited effect.

But a spokeswoman for Eli Lilly, Judy Kay Moore, said the new approval will bring relief to thousands of small children. "These kids have a growth disorder, just like the ones who have been getting Humatrope for years," she said. "The difference is simply that the origins of their growth disorders are not now known. But that shouldn't keep them from getting treatment." The FDA decision draws on the results of two studies that followed children who were unusually short for unknown reasons, for four years and six years. The first group received injections three times weekly, and the second group received larger dosages six times a week until they reached adult height.
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