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