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MEDICINE:The drug,used to treat leprosy,would be the most regulated ever if
FDA panel's advice is taken
By LAURAN NEERGAARD
The Associated Press

BETHESDA,Md.Thalidomide,once the world's most notorious drug was
recommended by a federal panel Friday for sales at U.S. pharmacies with
tight restrictions aimed at avoiding the birthdefect horrors of the 1960s.

The scientific panel urged approval by the Food and Drug Administration
just for a small number of leprosy patients. But doctors are expected to
prescribe it for a wider range of conditions, and all sides agreed that
accidents were inevitable.

Even one of the world's top leprosy physicians, Dr. Thomas Rea of Los
Angeles County Medical Center, told the FDA'S advisory panel that "one day
a thalidomide baby will be born" because of the approval.

"I don't know what I will do when I look that child in the eye," Rea said.

If the FDA follows the panel's advice, thalidomide would become the most
severely restricted drug ever sold in this country.

That would be far different from 35 years ago, when the drug was banned
worldwide after causing horrific birth defects in 12,000 babies. At that
time, it was sold as a sleeping pill and morningsickness cure in 48
countries.

The drug was never sold in the United States because and FDA scientist
uncovered early signs of toxicity and blocked approval. Still, some
Americans got it overseas or in clinical trials.

Today, said the agency's Dr. Murray Lumpkin, experts know the risks, and
the drug is being studied as a medicine to treat only devastating diseases
that leave their victims little hope.

Americans with leprosy are very rareunder 50 a year are diagnosed with the
agonizing inflammation the drug targetsand most of them are in special
research programs that already allow them to get experimental doses.

But the drug also is being studied for a host of diseases from AIDSrelated
wasting and ulcers to cancer, lupus and rheumatoid arthritis.

That means doctors probably will prescribe it to many more people than
leprosy patients, the FDA panel acknowledged. But the scientists said
thalidomide would still pose a danger without approval because it is sold
underground, sometimes via the Internet, and smuggled from abroad with no
government oversight.