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July 11, 2004

Sometimes Government Works

Rare, but it does happen.

The next time I don't notice how few Thalidomide-deformed Americans I'm not meeting, I'll try to remember that it was actually one good bureaucrat doing her job right I have to thank for that:

As autumn closed in on the Christmas holiday season—the most lucrative time of the year for the sale of sedatives—the pharmaceutical company, frustrated by the repeated—and in their view, unnecessary—delays, began to pressure Dr. Kelsey with visits and phone calls to her superiors. Despite the increasing pressure, Dr. Kelsey remained steadfast in her demand for thorough clinical studies demonstrating the drug’s safety.

...

In the few years that the drug was on the world market, thousands of children were born with Thalidomide-related deformities[6]. Many did not survive their first year. Countless more miscarriages were traced to the use of Thalidomide. The damage in the United States, due to the work of Dr. Kelsey, was small by comparison, with 17 children documented to have Thalidomide-associated deformities. These children were affected during clinical trials of the drug, prior to its approval. During this investigational period, Richardson-Merrell distributed more than 2.5 million Thalidomide tablets to more than 1,000 doctors who, in turn, gave the tablets to nearly 20,000 patients—several hundred of whom were pregnant women.


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posted by Ace at 12:04 AM

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