Sept. 15--WASHINGTON -- The physician credited with blocking the drug thalidomide from
the US market in the 1960s was headed for the spotlight later Wednesday when
the US Food and Drug Administration (FDA) makes its first award in her honour.
Dr Frances Oldham Kelsey, 96, a retired FDA employee who started working
there in 1960, refused to allow the pharmaceutical company William S Merrell
to distribute thalidomide in the US after she heard reports that it had been
connected to birth defects in Europe.
Thalidomide was prescribed to pregnant women for morning sickness. At the
time, it was not known that drugs taken by a mother could affect the foetus,
the New York Times reported.
In Europe, thousands of children were born without limbs in the late
1950s and early 60s. The defects were connected to their mothers' taking the
drug.
In the US, the drug had been distributed through physicians to about
20,000 patients as part of a trial, without the need for FDA approval. Most of
the pregnant women who took the drugs were not informed of the experimental
nature of the pills.
About 40 children were born with defects blamed on the drug, the
Washington Post reported.
Kelsey withstood industry pressure to license the drug. Her work led to
the US Congress setting up a rigid set of rules for testing and marketing new
drugs, including informed consent for patients and rigorous clinical trials.
Kelsey is expected to be present when her namesake award is given to an
FDA staffer, the first of what is expected to be an annual ritual to honour
scientists who protect consumers as new drugs are developed.
-----
To see more of dpa, go to http://www.dpa.de/English.82.0.html
Copyright (c) 2010, dpa, Hamburg, Germany
Distributed by McClatchy-Tribune Information Services.
For more information about the content services offered by McClatchy-Tribune Information Services (MCT), visit www.mctinfoservices.com, e-mail services@mctinfoservices.com, or call 866-280-5210 (outside the United States, call +1 312-222-4544).