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Prudence and the Pill: Testing Thalidomide in the Global South
Posted by Harriet A. Washington, Biopolitical Times guest contributor December 13, 2010
Biopolitical Times
A momentous act of prudence stands out as the US Food and Drug
Administration’s shining hour. In 1962, pharmacologist Dr. Frances
Oldham Kelsey refused to approve the German drug thalidomide for the
prevention of insomnia and morning sickness in pregnant US women, even
though it had been distributed in Europe since 1957 by the German drug
firm Grünenthal. Kelsey, now 96, gave thalidomide a thumbs-down because
she determined that the safety tests had been performed incorrectly. In
doing so, she - and a supportive FDA - defied Merrell-Richardson, the
pharmaceutical company that wanted to market it to the lucrative US
market and threatened lawsuit in response.
Kelsey was correct. Thalidomide proved horribly unsafe, a teratogen that crosses the placental barrier and caused birth defects in 10,000 children in 46 countries. The children of women who took thalidomide were born with gross injuries including phocomelia, which is characterized by internal organ damage and missing or dramatically shortened limbs.
But only 16 American children suffered phocomelia, and the FDA takes justified pride in having saved Americans from sharing in this global tragedy.
Kelsey’s achievement is a refreshing, even reassuring, reminder of the blessings that the US medical research system can impart when at its best. Unfortunately, today’s largely overwhelmed FDA lacks the effectiveness and independence of the agency Kelsey knew, according to a 2006 report by the Institute of Medicine. The IOM report found major deficiencies in the FDA’s system for ensuring that medications on the US market are safe. Moreover, the agency is now largely dependent upon the very drug makers whose products it evaluates for approximately 40 percent of testing costs. Because of this, even some insiders criticize the FDA as loath to deny approval to even the most troubled drugs.
In 2005, for example, Dr. David Graham, currently the Associate Director of the FDA’s Office of Drug Safety, told CBS News that "FDA has a system in place now that will guarantee that unsafe drugs will remain on the market."
Read more
Kelsey was correct. Thalidomide proved horribly unsafe, a teratogen that crosses the placental barrier and caused birth defects in 10,000 children in 46 countries. The children of women who took thalidomide were born with gross injuries including phocomelia, which is characterized by internal organ damage and missing or dramatically shortened limbs.
But only 16 American children suffered phocomelia, and the FDA takes justified pride in having saved Americans from sharing in this global tragedy.
Kelsey’s achievement is a refreshing, even reassuring, reminder of the blessings that the US medical research system can impart when at its best. Unfortunately, today’s largely overwhelmed FDA lacks the effectiveness and independence of the agency Kelsey knew, according to a 2006 report by the Institute of Medicine. The IOM report found major deficiencies in the FDA’s system for ensuring that medications on the US market are safe. Moreover, the agency is now largely dependent upon the very drug makers whose products it evaluates for approximately 40 percent of testing costs. Because of this, even some insiders criticize the FDA as loath to deny approval to even the most troubled drugs.
In 2005, for example, Dr. David Graham, currently the Associate Director of the FDA’s Office of Drug Safety, told CBS News that "FDA has a system in place now that will guarantee that unsafe drugs will remain on the market."
Read more