Physician to be honored for historic decision on thalidomide

[mahatmakanejeeves]

NOT late-breaking news. Just a reminder of why all those people who commute to regulatory agencies are there.

Physician to be honored for historic decision on thalidomide

By Lyndsey Layton
Washington Post Staff Writer
Monday, September 13, 2010; 9:17 PM

It was a straightforward assignment for a newcomer to the Food and Drug Administration, such a simple task that Frances Oldham Kelsey was given a cubbyhole of an office and the bare basics to get it done: review an application from a drug company to market a new sedative called Kevadon.

The drug was already widely used in Britain, Germany and about 20 other countries and it was a lucrative success for its manufacturer, the William S. Merrell Co., which was eager to get it into medicine cabinets in the United States.

At the time, in 1960, Americans were dazzled by vaccines, antibiotics and the vast array of new discoveries defining modern life.

But Kelsey, a physician and a pharmacologist, questioned the safety of Kevadon, the brand name for thalidomide, and refused approval. "It just came with so many extravagant claims that I didn't believe," Kelsey, now 96, said Monday in an interview at her Bethesda home.

The drug company pushed back and started an intense campaign, repeatedly calling and meeting with Kelsey and her superiors, including the FDA commissioner.

Kelsey was steadfast, and her resistance became the stuff of legend when it turned out that thalidomide caused severe birth defects in thousands of babies born in Europe and elsewhere. The drug had been prescribed for women to help them sleep or manage morning sickness. The babies often had malformed arms or legs or extra appendages.

[monmouth]

1. I was having babies during this time and no one knew the side effects

of this horror..It was a very scary time.

[WinkyDink]

2. "At the time, in 1960, Americans were dazzled by vaccines,..." To be re-read, slowly and often.

[gratuitous]

3. Another greedy public employee

She wasn't even working a real job! Probably making scads more money than her private sector counterparts! Fraud!

See how stupid that sounds, Freeperati?

[pnwmom]

4. "FDA remains under constant pressure from the companies it regulates"

Something to keep in mind.

[indepat]

5. Our girls were born in 1960 and 1962: thank you Dr. Frances Oldham Kelsey and best wishes from

all of us in America who were starting our families about that time. :loveya:

[shraby]

6. I had one in 1961. Fortunately I didn't have morning sickness.

The doc asked me if I needed anything for it and I said "nope, don't have it." To this day I wonder what it was he would have given me.