2010: Physician to be honored for historic decision on thalidomide

[mahatmakanejeeves]

Physician to be honored for historic decision on thalidomide

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.

{snip}

[e-mail]

[TreasonousBastard]

1. Jeez... do we really want to remind antivaxers about thalidomide? I remember that horror.

[mahatmakanejeeves]

2. I was thinking more along the lines of cattle de-wormer. NT

[DURHAM D]

3. I have always thought of this as a very very positive story about the FDA.

Thank god for Dr. Kelsey and the other research scientists.

[NNadir]

6. This has nothing to do with anti-vax rhetoric. On the contrary, it is a classic tale of...

...careful regulation.

There is no reason to kiss up to the fear and ignorance of anti-vaxxers.

For the record, thalidomide is now an approved anticancer drug, which works by the restriction of angiogenesis to fast growing cancer cells. This angiogenic effect is deforming to fetuses but is also capable of slowing the growth of tumors.

It is now on the list of WHO's essential medicines.

Thalidomide is a classic tale in interconversion of stereoisomers (racemization) and the relationship to physiology. Only one of the two enantiomers is antiangiogenic.

[TreasonousBastard]

8. You are being far too reasonable, which the science deniers are, by definition, not.

[NNadir]

9. I'm past the point of caring about them. They will be herd thinning by winning Darwin Awards.

I'm trying to think of a downside to that, but I'm at a bit of a loss to do so.

I'm no more interested in catering to them than I am to catering to white supremacists. The Venn diagram shows a huge overlap in these two sets, by the way.

[TreasonousBastard]

10. I wholeheartedly agree, but my original point was not to...

confront them, but not to remind them of an incident they would misuse

[NNadir]

11. Misuse for what?

To convince themselves to remain stupid?

The bottom line is that anyone who can be convinced that the thalidomide history has some bearing on vaccines is already beyond hope by definition. They're a closed set.

Anyone who is reasonable will understand that this wonderful bit of history is an argument for regulation and for having confidence in the regulators, including those who make emergency authorizations, which in this case, that of the Covid vaccines, saved lives, mostly lives worth saving.

[TreasonousBastard]

12. Just more confusion. Someone on Facebook brings it up...

as evidence of something, and too many people won't have the ability to understand the two situations are different.

And one more idiotic idea takes root.

[NNadir]

13. Well, from my perspective, failing to honor a scientist who did...

...something outstanding and very important because there are weak minded people on Facebook would be a tragic injustice.

[DURHAM D]

4. I am surprised. The article says just 40 babies were born in US.

I have known 2.

[Midnight Writer]

7. I knew one.

[applegrove]

5. She was a Canadian. Unfortunately Canada did approve the drug and

hundreds were born with birth defects.