Some follow-up on the Basso et al article

The authors write:

"When the morning sickness drug thalidomide came to market in Europe in the 1950s regulators failed to identify that it caused serious congenital malformations in pregnant women. In the USA, FDA reviewer Dr. Frances Oldham Kelsey rejected the drug’s application on the grounds of insufficient preclinical pregnant animal data and pregnant human data."

But this does not appear to be accurate. An essay about her career is available from the University of Chicago.

It is true that William S. Merrell Co. was seeking approval to market thalidomide in the U.S. and that Dr. Frances Oldham Kelsey was the FDA reviewer. And, it is true that thalidomide could cause tragic birth defects. But Basso et al's claim is false:

When the morning sickness drug thalidomide came to market in Europe in the 1950s regulators failed to identify that it caused serious congenital malformations in pregnant women. In the USA, FDA reviewer Dr. Frances Oldham Kelsey rejected the drug’s application on the grounds of insufficient preclinical pregnant animal data and pregnant human data.

In the articles about Dr. Frances Oldham Kelsey's concerns that I have been able to locate, it wasn't the animal data that worried Oldham Kelsey; in fact, animal data was available and was (false) evidence that the drug was harmless.

See for instance 'Heroine' of FDA Keeps Bad Drug Off Market By Morton Mintz Washington Post Staff Writer. July 15, 1962. To wit:

The drug had come into widespread use in other countries. In West Germany, where it was used primarily as a sedative, huge quantities of it were sold over the counter before it was put on a prescription basis. It gave a prompt, deep, natural sleep that was not followed by a hangover. It was cheap. It failed to kill even the would-be suicides who swallowed massive doses.

And there were reports on experiments with animals. Only a few weeks ago the American licensee told of giving the drug to rats in doses of 6 to 60 times greater than the comparable human dosage. Of 1510 offspring, none was delivered with "evidence of malformation."

In a separate study, one rat did deliver a malformed offspring, but the dosage had been 120 times the usual one. Rabbits that were injected with six times the comparable human dose also were reported to have produced no malformed births.

... she said she could not help regarding thalidomide as a "peculiar drug." It troubled her that its effects on experimental animals were not the same as on humans – it did not make them sleepy.

At every turn, it seems that Basso et al get almost everything wrong. This seems to be a relatively common phenomena in many professions and walks of life. Our preconceptions and beliefs color our perception.