Replies to post #358831 on Innovation Pharmaceuticals Inc (IPIX)

[sunspotter]

"Guess what, thalidomide was FDA Approved!!!"

But guess what? Not for for morning sickness, unlike in Europe where it caused countless tragedies:

"In 1960, the limited liability corporation Richardson-Merrell applied to the US FDA, headquartered in Maryland, for approval to sell Kevadon, the company's trade name for thalidomide. The company hoped to approve thalidomide as an over-the-counter drug and recommended it to treat a variety of ailments including alcoholism, anorexia, asthma, cancer, poor schoolwork, premature ejaculation, and tuberculosis. The application went to Frances Kelsey, a physician and pharmacologist at the FDA. Kelsey noticed reports of thalidomide's adverse effects in Germany. Because one of thalidomide's recommended uses was treating morning sickness, Kelsey requested more data from Richardson-Merrell to show that thalidomide was safe for use during pregnancy."

https://embryo.asu.edu/pages/us-regulatory-response-thalidomide-1950-2000

The FDA actually did the right thing.

Subsequently thalidomide was approved for other indications including leprosy and myeloma but with an absolute contraindication for pregnancy.

[zandant]

Interesting article. Thanks.

Just to be clear though - it was not approved by the FDA during the late 50s early 60s when the drug gave rise to birth defects. It was used for clinical trials in the US but was not FDA approved.
"Thalidomide was approved by the FDA in 1997 under tight restrictions to treat inflammation in leprosy patients. It has since been approved for other uses although it is not approved for use by pregnant women."

[TheDane]

What happened there was pure evil. I didnt know the circumstances of how it was delivered to U.S. patients. Dastardly!

It’s beyond most people’s understanding how a drug that does good and is safe, like Ivermectin, gets shunned and canceled by the media and Big Pharma and a drug like Thalilomide that does great harm gets pushed into a population. Motivation seems to be the same...$$$.

And our BrilAcidin sits hidden away, buried in a clinical trial that, while it appears to be moving along as planned, is taking way too long.

Whatever! In for a penny...!!! As they say.