Ketek FDA approval

Описание: There are a significant amount of drugs that are approved by the F D A that get approved even over the medical reviewer’s objections on safety grounds.

A big reason for this is that the F D A does no independent drug testing. It never tests a drug it approves.

It relies entirely on the drug advocate or the company that submits the drug application so there is inherently conflict of interest.

A great example of this is the drug Ketek. Ketek is a ketolide antibiotic manufactured by Sanofi-Aventis and how this drug got approved is a prime example on how corruption infiltrates the drug testing process.

There were 1800 physicians who were enrolled in the testing and got paid for each patient enrolled - which ended up being about 24,000 people.

Once the drug was approved by the F D A there were numerous problems with dozens of people presenting with liver toxicity, which led to a congressional investigation of the F D A.

It was found that the top leading physicians who submitted the most patients to the testing never actually did any enrollment at all, it was a complete a fraud. At the end of the investigation it was found that 4/10 sites inspected had fraud and these physicians were sentenced to prison.

The craziest part is that even after this fraud was discovered the F D A kept the drug on the market and did no further testing.

What are your thoughts on this?

https://www.nejm.org/doi/full/10.1056...

https://thevaccinereaction.org/jonath...

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