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kleinbl00  ·  3353 days ago  ·  link  ·    ·  parent  ·  post: The FDA buries evidence of fraud in medical trials. My students and I dug it up.

Never attribute to malice that which is more easily explained by incompetence.

Articles like these are written for people who have never worked with the FDA, never known anyone in the FDA, never worked in an industry that interfaces with the FDA. Here's a hint: The FDA's budget in 2014 was $4.7 billion. The pharmaceutical industry, meanwhile, spent $250m on lobbying. And the majority of the FDA's budget comes from fees paid by pharmaceutical and medical device companies.

Know how you run an FDA clinical trial? You write up a manual that says "we're going to test like this because it's going to prove this." The FDA then gets to say "yay" or "nay." They don't assist you in your model, they don't offer suggestions, they just tell you whether they buy it or not. And as FDA inspectors are just about the only people in the pharmaceutical ecosystem who aren't making phat stax, it's pretty easy to get someone clever to snow them with doublespeak. I mean, these are the guys that couldn't get a job with the place they're auditing. Hijinks will ensue.

As far as all the "redacteds" in the report, that's a trade secret thing. If the FDA is going to come inspect your proprietary money-making anti-baldness drug, they aren't allowed to leak the details to your competitors. You'll find the same for any industry with trade secrets.

Not saying there isn't a bunch of bullshit associated with the FDA and the pharmaceutical industry... but saying the "FDA buries evidence of fraud" is sort of like saying "Mr. Bean accosts strangers and vandalizes property."