That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn't get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.


kleinbl00:

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."


posted by rrrrr: 1315 days ago