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That is some really utterly fascinating spin right there. Next up: criminals are not really responsible for crime, since "government entities" like municipal p
by logjam 13y ago
That is some really utterly fascinating spin right there.
Next up: criminals are not really responsible for crime, since "government entities" like municipal police forces supposedly "strictly enforce" criminal conduct.
I'm going to take a wild guess here and assume you've never had anything whatsoever to do with a clinical trial, because the modern FDA has almost nothing to do with the way a clinical trial is conducted.
A pharma company (the capitalists) writes the protocol the way they want, and hires a university/researcher to run the study. They file a simple two page form with the FDA to apply for an "indication" to study a treatment. The university/researcher gets the university IRB to sign off on the study protocol. Sometimes, if the IRB is any good at all, they'll tweak the protocol to try to protect the research subjects. But guess who picks the IRB members? The university/researcher making money off the capitalist pharma company. Guess how that influences an IRB.
The FDA has no input. There is no supervision in any meaningful sense by the FDA. The capitalists - researcher and sponsor - run every aspect of the study. Each decision is theirs.
The decisions spelled out in the article were made by the capitalists - the pharma company and researchers.
Barring some complete misstep like all the active arm study patients suddenly dropping dead, the FDA will eventually (read: years after the study is completed) examine the data (typically highly massaged by the capitalists) from the study to make a determination on whether to approve a medication for sale.
But pretending that the FDA (especially after years of being stripped of regulatory powers by, you guessed it, capitalists who buy and sell legislators) has much of anything to do with the way a clinical trial is conducted is complete bullshit.
- refurb 13y agoWow, that is a very inaccurate description of how clinical trials are run. How do you explain the clinical holds the FDA puts on clinical studies? The FDA does monitor clinical studies and stops the bad ones. The often stop them before a trial is over. I'm guessing you minimal experience with how clinical trials are run. Most drug companies walk on egg shells around the FDA since they know how much power their yield.
- protomyth 13y agoI worked in clinical trials and you are totally out to lunch on how they worked. Saying the FDA has no power is the dumbest thing I have ever heard and belongs on a conspiracy website, not HN.