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Originally Posted by Jeysie
I'm not going to say there ain't a lot of crap coming from the FDA's direction (Thalidomide, anyone? Or fen-phen?)... but mass conspiracies where doctors fake test results to use dangerous drugs on people who aren't sick? Like I said, it sounds like a pulp medical thriller.
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The principal investigator may not have faked the results, but he may have been so eager to get study participants that he did not follow procedure properly. Deceiving clinical trial participants and not treating them with due care is common. It might not result in death, and it might not make Harper's Bizarre, but it does happen regularly. These studies typically attract the poor and the under-educated who do not clearly understand the risks of taking part in the trial and desperately need the money, this makes it very easy to take advantage of clinical trial participants.
The Tuskegee Syphilis study was run for 40 years, starting in 1932, and was only terminated because of bad press. Thanks to the Tuskegee Study and the Willowbrook Hepatitis Studies the U.S. now has IRBs (Institutional Review Boards, also called Research Ethics Boards in Canada), who must follow FDA regulations when monitoring clinical trials of FDA regulated products (i.e, drugs), but IRBs are not closely monitored by the FDA. IRBs are often funded by pharmaceutical companies, the same pharmaceutical companies running the clinical trials of new drugs. If you wanted to you could found your own IRB to monitor your own clinical trial. No wonder ethical breaches happen.
(WIRB is the most notorious and the largest of review boards if you're curious and want to read more about IRBs.)
Ever wonder how in the world would a drug like Vioxx get approved? Merck's own studies showed that it increased the risk of heart attack fivefold. Merck did manipulate the data, but the FDA sat by and twiddled its thumbs while people were dying.
The FDA is partially funded by drug companies now, something a lot of people aren't aware of. When AIDS activists were pushing for AIDS drugs to be pushed through the approval process more quickly it opened the door for the FDA to start charging drug companies fees to get their drugs approved quickly. The pharmaceutical industry is incredibly profitable. They are ruthless businesses, they do not care about curing disease, their primary directive is to get blockbuster drugs approved and to make obscene amounts of money. Prilosec topped $6 billion in profits a year. That BLOWS MY MIND.
I'm going to stop now before I get carried away and bore you all. I have a huge interest in the FDA, clinical trials, REBs/IRBs and especially Big Pharma. Many people do not understand just how underhanded and ethically questionable Big Pharma is. They sell the disease, then the drug. Drug company reps give money and gifts to pharmacists and physicians (who are referred to as "script writers" because to Big Pharma that's all doctors are). Drug companies will even ghostwrite articles about their star drugs and pay a doctor to sign the article to give it more credibility. Medical schools receive huge amounts of money from drug companies, drug companies start wooing doctors before they've even gotten their MDs. It all really gives me a bad feeling.
