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by Houshalter
3552 days ago
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http://www.fdareview.org/05_harm.php I also recently read The Right to Try about how the FDA delays the approval of drugs for terminal diseases costing countless lives. This is less statistics based, but it shows many absurd decisions by the FDA. Terminally ill people are more than happy to take risks for drugs even if there is a small chance of them working. The FDA delays approval of drugs even when they are known to be safe, because they haven't yet proven efficacy, which is just silly. In one case they wouldn't approve a drug because they demanded a clinical trial larger than the number of patients that existed with that disease, and way larger than necessary to establish statistical significance. They ignore data from previous studies and from other countries. So there are cancer drugs that are known to be very effective and have been used for decades in Europe, but still aren't approved in the US. The death toll of this decision alone is enormous. Thousands of people could have been saved if this treatment was allowed in the US, but we are stuck with much less effective, older treatments. |
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