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Drug Quotes

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Drug Quotes

“When birth control pills were available in Europe but not in the United States, American women created an uproar about how the unwillingness to make the pill available showed a contempt for the lives of women. When the Food and Drug Administration (FDA) released birth control pills with high dosages of hormones that were later found to be unnecessarily high, they were attacked for not caring about women enough to do the necessary tests.”

“When a drug comes out [that's broadly prescribed] there are going to start to be a lot of people on it [in a million person cohort] and you might get therefore an early signal of something unexpected that hadn't come through in the clinical trials. And I'm sure [drug companies] would love it if, in fact, FDA, recognizing that, would say, OK, maybe you don't have to do your trial with 30,000 people because we're going to find out shortly after registration because we'll have a lot of people taking the drug and we'll be able to see what happened using PMI.”