Here are a couple of notable examples. Clozapine was approved and used in 1972 in Europe. Clozapine's ability to treat schizophrenics who did not respond to other medicines became well-known by 1979. Yet the drug was not approved in the United States until 1989 because companies believed that the FDA would reject it on the grounds that 1 percent of patients who took the drug contracted a blood disease. As an article in The New England Journal of Medicine stated, "what is remarkable is that clozapine has a beneficial effect in a substantial proportion (30 to 50 percent) of patients who have an inadequate response to other ... drugs." Nearly 250,000 people with schizophrenia suffered needlessly, when relief was at hand.
According to Robert M. Goldberg, writing for the journal Regulation, "Mevacor is a cholesterol-lowering drug that has been linked to reduction in death due to heart attacks. It was available in Europe in 1989 but did not become available in the United States until 1992. Studies confirm what doctors saw to be the case: taking the drug reduces death due to heart disease by about 55 percent. During that three-year period as many as a thousand people a year died from heart disease because of the FDA delay."
There is self-correction when a drug that has unanticipated dangerous side effects has been marketed. The drug is removed. But there's no self-correction when a safe, effective lifesaving drug is not approved or is delayed. Those 5,000 ALS patients who will die of their disease this year are invisible, and FDA officials are unaccountable. "Right to Try" legislation is a step in the right direction to remedy that.
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