Beta blockers regulate hypertension and heart problems. The FDA held up approval of beta blockers for eight years because it believed they caused cancer. Dr. Louis Lasagna of the Tufts University Center for the Study of Drug Development estimated that 119,000 people died who might have been helped by that medication.
Clozaril was first approved and used in 1970 in Europe to treat schizophrenics who did not respond to other medicines. The drug was not approved in the United States until 1990 because companies believed the FDA would reject it on the grounds that 1 per cent of all patients who take the drug contract a blood disease. Clozaril has a beneficial effect on 30 to 50 per cent of patients. FDA delay meant nearly 250,000 people with schizophrenia suffered needlessly.
Mevacor is a cholesterol-lowering drug that became available in Europe in 1989 but did not in the United States until 1992. Taking the drug reduced death due to heart disease by about 55 per cent. During that three-year period as many as a thousand people a year died from heart disease because of this FDA delay.
From 1938 until 1962, the FDA had sixty days to disapprove the application of a new drug. If it did not, the drug could be marketed. The system worked without significant incident.
The dead are many but who did the FDA save from unsafe drugs. There is an infallible test. That test is based on the FDA not being infallible.
The FDA must have made some errors and let some unsafe drugs slip through which caused the hundreds of thousands of deaths needed to make up for the deaths – the premature deaths – that were the result of drug delays. What were those drugs that slipped through the net?