78-08-B2

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Drugs

Transcript Back in 1962 the late Senator Estes Kefauver tacked an amendment onto the Food, Drug and Cosmetics act. It was the time of near-hysteria over the Thalidomide tragedies in Europe (no one paid much attention to the fact that Thalidomide had been banned in the United States since 1938.) The seemingly innocuous amendment was passed and we're still suffering from the unexpected repercussion. The Federal Drug administration exists to protect us from drugs or medicines such as Thalidomide that could prove harmful to our health. Senator Kefauver's amendment stated that - in addition - the F.D.A. had to establish that the drug was effective. This is a nearly impossible task. What is effective for one patient may do nothing for another. So long as the medicine is not a menace to health, the doctor discovers which patient responds to what medication. The result of the Kefauver amendment was a toboggan slide for the United States pharmaceutical industry which, till then, had led the world in the discovery and production of health-giving medicines. The average time for developing a new drug went from about two years to eight or 10 - or more. The cost jumped from an average of about $1 million to $20 million and sometimes twice that. The time between application for a license and approval jumped from seven months to more than two years. We dropped from about 56 new medicines a year to 17 in the first year the amendment was in effect. Smaller firms were forced out of the market and only a few major corporations could carry on. The F.D.A. protests that we haven't been denied any "important" drugs because of the 1962 amendment. Is that true? Hardly. All but one of the 11 drugs introduced for epilepsy in the United States since 1962 were first introduced in England by margins up to a dozen years. Half of the drugs for epilepsy in use there are still not available here. I chose this particular illustration because the F.D.A. has just gotten around to approving Sodium Valproate, the most effective drug known to medical science in the treatment of epilepsy. It's been in use in Europe for 10 years. The Commission for the Control of Epilepsy says it can prevent a million epileptic seizures a year. FDA's claim that Americans have not been denied access to important drugs is just not true. In addition to Sodium Valproate there are medications for high blood pressure, hypertension and asthma which were proven successes in Europe for years before they were made available in the United States. And many are still banned here. A Congressman from Idaho, Steve Symms has introduced a bill to simply repeal the Kefauver amendment. He has 113 co-signers. He needs more, and we need the result that repeal of the amendment would bring.		Details Batch Number 78-08-B2 Production Date 06/05/1978 Book/Page RPtV-313 Audio Youtube? No
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