Word: fda
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Growth Spurts. In 1938, at the start of the wonder-drug era, FDA was given broader powers after a sloppy preparation of sulfanilamide killed 107 people. But the sulfas were only the first of several families of potent drugs developed by inventive chemists working with imaginative physicians. And the high tide of new drugs was arriving at a time when the food industry, which gives FDA 70% of its work, had begun its own technical revolution with new preservatives, additives, and other chemicals. The agency did not have nearly enough manpower to do a thorough job, nor was its prestige...
...FDA got a shot of growth hormone in 1962 with the Kefauver-Harris law, which made the agency responsible for the efficacy as well as the safety of new drugs. But growth (from 800 employees and a $5,000,000 budget in 1955 to 4,400 and $53 million today) also meant growing pains. FDA was ill organized and ill housed-some of its most vital scientific work had to be done in a made-over garage. Worse, many of its difficulties were homemade...
...review. Relayed to press and public, review items often cause alarm. But they consist largely of unevaluated "raw data"; many of the cases, said Dr. Shaw, have not been checked to make sure whether the patient was indeed taking the drug named, or taking other drugs with it. The FDA, which cannot afford to investigate every case, keeps the names of doctors and patients confidential. This information, suggested Dr. Shaw, should be given to manufacturers-who have the means and the motivation to ferret out the facts...
Amphetamines and barbiturates get into illegal channels from makers of basic chemicals, drug manufacturers, distributors, retail drugstores, and, says the FDA's Sadusk, "even from physicians." In an effort to plug that last leak, the A.M.A. issued a warning to doctors to prescribe only the required amount of any drug for specific symptoms, and not to write prescriptions that can be refilled indefinitely...
...National Cancer Institute at $170,000 a gram, though Krebiozen is creatine monohydrate, a common chemical costing 300 a gram-and "even if Krebiozen could be produced by the method allegedly used by Durovic, would cost [only] about $8,000 per gram." > Drs. Durovic and Ivy told the FDA that as of 1961 a patient had been "well and free of complaints for nine years since the start of Krebiozen," when in fact the patient died of cancer in 1955. - > Dr. Phillips certified that a patient had died of virus pneumonia in 1953 and an autopsy had been refused, when...