Word: fda
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Dates: during 1980-1989
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...FDA approval is a victory for Dr. Lyman Smith of Elgin, Ill., an orthopedist who developed and promoted use of the enzyme to treat herniated discs. Smith had been fascinated with a 1956 paper by Dr. Lewis Thomas, author of Lives of a Cell and now Chancellor of Memorial-Sloan Kettering Cancer Center. Thomas had been trying to see if various enzymes could alter concentrations of proteins in the blood. One evening, he gave adolescent rabbits intravenous injections of papain. Next morning, he found that the rabbits' normally erect ears had flopped; the papaya enzyme had dissolved the gelatinous...
Smith, now 70, became determined to find out if chymopapain, another papaya enzyme, could be used to dissolve the similarly gelatinous core of herniated discs. From 1964 until 1978 more than 15,000 patients had chymopapain injected into their discs in FDA-approved experiments. The chemical proved to be as successful as a laminectomy in relieving pain: about 70% of patients improved with either therapy. In 1971, chymopapain was approved for use in Canada, Britain and Australia. But a study of almost 100 patients in the U.S. showed that placebo injections were just as effective as chymopapain. That controversial experiment...
...chymopapain does have one drawback. Injection of the chemical can trigger a potentially fatal response known as anaphylactic shock. The reaction, which cannot be predicted in an individual, can lead to the collapse of the respiratory and cardiovascular systems. The FDA points out, however, that in the new clinical trials with more than 1,400 patients, anaphylaxis occurred in only 1% of cases, and of these just two patients died. The mortality rate of .14% for chymopapain is about the same as that for lumbar disc surgery. Still, surgeons are cautioning patients that chymopapain is a last-ditch therapy short...
Still, gene splicing shows promise of living up to most of the extravagant claims made by its supporters, who expect it to reap sales of $25 billion by the year 2000. One of the most encouraging signs is the quick action by the FDA, which licensed Humulin after just five months of testing, one of the quickest approvals in the agency's history. Genentech President Robert Swanson said last week that his company expects to market a number of other new products in the next few years, including an agent that dissolves blood clots and could be useful...
Efforts to protect the public from the Tylenol killer and his imitators are lumbering along. The FDA last week submitted a proposed regulation on tamper-resistant packaging of over-the-counter drugs to the Office of Management and Budget for approval. The regulation would not specify which of many types of packaging the industry should adopt; it would set a standard for the industry to meet in any way that companies might choose. Estimates are that new packaging will cost the industry between $20 million and $30-million a year and will add anything from a penny to a dime...