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Special (Slow-K / The FDA) #488149

NBC Evening News for Tuesday, Apr 06, 1976
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(Studio) Congress cmtes. to investigate FDA (Food and Drug Administration) regulation of drugs.
REPORTER: Edwin Newman

(No location given) Slow-K is world's leading potassium supplement. Elderly and those with heart problems and high blood pressure take it. Some doctors feel Slow-K dangerous. FDA (Food and Drug Administration) criticized for relying on honesty of drug companies
REPORTER: Linda Ellerbee

(Summit, New Jersey) In 1965, Ciba-Geigy Pharmaceuticals test Slow K for 1st time. [Hd. American Ciba test unit, Dr. Gilbert McMAHAN - says monkeys got ulcers from Slow-K.] Company applied for Slow-K approval from FDA (Food and Drug Administration) after McMahan leaves Ciba. McMahan wrote FDA (Food and Drug Administration) with regard to monkey study. Without letter, FDA (Food and Drug Administration) would have relied on Ciba's information FDA (Food and Drug Administration) criticized for being unwilling to punish drug companies
REPORTER: Linda Ellerbee

(DC) In February 1973, Dr. DeVaughn Belton, head of FDA (Food and Drug Administration) cardio-remal division, asks that case of missing monkey study be turned over for prosecution of Ciba. Bureau of Drugs Director Richard Crout doesn't sign memo. [CROUT - says div. probably lost memo. Have had several examples of potential prosecutions which didn't go forward well.] Ciba not investigated. FDA criticized for being influenced by drug mfrs. In September 1973, FDA (Food and Drug Administration) staff reviews Slow-K. [FDA (Food and Drug Administration) medical ofr. Dr. Stanley CORTELL - cites his opposition to Slow-K. People can die from it; some patients have died in United Kingdom.] Chart shows who objected to and who approved Slow-K. FDA criticized for advisory cmtes.' rubberstamping FDA (Food and Drug Administration) executive decisions. On December 6, 1973, Crout takes Slow-K to advisory committee Committee votes to go along with Crout. Slow-K gets okay on April 25, 1975. Ciba spent $10 million getting drug to market 1/2 million Americans take it. Reports of ulcers and bleeding reported to FDA. 35 doctors call Slow-K dangerous in August article in "The Medical Letter." Senate committee to study Slow-K. FDA (Food and Drug Administration) warns Ciba to not withhold information in future, 3 years after monkey study withheld. FDA may require box warning on drug.
REPORTER: Linda Ellerbee

(Studio) Report is on way FDA (Food and Drug Administration) handled Slow-K, not an editorial statement.
REPORTER: Edwin Newman

Ellerbee, Linda;
Newman, Edwin

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