Healthy Skepticism Library item: 11490
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Drug Maker Pleads Guilty Over Lethal Side Effects
Associated Press 1984 Dec 14
http://query.nytimes.com/gst/fullpage.html?sec=health&res=9501E2DF1338F937A25751C1A962948260
Full text:
The SmithKline Beckman Corporation has pleaded guilty and two of its medical officials have pleaded no contest to charges of failing to report to the Food and Drug Administration the lethal side effects of the blood-pressure drug Selacryn.
In June the Philadelphia-based pharmaceutical giant and the three officers were charged with 14 counts of failing to file reports with the drug agency of adverse reactions to Selacryn and 20 counts of falsely labeling the drug with a statement that there was no known cause-and-effect relationship between Selacryn and liver damage.
Doctors across the country have reported 36 deaths and at least 500 severe cases of liver and kidney damage linked to Selacryn.
Two top officials of SmithKline’s medical affairs department, Dr. Ralph M. Myerson of Merion, Pa., and Dr. Philip J. Tannenbaum of Broomall, and Dr. Theodore Selby of Haverford, a former official, pleaded no contest Wednesday in Federal District Court here to 14 counts of failing to file reports. The Government indicated it would drop charges against a fourth company official, Dr. Thomas G. Davis. Company’s Guilty Plea
The company pleaded guilty to all 34 charges filed this summer.
Judge Edward Cahn, who heard the pleas at a two-hour hearing, set no date for sentencing.
J. Peter Smith, an assistant United States attorney, said part of the plea- bargain agreement was that the Government would make no recommendation on sentences.
Donald J. Goldberg, Dr. Selby’s attorney, said the individual defendants would withdraw no-contest pleas and go to trial if Judge Cahn decided their sentences would include jail time.
SmithKline faces up to $34,000 in fines, and the individual doctors could receive up to 14 years in jail and $14,000 in fines. But Judge Cahn said community service could be part of whatever sentence he would impose.
The defendants were charged with failure to report to the drug agency within 15 days any unusual adverse effects of a drug.
Selacryn was developed 15 years ago by Anphar Laboratories, a subsidiary of Albert Rolland S. A., a French pharmaceutical company. In 1973, SmithKline obtained a license to develop and sell the drug in the United States.
Drug Won Quick ApprovalThe drug was introduced on May 2, 1979, after an unusually speedy review by the F.D.A. Typically the agency’s approval of new drugs follows clinical tests on up to 1,500 patients. But in April 1979, after Selacryn had been tested on 533 patients, officials of the agency concluded that no further tests were required.
That same month, SmithKline and the three physician-defendants received reports from Anphar Laboratories that Selacryn had damaged patients’ livers. The information was translated from French to English at SmithKline headquarters in Philadelphia in May 1979.
The information was never reported to the drug agency but ‘‘dropped through the cracks,’‘ Mr. Goldberg told Judge Cahn Wednesday. ‘‘There was a very human error here, and there was damage that resulted from it.’‘
The company and the drug agency removed Selacryn, which was sold from May 1979 to January 1980, from the market after the Federal agency learned of deaths among its users.
Jeremy Heymsfeld, a SmithKline spokesman in Philadelphia, said the company was now involved in 13 outstanding lawsuits involving the drug and had settled numerous other legal cases.
Dr. Sidney Wolfe, executive director of the Public Citizen Health Research Group, founded by Ralph Nader, said SmithKline had already paid $100,000 to $500,000 in out-of-court settlements in numerous cases.
