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Report: Executives Warned of Hazards Years Before Sedative Caused Deaths

July 4, 1991

NEWARK, N.J. (AP) _ Hoffman-La Roche marketed a concentrated sedative that has sometimes deadly side effects even though its executives were warned of the danger long before the product was marketed, a newspaper reported Thursday.

A company spokeswoman, however, said the report about the drug Versed, based on documents obtained by The New York Times, was off the mark.

The drug, produced by F. Hoffmann-La Roche of Basel, Switzerland, was designed to sedate patients during minor surgery or before and during general anesthesia.

Within 18 months after Versed went on the U.S. market, the Federal Drug Administration received 46 reports of deaths linked to the drug, according to the Times.

Internal company documents show that executives at the company’s U.S. affiliate, Hoffmann-La Roche Inc. of Nutley, twice urged Swiss executives to market the drug in a less concentrated form, the Times said. The documents were supplied by a person who said he was outraged at the company’s conduct, according to the newspaper.

Despite the warnings from researchers in Nutley, Basel pressed forward, placing economic objectives over safety concerns, the Times said.

A confidential memorandum to the company from its law firm, Arnold & Porter, suggested that ″Roche-Nutley disregarded its own concerns for safety of the drug in favor of marketing and political pressure from Roche- Basel.″

In 1979 and 1980, Dr. Ronald Kuntzman, a vice president for pharmaceutical research and development at Nutley, urged officials at the Basel headquarters to use a less concentrated form of the drug.

Kuntzman said he was concerned about patients experiencing a temporary cessation of breathing and cardiovascular collapse in minor medical and dental procedures in which resuscitation equipment or emergency personnel were unavailable.

Versed was designed to look like injectable Valium, also manufactured by Hoffman-La Roche, and was marketed in the same sort of sealed glass containers, or ampuls. But Versed was up to four times as potent as Valium and left doctors little room for error, the Times said.

Kuntzman’s concerns were overruled by the executives in Basel, the Times said. Eventually, however, he notified them he had changed his mind and went along with the marketing plan, the newspaper said.

A company spokeswoman said instructions for the safe use of the drug are clear.

″Versed is the safest and most effective of anesthetic drugs,″ said the spokeswoman, Carolyn R. Glynn. ″It’s safe and effective when used according to labelling.″

Ms. Glynn said it had been used on 15 million people since it was put on the U.S. market in 1986.

Ms. Glynn said the company introduced a second version of the drug after receiving reports that some physicians wanted a less concentrated form of Versed. Both forms of Versed marketed in the United States are packaged in vials, not ampuls, Ms. Glynn said.

″Both are currently available, and in fact the more concentrated form is the more popular of the two,″ Ms. Glynn said. ″The concentration is not the issue.″

Dr. Robert M. Julien, a former professor of anesthesiology from Oregon, wrote the company in 1987 criticizing the formulation of the drug, saying that in a typical situation a doctor would have to drip in 0.056 cubic centimeter of the drug a minute, much less than a drop.

″I would state to any jury that 56-1,000 cc. is virtually impossible for any physician to accurately inject by any known human technology,″ Julien wrote.

During government hearings into the dangers of the drug several years ago, Rep. Ted Weiss, D-N.Y., said the FDA approved Versed for use at a dose two to three times higher than the level recommended in Europe, apparently without knowing about or reviewing studies of the European experience.

He has said he would call for a criminal investigation of the company.

Phone calls to Arnold & Porter went unanswered Thursday. Ms. Glynn said she had not seen the legal memo, which she described as a Arnold & Porter document, not one from Hoffman-La Roche.

Max W. Gurtner, director of corporate information at the company’s Basel headquarters, did not return phone calls Thursday from The Associated Press.

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