Firm Allegedly Knew Its Drug Was Risky

Hoffman-La Roche sold 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.

However, a company spokeswoman 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 newspaper.

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

Kuntzman’s concerns were overruled by the executives in Basel, the paper 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 labeling.”