Tape Hints Drug Maker Laughed at Product’s Potency
A congressional panel, probing a new anesthetic involved in dozens of deaths in the last two years, replayed Thursday an extraordinary taped conversation that suggests that the drug’s manufacturers may have realized--and even laughed about--their product’s great potency long before warning doctors about its full risks.
The disclosure marked a dramatic climax in a contentious, day-long hearing on the potential dangers of Versed, a powerful anesthetic and sedative that has gained widespread use in operating rooms as an alternative to Valium.
The drug’s quick acceptance, medical professionals and House critics charged, has brought breathing and cardiac complications linked to at least 42 reported deaths, which they say could have been avoided through better testing and regulation of the drug.
Federal officials and Hoffman-La Roche, Inc., which makes Versed, defended the drug’s initial marketing in early 1986 and its continued use. But the chairman of the House drug oversight panel threatened to seek criminal prosecution against the company for allegedly holding back information on Versed’s dangers.
Relevant Safety Information
The Food and Drug Administration “is apparently approving potentially toxic new drugs for use by millions of people without familiarizing itself with important and relevant safety information,” charged Rep. Ted Weiss (D-N.Y.), chairman of the Government Operations human resources subcommittee, which oversees the FDA.
Weiss’ panel is scrutinizing the development and marketing of Versed as part of a larger probe of the FDA’s regulation of the drug industry, a process that some congressmen say is in desperate need of overhaul.
Versed was first marketed in this country in March, 1986, and since has been used by an estimated 13 million patients in diagnostic and surgical operations. It was marketed heavily by Hoffman-La Roche as a powerful alternative that did not carry some of Valium’s negative side effects.
In the drug’s two years on the market, however, the FDA has received reports of 42 deaths that were believed connected at least in part to the use of Versed.
Nevertheless, Hoffman-La Roche assistant vice president Philip Del Vecchio insisted in a telephone interview that “the drug is completely safe.” Company officials say that the fatality figures are distorted by other factors.
Critics argue that officials of the firm have misled doctors about the drug’s potential dangers. They pointed with alarm and indignation to a tape recording obtained of a company board meeting in October, 1986--more than a year before the firm significantly cut its recommended dosage and instructed doctors to consider the drug three to four times as powerful as Valium.
In the recording, Versed’s product manager at the firm told an advisory panel of anesthesiologists that the company expected to make $15.2 million from Versed in its first nine months.
Laughter Heard
“And that’s even with the product being more potent than we expected,” she says to laughter. “Had we known then, our goal--we probably would have been up closer to $40 million.”
In the tape, a Hoffman-La Roche adviser then responded that “we all knew” Versed was more than twice as strong as Valium, the ratio initially reported, “but we didn’t tell you.” There is more laughter.
The product manager said: “I know. I’ll never forgive you either (more laughter). . . . Our major problem is dosing. We have over-sedation, agitation--it’s more potent than was reported.”
After listening to the tape, Dr. Douglas C. Walta said: “This isn’t funny--it makes me furious.” Walta, a Portland gastroenterologist, was among a panel of medical professionals who testified to congressmen about patients they believe died because of Versed.
Even Del Vecchio of Hoffman-La Roche said later of the tape: “It sounds awful, terrible, and I’m dismayed. It sounds like people don’t care and I know that’s not so. . . . I have no idea what they meant, and I don’t think we had any evidence (on the greater potency of Versed) at that time.”
