A Nader-founded health group will ask the government today to "seriously consider" banning or restricting use of the sleeping pill which was reportedly responsible for a recent drug withdrawal reaction in Supreme Court Justice William H. Rehnquist.
Dr. Sidney Wolfe, of the Public Citizen Health Research Group, charged that the widely prescribed drug Placidyl, a sleeping medication, represents "yet another example of doctor-induced drug abuse of massive proportions" which is endangering "thousands of patients such as Mr. Justice Rehnquist."
He also planned to ask the Department of Health and Human Services to require that patient package inserts, explaining the possible side effects, accompany the drug if it remains on the market.
Wolfe called this a "further step toward decreasing its abuse, as consumers become aware of how dangerous Placidyl is." The general use of such patient brochures has recently been rejected by the department.
Although the drug has not been officially named, sources have indicated that Rehnquist was receiving Placidyl to help him sleep because of a long-term back problem.
Several doctors and drug experts interviewed by The Washington Post, although not privy to the case, expressed surprise that Placidyl had been prescribed for the justice. They cited the published warnings to physicians that it should be administered for only short periods and can cause "psychological and physical dependence" with "prolonged use."
A San Diego doctor also complained that further government studies of this drug and other sleeping medications were needed, given the general lack of data on safety and effectiveness.
Dr. Daniel Kripke, a sleep researcher at the University of California at San Diego, said that preliminary indications, based on his own limited studies and those of others, are that Placidyl is "less effective and more dangerous" than many other sleeping drugs.
Rehnquist was reported to have difficulties with slurred speech in appearances late last year, a known side effect of the drug. And after doctors sought to cut back the medication, he underwent a severe withdrawal reaction in George Washington University Hospital on Dec. 27 in which he suffered from what a spokesman called temporary loss of mental clarity and perceptual capability.
Rehnquist, who has refused to comment on his medical condition, returned to the bench this week, and read a summary yesterday without faltering.
Placidyl, whose generic name is ethchlorvynol, is manufactured by Abbott Laboratories and has been on the market since the mid-1950s. Its earlier popularity was eclipsed by other products and its use declined during the last decade to an estimated 7 percent of sleeping prescriptions in 1977.
An Abbott spokesman declined to give current use numbers. But Wolfe said he had obtained industry data showing that in 1980 there were still more than 1 million prescriptions filled in retail drug stores at a cost of $7.4 million.
Despite warnings that the drug should be used only for a week at a time, Wolfe noted that the average prescription for the most commonly used dose was for more than 30 pills and that almost 50 percent of the prescriptions were for refills, "which do not require that the patient go to the physician for reevaluation."
Placidyl is regulated under the Controlled Substances Act as a Schedule IV drug, which allows it to be refilled up to five times in six months. Wolfe's organization is urging that it be moved to the stricter Schedule II, which would prohibit refills and limit its production.
Barbiturate sleeping pills are currently in this more restrictive category, as is methaqualone or Quaalude.
FDA associate director Dr. Marion Finkel said that the agency had no evidence of a need to review Placidyl's status, but that she awaits receipt of the Wolfe letter.
The concerns of Wolfe and Kripke were voiced in two earlier government reports on sleeping pills and are reflected in federal drug abuse statistics.
A National Institute of Drug Abuse study in late 1977 on "sedative-hynotic drugs" concluded that Placidyl was one of a group of nonbarbiturates whose use at "current levels is not justifiable."
A 1979 study by the National Academy of Sciences' Institute of Medicine also raised questions about the risks and benefits of Placidyl. It noted that in two out of three clinical studies the drug was no better than sugar pills and in two other sleep studies its effects were weak.
The institute study also cited what it called the "disconcerting" Kripke research, which found that in four subjects there were "adverse daytime effects," including loss of concentration, confusion and alterations in mood. The Placidyl study was funded by a competing drug company but was independently conducted, Kripke said.
In addition, the Drug Abuse Warning Network operated by the government continues to pinpoint the potential for abuse and the difficulties in treating overdose from the drug, Wolfe said.
In 1980, DAWN surveys of emergency rooms in regions representing about one-third of the population documented 1,828 visits related to Placidyl, putting it in the "top 20" list of brand name drugs of abuse. The medical examiner's survey found 103 deaths.
In almost one-fourth of the emergency room cases, the reason stated for using the drug was dependence, Wolfe said.