Halcion may induce drowsiness in insomniacs, but it's causing an epidemic of heartburn among government officials. Reports of severe side effects--from anxiety and memory loss to hallucinations and violent behavior-have dogged the world's leading sleep medication ever since The Upjohn Co. introduced it in the late '70s. Upjohn officials have long maintained that their own large studies vindicate Halcion. But last week, after reviewing previously undisclosed data from those studies, British health officials imposed an immediate ban on the drug. Officials at the U.S. Food and Drug Administration are now reviewing the British action, and though no one is predicting a U.S. ban, Halcion's days as a best seller may well be numbered.
The latest chapter in the Halcion controversy started with a Utah woman named Ilo Grundberg, who killed her mother while taking the drug in 1988. After court psychiatrists absolved Grundberg of responsibility for the killing, she filed a $21 million suit against Upjohn, charging that the firm had misled the FDA and the public about Halcion's known hazards (NEWSWEEK, Aug. 19). In preparing Grundberg's case her lawyers requested thousands of pages of company documents. Those documents included an unpublished study called Protocol 321, which the company had used in its license applications.
Upjohn officials say that as they prepared to release the old study, they noticed that adverse reactions documented in the raw data had been inadvertently left out of the summary results. So before turning the study over to Grundberg, Upjohn alerted regulatory agencies to the errors. In response British officials demanded further data from other studies as well. Dr. Theodore Cooper, the company's chairman, denies that any of the material Upjohn then produced cast doubt on the drug's safety. "There is absolutely no scientific or medical evidence that warrants withdrawal of Halcion," he says. But after reviewing the new evidence, Britain's Department of Health concluded that "the risks of treatment with [Halcion] outweigh the benefits." In late September it gave Upjohn a chance to withdraw the drug, but the company declined, prompting last week's ban. Upjohn is appealing the ruling.
So far, the firm has refused to make public any of its unpublished side-effect data. Protocol 321 would have become a public record once it was presented in court. But Upjohn settled the Grundberg case last August, after losing a battle to exclude the study from her trial. The settlement effectively silenced experts who had reviewed Upjohn documents, since each expert had agreed not to discuss them before testifying. Consumer activists are now asking the FDA and the judge in the Grundberg case to lift the confidentiality order on the disputed records. Cooper denies that his company is suppressing information. The unpublished data will likely come out during public hearings at some point, he says, and it will only confirm that Halcion is "an excellent drug when properly used."
Meanwhile, regulators are looking at the data for themselves. Finland has suspended the drug's license in light of the British action, and some analysts predict that U.S. doctors will now prescribe Halcion less often. "I don't think governments go out of their way to hurt a drug," says analyst David Saks of Wedbush Morgan Securities. "Doctors will take note." As long as Halcion's full record is under wraps, they'll have reason to wonder whether the drug is really safe.