The alleged pattern took hold before the FDA even approved the drug. Upjohn had clear evidence by 1982 that “long term use [of Halcion] was both dangerous and medically untenable,” the investigators write, but company officials “misrepresented the data” to keep the FDA from limiting prescriptions to 14 days. According to the report, “the firm chose to disregard the potential harm of inappropriate use, in order to gain additional sales (profits).” The investigators contend that after Halcion hit the U.S. market in 1983, Upjohn misled the FDA about the significance of patients’ adverse reactions, which ranged from amnesia to paranoia. They also accuse Upjohn of misreporting side-effects data to French and Japanese regulators, and they criticize the company for running an “ongoing campaign to discredit or neutralize any individual or publication reporting adverse information about Halcion.”
Upjohn rejects the report’s conclusions-“We put nothing ahead of patients’ health,” says company spokeswoman Kaye Bennett-and FDA officials say the report is not likely to prompt any official action, since it contains little new information. But the document won’t help Upjohn in its legal battles with critics and former customers. And it’s sure to rekindle the fury of health activists who want the drug banned.
