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New report criticises Upjohn over Halcion

Upjohn, the maker of the banned sleeping pill Halcion (triazolam), "engaged in an ongoing pattern of misconduct" over the drug, according to a report from the US Food and Drug Administration (FDA) investigators. The company failed to report 30% of adverse side effects in a pivotal early study, protocol 321, the report concludes. Upjohn seemed to have misrepresented data to persuade the FDA to waive a proposed 14 day limit on use, "even though available evidence indicated that long term use was both dangerous and medically untenable.... The firm chose to disregard the potential harm of inappropriate use, in order to gain additional sales (profits)."

The conclusions come from the report of an investigation sparked off by allegations during litigation over Halcion in the US that adverse reactions from protocol 321 had been underreported to the FDA. The investigation was stopped in March 1992 after three months, but the report was finalised only last month, when it became available under the US Freedom of Information Act.

Upjohn is suing Professor Ian Oswald, emeritus professor of psychiatry at Edinburgh University, over remarks, quoted in the New York Times, accusing the company of deliberately misleading drug regulators over Halcion's side effects. Professor Oswald is counterclaiming over Upjohn's description of his work as "junk science" and suggestions that he was influenced by fees received in litigation in the US. Mr Justice May is expected to deliver judgment in the four month case, which was heard without a jury, later this month or next month.

The FDA investigators, who interviewed current and former employees and inspected internal company documents at Upjohn's headquarters in Kalamazoo, Michigan, say that the company attempted to obtain approval for a 1 mg dose, even though available evidence indicated that this was too high. Halcion, which was approved for sale in Britain in 1978 and in the US in 1982, became the world's best selling sleeping pill, generating worldwide sales of $240m ((pounde sterling)160m) a year. As motivation for resisting a 14 day limit the investigators cite an internal memorandum stating that this "could reduce projected sales by 50% over a 10 year period."

Upjohn's licence for Halcion in Britain was suspended in 1991 after the Committee on Safety of Medicines and the Medicines Control Agency learnt that protocol 321 had been misreported. The company's explanation - transcription errors - was "false and misleading," the report says. "There was, at minimum, a gross and seminal failure to properly tabulate the data." Halcion remains on the market in the US.

The investigators also accuse the company of conducting "a continuous, ongoing campaign to discredit or neutralise any individual or publication reporting adverse information about Halcion." This included attempting to discredit and counter statements made by Professor Oswald; preventing publication of an article in the New England Journal of Medicine; supplying incomplete information to a conference; writing an "inaccurate and misleading" letter to the Lancet; and supplying "incomplete and inaccurate" information to drug agencies in France and Japan.

A spokeswoman for Upjohn, Kaye Bennett, said that the company disagreed with the report. "Upjohn puts nothing ahead of patients' health. The company presented corrected data regarding the safety and efficacy of Halcion to an FDA advisory committee meeting in May 1992." Upjohn accepts that it has made "some human errors" in the past but says that it has implemented systems to prevent recurrence.

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