- C Dyer
An investigation by the United States Food and Drug Administration (FDA) into possible misconduct by Upjohn, makers of the sleeping pill Halcion (triazolam), “strongly suggested” that the company knowingly concealed side effects in an early clinical trial, according to an FDA memorandum. Subjects in protocol 321, a study of 28 healthy prisoners for 42 days in 1972, experienced more adverse reactions than were shown in the summary that the pharmaceutical giant submitted to the FDA in its application for approval. The true incidence of side effects emerged only in 1991, when the original data came to light during a court case in the US over Halcion.
The memo of December 1992, obtainable under the US Freedom of Information Act, shows that the FDA considered referring the case to the US Department of Justice for an investigation by a grand jury. But it decided not to go …
Sign in
Article access
Article access for 1 day
Purchase this article for £20 $30 €32*
The PDF version can be downloaded as your personal record







CiteULike
Connotea
Del.icio.us
Digg
Facebook
Mendeley
Reddit
Technorati
Twitter
Stumbleupon
Rapid responses
Latest Responses
Re: Bringing Nightingale down to size
Published 29 May 2012
Re: Avoid antimuscarinic drugs in people with dementia
Published 29 May 2012
Re: Strengthening primary health care: Related to the integration of medical training, community service need and health administration
Published 29 May 2012
Re: Strengthening primary health care: Related to the integration of medical training, community service need and health administration
Published 29 May 2012
Health Literacy: Patient involvement and engagement with healthcare
Published 29 May 2012
Most responses
Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10 (12 responses)
Published 10 May 2012 - 23:32
The psychiatric oligarchs who medicalise normality (9 responses)
Published 2 May 2012 - 15:42
Are doctors justified in taking industrial action in defence of their pensions? No (8 responses)
Published 8 May 2012 - 12:21
Are doctors justified in taking industrial action in defence of their pensions? Yes (8 responses)
Published 8 May 2012 - 12:21
The hardest thing: admitting error (7 responses)
Published 2 May 2012 - 12:27