H O U S E OF C O M M O N S
LONDON SW1A 0AA
Member of Parliament for Oldham East and Saddleworth
Dr June Raine
Director - Post Licensing Division
Medicines Control Agency
Market Towers
1 Nine Elms Lane
LONDON SW8 5NQ
26 February 2002
Dear Dr Raine
Re: Benzodiazepine Drugs
I have been asked by members of the Beat the Benzos group to obtain some clarification on their behalf. They have asked various questions of me and I trust that you will be able to assist me in answering their queries.
Did John Wyeth & Bros Ltd contravene The Medicines Act (1968) by their non disclosure to yourselves of the 1972 clinical trials (De Buck Report) which showed withdrawal symptoms, notably epileptiform seizures, asthenia, ataxia, drowsiness, impairment of vision, nausea and memory impairment due to therapeutic dosage of Ativan for one month?
By their non-disclosure of the De Buck Report, did John Wyeth & Bros Ltd contravene any regulations following the granting of a full licence of Right to Ativan, given that they knowingly denied to the Committee on the Review of Medicines dangerous withdrawal symptoms and contraindications?
Could John Wyeth & Bros Ltd be prosecuted as a result of this non-disclosure under Sections 28 and 124 of the Medicines Act (1968)?
I would be most grateful if you could look into all aspects of these queries for me, and in addition explain why data sheets did not warn patients against abrupt withdrawal of Lorazepam until 1990.
I look forward to your reply.
Yours sincerely
Oldham East and Saddleworth
