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Seroxat Archives - British Medical Journal, Oct 9, 1999

CSM takes small step towards openness - News - Statistical Data Included
British Medical Journal, Oct 9, 1999

The Committee on Safety of Medicines is to publish edited minutes of its meetings on its website, including details of any members who declared links with pharmaceutical companies. Its decision to adopt a more open approach to the public follows a ruling by Michael Buckley, the health service ombudsman, in August.

The committee is one of the independent advisory bodies that give advice to the Medicines Control Agency (Now the MHRA) on whether a particular drug should receive a licence in the United Kingdom.

The ombudsman's ruling resulted from a complaint made by Charles Medawar, director of the consumer lobby group Social Audit, who had asked the committee for information which he said should have been made available to him under the government's Code of Practice on Access to Government Information.

In particular, he wanted the names of committee members who had declared conflicts of interest at meetings when the class of antidepressant drugs known as selective serotonin reuptake inhibitors was being discussed. He also asked for copies of the minutes of committee meetings held during 1998. The committee refused to give Mr Medawar the information he requested and passed him on to the Medicines Control Agency. (MHRA)

The agency eventually provided Mr Medawar with some anonymised data from their records but withheld much of the information requested, citing exemptions from the code of practice.

After a 16 month battle for information Mr Medawar took his case to the ombudsman, who ruled that there was no reason to justify withholding most of the information requested.

However, he allowed that when relevant regulatory action was ongoing the information should be released only once the action was complete. The ombudsman also strongly criticised the agency for the long delay in dealing with Mr Medawar's requests.

One of the surprising things to come out of the case is that the Committee on Safety of Medicines, unlike the Medicines Control Agency, (MHRA) is not obliged to comply with the Code of Practice on Access to Government Information.

Mr Medawar said last week that the committee had lost sight of its original remit: "The [committee] has emerged as an almost uniquely unaccountable quango." He added that when it was originally set up, following the recommendations of the Sainsbury Commission, it was intended to be "a stalwart, independent, competent guardian of the public interest" but had become instead a committee that did nothing more than give advice to the licensing authority.

Mr Medawar had originally criticised the committee for accepting as valid the main conclusions of a study conducted on paroxetine (Seroxat) which had been jointly conducted by someone who was then a member of the committee and an employee of the manufacturer of the drug. Their study was later published in a journal edited by the same committee member, who also had personal interests in the manufacturer of the drug.

Details of Mr Medawar's concerns were published in the International Journal of Risk and Safety in Medicine and can be found on the Social Audit web site (

Dr Andrew Herxheimer, emeritus fellow at the UK Cochrane Centre, said that the committee's move to publish minutes on the web was a step in the right direction. But he said that it was worrying that the committee was not even subject to basic citizen's charter standards on giving out information.

He strongly criticised members of the committee for not being prepared to justify any of their decisions. "They had no willingness to respond to specific criticisms of the trial [of paroxetine]. That is against the public interest," he said.

The Committee on Safety of Medicines website is

COPYRIGHT 1999 British Medical Association
COPYRIGHT 2000 Gale Group

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