Government refuses to independently publish data on psychiatric drugs

September 5, 2005
by Angela Hussain

The government has refused to independently publish all full clinical trial data on psychiatric drugs.

This is despite a health committee warning in April that the drugs monitoring body - the Medicines And Healthcare Products Regulatory Agency (MHRA) - prioritised the interests of the pharmaceutical industry over public safety.

Critics believe the government's MHRA has failed to alert doctors and the public to disabling and dangerous side-effects, including suicidal urges, of the SSRI anti-depressants.

The committee had made a raft of recommendations, including there be an independent publication of full clinical trial data on all licensed drugs, including psychiatric medication.

It also called for a wholesale review of the MHRA, saying it has grown too close to industry and inadequately scrutinised clinical trials for some drugs, including the SSRI antidepressant, Seroxat.

The government has responded by saying that new European law will mean that from October the MHRA will be obliged to publish summary clinical data of licensed drugs.

But full clinical trial data on drugs will not be available to non-MHRA researchers, the government has decided.

The MHRA - which is entirely funded by pharmaceutical firms - will also still retain the right to decide what information is publicly accessible.

The government has, however, accepted, or partly accepted, many of the committee's recommendations, including the importance of receiving patient input in drug regulation. It said it will do this through an involvement of patients and lay people in the drug licensing advisory process.

Richard Brook, chief executive of the mental health charity Mind, said: "While we welcome the government's apparent commitment to improving the accountability of the pharmaceutical industry in the UK, many issues have yet to be resolved.

"We remain concerned at the pharmaceutical industry's close relationships with government and the MHRA...As recent experiences with Seroxat…have shown, profit is too often put before the patient - with potentially lethal consequences."

Read for yourself:
The government's response to the health committee's report on the influence of the pharmaceutical industry (pdf)

See also:
April 26, 2005: Most GPs prescribe anti-depressants even though they believe other approaches might be more effective, research claims - charity launches campaign for exercise to be first-choice treatment for people with mild to moderate depression
April 26, 2005: European warning on Prozac for under-18-year-olds contravenes advice in Britain - GPs and psychiatrists in Britain now face conflicting advice
April 11, 2005: Overhaul drugs regulatory system, MPs urge - the MHRA criticised for prioritising the interests of the industry over public safety.
Feb 2, 2005: 'SSRI antidepressants are safe' drugs regulator repeats to doctors - publication of research linking suicidal behaviour to SSRIs prompts reaction by MHRA.

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