Drug safety Bill offers patients right to know: Government opposes measure that would shed light on Halcion and other mysteries

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Indy Politics
HALCION, the sleeping pill banned in Britain 18 months ago after reports that it was linked to paranoia, suicide, murder and amnesia, may soon be back on pharmacy shelves.

If the drug is reinstated, patients and doctors will not be told the reasons for this; nor will they learn why it was withdrawn in October 1991 at 24 hours' notice by the Committee on Safety of Medicines, the body which advises ministers on drug licensing.

Exactly why another expert committee, when presented with the same data as the CSM, recommended that the ban on Halcion (also known as triazolam) should be lifted, will also remain a mystery. A clause in the Medicines Act 1968 makes it an offence for the authorities to give to the public any information on the safety of medicines submitted to them by drug companies.

Tomorrow, the Medicines Information Bill, which would amend this clause and give patients, doctors and independent experts the right to know just how safe and effective drugs are - and why they are withdrawn - has its Report Stage in the House of Commons.

The Bill, sponsored by Giles Radice, Labour MP for Durham North, is firmly opposed by the Government. But ministers are likely to be embarrassed by the last-minute recruitment of Professor Sir William Asscher, who retired in January after five years as chairman of the CSM, to support the Bill. He was closely involved in the triazolam case, and said yesterday that he had wanted to make public the reasons for the drug's withdrawal. 'We (the CSM) wanted to publish our reasons. I would love to have done that . . . We were stopped by the company from publishing on the grounds that it was confidential, commercial information.'

Sir William, dean of St George's hospital medical school in London, said: 'I am not averse to providing information about drugs and I don't think any of the 21 scientists who make up the CSM would be. Scientists are in favour of good communication and making things clear.' However, he opposes the publication of 'undigested' data on drug side-effects because it could be misinterpreted by the public.

The CSM has a policy of licensing drugs quickly, on the grounds that it is the only when the drugs are being used in real life that problems will show themselves. Sir William said: 'This doesn't mean that the British people are being used as guinea-pigs, because we have good post-marketing surveillance. But there are going to be instances when drugs cause problems, and these must be assessed (before publication).'

More than 100 medicines have had their licences withdrawn or suspended since 1979. They include Opren, an anti-arthritis drug, which was linked to 100 deaths and more than 4,000 complaints of serious side-effects. Data on its safety was protected under Section 118 of the Medicines Act, and it was difficult to establish what evidence of problems existed and how they were investigated. The fact that Opren had not been adequately tested in elderly people, the group most likely to take it, was concealed. As in many of the recent drug scare cases, much of the data came from America, where information on British medicines sold there is available under the Freedom of Information Act.

Mr Radice said yesterday that the Bill was in line with John Major's policy of greater openness in government, while protecting drug company interests by allowing for the 'screening out' of commercially sensitive information. But Tom Sackville, the health minister in charge of the Patient's Charter, who voted against the Bill in committee, saw a danger in revealing too much to the public about the drugs they take. 'We have to be careful that we do not err to much on the fashionable side of openness,' he has said. Patients, who received some of the 18 million prescriptions written for Halcion in the 12 years it was available here, might disagree.