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Unwarranted secrecy over the way medicines are licensed for use in Britain
is the target of a private member’s bill to be put before the House of Commons
next January. That secrecy was exemplified last week by the announcement
that the government’s two drug advisory committees disagree over whether
patients should be allowed to take the sleeping pill triazolam (Halcion),
which was banned last October. Although the conclusions of the committees
are known, details of the evidence on which they based their verdicts and
how they measured the risks and benefits of triazolam are kept from the
public by law.

Triazolam was suspended on the advice of the Committee on Safety of
Medicines after a review of the drug’s record since the early 1970s and
recent evidence from the US. The CSM said that the drug caused psychiatric
side effects such as amnesia and depression.

At the time, as thousands of people visited their doctors to seek an
alternative remedy for insomnia, the CSM’s chairman, William Asscher, said
he would like to explain his reasoning but was prevented from doing so by
the Medicines Act 1968. Section 118 of that act – included to protect the
commercial secrets of drugs companies – states that anyone who discloses
‘information obtained by or furnished to him in pursuance of this act’ is
liable to prosecution.

Speculation over the safety of triazolam was heightened last week when
Upjohn, the manufacturer of Halcion, released the verdict of the Medicines
Commission, which operates as an ‘appeal court’ for judgments made by the
CSM. Upjohn revealed the commission’s conclusion that prescribing Halcion
at low doses should be allowed, but declined to publish the full report.
But ministers, who are ultimately responsible for licensing drugs, sided
with the CSM and decided not to lift the ban.

The Department of Health said that it was prevented by the Medicines
Act from releasing the commission’s report unless it was made public by
Upjohn. Upjohn said it could not release the report, also because of the
act.

Now the Labour MP Giles Radice intends to call the licensing system
to account with new legislation. His Medicines Information Bill is being
put together by the Campaign for Freedom of Information and the consumer
groups Social Audit and the National Consumer Council. Its aim, said Charles
Medawar, cofounder of Social Audit, is to eradicate the ‘nanny knows best’
attitude, by giving the public a right of access to the safety data given
by drugs companies to the CSM.

The benefits of the bill to the public would be huge, says Medawar.
Doctors and the public will be able to compare the performance and safety
of one drug against another and judge the wisdom of the government’s advisers.
Medawar says: ‘It will place on the decision makers a need to explain and
justify their decisions.’

If the bill succeeds, section 118 of the Medicines Act will have to
go: a fact that will make the bill a target for the drugs companies. ‘We
are against a total repeal of section 118,’ said a spokesman for the Association
of the British Pharmaceutical Industry.

Meanwhile, Maurice Frankel, director of the Campaign for Freedom of
Information, is reviewing ‘what commercial interests are in the safety data
and what concessions need to be made on legitimate commercial grounds’.

The bill will be modelled on the pesticide approval system. Since 1986,
when a new chemical is approved or an old one reviewed, the Advisory Committee
on Pesticides is obliged to publish an evaluation of its safety and efficiency.
Commercial use of these documents is forbidden.