Call for medical contract

August 30, 1996

A new "contract" between patients, doctors and medicines' regulators is needed to improve communication about the safety of different medicines, according to a new study, writes Kam Patel.

Expert and Public Assessments of Medicines Safety, carried out by John Abrahams and Julie Shephard of Reading University, says that doctors and medical experts need to be candid about the uncertainty inherent in the risk assessment of different medicines. In return patients should agree to bear greater responsibility for the risks that are taken.

The research, backed by the Economic and Social Research Council, compared the perspectives of experts and non-experts, including patients. It also looked at divisions within the medical community, using the controversy surrounding the use of the tranquilising drug Halcion.

In the late 1980s and early 1990s the use of Halcion exposed deep divisions between the Committee on the Safety of Medicines and the Medicines Commission. Both advise the Government on the safety of medicines. The commission disagreed with CSM's view that Halcion was not safe to be marketed.

Dr Abrahams, a sociologist now based at Sussex University, said that the CSM withdrew Halcion from the market after data became available which it believed confirmed the drug caused a number of serious, adverse psychiatric effects. These effects had previously been merely associated with the drug.

Dr Abrahams contends that the CSM took a "hierarchist" view, believing in the need to regulate technology to certain minimum standards but without hampering industrial development.

By contrast the Medicines Commission took a more "individualist" perspective, believing that the patient population was fairly robust and the technology relatively benign. In considering the media, the researchers regard a Panorama programme on Halcion, screened in 1991, to be "anti-individualist". Dr Abrahams says such a view "attempts to demonstrate the hazardous consequences for the public of putting too much trust in market forces such as commercial firms".

Among the non-expert group there was a tendency towards an "egalitarian" view. The patients' group in particular questioned expertise.

This often brought them into conflict with medical authority. Like Panorama, this group was dissatisfied with the existing system of regulating medicines which they saw as complacently exposing patients to risks. Dr Abrahams adds non-expert groups are suspicious of experts' financial links with commercial drug firms.

He said: "It is unlikely experts will enjoy public confidence unless strident efforts are made to introduce a distanced independence of scientists in drug testing and regulation."

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