Drug review halted over company links

Sarah Boseley, health editor
Wednesday March 26, 2003
The Guardian

The inquiry into the safety of the widely prescribed antidepressant
drugs Seroxat and Prozac, and others of their class, has been halted
by the medicines control agency after the revelation that two of its
members have drug company shareholdings.
A statement from the agency yesterday confirmed that the expert team
had been dissolved, a week after the Guardian revealed that two of the
four members held shares in GlaxoSmithKline, which manufactures
Seroxat, and that an expert witness at the first hearing had not
disclosed his connections with it and other drug companies making
similar anti-depressants.

The "intensive review" of the drugs known as SSRIs (selective
serotonin reuptake inhibitors) was announced in the Commons in
December by the health minister Hazel Blears after public concern
about withdrawal effects experienced by people who wanted to stop
taking Seroxat.

Claims that a small minority of patients became suicidal soon after
starting a course were also on the agenda.

Recently the Brecon coroner called for Seroxat to be withdrawn pending
an investigation after he recorded an open verdict on a retired
headteacher who had killed himself soon after being prescribed
Seroxat.

The statement from the medicines control agency (MCA), which is part
of the Department of Health, said: "We can confirm that we have now
decided to dissolve the original group and appoint a new expert group
to conduct the review.

"The membership of this new expert group has yet to be decided, and
individuals' interests in the pharmaceutical industry will be taken
into account when considering the appropriate membership. The
timescale for completion of the review is uncertain."

The original group was drawn from the committee on the safety of
medicines, which advises the MCA.

It is routine practice at CSM meetings for scientists to declare their
shareholdings, consultancies and other payments from drug companies
whose medicines are being discussed. In the case of shareholdings,
they must leave the room.

When the group met for the first time to review the SSRIs in November,
before Ms Blears announced its existence, the two Glaxo shareholders
had to leave the room when Seroxat was discussed, but they were able
to be present during general discussions of the SSRIs.

The minutes show that an expert witness with many drug company links
did not make a full disclosure, although his recollection is that he
did.

"We would emphasise that the members of the Medicines Act advisory
committees are required to follow a code of practice relating to
declarations of interests in the pharmaceutical industry," the
statement said.

"We seek to ensure that the code is applied where members attend
meetings of expert working groups such as those in the present case."

The Seroxat Users Group was unhappy about the conflict of interest on
the review team and its apparent reluctance to look at evidence of the
side-effects suffered by its 4,000 members. Sarah Venn, of the group,
said: "I think it is a decision that had to be made. The review
members that they had were put in an untenable position faced with
personal conflicts.

"But we definitely want the review to take place. The most important
thing we want them to do is take account of the patient experiences,
which the review has not yet agreed to do. We got as far as an
agreement that they would meet with us."