Seroxat Archives - The Guardian - Monday March 17, 2003

Drugs inquiry thrown into doubt over members' links with manufacturers
Sarah Boseley, health editor Monday March 17, 2003
The Guardian


The credibility of a government inquiry intended to settle the controversy surrounding widely prescribed anti-depressant drugs was thrown into question yesterday by revelations that most of the members have shareholdings or other links to the manufacturers.

The "intensive review" of the side effects of Seroxat, Prozac and other antidepressants of the SSRI (selective serotonin reuptake inhibitor) class was announced in the House of Commons by health minister Hazel Blears in December last year. It was a response to mounting concern from large numbers of patients who say they have been unable to come off Seroxat because of severe withdrawal symptoms.

It is also looking at allegations that the SSRIs have caused a small number of people who were previously not in a severely depressed state to kill themselves. Last week a coroner in Wales called for Seroxat to be withdrawn pending an investigation after returning an open verdict on a retired headteacher who killed himself shortly after starting the drug.

But campaigners and patients say they are deeply unhappy with the membership of the review team, drawn from the committee on the safety of medicines, which is part of the Department of Health's medicines control agency, and with one of the expert witnesses.

Two of the four CSM scientists, Michael Donaghy, a reader in clinical neurology from Oxford University, and David Nutt, professor of psychopharmacology at Bristol University, hold shares in GlaxoSmithKline, manufacturers of Seroxat. They have to leave the room when Seroxat is discussed, although they stay for debate on the SSRI drugs as a class.

Prof Nutt and the invited expert, David Baldwin, senior lecturer in psychiatry at Southampton University, jointly fronted the promotional press launch of Seroxat after it won a licence to be prescribed for social anxiety disorder and was popularly dubbed the "shyness pill".

Charles Medawar, of the watchdog organisation Social Audit, is seeking a reference to the ombudsman over the composition of the review.

He is also unhappy with the choice of chairman. Angus Mackay, director of mental health services in Lomond and Argyle, Scotland, was one of the signatories to an influential paper produced by the CSM in 1996 which concluded that withdrawal symptoms from SSRIs are rare, "relatively mild and do not have features of a physical drug dependency syndrome".

Mr Medawar said the review must be impartial and seen to be impartial. The Seroxat users group, which has 4,000 members who have experienced problems with the drug personally or through relatives, is equally concerned. "We're not at all happy," said Sarah Venn of the group.

Their Cardiff-based lawyer, Mark Harvey, said he was concerned that two of the review members had shareholdings in GSK. "The review could go two ways," he said. "If it says the drug is beneficial, the share price goes up and you make a profit. If it says the drug is dreadful, the price goes down and you make a loss. I do not see any way at all that you can be expected to give an impartial judgment. This is absolutely unacceptable."

Mr Harvey was also unhappy that the review has not undertaken to consider the first-hand evidence of patients on the side effects they say they have suffered - only the reports from their doctors will be considered - although it has invited representatives of the Seroxat users group to a meeting.

The medicines control agency and the committee on the safety of medicines have always maintained that it is sufficient for members to declare their interests in drug companies before meetings and to leave the room if they have personal interests such as shareholdings.

At the meeting of the review group on November 21, Prof Nutt and Dr Donaghy declared personal interests in GSK and left the room for two items on the agenda that dealt with Seroxat, although they remained for discussions on the SSRIs as a class of drug.

Dr Baldwin declared a personal interest in Lundbeck, manufacturers of the drug Citalopram. According to the minutes, however, he did not declare his connections with five other companies, including Seroxat manufacturers SmithKline Beecham, which is now GlaxoSmithKline.

Questioned by the Guardian, he said that although it was hard to remember the detail, he did declare participating in advisory boards for SmithKline Beecham, Bristol-Myers Squibb, Eli Lilly, Organon, and Pharmacia. His department had also been funded for studies by the same five companies and he had been paid by them for speaking at symposia to other doctors about the drugs. "I mentioned all this at the meeting," he said.

A spokesman for the MCA said the minutes would not have omitted anything. "The minutes containing the declared interests would contain everything, including studies declared," he said

The MCA insists, however, that the system for preventing conflicts of interests works well. "All members of committees and associated working groups are professionals of the highest standing in their fields and there has never been any evidence that members have acted other than with the highest integrity," it said.



Hmmmm?