News Roundup [abridged Versions Appear In The Paper Journal]

Lawyers may seek judicial review of panel reviewing paroxetine

BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7390.618 (Published 22 March 2003) Cite this as: BMJ 2003;326:618
  1. Roger Dobson
  1. Abergavenny

    Lawyers acting for more than 4000 people who allege side effects from the antidepressant drug paroxetine (Seroxat) may seek a judicial review over the composition of a review panel set up to look at the drug and other selective serotonin reuptake inhibitors (SSRIs).

    The lawyers say they are unhappy that some of the committee members have links with the drugs industry. It has been claimed that some members of the review team, which is drawn from the Committee on Safety of Medicines, have shares in GlaxoSmithKline, the maker of paroxetine (Guardian 17 March: 1).

    The review of the side effects of the SSRIs was announced at the end of last year and came in the wake of reports from patients of severe withdrawal symptoms.

    The Department of Health is also facing a call for an inquiry into paroxetine from the coroner for Powys, Geraint Williams, after the death of retired head teacher Colin Whitfield, who slit his wrists two weeks after being prescribed paroxetine.

    His wife told the coroner that her husband's action was totally out of character and that she believed his mind had been affected by the drug. It had been claimed that paroxetine could induce agitation and lead to suicidal thoughts.

    Mark Harvey, of the Cardiff solicitors' firm Hugh James, which represents a group of more than 4000 people who say they have experienced problems with the drug, said he was concerned that two members of the review team held shares in GlaxoSmithKline.

    “We were promised a thorough and intense review of SSRIs and in paroxetine in particular. Great faith was placed in it [the review] at the time, but to discover now that it is effectively being led by people who stand to profit from the outcome of that review is not acceptable,” he said.

    “It is not an independent review,” he continued. “The group wrote to the review committee last week about the interests of its members. There has been no response yet, but if their position is as it has been publicly stated—to continue without change—we will be applying to the court for a judicial review.

    “Justice is about being seen to be done. I cannot see how the government can sit back and feel satisfied it has carried out a review, which after all is designed to assist public confidence. Whatever the decision of the committee, it is not going to increase public confidence when the bill of health is given by people who stand to benefit.”

    He said the courts may also be asked to say that patients in the group should be able to give evidence of their experiences to the committee.

    A spokesman for GlaxoSmithKline said: “As a company, GSK operates to the highest levels of integrity and would not under any circumstances seek to unduly influence the workings of an independent committee.

    “In any case, as the Medicines Control Agency has said, 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.”

    A health department spokesman said, “A full review looking at SSRIs, the class of drugs that paroxetine belongs to, is being carried out by the Medicines Control Agency (MCA) and Committee on Safety of Medicines (CSM). This review, considering all available data on SSRIs, is ongoing, and the working group leading the review is due to meet shortly. Any recommendations by the group will then be considered by the CSM. The findings of the working group will be communicated when it has concluded its work.”

    The spokesman added, “Members of the Medicines Act advisory committees and related 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.”

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