Bachtold, Daniel. "Conflict-of-Interest Allegations Derail Inquiry Into Antidepressant's ‘Dark

 

Bachtold, Daniel. "Conflict-of-Interest Allegations Derail Inquiry Into Antidepressant's ‘Dark
Side,'" Science 300 (4 April 2003), p. 33.

Cambridge, U.K. - A government review of the safety of antidepressant drugs is in disarray
following revelations that some experts involved in the inquiry are shareholders ijn a company
that makes one of the drugs. Last week, the U.K.'s Medicines Control Agency (MCA) deibanded
a panel that had been scrutinizing the track record of selective serotonin reuptake inhibitors
(SSRIs), a widely prescribed group of drugs that includes the brands Prozac and Seroxat (sold as
Paxil in the United States).

The panel bust-up came on the heels of a report in The Guardian, a U.K. newspaper, disclosing
the two members of the four-person panel hold shares of GlaxoSmithKline, which produces
Seroxat. MCA is now seeking to form a new panel but has not said publicly when it expects the
inquiry to resume.

The government launched the SSRI review last autumn to investigate anecdotal evidence linking
SSRIs to violent and suicidal behavior in a handful of patients on the medication. Reports on
such unexpected side effects have in recent years received widespread publicity and sparked
litigation. For example, a Wyoming court in 2001 ordered SmithKline Beecham - now
GlaxoSmithKline - to pay $6.4 million to the surviving family members of Donald Schell, who
shot his wife, daughter, and granddaughter before killing himself. Schell started to take Paxil 2
days before his killing spree. And last month, a coroner in Wales called for Seroxat to be taken
off the market pending an investigation into the death of a retired schoolteacher who had
committed suicide shortly after starting a prescription. There has been no move to ban Seroxat,
which GalaxoSmithKline expects to be vindicated. "We believe in the safety profile of Seroxat
and will vigorously defend the integrity of our medication," says a company spokesperson.

Many experts say that the anecdotal reports do not establish a firm link between the drugs and
violent behavior, and they profess doubts that one will emerge. Nevertheless, "it looks as thought
the government has to do something to reassure patients and people who need to be treated," says
psychopharmacologist Philip Cowen, a Medical Research Council clinical scientist at Oxford
University. Seroxat is effective in most patients treated for depression, adds Anthony Cleare, a
psychiatrist at King's College London. "We risk throwing out the baby with the bath water," he
warns.

Others, however, believe that SSRIs may in fact be dangerous. Last November the MCA's
review panel, chaired by Angus Mackay, director of Mental Health Services in Lomond and
Angyll, Scotland, heard f rom David Healy, a psychiatrist at the University of Wales, College of
Medicine in Bangor, U.K. He presented epidemiological data on withdrawal symptoms and
increased suicidal tendencies in patients treated with SSRIs. Healy, who served as an expert
witness for the plaintiffs in the Schell case and has combed through GalaxoSmithKline archives
not open to the public, puts it bluntly: "SSRIs can cause people to become suicidal or actually
commit suicide," he says.

MCA pulled the plug on the panel after the newspaper reported on the panel members'
GlaxoSmithKline investments. In a 25 March statement, MCA said that "in light of issues raised
at the meeting [with Healy] and the further work these will require, we are cognizant of the need
to carefully consider the appropriate membership of an expert group. ... Individuals' interests in
the pharmaceutical industry will be taken into account." The GlaxoSmithLKline spokesperson
insists that the company would not "under any circumstances seek to unduly influence" the
inquiry. Members of the recently disbanded panel declined to speak with Science.

MCA said that a new expert panel will consider all relevant data including a detailed report from
the Welsh coroner and patient testimony. The agency had not appointed a new panel before
Science went to press.