Healthy Skepticism Library item: 1436

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Publication type: news

Boseley S.
Scientist in rethink over drug link to suicide
The Guardian 2003 Oct 1

Full text:

The scientist who led the latest trial of an antidepressant drug given to children, which claimed that it was effective and safe, has conceded to the Guardian that the drug’s potential to cause suicidal thinking needs to be investigated.

Last month the Journal of the American Medical Association published results from two trials of children treated with Pfizer’s antidepressant drug Lustral, known in the US as Zoloft.

Seventeen children who were given the drug were pulled out of the trial because of side effects, compared with five who were given a placebo. Only 10% more children improved on the drug than improved on a placebo.

The researchers nonetheless concluded that “the results of this pooled analysis demonstrate that sertraline (Lustral) is an effective and well-tolerated short-term treatment for children and adolescents with major depressive disorder”.

The lead author of the study was Karen Wagner of the department of psychiatry at the University of Texas. She was also one of the authors of studies of a similar antidepressant, Seroxat, which was banned for use in children in June by the UK licensing body, the medicines and healthcare products regulatory agency.

The MHRA said a re-analysis of the data from the Seroxat trials showed an increase in the numbers of children who became suicidal on the drug. The studies that Dr Wagner and colleagues carried out on Seroxat in children had also concluded that Seroxat was effective and well-tolerated.

Asked whether she still believed both drugs were safe, after the MHRA ban on Seroxat and the inquiry that has now been launched by the US regulator, she replied: “I think it requires further investigation and looking at the entire database of these medications. With regards to paroxetine [Seroxat], it is being investigated.”

But Dr Wagner maintained that the numbers of children who became suicidal in the Lustral trial were small, and that in her experience, “these medications are extremely effective in children who are suffering from depression”.

Manufacturers of this class of drug, the selective Serotonin re-uptake inhibitors which includes Prozac, have always said that suicidal thinking or gestures are caused by the illness, not by the drugs.

An expert report written in 1997 for the US food and drug administration reviewed two trials of Lustral carried out on children. “The adverse events which led to discontinuation were generally psychiatric in nature,” it said, concluding that the drug “is well tolerated” by children.

Yet four out of 44 children with depression in one of the two studies became suicidal while taking Lustral – a rate of 9%. The expert report stated that only side effects that occurred in more than 10% of patients were significant.

In the second study, on children with obsessive compulsive disorder, or OCD (repetitive behaviour such as continual hand washing), two children became suicidal on Lustral and one on a placebo.

Wilma Harrison, a senior Pfizer executive, was questioned by a US lawyer about one of the two children who became suicidal while taking Lustral during that OCD study. Matt Miller, 13, killed himself, and his family are suing Pfizer, alleging that the drug was responsible for his death. Pfizer denies the charge.

After the expert report, the drug was licensed for use in children suffering from OCD in the US. David Healy, director of the North Wales department of psychological medicine says that because of this licence, and after last month’s positive report in the American Medical Association’s journal, doctors will be more inclined to prescribe it for depressed children, for whom it is not licensed.

There are around 50,000 children in the UK on antidepressants, none of which is licensed for use in children. Doctors are permitted to prescribe adult drugs for children on their own responsibility.

Both Seroxat and another drug, Effexor, have effectively been banned for use on children by the MHRA because of concerns about the drugs’ potential to cause suicide.