Suicide statistics may have allegedly been incorrectly reported in drug trials

GlaxoSmithKline (GSK) is currently engaged in a fierce legal battle over its antidepressant pill, Paxil (Seroxat in the U.K.).

Marketed as an antidepressant, Paxil is supposed to reduce the risk of suicide in users.

When it was first made for production, GSK conducted clinical trials to test how effective the drug was. In 1989, it presented the drug to regulators along with the results that indicated Paxil was much safer than taking a placebo.

In the report, GSK said that, of the 3,000 people who took Paxil, five people had tragically committed suicide. 554 patients were randomly selected and provided a placebo pill. From this much smaller group of people, two committed suicide. This meant that one in 600 (0.16%) people on Paxil committed suicide, whereas one in 275 (0.36%) committed suicide while taking the placebo.

Using this result, GSK said that Paxil was twice as effective in preventing suicides than using a placebo.

Widow Wendy Dolin disagrees with these findings. Her late husband, Stewart Dolin, took a generic form of Paxil called paroxetine. She believes the drug contributed to his suicide, rather than preventing it.

Dolin’s lawyers are disputing the findings of the report’s suicide statistics for allegedly neglecting one key point in the study. The lawsuit brought by Dolin alleges that the two suicides that occurred in the placebo group should not have been taken into account as they happened during the “run-in” period. This is a stage where patients about to take part in a new clinical trial are slowly weaned off of any previous medication they may have been taking. This is before the trial officially starts, and random assignments for placebo replacements are made.  During this period, it’s widely known that patients are statistically at a heightened risk of suicide.

After studying reports made to regulators, Dolin’s lawyers noted that, in the older ones, participants who died during the ‘run-in period’ were marked with an asterisk and an accompanying footnote. However, later reports apparently did not show the same marks.

A GSK spokeswoman said in an email that, “the approach G.S.K used in 1989 and in 1991 in counting events that occurred during the any phase of a clinical trial, including during the placebo run-in phase, was also used by F.D.A (regulators) in its safety review of Paxil in 1991.”

However, the regulator’s own experts apparently later said that those placebo suicides should not have been taken into account. One medical reviewer, Michael Seika, noted in a memo to the major pharmaceutical company that if a patient died during the run-in period and before randomisation was carried out, “such a person should not be counted in our analyses.”

The allegations arguably bring Paxil’s effectiveness into question.

Results from clinical trials must be accurately documented, alongside any additional information that may skew the findings. Any and all risks of harm must be noted to allow doctors to advise patients properly on the side-effects they can expect when taking medication. In failing to disclose that two of the placebo suicides may have occurred during the ‘run-in period’, it may have been included in the calculation incorrectly.

Ms Dolin said:

“Drugs play an important role in so many people’s lives and can be lifesaving, but people need to know about the side effects… We want transparency.”