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Ploughing the archives
Dr David Healy
Access to the archives - Dr David Healy

Almost immediately after I got involved as an expert witness in the Tobin case in the second half of 2000, there was an upheaval in my personal and professional life.

I was due to move to the University of Toronto, but in the wake of a lecture there in November 2000, which, as an aside, I mentioned that there had been an almost complete lack of research on the risks of suicide on SSRIs, I was informed I had lost my job there.

When I tried to chase what had happened with the University, I ran into a brick wall. There was no reply. My instincts at this point were probably in line with almost everybody else's instincts in a situation like this - namely to lie low.

But I had little option but to do something, as it seemed all too likely that the first question on the witness stand would be about being sacked from the University of Toronto.

Wrongful death

The lack of response from the University therefore led directly to media interest and ultimately a legal action against the University.

The Tobin case began at the end of May 2001. Donald Schell was a man with a history of several relatively brief episodes of depression. He had a prior history of an adverse response to Prozac in 1990.

He had then subsequently been put on Seroxat by another physician in 1998 and 48 hours later had murdered his wife, along with his daughter and granddaughter who were staying with Don and Rita Schell for a few days before killing himself.

His surviving son-in-law, Tim Tobin, took out a case for wrongful death against Glaxo-SmithKline.

Final report

Tim Tobin
Tim Tobin: sued the drug company
As part of my background research for this case, I had been given access to GlaxoSmithKline's Seroxat healthy volunteer archive. This involved being brought into a room with several hundred thousand pages of data from healthy volunteer trials.

The reason to chase these files was that it had shortly before become clear to me from a study conducted in north Wales on healthy volunteers taking sertraline, another SSRI, and from looking through the healthy volunteer archives held by Pfizer on sertraline, that SSRIs could trigger suicidality in even healthy volunteers.

Access to GlaxoSmithKline's archive in Harlow had only been granted, as far as I know, essentially a week before my final report in the case was due to be submitted.

Nevertheless, it was possible to find and assess all the records that were present from studies conducted before Seroxat came on the market. Some records were clearly missing and have not been provided since.

Key studies

It was clear from this that Seroxat caused agitation in around 25% of takers, that it made things worse when the dose of the drug was increased and problems cleared up when the drug was stopped only to re-emerge when it was restarted.

According to the usual rules therefore this drug was causing agitation. There had also been a suicide in the program. And Seroxat in one healthy volunteer study was linked with withdrawal effects in around 85% of subjects.

The Tobin case raised questions about how much of a company's defense in these SSRI cases depended on ghost-written, or company only authored publications, or how often when there was medical testimony it was based on tabulated figures provided to an expert rather than the raw data.

In the course of the proceedings, it was not contested that key studies had been terminated early with their results left unpublished.

Verdict


the experts for SmithKline in the case agreed they had not seen the raw data from the clinical trials programme for Seroxat

Dr David Healy
It was also not contested that despite a backdrop that gave grounds for concern, there had been a failure to test whether Seroxat or other SSRIs could make people suicidal, and finally even the experts for SmithKline in the case agreed they had not seen the raw data from the clinical trials programme for Seroxat.

On June 6th the Court came to a verdict, which found against GlaxoSmithKline and awarded damages of $6.4m. This may have been the first verdict against a pharmaceutical company for a psychiatric side effect of a psychotropic drug.

All the records in my possession have now had to be returned, and as far as I know the only other outsiders who could conceivably get access to them, would be expert witnesses in further legal cases.

The verdict in the Tobin case had little effect on the University of Toronto. But the legal process did help make it clear what had happened.

Effective

There was clear input from outside. The University and myself disagree on how to characterize what happened.

As far as I can see, they have put no mechanisms in place to stop something like this happening in the future to others who might decide to follow their legal and moral duty and speak out about the hazards of psychotropic drugs.

GlaxoSmithKline strenuously denies claims of serious side effects and insist that the drugs are a safe, effective treatment.


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