Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Monday, February 27, 2012

Leeds 1983 - The Hidden Zoloft Clinical Trial



Far be it from me to promote David Healy but his latest posts on his blog have certainly left food for thought.

Yesterday I wrote about one of the two published papers from Healy with regard to the safety and efficacy in antidepressant medication, a paper that should be downloaded, printed and shown to healthcare professionals next time you visit their surgeries.

Today sees Healy write about an early clinical trial for Zoloft [sertraline], a trial from 1983 that was undertaken in Leeds, UK.

He writes:

There were 12 female volunteers aged between 34 and 40. The study was supposed to randomize half to sertraline and half to placebo for a week followed by a cross-over between drugs. It was abandoned before the first week was out.

And why was the trial abandoned?

Side effects.

So, back in 1983 Pfizer learned that Zoloft could cause  apprehension, insomnia, movement disorders, tremors and akathisia, what did they do about it?

Nothing.

The study was never published but Healy got to hear about it in 1998 from Ian Hindmarch, the doctor who ran the trial. Hindmarch went on to conduct another Zoloft trial in later years, this time the patients were given much lower doses of Zoloft resulting in more favourable results for Pfizer. That particular study, unsurprisingly, was published but very little is known about the Leeds study...until now.

Healy, who has had access to Pfizer's archives, also notes that, "...many years before these drugs triggered tens of thousands of suicides and acts of violence, was a great deal of evidence outlining the nature of the problem and their understanding of it."


The British drug regulator should investigate but they are probably too busy writing to doctors about SSRi specialists...that don't exist.

I'm not alone in thinking that pharmaceutical companies do everything in their power to make the 'perfect product' - trouble is...they don't pull it if it's not perfect, they simply hide the fact that it's defective.

The 7 women who received doses of Zoloft in the 1983 study may still be alive today. According to Healy these women would now be between the ages of  61 and 69 and may still be living in or around Leeds.

Wouldn't it be interesting if these women came forward. Where are the media when you need them, eh?

Healy's post, Mystery in Leeds, can be read HERE



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