The following legal brief has rarely been seen by members of the public. Read through it and you'll understand why.
It's a fascinating read and highlights just how GSK hid the withdrawal issues surrounding their popular antidepressant, Paxil.
Many readers will find the following PDF too much to bear. Many will be angered by it, and rightly so. I hope many of you will pass it on to family, friends and even healthcare professionals.
For me, at least, it's the most damning document to ever surface out of litigation. The litigation in question saw GlaxoSmithKline settle with over 3,000 plaintiffs who had struggled to taper off Paxil. Much of the evidence was sealed as part of the 'gagging order' - However, this legal brief gives us an insight into the incestuous relationship between GSK and the FDA. It also shows us how GSK carefully manipulated the system thus putting thousands of future patients through utter misery with debilitating side-effects of withdrawal.
The Yugoslavia trials, mentioned in the document below, are very interesting. Glaxo sponsored the two phases of these trials. In Phase I all patients were given Paxil, in Phase II some were switched to placebo. It was at this stage that the placebo patients began experiencing severe withdrawal issues. Glaxo chose to define this as "relapse" data. This would give them the ammunition to announce later that patients who stayed on Paxil continued to enjoy a normal, "depression free" life, but those abandoning the drug would suffer relapse back into a depressive state.
Back in 2015 I, under the Freedom of Information Act, requested from the MHRA the protocol for this particular clinical trial and whether or not that protocol included information and/or guidance on Paxil withdrawal. The MHRA wrote me and said they "didn't hold that information."
Here's the legal brief.
Bob Fiddaman
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