Zantac Lawsuit

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

Wednesday, September 23, 2015

Seroxat - Project 1059 Laden With Withdrawal Problems

GlaxoSmithKline are defending allegations that it's antidepressant, Seroxat, known as Paxil in the US, causes severe withdrawal reactions when patients have tried to taper of of it. They have settled similar allegations in the US with over 3,000 claimants, all of whom went on to sign confidentiality agreements - the official line of that particular case was that it was "resolved."

Later this year sees GlaxoSmithKline defend the same allegations, this time in the UK. The case has been running for 8 years plus and at no time have GlaxoSmithKline, via their representative lawyers, Addleshaw Goddard, made any offer of settlement to the 105 plaintiffs in the case.

So, there's a kind of stale-mate. 105 claimants allege they suffered severe withdrawal reactions when trying to wean themselves from Seroxat - Glaxo have maintained that "We believe the product is not defective and that there is therefore no merit in this litigation."

No merit?

Let's go back in time, to the year 2000.

James Ballenger, MD, was chair of the Medical University of South Carolina’s Department of Psychiatry, and he had been carrying out a long-term panic disorder study in 2000, Seroxat was the choice of drug. The study was cancelled by GlaxoSmithKline (then SmithKline Beecham) after they learned that Ballenger's findings had found something that they wanted to keep quiet - Severe withdrawal effects in adults that take them!

"There are some data that no amount of spin will fix."

As with most clinical studies, Glaxo had, just like they did in Study 329, hired a ghostwriter to draft the positive results from Ballenger's study.

Once again, just as in Glaxo's infamous 329 study, Sally K. Laden was handed the job of turning bad into good. Sadly, for Glaxo at least, even Laden couldn't spin the results of Ballenger's study, (known as "project 1059")

Internal emails between Laden and Daniel Burnham of SmithKline Beecham show Burnham write the following...

"The issue of discontinuation sx [side effects] vs. relapse is obviously a concern of the J Clinical Psychiatry reviewers... Thus we have decided to terminate further work on this manuscript."

The industry prefer to call withdrawal issues "discontinuation problems".

What is striking about this correspondence is Laden's response to Burnham...

“We understand your reasons for cancelling this project. There are some data that no amount of spin will fix, and these certainly fall into this category.”

This, to me at least, suggests that Laden was familiar with spinning poor results into bad.

Laden then told her bosses at Scientific Therapeutics Information, Inc. (STI)...

“Yes, Virginia, there is a God. SB cancelled our project 1059 (long term panic disorder study). Reason: the side effect data was terribly unfavorable to our favorite antidepressant. And we hate when that happens!”

Definition of 'terribly' -  very, extremely, hugely, intensely, immensely, dreadfully, incredibly, extraordinarily, seriously.

In a 2012 interview with investigative journalist Dyan Neary, Ballenger said...

“What that study in retrospect probably showed for the first time was that there’s withdrawal from the medicine…your body might miss it.”

Hmm, dependency anyone?

Question we really should be asking here is why didn't GlaxoSmithKline, when they knew of the severe withdrawal problems, carry out their own study into these problems raised in Ballenger's study? Why did they sit on this information? Myself, and others, would then not have had to endure the horrific withdrawal problems - had myself, and others, had previously know about these "terrible" side effects, we would never had taken Seroxat.

The prosecution rests, m'lud.

Here's the emails. (Click to enlarge)

Something for Glaxo's UK lawyers, Addleshaw Goddard, to mull over, perhaps.

Bob Fiddaman.

Competing interests

I am one of the 105 claimants in the UK group action.

No comments:

Please contact me if you would like a guest post considered for publication on my blog.