Zantac Lawsuit

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

Sunday, June 28, 2015

The Seroxat/Paxil Cake.

Cake stars Jennifer Aniston as Claire, a member of a support group for people who are affected by chronic pain. As she learns that one of her fellow group members attempted suicide, Claire becomes obsessed with the woman's story, gets to know the woman's husband, and faces her own inner demons.

I've not seen the movie yet and, to be honest, I had no intentions of seeing it, until, that is, I recently learned that the screenplay for the movie was written by Patrick Tobin.

So, who is Patrick Tobin?

Patrick Tobin

Feb. 13, 1998

Before killing himself, Donald Schell, 60, killed his wife, Rita Schell, 55. their daughter, Deborah Tobin, 31; and Alyssa Tobin, 9 months. Tobin's widower, Tim Tobin, and Donald Schell's sister, Neva Hardy, filed a wrongful-death lawsuit against GlaxoSmithKline (then known as SmithKline Beecham) because they believed that Don Schell acted out of character due to the antidepressant he had been prescribed, Paxil (known as Seroxat in the UK and Europe). Schell had taken just two Paxil pills prior to shooting family members and then himself.

On June 7, 2001, a jury in Cheyenne, Wyoming, found SmithKline Beecham liable for the deaths caused by a Schell. Furthermore, the jury concluded that Paxil could cause someone to commit suicide or homicide and that the drug was in fact a proximate cause of the deaths in this case.

The jury attributed 80 percent of the fault in the case to the drug maker and 20 percent to Donald Schell. Verdict here.

SmithKline, being SmithKline, appealed the decision which saw Tim Tobin et al awarded $6.4 million.

The Tobin family were represented by Andy Vickery and James Fitzgerald.
SmithKline Beecham were represented by Thomas Gorman, Charles Preuss and Tamar Halparin.

During the trial SmithKline internal documents surfaced and showed how they was aware that a small number of people could become agitated or violent from Paxil. Despite this knowledge, Paxil packaging did not include a warning about suicide, violence or aggression.

Before the trial date attorneys representing SmithKline Beecham filed a motion which, if granted by the presiding judge, would have excluded expert testimony from Andy Vickery's two expert witnesses, British psychiatrist Dr. David Healy and Dr. John T. Maltsburger, an associate clinical professor of psychiatry at Harvard Medical School. Their motion was not granted.

Why did SmithKline try to file this motion? Well, they knew that, in the instance of Healy, that he had had access to SmithKline documents that showed results of a Paxil test involving more than 2,000 healthy volunteers taking either the drug or a placebo.

The test showed results of volunteers who had adverse reactions - ranging from insomnia or anxiety to attempted suicide - that Beecham doctors said were either "possibly," "probably" or "definitely" caused by Paxil. Plaintiff attorney, Andy Vickery, pointed out that volunteers in the Paxil test experienced anxiety, nightmares, hallucinations and other side effects definitely caused by the drug - within two days of taking it. As early as four days, one volunteer experienced akathisia, a form of agitation that increases the risk of violence and suicide. Two volunteers attempted suicide after 11 and 18 days, respectively.

SmithKline's attorneys argument was basically that two pills didn't cause this crime but evidence produced during the trial proved otherwise. Vickery showed  results of SmithKline's own Paxil test that showed a whole range of adverse reactions that had, in the main, all occurred within a day or two of the healthy volunteers taking Paxil.

What is striking about the depositions in this trial is the lengths that SmithKline Beecham would go to keep this evidence away from the public, healthcare professionals and medicine regulators.

Ironically, at the time, Dr Ian Hudson, was head of World Safety at SmithKline Beecham. Today, Dr Ian Hudson is the Chief Executive of the British medicine regulator, the MHRA. Parts of his deposition can be seen in the video (The Secrets of Seroxat) below. The documentary was aired on British TV a year after the Tobin verdict.

I'm a bit of a geek when it comes to reading court documents, particularly depositions, none more so than the deposition, in this case, of Dr. Tadataka Yamada who, at the time of his deposition, was Chairman GSK Research and Development at SmithKline Beecham.

During his deposition Yamada was asked the following. I include this because I wish to highlight how SmithKline employees, including Ian Hudson, specialised in answering questions about the Paxil suicide link - One can only assume that their evasiveness was engineered by the attorneys representing SmithKline during this particular trial. I'm also including it because it's a fascinating exchange.

Q.    Suicide is a risk of depression, correct?

A.    That's correct.

Q.    Now, if a patient is on an antidepressant such as Paxil and they become suicidal or more suicidal or actually kill themselves or attempt to do so, then the question that confronts us as we examine that situation is well what caused it or contribute to it.  Was it the depression, was it the drug, was it a combination of both, were there other factors. Would you agree with me that that's the case?

A.    Uh huh.  Yes.

Q.    But if the patient was not depressed and had no other physical condition that we know about that would cause them to become suicidal and yet they became suicidal on the drug, that's the kind of thing that would sort of make us, make our antenna go up, make red flags go off or bells go off?  In other words, concern us; wouldn't it? If people from a healthy study which means that they didn't, did not have any underlying disease process that put them at risk for suicide became suicidal on taking Paxil or any other SSRI drug, would that be a cause for concern that the drug may be causing or contributing to this suicidality?

A.    We would look at all of the data obtained in our healthy volunteers and examine in the proper context.  I can give you an example, examples of drugs that caused people to faint in Phase I studies that we took forward in the clinical studies, because viewed in the proper context the fainting episode was not relevant to the effect of the drug. We have had other circumstances when people would have altered rhythms of the heart during the course of a Phase I study.  That would not necessarily prevent us nor would it the FDA prevent us from continuing on those clinical studies, because bad things happen to people all the time and the temporal relationship does not necessarily imply causation.

Q.    We can certainly agree on that. Can we also agree that if the bad thing happens to a person on a drug and that person is a healthy volunteer that at east we can take some underlying disease process out of the equation in trying to figure out what caused Mr. Jones to have this bad result?

A.    No.  I think the reason why I answered your question originally the way that I did was because nobody's healthy.  See, healthy. I mean you're not healthy and I'm not healthy. We all tomorrow could have some event that we didn't know about, and that event might be temporally associated with drinking a cup of coffee or signing your name.  You know, one can develop a lot of superstitions about what may or may not be associated between an illness and supposed causation that was association, associated in the events starting that illness. So, you know, some people may feel a cold coming on.  They'll do certain things because they think it makes them, it will prevent the cold.  It doesn't mean that whatever they're doing will either prevent the cold or one fact have any bearing on the evolution of that cold.  This is the reason why the FDA and also pharmaceutical companies always take any event that occurs in healthy volunteers in the context of the overall phase of our program to make a decision about whether a Phase, further patients should be exposed to the medication.

In essence here, Yamada cannot give a straight answer regarding healthy volunteers who became suicidal whilst taking Paxil. Instead he deflects it all by claiming that nobody is healthy. It baffles me, then, why SmithKline would label such studies as 'healthy volunteer studies'. Surely, given Yamada's deposition, these studies should be called, 'The we don't know if they are healthy volunteer studies'?

I mean, what is the point of putting healthy volunteer studies into place when you can't even agree if the volunteers are healthy?

What is also striking about the deposition of Yamada is that he testified that a GlaxoSmithKline decision to put proper warning label on Paxil is "never a business decision."

Yet an internal  1997 GlaxoSmithKline document showed otherwise (Fig 1)

Fig 1


I've yet to see the  movie, Cake, but look forward to it, if only to see if Patrick Tobin's screenplay relates to the shocking incident of his extended family.

The link between the movie and the Tobin case was brought to my attention by members of The International Coalition For Drug Awareness Facebook group, which is run by Dr Ann Blake-Tracy. Members had posted and commented on a recent Daily Mail article who had wrote "The true story behind Jennifer Aniston's Cake - how movie's scriptwriter was inspired by the brutal murder of his brother's wife, baby daughter and mother-in-law."

The video below highlights the Tobin case and also shows the difficulty people have had when taking or trying to stop Seroxat. It was the first Seroxat documentary screened in the UK in a series of Panorama specials. The BBC commissioned a further three documentaries after this. To date, there has not been any other drug that has been covered regarding its side effects more times than GlaxoSmithKline's Seroxat.

The video will show you yet more evasiveness from the current CEO of the MHRA, Dr Ian Hudson, who remember, at the time, was the World Safety Officer for SmithKline Beecham.

Pay special attention also to GSK's Alistair Benbow. His answers to Shelley Jofre's questions are, at best, staggering!

Bob Fiddaman.

Tobin v SmithKline Beecham Pharmaceuticals Depositions can be found here.

Tobin v SmithKline Beecham Pharmaceuticals Transcripts can be found here.

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