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Sunday, December 28, 2008

More on Sara Carlin Inquest

Regular readers of this blog will know that I have followed this story closely. Each time I write about the plight of the Carlin's I am overcome with emotion. Sara's death echoes that of Sharise Gatchell, they were both roughly the same age, both beautiful girls, both hanged themselves... both were taking GlaxoSmithKline's Seroxat.

I've almost finished Alison Bass' book, 'Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial.' Alison goes to great length to show how GlaxoSmithKline and their legal team tried to fight their wrong doings over the suppression of data from the Paxil 329 Study. It also highlights the failings of the Food and Drug Administration [FDA]

GlaxoSmithKline owe The Carlin's and Gatchell's an explaination as to why they were not forthcoming with the pediatric trial data. If, at the time, they had came out and stated that under no circumstances should Paxil be administered to children or adolescents then maybe, just maybe, Sara and Sharise would be both looking forward to 2009. Instead, Glaxo, then SmithKline Beecham, suppressed the results because it would have had a detrimental effect on their sales. They put profit before human life. They knew their product could cause suicide in some children yet they wrote papers, that were later passed off as being written by key opinion leaders, such as Martin Keller. His opinion swayed doctors. It's an utterly shameful act on behalf of GSK to be part of this wanton neglect for children and when I read comments left by GSK spokespersons regarding the death of Sara Carlin, I feel sickened.

Sara's parents, Neil and Rhonda Carlin, have now been granted an inquest into the death of their daughter. Neil has applauded the decision. He shouldn't have had to. Any child or adolescent that kills themselves whilst on Glaxo's Paxil [Seroxat] should be granted an inquest. There should be no argument about that.

I hope Ontario's chief coroner researches the resources on the Internet. A good start would be Healthy Skepticism and also new internal documents that have appeared on Christopher Lane's website.

My behaviour whilst tapering from Seroxat was that of a violent person. There are literally thousands of other patients, both children and adults, who have experienced those same violent traits whilst on or tapering from Glaxo's drug.

There is no protocol for tapering from Seroxat other than 'you must taper slowly' - it's a nonsense. People and doctors need guidance, they need to be told breaking a tablet in half is too drastic and it could possibly cause untold side effects. People and doctors need to be told that a liquid formulation exists for Seroxat and the only way to safely taper is by using this liquid.

I am aware of the term 'one size does not fit all' - I think this term is used loosely and was probably behind GSK/SKB and Keller's thinking when they give this drug the thumbs up for children. Remember GSK's Internal memo to its sales reps claimed Paxil's REMARKABLE safety and efficacy [The word 'remarkable' was written with capital letters]

On September the 9th, 2005, Rep. Peter Deutsch wanted to know whether David Wheadon, GSK's senior vice president for regulatory affairs, thought Paxil did in fact have "remarkable" safety and efficacy. Wheadon backpedalled and said, "We, in the case of Paxil, have not been able to discern a significant effect versus placebo"

Let's take a closer look at Wheadon's deposition from October 19, 2000:

Deposition of David Wheadon of GSK on issue of counting washout suicides against placebo.

Q: So in this whole period, we only have 2 placebo suicides, correct?

A: That is correct.

Q: Now, got back to the final page, which is Appendix 1, we haven’t looked at that page before, it has got a number of SB020 at the back. And at the bottom, we have an asterisk, and it says both—I will read it. ‘Suicides were committed during the placebo wash-out phase of an active control study. These acts were committed two days and seven days prior to the baseline evaluation.’ What does that mean?

A: That means that the suicides were committed while the patients were on placebo in the placebo run-in or wash-out phase, which way you want to describe it.

Q: That was my question. Is wash-out and run-in the same?

A: Yes.

Q: Why were they counted? If it didn’t occur during the baseline period, why were they counted at all?

A: Because it happened during the control phase of the trial.

Q: Was that consistent with protocol, that these – maybe I’m operating under a mistaken assumption. I thought data that occurred during these wash-out, lead-in phases were not counted in the data.

A: That is not correct. The way this data was collected – and I need to correct myself. It wasn’t because they happened during the control phase of the trial. The way these data were collected, any suicide that occurred during the course of observation of a clinical trial was included in this data base…So –just a minute—Placebo run-ins were counted as placebo, because they were on placebo. There were also suicides that occurred in patients that were on Paxil, for example, in long term extension, where there was no placebo, there was no active comparator, so the full breadth of the experience was accommodated in this particular analyses.

Q: I agree, that’s what happened, that’s exactly what the data represents, but my question is whether that is a valid scientific measuring device for conducting clinical trials.

A: Absolutely.

Q: Well, you have rules for collecting data, right? You had rules for establishing a wash-out phase. I mean that concept --

A: You have to recall, Mr. Farber, the protocol for these studies were for different purposes. They were for treating depression. The protocol for establishing an answer to the question of the occurrence of suicides on placebo or drug or active comparator did included that as I described, and that is collecting all suicides that occurred during observation in a clinical trial, regardless of whether it happened in placebo run-in, during randomization or during extension, open label extension, where people were on Paxil, and they, in some cases, knew they were on Paxil.

Q: And you consider this a valid scientific practice?

A: Absolutely.

(Wheadon deposition transcript P404 L17 through P407 L17)

Remember, Wheadon was under oath during this deposition.

Corporate manslaughter?

I certainly hope that Sara Carlin's and Sharise Gatchell's parents will one day find closure as to why their daughters were given a drug that was known not to work in their age group and that there was a high risk of suicide should they ever be prescribed it.

Time will tell.

Fid



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