Last week news broke in the New Scientist that Glaxo’s own researchers had been responsible for “an inappropriate analysis” of clinical trials that “obscured” suicide risks associated with Seroxat/Paxil for 15 years (see the court documents released last month).
Not until 2006 did GSK alert people to raised suicide risks associated with the drug, marketed as Paxil and Seroxat.
An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data demonstrating an eightfold increase in suicide risk as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it’s “virtually impossible” that GSK simply misunderstood the data.
Glenmullen’s report rests on documents obtained by lawyers in Los Angeles, who are bringing around 30 cases against GSK linking suicides and suicide attempts to the use of Paxil. The report was under seal at a district court in Sacramento, California, until 18 January, when the judge agreed to make parts of it public.
Read that last sentence again – “… the judge agreed to make parts of it public…”
What was released to the public was 83 pages of Dr Glemullen’ report – 9 pages have been withheld.
Over now to United States Senator Chuck Grassley, I think.
Senator Grassley has written to Mr. Christopher Viehbacher, President of GlaxoSmithKline (United States) asking for the missing nine pages. The full letter is here.
Part of it reads:
It is my understanding that 9 pages of Dr. Glenmullen’s report are not available publicly. Accordingly, please respond to the following questions and request for information. Please repeat each enumerated question and follow it with your response.
1. When did GSK first learn that Paxil was associated with an increased suicide risk?
2. When did GSK first report to FDA that Paxil was associated with an increased suicide risk?
3. When did GSK first notify patients and doctors that Paxil was associated with an increased suicide risk? Please provide all pertinent documents and communications.
4. Please provide the Committee with the complete, unredacted version of Dr. Glenmullen’s report. Along with that report, please provide the appendix and all documents that are referred to in the report, in the order that they are referenced.
5. Please provide the Committee with the accompanying children and adolescents report.
Now, I think at this point we should turn to Professor David Healy.
As an expert witness in the Schell/Tobin case, Professor Healy had been granted access to Glaxo’s archives and made shocking discoveries, so much so that on the 7 June 2000, he wrote to Dr June Raine of the UK’s Licensing body the MHRA.
“… All of their [GSK] healthy volunteer studies were supposed to have been made available to me but not all were. Of the ones that were missing there was trace correspondence left in once indicating that the investigator had never witnessed such a level of problems in a study with healthy volunteers. Another study was a single dose study which in a dose dependent fashion yielded a 75% rate of severe adverse events most of which involved the central nervous system. There were other disturbing indications from one of the other missing studies”.
“My testimony in this case also bore witness to sealed studies and other unreported data. It commented on the Montgomery Baldwin Study which yielded a projected rate of 45 suicide attempts in a group of recurrent brief depressive disordered patients on paroxetine per annum versus 12 on placebo. The figures were not statistically significant in great part one has to suggest because the company had terminated the study early. This termination and subsequent non-publication I would imagine the jury will have found and others will find significant.
In conclusion, Professor Healy wrote:
“I think what will also be clear is that SmithKline Beecham recognised the presence of withdrawal syndromes in their volunteers from the early to mid 1980s. That withdrawal syndromes occurred at a much higher rate than occur on benzodiazepines. Nevertheless they applied for and have received from you and other regulators a licence to claim that their drug is effective in the prophylaxis of depression and these claims have been based on designs which almost certainly are designs better suited to show the presence of a withdrawal syndrome than designs suited to demonstrate prophylaxis in depressive disorders. A great number of people have in recent years been told that when they begin to feel ill on discontinuing treatment that this is the recrudescence of their mood disorder rather than a discontinuation syndrome from their drug. I would imagine that a great many such people and others on their behalf will feel extraordinarily let down and angry when faced with the evidence that I’ve been faced with”.
Anyone see a pattern forming here?
Senator Grassley has given GlaxoSmithKline until February 14 to respond to his letter…