Monsanto Roundup Lawsuit

Sunday, February 10, 2008

GSK Have 9 'Lives'... or pages they are STILL witholding

So the recently opened court documents that were previously sealed are not all what they seem to be?

Apparently there are nine (count them) pages missing. A clerical error? Lost in transit? Or merely GlaxoSmithKline keeping hold of the damning evidence that showed an 8-fold increase in suicide amongst patients taking Seroxat during the clinical trials?

When one reads through the papers it becomes clear that this is NOT just about people under the age of 25 - Do these missing 9 pages throw more light on the suicidal reactions in adults?

Why are they being held back? More importantly, How can they be held back?

Well, a Senator in the United States (one with balls) is asking questions about the missing 9 pages and the recently opened documents. Unlike our Ministers of Parliament here in the UK, we have here a man with compassion, one who actually cares about life.

Senator Grassley has wrote to Mr. Christopher Viehbacher, President of GlaxoSmithKline (United States) asking for the missing nine pages.

February 6, 2008
Mr. Christopher Viehbacher President
U.S. Pharmaceuticals
GlaxoSmithKline
5 Moore Drive
P.O. Box 13398
Research Triangle Park,
NC 27709

Dear Mr. Viehbacher:

As the Ranking Member of the United States Senate Committee on Finance (Committee), I have an obligation to the more than 80 million Americans who receive health care coverage under Medicare and Medicaid to ensure that taxpayer and beneficiary dollars are appropriately spent on safe and effective drugs and devices. This includes the responsibility to conduct oversight of the medical and pharmaceutical industries that provide products and services to Medicare and Medicaid beneficiaries.

As reported today in New Scientist, several documents were unsealed on January 18, 2008, in the case of O'Neal v. SmithKline Beecham d/b/a GlaxoSmithKline. Several of these documents and transcripts suggest that GSK knew as far back as 1989 that Paxil is associated with an increased risk of suicide. However, the American public was never adequately informed of this risk until May 2006 in a "Dear Healthcare Professional" letter that reported a "higher frequency of suicidal behavior" associated with Paxil as compared to placebo.

Specifically, Dr. Joseph Glenmullen, a Clinical Instructor in Psychiatry at Harvard Medical School, prepared an expert report based on a review of internal GSK documents. Dr. Glenmullen's report suggests that GSK ensured that suicides and suicidal attempts were systematically included in the placebo arm of GSK's study, which had the effect of making it more difficult to detect suicide risks associated with Paxil. This information was then submitted to the FDA.

Dr. Glenmullen concluded in his report: Analyses of GlaxoSmithKline's data demonstrate a causal link between the antidepressant and suicidal behavior. This has been true since 1989 although the "bad" Paxil numbers obscured the risk for a decade-and-a-half.

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.

Along with this report, please provide the appendix and all documents that are noted in the report, in the order that they are referenced.

Thank you again for your continued assistance in this matter. Because I understand that these documents are already available in electronic format, I would appreciate receiving the documents and information requested by no later than February 14, 2008.

Sincerely,

Charles E. Grassley Ranking Member Committee on Finance
Post a Comment