So Senator Grassley wrote to GSK wanting to know when they first learned that its antidepressant, Seroxat, might have been associated with an increased risk of suicidal behaviour. He was of course citing the recently unsealed report by Joseph Glenmullen, a clinical instructor in psychiatry at Harvard who was hired by lawyers in a suit against the company. Grassley also requested pages that were missing from Dr Glenmullen's report, there were 9 pages missing in all. He added, "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." It is not known yet whether GlaxoSmithKline met this deadline.
Grassley also became involved when Steven Haffner of the University of Texas Health Science Center in San Antonio faxed an article to the GlaxoSmithKline after agreeing to read it as part of the peer-review process thus tipping the company to the imminent publication of safety questions involving the company’s diabetes drug Avandia.
...The purpose of this letter is to determine what action, if any, GlaxoSmithKline (GSK) took after receiving a leaked manuscript of a study prior to its publication on May 21, 2007 in The New England Journal of Medicine (NEJM).This study reported a link between heart attacks and Avandia, a drug GSK sells to control glucose levels in diabetics
...Dr. Haffner told Committee investigators that no one at GSK asked him to send them this study about Avandia. Nonetheless, I am interested in what GSK did after receiving the study. Did GSK return the study to Dr.Haffner? Did GSK contact the NEJM to report this violation of publishing ethics? I would appreciate a detailed description of what GSK did after receiving the unpublished study regarding one of their leading drugs. Accordingly, please respond to the following questions and request for documents:
1. Please provide a list of all GSK employees who received and/or learned of the results contained in the leaked copy of the manuscript prior to publication by NEJM.
2. Please provide copies of all documents, records, and recordings of telephone messages regarding the NEJM manuscript that was leaked to GSK before publication.
3. Please provide the following dates:
a. When did GSK first contact the data safety monitoring board of the RECORD trial to begin publication of interim results?
b. When did GSK begin pulling together the interim data of the RECORD trial?
c. When did GSK submit the interim results of the RECORD trial to NEJM for possible publication?
4. Please provide copies of all documents, records, communications, and recordings of telephone messages regarding the publication of the interim results of the RECORD trial.
5. Please provide copies of any other pre-publication study drafts that GSK received about one of its products. Please do not include these drafts if a GSK employee was an author on the study.
This request covers the period of January 1, 2000 to the present.
Again Grassley gave GSK a deadline, a much bigger one than his request for the missing 'Paxil' 9 pages. This time however GSK did respond.
GlaxoSmithKline responds to letter from Senator Grassley
On 3 May 2007, a peer reviewer contacted GlaxoSmithKline (GSK) about an article related to Avandia ® (rosiglitazone maleate) that he had been asked to review by the New England Journal of Medicine. The reviewer told GlaxoSmithKline he had concerns and questions regarding the methodology of the analysis, and sent the article to GlaxoSmithKline for advice from experienced statisticians. GlaxoSmithKline did not provide comments or any other input on the manuscript to the reviewer. We believe GlaxoSmithKline acted appropriately and responsibly in responding to the situation.
They hardly answered Grassley's questions now did they?
So, here we are again, this time Grassley requesting that GlaxoSmithKline release 9 pages missing from Dr Glenmullen's damning report that clearly showed how GSK held back vital information that (in a nutshell) could have saved lives. The deadline of Feb 14 2008 has passed and no statement has been made by GSK, at least not at the time of writing this.
So Glaxo merely put their side of the story across regarding Haffner and... well basically, that's it!
Will they release the same kind of statement regarding the 9 missing pages?
The next 7 days should prove interesting
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
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Author of The evidence, however, is clear, the Seroxat scandal
Citizens Commission on Human Rights Award Recipient (Twice)