February 06,2008

Grassley letter to pharmaceutical drug maker about notice of drug trial findings


Sen. Chuck Grassley is asking drug maker GlaxoSmithKline for documents regarding theantidepressant medication Paxil. Sen. Grassley is making his request based on a review ofdocuments recently made public and reported today in the magazine New Scientist. The newlypublic documents include a report about risks of suicidal behavior associated with Paxil. Ninepages of that report are missing in the publicly available material. In May 2006, GlaxoSmithKline distributed a "Dear Healthcare Professional" letter informing doctors of "ahigher frequency of suicidal behavior" associated with Paxil compared to placebo. The NewScientist report today indicates that GlaxoSmithKline allegedly knew about such an increasedrisk in 1989.

Sen. Grassley's comment:

"With new questions about when GlaxoSmithKline knew about risks for suicidalbehavior compared to when it let the public know about those risks, it seems like it'd be in thedrug maker's best interest to provide every bit of information about this issue. At this point, anysense that more information is being withheld only leads to more suspicion about what went onand what still might be going on. The public has a right to know what there is to know about thisand other drugs."

Background information:

Sen. Grassley has conducted active oversight of the Food and Drug Administration since2004 and has put pressure on the drug safety agency to act with more independence andtransparency in order to build public confidence and strengthen public safety. Sen. Grassley hascalled the FDA's relationship with the drug industry "too cozy." Grassley has also conductedoversight of the pharmaceutical industry to ensure that Medicare and Medicaid dollars are spentappropriately on safe and effective drugs. His investigations have revealed attempts by drugcompanies to suppress negative data and intimidate scientists who voice concerns about theirdrugs.

The publicly available portions of the report on Paxil that is missing nine pages is postedat http://finance.senate.gov along with this press release.

Sen. Grassley's letter:

February 6, 2008

Mr. Christopher Viehbacher
PresidentU.S. Pharmaceuticals
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 coverageunder Medicare and Medicaid to ensure that taxpayer and beneficiary dollars are appropriatelyspent on safe and effective drugs and devices. This includes the responsibility to conductoversight of the medical and pharmaceutical industries that provide products and services toMedicare 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 thesedocuments and transcripts suggest that GSK knew as far back as 1989 that Paxil is associatedwith an increased risk of suicide. However, the American public was never adequately informedof this risk until May 2006 in a "Dear Healthcare Professional" letter that reported a "higherfrequency of suicidal behavior" associated with Paxil as compared to placebo.

Specifically, Dr. Joseph Glenmullen, a Clinical Instructor in Psychiatry at HarvardMedical 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 weresystematically included in the placebo arm of GSK's study, which had the effect of making itmore difficult to detect suicide risks associated with Paxil. This information was then submittedto the FDA.

Dr. Glenmullen concluded in his report:

Analyses of GlaxoSmithKline's data demonstrate a causal link between the antidepressantand suicidal behavior. This has been true since 1989 although the "bad" Paxil numbers obscuredthe 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. Pleaserepeat 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 suiciderisk?

3. When did GSK first notify patients and doctors that Paxil was associated with anincreased suicide risk? Please provide all pertinent documents and communications.

4. Please provide the Committee with the complete, unredacted version of Dr. Glenmullen'sreport. Along with that report, please provide the appendix and all documents that are referred toin 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 thereport, in the order that they are referenced.

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


Charles E. Grassley
Ranking Member
Committee on Finance