January 30,2008

Senator Grassley’s letter to the President of U.S. Pharmaceuticals, GlaxoSmithKline

January 30, 2008

Via Electronic Transmission

Mr. Christopher Viehbacher
U.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 receivehealth care coverage under Medicare and Medicaid to ensure that taxpayer andbeneficiary dollars are appropriately spent on safe and effective drugs and devices. Thisincludes the responsibility to conduct oversight of the medical and pharmaceuticalindustries that provide products and services to Medicare and Medicaid beneficiaries.

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 May21, 2007 in The New England Journal of Medicine (NEJM).1 This study reported a linkbetween heart attacks and Avandia, a drug GSK sells to control glucose levels indiabetics.

GSK representatives informed the Committee last summer that a peer reviewerleaked the study to them weeks before it was published. GSK later acknowledged to theCommittee that the peer reviewer was Dr. Haffner. Dr. Haffner confirmed this factnoting also that he was peer reviewing the study for NEJM when he faxed the study toGSK. According to documents filed at the FDA, GSK has paid Dr. Haffner around$75,000 in consulting fees and speaking honoraria since 1999.

Dr. Haffner told Committee investigators that no one at GSK asked him to sendthem this study about Avandia. Nonetheless, I am interested in what GSK did afterreceiving the study. Did GSK return the study to Dr. Haffner? Did GSK contact theNEJM to report this violation of publishing ethics? I would appreciate a detaileddescription of what GSK did after receiving the unpublished study regarding one of theirleading drugs. Accordingly, please respond to the following questions and request fordocuments:

1 Steven E. Nissen et. al. “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death fromCardiovascular Causes” The New England Journal of Medicine, May 21, 2007.

1. Please provide a list of all GSK employees who received and/or learned of theresults contained in the leaked copy of the manuscript prior to publication byNEJM.

2. Please provide copies of all documents, records, and recordings of telephonemessages regarding the NEJM manuscript that was leaked to GSK beforepublication.

3. Please provide the following dates:

a. When did GSK first contact the data safety monitoring board of theRECORD trial to begin publication of interim results?

b. When did GSK begin pulling together the interim data of the RECORDtrial?

c. When did GSK submit the interim results of the RECORD trial to NEJMfor possible publication?

4. Please provide copies of all documents, records, communications, and recordingsof telephone messages regarding the publication of the interim results of theRECORD trial.

5. Please provide copies of any other pre-publication study drafts that GSK receivedabout one of its products. Please do not include these drafts if a GSK employeewas an author on the study. This request covers the period of January 1, 2000 tothe present.

Thank you again for your continued assistance in this matter. I would appreciatereceiving the documents and information requested by no later than February 15, 2008.If you have any questions, please feel free to contact Paul Thacker or Emilia DiSanto ofmy Committee at (202) 224-4515. All formal correspondence should be sentelectronically in PDF format to Brian_Downey@finance-rep.senate.gov or via facsimileto (202) 228-2131.


Charles E. Grassley
Ranking Member