[Congressional Record (Bound Edition), Volume 154 (2008), Part 1]
[Senate]
[Page 1180]
[From the U.S. Government Publishing Office, www.gpo.gov]




                              DRUG SAFETY

  Mr. GRASSLEY. Mr. President, last May, Senator Baucus and I began 
investigating GlaxoSmithKline regarding their diabetes drug, Avandia.
  We began this investigation when Dr. Steve Nissen at the Cleveland 
Clinic published a study in the New England Journal of Medicine. That 
study found a link between Avandia and heart attacks.
  Shortly after we began our investigation, Dr. Scott Gottlieb, a 
former Deputy Commissioner at the Food and Drug Administration, wrote 
an op-ed in the Wall Street Journal. In that article, he insinuated 
that congressional investigators had obtained a copy of the Nissen 
study before it was published. Dr. Gottlieb suggested that this action 
called into question the integrity of both congressional investigators 
and Dr. Nissen.
  Well, congressional investigators did not get a copy of the Nissen 
study until it became public. But you can imagine my surprise when I 
learned that one of GlaxoSmithKline's own consultants leaked a copy of 
the study to GlaxoSmithKline weeks before it was published. The man who 
did this is Dr. Steven Haffner. He confirmed to my investigators that 
he faxed a draft of the study to GlaxoSmithKline weeks before it was 
published.
  The New England Journal of Medicine picked Dr. Haffner to peer review 
the study submitted by Dr. Nissen. That means that Dr. Haffner was 
supposed to check the study for quality. He was not supposed to pass it 
back to GlaxoSmithKline.
  Not only did Dr. Haffner breach his agreement with the New England 
Journal of Medicine to properly peer review the Nissen study, but he 
violated practically every tenet of independence and integrity held 
sacred by the major medical journals.
  Dr. Haffner told my investigators that GlaxoSmithKline did not ask 
for an early copy of the Avandia study. But the question still remains 
about what the company did once they had the study. Maybe 
GlaxoSmithKline's executives returned the study to Dr. Haffner or maybe 
they contacted the New England Journal of Medicine to report this 
violation of publishing ethics. I don't know, but I have sent 
GlaxoSmithKline a letter asking how they behaved after Dr. Haffner 
leaked the study to them.
  But the most troubling aspect of this situation is that the integrity 
of another aspect of the scientific process is called into question--
scientific peer review.
  This process ensures that other scientists will judge a study's 
quality before it is made public and becomes used as a marketing tool.
  It is only good quality science that separates modern pharmaceuticals 
from old-fashioned snake oil.
  Over the last few years, my investigations have found that the Food 
and Drug Administration has a very cozy relationship with drug 
companies. I have also discovered that drug companies spend big bucks 
to influence which drugs doctors prescribe.
  Finally, I have shown that some drug companies intimidate scientists 
who speak up about bad drugs. Now it appears that even peer-reviewed 
science is not completely without its own problems.
  Before I close, I would like to ask unanimous consent to have printed 
in the Record my letter to GlaxoSmithKline.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                                      U.S. Senate,


                                         Committee on Finance,

                                 Washington, DC, January 30, 2008.
     Mr. Christopher Viehbacher,
     President, U.S. Pharmaceuticals, GlaxoSmith-
         Kline, Research Triangle Park, NC.
       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.
       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.
       GSK representatives informed the Committee last summer that 
     a peer reviewer leaked the study to them weeks before it was 
     published. GSK later acknowledged to the Committee that the 
     peer reviewer was Dr. Haffner. Dr. Haffner confirmed this 
     fact noting also that he was peer reviewing the study for 
     NEJM when he faxed the study to GSK. 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 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.
       Thank you again for your continued assistance in this 
     matter. I would appreciate receiving 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 of my Committee.
           Sincerely,
                                              Charles E. Grassley,
     Ranking Member.

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