[Congressional Record Volume 154, Number 15 (Wednesday, January 30, 2008)]
[Senate]
[Pages S486-S487]
From the Congressional Record Online through the 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)
[[Page S487]]
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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