[Congressional Record Volume 153, Number 135 (Wednesday, September 12, 2007)]
[Senate]
[Page S11492]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
DRUG SAFETY
Mr. GRASSLEY. Mr. President, I wish to speak for a short period of
time on another issue that I have been working on.
Yesterday, the Journal of the American Medical Association published
a study on the diabetes drug Avandia. This study concluded Avandia
significantly increases the risk of heart attacks, a subject that
Senator Baucus and I have been investigating for some months. You will
remember that it was back in May that a study in the New England
Journal of Medicine first alerted the public of an increased risk of
heart attacks from Avandia.
When that study was published, Senator Baucus, chairman of the Senate
Finance Committee, and I raised concerns that the drugmaker had sought
to silence a critic who voiced apprehension about Avandia back in 1999.
Remember, this is 8 years ago. At the time, SmithKline Beecham
manufactured Avandia. The company later merged with Glaxo Wellcome to
form today's GlaxoSmithKline.
According to the Wall Street Journal, GlaxoSmithKline said the
allegations that the company silenced critics of Avandia were
``absolutely false.''
Today I would like to discuss some internal company communications
that suggest otherwise. The person who first blew the whistle about
cardiovascular problems with Avandia was Dr. John Buse. He was a
professor at the University of North Carolina.
Shortly after Avandia came on the market, back in 1999, Dr. Buse
began warning his colleagues at medical meetings that the drug might be
dangerous.
How did this company respond when this professor brought up these
issues? In an e-mail dated June 25, 1999, two company executives
discussed ways to silence Dr. Buse. I would like to read parts of the
e-mail. One executive wrote of a plan to ``write him a firm letter that
would warn him about doing this again . . . with the punishment being
that we will complain up his academic line and to the CME granting
bodies that accredit his activities.''
CME stands for continuing medical education. I will come back to that
in just a second.
In response, another company executive e-mailed back, proposing to
sue Dr. Buse and launched a media offensive promoting Avandia.
Based on this e-mail exchange, it seems to me that at least two drug
company officials did attempt to silence a critic. In fact, Dr. Buse
stopped making any critical statements about Avandia shortly after this
e-mail exchange. Scientists should be able to raise issues related to
public health and safety in a free and uncensored manner, not the way
they do things in China. And when these scientists are suppressed, we
ought to consider that a very serious problem. The reason why is
because the scientific process will take care of itself. If scientist
Grassley has a suggestion and you think it is crazy, you are a
scientist, my work can be reviewed by you and it has to stand the test
of peer review. So I think it is a very good process, and if we just
let it go on, it will show whether this scientist or that scientist is
right or wrong.
The scientific process, if suppressed, I say, is a very serious
problem. But more important in this whole process, the American public
loses. Instead of Avandia being more critically examined for safety, it
was heavily marketed and became what experts have called the best
selling diabetes drug in America. It has been reported to me that this
huge volume of sales may have resulted in 60,000 to 100,000 heart
attacks from 1999 until the year 2006--that is about 20 a day--from the
users of Avandia.
What happened to the company executives who sought to attack Dr. Buse
for voicing his scientific opinion? Based on the information I have
received to date, nothing has happened to these corporate executives.
Let me return to the issue of continuing medical education. In the e-
mail exchange I quoted, the two company officials discussed complaining
about Dr. Buse to the accrediting bodies of continuing medical
education. Every year, medical professionals must get continuing
medical education credits to stay current in their profession. The
continuing medical education companies and the doctors who teach the
classes are supposed to be independent of drug companies that fund the
courses. But I think we now know what we have often suspected:
Continuing medical education courses often are not independent at all.
In fact, the drug companies have a lot to say about what goes on in
these courses and who gets paid to teach them.
In April, the Finance Committee staff released a report on
pharmaceutical company support of continuing medical education. Drug
companies pour about $1 billion every year into continuing medical
education, and the report noted that some educational courses have
become veiled forms of advertising.
Of course, this also ties in to last week's introduction of the bill
I submitted called the Physicians Payments Sunshine Act. I introduced
that bill with Senator Kohl, who is chairman of the Aging Committee,
because Americans have a right to know how the drug companies are using
money to try to shape the medical field. The bill requires drug and
device companies to report payments and other gifts they give to
doctors, bringing a little transparency to the practice of companies
such as GlaxoSmithKline. I hope to see more of my colleagues sign on to
this legislation. I cannot spotlight every instance where a drug
company goes after an independent scientist with a stick, as they did
with Dr. Buse, but together we can splash some sunlight on the
financial carrots drug companies use to try to shape doctors' behavior.
Before I yield the floor, I ask unanimous consent to have the e-mails
I referred to printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
From: Tachi Yamada
To: William D Claypool
CC: David M Stout, Jean-Pierre Garnier
Subject: Re: Avandia Renegade
Date: 06/25/1999 19:15:33 (GMT-05:00)
Bill: I spoke to both JP and David Stout today about this
situation. I doubt that speaking to his chairman about him
will do much good--in fact if he's as bad as he seems to be,
his chairman probably already has doubts about him. In any
case, I plan to speak to Fred Sparling, his former chairman
(they are actively looking for his replacement) as soon as
possible. I think that there are two courses of action. One
is to sue him for knowingly defaming our product even after
we have set him straight as to the facts--the other is to
launch a well planned offensive on behalf of Avandia so that
the listeners begin to understand at the very least that
there are two sides to this story. I suspect that the latter
approach would be preferred--it wouldn't look good for SB to
be at war with a KOL.
Tachi.
______
William D Claypool on 25-Jun-1999 12:23
CLINICAL RESEARCH AND DEVELOPMENT
To: Tachi Yamada
Subject: Avandia Renegade
Tachi: At Avandia Day today, mention was made of John Buse
from UNC who apparently has repeatedly and intentionally
misrepresented Avandia data from the speaker' dais in various
fora, most recent among which was the ADA. The sentiment of
the SB group was to write him a firm letter that would warn
him about doing this again (he will be speaking next at a
major European congress in Stockholm in July) with the
punishment being that we will complain up his academic line
and to the CME granting bodies that accredit his activities.
There was brief mention of a law suit but this was reserved
for a later approach. The question comes up as to whether you
think this is a sensible strategy, whether you know any of
the principals at UNC (I don't), and whether we have other
avenues to ensure his accuracy in the future (we don't really
do too much work at UNC to make any threats)? I imagine that
Paul Wadkins is too new in post for us to ask him to exert
any influence on our behalf at his new institution.
Any thoughts?
Thanks.
Bill.
Mr. GRASSLEY. I yield the floor, and I suggest the absence of a
quorum.
The PRESIDING OFFICER (Mr. Casey). The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mrs. MURRAY. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
____________________