[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.

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