[Congressional Record (Bound Edition), Volume 153 (2007), Part 9]
[Senate]
[Page 13294]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           SAFETY OF AVANDIA

  Mr. GRASSLEY. Mr. President, I am here today to talk about another 
potential failure by the FDA that may have endangered the lives of 
millions of Americans. Avandia is a drug that was approved by the FDA 
in 1999. It is a diabetes drug and is used to lower blood sugar. This 
is important because lowering a diabetic's blood sugar can help prevent 
or at least postpone two of the biggest killers among diabetics: heart 
attacks and strokes.
  But today, Dr. Steven Nissen, the chairman of Cardiovascular Medicine 
at the Cleveland Clinic and the immediate past president of the 
American College of Cardiology, and his colleague, Ms. Kathy Wolski, 
reported in the New England Journal of Medicine that there is a serious 
problem with Avandia. Avandia, according to Dr. Nissen and Ms. Wolski 
is increasing the likelihood that a diabetic will have a heart attack 
and maybe even die. I want everyone to pay attention to the fact that 
the New England Journal of Medicine accepted this analysis of Avandia 
on a ``fast track'' review. The New England Journal of Medicine did 
that because it was requested by the authors and because in its 
opinion, the analysis of adverse effects related to Avandia suggests 
serious patient health risks.
  Dr. Nissen and Ms. Wolski based their finding on an analysis of 42 
clinical trials.
  FDA also decided to say something to the American people today in 
response to Dr. Nissen's analysis. Around 1 p.m. today, the FDA told 
the American people that they intend to call for an advisory board 
meeting to discuss Avandia and that they could not yet reach a ``firm 
conclusion'' on what to recommend to people taking Avandia. It was 
interesting to listen to the call because Dr. Dal Pan, who is the head 
of the Office of Surveillance and Epidemiology, didn't say a word, 
although he is in charge of postmarketing surveillance. I guess the FDA 
thinks that the decision to go to an advisory committee meeting takes 
the heat off what looks like another failed decisionmaking process. We 
will see.
  Avandia has a long history. It has been on the market for about 8 
years. Tens of millions of prescriptions have been written for Avandia, 
and Medicare and Medicaid have paid hundreds of millions of dollars for 
this drug.
  There have been many clinical trials involving Avandia over the years 
and there have been numerous postmarketing changes to Avandia's label. 
I also understand that FDA has known about the possibility of problems 
with this drug since about October 2005. That is about 19 months ago.
  The article appearing today in the New England Journal of Medicine 
raises a lot of serious questions for me about the real story behind 
the safety of Avandia. When I couple that article with the FDA 
conference call that ducked lots of questions I become very suspicious.
  Over the last 3 years, my investigations into the FDA showed that the 
agency was too cozy with the drug industry and did not always put 
safety of the American people first. The FDA is supposed to regulate 
the drug industry, but in the case of Vioxx, just to name one debacle, 
American lives were endangered unnecessarily.
  My question today is, Do we have another Vioxx on our hands with 
Avandia? I am not sure, but I intend to find out. In fact, today 
Senator Baucus and I sent out several document requests including one 
to the FDA and one to the drug sponsor. We want to understand what did 
FDA know about this drug, when did it know it, and what did it do about 
it?
  The authors of the New England Journal of Medicine article report a 
43 percent increase in the risk of myocardial infarction/heart attack 
and potentially a 64 percent increase in the risk of cardiovascular 
death. I need the FDA to tell me why a diabetic would take a drug that 
may increase the risk of the very thing they are trying to avoid--a 
heart attack. I also want to know why the FDA did not require the drug 
sponsor to conduct long-term safety studies instead of small, short-
term trials that resulted in few adverse cardiovascular events or 
death. I want to know what the FDA has been doing for the last 18 
months. We want to know the same from the drug sponsor.
  Interestingly, in an editorial that accompanied the study, two other 
veterans of the Vioxx controversy--Dr. Bruce Psaty of the University of 
Washington and Dr. Furberg of Wake Forest University--write that: ``. . 
. the rationale for prescribing rosiglitazone at this time is 
unclear.'' Additionally they call for the FDA to take regulatory action 
and note that bigger and better long-term studies of long-term 
treatments for conditions such as diabetes should be completed as soon 
as possible after a drug is approved.
  Let me also say something else to all those FDA employees trying to 
do their job who probably know the answers to many of my questions: 
Please feel free to call the Finance Committee if you have any 
information about this drug and how the FDA handled the situation. You 
can also call or contact us anonymously if you want. If you want to fax 
information to me, here is my fax number: 202-228-2131. We welcome your 
help and insight because I know that many of you want to protect the 
American public first and foremost and sometimes that is not as easy as 
it should be at the FDA.
  You will also remember that just a few weeks ago I came before the 
Senate several times to talk about drug safety. I told everyone then--
as we were discussing S. 1082, a bill that was intended to dramatically 
improve postmarketing drug safety, that I was concerned that the bill 
would not do that. In my mind and in light of all the work I have done 
over the past 3 years on the FDA, I told everyone that the litmus test 
for me was whether or not the new drug safety bill would prevent 
another Vioxx.
  My position has consistently been that S. 1082 did not go far enough 
and would not prevent another Vioxx. That was why I proposed and 
insisted on a vote giving joint authority between the office that 
approves new drugs for the market and the office that is responsible 
for postmarket safety. Forty-six Senators listened to what I had to 
say, but I was one vote short and the amendment did not pass.
  Drs. Psaty and Furberg also said in their editorial, and I quote, 
``On May 10, 2007, the Senate passed the Food and Drug Administration 
Revitalization Act. Although the Senate bill has many strengths, 
including the allocation of new authority to the FDA, none of its 
provisions would necessarily have identified the cardiovascular risks 
of rofecoxib or rosiglitazone in a timely fashion.''
  The drug industry has brought us miracle drugs. These drugs have 
vastly improved the lives of millions throughout the world. At the same 
time, we all know that drugs have risks and benefits. Each of us tries 
to consider those risks and benefits when we consult with our doctors 
to make the best decision for ourselves or our family members as to 
whether we will take a particular drug. But we can't do what is best 
for ourselves or our family members if we don't know all the relevant 
information in a timely manner.

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