[Congressional Record (Bound Edition), Volume 153 (2007), Part 10]
[Senate]
[Pages 14047-14048]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           SAFETY OF AVANDIA

  Mr. GRASSLEY. Mr. President, over the last few days there have been 
countless articles about the popular diabetes drug Avandia. For me, 
some of the most important questions that need to be answered here are 
what did FDA know, when did it know it, and what did it do with the 
information.
  Since The New England Journal of Medicine first reported on a new 
study by Cleveland Clinic Cardiologist Dr. Steven Nissen, my 
investigative staff has continued to gather information about both FDA 
and the drugmaker.
  We are hearing a lot about what's called the ``RECORD'' study, which 
was requested by the Europeans. There was talk at the FDA, before this 
week's stories started appearing, that the agency wanted to wait for 
that study

[[Page 14048]]

to be completed before it made a decision about whether or not to say 
anything about Avandia and the possible increased risk in heart 
attacks. Believe it or not, FDA officials have confirmed for my 
investigators this week that the ``RECORD'' study is not expected to be 
completed for 2 more years--until the summer of 2009. That's a long 
time from now when you have millions of American's taking this drug.
  Second, there is something I would like to clarify. We have been 
reading this week that the FDA was not in a position to tell the 
American people about its concerns with Avandia because it needed 
``conclusive'' information. That doesn't make sense to me. The 
preliminary findings of the FDA's ongoing ``meta-analysis'' of the 
Avandia clinical trials have been consistent with Dr. Nissen's findings 
of an increased heart attack risk, as well as the drug maker's 
findings. It goes like this: the drugmaker sees a 31-percent increased 
risk of a heart attack; the FDA sees a 40-percent increased risk for 
heart attacks; and Dr. Nissen sees a 43-percent increased risk for 
heart attacks. Those numbers seem like a high enough threshold to me 
for the FDA to warn the American people of the possibility of a 
problem.
  Third, several months ago, the Division of Drug Risk Evaluation, 
which sits within the Office of Surveillance and Epidemiology, 
recommended a ``boxed'' warning for Avandia. Why? Because it was 
believed that Avandia increased the risk of heart attacks. To date, FDA 
has not acted on upon this recommendation.
  In a statement I released on Tuesday, I also pointed out that about a 
year ago some FDA scientists recommended a black box warning for 
congestive heart failure. There is still no black box warning for 
congestive heart failure, and I understand that happened because the 
office that put Avandia on the market in the first place wanted to look 
into it further. America is still waiting for a decision.
  It was also reported to me that the incidence of heart attacks with 
Avandia could be about 60,000 to 100,000 from 1999 to 2006. That is a 
lot. Just doing the math and using conservative numbers, that means 
about 20 or more unnecessary heart attacks a day.
  At a minimum, I think that the office responsible for post marketing 
safety needs to have the ability to warn Americans when it thinks it 
needs to do so. If not, we have what we have here today, delays in 
telling the American people about a possible serious safety problem. It 
is not right, and I am going to keep working to change things once and 
for all. The FDA legislation passed by the Senate two weeks ago dropped 
the ball on this important reform. The Avandia case sets it up for the 
House of Representatives to give real clout to the FDA office that 
monitors and assesses drugs after they are on the market and taken by 
millions of people. If the Office of New Drugs continues to call all 
the shots, like it does today, then it is more status quo and less 
public safety from the FDA. Both the evidence and the experts 
underscore the need for real reform here.
  One opportunity to improve upon postmarketing drug safety stems from 
the Access to Medicare Data Act that I filed today with Senator Baucus. 
This bill is based on S. 3897, the Medicare Data Access and Research 
Act, which Senator Baucus and I introduced in the 109th Congress. The 
purpose of the bill is to provide federal health agencies and outside 
researchers more sources of data for examining adverse events so that 
serious safety questions are identified promptly and timely action can 
be taken to protect American consumers.

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