Patrick McHenry, R-N.C.: At what point did you begin your conversations
Chairman Waxman and his staff?
Steven Nissen: In February, I had looked at the DREAM and the ADOPT
but I didn't have enough information actually to answer the question
scientifically. ...At the time, I was discussing with various
committees the pending legislation around the similar version of the
Kennedy/Enzi bill on the House side, and so I mentioned to them I had
concerns about the cardiovascular safety of Avandia. And I actually
requested their assistance in getting access to the data. I had
a scientific mystery: I didn't have the means to answer the question in
robust scientific way, and I really was looking for help.
McHenry: Did you provide your interim analysis to any member of the
Nissen: There were no interim results. Basically what we had done was a
preliminary analysis - nothing formal...
McHenry: Did you provide a preliminary analysis?
McHenry: At what point did you have that and did you share it with Mr.
Nissen: The same time - February.
McHenry: So they were aware you were going through the process?
Nissen: They were aware.
McHenry: Why didn't you discuss your preliminary analysis with the Food
Nissen: The Food and Drug Administration had all of these studies on
When you do a study, you submit a study report to the FDA.
McHenry: But you were actually submitting to a medical journal a new
...You proffer your work as original do you not?
Nissen: It is original.
McHenry: Then why didn't you share that study with the Food and Drug
Administration? After all, as members of Congress we have a regulatory
structure we put in place for drug safety. Why didn't you go to the
Nissen: This is not how it's done.
McHenry: So, going to Capitol Hill for political purpose to get
during a hearing is actually the way it is done?
Nissen: With all due respect, sir, this is about patients, and it's not
McHenry: If it is about patients, why would you not go to the regulator
has the authority and oversight of drug safety?
Nissen: This is about patients - not politics. I had a preliminary
was looking for assistance to complete the study. When it was
did what any scientist would do. I sent that for peer review and for
McHenry: What peers do you have on the Oversight and Government Reform
- the Democrat staff? Because you shared your findings with them. Is
what you consider peer review? Is that what you consider putting
Nissen: I did not give out my manuscript to this committee or anybody
until it was published.
McHenry: It seems very peculiar to me that if you are considering the
patients first that you not go to the regulator who is overseeing drug
safety, that you would go to Capitol Hill ... and we don't have any
authority to take a drug off the market like the FDA does.
Nissen: The regulatory agency had all of the data that I had and much,
more. ...It made no sense for me to take study-level data and submit it
the FDA when they already had the patient-level data. So I would not
given them anything they hadn't had for many, many months.
Elijah Cummings, D-Md.: I hate that we have to make these accusations
people [are] putting politics over the health of the American people.
bothers me. ...Dr. Buse and Dr. Psaty you've heard this line of
You've heard what Dr. Nissen has said. Do you all have any issues with
professionalism that he has [exhibited] doing what he has done to get
John Buse, University of North Carolina: I have no issues at all, and I
think he did a nice job of organizing data and setting out that it was
imperfect but important for people hear about.