In case you didn't see it in many press accounts, here's some of the exchanges between Steve Nissen and members of the House Oversight Committee
Patrick McHenry, R-N.C.: At what point did you begin your conversations
with
Chairman Waxman and his staff?
Steven Nissen: In February, I had looked at the DREAM and the ADOPT
study,
but I didn't have enough information actually to answer the question
scientifically. ...At the time, I was discussing with various
congressional
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
essentially
a scientific mystery: I didn't have the means to answer the question in
a
robust scientific way, and I really was looking for help.
McHenry: Did you provide your interim analysis to any member of the
Hill or
staff?
Nissen: There were no interim results. Basically what we had done was a
very
preliminary analysis - nothing formal...
McHenry: Did you provide a preliminary analysis?
Nissen: Yes.
McHenry: At what point did you have that and did you share it with Mr.
Waxman's staff?
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
and
Drug Administration?
Nissen: The Food and Drug Administration had all of these studies on
record.
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
study.
...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
FDA?
Nissen: This is not how it's done.
McHenry: So, going to Capitol Hill for political purpose to get
publicity
during a hearing is actually the way it is done?
Nissen: With all due respect, sir, this is about patients, and it's not
about politics....
McHenry: If it is about patients, why would you not go to the regulator
who
has the authority and oversight of drug safety?
Nissen: This is about patients - not politics. I had a preliminary
result. I
was looking for assistance to complete the study. When it was
completed, I
did what any scientist would do. I sent that for peer review and for
publication.
McHenry: What peers do you have on the Oversight and Government Reform
staff
- the Democrat staff? Because you shared your findings with them. Is
that
what you consider peer review? Is that what you consider putting
patients
above politics?
Nissen: I did not give out my manuscript to this committee or anybody
else
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,
much
more. ...It made no sense for me to take study-level data and submit it
to
the FDA when they already had the patient-level data. So I would not
have
given them anything they hadn't had for many, many months.
Elijah Cummings, D-Md.: I hate that we have to make these accusations
that
people [are] putting politics over the health of the American people.
That
bothers me. ...Dr. Buse and Dr. Psaty you've heard this line of
questioning.
You've heard what Dr. Nissen has said. Do you all have any issues with
the
professionalism that he has [exhibited] doing what he has done to get
this
information published?
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.
Patrick McHenry, R-N.C.: At what point did you begin your conversations
with
Chairman Waxman and his staff?
Steven Nissen: In February, I had looked at the DREAM and the ADOPT
study,
but I didn't have enough information actually to answer the question
scientifically. ...At the time, I was discussing with various
congressional
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
essentially
a scientific mystery: I didn't have the means to answer the question in
a
robust scientific way, and I really was looking for help.
McHenry: Did you provide your interim analysis to any member of the
Hill or
staff?
Nissen: There were no interim results. Basically what we had done was a
very
preliminary analysis - nothing formal...
McHenry: Did you provide a preliminary analysis?
Nissen: Yes.
McHenry: At what point did you have that and did you share it with Mr.
Waxman's staff?
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
and
Drug Administration?
Nissen: The Food and Drug Administration had all of these studies on
record.
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
study.
...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
FDA?
Nissen: This is not how it's done.
McHenry: So, going to Capitol Hill for political purpose to get
publicity
during a hearing is actually the way it is done?
Nissen: With all due respect, sir, this is about patients, and it's not
about politics....
McHenry: If it is about patients, why would you not go to the regulator
who
has the authority and oversight of drug safety?
Nissen: This is about patients - not politics. I had a preliminary
result. I
was looking for assistance to complete the study. When it was
completed, I
did what any scientist would do. I sent that for peer review and for
publication.
McHenry: What peers do you have on the Oversight and Government Reform
staff
- the Democrat staff? Because you shared your findings with them. Is
that
what you consider peer review? Is that what you consider putting
patients
above politics?
Nissen: I did not give out my manuscript to this committee or anybody
else
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,
much
more. ...It made no sense for me to take study-level data and submit it
to
the FDA when they already had the patient-level data. So I would not
have
given them anything they hadn't had for many, many months.
Elijah Cummings, D-Md.: I hate that we have to make these accusations
that
people [are] putting politics over the health of the American people.
That
bothers me. ...Dr. Buse and Dr. Psaty you've heard this line of
questioning.
You've heard what Dr. Nissen has said. Do you all have any issues with
the
professionalism that he has [exhibited] doing what he has done to get
this
information published?
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.
