69
Or that maybe the charge that you are protecting some drug
firms that may view this as a marketing threat of some sort. Or
last, you have a very legitimate case based on clinical or controlled
evidence that you referred to today.
But I would hope, as a result of these hearings and the chair-
man's expressed concern, that maybe you would take a new look or
review of this chemical, and see in light of the testimony and the
evidence that abounds that perhaps it warrants a new review and
hopefully a different decision.
Dr. CROUT. I accept that. We will do our best to cooperate.
Mr. BONKER. Thank you.
The CHAIRMAN. Ms. Oakar?
Ms. OAKAR. Thank you, Mr. Chairman, and thank you, doctor,
for being with us today.
Would you submit, then, for the record the regulations for this
controlled testing. Obviously they are not in the law. I don't think
we want to be misled about that.
Dr. CROUT. No. The controlled trials, the words "controlled inves-
tigations" is statutory.
Ms. OAKAR. Yes, but the regulations with respect to defining that
term, which we all understand are very flexible-it is not uncom-
mon, is it, that regulations frequently do not do what we intended.
I am astounded when I see HUD regulations, for example, and I
am on the Subcommittee on Housing, and I say did we pass that
law? Is that really what we intended? So, I think for the record we
ought to get that.
Dr. CROUT. I would be delighted. Those regulations have been in
effect since 1970.
Ms. OAKAR. Right. And there are no new regulations.
Dr. CROUT. No, ma'am.
MS. OAKAR. Since 1970.
[Copy of regulations submitted are retained in committee files.]
Ms. OAKAR. Also, I asked the various doctors that we had here
about their credentials and, being from Cleveland, I am very proud
of Dr. Scherbel, for example, and the Cleveland Clinic's research.
He apparently has done a lot of research and has a fairly bal-
anced view of this drug. But I think you should tell me something
about these people who are on the panels that you appoint to
review this research.
Dr. Jacob, for example, indicated that none of them had had
actual experience with the drug. Do you try to get a balanced point
of view? Do you have doctors, let's say, or nurses or people who are
in research, such as the doctor we had who had a lot of experience
with respect to animals?
Are any of the pro advocates on the panel along with those who
might be disposed negatively? How objective are these people?
What are their credentials? Have they worked with the drug ex-
perimentally, et cetera?
Dr. CROUT. On our advisory committees we try to get national
experts in the particular area of the committee's work. We have 13
advisory committees that advise on prescription drugs. So, in the
arthritis area, for example, our advisory committee is mainly com-
posed of rheumatologists, physicians who either practice rheumatol-
ogy or are on the faculties of medical schools.
