42
Mr. MICA. When you say prescriptive, I gather what we are
talking about today is to make it prescriptive for a broader range
of uses?
Dr. JACOB. I would like to see it prescriptive for topical uses for
everything and prescriptive for head and brain damage in the
United States.
Mr. MICA. In other countries is it more limited in its use or more
widespread?
Dr. JACOB. It is more limited in the United States than in some
countries. It is more widespread in the United States than in some
countries where it is not prescriptive.
Mr. MICA. Do we have, with regard to other drugs, international
agreements to utilize the basis of their scientific testing and analy-
sis as a basis or a portion of our approval process for drugs in this
country?
Dr. JACOB. That would be a question that would be best answered
by the FDA.
Mr. MICA. I will reserve that for the FDA. I know the answer to
that. What I am leading up to, Mr. Chairman, if I may with all of
this, I am a layman and I don't have the answer to whether or not
this really does everything that is indicated that it will do. But I
have had 12 years of background in health legislation. I think that
we are seeing a classic case being built for a total review of FDA
policy, of the laws that we as a Congress have enacted and for
what I have termed for many, many years a lack of affirmative
action on the part of our Government in bringing to the market
drugs that may-and I say may because I don't know-that may be
of service to large numbers of people.
I can cite example after example. You may remember the
papaya extract used in injections in the spine. They did a double
blind study and found that water cured as many people as the
papaya extract and they took the papaya extract off the market.
But in my mind the result was that water could help cure people
with certain spinal problems. The FDA didn't rule on that. They
simply ruled it could not be used.
We have had these cases and I dare say with this particular
substance we will see other substances, maybe of more limited use,
come to the attention of this committee that are suffering the drug
lag that is occurring in this country. The statistics on drug approv-
al, drug lag in this country are among the worst in the world.
Again, I reserve comment and judgment on the use of this partic-
ular drug, but I do think we are building a case and maybe it
would be appropriate for our committee at a future date to look at
the entire FDA approval process and maybe propose an affirmative
action plan, because to my knowledge no Government agency will
follow up on a drug that is not profitable. As Ms. Oakar said, any
time they come up with a drug that is not profitable or not in
widespread use, the drug companies do not pursue it and our
Government does not.
My last question: Is NIH doing any research on this?
Dr. JACOB. NIH has invested a few hundred thousand dollars in
DMSO research, but not on a large scale.
Mr. MICA. Thank you.
Thank you, Mr. Chairman.
