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objectivity because of the chronic nature of the diseases with which they
deal. They must be suspicious of unproven remedies, because of the fear
of giving false hope to their patients.
I understand Congresswoman Oakar's statements and in frustration I have
occasionally felt the same way about the review of a drug upon which I have
worked.
Dimethyl sulfoxide (DMSO) appears to remain a special case. I am
frustrated by the lack of studies on conditions where I feel this drug
can have a beneficial effect; that is, athletic injuries and perhaps osteo-
arthritis. I made this statement in 1974 as a member of the Academy of
Science ad hoc committee and I repeated it in 1975 at a conference on this
drug which was chaired by Dr. Jacob. I made it at your meeting and it looks
as though I will be making the same statement for years to come.
I think that Dr. Scherbel, because of his eminence and work over the
years, might provide the impetus for the studies that were discussed. In
1965 he had already treated 44 patients with scleroderma. He continued
to treat patients until the present time. There is no doubt in my mind as
I stated at the hearing, that he has probably treated more patients with
scleroderma with DMSO than anybody else. I feel that he should collect
all of his data and publish it so that the medical profession and the world
in general for that matter, can see the evidence that he has collected over
the years for the efficacy of this drug. I am somewhat saddened that he
has not chosen to do so. The followup 15 years later of 40 patients who
have been treated with DMSO to see what has happened to their disease would
be invaluable. I would even propose that the government support the follow-
up of these cases to use Dr. Scherbel's data to help establish what he feels
and what Dr. Jacob feels is the value of this drug in scleroderma.
There
I do not believe that this drug cannot be objectively tested.
is no drug in the world which by proper experimental design cannot be tested.
Dr. Crout said the FDA was willing to work and aid in the design of such
studies and I believe him. Hundreds of different types of studies of
different drugs come into the FDA every year and I am sure that they are
better acquainted with the design of drug studies than any place else in the
world.
I do not believe that this problem will be settled by rhetoric or an
attack on the FDA. It can be solved only by proper investigation that will
prove to the physicians the efficacy of this drug. If the drug was to be
released without proper evidence, I as a physician would be reluctant to use
it and I think that most of my colleagues would feel the same way.
Thank you again, not only for your courtesy to me, but for the members
of your staff who were most considerate.
Sincerely,
JB:mel
copies to:
John Baum, M.D.
Professor of Medicine and
Pediatrics and of Preventive,
Family, and Rehabilitation Medicine
Congresswoman Mary Rose Oakar
J. Richard Crout, M.D.
