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case studies, what do you have to do to satisfy them? You are a
noted expert in this field.
Dr. SCHERBEL. Ms. Oakar, today drug studies are becoming more
and more complex. I just came back from a meeting in San Fran-
cisco where we had symposia after symposia on design and drug
trials. The problem today is that FDA is demanding very sophisti-
cated drug trials that take months, may take years, thousands of
dollars. This is the direction in which we are going.
Many times it is very frustrating because one cannot conform to
FDA demands. This is exactly what has happened with DMSO. We
can't double blind this drug. It smells and one can taste it. If you
have a patient who has been taking it and you touch that patient's
skin, you are going to taste it. So there is no way of blinding this
study.
One of the other things I didn't bring out, maybe Dr. Jacob
implied it, it is a very unique drug. There is no drug similar to
DMSO that has ever been used in the history of medicine. I am not
criticizing FDA, but FDA has no experience with this drug. More-
over, FDA consultants who evaluated DMSO, had no experience
with the use of the drug.
Ms. OAKAR. In all humility do these investigators have the cre-
dentials that you do?
Dr. SCHERBEL. I can name many, many--
Ms. OAKAR. Do any of the doctors there?
Dr. SCHERBEL. I know many investigators who think DMSO is a
drug that should be approved immediately. I know just as many
good people, and you will probably hear some this afternoon, who
disapprove strongly of the drug. So there is an individual opinion.
You can bring people to this committee hearing who are pro-DMSO
and you will find some who are anti-DMSO. Those authorities
biased against DMSO are unable to show studies where DMSO has
failed. Their bias is made up of impressions about the smell or the
skin irritation or they didn't find it effective in relieving all the
pain in a patient with arthritis. There are some investigators who
will never accept DMSO. If this drug is released for clinical use
there will be people who will benefit and others who won't. This is
typical of all drugs.
Ms. OAKAR. You mentioned that when you are attempting to
treat people with various forms of arthritis, that you try a variety
of ways, that none of them are perfect. You mentioned specifically
aspirin and the fact that in some cases it has a very detrimental
effect on older Americans, and in fact, it can cause impaired hear-
ing.
We have a person on our staff with a master's in gerontological
nursing who checked with the medical staff at Case Western about
this-that a low but consistent use of aspirin can produce a low
plasma vitamin C level and that is counterproductive to treatment
of, let's say rheumatoid arthritis.
In our evaluation of what kinds of medication older people are
given, which in many cases affects the poor elderly, the most
frequent type of treatment given to older people in the 200 or more
people that we interviewed was aspirin. Yet, on my little bottle of
aspirin, there is nothing that says anything about harmful side-
effects. It is supposed to be the cure-all. The only thing it says that
