88
which thousands of patients received it. But in 1965 further testing was banned as a
precaution, following reports of eye damage in test animals given the drug.
In 1968, the FDA again permitted clinical testing, under limited conditions, which
have since been relaxed. DMSO continued over the years to be the subject of often
bitter public controversy, fueled in part by the Mexican clinic connection and the
false image of DMSO it caused. The target of critics was the FDA.
In 1972 the FDA asked the National Academy of Sciences to review all available
information on the effectiveness and toxicity of DMSO and come up with an inde-
pendent judgment on these concerns. A committee of experts was appointed which
studied 1,200 papers on DMSO and 193 volumes of reports in the process of review
and preparation of its comprehensive medical and scientific evaluation.
In sum, the Academy concluded that there was still inadequate scientific evidence
of effectiveness of DMSO for the treatment of any disease; and although it appeared
to be safe for short-term use, all potential for toxicity had not been eliminated by
studies to date. These conclusions were in agreement with the position of the FDA,
and were accepted by the Arthritis Foundation.
A noteworthy fact about DMSO: No matter how administered, and even when
only a small amount is used by a patient, it always results in an oyster-like taste in
the mouth and a strong garlicy breath odor. This makes normal controlled trial
testing under "blind" conditions virtually impossible, because the odor is a giveaway
as to who gets the drug and who doesn't.
The CHAIRMAN. Mr. Bennett, you personally have not seen evi-
dence of the efficacy of this drug in respect to arthritis.
Mr. BENNETT. No, sir, I have not. I have seen many times, as we
all did on "60 Minutes" last night, the testimony that individual
patients provide, which I do not discount.
The CHAIRMAN. Have you known of instances where it has been
applied to patients who have arthritis?
Mr. BENNETT. Not people I know personally, but second-hand I
have heard about it, yes.
The CHAIRMAN. You have never actually seen a patient who had
a complaint, pain, swelling, and the like, actually apply this sub-
stance and then see what effect it had?
Mr. BENNETT. No, sir, I have not.
The CHAIRMAN. You simply base your decision or your opinion
upon your presumption that the Food and Drug Administration
acted fairly and objectively in denying the approval of the drug.
Mr. BENNETT. Well, yes. I think I should qualify it a little bit by
saying this: We accept the opinions of the scientific community,
primarily the rheumatologists, the experts in the field. They serve
as our advisers; they are the people who deal mostly with arthritis
patients. They are the ones who conduct the key research.
They, incidentally, are the people that serve on the FDA's arthri-
tis advisory panel. And there are many more experts in addition to
those that serve on the panel and to those in this room, experts
whose opinions I think might not necessarily agree with everything
we have heard here today and that might be of value for the
committee to hear.
The CHAIRMAN. Did some of those people actually see the appli-
cation of the substance to pain and swelling and sprain, strain?
Mr. BENNETT. Yes. For example, I believe Dr. Baum has here on
my right.
The CHAIRMAN. Dr. Baum, he will be the next witness.
I have what appears to be Dr. Baum's statement, at the conclu-
sion of which he says it might be of some use as an analgesic agent
in a kind of arthritis called ankylosing spondylitis.
