86
For the Arthritis Foundation, I recommend this proposal for your consideration.
OBJECTION
I feel it necessary to state for the record strong objection to certain comments
made during the Committee's hearing on March 24. The professional integrity of
two rheumatologists by name and others by inference was attacked by Dr. Stanley
Jacob. This was permitted to go unchallenged and was even used as the basis for a
suggestion by a member of the Committee that the FDA should drop certain
individuals from its Arthritis Advisory Committee for bias.
Dr. Jacob himself is admittedly and demonstratively biased for DMSO, which
should make him the least qualified person to judge the bias of others who are not
in agreement with him on the subject. As the record should show, he identified Dr.
John R. Ward and Dr. Evelyn V. Hess as being totally "against" DMSO, and
therefore unqualified to serve on the FDA's advisory committee or otherwise evalu-
ate the drug. By extension, it was implied that other members of the committee who
may have "voted" against approval of DMSO for scleroderma were also guilty of
bias that should disqualify them from serving on the committee.
This comes through to me as saying, in effect, that being "for" DMSO is being a
Good Guy, whereas voting against it in the jury room is criminal.
No one challenged or contradicted these accusations by Dr. Jacob. Does the
Committee not believe it possible for scientists of repute to put aside whatever their
personal experiences might have been with a drug and to evaluate evidence placed
before them without prejudice, and pass fair judgement? I am not aware of a shred
of evidence showing that the FDA advisors acted on any basis other than their best
scientific judgment.
The atmosphere in the hearing room was that FDA advisors and staff were
convicted of bias simply because other people did not agree with their judgment. I
submit that many of these people were not and are not in possession of the factual
scientific evidence on which the judgment was based.
Dr. John R. Ward for a number of years has been director of a national "cooperat-
ing clinics" program in which a variety of drugs and other remedies for arthritis
have been submitted to controlled trials at a consortium of centers, with the
information collected in a central data bank. For many years this has been the
largest single testing mechanism for arthritis remedies. The project has been sup-
ported on an ongoing basis by the federal government, and is conducted completely
independent of the pharmaceutical industry.
The position of director is one of considerable prestige and Dr. Ward has to be one
of the most knowledgeable people in the country about what it takes to prove or
disprove the scientific merits of an arthritis drug. He is a scientist in the truest
sense, for all that implies about objectivity. If he is, as Dr. Jacob stated, "against"
DMSO, it is on the basis of some scientific knowledge he has rather than because of
some personal prejudice. Dr. Jacob's accusations and inferences were supported and
uncalled for.
The same is true of his comments concerning Dr. Hess. The Arthritis Foundation
knows Dr. Hess also to be a totally reputable scientist whose very training, like that
of all scientists, included conscious drilling in the elimination of bias of all kinds in
the consideration of scientific evidence. She is a highly respected teacher, and
researcher in rheumatology, and a clinician with serious concern for the welfare of
her own patients with arthritis.
I believe that the Select Committee on Aging owes these two individuals an
apology for permitting the attacks on their integrity to go on the record without
challenge; and I appreciate this opportunity to come to their defense.
[News Release]
ARTHRITIS FOUNDATION,
Atlanta, Ga., March 30, 1980.
FOUNDATION SEEKS APPROVAL FOR CONTROVERSIAL ARTHRITIS DRUG
[NOTE: STATEMENT ATTACHED]
ATLANTA, March 30.-While debunking "wonder drug" claims for a controversial
arthritis remedy, the Arthritis Foundation has for the first time endorsed it, for
limited use as a pain-reliever.
Text of a proposal for achieving approval of DMSO (dimethyl sulfoxide) by the
FDA was released here today by the Foundation. It was addressed to a committee of
Congress which held hearings on the drug in Washington last Monday (March 24).
