» ow” DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

  

 

PUBLIC HEALTH SERVICE e BETHESDA 14, MD.

NATIONAL INSTITUTES OF HEALTH

JAN 1 4 1959

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Dear Mr. Fogarty:

This is in reply to your letter of December 30 forwarding
a copy of a letter from John M. Davis, Committee for a Fair
Test of Krebiozen, Incorporated, and requesting my comments.

We are aware of the activities of Mr. Davis' committee,
and his letter presents the arguments which have been freely
circulated and publicized by the proponents of Krebiozen,
particularly during the past few months, I should like to
summarize for you the principal developments in this matter
since the first public announcement of Krebiozen was made by
Dr. Andrew C, Ivy in 1951.

The National Cancer Institute has not participated in any
testing of Krebiozen and therefore has no direct knowledge of
its possible usefulness in treating cancer. Two disinterested
studies of clinical data on the agent have been published.
Studies of 100 case histories of cancer patients treated with
Krebiozen, from seven sources in four widely separated regions
of the country, were reported in the Journal of the American
Medical Association on October 27, 1951, by a subcommittee of
the Committee on Research, Council on Pharmacy and Chemistry,
of the American Medical Association. The subcommittee con-
cluded that the patients failed to show objective evidence of
improvement. The Committee on Cancer Diagnosis and Therapy
of the National Research Council reached a similar conclusion
on the basis of 63 case summaries received from six investi-
gators or groups who had evaluated Krebiozen and also on the
basis of data in the American Medical Association report.

This committee reported in the November 2h, 1951 issue of the
Journal of the American Medical Association that no evidence
had been found of any curative effect of Krebiozen nor any
proof of palliative effect attributable to the agent itself.

As you are no doubt aware, Senator Douglas, in a speech
on the Senate floor on August 22, 1958, requested that the
Public Health Service investigate the possible anti-tumor
properties of Krebiozen as a treatment for human cancer,

The National Cancer Institute has responded by participating
in conferences and communications with the interested parties,
These have been for the purpose of establishing 1) whether
available information about the agent itself, and data on

National Cancer Institute National Heart Institute National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Metabolic Diseases
National Institute of Dental Research National Institute of Mental Health National Institute of Neurological Diseases and Blindness The Clinical Conter
Division of Biologics Standards Division of Business Operations ' Division of Research Grants Division of Research Services
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its use in treating cancer merit further evaluation of the
therapy, and 2) the procedure for carrying out such an evaluation.

The first step taken by the Institute after Senator Douglas
made his request was to ask Dr. Ivy, medical consultant to the
Krebiozen Research Foundation of Chicago, to supply information
about the nature of the substance and its use in treating cancer.
This was done by Dr. Ivy. The Institute then undertook to select
a panel of medical scientists mutually acceptable to the Institute
and Dr. Ivy, to study this information and advise whether further
evaluation of the treatment should be made and how it should proceed.

It has been agreed by all parties involved in these preliminary
discussions that if further evaluation is undertaken, it should be
done in a scientifically acceptable manner. This agreement was
reached at a meeting on September 2l attended by Dr. Ivy and
Dr. Stevan Durovic of the Krebiozen Foundation, Mr. Frank McCulloch
of Senator Douglas's staff, myself and other members of the National
Cancer Institute staff. The following statement was made public at
the conclusion of the meeting: "It is generally agreed that the
evaluation of Krebiozen should be explored further and we are
seeking to develop an agreed procedure that will be acceptable to
the scientific community."

Dr. Ivy and the Krebiozen Foundation have not been willing
to accept the findings of the American Medical Association and the
National Research Council groups. Agreements by Dr. Ivy and the
Institute have now been reached on the composition of an evaluating
panel which will be unbiased. Dr. Ivy at a meeting with Senator
Douglas and representatives of the National Cancer Institute on
December 5, expressed his desire to spell out in writing his under-
standing of his role in relation to the evaluating panel. Neither
Senator Douglas nor the National Cancer Institute has heard from
Dr. Ivy since the December 5 meeting.

It should be pointed out that many cancer patients can receive
some benefit from chemical agents already available and that several
new ones are currently in clinical trials on the basis of promise as
determined by a group of outstanding consulting experts skilled in
evaluation of treatments for cancer. It is necessary, therefore,
that the scientific evidence indicate the likelihood of a new
material showing benefit to cancer patients which is at least equal
to that already available; otherwise, there is no valid reason for
denying to cancer subjects the use of current agents, for reising
the hopes and expectations of these unfortunate victims only to have
them fall at a later date, or for pre-empting the services of those
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few highly skilled investigators who can critically evaluate

by objective criteria the result of cancer therapy. The manner

in which these evaluations are to be made must ensure that objective
criteria of benefit to the patient are the basis of determination,
for it has been shown repeatedly in medical research that subjective
improvement is not a valid criterion for evaluation of a therapeutic
agent.

Several books and a number of articles have been published
on the subject of Krebiozen since the first announcement about
the product by the sponsors. A selected bibliography is enclosed,
and if you would like to have additional copies we shall be glad
to provide them.

I am very glad to supply this information and trust that
it will meet your needs.

Sincerely yours,

 

Té =

J, R, Heller, M. D.
ed Director
National Cancer Institute

Hon. John E. Fogarty
House of Representatives
Washington 25, D.C.

Enclosure