June 3, 1959

Mr. J. R. Albi

Cascade Laundry and Dry Cleaners
1847 Market

Denver 2, Colorado

Dear Mr. Albi:

Please forgive my delay in replying to your
letter of May 11 which was held here in Washington
pending my return from the World Health Conference
in Geneva. I was most pleased to have your views
concerning the testing of Krebiozen as a treatment for
cancer, and in reply, I am glad toprovide you with in-
formation on the subject which has been made available
to me by the National Cancer Institute of the Public
Health Service.

It is my understanding that the National Cancer
Institute has not heretofore participated in any test-
ing of Krebiozen and has no direct knowledge of its
possible usefulness in the treatment of cancer. As you
may be aware from your reading, two medical groups who
examined clinical data on the use of the agent have pub-
lished their findings in the scientific literature. One
group you referred to in your letter, namely, a subcom-
mittee of the Committee on Research, Council on Pharmacy
and Chemistry of the American Medical Association; a
second group was the Committee on Cancer Diagnosis and
Therapy of the National Research Council. Neither group
found evidence from the data examined that Krebiozen was
an effective treatment for cancer.

As you may be aware, Senator Douglas, in a speech
on the Senate floor on August 22, 1958, requested that the
Mr. J. R. Albi -2-

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 its use in treating cancer, merit further
evaluation of the therapy, and 2) the procedure for carry-
ing out sitch an evaluation.

The general plan of procedure was discussed at
a meeting on September 24 attended by Dr. Ivy, Dr. Steven
Durovic of the Krebiozen Research Foundation, Mr. Frank
McCulloch of Senator Douglas’ staff, Dr. J. R. Heller,
Director of the National Cancer Institute and other members
of the Institute's staff. At the conclusion of this meeting
the following statement was issued: “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." It is believed
that acceptance by the scientificcmmunity is necessary
since it is only from this group that it is possible to
find research scientists who have the training, knowledge
and skills necessary for making a valid evaluation as to
whether an agent is or is not a worthwhile addition to the
group of agents already available for providing benefit to
cancer patients. I am enclosing for your information three
articles which tell of the extensive activities under way
in the search for effective anti-cancer agents. You will
note that a number of agents are helpful in prolonging
comfortable life in some types of cancer, and it AES be
of interest to you to know that some 80 compound ve
shown anti-tumor activity in experimental animals are now
_ being evaluated in clinical studies in several instituti ons
throughout the country. Cancer has been completely eliminated
in experimental animals through the use of drugs alone, and
extensive efforts by research scientists and physicians are
under way in an attempt to find the correct method of doing
the same for patients. Thus we have a considerable number
of outstanding scientists in this country who are highly
skilled in evaluating agents for their value in the manage-
ment of cancer patients, and the procedures for this evaluation
are well worked out.
Mr. J. R. Albi “j3-

The National Cancer Institute at theSeptember 24
meeting suggested that a committee of scientists experienced
in evaluation of the management of cancer patients and ac-
ceptable both to Dr. Ivy and the Institute be constituted
to decide whether clinical trials should be undertaken and
how they should be conducted. Discussion on this proposal
was continued at a meeting on December 5. This conference
was attended by the Senator, Drs. Ivy and Durovic, Mr.
McCulloch, Dr. Hellerand members of the Institute's staff.
Senator Douglas expressed the opinion that the Institute's
alternative proposal to his original test procedure was a
proper one, and encouraged Dr. Ivy to proceed with it. Dr.
Ivy was invited to define his role as consultant to the
evaluating committee to which he had agreed, but preferred
to do this later in writing.

In a letter to the Institute dated February 1, 1959,
Dr. Ivy reverted essentially to his original proposal that
he personally should be a member of “an arbitration type
of committee” and HA"party to the administration of the
therapy and the interpretation of the results under con-
ditions where bias cannot operate." This isa procedure
which, as pointed out in two conferences attended by Dr.
Ivy, could admit bias and would not be acceptable to the
scientific community.

The Institute responded to Dr. Ivy’s letter on
February 6 by asking him to clarify his apparent rejection
of the previous plan made between him and the National
Cancer Institute, but in reply he reiterated the state-
ments made in his letter of February 1. It is the desire
of the Institute to get on with the evaluation of Krebiozen
as soon as a scientifically acceptable procedure can be
effectuated, and efforts to resolve this matter are being
continued. —

With regard to the statement in Dr. Shannon's
testimony which you quoted, I am sure that by putting
the issue “at rest" he meant that the Krebiozen question
should be settled through a scientifically acceptable
evaluation procedure and that he was not prejudging the
outcome of such an evaluation.
Mr. J. R. Albi -~ 4-

I trust that this information will be helpful
to your understanding of the responsibility of the

Public Health Service in approaching the evaluation
of Krebiozen.

Kindest regards,

Sincerely,

John E. Fogarty
Member of Congress