IA #57-04 - 2/6/04, IMPORT ALERT #57-04 "DETENTION WITH PHYSICAL
EXAMINATION OF IMMUNO-AUGMENTATIVE THERAPY (IAT)"
This alert is being revised to remove all reference regarding the drug UKRAIN.
This unapproved anticancer drug is being placed on IA66-41.
TYPE OF ALERT : *DETENTION WITHOUT PHYSICAL EXAMINATION*
*(Note: This import alert represents the agency's current
guidance to FDA field personnel regarding the manufacturer or
product at issue. It does not create or confer any rights
for or on any individual and does not operate to bind FDA or
the public.)*
PRODUCT : Immuno-Augmentative Therapy Drugs
PRODUCT CODE(s): *All Human Drug/Biologics Codes*
PROBLEM : Health Fraud, Misbranding
PAC : 63001
COUNTRY : Bahamas, Germany, etc., (as identified)
MANUFACTURER/
SHIPPER : Dr. Lawrence Burton's Immunology Research Centers
CHARGE : The article is subject to refusal of admission pursuant
to Section 801(a)(3) in that it appears to lack adequate
directions for use, and appears to be misbranded under
section 502(f)(1) of the FD&C Act.
RECOMMENDING
OFFICE : *HFD-316, Office of Compliance - Center for Drug
Evaluation and Research.
REASON FOR ALERT: "Immuno-Augmentative Therapy," (I.A.T.), is a method of
cancer management proposed by Lawrence Burton, Ph.D, and
available at the Immunology Researching Center, Ltd.,
Freeport, Grand Bahama Island, Bahamas, which opened in
1977.
In December 1974, the Immunology Research Foundation,
Inc. submitted an Investigational New Drug application
(IND) to the U.S. Food and Drug Administration (FDA)
seeking to initiate human investigational trials with
I.A.T. agents. The IND application was placed in a FDA
"inactive file" in March, 1976. Following investigation
of the Freeport Clinic in 1978, the National Cancer
Institute reported that records were inadequate to
evaluate I.A.T.
There have been legislative efforts at both the state
and federal levels, to legalize the use of I.A.T. In
1980, a federal bill failed which was intended to exempt
for five years the "blood fractions" used in I.A.T. from
the requirements of the Federal Food, Drug, and Cosmetic
Act. Similar lobbying efforts are currently being
sponsored today by the I.A.T. Patients Association.
Laws were enacted in the states of Florida and Oklahoma
that would have the effect of making I.A.T. agents
available in those states. The Florida law was
subsequently repealed.
Oklahoma requires informed consent advising that the
efficacy of I.A.T. is unproven.
The American Cancer Society has stated that it has found
no scientific evidence supporting the claims that I.A.T.
can prevent, detect, or predict the occurrence of cancer
and none was found indicating I.A.T. is safe or
effective for any or all types of cancer.
Dr. Burton has also been reported to use I.A.T. in the
treatment of AIDS patients.
Dr. Burton claims that I.A.T. bolsters the deficient
immune mechanism present in cancer victims with specific
immune human serum fractions. He claims to determine
the titer of "blocking protein," "tumor antibody,"
"tumor complement" and "deblocking protein" and then
administers one or a combination of the "immune
substance" (except "blocking protein").
In 1984, CDC reported 16 cases of injection site abscess
formation experienced by patients of the clinic. One
vial of each of the human serum protein injections, four
in all, were examined for sterility by CDC. All were
found non-sterile. Contaminants included species of
Staphylococcus, Bacillus, Acinetobacter, and
Moraxella-like organisms. In 1985, Washington State
laboratories tested eighteen vials of I.A.T. and
reported that eight were positive for the HTLV-III
antibody and all eighteen for the hepatitis B surface
antigen (HBsAG). Confirmation samples tested by CDC
demonstrated six of eighteen positive for HTLV-III and
all eighteen positive for HBsAG. The presence of the
HTLV-III antibody may indicate presence of the AIDS
retrovirus. Over half of the 72 vials examined by NCI
thus far have revealed these antibodies.
In July 1985, representatives of the Bahamas Ministry of
Health, CDC, and the Pan-American Health Organization
visited the clinic and determined that it constituted a
public health hazard. The Ministry of Health ordered
the clinic closed in July 1985; however, it subsequently
reopened. We are not aware that any corrective actions
were taken to preclude further direct hazards associated
with contaminated I.A.T. agents.
A sample of Dr. Burton's Immuno-Augmentative Therapy
frozen in a block of ice contained in a cooler was
offered to FDA in Boston district during the summer of
1987. Boston district analyzed and found the product
non-sterile. Biologics analyzed the AIDS and HG2 AB
virus and found both negative. This is the only sample
of IAT that we have been able to collect since Dr.
Burton reopened.
*GUIDANCE :* Due to the direct hazards that have been associated with
I.A.T. agents, all entries, whether in personal
possession or mail, should be detained. Alert your
local U.S. Customs and Postal Service officials
informing them of the hazards involved with these
products and the importance that extra efforts be made
to cover mail imports and personal possessions of
persons coming from the countries.
Dr. Burton's drugs have been identified as follows: 5 ml
white opaque "flip top" plastic vials labeled I, II, III
or, alpha 2. The name of the clinic or other
identifiers are generally absent. As the agents require
refrigeration, they may be smuggled in thermos bottles
or similar insulated containers.
*For questions or issues concerning science, science
policy, sample collection, analysis, preparation, or
analytical methodology, contact the Division of Field
Science at (301) 443-3320 or 3007.*
Center contact: Ada Irizarry, HFD-316
ORO contact: DIOP HFC-170, (301) 594-3872.
*KEY WORDS : Immuno-Augmentative, Dr. Lawrence Burton
FOI : No purging required.
*REVISED BY : Dave Krawetz, DIOP, HFC-170, (301) 594-3872
*DATED LOADED
INTO FIARS :* February 6, 2004
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