Import Alert 66-75

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 66-75
Published Date: 04/23/2019
Type: DWPE

Import Alert Name:

DETENTION WITHOUT PHYSICAL EXAMINATION OF IMMUNO-AUGMENTATIVE THERAPY (IAT)

Reason for Alert:

The issuance of this Import Alert replaces Import Alert #57-04, reflecting a transfer of the products from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). The import alert number and legal charges have been updated.

"Immune Augmentation Therapy," "Immuno-Augmentative Therapy," or "IAT," is an alternative method of cancer management developed by zoologist, Lawrence Burton, Ph.D. IAT is used at the Immunology Researching Center, Ltd., located in Freeport, Grand Bahama Island, Bahamas. The Center was opened by Dr. Burton in 1977. Dr. Burton passed away in 1993, but the clinic, now known as the Immune Augmentative Therapy Centre or Immune Augmentative Therapy Clinic, remains in operation headed by Medical Director, John Clement, M.D.

The Immune Augmentative Therapy Centres website includes several statements regarding the Centres use of IAT. For example:

--"Thus, our prime objective at the IAT Clinic is to strengthen the immune system to kill cancer cells."

--"Immuno Augmentive Therapy. Each cancer treatment plan is customized to the person with cancer. In addition to immune therapy, such as cancer vaccine, we provide angiogenesis inhibition (blocking new blood vessels that feed tumor), apoptosis inducing agents (to help tumor cells to commit suicide), and cytotoxic agents that kill tumor cells while not destroying normal cells."

--"The objective of IAT is to restore the cancer patients immune competency to a level by which it can control cancer."

--"Joan was diagnosed in April, 1979, after her salivary gland was excised...Her prognosis was 'terminal' by a well known head & neck surgeon in NYC. ..she began the IAT treatment in September of 1979...Now 32 years later, she continues to be cancer free, thanks to the Immuno Augmentative Therapy."

-- "In March 2000 I was diagnosed with mesothelioma and given a few months to live. A week later my husband brought me from England, traveling in a wheelchair, to the Cancer Clinic in the Bahamas. Within a few weeks of treatment I was much stronger, swimming in the sea and going for long walks on the beach. I have remained completely fit and healthy since then. My last 3 annual CT scans showed no growth of the cancer-hooray!"

--"In July of 1992, Sharon was diagnosed with large cell lung cancer...Her parents had been going to Grand Bahama Island for some years. They advised her to go to the clinic and find out about the cancer treatment...On February 7, 1993, Sharon began the IAT treatment. Six months after starting IAT, the tumor disappeared and has stayed away."

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 IAT agents. FDA responded with questions about the research, which, despite several exchanges of correspondence, were not fully answered. The IND application was withdrawn in 1976.

Following a review of patients┐ records at the Freeport Clinic in 1978, representatives of the Pan American Health Organization (PAHO), Bahamas Ministry of Health, and National Cancer Institute (NCI) found no objective evidence that IAT was effective in treating cancer and recommended that the clinic be closed. However, the clinic remained open. In 1984, NCI analyzed IAT treatment materials obtained from a deceased patient and found the products contained only dilute blood proteins, primarily albumin. There was no biologic distinction between the various fractions, which were not present in sufficient amounts to affect the purported immunologic activity.

There have been legislative efforts at both the state and federal levels to legalize the use of IAT. In 1980, 1981, and 1983, federal bills intended to exempt for five years the "blood fractions" used in IAT from the definition of drug under the Federal Food, Drug, and Cosmetic Act were introduced but not enacted. Laws were enacted in Florida and Oklahoma intended to allow the availability of IAT agents in those states. However, the Florida law was repealed in 1984 followed by the Oklahoma law in 1985.

In 1984, the Centers for Disease Control and Prevention (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, county laboratories in Washington state tested eighteen vials of IAT and reported that eight were either repeatably reactive or borderline positive for the HTLV-III (now known as the human immunodeficiency virus [HIV]) antibody and all eighteen were weakly positive for the hepatitis B surface antigen (HBsAG). Confirmation samples tested by CDC demonstrated six of eighteen positive for HTLV-III and thirteen positive for HBsAG.
In July, 1985, representatives of the Bahamas Ministry of Health, CDC, and PAHO visited the clinic and determined that it constituted a public health hazard. The Ministry of Health ordered the clinic closed. It reopened in March 1986 with assurance from the Ministry of Health that conditions had been set down that were designed to eliminate the health hazards to clinic clients and staff. However, no information is available about the specific quality controls put into place to preclude further direct hazards associated with contaminated IAT agents.

The American Cancer Society has stated that available scientific evidence does not support claims that IAT is effective in treating people with cancer. Note: Charge statement revised on 04/23/2019.

Guidance:

Districts may detain, without physical sampling and analysis, shipments of Immuno Augmentive Therapy products.

Districts should alert their local U.S. Customs and Border Protection and U.S. Postal Service officials informing them of the hazards involved with these products, and request notification to FDA of mail/personal importations of such products coming from the Bahamas.

IAT drugs from the manufacturers/shippers listed above have been packaged as 5 ml white opaque "flip top" plastic vials labeled I, II, III or, alpha 2 or as glass ampules. They have been identified in the OASIS product description field as dendritic vaccines, heat shock protein vaccines, vaccines for the immune system, immkine supplements, serums, and lab reagents. They may be shipped with dietary supplements. As the agents require refrigeration, they may be smuggled in thermos bottles or similar insulated containers.

CENTER CONTACT:
CDER Office of Compliance; Office of Drug Security, Integrity and Recalls; CDERIMPORTSEXPORTS@fda.hhs.gov


RECOMMENDING
OFFICE:
HFD-310, Center for Drug Evaluation and Research (CDER) Office of Compliance; Office of Drug Security, Integrity and Recalls.

Product Description:

Immuno-Augmentative Therapy Drugs

Charge:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA) [Unapproved new drug, Section 505(a)].

OASIS charge code - UNAPPROVED

And

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.
OASIS charge code - DIRECTIONS

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


BAHAMAS


Immunology Research Centre
Date Published : 06/26/2012
1 East Atlantic Drive , Freeport, FN BAHAMAS
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 06/26/2012

Notes: Immuno-Augmentative Therapy Drugs; NOTE: Immunology Research Centre may be dba Bahamas Immuno-Augmentative Therapy Centre, IAT Clinic, Immune Augmentative Therapy Centre, Immune Augmentation Therapy Clinic, Immuno- Augmentative Clinic, or Lawrence Burton Immunology Research Center, Ltd.

60 - - - -- Human and Animal Drugs
Date Published: 06/26/2012

Notes: Immuno-Augmentative Therapy Drugs; NOTE: Immunology Research Centre may be dba Bahamas Immuno-Augmentative Therapy Centre, IAT Clinic, Immune Augmentative Therapy Centre, Immune Augmentation Therapy Clinic, Immuno- Augmentative Clinic, or Lawrence Burton Immunology Research Center, Ltd.

61 - - - -- Human and Animal Drugs
Date Published: 06/26/2012

Notes: Immuno-Augmentative Therapy Drugs; NOTE: Immunology Research Centre may be dba Bahamas Immuno-Augmentative Therapy Centre, IAT Clinic, Immune Augmentative Therapy Centre, Immune Augmentation Therapy Clinic, Immuno- Augmentative Clinic, or Lawrence Burton Immunology Research Center, Ltd.

62 - - - -- Human and Animal Drugs
Date Published: 06/26/2012

Notes: Immuno-Augmentative Therapy Drugs; NOTE: Immunology Research Centre may be dba Bahamas Immuno-Augmentative Therapy Centre, IAT Clinic, Immune Augmentative Therapy Centre, Immune Augmentation Therapy Clinic, Immuno- Augmentative Clinic, or Lawrence Burton Immunology Research Center, Ltd.

63 - - - -- Human and Animal Drugs
Date Published: 06/26/2012

Notes: Immuno-Augmentative Therapy Drugs; NOTE: Immunology Research Centre may be dba Bahamas Immuno-Augmentative Therapy Centre, IAT Clinic, Immune Augmentative Therapy Centre, Immune Augmentation Therapy Clinic, Immuno- Augmentative Clinic, or Lawrence Burton Immunology Research Center, Ltd.

64 - - - -- Human and Animal Drugs
Date Published: 06/26/2012

Notes: Immuno-Augmentative Therapy Drugs; NOTE: Immunology Research Centre may be dba Bahamas Immuno-Augmentative Therapy Centre, IAT Clinic, Immune Augmentative Therapy Centre, Immune Augmentation Therapy Clinic, Immuno- Augmentative Clinic, or Lawrence Burton Immunology Research Center, Ltd.

65 - - - -- Human and Animal Drugs
Date Published: 06/26/2012

Notes: Immuno-Augmentative Therapy Drugs; NOTE: Immunology Research Centre may be dba Bahamas Immuno-Augmentative Therapy Centre, IAT Clinic, Immune Augmentative Therapy Centre, Immune Augmentation Therapy Clinic, Immuno- Augmentative Clinic, or Lawrence Burton Immunology Research Center, Ltd.

66 - - - -- Human and Animal Drugs
Date Published: 06/26/2012

Notes: Immuno-Augmentative Therapy Drugs; NOTE: Immunology Research Centre may be dba Bahamas Immuno-Augmentative Therapy Centre, IAT Clinic, Immune Augmentative Therapy Centre, Immune Augmentation Therapy Clinic, Immuno- Augmentative Clinic, or Lawrence Burton Immunology Research Center, Ltd.