Quackwatch Home Page ||| Special Message for Cancer Patients
MGN-3 Immune Enhancing Complex is an extract of arabinoxylan from rice bran that has been enzymatically modified to increase its immunomodulatory function [1]. Its manufacturer, Lane Labs-USA, of Allendale, New Jersey, has stated that MGN-3 is "revolutionary," "could be the magic bullet!" and is "the only natural immune complex proven to triple Natural Killer (NK) cell protection." [2] The product was developed by Mamdooh H. Ghoneum, Ph.D., an immunologist at Charles Drew University of Medicine and Science, Los Angeles, who does cancer immunology research and has been studying rice ban's effects for several years [3]. Ghoneum patented the production process in 1996 [4]. In an interview published on the company's Web site, he claimed that "MGN-3 will boost natural killer cell activity to destroy any remaining abnormal cells after surgery or adjuvant treatments." and "with the exception of very terminal cases, all of the other patients have shown dramatic results." [5]
Ghoneum has reported that administering arabinoxylan to mice and to cancer patients has led to increases in natural killer (NK) cells, a type of white blood cell that can destroy certain types of cancer cells in the laboratory [6-9]. He has also reported that some patients who took MGN-3 after receiving standard treatment showed increased NK activity, remained cancer-free, or lived longer than their doctors predicted [1,3]. However, these studies did not examine whether patients who receive MGN-3 would do better than similar patients who do not.
The key question in evaluating a proposed anti-cancer product is not whether it affects blood levels of various cells but whether it can influence tumor growth and survival time. Only well-designed clinical trials can determine that -- and no such study has been published. Arabinoxylan is a complex sugar (polysaccharide). It has been known for many years that various large polysaccharide molecules can stimulate immune responses in mice. However, it has not been demonstrated that NK cells destroy cancer cells in humans.
Without clear-cut evidence of human benefit, it is illegal to market MGN-3 as an anti-cancer product. Under federal law, products intended for the prevention, mitigation , or treatment of disease are considered drugs, and drugs cannot be legally marketed without FDA approval. Lane Labs claimed it was merely marketing it as a "dietary supplement." But I believe -- as does the FDA -- that statements the company made constitute drug claims as defined by federal law.
In December 1999, a lawsuit initiated by the FDA was filed against Lane Labs and its president, Andrew J. Lane. An FDA Talk Paper announcing the suit stated that, despite warnings that began in 1997, Lane and his company had continued to promote the products as remedies for cancer and other diseases through books, articles, Internet web sites, and employee statements [10]. The FDA's September 1997 warning letter had stated that based on claims and their intended uses, the three products were unapproved drugs and misbranded [11]. Lane sold MGN-3 for $53.96 per bottle of 50, which would make the cost about $13 per day for the first two weeks and about $4 per day after that.
In March 2001, the Mississippi Attorney General issued a cease-and-desist order to stop Dallas Dupre, of Picayune, Mississippi, from distributing MGN-3 with claims that it could cure cancer in any part of the body. According to a local newspaper report, Dupre had distributed flyers claiming that "If your immune systeme weaken and you get cancer the first thing to do . . . is to beef up your immue system. Forunately, MGN-3 does that more powerfully than any substance known to man and it acts within hours turning hard tumors into harmless jelly like blob and shrinking them . . . . It costs lest than $3,000 to cure breast cancer and no side effect." [12]
In July 2004, a New Jersey Federal Court Judge ordered Lane Labs and Andrew Lane to stop selling products containing MGN3, shark cartilage and SkinAnswer (a skin cream, claimed to be effective against skin cancer. The judge ordered all inventory of these products destroyed except for a quantity of shark cartilage that may be needed to for research purposes. The court order permanently enjoins the company from selling any unapproved new drugs and orders it make restitution to any one who purchased the products since Sept. 22, 1999. The judge noted that Lane Labs used Ghoneum's writings for marketing pruposes and thad agreed to pay him a 9.5% royalty plus an 8.5% research allocation on all MGN-3 purchases that the company made from its Japanese distributor [13].
It remains to be seen whether MGN3 has any practical value. It is certainly not revolutionary or a magic bullet.