MGN-3

Hi,

I was operated for a 1,8 cm ER positive breast cancer last march, my lymph nodes were not affected.  I have undergone chemotherapy and radiotherapy.  I am now on tamoxifen.  It was recommended that I take MGN-3 to eradicate leftover cancerous cells (if any).  I would like to ensure that cancer doesn't come back and I would like to have your thoughts on this alternative treatment.

Thank you.

[CCF-RN,MSN-rf]

Dear Wonderful:  We do not advocate any alternative treatment that has not been investigated in randomized clinical trials and published in peer-reviewed medical journals.  To date there is no evidence that these products have any impact on cancer or immunity in humans.  The attached is a document from the FDA regarding this product in particular.

FDA
TALK PAPER
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

T99-56 Print Media: 301-827-6242
December 10, 1999 Broadcast Media: 301-827-3434
                   Consumer Media: 888-INFOFDA

FDA TAKES ACTION AGAINST FIRM MARKETING UNAPPROVED DRUGS
The Food and Drug Administration today stepped up its efforts to protect the public against unproven claims for unapproved drugs by seeking a permanent injunction against the marketing of three unapproved drug products being illegally promoted as treatments for cancer and other diseases by a New Jersey corporation and its top officer.
The products, called BeneFin, SkinAnswer and MGN-3, are promoted and sold by Lane Labs-USA, Inc., in Allendale. In addition to Lane Labs-USA, Inc., the complaint names as defendant its President, Andrew J. Lane.

The government's complaint, filed by the United States Department of Justice in the United States District Court for the District of New Jersey, charges the individual defendant and his company with unlawfully promoting and marketing three products for the following diseases:

BeneFin, which is produced from shark cartilage, as a treatment for cancer and other diseases; SkinAnswer, a glycoalkaloid skin cream, as a treatment for skin cancer; and MGN-3, a rice-bran extract, as a treatment for cancer and HIV, the virus that causes AIDS.
BeneFin is being studied as a potential cancer therapy under an Investigational New Drug application reviewed by the FDA. As such, it can be distributed for use in clinical trials. Like the other two products, however, it may not be promoted and marketed until its safety and effectiveness are demonstrated, and FDA reviews and approves the sponsor's marketing application.
Today's action against the BeneFin brand of shark cartilage does not affect brands of shark cartilage that are not intended for use in the treatment of disease and that are otherwise lawfully marketed as dietary supplements.

FDA began warning the defendants about the illegal nature of their promotion in June, 1997. Nevertheless, the defendants have continued promoting BeneFin, SkinAnswer, and MGN-3 as remedies for cancer and other diseases through such means as books, articles, Internet web sites, and employee statements.

The government

[surgeon]

I copied the following from a website:
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 claims it is merely marketing it as a "dietary supplement." But I believe -- as does the FDA -- that statements the company is making 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. The suit's goal is to stop them from marketing MGN-3, shark cartilage, and another product with unsubstantiated claims of effectiveness against cancer and other diseases [10]. 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 [11]. 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.


Lane Labs sells 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. Whether it has any practical value remains to be seen. It is certainly not revolutionary or a magic bullet.


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.

[surgeon]

I copied the following from a website:
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 claims it is merely marketing it as a "dietary supplement." But I believe -- as does the FDA -- that statements the company is making 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. The suit's goal is to stop them from marketing MGN-3, shark cartilage, and another product with unsubstantiated claims of effectiveness against cancer and other diseases [10]. 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 [11]. 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.


Lane Labs sells 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. Whether it has any practical value remains to be seen. It is certainly not revolutionary or a magic bullet.


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.