What is GcMAF (Globulin component Macrophage Activating Factor)?
It’s a protein that is normally found in the blood of healthy people. It is an immunomodulatory protein, in that its activity affects the function of the immune system. The glycoprotein (a protein with sugar molecules attached) GcMAF results from sequential deglycosylation of the vitamin D-binding protein (the Gc protein), and the resulting protein is felt to be a macrophage activating factor (MAF). MAFs are a class of protein known as a lymphokine, and they regulate the expression of antigens on the surface of macrophages. One of their functions is to “activate” macrophages, which can under the proper circumstances attack cancer cells.
(From: GcMAF and the life and death of an autism quack – this article also includes much of the history of the claims for using GcMAF in autism as well as the conspiracy theories about the suicide of one of the main proponents of GcMAF for autism, Dr. Bradstreet)
No GcMAF treatments for anything have been approved by the FDA, making selling it for medicinal use illegal. It has not been demonstrated to be either safe or effective, although studies are ongoing to at least determine safety.
The U.S. Food and Drug Administration is clear: GcMAF is not a recognized treatment for autism.
“GcMAF treatments are considered investigational, and none are approved or licensed for use by the FDA in the U.S.,” the agency said in a statement sent to The Washington Post.
Nearly all doctors agree.
“Given there is no evidence that modulating the immune system would have any benefit for children with autism spectrum disorder – especially given ASD’s genetic or epigenetic basis – I am not sure why Dr.Bradstreet would want to use this for ASD,” Peter Jay Hotez, dean of Baylor’s National School of Tropical Medicine, told The Post in an e-mail.
It’s not even clear if GcMAF injections are safe. An initial “safety study” — the first of its kind — is still trying to recruit participants.
GcMAF is a product made from human blood
Because it is derived from human blood, it is subject to stringent regulations because it comes from human blood. The Medicine and Healthcare Products Regulatory Agency (MHRA) – the UK’s FDA counterpart – has issued a warning about the safety of GcMAF.
Investigators from MHRA carried out an unannounced inspection of a production site in Milton, Cambridgeshire, after the medicines regulator in Guernsey raised concerns in relation to the product. The blood plasma starting material being used to make this drug stated “Not to be administered to humans or used in any drug products”. It was concluded that the production site does not meet Good Manufacturing Practice (GMP) standards and there are concerns over the sterility of the medicine being produced and the equipment being used. There are concerns that the product may be contaminated.