rodgergrummidge
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Below is a summary of some of the issues regarding the clinical evidence behind GcMAF treatment. I am tagging a few people @Mij @xandolf @Nico @Symptomatic @BossmanPL @Ali @inester7 @lemonsnlyme @BenFromNZ @Olena @Vox @fullofbeans @Jesse2233 that might find discussion of the potential risks and dangers of GcMAF injections in the treatment of CFS.
GcMAF: what is it and how does it work? Macrophages are white cells that patrol the blood stream for foreign pathogens such as bacteria and fungi. Gc protein-derived macrophage activating factor (GcMAF) is a naturally occurring sugar-coated protein (glycoprotein) that stimulates macrophages to find, engage and destroy foreign pathogens. The claims are that GcMAF could be used as an immunotherapy to spur macrophages into action and destroy cancer cells or virus-infected cells. It is also claimed that it is perfectly safe as it is a natural substance found in our bodies. So, does it work?
GcMAF therapies in humans: A number of publications have reported that GcMAF has remarkable curative activities in a range of conditions including cancer and viral infections. The hype around GcMAF arose in 2008 from a series of studies by lead author, Yamamoto, examining prostate (Transl Oncol 1:65–72), colorectal (Cancer Immunol Immunother 57:1007–1016) and breast (Int J Cancer 122:461–467) cancer. These publications reported quite spectacular anti-tumor responses in patients treated with GcMAF. For example, the authors claimed remarkable cures in human clinical trials where “weekly administrations of 100 ng GcMAF to metastatic adenocarcinoma (breast and prostate cancer) patients (n=32) and metastatic colorectal cancer patients eradicate tumors in 16–25 weeks and 32–50 weeks, respectively”.( Journal of Medical Virology 81:16–26 (2009) Later in 2009, an additional paper from the same investigators claimed that GcMAF could be used as an immunotherapy to cure HIV patients.( J Med Virol. 2009 Jan;81(1):16-26)
These findings suggested a major breakthrough in cancer and viral biology. But, could GcMAF really cure cancers, HIV, perhaps even CFS?
Unfortunately no.
In 2014, the validity of several Yamamoto papers where patients were injected with GcMAF in clinical trials were questioned in a publication authored by Ugarte, Bouche and Meheus. In their review, Ugarte, Bouche and Meheus identified serious concerns not only in the claims that GcMAF has clinical activity, but also in the safety of the drug ( Cancer Immunol Immunother (2014) 63:1347–1348). Their assessment focussed on 3 publications by the Yamamoto labs where GcMAF was examined in colon, prostate and breast cancer patients. (Cancer Immunol Immunother 57:1007–1016 ; Transl Oncol 1:65–72 ; Int J Cancer 122:461–467). Concerns were detailed including i) how the research was conducted, ii) the interpretation of results and the iii) ethics of conducting human trials with GcMAF.
Are the issues identified by Ugarte, Bouche and Meheus really that bad? The concerns and oversights in the data supporting the use of GcMADF identified by Ugarte, Bouche and Meheus are not minor and have important ramifications for anyone contemplating using GcMAF. They state that the claims that GcMAF is safe is “wrong and dangerous”. Furthermore, there are no other published studies that clearly demonstrate the safety or toxicity of GcMAF in humans. The deficiencies were so significant that they led to the retraction of 2 papers reporting that 1) GcMAF could cure HIV patients with no evidence of toxicity (J Med Virol. 2009 Jan;81(1):16-26) and 2) GcMAF could cure colorectal cancers (Cancer Immunology, Immunotherapy July 2008, Volume 57, Issue 7, pp 1007–1016).
GcMAF following the Yamamoto retractions: More recently, a number of reports that GcMAF can be used to treat a range of disorders including multiple sclerosis, thyroid cancer and breast cancer (ANTICANCER RESEARCH 36: 3771-3774 (2016)(ANTICANCER RESEARCH 36: 3767-3770 (2016)(J Cancer Res Ther. 2015 Oct-Dec;11(4):1041)(ANTICANCER RESEARCH 34: 4589-4594 (2014). However, data in these papers supporting the therapeutic activity of GcMAF is extremely limited and not clinically convincing. For example, in a report where GcMAF was given to an MS patient, the findings were reported as a series of photographs of the patient performing various tasks. No clinical measurements of any specific MS symptom or biomarker nor were any biochemical blood analysis performed. Potential toxicities or adverse reactions were not specifically assessed. (ANTICANCER RESEARCH 36: 3771-3774 (2016)
Other groups have treated larger cohorts of cancer patients (n=20) with GcMAF, however, like the studies of Yamamoto, standard measurements of tumor growth and regression were not made and so the actual anti-tumor activity of GcMAF cannot be determined. Unfortunately, unscrupulous practitioners and internet gurus have used the questionable findings of the Yamamoto labs and other labs to spruik GcMAF for the treatment of a range of conditions including viral infections, MS and CFS. Now, there are many internet sites selling and promoting GcMAF injections as a miracle cure for a whole range of ailments.
“So what? I don’t care about the science. Some practitioners are really positive about the potential of GcMAF for CFS. I’ve tried everything and nothing has worked so far. I’m desperate and will try anything. And its natural!! What could be the harm?” I know the feeling. But it is precisely this desperation that is preyed upon by the unscrupulous. GcMAF is expensive, but even with no published evidence that it works in CFS, it is a lucrative cash-pot for those selling it. Don’t be mis-led, there are considerable dangers in self-medicating by injection of human proteins. The argument that GcMAF is safe because its natural, ignores what has been long understood regarding the potential clinical toxicities and adverse reactions that can occur when ‘natural’ human proteins are injected as therapeutics. Without careful and rigorous testing in human trials injecting human proteins can be dangerous, perhaps even lethal (eg. check out the well documented toxicities that have occurred with specific preparations of insulin, growth hormome and epinephrine). Clinical practitioners with good training will be aware of these significant risks. They should also be able to assess the lack of high quality clinical data supporting the use of GcMAF injections for CFS or other diseases. One can only imagine that 'practitioners' willing to treat patients with GcMAF injections are aware of these issues but are willing to ignore the risks.
Some questions to ask your practitioner/supplier of GcMAF. In any treatment, it is important to balance the risks and potential benefits. GcMAF is no different. With no published clinical evidence that GcMAF can be used to treat CFS, the substantial risks involved in injecting the GcMAF protein clearly outweigh (in my opinion) any unlikely benefit. However, many CFS sufferers indicate in these forums that they are going to ‘give GcMAF a try’. It should be understood that GcMAF is not just a simple vitamin supplement taken orally. It is a human protein that is injected and so carries significant risks. So I thought it might be useful to list some of the key questions that any CFS sufferer should ask themselves and their practitioners before embarking on the GcMAF road.
Was the GcMAF glycoprotein made in a GMP facility that is subject to TGA or FDA regulations? If not, how are you assured of the actual doses, potency, contaminants and toxicities of the batch of GcMAF purchased? What is the clinical evidence for the doses recommended? Dont just rely on liability statements at the bottom of order forms Demand the actual clinical data. Is the GcMAF purified from human serum and if so, has it been screened for correct folding, possible infectious agents and complement activating agents? If not, there are significant risks. If the GcMAF is recombinant, how did the manufacturers determine whether the protein is correctly folded and the sugar attachments are the same as those in the normal GcMAF human protein? Those who claim that just because the GcMAF is ‘natural’ it must be safe do not understand how the immune system can respond to the injection of 'natural' proteins. If any aspect of the purchased GcMAF differs in its folding, sugar attachments or sequence, it may be recognized by your immune system as being foreign and generate ‘auto-antibodies’ to GcMAF. Thus, can your supplier provide clinical data that the specific GcMAF that you are injecting will not be recognized by your immune system as being foreign (which can occur when injecting human proteins) and generate ‘auto-antibodies’ to GcMAF? Could such auto-antibodies block your ability to produce your own GcMAF and so reduce the longer-term ability of your macrophages to fight infections? Can your supplier provide you with clinical data documenting toxicities, likely adverse reactions, and efficacy?
I hope that this overview is helpful for those contemplating possible GcMAF injections for the treatment of CFS and other diseases.
Rodger
