Catherine and Others:
I have been amazed at the uncritical heralding of GcMAF across hundreds of Internet sites and blogs by hundreds of naive observers and commentators, to the point of dozens and dozens of sites suggesting that the claimed results are such that, since they have not lead to acceptance within the medical community, there must be some concerted conspiracy to suppress or halt the progress of the findings or the commercial advance of this putative cure. This is errant nonsense, and one fears for the future of scientific assessment and commonsense. It is one thing for patients lacking necessarily the critical appraisal skills to find the widely hyped results seductive - no fault of theirs and no discredit - and quite another for professionals to have allowed the vast misperceptions to have continued so far and for so long. Kudos to Gina for her healthy suspicions, but really no dishonor to anyone else hoping for positive results against a stealthy destroyer of so many lives. Indeed, I sincerely commend all the users who posted to in fact ask for a critical assessment of the findings before accepting them as valid.
GcMAF: Nor Heed the Rumble of a Distant Drum
Several studies on small numbers of patients with solid malignancies (including prostate, CRC, and breast cancer) have purported to provide (highly questionable, see below) evidence of benefit on survival and/or recurrence of GcMAF ( (Vitamin D-binding Protein-derived Macrophage Activating Factor). However all studies have been undertaken by the same key Japanese investigators under Nabuto Yamamoto, the holder of the patent on GcMAF, and these positive results have never been confirmed independently. In addition, the claim of a cancer cure via a single agent like GcMAF is strained, given that cancer appears to be a highly multifactorial entity with complex etiology and pathogenesis.
Fatal Flaws in the Edifice
In addition, in breast cancer in particular, I critically appraised his late 2007 publication which he published in the International Journal of Cancer (IJC) on GcMAF immunotherapy in breast cancer patients and found it uncompelling. I noted that the sample size was small, at only 16 patients, as the sample size was in all the trials conducted by Dr. Yamamoto in any cancer type. Furthermore, 8 of these 16 patients had priorly received chemotherapy (CT), while another 7 had priorly received radiation therapy (RT) one of whom had also received both CT + RT, leaving only one patient was not pretreated with CT or RT, making for 15 out of 16 patients treated priorly by either radiotherapy or chemotherapy or both.
Moreover, the study is silent on the issue of what kind of breast cancer patients - ER / PR / HER2 status is not reported, nor is lymph node status, but the cited result of no recurrence for over four years is not necessarily exceptional in 16 undifferentiated breast cancer patients, and the NNT (numbers needed to treat) and other evidence-based critical appraisal factors associated with the extremely small sample size, limited follow-up, undifferentiated breast cancer type, and near universal pretreatment of patients by chemo- or radio-therapy suggests the study to be underpowered to support its conclusions and weak methodologically, and we have insufficient power to determine what part of recurrence free survival to allocate to GcMAF, if any, and what part to allocate to previous chemotherapy and/or radiotherapy treatment. This is considered in evidence-based critical appraisal to be a fatal methodological flaw, in its nature disqualifying of the studies integrity to deduce anything let only its own conclusions.
Furthermore, tumor progress was in fact not formally monitored at all in the patients, but rather the investigators monitored a wholly non-standard outside-the guidelines blood enzyme known as Nagalase. This too is a fatal methodological flaw - from the levels of Nagalese observed, Dr. Yamamoto concludes this to be "indicating eradication of the tumors". It indicates no such thing to this evidence-based medical researcher, namely me, nor would it to any health professional with evidence-based training and critical appraisal skills. The patients could have had significant tumor progression without having a recurrence in four years, this happens every day as any oncologist can tell us (and 80% of women with undifferentiated breast cancer survive for 5 years independent of therapy).
Finally, and also disturbing is the wholesale lack of any patient control arm, as the GcMAF intervention was not compared to any untreated population, making all conclusions as drawn by the investigators illicit and unfounded.
This Too Shall Pass
I conclude therefore that we need more robust and methodologically stronger studies to validate these independently unconfirmed, isolated, at best questionable and at worst, as I have shown, fatally flawed results, and we would require patient samples in the thousands, a comparative control arm, a standard tumor progression assessment, and all from teams unassociated with Dr. Nabuto Yamamoto and his colleagues, and outside the narrow spectrum of the Socrates Institute for Therapeutic Immunology in Philadelphia, and in over a decade of time it is disconcerting that none have been forthcoming.
Breast Cancer Watch