A paper about a protein being used — unapproved by health agencies — to treat diseases including cancer and autism has been retracted.

Here’s the notice from the International Journal of Cancer about a 2007 paper purporting to show that the substance, GcMAF, is useful against breast cancer:

This article has been retracted at the request of Editor-in-Chief ‘Immunotherapy of metastatic breast cancer patients with vitamin D-binding protein-derived macrophage activating factor (GcMAF)’ by Yamamoto, N., Suyama, H., Yamamoto, N. and Ushijima, N. The International Journal of Cancer, published online on 12 October 2007 in Wiley Online Library and in Volume 122, Issue 2, pp 461–467, has been retracted by agreement between the journal Editor-in-Chief Peter Lichter and Wiley Periodicals, Inc. due to irregularities in the documentation for institutional review board approval. Reference: Yamamoto, N., Suyama, H., Yamamoto, N. and Ushijima, N. (2008) ‘Immunotherapy of metastatic breast cancer patients with vitamin D-binding protein-derived macrophage activating factor (GcMAF)’ Int. J. Cancer, 122: 461–467. doi: 10.1002/ijc.23107

Here’s the abstract for the paper, which has been cited 34 times, according to Thomson Scientific’s Web of Knowledge:

Serum vitamin D3-binding protein (Gc protein) is the precursor for the principal macrophage activating factor (MAF). The MAF precursor activity of serum Gc protein of breast cancer patients was lost or reduced because Gc protein was deglycosylated by serum a-N-acetylgalactosaminidase (Nagalase) secreted from cancerous cells. Patient serum Nagalase activity is proportional to tumor burden. The deglycosylated Gc protein cannot be converted to MAF, resulting in no macrophage activation and immunosuppression. Stepwise incubation of purified Gc protein with immobilized b-galactosidase and sialidase generated probably the most potent macrophage activating factor (termed GcMAF) ever discovered, which produces no adverse effect in humans. Macrophages treated in vitro with GcMAF (100 pg/ml) are highly tumoricidal to mammary adenocarcinomas. Efficacy of GcMAF for treatment of metastatic breast cancer was investigated with 16 nonanemic patients who received weekly administration of GcMAF (100 ng). As GcMAF therapy progresses, the MAF precursor activity of patient Gc protein increased with a concomitant decrease in serum Nagalase. Because of proportionality of serum Nagalase activity to tumor burden, the time course progress of GcMAF therapy was assessed by serum Nagalase activity as a prognostic index. These patients had the initial Nagalase activities ranging from 2.32 to 6.28 nmole/min/mg protein. After about 16–22 administrations (approximately 3.5–5 months) of GcMAF, these patients had insignificantly low serum enzyme levels equivalent to healthy control enzyme levels, ranging from 0.38 to 0.63 nmole/min/mg protein, indicating eradication of the tumors. This therapeutic procedure resulted in no recurrence for more than 4 years.

The corresponding author, Nobutu Yamamoto, did not respond to a request for comment. However, the Anticancer Fund, which has been pushing journals to correct the record on GcMAF, laid out for Retraction Watch the problems it saw with this paper:

This paper and 2 other papers from the same group report results of the use of GcMAF to treat cancer patients. Later in 2009 this group published another article reporting their results treating HIV using again GcMAF. GcMAF is supposed to be a naturally occurring protein capable of activating macrophages. It is claimed that an enzyme called Nagalase would deglycosilate GcMAF, impeding macrophages’ activation. With all this background the authors of this series of articles claim they created a GcMAF resistant to Nagalase. The authors reported treatment success by measuring Nagalase in serum, stating, in the cancer-related articles, that it is produced by cancer cells. In the HIV-related article they claim Nagalase is a viral component. After several patients asked our organization, the Anticancer Fund, about GcMAF as a cancer treatment, we decided to look for the evidence supporting its use in cancer. The IJC article reports the use ofGcMAF in 16 breast cancer patients. All patients had previously mastectomy or lumpectomy and all but one received radiotherapy or chemotherapy, prior to the initiation of the treatment with GcMAF. The authors do not give any information on the staging of these patients. However, they determined that these patients had metastatic disease, based on an elevated level of serum Nagalase. Elevated Nagalase level is not a criterion to define metastatic disease in the TNM classification of cancer, 7th edition. There is therefore no proof that the patients had residual disease after the standard treatment they received. According to the information presented in Table 1, no patient received both radiotherapy and chemotherapy, which is rather unusual in the management of breast cancer patients. Especially, two patients who had lumpectomy did not receive radiotherapy which is recommended after lumpectomy. Our organization tried to contact Yamamoto’s co-authors. We found out that Hirofumi Suyama, a co-author affiliated to the Nagasaki Immunotherapy Research Group in Japan, passed away in 2009. Pr. Hirofumi Suyamawas a professor of Forensic Medicine at the Nagasaki University who retired in 1987 and did not publish papers from 1991 until 2007, when he co-authored several papers together with Nobuto Yamamoto. The co-authors affiliated to the Socrates Institute for Therapeutic Immunology in Philadelphia, organization from which Yamamoto appears to be director, are untraceable. The Nagasaki and the Hyogo Immunotherapy Research Groupst hat gave IRB approvals for these trials do not exist anywhere except in the papers from Nobuto Yamamoto. Moreover, three people listed in the approval documents denied being part of those groups or having ever participated in Yamamoto’s work. The purported sponsors of this trial denied having supported clinical research on GcMAF. They supported Yamamoto’s preclinical work, in the 90s. The US Public Health Service from 1992-1994 and the Elsa E. Pardee Foundation only in 1998. When he was associated to other institutions rather than the Socrates Institute for Therapeutic Immunology. We also found that Yamamoto forged the name of Pr. Charles E. Benson from the University of Pennsylvania, when he presented further results of GcMAF to treat some types of cancer and HIV to FOCIS meetings. The most worrisome problem is that this article and others published in other peer-reviewed journals is used by some GcMAF manufacturers to support their claims and sell it illegally to patients. Plus these people are reporting their outcomes treating cancer, HIV, Chronic Fatigue Syndrome, Autism and other ailments, using invalid endpoints such as Nagalase; to promote the illegal marketing of GcMAF. We have serious concerns at many levels concerning the development of this research and we have an obligation to find answers for the sake of desperate patients using this therapy.

GcMAF has also caught the attention of Jeffrey Beall, who wonders, “Would You Take a Cancer Cure Proven Effective in a Predatory Journal?” Here are some of the claims being made by GcMAF.eu, which sells the substance:

The results from all the diseases we list are astonishing, but in late stage cancer the clinics achieve an average of 25% tumour reduction per week. (We get that reduction with pancreatic cancer too.) These results are peer reviewed and published in prestigious scientific journals… CFS/ME [Chronic Fatigue Syndrome/Myalgic Encephalomyelitis]: Full recoveries in 70% of cases Cancer Cured For Good

An early-stage trial — not designed to test whether GcMAF actually works, just whether it is safe — is now underway.

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