Betteridge’s Law of HeadlinesW states: Any headline which ends in a question mark can be answered by the word No. This is probably the fundamental law of misleading health journalism, most especially the perennially unreliable Daily Mail and of course most of all WDDTY.
The story itself is a classic piece of WDDTY, combining conspiracist claptrap, the self-serving claims of charlatans, anecdotes masquerading as data and presenting GcMAF as the One True Cure™. As Marvin might say: “Oh no, not another one”.
What is GcMAF?
GcMAF, or Gc-MAF, stands for Gc protein-derived macrophage activating factor. It’s an immunomodulatory protein that is being investigated for its potential to play a role in the management of various diseases.
The claims for GCMAF as a “miracle cure” for everything – and we do mean everything, including cancer, AIDS, CFS and autism (of course!), is founded on the work of Nobuto Yamamoto, published between 2007 and 2009. Three out of Yamamoto’s four studies have been retracted. At present GcMAF is marketed illegally with purported support from subsequent publications in low impact and predatory (pay-to-play) journals. Numerous organisations have warned over these illegal claims. Cancer Research UK describes GcMAF thus:
Some companies are selling Gc-MAF for use by cancer patients. This treatment is not approved or licensed in the UK for treating cancer or any 0ther disease. Given that there is no solid scientific evidence to show that the treatment is safe or effective, we would not recommend that cancer patients use it.
To suggest that there is a ‘magic bullet’ that cures all cancers is simplistic in the extreme.
Meanwhile, a single Phase I trial is recruiting to investigate the basic safety and potential toxicity of GcMAF. None of the companies selling the product online appears to be involved in this study.
The WDDTY article gets off to a bad start. It relates the story of Marco Ruggiero, an “Italian microbiologist”, and how, on a visit to the US to study AIDS, he met Peter DuesbergW. According to WDDTY:
Like Ruggiero, Duesberg was trying to figure out the cause of AIDS to be better able to produce a cure. Over the months as they sat side by side, it began to dawn on both scientists that the human immunodeficiency virus (HIV) may not be the sole cause.
This is slightly disingenuous. Duesberg did not dispute that HIV is the sole cause of AIDS, he is actually an HIV-AIDS denialist. And, it turns out, so is Ruggiero – in fact Ruggiero goes one better than Duesberg in that he was actually teaching AIDS denialism in his academic work. He’s previously spoken at the autism quackfest Autism One. This is not the first time WDDTY have promoted AIDS denialists, and there’s an interesting link to a recent statement that they believe the subject merits another outing.
From here it is but a small step to the exalted status of Brave Maverick Doctor™, and this is precisely what WDDTY do:
Ruggiero and Duesberg ultimately concluded that
the focus of AIDS research should be on rebuilding an immune system weakened by a toxic lifestyle. Ultimately, both were praised and vilified in equal measure when they co-authored a paper rejecting the standard accepted theory of the cause of AIDS, a paper that is now permanently withdrawn.
This Article-in-Press has been permanently withdrawn. The editorial policy of Medical Hypotheses makes it clear that the journal considers “radical, speculative, and non-mainstream scientific ideas”, and articles will only be acceptable if they are “coherent and clearly expressed.” However, we received serious expressions of concern about the quality of this article. Given these important signals of concern, we commissioned an external expert panel to investigate the circumstances in which this article came to be published online. The panel recommended that the article should be externally peer-reviewed. Following a peer-review process managed by The Lancet editorial team, all five external reviewers recommended rejection, as a result of which the expert panel recommended permanent withdrawal.
As WDDTY keeps telling us: follow the money. In this case, the money trail leads to litigious vitamin quack and “killer of thousands“, Matthias RathW, and to a company making extravagant claims for its unproven drug.
The “Brave maverick doctor”
In WDDTY, it’s never enough for a piece of research to be rejected. There has to be a conspiracy.
As with so many major groundbreaking shifts in scientific theory, it is often the case that many minds begin to ask the same question at the same time, and also the case that the scientific Establishment invariably responds to any such enquiry with total scepticism.
They say that like it’s a bad thing. Striking findings are very often wrong, and striking findings that go against robust consensus are pretty much always wrong.
Dr Yamamoto had been carrying out research showing that, when HIV patients were given GcMAF protein, the HIV infection was eradicated within at most five months, and without the need for antiviral drugs like azidothymidine (AZT). This report, however, was also retracted this year by the journal itself.
Another retracted paper, this time from Nobuto Yamamoto, a professor of microbiology and immunology at Hahnemann University HospitalW (yes, that Hahnemann), affiliated with Drexel University College of MedicineW in Philadelphia.
The above article, published online on 21 Nov 2008 Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between Dr. Ari Zuckerman, Editor-in-Chief, Journal of Medical Virology and Wiley Periodicals, Inc. due to irregularities in the documentation for institutional review board approval.
As Retraction Watch points out, retraction for IRB documentation problems is the medical equivalent of jailing Al CaponeW on tax evasion charges. It’s the easiest thing to prove but likely to be very far from the worst problem. It’s worth noting that IRB approval was an issue with the notorious Wakefield MMR-autism studies.
CRUK note that all the studies are small, all patients had also undergone standard therapy likely to be curative, and there is no evidence of followup, no TNM status, and basically no real data.
As noted above, Yamamoto has four studies listed in PubMed on GcMAF, three of which are retracted. These are the three which were reported by the Anticancer Fund. The fourth looks, superficially, like a duplicate, a problem in itself.
As an aside, a third individual is named in the WDDTY story: Luc MontagnierW, a French virologist and Nobel prizewinner beloved of homeopathy fans for his support of the discredited Benveniste water memoryW conjecture. So that’s a second of WDDTY’s previously fêted “maverick” scientists: one known for AIDS denialism and one known for support of homeopathy.
I wonder what other red flags there might be?
The plural of anecdote
It is a truism that the plural of anecdote is anecdotes, not data.
The first callout box is a “case study” of a woman “cured” of Stage IV ovarian cancer. This is an interesting anecdote because it shows that the patient had surgery and chemotherapy, and also that far from her doctor not telling her stuff, the doctor said “if you can
afford to waste money, you could look into GcMAF” – though this may have been in response to promoting from the patient as the CEO of Immuno Biotech was a friend of a friend.
Two more case studies are featured, both treated by Immuno Biotech, one in response to a letter in a Guernsey paper and another a lecture by Ruggiero.
Follow The Money: Immuno Biotech
Immuno Biotech is a company that sells GcMAF, but this is a conflict of interest in the good way, i.e. selling something suppressed by evil big pharma, rather than in the bad way of actually being evil big pharma.
WDDTY cites two “papers” from the American Journal of Immunology, a legit-sounding journal which turns out to be a predatory pay-to-play rag with no peer review (for an amusing example of the peer-review standards of these journals, see “Get Me Off Your Fucking Mailing List“).
Both these papers list as co-author Ruggiero’s wife Stefania Pacini. Both discuss patients treated by Immuno Biotech, where Ruggiero is listed as “director of science”. Both have full text online (first, second). Both list potential conflicts of interest in respect of David Noakes, the CEO, but not of Pacini, whose institutional affiliation is listed as the University of Firenze, Italy. A third paper in the same journal also includes Ruggiero as co-author, with institutional affiliation listed as Department of Experimental and Clinical Medicine, University of Firenze. This notes the conflict in respect of Noakes and says “Since November 1st, 2013, Marco Ruggiero is consulting scientific director of Immuno Biotech Ltd.” but again fails to note the link between Ruggiero and Pacini and thus the inherent conflict of interest of Pacini. This might actually be important if it weren’t for the fact that the journal is basically worthless.
WDDTY can scarcely be unaware of the link as they note that Pacini is Ruggiero’s wife. Follow the money, Lynne.
David Noakes bizarrely claims that:
“Cancer Research is a front man – it’s rubbished the research saying it all depends on one person, but there are 119 other eminent scientists who have done their own research too.”
Actually none of that independent research has yet been published in decent journals, and much of it is in the canonical opposite of decent journals.
The obvious source for the claim of 119 “eminent” scientists, but the majority of material on GcMAF appears to be conference abstracts and other low-grade material. There’s nothing at all in the top-tier journals that would normally
The Galileo Gambit
Like many other scientific explorers, Ruggiero has suffered a certain amount of persecution for taking on the Establishment, first for AIDS and then for cancer.
Which scientific pioneers who suffer persecution from the scientific establishment? Galileo’s persecutors were not the scientific establishment but the Catholic Church. Thus WDDTY merge the Galileo gambit with an associative fallacy: the assertion that “the establishment” is equivalent in the cases of the scientific establishment and the ecclesiastical establishment. This is an irrational and incorrect association.
After one of his AIDS articles was published, although it had been peer-reviewed, the head of the university threatened to sack him and launched an internal investigation. And even when Ruggiero was found innocent of any untoward behaviour, he was reported to and denounced by the Italian medical
This is not strictly accurate: the university did not sack Ruggiero, but they did impose significant controls on what he could and could not teach and promote. Essentially, they accepted that he sincerely believed in AIDS denialist claptrap, but recognised the danger inherent in promoting it as fact.
In November 2012, an Italian police investigation discovered that a pharmaceutically backed organization was behind defamatory statements made about him.
Really? Or was this a “pharmaceutically backed organization” in the same sense as Sense About ScienceW? I cannot find any reference to this case from independent sources but note that in responses to an article on Duesberg, AIDS denialist commenters refer to “pharmaceutically funded gay activists”. It could be that there is a genuine effort by big pharma to defame Ruggiero on the basis that he threatens their business, but it’s much more likely to be generic paranoid conspiracist claptrap.
Meanwhile, back in the real world
Let’s give the floor to Cancer Research UK here:
Although this particular approach isn’t all it’s hyped up to be, harnessing the power of immune system could be a very potent way to treat cancer. We’ve blogged many times already on high-quality research into immunotherapy (for example here, here, here and here)
And many Cancer Research UK-funded scientists are also working in this field. For example,Professor Fran Balkwill and her team are working on ways to trick macrophages and other immune cells into attacking cancer cells.
In 2014, researchers in Israel started a small-scale early-stage clinical trial looking at the dosage and safety of GcMAF in cancer patients. The full protocol and further information are available on the Clinicaltrials.gov register.
So, there might eventually turn out to be something in this protein, or one similar, and real cancer scientists are investigating it carefully, but it is way too soon to tell if it’s likely to be useful in real clinical practice.
Whatever those selling it might tell you.