Wham, Bam, Autism Scams - The bad actors and bad science behind the most egregious claims about the causes and cure for Autism

Bronwyn Rideout - 2 October 2023

Part 2 - GcMAF (Group specific component protein Macrophage-activating factor)

In 2008, four papers were published by Nobuto Yamamoto and colleagues reporting that GcMAF immunotherapy had been successful in treating cancer and HIV-1 in 39 people (8 with colon cancer, 16 with breast cancer, and 15 with HIV-1). Using serum nagalase as a marker for malignant tumour burden, Yamamoto et al claimed that once the marker reached basic levels the immunotherapy was discontinued; all patients in this study remained symptom free for many years, sometimes up to 7 or 10 years. As retired biochemist Simon Albracht comments in his overview of Yamamoto’s work, the symptom-free periods imply that research commenced around the 2000s, or likely even earlier.

In Albracht’s summary, Yamamoto and his group had been beavering away in Philadelphia since the 1980s, researching blood components involved in the activation of macrophages, which are specialised white blood cells that destroy bacteria and other harmful organisms (but they aren’t so hot at fighting cancer cells). Our bodies naturally make protein GcMAF, but an enzyme released by cancer cells (nagalase) may hamper the production of GcMAF. Using mice, the group found that the addition of acylglycerol DDG was very effective in activating B and T lymphocytes, as well as Gc protein. The group manufactured their own GcMAF, and found that it was as effective as the GcMAF made by B and T lymphocytes. Thus, Yamamoto hypothesised that injecting GcMAF will overcome the enzyme action of nagalase and be a potent cancer treatment.

Yamamoto applied for, and received, several patents for his findings, starting in 1993. His products included Gc purified from blood, treated with immobilised enzymes and filter sterilised. The dosing was 30 to 35 ng every three to five days. Yamamoto also patented the NaGalase test that monitored the effectiveness of the GcMAF therapy, which he also invented. When the last patent was issued in 2002, with little interest from researchers or big pharma, Yamamoto went to press in 2008 with the findings of the initial research he had conducted in the 1990s. In 2009, the GcMAF IP was sold to an Israeli pharmaceutical company, Efranat Macrophage, where Yamamoto was listed as a co-founder.

In the aftermath of the sale, claims around the effectiveness of GcMAF finally brought international attention to (and pushback against) Yamamoto’s original research. Ana Ugarte and team from the Anticancer Fund pointed out numerous inconsistencies in Yamamoto’s 2008 articles. Amongst Ugarte’s criticisms was the lack of information about the extent and stages of participants’ cancer, a lack of histological evidence, the inability to locate Yamamoto’s coauthors, the absence of expert opinion regarding the use of Nagalase as a disease marker, and multiple mistakes and errors. Ugarte also suggested that Yamamoto had possibly fabricated the research group that approved the trial, and misrepresented the sponsors of the trials.

All three of Yamamoto’s papers on the topic of GcMAF and cancer were retracted, but other journals such as Translational Oncology and AIDS Research & Human Retroviruses that published related papers declined to do so.

It would be a 2017 article by Alex Kasprak, published on snopes.com, which would provide illumination on Yamamoto, the Socrates Institute for Therapeutic Immunology he was “affiliated” with, and increased suspicions about how much of his work was fabricated.

Yamamoto has/had a publishing record that began in the late 1950s, including in prestigious journals such as Science. He worked as a researcher in the US with legitimate Universities and Cancer centres through to the 1980s, before being employed at Einstein Medical Center, a private hospital, in 1993. Yamamoto would leave the medical centre in 1999 for unknown reasons. He had filed a libel suit against a superior and settled out of court, but records of the proceedings were destroyed in 2004.

Yamamoto and colleagues

At the time of his departure from the medical centre, Yamamoto started to fashion himself as the director of the Socrates Institute, which was based in his private home. Kasprak and the Anticancer fund uncovered a complicated web of lies and falsehoods spun by Yamamoto: A possible fabrication of co-authors, two instances of misattribution of scholarship, and even an instance of unethical behaviour that made an alternative medicine proponent uneasy, make for a fascinating read.

While Yamamoto made some big claims about cancer, claims about the efficacy of GcMAF to treat Autism and other chronic conditions came from elsewhere - largely the studies published by Immuno Biotech. It’s here that the story of GcMAF gets significantly weirder.

IMMUNO BIOTECH

Soon after the sale of the GcMAF IP, biopharmaceutical companies popped up and started manufacturing and/or selling GcMAF, allowing for the number of egregious claims about the efficacy of GcMAF to grow beyond merely treating cancer. Yamamoto claims that the Efranat Macrophage were unsuccessful in their attempts to sue one company in particular, Immuno Biotech.

Between 2014 and 2015, three articles were published in the American Journal of Immunology (a middle-of-the-pack journal printed by an allegedly predatory publisher) that were positively inclined towards the ability of GcMAF to treat cancer, and speculated on its effectiveness to treat viral infections, autism, and chronic diseases. Two of the papers (1, 2) were about the experiences of patients being treated at the Immuno Biotech Treatment Centre (trade name First Immune), a company founded in 2010 by computer consultant and failed UKIP candidate David Noakes for the express purpose of promoting GcMAF. Noakes was also listed as co-author in all three papers.

Vial of GcMAF from ImmunoBiotech

Stef Brezgov wrote for SCHOLARLY OA in 2019 pointing out multiple issues with the articles, including the lack of disclosure of their connection to Immuno Biotech, and the absence of information that he was able to find about the centre at the time. Brezgov also noted the exorbitant price of what is essentially an unlicensed and unregulated treatment: 600 euros for the GcMAF alone, 1,800 euros for a hotel, and 6,000 euros a week for treatment at the centre. Brezgov questioned why anyone would need to stay at the centre for what is essentially an outpatient procedure.

The website of GcMAF is a fascinating time capsule for that time. It included claims such as “Root canals suppress the immune system”, and sold products like yoghurt and a mouthwash that could eradicate diseases like herpes and throat/mouth cancer.

David Noakes

Despite the cost and dubious nature of the treatment, people were willing to pay. At one point it was claimed that Immuno Biotech was making over a million pounds a month in sales from 9,000 clients worldwide. However, it didn’t take long before the negative attention given to Yamamoto was visited ten-fold upon Noakes. 2015 was an especially bad year for Noakes and his company. Noakes’ former personal assistant, Ann O’Connor, claimed that Noakes told her that the GcMAF the company distributed, as a human blood product, came from him (a claim Noakes denied). A medicines regulator in Guernsey, where Noakes lived, raised concerns about Noake’s products in early 2015, prompting the Medicines and Healthcare products Regulatory Agency (MHRA) to conduct a surprise inspection of the Immuno Biotech facilities. Along with seizing 10,000 vials (valued at 5.5 million pounds), it was discovered that the blood plasma used had a warning label which advised that it was “…not to be administered to humans or used in any drug products”, and there were fears of product contamination due to issues with the sterility of the medicine and equipment. The MHRA brought a criminal prosecution against Noakes because there was no marketing licence for GcMAF, which could only be issued if the MHRA had clinical data demonstrating that it was safe for humans. Soon after the raid, Noakes relocated the business to France, where he evaded arrest until 2017 - when he was apprehended after flying to Dorset on a private aircraft.

Noakes also became a person of interest for the Swiss police, when five former patients at a Lausanne facility, which he owned and operated, died. Said facility was not officially registered in Switzerland. That clinic, and related branches in Germany, were soon closed. It is unclear if the deaths were caused by GcMAF; due to the end-stage cancer; or due to forgoing traditional cancer treatment in favour of ineffective GcMAF.

First Immune SA Clinic in Bussigny, Vaud

Despite the raid, and not being able to ship to the UK, Noakes’ product continued to be sold within Guernsey and to Europe; this allowed UK customers to access GcMAF through alternative routes.

During a three-year investigation, the MHRA found that Noakes made approximately 10 million pounds between 2012 and 2015. MHRA efforts were finally successful in 2018, with the sentencing for Noakes, ex-wife Lorraine, and three others on various charges relating to the illegal sale, export, and supply of unlicensed medicines. Noakes himself pled guilty, and was sentenced to 15 months and disqualified as a company director for 8 years. In 2020, a 1.4 million pound confiscation order was issued under the Proceeds of Crime Act (2002). In 2021, Noakes was sentenced to 4 years imprisonment in France for the manufacturing and sale of fake medicines over the internet.

Jeff Bradstreet

You might be surprised to learn that you may already have heard of James Jeffrey “Jeff” Bradstreet, even if you don’t remember his name or recall what his face looks like.

His shocking death in 2015, and his work in alternative medicine, means he is often the first person listed in a conspiracy theory about the alleged murders of holistic doctors throughout the US that occasionally pops up on social media.

It appears HealthNutNews is the progenitor of the original list, and continues to update it, claiming 100+ holistic doctors have now been murdered. Snopes and Vaxopaedia debunked many of the claims; while some were murdered, the culprits in those cases were arrested. Others died by accident, suicide, natural causes, or misadventure, and there was uncertainty as to whether some of them were holistic doctors. Sadly, more than one female doctor died in an act of domestic violence. There were also 29 people included on one list who were allegedly poisoned at a homoeopathy conference by taking a decidedly non-homoeopathic dose of an hallucinogen called Aquarust; all were taken to a hospital, and no one died.

In order to understand Bradstreet’s prime position on this list, it is important to know who he was and what he did.

Jeff Bradstreet obtained his medical training from a legitimate institution, and even had postgraduate training from a US Air Force Medical treatment facility. However, even before Noakes and Immuno Biotech were on the scene, Bradstreet was vocal about his beliefs that vaccines cause autism, and he promoted various pseudoscience therapies (i.e. chelation and hyperbaric oxygen therapy) as effective treatments for Autism. It’s important to note that Bradstreet had a personal stake in this game because his son is Autistic, something which Bradstreet blamed on the vaccines his son received when he was 15-months-old.

Bradstreet’s hypothesis about GcMAF’s effectiveness in treating Autism is laid out in a 2014 paper called Initial observations of elevated alpha-N-acetylgalactosaminidase activity associated with autism and observed reductions from Gc protein—macrophage activating factor injections. Bradstreet argued that Autistic children had higher levels of Nagalase than non Autistic children, and that elevated nagalase contributed to the autoimmune conditions found in that population. Bradstreet’s study found that exogenous GcMAF (provided by Immuno Biotech, of course) reduced Nagalase levels to healthy levels, and reduced Autism symptoms. All it took was five months of injections, at $90USD a shot.

Unfortunately, just as Bradstreet rode the highs alongside Immuno Biotech, it tragically all came crashing down for him just as quickly. Fiona O’Leary, an Irish Autism rights campaigner whose complaints contributed to the MHRA raids, was also hounding US authorities to do the same thing. Finally, four months after Immuno Biotech was raided, the FDA and the Georgia Drugs and Narcotics Agency confiscated vials of GcMAF and various records from Bradstreet’s clinic on June 18th, 2015. Bradstreet left town that same day, and travelled to North Carolina and checked into a hotel. The next day was when Noakes’ clinic in Switzerland was shut. A few hours later, Bradstreet’s body was found by a local fisherman. Officials ruled the death a suicide by gunshot to the chest, with the weapon found nearby in the water.

Bradstreet was facing a possible 20 years in prison had he been indicted.

Instead, Bradstreet’s legacy lives on in infamy. His family’s grief and Noakes’ flair for the dramatic have stoked the fires of a rumour amongst supporters that Bradstreet was murdered, a fire that still burns nearly a decade later and has been dramatised for true crime television.

Marco Ruggiero and Michael Kelly: The NZ connection

Of course, what would any article like this be like without an NZ connection. But before we talk about Aotearoa, we need to talk about an Italian named Marco Ruggiero.

Marco Ruggiero is a medical doctor with a PhD in Molecular Biology. He worked in the US and throughout Europe before retiring from academia in 2014, but not before publishing a paper with the aforementioned Nobuto Yamamoto about GcMAF in 2010. Ruggiero has garnered a reputation for his fairly out-there beliefs, including believing that HIV does not cause AIDS, which led him to be investigated by said University in 2012. Between 2014 and 2020 he was the CEO of a Swiss company that researched and developed supplements. Other, more recent gigs include editorship of Madridge Publications, and work as a researcher with the National Coalition of Independent Scholars. His most recent publication was in 2022, and his most updated website advertises a very expensive dietary supplement called Intracellular Klotho Formula: $850 for 60 capsules. This product seems to be a rebranded survivor from the Immortalis protocol, which appears to be a weird, failed attempt at an anti-aging movement. In a 2017 article in Vogue Magazine, Ruggiero was said to claim the following about his product:

But, Ruggiero claims, the Klotho these bacteria produce in your gut will in turn, through “quantum entanglement” (when unconnected cells can communicate), instruct our bodies to make Klotho, too; not just that, his concoction will also make time slow down through “relative time dilation”, so that cells have a better chance of repairing themselves before they get damaged or mutated. In short, Ruggiero states that Klotho Formula “will induce age-reversal”.

This is not the only time Ruggiero abused the rules of quantum mechanics; he and wife Stefania Pacini co-authored an editorial titled On the impact of quantum biology and relativistic time dilation in autism.

As I said, It appears Immortalis went bust; maybe the quantum entanglement became undone?

So, why am I talking about Ruggiero? While most information connecting Ruggiero to Immuno Biotech has been scrubbed from the web, thankfully there are very old profiles which indicate that he served as the company’s Director of Science. Ruggiero also co-authored one of the three pro-GcMAF papers I wrote of earlier with Noakes, leaning on his role at the University of Florence rather than his work at Immuno Biotech. As the company’s Director of Science, Ruggiero is said to have been the co-founder of the infamous Swiss clinic, the development and marketing of GcMAF probiotic yoghurt, and the creator of what became known as the Swiss/Ruggiero Protocol.

The protocol is the epitome of scam. Claiming to shrink tumours by 25%, it was guaranteed to shrink your bank account by $2,500 NZD at least, maybe even more if you needed a high dose or longer treatment. The protocol was a ketogenic diet supplemented with lots of Immuno Biotech/GcMAF products, administered by intramuscular injection near the lymph nodes, nebulised into the lungs, orally via the yoghurt, rectally with suppositories, and through exposure to high-powered ultrasound.

Somehow, Marco was able to avoid the legal repercussions his colleagues received, with his reputation largely intact, and he went on with several new schemes and protocols.

So, what about New Zealand…

A fairly in-depth commentary on Ruggiero, Michael Kelly, and the legacy of GcMAF can be read courtesy of the blogger Smut Clyde here, and on Riddled.

Hidden in the depths of the Internet Archive are cached versions of the Immuno Biotech Ltd website for NZ. The business was registered by Michael Kelly, an Auckland-based naturopathy businessman, in March 2015, and then closed shop in March 2016. It was located at 40 St. Benedicts Street, Newton, Auckland. Kelly is known as the operator of the St. Benedicts Health Care centre, and has a history selling Ruggiero’s various products (clearly) and other pseudoscientific offerings such as Electronic Gem Therapy.

While Immuno Biotech was dead, the “technology” lived on. Michael Kelly would retain the Newton premises and register another business there, Natural Health Limited, in March 2017.

On November 26, 2020, Kelly still listed the Newton location as his residential address when he registered as director of MKA Merchandising; on the same day, MKA merchandising changed its name from MKA Merchandising to Praesidium NZ Ltd.

Now, if you know your fringe New Zealand politics, Praesidium might ring a bell.

A Jami-Lee Ross shaped bell. In March 2021, it was revealed that former National MP Jami-Lee Ross co-founded Praesidium Life with Kelly, which was going to sell a nutritional supplement called Praesidium. The supplement was developed by none other than Dr. Marco Ruggiero, and promised to protect users from electromagnetic radiation. NZ Skeptics Secretary Mark Honeychurch even commented on the situation to RNZ when it happened.

In the same Stuff article, the Natural Solutions website was identified as the online storefront for the clinic at the time. A review of the companies register has Natural Solutions registered in 2015 under a Jenny Leeb, before Michael Kelly is made co-director at the same time.

However, Tony Falkenstein (CEO of the Just Life Group) acquired the business in August 2022. The legacy of Immuno Biotech lives on, with Falkenstein’s decision to continue to stock Ruggiero’s line of GcMAF products: 1) Imuno, which includes injectable solutions (between $580 and $1160) and a cream ($276) and b) Bravo Probiotics, a dietary protocol which includes the rebranded Immuno Biotech yoghurt, and costs almost $10,000 NZD for a 3 month supply. Maybe it is a surprise to no one, but these items are currently in stock, and are available for pick up within 24 hours of ordering.

What should be a surprise, and dismay, to us all, especially in light of the decisions made with the Therapeutic Products Bill, is that products from the Imuno line are marketed in Singapore as being produced under licence in a pharmaceutical facility that is audited by Medsafe.

Further clinical claims, and repetition of the Medsafe audited facility, can be found on the Imuno website. Where Imuno is actually manufactured is unclear. A check of the biographical trademark for Imuno (#1099094) in 2018 gives two addresses, a physical one at the Law Partners House along Lini Highway in Port Vila, Vanuatu, and a service one at the Newton location. No changes have been made to the addresses listed in the trademark register, although Natural Solutions NZ Limited is listed as the owner of the original application.

Given other pharmaceutical manufacturing/production businesses operating in Vanuatu, it isn’t inconceivable that some Imuno products would be formulated there for distribution in the South Pacific. Another point in favour of the existence of a Vanuatu facility is a very recent court case.

Michael Kelly’s connection to Advance NZ is not limited to Jami-lee Ross. According to a report by Edward Gay for Stuff.co.nz on September 5th, 2023, Kelly claims to have given Billy TK an envelope with $10,000 cash. The handover occurred during a 2020 fundraising event in Eden Terrace which Kelly organised for Advance NZ. TK would then receive another 5Gs (hahaha) the next month. Kelly claimed that the donation was intended for billboards but had noticed that TK didn’t disclose the donation. It was Kelly who raised the issue with the Electoral Commission, who in turn referred the matter to the police, who in turn charged Billy TK in September 2021.

Billy’s defence was that the cash was not a campaign donation, but a gift, and Kelly was acting vengefully when Billy resigned from Advance NZ.

It is not clear if Kelly was made party chairman before or after the donation, but he did try to fool the jury into thinking that he’s working class and not very bright. Regardless, Kelly complained about TK’s actions to his face and via memes on social media. Leeb, who is identified in the article as Kelly’s partner, gave evidence via video from Vanuatu, claiming that they don’t normally give cash to people.

Billy TK was found guilty of failing to declare donations on September 8th, 2023, and will be sentenced in December.

Final Thoughts…

With the teeth being taken out of the Therapeutic Products bill, untested and unapproved products like GcMAF will continue to be rebranded and promoted as the cure-all for the disease or illness of the day. Marco Ruggiero’s particular style of cockroach-style tenacity and shameless reinvention may appear to have landed on a far more profitable target than desperate parents: the ageing wealthy. Further, the lionisation of Jess Bradstreet as a radical who was silenced for telling the truth further cements GcMAF as a Autism cure that Big Pharma wants hidden from the people. However, it appears Ruggiero has stepped away from the Autism game, by and large, and the big price tag on products like Imuno and Bravo Probiotics are excessive compared to the more prevalent and accessible Chelation, Miracle Mineral Supplement, and others.

David Noakes may be released from a french prison in 2025, if not earlier. It will be interesting to see if, once the disqualification period from Directorship expires, he reinvigorates Immuno Biotech, and if so what he rebuilds his brand on.