GcMAF and an unscrupulous quack, profiled by the BBC

A week ago, I noted that one of the stranger and less credible conspiracy theories promulgated by quacks and their believers was still going strong nearly three months after the first death that triggered it, the death of autism quack Jeff Bradstreet, apparently by suicide. Basically, three months ago, Dr. Bradstreet, who has long been a fixture in the “autism biomed” movement and a frequent speaker at autism quackfests like Autism One, was found dead in a river from a gunshot wound to the chest, an apparent suicide. A recent story about the investigation into Dr. Bradstreet’s death included an interview with the investigating police officer, who described what appeared to be an open-and-shut case of suicide, although clearly many of Dr. Bradstreet’s fans refuse to believe this.

Since Bradstreet’s death, there have been a number of conspiracy theories, mostly originated by Erin Elizabeth at the appropriately named HealthNut News. Elizabeth is the significant other of über-quack Joe Mercola, and her construction of a conspiracy involving the deaths of multiple “holistic” practitioners under allegedly suspicious circumstances, including the death of Nicholas Gonzalez has been epically entertaining. After all, Nicholas Gonzalez appears to have died of a sudden cardiac death, and there’s no compelling evidence that his death was due to anything other than natural causes. Now, each time a “holistic” practitioner dies, Elizabeth seems to find a way to weave the death into a grand pharma conspiracy.

What started this conspiracy is not so much the death of Jeff Bradstreet due to suicide, though. What started the conspiracy is that Bradstreet’s suicide occurred soon after his clinic, the Bradstreet Wellness Center in Buford, had been raided by the FDA. Given Bradstreet’s long history of peddling various quack treatments for autism, the raid could have been provoked by almost anything, but it just so happens that in this case it was provoked by Bradstreet’s latest and greatest quackery for autism. I’m referring, of course, to Globulin component Macrophage Activating Factor (GcMAF), which is isolated from human blood and his business collaboration with David Noakes, the head of the Guernsey-based company Immuno Biotech, which manufactures and sells GcMAF The reason the time is ripe for another update on the Bradstreet saga is because the BBC’s 5 Live Investigates just broadcast a new investigation into Immuno Biotech and First Immune, which is the trade name under which GcMAF is sold. (The MP3 can be heard here and downloaded here. The GcMAF story starts around 5:49.) In it, Adrian Goldberg takes a tough look at Immuno Biotech.

Before I discuss the report, I should probably do a brief recap about GcMAF. The full version is here; the CliffsNotes version follows. So what is GcMAF? It’s an immunomodulatory protein that is found normally in the blood of healthy people. By “immunomodulatory,” I mean that GcMAF activity affects the function of the immune system. The glycoprotein (a protein with sugar molecules attached) GcMAF results from sequential deglycosylation (removal of sugar molecules) of the vitamin D-binding protein (the Gc protein). The protein that results is thought to be a macrophage activating factor (MAF). MAFs are a class of protein known as a lymphokine, and they regulate the expression of antigens on the surface of macrophages. One of their functions is to “activate” macrophages, which can under the proper circumstances attack cancer cells. Of note, the production of GcMAF can be blocked by an enzyme called Nagalase (alpha-N-acetylgalactosaminidase), produced by many cancers, which led to its first incarnation in quackery, as a “cure” for many cancers by Bill Sardi and Timothy Hubbell based on dubious science and a clinical trial that didn’t show what its proponents claimed it did and was later retracted.

Over the years, the therapeutic claims for GcMAF expanded, so that it wasn’t just for cancer any more. Thanks to Bradstreet and other autism quacks, GcMAF became the next big thing in “autism biomed,” and Bradstreet was a true believer in it as a potential cure for autism, as evidenced by this video of one of his talks from 2012 touting the miracle of GcMAF. In a single-arm, uncontrolled study published in a highly dubious journal, Bradstreet claimed to have observed improvement in autistic symptoms due to GcMAF. Another study with which Bradstreet was involved in claimed that GcMAF could normalize abnormal gene expression in the endocannabinoid system of autistic children, which, of course, links his work with claims made by some in the “autism biomed” movement that medical marijuana treats autism. Of course, this was an unrandomized, unblinded study.

Thanks to the efforts of an Irish woman named Fiona O’Leary, who investigated Immuno Biotech and complained to UK health authorities, the First Immune GcMAF production facility in the UK was raided by British health authorities earlier this year. They found that the facility did not meet Good Manufacturing Practice (GMP) standards and expressed concerns over the sterility of the medicine being produced and the equipment being used, leading to further concerns that the product could well be contaminated. More than 10,000 vials of GcMAF were seized and production was halted.

So what’s become of Immuno Biotech and First Immune? That’s where Adrian Goldberg’s report comes in. As he notes at the beginning of his report, GcMAF is represented as a “miracle cure,” a claim that’s not supported by science. The product is not licensed in the UK, and it’s been put on the market by an entrepreneur with no medical training, a man who makes claims like: If you have terminal cancer with two months to live and use GcMAF you can confidently expect to be cancer-free in a year. I kid you not. The audio is there. Immuno Biotech claims that First Immune GcMAF can cure cancer, autism, chronic fatigue syndrome, and HIV/AIDS. For such a miracle, Immuno Biotech charges £500 for a small vial of the substance, which if you believe the hype is a bargain.

One of the stories culled from online discussion forums sounds like a Stanislaw Burzynski story. It’s a tragic story of a 6 year old girl with a brainstem tumor that’s grown to the point where she can no longer function. She’s bed ridden, has trouble communicating and eating, and was estimated to have only about a month to live by her oncologists. It’s a heart-rending situation. The reporters also note that David Noakes recommends that people who start using GcMAF for cancer stop using conventional chemotherapy and other treatments, claiming that his treatment “rebuilds the immune system” with no side effects.

The good thing about this report is that it brought Kat Arney, of Cancer Research UK, who wrote this excellent deconstruction of the claims made for GcMAF. I actually had wanted to meet up with her while I was in London a couple of weeks ago, but unfortunately it just didn’t work out between her travels, my conference, and other issues. Such is life. Here, she does a fine job of explaining why the claims made by Noakes about GcMAF are not credible. I particularly love how she echoes a statement I make a lot (as do other skeptics examining miracle cure claims for cancer) about the conspiracies cancer quacks invoke in which “pharma” is keeping a cure for cancer from you. As she points out (and as I have pointed out), cancer is such a common group of diseases that few are the human beings who have made it to adulthood who haven’t had a friend or relative suffer and/or die from some form of cancer. Certainly, I’m no exception. My grandfather died of liver cancer when I was a child; my aunt died of lung cancer; my uncle died of lymphoma; and most recently my mother-in-law died of metastatic breast cancer. If GcMAF were really a cure for many forms of cancer or if there really were an alternative cure for cancer, I’d be all over it, as would anyone with a career in cancer research and treatment. We battle cancer because we’ve seen what it can do.

Another point she makes that I and others frequently make is that dead people can’t give testimonials. Only the living can. In these testimonials, we have no idea what conventional therapies the patients had undergone, what stage they were, and the like. I myself started this blog pointing out that many of these alternative cancer cure testimonials rely on a confusion between primary therapy for cancer and adjuvant therapy for cancer given after the primary treatment (almost always surgery) in order to decrease the risk of recurrence.

Then there’s the issue of how GcMAF is made. I didn’t even really mention this in my previous post on the topic other than in passing, but GcMAF is a blood product. Part of the reason why the British Medicine and Healthcare products Regulatory Agency (MHRA) found that David Noakes’ First Immune manufacturing facility did not meet Good Manufacturing Practice (GMP) standards and expressed concerns over the sterility of the medicine being produced and the equipment being used, leading to further concerns that the product could well be contaminated. Also, the MHRA found that the plasma used to make GcMAF was designated for research purposes only and was therefore not intended to be used to make products to be administered to humans or used in human drug products. It was also pointed out that the filtration system in the manufacturing facility was inadequate.

There are two disturbing parts of this story (as if the above weren’t disturbing enough) that are new. The first is an interview with David Noakes, who makes all sorts of excuses for his activities, claiming that he employs doctors and claiming that the papers that were withdrawn on GcMAF were the victim of pharma and that the MHRA protects the interests of big pharma manufacturers. He invokes the “two percent gambit” on chemotherapy. He accuses the MHRA of corruption without answering the specific charges other than denying them. We later learn from a former PA who “hated everything he was doing” who worked for Noakes that he often used his own blood to make the products.

Overall, Noakes comes across as incredibly slimy, unctuous, condescending, and, to be frank, a liar—and not a very good one. As a cancer surgeon and researcher listening to him, I felt a rising urge to reach through the computer and strangle him (metaphorically, of course). The man is a despicable quack, and hearing the story of a Swiss clinic where GcMAF was administered to desperate cancer patients for £2,000 a week to stay there.

Of course, the way that GcMAF became famous after the death of Dr. Bradstreet was because of his claims that it can cure autism. Indeed, the report points out that David Noakes claims an 85% response rate in autism, as he does in this video, and this is how the story circles around to its conclusion, with interviews with a mother who gave GcMAF to her child and a representative of the Guernsey branch of the National Autistic Society, who accused him of contacting various autism groups to promote his product. He also apparently spoke of autism as a viral disease, which shows a lack of basic understanding of the pathophysiology of autism, which is a neurodevelopmental disorder, not a disease.

Finally, a reporter called the company posing as a customer, a mother trying to buy GcMAF for her autistic child. The company was apparently willing to sell GcMAF, as long as it wasn’t shipped to a UK address. As long as the reporter provided a European shipping address, the company was willing to sell the drug, this after the MHRA had raided it months ago and shut down its manufacturing facility. The reporter’s phone call was replayed, and the customer service representative was rather cagey about where the GcMAF was being sold from, telling the reporter that it was being shipped from within Europe to European addresses. Noakes, when confronted about his company selling GcMAF, claims that it’s a substance that “mimics GcMAF” and that this supplement is legal in Germany and Europe and that people who order GcMAF get that supplement instead, not GcMAF—and that customers are told that. This leads Goldberg to make a sarcastic remark about how Noakes is now telling him that his company can’t be trusted to provide what it says it will, after which the reporter states that she asked for GcMAF, was told about the new product, but was told she was ordering GcMAF.

The whole thing is even more damning than I thought it would be. David Noakes comes across as what he has appeared to have been all along: An unscrupulous scammer. One can only hope that he really is shut down this time.