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Zero dark dirty

MagazineApril 2015 (Vol. 26 Issue 1)Zero dark dirty

Besides wars in the Middle East, the government is increasingly waging war on promising innovative treatments, particularly those for cancer, says Lynne McTaggart

Besides wars in the Middle East, the government is increasingly waging war on promising innovative treatments, particularly those for cancer, says Lynne McTaggart

When it comes to war, where America goes, Britain usually follows, whether in political wars like Afghanistan or skirmishes fought on behalf of the pharmaceutical industry.

In the latter case, the aggressor is usually the government's regulators, and they've not been known for treading lightly, particularly about any new agent that purports to be an innovation that doesn't happen to be a drug.

In 1992, armed police and Food and Drug Administration (FDA) officials burst into the offices of nutritional pioneer Dr Jonathan Wright in Seattle, Washington, guns drawn, and seized more than a hundred thousand dollars' worth of computers, medical records and nutritional supplements. The reason for the raid was mystifying; there had been no patient complaints against him.

Wright's crime? Treating patients with vitamins. Although no charges were ever filed against him, it took Wright years to get his seized property back. As health writer Dr Julian Whitaker wrote, it was a wonder he didn't go out of business.

While the FDA has carried out more than 25 such 'vitamin raids' since that time, Britain has now enthusiastically entered the fray with similar commando-style attacks on natural medicine. On 3 February of this year, 10 investigators from the Medicines and Healthcare Products Regulatory Agency (MHRA) arrived unannounced at the new laboratory of Immuno Biotech in Milton, Cambridgeshire-four of them wearing bullet-proof vests-and, in front of two terrified female scientists, confiscated 10,000 vials of the naturally occurring glycoprotein called 'GcMAF' before closing down the facility.

The MHRA issued a statement on its website to justify its draconian measures, claiming that the production site did not meet Good Manufacturing Practices (GMP) standards. There were also "concerns" over the sterility of the medicine being produced and the equipment being used, and the possibility of contamination.

As Gerald Heddell, MHRA Director of Inspection, Enforcement and Standards announced when justifying the Navy SEAL-like tactics, "These products may pose a significant risk to people's health. Not only were the manufacturing conditions unacceptable, but the originating material was not suitable for human use."

The MHRA claimed that the blood plasma starting material used to make GcMAF was marked with the warning: 'Not to be administered to humans or used in any drug products'.

"GcMAF products labelled as 'First Immune' are not licensed medicines and have not been tested for quality, safety or effectiveness," the MHRA said in its official statement. "People should not start treatment with these specific products. It is important that patients currently taking these products seek their doctor's advice as soon as possible. People should continue taking prescribed medicines and follow the advice of their doctor."

The confiscated goods are not officially a 'medicine', but a protein, produced naturally by the body. David Noakes, the CEO of Immuno Biotech, says that all these assertions are "lies" and mostly evidence of the MHRA's "incompetence". He claims they have so far made 18 false allegations against his company, his lab and his product.

According to Noakes, all the claims about the production process are invalid because the 10,000 vials were in fact produced elsewhere. Immuno Biotech had just moved laboratories over Christmas, he says, into a larger facility meant to house research and production of the product, built to better standards than their previous one.

"Although the manufacturing equipment and all existing stock had been moved and stored, it was a shell of a building which we were converting," he says. Builders had not yet finished transforming the facility, which had previously been offices, into a laboratory.

Furthermore, the laboratory's chief scientist, Rod Smith, had suffered a heart attack during Christmas and was still at home recuperating, according to GcMAF discoverer Dr Marco Ruggiero. No product manufacture could proceed without him, said Ruggiero. The MHRA had originally referred to the facility as a "makeshift lab" and the scientists as "hobbyists with a degree in real ale brewing".

The laboratory where the vials were actually produced is a purpose-built campus of laboratories in the Cambridge Science Park's Innovation Centre, says Noakes, and the chief scientist Rod Smith is a biochemist with a PhD. Marco Ruggiero, the Italian doctor who discovered the importance of this glycoprotein in relation to cancer, is a microbiologist once hired by the US's National Institutes of Health to investigate the cause of AIDS and treatment of cancer.

According to Noakes, the MHRA has now withdrawn its statement. But Noakes also rejects the charge that their supplies are contaminated. "Every batch is checked by Wickham Laboratories in Hampshire using rigorous tests for sterility. There are nine tests carried out on every batch. Our own entotoxin tests show they are one of the most sterile of products," he says, as did independent tests carried out by the Dutch government.

An MHRA official claims a licence would cost lb11,000, but Noakes disputes this, claiming that the only reason he does not have GMP certificates is the lb5 million or so required to get the "bucketful" of licences needed .

Up until the February raid, Immuno Biotech had been supplying hundreds of clinics around the world and more than 9,000 patients, according to Noakes. As a resident of Guernsey, where his company's head offices are, he had also supplied some 170 Guernsey residents suffering from a variety of illnesses with GcMAF-purportedly for free.

Noakes says he was not surprised he'd been raided. "We knew it was only a matter of time." The tip-off to the MHRA, says Noakes, came from the Health and Social Services Department (HSSD), Guernsey's equivalent of the National Health Service.

Doing no harm

For years, Noakes had been in constant contact with various ministers about his product, according to Guernsey's Commerce Minister Kevin Stewart, even setting up a special private conference for a number of ministers at which scientists presented the evidence for GcMAF. Until February, the HSSD had tolerated the import of GcMAF for their residents, so long as it was not supplied for commercial gain.

In fact, Ed Freestone, Guernsey's chief pharmacist, has been quoted as saying, "There is no current information suggesting the product has caused direct harm to anyone's health." An MHRA press statement has also confirmed: "To date we have received no reports of side-effects caused by this product."

Since the raid, Guernsey authorities have now banned both the import and export of the product, leaving around 100 patients with serious illnesses, including cancer, without the product they claim is saving their lives.

These patients formed a Cure Cancer Support Group and had an advert printed by the Guernsey Press, pleading with the HSSD to allow them to continue receiving supplies of GcMAF.

"We are united in our support of treatments like GcMAF which have made us feel better and even saved some of our lives or given us a better quality of life," says the ad. Ruggiero says that he receives daily emails from these patients, many of them desperate. Noakes believes the real trigger behind the raid was government's cosy relationship with the pharmaceutical industry. "The MHRA does not want to see this product on the market because its job is to maintain the monopoly and stick up for vested interests in the pharmaceutical industry," he says.

Immune modulators like GcMAF, found naturally in mushrooms and oats as well as zinc, which is part of the body's defense mechanism, are seen as major new growth areas for Big Pharma.

In addition, Guernsey has been targeted to abide by pharmaceutically-led European law concerning unregistered medicines and food supplements. According to the Alliance for Natural Health (ANH), Guernsey's medical regulator has been heavily lobbied by UK authorities and businesses, including the UK's Health Food Manufacturers' Association (HFMA), which makes food supplements.

The ANH also says the claim about unsanitary conditions was a 'belt-and-braces' approach because it's not altogether clear that all of Immuno Biotech's products fall under the MHRA's jurisdiction. As Noakes points out, some 7,500 of the vials seized were GoleicTM, a supplement containing GcMAF. If it's not a medicine making a medicinal claim, the MHRA has no regulatory power over it.

Drug company influence is now increasingly inherent in drug regulatory agencies. In the US, the pharmaceutical industry now largely funds the FDA. And likewise, the UK government has handed regulatory financial muscle over to Big Pharma.

In the States, as Dr Peter Gotzsche has enumerated in his book Deadly Medicines and Organised Crime, allowing the drug industry to fund the FDA has opened the door to strong-arm influence, sympathetic regulation, bribery and worse. An MHRA statement to WDDTY confirmed that the "cost of medical regulation is met through fees from the pharmaceutical industry".

According to his MHRA biography, chief inspector Heddell has previously held senior roles in manufacturing and quality assurance for The Wellcome Foundation, Glaxo Wellcome and GlaxoSmithKline.

The MHRA claims it is working with "colleagues in other countries to alert them to the potential risks". One such country is Belgium, whose authorities are investigating Immuno Biotech's European web address, which originated in Brussels.

Counting the cost

This is not the first time Noakes has encountered official harassment. In July 2014, NatWest closed his business bank account, forcing him to move his funds to Shroders Bank Guernsey. But following the recent raid, this account has also been closed-only this time, the bank has not yet returned lb1.2 million in the account,which Noakes doesn't believe he'll ever get back from the UK government. Claims that the funds were being used illegally are blatantly false, he says, but he has no recourse to sue the government while it holds all his money.

If the money is not returned, Noakes is likely to agree to a takeover of Immuno Biotech by a competitor in a European country with kinder regulatory laws.He says he's 'done' with the UK, a decision no doubt aided by the recent Parliamentary vetoing of Lord Saatchi's Medical Innovation bill, which would have allowed doctors to test new cancer treatments on patients without the fear of being sued.

If the evidence continues to pour in on the benefits of GcMAF, let's hope Noakes's successors can continue to dive clear of stealth bombers.

Is GcMAF a drug?

GcMAF's role as a treatment of disease was discovered by Italian molecular biologist Marco Ruggiero, who was working at the US National Cancer Institute (NCI) in Bethesda, Maryland, when he and his colleagues began to recognize the vital role of this sugar-coated protein-ultimately dubbed 'Gc protein-derived macrophage activating factor', or 'GcMAF' (pronounced 'Gee-cee-maff')-in signal transduction, or how cancer cells stealthily sabotage signals coming from elsewhere in the body.

Ruggiero's experiments showed that GcMAF not only stopped cancer from spreading, but also caused cancer cells to transform into healthy cells (see WDDTY November 2014). GcMAF has also proved to be a powerful 'immune modulator': it stimulates the body's immune system and the body's own natural detoxification system, and also increases energy production in mitochondria.

Furthermore, Ruggiero found that, in some people, particularly those with cancer or autism, the production of GcMAF is compromised. By now, he and some 180 scientists from eight countries have spent many years researching the role of GcMAF, publishing dozens of papers on the protein and presenting their findings at dozens of professional medical conferences.

Ruggiero has developed the Swiss Protocol for GcMAF treatment, which is currently being followed by several hundred clinics around the world. Many doctors consider it one of the more promising new treatments for cancer.

But, as it's something that occurs naturally in the body, is it a drug or, like vitamin C, a special nutritional friend with benefits?


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