Regulator shuts down GcMAF production at unlicensed facility in Cambridge | MHRA press release | 3 February 2015

February 5, 2015


The Medicine and Healthcare products Regulatory Agency has shut down production of an unlicensed medicine called GcMAF at a site in Cambridge and urged those who have bought the product – including it is believed some people with ME/CFS – to see their doctors.

The agency (MHRA) have also warned people who may have purchased GcMAF labelled as ‘First Immune’ from an online website or other unregulated sources.

Dr Charles Shepherd, medical adviser to the ME Association, commented: “We are aware that people with ME/CFS have been using this product. However, there is no evidence at present from clinical trials to show that it is a safe and effective form of treatment for ME/CFS.”

In a press release issued on February 3, MHRA said:

GcMAF (Globulin component Macrophage Activating Factor), a blood product, claims to treat a range of conditions including cancer, HIV and autism. People who have bought this product should speak to their doctor.

Investigators from MHRA carried out an unannounced inspection of a production site in Milton, Cambridgeshire, after the medicines regulator in Guernsey raised concerns in relation to the product. The blood plasma starting material being used to make this drug stated “Not to be administered to humans or used in any drug products”.

It was concluded that the production site does not meet Good Manufacturing Practice (GMP) standards and there are concerns over the sterility of the medicine being produced and the equipment being used. There are concerns that the product may be contaminated.

More than 10,000 vials were seized at this site and production of this unlicensed medicine has now ceased. These products were sold through various European websites and UK patients may have bought it from one of these websites. We are working with colleagues in other countries to alert them to the potential risks. Our investigations are ongoing and we have received no reports to date of side effects caused by this product.

Gerald Heddell, MHRA Director of Inspection, Enforcement and Standards said:

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. GcMAF products labelled as ‘First Immune’ are not licensed medicines and have not been tested for quality, safety or effectiveness. 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 advice is, do not buy medicines online from an unregistered pharmacy as you don’t know what you are getting, where it came from or if it’s safe to take. The dose could be too high or too low, or the product may be contaminated.
 
We would advise anybody needing treatment to seek professional medical advice and not to buy medicines from unauthorised sources.

BACKGROUND

The list of websites that people may have purchased GcMAF are:

www.GcMAF.eu
www.immunobiotech.eu
www.immunocentre.eu
www.petgcmaf.com
www.firstimmune.fr
www.firstimmune.de
www.firstimmune.it
www.gcmaf.gr
www.gcmaf.se
www.gcmaf.es
www.gcmaf.ru
www.gcmaf.pl

MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health.

4 thoughts on “Regulator shuts down GcMAF production at unlicensed facility in Cambridge | MHRA press release | 3 February 2015”

  1. Pretty unimpressed by the statement from Dr Shepherd.
    In my opinion it doesn’t represent a balanced view, insofar as it fails to acknowledge the experience of some patients who have been helped by GcMaf. Furthermore, in failing to acknowledge that evidence, it misses an opportunity to properly portray ME – as an illness mediated by an immune system defect.
    Yes, there may be an absence of published studies, but there is plenty of anecdotal evidence of efficacy.
    Therein lies the whole problem in this story.

    1. Thank you for commenting. Now, there are PLENTY of studies on how helpful GcMAF is at healing MANY things, from autism, to cancer to autoimmune diseases. Refined treatment protocols have upped the positive results for M.E. I am an adult, and I am capable of researching and deciding what treatment I want to use for me AND my children, thank you very much. I certainly don’t need or want government and the police state taking away my choices and forcing me to forgo a treatment that I wanted, or forcing me to have something like vaccines. I am vaccine injured, by the way, just like almost every child and adult with autism. I have autoimmune diseases.

  2. The company – Immuno Biotech Ltd – have released the following statement today:

    “The MHRA investigation is still at the incompetent stage. 10 of them arrived, 4 in bullet proof vests, to terrorise the two female scientists who were there. And threaten and terrorise is exactly what they did.
    They raided the wrong lab, a new one we are building, in which we have never made GcMAF. They thought our chief scientist has a degree in Real Ale brewing, when he’s a PhD biochemical scientist at the top of his profession.
    180 scientists from 8 nations have written scientific research papers on GcMAF. They said we do no research at the lab, when we’ve published 31 research papers from there, more than any other group. They had clearly never read a GcMAF research paper, and probably never will.
    They sent some of our GcMAF off to two government laboratories to test for sterility, not knowing that we already use the governments HPA laboratory to test and confirm for sterility. They don’t know we do 9 tests on our batches.They will find, as the Dutch government did, that the sterility is excellent. Unlike the Dutch government, they will not tell us that, as a result, it is safe for people to use.
    They made a number of false statements on their website about us. There have never been concerns that the product is contaminated. We test for sterility internally and externally. The University of Florence was astonished that, after four years of experiments, the sterility was always intact, there had never been any contamination, and every batch was active. (The MHRA won’t be sufficiently competent to test for activity.)Rather surprisingly the MHRA stated “we have received no reports to date of side effects caused by this product.” They’ve never licensed a drug without side effects, so our protein is a first for them. The drugs they license are full of side effects, and are the number 4 killer of mankind according to the American regulator, the FDA, on their website (see http://www.chemokills.info for a link)
    Bad law kills, and the UK has the worst medicines laws in Europe. 160,000 die of cancer unnecessarily every year as a result, and tens of thousands from dangerous drugs that the MHRA license.
    The MHRA block the public’s access to modern science, and protect the old monopolies of the billion dollar pharmaceutical companies, who fund them. Hundreds of thousands of British lives would be saved every year if the MHRA were closed down. The MHRA are about absolute power and control. They won’t even allow people to have a few billionths of a gram of GcMAF, our own protein that we make ourselves. So they even want human body parts to be subject to their licensing.The MHRA’s jurisdiction covers the UK only, and doesn’t cover Guernsey; Guernsey elects to follow the MHRA by choice.
    GcMAF is the best treatment currently known for about 50 diseases including cancer, and over 9,000 people have taken it.
    If you would like to know more please join us tomorrow at St. Pierre Park at 10am.”

  3. I have more information about what is currently happening to some GcMAF manufacturers, distributors and clinics using it. It is horrifying. Anyone reading this who is involved, “HOW CAN YOU SLEEP AT NIGHT?” GcMAF has helped MANY MANY people. With little to NO side affects. It is something the body is supposed to make. It is so much better that pharmaceuticals with HORRIBLE side affects. The CDC is a liar. Research Dr. William Thompson and watch the movie VAXXED.

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