MHRA shuts down unlicensed cancer drug facility
pharmafile | February 9, 2015 | News story | Manufacturing and Production, Sales and Marketing | Cambridge, GcMAF, MHRA, first immune, globulin component macrophage activating factor
The MHRA has shut down an unlicensed Cambridgeshire plant that was producing a potentially dangerous drug to be sold online.
The drug, labelled as First Immune, was made from blood product GcMAF (globulin component macrophage activating factor) and claimed to treat a range of conditions including cancer, HIV and autism. However the blood plasma starting material used to make the drug stated “Not to be administered to humans or used in any drug products”.
The MHRA also says that there were concerns over the sterility of the medicine and the equipment being used, and that the product may be contaminated, although so far the UK regulator has received no reports of side effects from the drug.
Gerald Heddell, the MHRA’s director of inspection, enforcement and standards, says: “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.
“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.”
The regulator was alerted to the Milton, Cambridgeshire facility after the medicines regulator in Guernsey raised concerns about the product in December. More than 10,000 vials of GcMAF were seized at the site, which has now been shut down.
The drug was being sold online through various European websites, and the MHRA says it has alerted regulators in other countries of the potential risks as it continues its investigation.
Globulin component macrophage activating factor is indeed being investigated as a potential cancer immunotherapy, but it is not yet approved for use.
George Underwood
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