Fool's Goldic
Stem cells, Issue 1619 EIGHT months after Eye 1601 revealed how unscrupulous medics and private clinics were flogging dodgy gold-infused "stem cell" treatments at rip-off prices, regulators have stepped in.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has written to Patient Choice International Ltd, the UK distributor for "Goldic" (aka "iRegMed") jabs, warning the product cannot be marketed without regulatory approval.
As a "medicinal product" it needed marketing authorisation from the MHRA, which would have demanded stringent checks on safety, efficacy and quality.
But the self-styled "Prof" Ulrich Schneider, the man behind Goldic, was trying to claim it was not medicinal, more "medical device technology".
It involves mixing a sample of the patient's blood with gold particles to make "Goldic serum", which is injected back into the patient to "stimulate the body's own power in such a way that damaged or injured tissue can be regenerated".
Quack squad
All of which is "quackery" says Patricia Murray, professor of stem cell biology at Liverpool University, whose detailed complaints to the MHRA and the Human Tissue Authority (HTA) prompted the sales ban. She told the Eye she did not think Schneider would be able to meet the MHRA's rigorous criteria.
Eye readers will recall that while Schneider, a medic specialising in orthopaedics, has published research supposedly supportive of his product, most of it was flawed. Peer reviews of a study on Goldic's effect on damaged knees, for example, pointed out there was no control to show the treatment was any more effective than injecting saline!
Raphaël Lévy, professor of physics and an expert in nanomaterials at the Université Sorbonne Paris Nord, told the Eye none of the studies provided "experimental evidence for the biochemical mechanisms of Goldic". He said: "An illusion of scientific support is provided through the publications by making bold statements without any supporting evidence or by mis-citations to irrelevant evidence."
Froth of Khan
Another big promoter of Goldic is none other than Harley Street cosmetic doctor Aamer Khan. As the Eye went to press, his website too was still promoting iRegMed for "many ongoing chronic conditions" such as lung, kidney and digestive disorders.
He is better known to Eye readers, however, for being one end of an illicit supply chain in umbilical cord stem cell therapies. A "serious incident" report, obtained by the Eye under freedom of information rules, blamed a lack of proper oversight at the Royal Free NHS hospital, London – where the cords were stored and processed.
As the Eye was going to press, Patient Choice was still promoting the Goldic "device", though a note at the end says it "currently" doesn't sell human kits – just ones for horses and dogs.
More top stories in the latest issue:
TIGHT SHIPS
The government's new "statutory code of practice" for employers is a half-hearted response to the "fire and rehire" tactics of the likes of P&O Ferries.
EMERGENCY FUNDS
Private health firms are making millions out of contracts that give them control over patients' access to NHS A&E departments.
BIG UP BEN!
Nine months after joining the House of Lords, Tees Valley mayor Ben Houchen has made one written question – and even that's of the "all about me" variety.
THE DESERT FIX
The acquittal of two men on bribery charges over a UK/Saudi military telecoms deal raises more questions than answers for the government.
WAR OF WORDS
Despite frustration with Israel over getting aid into the Gaza war zone, the UK is still rolling out the red carpet for Israel at a major UK arms fair this summer.
THE OLD LADY GOES ROGUE
New evidence seen by the Eye shows that the Bank of England was colluding in fiddling the benchmark Libor interest rate.
COVERED TRACKS
Despite its persistent failures to deal with abuse, the Church of England remains reluctant to transfer safeguarding oversight to fully independent experts.
NUMBER PUZZLE
The government doesn't know how many children who were born via commercial surrogacy deals are being brought into Britain.