Government to crack down on stem cell therapies

REGULATIONS governing the use of controversial stem cell therapies will be introduced within a matter of months, Finance Minister Brian Cowen said last night.

He was responding to revelations in yesterday’s Irish Examiner that multiple sclerosis (MS) sufferers were paying up to €18,500 for the unlicensed treatment in Cork.

Up to 6,000 Irish people suffer from MS. Stem cell therapy involves the introduction of healthy new stem cells to repair and replace the damaged or lost cells. It is unlicensed in this country for use among MS sufferers.

Raising the issue in the Dáil yesterday, the Green Party’s Dan Boyle said people with MS were becoming victims on numerous levels because of the Government’s failure to introduce rules on stem cell therapy.

Tánaiste and Health Minister Mary Harney said she had just learned of the issue, and would be contacting the Irish Medicines Board (IMB) today.

Under 1998 Medical Products Licensing and Sale Regulations, doctors have the right, on a case-by-case basis, to prescribe an unlicensed product, including possibly stem cell therapy, if they believe the medicine will benefit the patient.

However, Fine Gael health spokesman Dr Liam Twomey said the regulations were introduced on the premise that medical practitioners would act responsibly. “That regulation is not there as an excuse to allow doctors to do what they want,” he said.

The IMB is investigating the provision of stem cell therapy in Cork. The controversial treatment is being provided by a Swiss-based biotechnology company, Advanced Cell Therapeutics (ACT), from the surgery of Dr John Dunphy in Carrigaline, Co Cork.

It is not known if the GP has any role in the administration or prescription of the treatment which the Irish neurological community has dismissed as “completely unproven”.

Dr Dunphy was unavailable for comment yesterday. ACT also failed to answer questions sent to them.

Any doctor who administers an unlicensed product could be struck off the register if the Medical Council determines that the doctor’s actions were inappropriate. However, one of the country’s leading neurologists said it would be difficult to sanction any non-medical person for providing such a treatment as they aren’t governed by a regulatory process.

Irish Institute of Clinical Neuroscience spokeswoman and Beaumont neurologist Dr Orla Hardiman said the provision of such unlicensed treatment is a grey area as non-doctors could legally provide the therapy. She also described the availability of unproven treatments at such a high cost as disgraceful.

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