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Gibbons asks FCO to check on stem cell oversight

Dr. Grant Gibbons

The Opposition United Bermuda Party has called for a halt to plans for an adult stem cell clinic in Bermuda until outstanding medical and regulatory questions have been answered.

The UBP has also written to the Foreign and Commonwealth Office to raise concerns about Premier Ewart Brown's intention to set up a private adult stem cell clinic on the Island.

Dr. Brown and his wife Wanda are teaming up with California-based Stemedica to set up the Brown-Darrell Clinic in Winterhaven, Smith's, with proposals to treat one or two "no option" patients every week. It is scheduled to open early next year.

However The Royal Gazette revealed this week that some scientists had questioned the effectiveness of adult stem cell science.

George Daley, president of the International Society for Stem Cell Research, fears patients across the world with life-threatening illnesses are already being treated by physicians who, he believes, take advantage of hype over stem cell treatment at great expense to the patient with no assurance of success.

And Dr. Arthur Tucker, a Bermudian medical ethics expert and clinical research scientist based in the UK, warned of the potential for complications during treatment procedures which could take place at any stem cell clinic, including one in Bermuda.

Opposition Education spokesman Grant Gibbons said serious ethical and scientific questions had been raised by well-respected and knowledgeable medical practitioners in the stem cell field.

Dr. Gibbons said: "We have to be very careful that Bermuda is not seen as a jurisdiction that allows unregulated human medical research and treatment. Nor do we want Bermuda to be seen as a jurisdiction where practitioners can come to circumvent ethical oversight by on-shore regulators such as the Food and Drug Agency or the European Medicines Evaluation Agency.

"Due to the current lack of credible regulatory oversight we believe that Bermuda is not an appropriate site at this time for this type of stem cell research and treatment."

A letter sent by Opposition leader Michael Dunkley to the FCO on September 19 raised the question of whether international medical conventions had been extended to Bermuda by the UK and whether Britain was responsible for making sure Bermuda was compliant.

The Royal Gazette understands Britain has yet to respond. The UBP also raised concerns about a potential conflict of interest due to the Premier's position.

Mr. Dunkley added in his letter: "The independence of the Chief Medical Officer in Bermuda is also at risk in this case because of his reporting relationship to his minister and Cabinet."

And Dr. Gibbons said the Opposition believed no licence or permit should be issued for the proposed clinic until the many serious and outstanding issues can be satisfactorily resolved by credible independent authorities.

Some of these issues include:

¦ The ethical guidelines and independent oversight needed to protect the safety of potentially desperate and seriously ill patients before they undergo stem cell procedures

¦ A clear understanding of the internationally accepted regulatory protocols that Bermuda should adhere to as a responsible jurisdiction

¦ The ability of the stem cell clinic and KEMH to handle complicated medical emergencies that potentially may result during the course of the treatment

¦ A thorough, independent review of the scientific/medical credentials and relevant experience of those who will be involved in the facility and their fitness for conducting this type of research/treatment – as would normally take place with an ethics review board in the US or the UK.

¦ The potential damage to Bermuda's reputation for allowing this type of unregulated medical activity.

Stem cells have the ability to self-renew and can replenish dying cells and regenerate damaged tissues.

Embryonic stem cells are taken from a developing embryo, while adult stem cells can be drawn from many parts of the donor's body, including the brain, bone marrow, placentas, liver and blood.

Stemedica is offering the ultimate hope for thousands of patients who have illnesses they fear nothing else can cure.

According to its website, adult stem cells have been used with "profound results" on sufferers of Alzheimer's, Parkinson's, multiple sclerosis and stroke.

The website goes on to list other diseases it claims adult stem cells have benefited, including neurodegenerative eye diseases, spinal cord injuries, brain injuries, scars, burns, diabetic ulcers and bone damage.