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UK to probe legality of proposed stem cell research facility

THE UK Government plans to investigate the legality of a controversial stem cell research clinic being set up on the island by Premier Ewart Brown and his wife, the Mid-Ocean News can reveal.

Dr. Brown and his wife Wanda recently joined forces with US-based Russian medical research company Stemedica Cell Technologies to develop a private research centre which eventually aims to treat patients using as-yet unproven, controversial and highly expensive scientific techniques.

But medical professionals both here and abroad have questioned why such a facility should be set up on the island - pointing out the fact that Bermuda lacks the resources to carry out extensive research and has no laws under which the treatment can be monitored.

And yesterday a spokesman for the Foreign and Commonwealth office in London confirmed that the matter needed "to be looked into" and that medical experts could be drafted in to assist in the probe.

The spokesman, speaking on condition of anonymity, confirmed that the department had found news of the development "very interesting" and was now looking for more details about the project.

The inquiry is believed to have been prompted by a recent communique to Whitehall from the Opposition United Bermuda Party.

In a letter to the Overseas Territories Department of the UK Government dated September 19, Opposition Leader Michael Dunkley called on the Foreign Office to insure that the facility was "not in contravention of international regulations".

The letter, addressed to Overseas Territories Deputy Head Helen Nelthorp and countersigned by Shadow Health Minister Louise Jackson, asked if the island was covered by the UK's more stringent medical laws.

And the memo also drew heavily on observations made by Bermudian doctor Arthur Tucker, the chairman of the East London and City Research Ethics Committee for the National Research Ethics Service.

Mr. Dunkley's letter reads in part: "Our principal reasons for bringing this matter to your attention relate to the apparent lack of appropriate regulatory oversight of such a facility in Bermuda, and the potential for Bermuda, by extension, to be in contravention of international agreements and research protocols that govern research on humans and the protection of human rights.

"There have been a number of articles in the local press citing a range of serious concerns by both local and overseas physicians since the proposed clinic was announced by Dr. Brown and Stemedica.

"However, we would particularly draw your attention to the attached letter from Dr. Arthur Tucker, a Bermudian clinical scientist and senior lecturer who is based in London at St. Bartholomew's Hospital and the William Harvey Institute.

"Dr. Tucker is also chairman of the East London and Research Ethics Committee for the National Research Ethics Service. As his letter indicates, he is intimately familiar with the issues related to stem cell clinical research, as his committee is responsible for the permission in the UK for the experimental treatment of coronary heart disease with stem cells."

The letter, which was also sent to Governor Sir John Vereker and Chief Medical Officer John Cann points out the alleged concerns of Dr. Tucker, including;

"The lack of sufficient infrastructure to ensure the compliance of the proposed clinic with international agreed standards...both for the protection of patience and adherence to good laboratory practices;

"The apparent attempt, by basing the clinic in Bermuda, to avoid and circumvent established regulatory oversight by on-shore regulators such as the FDA or the European Medicines Evaluation Agency;

"The potential damage to Bermuda's reputation from this type of questionable and unregulated medical activity."

Again citing Dr. Tucker, the letter reads: "Dr. Tucker also raises the specific question of legal jurisdiction - an issue that we would also ask you to explore. That is the question of whether, as an overseas territory, Her Majesty's Government is responsible for insuring that Bermuda is not in contravention of international medical regulations, and whether these international conventions have been extended to Bermuda by the UK."

The letter concludes: "As you can appreciate, this is a particularly sensitive issue due to the position of the Bermudian owners and the potential for conflict of interest. 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.

Obvioulsy we are concerned about the ramifications both for patient care and Bermuda's reputation as a responsible and well-regulated country. We would therefore ask that you address this matter with the appropriate authorities in the UK to insure that no inappropriate or unregulated medical activity takes place in our jurisdiction"

Yesterday a Foreign and Commonwealth spokesman confirmed the UBP concerns had been heard.

"We have received a letter and we have responded to it," the spokesman said.

"We want to look into this in a bit more detail and may need to call in some experts."

Dr. Brown unveiled plans for the new clinic in July, claiming it represented one of the most exciting healthcare developments on the island in recent years. But the news received a lukewarm welcome from physicians, who argued the technique was still in its infancy and could be open to abuse unless strict watchdog laws were in place. The Mid-Ocean News has subsequently printed several stories explaining the concerns of both island-based and overseas physicians. As a result, lawyers representing Stemedica and Dr. and Mrs. Brown have contacted this newspaper threatening legal action.

Yesterday Dr. Brown declined to comment on the letter.