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Brown seeks legal advice on stem cell research

A proposal to bring stem cell research to Bermuda is still in the works, even after the Government rejected it, according to Ewart Brown, the former Premier.

Dr Brown is seeking legal advice on his medical deal with the stem cell company Stemedica, which he maintains got turned down for “purely political reasons”. The plan dates back to 2007, but encountered controversy over the island's lack of a regulatory framework, in which patients with no other resort would come to the island to participate in clinical trials.

It resurfaced early this week when e-mails were shared with this newspaper, in which Dr Brown took to task both Michael Dunkley, the Premier, and health minister Jeanne Atherden for their role in the denial of his proposal.

The Stemedica idea was pitched last year, but turned down after a six-month wait, with Dr Brown telling The Royal Gazette that he had been referred by the minister back to a research committee at the Bermuda Hospitals Board.

Saying the island lacked any experience to vet a proposal in such a field, Dr Brown maintained that the plans had been given the green light by the Western Institutional Review Board in the United States.

“They are an international independent review board, and they approved the project. A little-known fact is that we have now received seven consecutive approvals from that agency,” Dr Brown said.

“When the new government came in, somebody decided that was insufficient, and we should get passed by a local research board. What kind of local research do we have?”

He said that “hurdles” had repeatedly been placed over the past three years.

“They asked questions; we answered,” he added. “We knew that it was essentially a blockade.”

Dr Brown maintained that the local group repeatedly contended that its questions had been inadequately addressed, prompting the group to approach Cabinet last year.

“They appeared to be impressed,” he said. “We waited six months for an answer, and by this time we had spent over $400,000.

“I told them they had to give some weight to the fact that the largest review board in the world had said we were good to go. BHB could still monitor it, but they don't have experts.

“We left, confident that they would let us go ahead. The health minister said we would have to go back to the research committee.”

Calling the response “outrageous”, Dr Brown added: “That's why I have concluded that the opposition is not medical, not ethical; it's political.”

A ministry spokeswoman said last night: “In March, the Ministry of Health and Seniors did encourage Dr Brown to resubmit his application, once complete, to BHB's Research Ethics Sub-Committee.”

Asked about initial concerns over a lack of regulations for new and largely untested procedures, Dr Brown said guidelines had been in train under the Progressive Labour Party government.

He also dismissed suggestions that the plans had sought to take advantage of “no option” patients desperate to try any remedy.

“There is no money to be made,” he added. “If so, it's a break-even operation.”

Dr Brown said that he was now seeking a legal opinion for his next options.

Meanwhile, Stemedica has announced that it is beginning clinical trials in the US on Alzheimer's disease treatment.

Update: this story has been amended to clarify that Dr Brown's proposal was not turned down by Cabinet but by the Research Ethics Sub-Committee of the Bermuda Hospitals Board.

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Published August 05, 2016 at 9:00 am (Updated August 05, 2016 at 10:19 am)

Brown seeks legal advice on stem cell research

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