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Premier, Stemedica silent on stem cell centre's progress

David Howe of Stemedica and Premier Ewart Brown.

More than a year after it was scheduled to open, Bermuda's stem cell facility doesn't appear ready for business any time soon.

The Brown-Darrell Clinic project in Winterhaven – involving Premier Ewart Brown, wife Wanda and California-based Stemedica – was announced amid fanfare in the summer of 2007, with Stemedica representatives flying to the Island for a press conference and the Progressive Labour Party championing the Premier for creating the ultimate hope for millions of people.

At that stage is was said to be opening in 2007, before the date was put back to early 2008.

However, on hearing of the proposal, International Society for Stem Cell Research (ISSCR) president George Daley announced he was very sceptical of anyone running experimental treatment in jurisdictions such as Bermuda, where there is no regulatory oversight.

Since Dr. Daley's comments, Bermuda has been dropped from Stemedica's website and never been restored, while requests for updates on how the plan is going have consistently been ignored.

Over the past two days, Dr. Brown, Mrs. Brown and Stemedica vice president Dave McGuigan have refused to answer when asked if the project is going ahead.

The last public comment regarding the project came last summer from Dr. Brown, who told a conference in Boston that stem cell transplants would be available in the "not-too-distant future" and praised the virtues of medical tourism.

The ISSCR last month published worldwide guidelines addressing ethical and social issues related to stem cell research.

It states: "The ISSCR recognises an urgent need to address the problem of unproven stem cell interventions being marketed directly to patients.

"Numerous clinics around the world are exploiting patients' hopes by purporting to offer new and effective stem cell therapies for seriously ill patients, typically for large sums of money and without credible scientific rationale, transparency, oversight, or patient protections.

"The ISSCR is deeply concerned about the potential physical, psychological, and financial harm to patients who pursue unproven stem cell-based 'therapies' and the general lack of scientific transparency and professional accountability of those engaged in these activities.

"The marketing of unproven stem cell interventions is especially worrisome in cases where patients with severe diseases or injuries travel across borders to seek treatments purported to be stem cell-based 'therapies' or 'cures' that fall outside the realm of standard medical practice.

"Patients seeking medical services abroad may be especially vulnerable because of insufficient local regulation and oversight of host clinics.

"Some locales may further lack a system for medical negligence claims, and there may be less accountability for the continued care of foreign patients."

It states that there are some responsible clinician-scientists legitimately practising medical innovation, which should follow ISSCR policy guidelines.

But it continues: "In all other circumstances, the ISSCR condemns the administration of unproven uses of stem cells or their direct derivatives to a large series of patients outside of a clinical trial, particularly when patients are charged for such services.

"Scientists and clinicians should not participate in such activities as a matter of professional ethics. Healthcare institutions and research institutions should not participate in such activities.

"Regulators in countries where such illegitimate therapies are offered have a responsibility to prevent exploitation of patients and, if necessary, to close fraudulent clinics and to take disciplinary action against the clinicians involved.

"The ISSCR recognises the value of having separate jurisdictions provide their own regulations covering medical innovations using stem cells or their direct derivatives and strongly recommends the creation of such regulations through consultation with expert scientists, clinicians, and ethicists."

The Brown-Darrell Clinic has pledged to welcome and encourage legislation consistent with the international protocol practised by countries engaged in stem cell work, but has repeatedly failed to respond when asked if it will postpone opening the stem cell side of its operation until such legislation is in place.

The Ministry of Health has repeatedly refused to say whether any stem cell legislation will be introduced in Bermuda.

Revealing its partnership with the Browns in 2007, Stemedica announced it provides treatment to improve the lives of patients with neurodegenerative and other diseases.

It said it was designing technologies and services to treat a wide array of conditions including stroke, Alzheimer's, Parkinson's, ischaemic brain traumas, spinal cord injuries, diabetes and diseases of the eye.

Stemedica's website says it has research clinics in Switzerland, Korea, Mexico and Russia.