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A Sun investigation: Are we ready for a stem cell clinic?

The Premier and his wife believe so, but are any checks and balances in place?

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Friday, September 14, 2007 4:03 AM

Premier Dr. Ewart Brown and his wife Wanda will be able to open a stem cell clinic without having to obtain permission from a regulatory body because our laws have failed to keep pace with medical advances, the Bermuda Sun has learned.

That's a major departure from the way it works in the U.K., the U.S. and Canada.

In those countries, research institutes and treatment centres that do experimental procedures are heavily regulated and subject to oversight from bodies, such as the Food and Drug Administration in the U.S., the Stem Cell Oversight Committee in Canada, and the Medicine and Healthcare Products Regulatory Agency and the Human Fertilisation and Embryology Authority in the U.K.

Both Canada's Stem Cell Oversight Committee and the Human Fertilisation Authority in the U.K. were formed in response to developments and ethical issues that have arisen in the field of stem cell research.

Dr. Brown, a physician, and Wanda Henton Brown went public in July with their plan to open a stem cell clinic at Winterhaven in Smith's, in partnership with San Diego-based firm Stemedica Cell Technologies.

The work that will be done at what will be called the Brown-Darrell clinic will involve the use of adult stem cells, not embryonic ones, which many religious groups oppose.

In 2004, Government passed a law that established the Bermuda Health Council to oversee all aspects of health care.

The law requires all individuals and organizations seeking to go into business as a health service provider to have a licence.

But the Bermuda Health Council is still writing the regulations and it is not known when they will be ready for review by Cabinet.

Health Council CEO Anthony Richardson told the Bermuda Sun, in a written statement: "The Bermuda Health Council is governed by the Bermuda Health Council Act 2004. One of the functions of the Council is to regulate health service providers. At this time, we are in the process of preparing recommended regulations for the Minister of Health. Consequently, the Council does not currently issue licences."

Other than for bone marrow transplants and skin grafts, treatment using stem cells is still in the experimental stage - the National Institutes for Health in the U.S. and the U.K. Stem Cell Initiative make it clear on their websites that the use of stem cells to treat diseases such as Parkinson's and Alzheimer's holds great promise, but significant hurdles need to be overcome before treatment becomes a reality.

Even when scientists achieve promising results with animals in a lab, they have to get the green light from the FDA or its U.K. counterpart before they are allowed to carry out trials on humans.

Dr. Ben Goldacre, who writes a science column for The Guardian and is familiar with the issues raised in our stories today, told the Bermuda Sun: "A stem cell laboratory doing meaningful research is a major scientific undertaking."

Efforts to get any comment on the record from the medical community or the Ministry of Health, which currently issues licences to health care providers, have been next to impossible.

Chief Medical Officer Dr. John Cann said, through a Government spokeswoman, that the Brown-Darrell clinic will need a licence, but refused to elaborate.

The Bermuda Sun has been informed by a health professional familiar with current legislation that the licence that the Brown-Darrell clinic would require would be the same as for any medical practice and would address health and safety issues as they relate to the physical set-up of the premises, rather than assessing what procedures are carried out.

Doctors have said little publicly, but privately they are sceptical about procedures that would be carried out at the Brown-Darrell clinic in the absence of oversight from an independent committee.

One doctor told the Bermuda Sun: "You just can't open up shop and say: 'I'm going to cure diseases with stem cells'. If we do, then we're a third world country."

Silence from medics

He also said physicians have not discussed the ramifications of the venture as a group. A second doctor we spoke to said he found the silence from the medical community "appalling." But neither wanted their names attached to their comments.

Dr. Delmont Simmons, chairman of the Bermuda Medical Council, which issues licences to doctors that allows them to practise, told the Bermuda Sun that the council would have no jurisdication over the procedures that would be done at the clinic if only research is carried out. If doctors plan to treat patients, they will need to obtain a licence from the council, he said.

Efforts to get a response from the Browns were unsuccessful. We first sought comment several weeks ago and last Friday, Kendaree Burgess-Fairn, spokeswoman for the Brown-Darrell Clinic, said the Browns have said all they want to say about the clinic at this stage.

The Browns are to operate the clinic as a private venture and plan to open it this fall.

Mrs. Brown, who is to be the clinic's consulting CEO, said in July that while research would be the initial priority, eventually the clinic would treat one or two patients with diseases such as Alzheimer's and Parkinson's per week.

She said the clinic will host "advanced research in the use of adult stem cells for human treatment."

She was also quoted as saying: "It is our hope and intention that what we do at Brown-Darrell will help lay the groundwork for the treatment of patients around the world who, without stem cell treatment, have no hope for a normal life.

"We believe that we will significantly improve the quality of life of those patients we treat, and that we will contribute to the research being conducted in this field that will some day make stem cell treatment available to all those who need it."

Stemedica says on its website that its physicians have "conducted stem cell transplantation with over 1,500 human subjects."

Stemedica has a 'clinical trials' heading on its website, but it merely lists website addresses such as the National Institutes for Health and the one set up by Parkinson's sufferer, actor Michael J. Fox.

Stemedica's principals are American businessmen who have teamed up with Russian-trained scientists and physicians, most of them now based in the U.S., on lucrative ventures such as bottled water, nutritional products and a top-selling laser that's used in cosmetic procedures.

Stemedica's president and chief medical officer Dr. Nicholai Tankovich, a Russian trained physician and physicist, has worked primarily as an inventor in the U.S. (see profile, page 5)

The Fraxel laser product he invented made $57.5 million in 2006 and $35.3 million for the first six months of this year.

Lower down the management chain at Stemedica are the 12 members of what its website describes as its "world-class team".

Dr. Tankovich is among the group, whose members, again according to the website, are located in Centers of Excellence in San Diego and Palo Alto, in California, and Eastern Europe and "are directed towards treating diseases that have no cure."

Nine of the 12 are physicians. California Medical Board spokeswomen Candis Cohen and Debbie Nelson confirmed that none of the nine - Dr. Tankovich, Nikolay Mironov, Illiya Mironov, Sergey Ivanov, Narik Markchyan, Katherine Chentsova, Rosa Gundorova, Natalie Gavrilova and Vadim Repin - have a licence to practise medicine in the state of California. Neither does Dr. Kharazi, Stemedica's vice president of medical research. We should make it clear that there is no suggestion that any of the physicians are practising medicine in California without a licence, or that their professional credentials are in doubt.

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