Because our laws have failed to keep pace with medical advances, a stem cell clinic will be opening without obtaining permission from a regulatory body. The clinic will be run by Dr. Ewart Brown and his wife Wanda.
However, Canada, the U.S., and the U.K. don’t normally cater to this manner of doing business.
Authoritative bodies such as the Human Fertilization and Embryology Authority and the Medicine and Healthcare Products Regulatory Agency in the U.K., the Food and Drug Administration in the U.S., and the Stem Cell Oversight Committee in Canada regulate and oversee all the treatment centers and research institutes that do experimental procedures in those respective countries. The system closely monitors all aspects of stem cell research and treatment.
It was the response to developments and ethical issues that have arisen in the field of stem cell research that prompted the establishment of Canada’s Stem Cell Oversight Committee and the Human Fertilization Authority in the U.K.
In partnership with San-Diego based firm Stemedica Cell Technologies, the stem cell clinic will open at Winterhaven in Smith’s. Dr. Brown, a physician, and his wife Wanda went public in July with their plans.
The soon to be established Brown-Darrell clinic will only use adult stem cells and avoid the controversial embryonic cells.
The Bermuda Health Council began overseeing all health care after the government passed a law in 2004.
By law, all health care service providers must have a license if they are seeking to go into business.
But it is not known when the regulations will be ready to be reviewed by Cabinet since the Bermuda Health Council is still in the process of writing them.
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 licenses.”
The National Institutes for Health in the U.S. and the U.K. Stem Cell Initiative make it clear on their websites that significant hurdles need to be overcome before treatment becomes a reality. They also say that the use of stem cells to treat diseases such as Parkinson’s and Alzheimer’s holds great promise. But other than for bone marrow transplants and skin grafts, treatment using stem cells is still in the experimental stage.
Before they are allowed to carry out trials on humans, scientists have to get the green light from the FDA or its U.K. counterpart. This is the case even if the scientist has achieved promising results in animal models.
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.”
The Ministry of Health currently issues licenses to health care providers, but contacting them for comment has been nearly impossible. The rest of the medical community has been equally difficult to reach.
the Brown-Darrell clinic will need a license to operate said Chief Medical Officer Dr. John Cann , through a Government spokeswoman. But no details were given.
Rather than assessing what procedures are carried out, the license 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 according to a health professional familiar with current legislation.
In the absence of oversight from an independent committee, doctors have privately stated that they are sceptical about procedures that would be carried out at the Brown-Darrell clinic. However, no public statements on this matter were made.
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.”
The ramifications of the venture as a group has not been discussed by physicians.
The silence from the medical community is “appalling” according to a second doctor the Bermuda Sun spoke with.
Neither wanted their names attached to their comments.
The Bermuda Sun was told that the council would have no jurisdiction over the procedures that would be done at the clinic if only research is carried out stated Dr. Delmont Simmons, chairman of the Bermuda Medical Council, which issues licenses to doctors that allows them to practice. A license will need to be obtained from the council if doctors plan on treating patients he added.
Efforts to get a response from the Browns were unsuccessful.
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 when the Bermuda Sun sought comment several weeks ago and last Friday.
The clinic should be opening this fall and the Browns plan to operate it as a private venture.
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 said Mrs. Brown in July, who is to be the clinic’s consulting CEO.
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.
Russian-trained scientists, most of whom are now based in the U.S., and physicians and American businessmen have teamed up to form Stemedica. They have been involved with past lucrative ventures in the industries of nutritional products, a top-selling laser that’s used in cosmetic procedures, and bottled water.
Having worked primarily as an inventor in the U.S., Stemedica’s president and chief medical officer Dr. Nicholai Tankovich is a Russian trained physician and physicist.
He made $35.3 million for the first six months of this year and $57.5 million in 2006 after inventing the Fraxel laser product.
The Stemedica website describes a “world-class team” when pointing out their 12 members in lower management.
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 license to practice 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 practicing medicine in California without a license, or that their professional credentials are in doubt.
