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Stem Cell News
Stem Cell Clinic to Open in Bermuda
Bermuda Sun, September 14, 2007
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.
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