MANILA - Foreign doctors are now required to secure a permit to perform stem cell therapy in the country or face criminal liability.

The Professional Regulation Commission (PRC)s Board of Medicine (BOM) made the announcement yesterday, explaining that the requirement is part of government efforts to regulate the practice of stem cell therapy in the country to ensure the safety of patients.

In a statement, the BOM said foreign physicians who intend to practice stem cell therapy here must obtain special temporary permit from the PRC to avoid being charged with medical malpractice.

Even local doctors who have aided foreign physicians illegal practice of stem cell therapy shall be also held criminally liable, the BOM added.

To secure the special temporary permit, a foreign doctor must submit proof of education and actual practice in the field of stem cell therapy and current license authenticated by the Philippine embassy and the embassy in the country of origin.

The board said physicians should have acquired the necessary education, supervised training and extensive clinical experience prior to performing the treatment. It noted that the argument that stem cell therapy falls under the general practice of medicine since it only involves injection of stem cell solution is erroneous.

As professionals, physicians should be able to conduct self-assessment and self-evaluation regarding what they can and what they should not do, they added.

The BOM also noted that stem cell therapy should be practiced only in hospitals and clinics licensed by the Department of Heath for assurance that these medical facilities have the necessary manpower and equipment to prevent risks and hazards to patients.

The board also warned patients desiring to undergo stem cell therapy abroad to first verify the status of clinics and hospitals as well as practitioners from regulatory authorities.

Earlier, the Food and Drug Administration and the Philippine Medical Association (PMA) reported receiving numerous complaints of foreign doctors performing stem cell therapy in hotels and other non-medical facilities. The PMA said foreign doctors injected patients with animal-based stem cells at P1 million per shot, but these foreigners are not even licensed to practice medicine in the country.

More here:
Foreign doctors need permit for stem cell therapy

By: Jet Villa, InterAksyon.com August 6, 2013 4:34 PM

InterAksyon.com The online news portal of TV5

MANILA, Philippines - Amid a flurry of reports about unregulated procedures that have led to serious injury or even deaths, the Professional Regulation Commission (PRC) is now requiring foreign doctors wishing to practice stem cell therapy in the Philippines to obtain a special temporary permit (STP).

In a position statement, the Professional Regulatory Board of Medicine (PRBOM) said foreign doctors must submit proof of education, training and clinical experience and actual practice in the field of stem cell therapy, plus a current license to practice authenticated by the Philippine Embassy/Consulate in the country of origin when they apply for the special permits.

The board warned: Any foreign physician who practices the professionwithout a STP will be criminally liable for illegal practice of medicine.And, it added, those who have aided and abetted the foreign physicianspractice of the profession are also criminally liable.

The position paper was signed by PRBOM chairman Dr. Edgardo Fernando and members doctors Miguel Noche Jr., Florentino Doble, Restituto de Ocampo, Jose Cueto Jr., and Mildred Pareja.

Controversy hounds new group

The position statement on stem cell therapy was issued amid a growing rift among doctors over recent controversial cases, including several lawmakers who had procedures done, but whose conditions worsened.

One newly-founded group of doctors doing stem-cell transplant, the Philippine Society of Stem Cell Medicine (PSSCM), has been pitted by the controversy against the Philippine College of Physicians, Philippine Society of General Internal Medicine (PSGIM), Philippine Society of Hematology and Blood Transfusion (PSHBT) andPhilippine College of Chest Physicians (PCCP). The latter groups all believe thatPSSCM's practices are unethical as it charges huge fees from patients for stem cell procedures that are still under clinical trial.

The PRBOM has backed the Department of Health in issuing Administrative Order 2013-0012 providing the guidelines for stem cell, cell-based therapy in the country. "The practice of stem cell therapy does not constitute standard care at the present time. The claim that it offers cure to numerous diseases and conditions has not been proven through scientific research and documentation, the PRBOM said. Right now, it said, "there is difficulty verifying claims of practitioners and institutions regarding the effectivity ofavailable treatment modalities.

Link:
PRC: Foreign docs doing stem cell therapy in PH must get special temporary permits

NewsLife: PCP pushes for more studies on stem cell therapy
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By: PTV PH

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NewsLife: PCP pushes for more studies on stem cell therapy - Video

Adult Stem Cell Therapy for Back Pain
A registered nurse describes her experience with an adult stem cell therapy procedure for back pain. More information at medrebels.org.

By: medrebels1

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Adult Stem Cell Therapy for Back Pain - Video

Advanced Topics - Stem Cell Therapy part 1

By: Jesse Matteson

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Advanced Topics - Stem Cell Therapy part 1 - Video

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O'Malley Highlights How Biotechnology Benefits The Economy CBS Local ANNAPOLIS, Md. (WJZ) — New technologies being developed in the University of Maryland biopark are making a difference to the state's economy. Pat Warren reports on some of the progress. Governor Martin O'Malley credits Maryland's biopark with ... O'Malley to highlight biotechnologyMiamiHerald.com all 17 news articles »

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“Diane and Nancy, I'm shocked that
you are either unaware or do not acknowledge that there are studies
of oocyte retrieval surgeries that show very persuasively that the
potential harm from this procedure is manageable. While you refer to 'stories' of women being harmed--that's called anecdotal
evidence and is the antithesis of science--you ignore the established
research in this area, which makes it clear that you are reacting
hysterically rather than responding to empirical evidence. I would
suggest that you read the National Academies Press workshop report:
Assessing the Medical Risks of Human Oocyte Donation for Stem Cell
Research (http://www.nap.edu/catalog.php?record_id=11832).
It cites numerous studies, including a German study that examined the
outcome of approximately 380,000 oocyte retrieval surgeries during
2000-2004. For the procedures for which there was information, the
rate of complications was very low: only 0.002 percent—2 in every
100,000—had complications that required surgery to correct.

“Studies have also examined the
potential risks of retrieval for a woman's future fertility.
“According to one large study, the
rate of infection after oocyte retrieval was about 1 in every 200 IVF
cycles, and surgery is needed to treat pelvic abscesses in less than
1 in 1,000 IVF cycles. 

“About five hundred egg donations
take place in Canada each year, according to the Canadian Fertility
and Andrology Society.The CFAS told me that, between 2001 and 2010,
only two donors in Canada, out of a total of 4,177 donations,
suffered from “severe” OHSS, which usually involves
hospitalization. Fourteen others had “moderate” OHSS. These
numbers are collected in a database called the Canadian Assisted
Reproductive Technologies Registry.

“So sure, you can find your 'stories' but they do not represent a scientific review of the available
data--you are trying to legislate based on fear. That's not science;
that's the dark ages, and it's exactly the tactics used by
anti-abortionists (and indeed by organizations like the Center for
Genetics and Society which opposes such beneficial advances as
mitochondrial replacement surgery).

“Furthermore, because women have a
set of two ovaries and two fallopian tubes, they can remain fertile
even if one set is damaged, and there is no evidence that both might
be threatened simultaneously by the side effects of retrieval
surgery. 

“Today doctors have had two decades
of experience with the use of hormone treatments to maximize the
number of eggs that can be harvested from a woman, and they have
become quite proficient in the production of oocytes. During that
time they have also worked to improve the safety of the procedure and
decrease the potential risks. Despite these improvements some risk
will remain, because hormones have a powerful effect on the body—they
could not increase egg production so dramatically if this were not
true—and anything with a powerful effect on the body has the
potential for harmful side effects as well. 

“Egg donations are done for a reason.
There are risks and benefits. For you to exaggerate the risks based
on 'stories' and ignore the evidence is unconscionable.
It's exactly what anti-abortion groups do and what opponents of
genetically modified foods do--you promote fear around manageable (or
in the case of GMOs, negligible) risk. 

“Your call for 'further studies' is the age old technique of reactionaries trying to control other
people and impose their values on other people. You know darned well,
because of your fundamental ideological opposition to this procedure,
no study results could ever meet your standard of acceptability. 

“You are trying to control other
women's bodies, claiming you have superior knowledge and
wisdom--those are pro-life talking points. Your views, and that of
the organizations that you represent, are illiberal.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ib44Z4ZI-j0/pay-for-eggs-legislation-comment-on-risk.html

“Dr. Diane Tober and Prof. Nancy
Scheper-Hughes  are 'pro choice'  social scientists who are
concerned about the absence of any evidence-based medicine on the
long term effects of hyper-stimulation for oocyte (egg) production in
young women research subjects. We are not concerned about abortion,
right to life, or obstructing  needed and valuable research on
stem cells. We are concerned about the safety for potential research
subjects who are being actively recruited to participate in
 invasive medical procedures without any medical research
studies on the possible risks and consequences of egg multiplication
and extraction. We are on record that we  fully support stem
cell research but not at the expense of unprotected egg donors.”  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/CdOjDrBctTE/comment-re-pay-for-eggs-item-and-forbes.html

“Should activist groups, working
through legislators, exercise their control over women’s
reproduction? Do we really 'own' our own bodies? Or does that tenet
only hold when nanny groups say it’s okay?”

“Well, if (when?) AB 926 is signed, I
think our committee should meet to consider what recommendations we
would make to the (the department) as a result of the bill.  Those
recommendations could lead, if the committee and the department
agree, to a revision of the state guidelines.  As a matter of
law, a statute, particularly a subsequent statute, trumps a guideline
where they are in conflict, but basically I expect we'll see what the
committee thinks and what the department decides.  I don't wish
to guess at the results of either process.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/sZ_beYvQCX8/pay-for-eggs-legislation-now-before.html

“If we went 10 years and had no
clinical treatments, it would be a failure. We need to demonstrate
that we are starting a whole new medical revolution.”

“The opportunity to run trails under
the well-funded CIRM could be a boon for CROs (contract research
organizations)....But the difficulties of handling the stem cells and
gathering enough patients to enroll in a trial may prove daunting for whatever
company tries to conduct the trials.”

 “No one has reached out to us yet
because the specific details of what we are looking for in the
clinics have not yet been decided.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/g-INer3wY50/skimpy-coverage-of-alpha-clinic-concept.html

The California stem cell agency is located south of Market Street in San  Francisco, close to the San Francisco Giants ballpark(upper right).  Since  the agency has been there, the area has grown from seedy to gentrified.

“I met with the mayor of San
Francisco(Ed Lee), who's a dear friend, and he encouraged us to be
aware that he's very committed to helping us find some space in San
Francisco. Whether it means tax credits or incentives to a potential
landlord, we still have to work that out. Obviously we still have to
work out what the space will be. But the fact that the mayor has
indicated very explicitly that he wants to keep us in San Francisco,
I think it will bode well for us down the road.

“The current owner of the property
(Stockbridge Capital Partners) has not been happy that for ten years
they've had to supply free rent to us. And what they didn't
anticipate was having to provide for over $755,000 in operating
costs, which they thought some donors would take are of. Those donors
-- some of whom passed away and others who chose to give money to
other institutions, UC San Francisco, in particular, to the stem cell
lab, which was very much appreciated, I know, by UCSF – but at
the end of the day, there's no room for negotiations with this
current owner.”

“I would not work on that assumption.
I would work on the assumption somewhere between a dollar and more,
again, dependent upon what kind of tax incentives the City of San
Francisco would provide. We're very fortunate that my son(Joaquin
Torres) is the deputy mayor for economic development, so we also have
him working on this as well.”

“I'll ask more questions offline.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/v8usDDMWucE/california-stem-cell-agency-looking-for.html

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