Consultant quits over DOH chief’s stand on stem cell therapy

By: Jet Villa, InterAksyon.com August 16, 2013 8:24 AM

InterAksyon.com The online news portal of TV5

MANILA, Philippines -- (UPDATE - 10:12 a.m.) A consultant of Secretary Enrique Ona resigned Friday, calling the Health chiefs position that patients undergoing experimental stem cell therapy should pay unacceptable.

Dr. Anthony Leachon, who is in Davao City, said he emailed his resignation letter to Ona.

It is with deep regret that I'm resigning asDepartment of Health consultant for non-communicable diseases effective today (Friday). I have been privileged and honored to be a part of your administration even as a one peso a year consultant. I value our friendship and camaraderie which started years ago, Leachon, vice president of the Philippine College of Physicians and Onas consultant for non-communicable diseases, wrote.

Because his position is directly opposed to Onas, Leachon told the Health secretary, I believe I have lost your trust and confidence and I might not be effective serving the DOH and fighting the PCP and medical societies ' cause in the service of the Filipino patient.

Leachon was Onas consultant for non-communicable diseases since November 2011.

Ang pinaka-hindi ko nagustuhan ay yung sisingilin ang pasyente kahit clinical trial pa lang. Yon ang unacceptable sa akin (What I disagree with most is charging patients even if what they undergo are just clinical trials. That is unacceptable), Leachon said.

His resignation came as the National Health Institute, the research arm for health sciences of the University of the Philippines-Manila, joined the growing opposition to the Health secretarys stand on experimental stem cell therapy.

Leachon, a cardiologist at the Manila Doctors Hospital, called Onas position a complete violation of the Code of Ethics (for doctors) and being the secretary of health, alam niya dapat yon (he should know that). This is not a sign of ignorance, pero siguro may mga taong iba ang sinasabi sa kaniya (but there may be people telling him otherwise).

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Consultant quits over DOH chief's stand on stem cell therapy

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Vet-Stem, Inc. Founder and CEO, Robert Harman, DVM, Invited to Speak at the Adult Stem Cell Therapy and Regenerative …

Poway, California (PRWEB) August 15, 2013

Robert J. Harman, DVM, Chief Executive Officer of Vet-Stem, Inc., a leading Regenerative Veterinary MedicineTM company located in San Diego, California, has been invited back to speak at the Adult Stem Cell Therapy and Regenerative Medicine Conference in Cleveland, Ohio August 19-21, 2013. The conference is presented by The National Center for the Regenerative Medicine (NCRM), Case Western Reserve University (CWRU), Cleveland Clinic (CC), and University Hospitals Case Medical Center (UHCMC) to bring together a global perspective on regenerative medicine and adult stem cell therapy.

Dr. Harman is scheduled as the first speaker of Session II titled Disease Models for Adult Stem Cell Therapy, and his presentation is One Medicine Natural Veterinary Disease Models.

He stands alone in his expertise in the field of Regenerative Veterinary Medicine among the 273 attendees from 100 institutions in 17 countries that make up the conference. Dr. Harman draws his knowledge from more than 10,000 horse, dog and cat patients treated over the last 10 years in both the U.S. and Canada using proprietary Vet-Stem technology.

Dr. Harman is sharing the podium with Case Western Reserve Universitys own Dr. Arnold Caplan, and revolutionary regenerative medicine companies such as BioTime, Terumo BCT, STROMALab, and Pfizer. Dr. Caplan, a technology pioneer in cell-based therapies in Regenerative Medicine, is a scientific advisor to Vet-Stem, Inc.

About Vet-Stem, Inc.

Vet-Stem, Inc. was formed in 2002 to bring regenerative medicine to the veterinary profession. The privately held company is working to develop therapies in veterinary medicine that apply regenerative technologies while utilizing the natural healing properties inherent in all animals. As the first company in the United States to provide an adipose-derived stem cell service to veterinarians for their patients, Vet-Stem, Inc. pioneered the use of regenerative stem cells in veterinary medicine. The company holds exclusive licenses to over 50 patents including world-wide veterinary rights for use of adipose derived stem cells. In the last decade over 10,000 animals have been treated using Vet-Stem, Inc.s services, and Vet-Stem is actively investigating stem cell therapy for immune-mediated and inflammatory disease, as well as organ disease and failure. For more on Vet-Stem, Inc. and Veterinary Regenerative Medicine visit http://www.vet-stem.com or call 858-748-2004.

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Vet-Stem, Inc. Founder and CEO, Robert Harman, DVM, Invited to Speak at the Adult Stem Cell Therapy and Regenerative ...

NIH joins opposition to charging patients for experimental stem cell therapy

By: Jet Villa, InterAksyon.com August 16, 2013 8:24 AM

InterAksyon.com The online news portal of TV5

MANILA, Philippines -- The National Institute of Health has joined the growing opposition to Health Secretary Enrique Onas stand that patients undergoing experimental stem cell therapy should pay for participating in what are essentially clinical trials.

The NIH, the research arm for health sciences of the University of the Philippines-Manila, issued a statement saying it fully support(s) the position statement of 21 medical organizations that clinical trials should be at no cost to the patients.

Officials of the NIH said making patients pay for participating in clinical trials is unethical since the procedures they undergo are not yet proven to be beneficial.

Speaking at the First Mid-Year Convention of the Philippine Society for Stem Cell Medicine on Monday, Ona said the country cannot completely adopt Western practices of offering these investigational therapies completely free for clinical trial participants.

Ona, the PSSCMs honorary chairman, cautioned that free clinical trials will not only be unaffordable for our institutions but very expensive and will forever relegate us to be a marketing testing ground after others have developed a technic in their country.

His position has triggered a backlash from leading medical practitioners.

In their statement, the NIH officials also urged the Department of Health and the Food and Drug Administration to issue clearer regulations for stem cell therapy for practicing clinicians to safeguard the health of Filipinos.

Stem cell therapy for unproven indications is proliferating in the Philippines and posing serious safety issues to unknowing clients (We are) alarmed by these uncontrolled practices which may include false claims, misinformation and exorbitant fees, they said, adding that the unproven use of stem cell therapy in these conditions should be restricted to clinical trials only.

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NIH joins opposition to charging patients for experimental stem cell therapy

Solon calls for probe into stem cell therapy

by Buena Bernal Posted on 08/15/2013 7:59 PM |Updated 08/16/2013 12:05 AM

PROBE STEM CELL THERAPY. Rep Paulino 'Doy' Leachon files a resolution to probe the conduct of stem cell therapy in the Philippines. Photo grabbed from islandsentinel.com

MANILA, Philippines - Rep Paulino Salvador "Doy" Leachon of Oriental Mindoro's 1st district filed on Thusday, August 15, a house resolution calling for a congressional inquiry in aid of legislation on the conduct of stem cell therapy in the country.

House Resolution 215 was filed a day after Leachon's scheduled privilege speech, calling for the resignation of Health Secretary Enrique Ona over the cabinet official's stand on stem cell therapy.

READ: Leachon asks Ona to resign over stem cell issue

The 40-year-old lawmaker also urged concerned government agencies to step up their regulatory oversight. These agencies include the Department of Health (DOH), the Food and Drug Administration (FDA), and the Professional Regulation Commission (PRC).

First attempt to regulate

Government regulation of stem cell treatment is still in its infancy stage, with the guidelines for accreditation of facilities released only in March.

It is DOH's first attempt at regulating the practice, despite the therapy having been administered by Filipino physicians for years now.

The types of stem cell treatment that are allowed, prohibited, and restricted (i.e. allowed but with limitations) in the facilities to be accredited by August 31 are listed in the released guidelines.

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Solon calls for probe into stem cell therapy

Bill filed to regulate stem cell therapy in PH

By Christian V. Esguerra Philippine Daily Inquirer

La Union Rep. Eufranio Eriguel. Photo from congress.gov.ph

MANILA, PhilippinesA congressman has joined the call to regulate stem cell therapy administered in the country.

La Union Rep. Eufranio Eriguel has introduced House Bill No. 212, which would put up a bioethics advisory board that would establish ethical standards governing the practice of stem cell research and therapy.

Under the proposed Stem Cell Research and Therapy Act of 2013, the board shall be responsible for addressing contentious ethical, scientific and legal issues in stem cell and cell-based or cellular research and therapies.

There is much to be learned from stem cell therapy, its benefits and application in the cure of some of the most devastating diseases and conditions. As of now, the full promise of stem cell treatment remains unknown, Eriguel said in a statement.

But the cost far outweighs its benefits because it is very expensive and only a few physicians are trained to do stem cell procedures here in the Philippines.

In his proposal, the board will be headed by the health secretary and the National Transplant Ethics Committee, while the Food and Drug Administration director will serve as vice chairman.

A proposed institutional review committee will be tasked to approve stem cell and cell-based or cellular research and therapies based on existing Department of Health guidelines.

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Bill filed to regulate stem cell therapy in PH

DOH gives health facilities engaged in stem cell therapy until Aug. 31 to register

By: Jet Villa, InterAksyon.com August 13, 2013 8:42 AM

InterAksyon.com The online news portal of TV5

MANILA, Philippines - The Department of Health (DOH) has given all health facilities practicing stem cell therapy and companies importing and producing stem cell products untilAug. 31to apply for accreditation and product registration, respectively.

Nick Lutero, director of the DOH-Bureau of Health Facilities and Services, said it will be considered illegal for facilities to do stem cell procedures if they fail to comply with the requirement.

Papatigil namin ang pag-conduct ng therapy. For those still continuing to practice, I think we have sufficient laws, particularly on the illegal practice of medicine. They could be criminally liable, he said in a chance interview.

Lutero lamented that only five hospitals have applied for registration although the DOH had issued the guidelines on this since March.

We have done preliminary visits sa mga hospitals na ito at mukang based sa initial inspection, merong sufficient compliance sa mga facilities, he said.

Companies importing and producing stem cell products, on the other hand, should apply for registration with the Food and Drug Administration, an agency attached to the DOH.

Products that will not be applied for registration will also be considered illegal after the deadline.

Experimental treatment not for free

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DOH gives health facilities engaged in stem cell therapy until Aug. 31 to register

DOH sets deadline for stem cell therapy accreditation

Manila, Philippines -- Hospitals and health facilities offering stem cell therapy have until August 31 to apply for accreditation from the Department of Health (DoH).

DoH Secretary Enrique T. Ona said a number of hospitals in Metro Manila have already applied for accreditation to perform this "innovative" treatment that has not yet been accepted as standard mode of care in the country since it needs further tests and several more layers of research.

In the first mid-year convention of the Philippine Society for Stem Cell Medicine at the Manila Hotel yesterday, Ona reiterated that stem cell therapy is "the future of medicine."

"Stem cell therapy is not a cure-all medical treatment. Patients have yet to be presented first with standard of treatment, and in many cases, stem cell treatments have to be done in conjunction with other standard modalities of treatment," he said.

The Bureau of Health Facilities and Services (BHFS) of the DoH is accepting the applications for accreditation while a bio-ethics committee and a hospital-based review board will go over the applications and decide on their approval.

Five big hospitals in Metro Manila have already applied for accreditation, said Nick Lutero, chief of the BHFS.

Lutero said initial checks have revealed that these hospitals possess the required equipment needed for the treatment but they would still have to check on requirements set by the Food and Drug Administration (FDA) in relation to the practice.

Lutero said institutions that are offering stem cell treatments can still perform the procedures pending the approval of applications. However, once formal accreditations are already given, unaccredited institutions should cease offering stem cell therapy.

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DOH sets deadline for stem cell therapy accreditation

Stem cell therapy shows promise in repairing brain damage

Stem cell therapy shows promise in repairing brain damage even hours after stroke occurs

Durham, NC Stroke is a major health concern and is a leading cause of death in the United States, according to the Center for Disease Control. Despite significant research efforts, developing treatments that ensure complete recovery for stroke patients poses an extreme challenge, especially when more than a few hours have passed between onset of the stroke and administration of treatment.

However, a new study released today in STEM CELLS Translational Medicine indicates that endothelial precursor cells, which are found in the bone marrow, umbilical cord blood, and as very rare cells in peripheral blood, could make a significant difference for these patients recovery even in the later stages of stroke. In animal studies, the treatment minimized the initial brain injury and helped repair the stroke damage.

Previous studies indicated that stem/progenitor cells derived from human umbilical cord blood (hUCB) improved functional recovery in stroke models, noted Branislava Janic, Ph.D., a member of Henry Ford Health Systems Cellular and Molecular Imaging Laboratory in Detroit and lead author of the study. We wanted to examine the effect of hUCB-derived AC133+ endothelial progenitor cells (EPCs) on stroke development and resolution in rats.

Dr. Janic and his team injected rats that had suffered strokes with the stem cells. When they later examined the animals using MRI, they found that the transplanted cells had selectively migrated to the injured area and that the stem cells stopped the tissue damage from spreading, instigated regeneration, and also affected the time course for stroke resolution. A significant decrease in lesion size also was observed, at a dose of 10 million cells, as early as seven days after the strokes onset.

This led us to conclude that cord blood-derived EPCs can significantly contribute to developing more effective treatments that allow broader time period for intervention, minimize the initial brain injury and help repair the damage in later post-stroke phases, Dr. Janic said.

The early signs of stroke are often unrecognized, and many patients cannot take advantage of clot-busting treatments within the required few hours after stroke onset, said Anthony Atala, M.D., editor of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. In this animal study, a combination of stem cells shows promise for healing stroke damage when administered 24 hours after the stroke.

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The full article, Intravenous administration of human umbilical cord blood derived AC133+ endothelial progenitor cells in rat stroke model reduces infarct volume magnetic resonance imaging (MRI) and histological findings, can be accessed at http://www.stemcellstm.com.

About STEM CELLS Translational Medicine: STEM CELLS TRANSLATIONAL MEDICINE (SCTM), published by AlphaMed Press, is a monthly peer-reviewed publication dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices.

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Stem cell therapy shows promise in repairing brain damage

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

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.

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