Manila, Philippines- The Professional Regulatory Board of Medicine (PRBOM) today, August 2, 2013 issued its official position on the status of and issues related to stem cell therapy in the wake of recent reports of doctors performing stem cell treatments in the country and the allegedly unscrupulous and questionable activities associated with such practice.
The full text of the PRBOM's position paper follows:
PRBOM's POSITION PAPER ON STEM CELL MEDICINE
1.The status of stem cell medicine
The Professional Regulatory Board of Medicine declares its agreement with DOH Administrative Order 2013-0012 providing 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 have not been proven through scientific research and documentation. At this time, there is difficulty verifying claims of practitioners and institutions regarding the effectivity of available treatment modalities.
2.Facilities and equipment
The PRBOM recognizes the authority of the DOH in the screening and licensing of health facilities, as contained in the DOH Administrative Order 2013-0012 (AO 2013-0012), also known as Rules and Regulations Governing the Accreditation of Health Facilities Engaging in Human Stem Cell and Cell-based or Cellular Therapies in the Philippines.
3.Drugs and stem cell solutions
The PRBOM agrees with FDA Advisory No. 2013-012, requiring FDA approval for the following stem cell preparations: a) genetically altered human adult and umbilical cord stem cells, b) adipose or fat cells derived human stem cell, c) human cells, tissues, and cellular and tissue-based products that are subjected to genetic manipulation, and d) live animal embryonic, fetal, or adult stem cells in parenteral form for human administration.
4.Qualifications of Practitioners, Education, Training, Credentials, Titles
At the present time, there is a universally accepted pathway to attaining the status of specialists, which is structured residency training with extensive supervised clinical experience, and with a system of quality assurance before a physician specialist is allowed to practice the specialty. As professionals, physicians should be able to conduct self-assessment and self-evaluation regarding what they can and what they should not do. From the time they were in medical school, they have been exposed to faculty members who have attained certification in their fields of specialization, obtained through a rigorous process of study/training and continuous evaluation.
5.Stem cell medicine as Specialty Practice
The argument that stem cell medicine falls under general practice because anyone can do it as it only entails the injection of stem cell solution is very narrow. Not anyone who can inject a chemotherapeutic drug qualifies to be a medical oncologist.
The list supposed to be treatable or curable with stem cell therapy are very complex clinical conditions, requiring multidisciplinary teams that are based in health care facilities with the necessary health manpower support and advanced facilities and equipment. The list of conditions being treated with stem cell therapy includes the following:
◦Cancer
◦Alzheimer’s disease
◦Parkinson’s disease
◦Autism
◦Diabetes
◦Emphysema
◦Erectile dysfunction
◦Multiple sclerosis
◦Heart disease
◦Rheumatoid and osteoarthritis
◦Spinal cord injury
◦Stroke
◦Liver disease
◦Idiopathic pulmonary fibrosis
◦Aging
The above conditions fall under specialty practice. Physicians who claim to be specialists and experts in stem cell therapy should have had extensive training in the treatment of the above-mentioned diseases and disorders, with their training to include structured rotations in different fields of medicine, and most importantly with well-defined core competencies and scope of practice. The training program should also include quality assurance mechanisms like evaluation during and at the end of rotations and training, with documentation of clinical experience in the diagnosis and treatment of the above-listed conditions. Given the complexity of the different conditions being treated, the training should be conducted in accredited institutions, with the presence of faculty members who have been recognized as experts in the field due to their education, extensive training and clinical experience.
Therefore, the PRBOM declares and maintains that physicians desiring to practice stem cell medicine should have acquired the necessary education, structured / supervised training and extensive clinical experience. The PRBOM as the regulatory body for the practice of medicine places the welfare and safety of patients above any consideration.
Foreign physicians who wish to practice stem cell therapy in the country are required to apply for and obtain special temporary permits (STP) from the Professional Regulation Commission. Foreign physicians will need to 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. Any foreign physician who practices the profession without a STP will be criminally liable for illegal practice of medicine. Those who have aided and abetted the foreign physicians’ practice of the profession are also criminally liable.
The PRBOM thus condemns the stem cell therapy done on DDB Chairman Antonio Villar, conducted in a hotel located in Metro Manila, purportedly by foreign nationals.
The PRC and the PRBOM join the DOH and DFA in warning patients who plan to undergo treatment especially abroad. There are precautions to be observed like verifying the status of institutions (clinics and hospitals) and practitioners from the regulatory authorities in foreign countries. Philippine embassies can also be contacted for information on these institutions. Foreign medical professional societies can be contacted to verify the status of physicians claiming to be experts in stem cell therapy. The rights of patients in foreign countries should be researched, including medical insurance, the system of administrative investigations for erring practitioners and the like. Lastly, patients should not expect the therapy to be able to cure all diseases and medical conditions.
6.Setting of practice
Stem cell therapy should be practised in appropriate safe settings like DOH-licensed hospitals and clinics with the necessary medical manpower and equipment. It should not be practised in hotels as they pose risks and hazards to patients.
Institutions with credentials committees and with a set of requirements for admission to the medical staff may have an advantage over stand-alone clinics, because they ensure the appropriateness of training of physicians before they are given clinical practice privileges. These institutions observe proper documentation of clinical practices which allows audit and review of procedures being performed with particular focus on the clinical outcomes.
Medical professional organizations and its officers/members are prohibited from misrepresenting themselves as specialists in a certain field of medicine when in reality they are not. In addition, they are not allowed to make false claims, like announcing collaboration in the field of stem cell medicine with certain institutions like the Professional Regulation Commission. The PRC has not collaborated with any medical organization in any field of medicine.
The stem cell society has to apply for and acquire SEC registration, a most basic requirement. This will allow them to engage in their official activities like conduct of conventions, recruiting members, or engaging in fund-raising activities.
A group of physicians cannot just form a society and declare that they are specialists in a certain field. In addition, they cannot just append the title of “Fellow” after their names without clarifying what kind of academic program and certifications they went through.
The Professional Regulatory Board of Medicine and the Professional Regulation Commission, the government regulatory bodies for the practice of medicine, were prompted to issue this position paper to inform and guide the public on the issues related to the practice of stem cell therapy, licensed institutions and facilities, drugs and stem cell solutions, credentials of practitioners, the need for special permits for foreign physicians, establishment of specialty societies, and pathways to specialization.
The full text of the PRBOM's position paper follows:
PRBOM's POSITION PAPER ON STEM CELL MEDICINE
1.The status of stem cell medicine
The Professional Regulatory Board of Medicine declares its agreement with DOH Administrative Order 2013-0012 providing 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 have not been proven through scientific research and documentation. At this time, there is difficulty verifying claims of practitioners and institutions regarding the effectivity of available treatment modalities.
2.Facilities and equipment
The PRBOM recognizes the authority of the DOH in the screening and licensing of health facilities, as contained in the DOH Administrative Order 2013-0012 (AO 2013-0012), also known as Rules and Regulations Governing the Accreditation of Health Facilities Engaging in Human Stem Cell and Cell-based or Cellular Therapies in the Philippines.
3.Drugs and stem cell solutions
The PRBOM agrees with FDA Advisory No. 2013-012, requiring FDA approval for the following stem cell preparations: a) genetically altered human adult and umbilical cord stem cells, b) adipose or fat cells derived human stem cell, c) human cells, tissues, and cellular and tissue-based products that are subjected to genetic manipulation, and d) live animal embryonic, fetal, or adult stem cells in parenteral form for human administration.
4.Qualifications of Practitioners, Education, Training, Credentials, Titles
At the present time, there is a universally accepted pathway to attaining the status of specialists, which is structured residency training with extensive supervised clinical experience, and with a system of quality assurance before a physician specialist is allowed to practice the specialty. As professionals, physicians should be able to conduct self-assessment and self-evaluation regarding what they can and what they should not do. From the time they were in medical school, they have been exposed to faculty members who have attained certification in their fields of specialization, obtained through a rigorous process of study/training and continuous evaluation.
5.Stem cell medicine as Specialty Practice
The argument that stem cell medicine falls under general practice because anyone can do it as it only entails the injection of stem cell solution is very narrow. Not anyone who can inject a chemotherapeutic drug qualifies to be a medical oncologist.
The list supposed to be treatable or curable with stem cell therapy are very complex clinical conditions, requiring multidisciplinary teams that are based in health care facilities with the necessary health manpower support and advanced facilities and equipment. The list of conditions being treated with stem cell therapy includes the following:
◦Cancer
◦Alzheimer’s disease
◦Parkinson’s disease
◦Autism
◦Diabetes
◦Emphysema
◦Erectile dysfunction
◦Multiple sclerosis
◦Heart disease
◦Rheumatoid and osteoarthritis
◦Spinal cord injury
◦Stroke
◦Liver disease
◦Idiopathic pulmonary fibrosis
◦Aging
The above conditions fall under specialty practice. Physicians who claim to be specialists and experts in stem cell therapy should have had extensive training in the treatment of the above-mentioned diseases and disorders, with their training to include structured rotations in different fields of medicine, and most importantly with well-defined core competencies and scope of practice. The training program should also include quality assurance mechanisms like evaluation during and at the end of rotations and training, with documentation of clinical experience in the diagnosis and treatment of the above-listed conditions. Given the complexity of the different conditions being treated, the training should be conducted in accredited institutions, with the presence of faculty members who have been recognized as experts in the field due to their education, extensive training and clinical experience.
Therefore, the PRBOM declares and maintains that physicians desiring to practice stem cell medicine should have acquired the necessary education, structured / supervised training and extensive clinical experience. The PRBOM as the regulatory body for the practice of medicine places the welfare and safety of patients above any consideration.
Foreign physicians who wish to practice stem cell therapy in the country are required to apply for and obtain special temporary permits (STP) from the Professional Regulation Commission. Foreign physicians will need to 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. Any foreign physician who practices the profession without a STP will be criminally liable for illegal practice of medicine. Those who have aided and abetted the foreign physicians’ practice of the profession are also criminally liable.
The PRBOM thus condemns the stem cell therapy done on DDB Chairman Antonio Villar, conducted in a hotel located in Metro Manila, purportedly by foreign nationals.
The PRC and the PRBOM join the DOH and DFA in warning patients who plan to undergo treatment especially abroad. There are precautions to be observed like verifying the status of institutions (clinics and hospitals) and practitioners from the regulatory authorities in foreign countries. Philippine embassies can also be contacted for information on these institutions. Foreign medical professional societies can be contacted to verify the status of physicians claiming to be experts in stem cell therapy. The rights of patients in foreign countries should be researched, including medical insurance, the system of administrative investigations for erring practitioners and the like. Lastly, patients should not expect the therapy to be able to cure all diseases and medical conditions.
6.Setting of practice
Stem cell therapy should be practised in appropriate safe settings like DOH-licensed hospitals and clinics with the necessary medical manpower and equipment. It should not be practised in hotels as they pose risks and hazards to patients.
Institutions with credentials committees and with a set of requirements for admission to the medical staff may have an advantage over stand-alone clinics, because they ensure the appropriateness of training of physicians before they are given clinical practice privileges. These institutions observe proper documentation of clinical practices which allows audit and review of procedures being performed with particular focus on the clinical outcomes.
Medical professional organizations and its officers/members are prohibited from misrepresenting themselves as specialists in a certain field of medicine when in reality they are not. In addition, they are not allowed to make false claims, like announcing collaboration in the field of stem cell medicine with certain institutions like the Professional Regulation Commission. The PRC has not collaborated with any medical organization in any field of medicine.
The stem cell society has to apply for and acquire SEC registration, a most basic requirement. This will allow them to engage in their official activities like conduct of conventions, recruiting members, or engaging in fund-raising activities.
A group of physicians cannot just form a society and declare that they are specialists in a certain field. In addition, they cannot just append the title of “Fellow” after their names without clarifying what kind of academic program and certifications they went through.
The Professional Regulatory Board of Medicine and the Professional Regulation Commission, the government regulatory bodies for the practice of medicine, were prompted to issue this position paper to inform and guide the public on the issues related to the practice of stem cell therapy, licensed institutions and facilities, drugs and stem cell solutions, credentials of practitioners, the need for special permits for foreign physicians, establishment of specialty societies, and pathways to specialization.
