Keynote Message of Secretary Enrique T. Ona Philippine Society for Stem Cell Medicine

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DATE: 
August 12, 2013

1st Mid-Year Convention August 12, 2013
Polakabal-Rigodon Hall, Manila Hotel

(Published in the Philippine Star August 14, 2013 by the Phil. Stem Cell Society.) 

(GREETINGS)

Thank you for this invitation to speak on an issue that seems to be dividing the medical community and pits the supposed medical scientists, the freewheeling practitioners and the regulatory arm of government.

Stem cell therapy has been considered as the future of medicine as it has been proven to be effective in several medical conditions. However, stem cell therapy is not a cure-all medical treatment. Patients have 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. Today, there is an increasing demand for the use of stem cells as therapy in oncology, end-organ diseases and regenerative medicine. We see around the proliferation of “centers” offering stem cell therapies for medical and aesthetic purposes.

Let me start by quoting what our Food and Drug Administration, headed by Dr. Kenneth Hartigan-Go, prominently inscribes in its letterhead: "Finding the balance between innovation and sound regulation."

Two days ago, 17 medical societies and sub specialty societies published a one page announcement of its position on stem cell treatments, intended to warn the public of its danger of unregulated use and urging the government, presumably the DOH and the FDA to be more vigilant in controlling the proliferation of these blatantly unsupported claims and advertisements in TV and print media on its supposed magical effects in restoring youth and vigor to aging men and women. Lately, some of our prominent citizens have made personal endorsements of stem cells therapies as their “fountain of youth”. I welcome all of these concerns coming from our specialty societies, especially from the sector I greatly admire and respect.

However, obviously, most, if not all of them have not read the DOH administrative order published in our newspapers, numbered 2013-0012 entitled “The Rules and Regulations Governing the Accreditation of Health Facilities Engaging in Human Stem Cell and Cell-Based or Cellular Therapies in the Philippines”, which was signed last March 18, 2013. They could have checked their facts first with the DOH and the FDA before releasing their statement.

The guidelines in the administrative order seek to, among others, ensure a minimum quality of service rendered by hospitals and other health facilities capable of utilizing  human stem cell preparations and cell-based therapies; and guaranteethat human stem cell preparations and cell-based therapies in the Philippines are safe and effective for their intended use. 

Indeed, the implementation of this administrative order is not an easy matter, as we have to contend with a public so hungry to hear more of the wonders of stem cell technology, especially the “well-to-do” looking for the wellspring of beauty and eternal youth.  Defining the "accepted" from the downright "bogus claims” in stem cell use today can be tricky. The issue is how one differentiates the "research aspect" and possible effective use from the frank claim as though it is a "standard practice". As a matter of fact, who decides when this thin line is breached, especially today when medical research from other countries often overwhelm the scientific literature with various successes in one or two attempts on a few patients?

Let me answer some of these and try to revisit our AO.

Administrative Order No. 2013-0012 prohibits and restricts the creation, importation, promotion, marketing and use of stem cell therapies from embryonic, aborted fetal, and genetically altered, animal and plant stem cells, as they have been proven to cause some fatal complications or tumor formations.

Stem cell preparations that are permitted for patient’s use are autologous adult human stem cells, allogeneic human stem cells, human umbilical cord stem cells and human organ-specific cells. Only DOH accredited health facilities are allowed to use these permitted stem cell preparations. Health facilities utilizing stem cell preparations and cell-based or cellular therapies are mandated to comply with the guidelines set by the Bioethics Advisory Board which has been established by the DOH. This Board ensures that ethical standards are upheld and that contentious scientific, ethical and legal issues are addressed. Meanwhile, an Institutional Review Board reviews and approves stem cell therapies, based on the guidelines set by the Bioethics Advisory Board.Standards have been defined regarding personnel qualifications, physical facilities, equipment and supplies, work environment, quality improvement activities, records keeping and reporting of results.

Furthermore, non-hospital based facilities such as free standing clinics should be affiliated with an accredited hospital before being allowed to engage in stem cell therapy. 

The DOH has started strictly monitoring the compliance of these guidelines. Essential to ensuring that this AO is effective is the cooperation of you, the medical practitioners and the general public. I ask the same physicians and the various medical societies to report to the DOH and FDA possible violations of these guidelines, as they are in a better position to discern which among the therapies being offered are phony and which ones have sound scientific basis.

The payment of services for certain unproven applications in stem cell therapies can be defined without necessarily measuring it only in pesos or dollars. Crucial in determining the cost of an innovative service is differentiating the cost of supplies from that of outright personal service.  We cannot completely adopt Western practices of offering these investigational therapies completely free to clinical trial participants. This approach 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 technique in their country. Fees for translational research work must be well defined and this is where government and the private sector can work together.

Let me cite an example in my field of interest. When we started vascular and organ transplant surgery of the kidneys, liver and pancreas in the late sixties and seventies, none of these operations were considered the standard of care. It took several years for  Medicare in the United States and other countries to consider these operations as standard of care and for government to pay for it, but research continued and fees were being paid by other parties like foundations or “out of pocket” payments.

Are we in a similar period with stem cell research and stem cell therapy today?

For now, most stem cells therapies fall under what we term “innovative therapy”. Let me share with you what Professor Patrick Taylor, Assistant Clinical Professor of Harvard Medical School and Co-Chair of the Standards Committee of the International Society for Stem Cell Research, has to say regarding innovative therapy: “Innovative therapy develops in diverse ways. Some fields, like oncology, have progressed through a close alliance between innovative therapy and research. With this model, innovative therapies are suggested by understanding where current therapies fail, and combining that knowledge with hypotheses about how changes in somewhat-known compounds might affect their action on other diseases. In clinical trials, toxic compounds of uncertain risks are offered to large cohorts, and the results, if positive, are incorporated in medical practice. However, other fields, like surgery, take a very different tack: innovative therapy to address an unexpected anomaly intraoperatively can be suddenly required, and predetermined adherence to a protocol might be a fatal rigidity. Only later, after multiple experiences — and perhaps never — may a surgeon test the novel procedure through clinical research, and on many patients. Even then it may be difficult to “reduce” a patient to a randomized research subject if the surgeon is convinced that the novel procedure is better, or that choosing the best care option requires patient-specific judgment.”

Professor Insoon Hyun of the Case Western Reserve University School of Medicine, in his article in the Journal of Law, Medicine and Ethics, raised the following questions as regards the regulatory approach towards stem cell therapies: Under what circumstances should stem cell-based innovative therapies be allowed outside the context of a clinical trial? And how should attempts at new stem cell-based therapies be regulated?

Concerns on regulation of stem cell therapies comes at a time when the interest of patients in stem cell medical travel is increasing in our country.

The 2008 guidelines of the International Society for Stem Cell Research (ISSCR) recommends — even while condemning fraud and generally urging research — that some limited innovative administration of unproven stem cell therapies be permissible outside a research setting.

The World Medical Association’s Declaration of Helsinki which was last updated in October 2008, Article 35 outlines the ethical uses of Innovative Treatment:[1]   “In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering.”

Article 35 then continues that whenever possible, the innovative treatment should also be made the object of research, designed to evaluate its safety and efficacy. However, unlike formal clinical trials which are based on gathering data rather than benefiting an individual patient,[2] the principle of innovative therapy is not solely aimed at producing generalizable knowledge but rather to improve an individual patient’s condition.[3]

The challenge, I believe among us, seemingly competing forces, is to sit down and craft a path of consensus, taking in consideration the most fundamental tenet why our profession exists: to save life, to alleviate pain, to do no harm.

In closing, let me pose this question to this aggrupation: Is there a need now to organize a separate society with academic pretentions akin to specialization or only an organization of physicians with interest in this developing field? I'm afraid of a situation where title might precede competence. I therefore ask the organizers to further review the initiatives of starting the granting of fellowships to our colleagues with particular interest in this field but only qith minimal exposure to training in this complex field.

I look forward to more discussion and a happy resolution of these issues on stem cell therapy. I hope this summit brings us closer to that goal. Thank you and good morning to you all.


[1] World Medical Association (WMA) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, 59th WMA General Assembly, Seoul, Korea, October 2008

[2] Patrick L. Taylor, “Overseeing Innovative Therapy Without Mistaking it for Research: A Function-Based Model Based on Old Truths, New Capacities, and Lessons From Stem Cells”, Journal of Law Medicine and Ethics 2010, p.287.

[3] Insoo Hyun, “Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges,” Journal of Law, Medicine and Ethics, Symposium on Law, Science and Innovation, Summer 2010, p. 279.