DOH: Stem cell therapy not yet proven to be curative
MANILA, Philippines (UPDATED) – Amid increasing interest in – and the risks of – stem cell treatment in the country, the health secretary said doctors are required to disclose to their potential patients that the procedure is still "investigative" – its potential is still being explored, and there's no definite word that it can heal diseases.
This is in line with the ethical standards of medical practice that seek to empower patients with enough information prior to consenting to the treatment.
“The patient must exactly know that he is part of an investigative process. And that is what we require as far as the Department of Health is concerned right now,” Department of Health (DOH) Secretary Enrique Ona said in an interview with Rappler on Friday, July 5.
Stem cell therapy or regenerative medicine is the use of the body’s repair cells as a substitute to old cells that may cause debilitating diseases. (READ: 6 things you need to know about stem cell therapy)
The treatment has gained controversy of late, after 3 unnamed high-profile politicians allegedly died due to botched procedures performed abroad. The deaths are currently being investigated by the Philippine Medical Association (PMA).
Not to stifle innovation
So why is the DOH encouraging the development of the science despite the treatment being “under clinical evaluation and study”?
Ona said there is no contradiction there.
“Yes, we are encouraging it, but part of an investigative process.... [The] use of stem cell has to be investigated and developed and eventually be proven if indeed it is effective,” he said.
The department, he said, just does not want to stifle innovation.
DOH is currently pulling in data from practicing stem cell transplant physicians, so they can take a look at the process as well as the source of the supposed stem cells per hospital.
Ona’s directive also echoes an earlier DOH public advisory on stem cell therapies that was released on October 19, 2012.
"While research has shown that adult stem cells and umbilical cord stem cells are the safest and most ethical, the public is warned that claims of preventive and curative benefits of stem cell therapy are still on their investigative stage," read the advisory issued last year.
Requirements for accreditation
According to Food and Drug Administration (FDA) Director Kenneth Hartigan Go, the DOH will look at 6 P’s as part of the accreditation process of stem cell transplant procedures conducted in the Philippines.
The 6 P’s include:
- Professional (if the medical doctor is qualified to perform the treatment).
- Place (if the procedure will be conducted in an accredited hospital with the proper facilities).
- Process (if the necessary laboratory testing is conducted, and if sterility and proper temperature control are maintained).
- Product (if the injectible stem cell product has been registered with the FDA).
- Publicity (if the practitioner’s claims match and are validated by scientific proofs).
- Population (if there has been substantial recorded data of patients who have benefited from the procedure in a span of a year).
On Monday, July 8, the FDA issued a circular stipulating the guidelines on registering stem cell line of products. The circular cover all products with a "claim, label, or poster" that says stem cells. (READ: FDA Circular: Registration of Stem Cell-Based Products)
Ona acknowledged the “tremendous potential” stemming from the innovation, calling stem cell therapy “the future of medicine.”
“Stem cell is our mother cell for all our organs. Can you imagine if the time comes when we have the capacity to really do something so that you can let it form into a bone or to a retina or to your spleen or to whatever organ that is diseased? But that is a long way yet,” he said.
“It’s not going to be something that you wake up in the morning, and it will be used for everything,” Ona explained.
“The public should just have to wait and make sure, when they allow it on their own body, that they are fully made aware of what is the status,” the health secretary said.
Dr Florencio Lucero, one of the first few doctors to introduce the treatment in the Philippines, also said stem cell therapy may improve one's medical condition on a case-to-case basis, but it is not curative in nature. He started the practice of adult-sourced stem cell transplant in 2006.
“Stem cells can help degenerative diseases. It cannot cure. We don’t promise a cure on that. And the improvement varies from person to person,” Lucero said in an interview.
Lucero was pertaining to diseases where the organs involved will progressively deteriorate over time.
Dr Lucero said that while the DOH has issued an administrative order and has set a deadline for the submission of requirements for accreditation by the end of August, the directives have been released “slowly and gradually.” – Rappler.com