Stem cell debate: Innovation or safety?

DISCUSSION. DOH Secretary Enrique Ona discusses the conduct of regulation for stem cell treatments in the country. Photo from the DOH Facebook page

MANILA, Philippines - The medical community has been divided by the stem cell therapy issue, with practitioners disagreeing on whether treatments should be allowed without clinical trials being approved by the Food and Drug Administration (FDA).

For Health Secretary Enrique Ona, to encourage medical innovations, local clinical trials or thorough drug testing prior to a drug's release to the market can be foregone in the meantime for stem cell and stem cell-based products.

In his speech during the mid-year convention of the Philippine Society for Stem Cell Medicine (PSSCM), Ona acknowledged that "predetermined adherence to a protocol might be a fatal rigidity."

But 21 medical and surgical societies found the health secretary's stand problematic, prompting them to issue a position statement calling for stricter regulation. The National Insitute of Health of the University of the Philippines Manila supported the dissenting doctors.

Dr Antonio Dans, an epidemiologist and the president of the Philippine Society of General Internal Medicine, believes it is unethical to charge patients for treatments that are not proven and have not undergone clinical trials.

Stem cell therapy is a medical intervention that involves extracting the body's repair cells and injecting them back to the body to replace old cells. Animal-sourced or xeniobiotic stem cells are restricted by the Department of Health (DOH).

READ: 6 things you need to know about stem cell therapy

The challenge now hounding the DOH and the FDA is "finding the balance between innovation and sound regulation."

Long and arduous clinical trials

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Stem cell debate: Innovation or safety?

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