Doctors warn vs weak FDA rules on stem cell therapy

MANILA, Philippines - A coalition of doctors and health practitioners warned the public against weak government regulation on stem cell therapy, saying this poses serious health risks to patients.

Dr. Priscilla Caguioa, president of the Philippine College of Physicians, said the recent guidelines issued by the Food and Drugs Administration (FDA) would not stop the proliferation of stem cell therapy for ailments that were not subjected to scientific study or clinical trials.

The group expressed their disappointment with the FDA and the Department of Health for failing to decisively act on the dangers posed by unregulated stem cell therapy in the country and for the holding of a conference promoting stem cell therapy yesterday.

They cited the FDA’s new guidelines stating that starting Sept. 1, all unregistered stem cell products that are processed, prepared and administered to patients in the country are illegal and in violation of the law. The FDA also advised patients that all stem cell and cellular-based treatments offered to patients are supposed to pass FDA standards for safety, efficacy and quality.

No specifics

Dr. Maricar Limpin, PCP chair of the advocacy committee, said the FDA Circular No. 2013-020 cited hematopoietic stem cell transplantation; corneal resurfacing with limbal stem cells; and skin regeneration with epidermal stem cells as recognized standards of health care but failed to specify the ailments or indications where these were proven safe and effective.

“It is the responsibility of the government to inform the public that the effectiveness and safety of stem cell therapy are still unproven in heart, lung, neurological, skin, rheumatological, kidney and gastrointestinal diseases, diabetes mellitus, hypertension, autism, cancer, aging and aesthetic, HIV, AIDS, and other conditions,” Limpin said.

Conference, not concert

Dr. Francisco Tranquilino, chair of the PCP ethics committee, raised alarm over what he said was the seeming disregard of ethical practice in medicine with the promotion of stem cell treatment among doctors through an event of the newly formed Philippine Society of Stem Cell Medicine yesterday.

“The event is spearheaded by no less than the past presidents of the Philippine Medical Association and is marketed like a concert with prizes and giveaways to boot,” he said.

He cited that the International Society for Stem Cell Research is concerned that stem cell treatments are being marketed to consumers around the world without safeguards in place to ensure the safety or likely effectiveness of experimental treatments, or truthfulness of claims about so-called proven therapies.

In a letter to the FDA on Sept. 10, the PCP urged the FDA to stop with sanctions any kind of promotional activities concerning stem cell therapy.