Stem cell guidelines inadequate, docs say

MANILA, Philippines—The new Food and Drug Administration (FDA) guidelines regulating stem cell therapy in the Philippines are “sorely inadequate and grossly misleading,” according to a group of doctors.

The Philippine College of Physicians (PCP), the umbrella organization of Filipino doctors specializing in internal medicine, said it was disappointed with the FDA and Department of Health for “failing to decisively act on the dangers” posed by unregulated stem cell therapy in the country.

“The recent guidelines released by the FDA fell short and will not stop the proliferation of stem cell therapy for ailments that were not subjected to scientific study or clinical trials,” PCP president Prescilla Limpin said in a statement

“We will not back down from our earlier call and we will not stop until stem cell therapy undergoes scientific studies to prove its safety, quality and efficacy on the ailments it has been propagated. We will not allow its promotion and use to helpless and unknowing patients and their desperate families,” said Dr. Prescilla Caguioa, the PCP president.

The FDA guidelines require that all stem cell and cellular-based treatments offered in the country should first pass the agency’s standards for safety, efficacy and quality.

Beginning Sept. 1, 2013, all unregistered stem cell products would be considered as “illegal and in violation of the law,” the FDA said.

However, Maricar Limpin, the head of the PCP advocacy committee, warned that the FDA guidelines might be used by unscrupulous people to continue offering “unproven” steam cell therapies to the public.

She noted that the FDA rules cited hematopoietic (pertaining to the formation and development of blood cells) stem cell transplantation; corneal resurfacing with limbal stem cells; and skin regeneration with epidermal stem cells “as recognized standards of healthcare.”

“This is grossly misleading because the FDA gave recognition to these procedures but failed to specify the ailments or indications where these were proven to be safe and effective,” Limpin said.

“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, neurologic, skin, rheumatologic, kidney and gastrointestinal diseases, diabetes mellitus, hypertension, autism, cancer, aging and aesthetics, HIV, AIDS and other conditions,” she said.

“We stand by our position that stem cell therapy can only be proven safe and effective for its intended purposes through science- and evidence-based medicine,” she added.

The public needed to be “protected against moneyed marketing and public relations machinery of doctors and hospitals peddling stem cell treatment,” the PCP reminded the government.

Dr. Francisco Tranquilino, chair of the PCP’s ethics committee, noted that the Philippine Society for Stem Cell Medicine held an event in a Pasay City hotel on Tuesday to promote stem cell treatment among doctors.

“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. This has got to stop,” Tranquilino said.

He pointed out that the International Society for Stem Cell Research (ISSCR) was concerned that stem cell treatments were 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.”