MANILA, Philippines – More and more doctors are supporting the stand that stem cell therapy should be administered only upon the completion of clinical trials approved by the Food and Drug Administration (FDA).
On Wednesday, August 28, seven more physicians’ groups signed a manifesto petitioning the Department of Health (DOH) and the FDA to enforce stricter regulations for the conduct of stem cell therapy in the country.
They are joining 21 medical societies and sub-societies who previously published their joint statement condemning DOH’s tolerance of the treatment. Their statement was, however, rebutted by DOH Secretary Enrique Ona in a controversial speech.
Ona’s speech argued that stem cell treatment for unproven therapeutic purposes may be allowed in the meantime — for innovation’s sake. Ona later backtracked after a lawmaker called for his resignation.
“We want to re-assert our demands, the non-negotiables to DOH and FDA now that the deadline is near,” said Dr Anthony Leachon, a former DOH consultant who resigned from his post to show his opposition to the health chief’s position.
The deadline Leachon was pertaining to is the deadline for accreditation of facilities offering stem cell therapy. All applications are expected by the DOH on Saturday, August 31.
As of August 15, only 5 hospitals have applied for accreditation.
Among the non-negotiables outlined in the manifesto signed by the participating physicians was non-payment by patients opting for stem cell therapy, which has yet to undergo thorough testing to determine its proven indication. The societies maintain that unproven treatments should be administered for free.
“It’s because of the public safety issue. A lot of our patients and even our doctors are being misled and being misguided. And we’re not just talking about hundreds of pesos or thousands of pesos but a million pesos as payment for unproven indications like rejuvenation, aging, autism, hypertension and diabetes,” Leachon added.
A proven indication is a clearly indicated therapeutic endpoint that is backed up by an FDA-approved clinical trial.
The doctors’ groups which aired their support were: Philippine College of Addiction Medicine, Philippine Society for Sleep Medicine, Philippine Society of Hypertension, Philippine Dermatological Society, Philippine College of Occupational Medicine, Philippine Society of Venereologists Inc, Philippine Association of Plastic Reconstructive and Aesthetic Surgery. – Rappler.com