‘Stem cell treatments still clinical trials’

MANILA, Philippines - Stem cell therapies are still considered clinical trials and could not be offered for free, Health Secretary Enrique Ona said yesterday.

“We cannot completely adopt the Western practice of offering these investigational therapies completely free for clinical trial participants,” said Ona in a speech during the 1st Midyear Convention of the Philippine Society for Stem Cell Medicine.

“This approach will not only be unaffordable for our institutions but very expensive and will forever relegate us to be a marketing testing ground,” he added.

Ona’s stand is contrary to the position of 21 medical organizations.

“When stem cell is given under a clinical study, it is unethical to make patients pay for the treatment. The cost of treatment should be shouldered by the sponsor of the study,” the medical organizations said in a statement.

Ona, however, cited the situation in the United States and other countries where it took several years to consider stem cell therapy “as a standard of care and for government to pay for it.”

He added that research continued in these countries but fees were being paid by other parties like foundations or “out of pocket” by patients.

Ona stressed that there is still no stem cell treatment that has been approved in the Philippines, although there are procedures being practiced here because they are “generally accepted” in other countries like the US.

Deadline for accreditation

Meanwhile, the Department of Health (DOH) has given all health care facilities doing stem cell procedure until Aug. 31 to file their applications for accreditation with the agency’s Bureau of Health Facilities and Services (BHFS).

The same deadline is given to companies importing, producing or marketing stem cell products to apply for “product registration” with the Food and Drug Administration.

BHFS director Nick Lutero said failure to apply within the deadline would make the stem cell practice and products illegal.

“We will stop them from conducting the therapy. For those still continuing to practice, I think we have sufficient laws, especially on the illegal practice of medicine. They could be criminally liable,” he said.

Lutero said only five hospitals in Metro Manila have so far filed for accreditation.

FDA acting director general Kenneth Hartigan-Go earlier said unregistered stem cell products would be considered illegal.

Go said the other option is for companies to go the “clinical trial route” but they also need to register their products with the FDA.