DOH stem cell treatment regulations 'flawed,' says former adviser

The Department of Health's (DOH's) Administrative Order 2013-0012 is flawed and unethical, said Dr. Anthony “Tony” Leachon, vice president of the Philippine College of Physicians (PCP) and the University of the Philippines' Manila Affairs Director.

 

The former DOH adviser resigned after Health Secretary Enrique Ona expressed his support for stem cell therapy in the keynote message he delivered at the Philippine Society of Stem Cell Medicine (PSSCM) at the Manila Hotel, August 12.

 

“(The AO) is a flawed regulation (because) you approve the centers without approval of the indication for its use,” he said in a phone interview with GMA News Online.

 

Accrediting clinics to conduct stem cell therapy without approved indications for the treatment’s uses is unethical and illegal, he adds. An experimental drug should only be used to treat ailments that it is intended to be used for, as per the Food and Drug Administration (FDA) regulations.

 

“(Just) because the infrastructure is there (doesn't mean) you are free to use it for anything,” Dr. Leachon said.

 

For example, the only approved indicated use for stem cell treatment by the United States Food and Drug Administration (US FDA) is for hematologic malignancies, he explained.

 

“So to use that other than the indicated use where it was really extensively studied will be unethical and in violation of the US FDA.” 

 

In the Philippines, stem cell therapy is not on the list of treatments approved by the Philippine FDA. Hence, its use for any ailment is in violation of FDA rules, Leachon asserts.

 

A list of accredited health centers allowed to conduct stem cell therapy will be released by the DOH on August 31, said Dr. Eric Tayag, DOH spokesperson, in a phone call.

 

Meanwhile, there are no stem cell treatments in line for approval as of August 14, reports said.

 

On 'innovative therapy' for compassionate use

 

Ona said in an interview that experimental treatment or “innovative therapy” can be applied in the context of compassionate use: doctors can turn to experimental drugs when commercially available drugs are able to help a patient.

 

That is, of course, with the patient’s consent after being fully informed of both benefits and risks of undergoing a treatment that is still in the developmental stage.

 

However, during his stint as DOH adviser, Dr. Leachon advised against this, citing the same ethical guides—Declaration of Helsinki and Good Clinical Practice (GCP).

 

“Yung compassionate use hanggang dalawang pasyente lang yan,” Dr. Leachon said. “If more than two patients ang nangangailangan, you have to start on a clinical trial or to plan an ongoing clinical trial. The compassionate use should not be used in perpetuity.”

 

He pointed out that stem cell therapy has been available for compassionate use in the country but has not been approved by the FDA.

 

“For so many years, violation siya ng FDA kasi we've been using these to our patients and yet hindi siya approved ng FDA. And yet we're charging patients here even with experimental studies,” he said.

 

Doctors who offer the treatment for a fee is also in violation of FDA regulation since stem cell therapy is not approved by the FDA.

 

Lack of funds a 'lame excuse'

 

In the same speech, Ona also said that these treatments “will not only be unaffordable for our institutions but [will be] very expensive”. Hence, he espoused their commercialization.

 

This statement prompted Leachon to resign from his post.

 

“You're not supposed to charge patients considering that it is an investigational or experimental drug,” he said.

 

Even with the full consent of the patient, charging him or her for a drug that has not been proven to be effective or safe is unethical.

 

If the DOH does not have enough money, he says, they should not be conducting experimental treatments on patients.

 

Furthermore, charging patients because of the lack of funds is a “lame excuse”, since sponsors like the Philippine Council for Health Research and Development (PCHRD), the World Health Organization (WHO), Bloomberg, and other academic institutions are available for sponsorship.

 

GMA News Online tried to call Secretary Ona again for a statement, but the latter could not be reached for further comment as of posting time.

 

Resolution for a congressional hearing

 

A resolution calling for a congressional hearing on stem cell therapy has been submitted by Mindoro Representative Paulino Salvador “Doy” Leachon, member of the Philippine Senate Blue Ribbon Committee (Committee on Accountability of Public Officers and Investigations) and brother of Dr. Tony Leachon.

 

The move was triggered by a letter sent by the PCP urging the DOH and the FDA “to issue stricter regulations on stem cell therapy”, Rep. Doy Leachon said in congress on August 13.

 

Rep. Leachon has also called on Secretary Ona to stop advocating stem cell therapy.

 

In an interview with GMA News Online, Rep. Leachon said that Ona, as an administrator, should be neutral in the matter.

 

“You cannot be an advocate of a drug not yet proven, the administrator, and then the regulator. So parang ang nangyayari dito, premature approval na agad ito,” Rep. Leachon said.

 

Aside from stem cell therapy being unapproved by the FDA, Rep. Leachon also said that there has not been a conclusive study stating that it is an effective treatment to certain ailments.

 

“As of now, we are governed by laws not of men,” he said. “Kung gumagaling sila [sa stem cell therapy], walang problema. Pero aprubahan natin ito sa batas.”

 

DOH has yet to release an official statement on the matter of stem cell therapy. — TJD, GMA News