MANILA, Philippines – On Wednesday, August 14, Mindoro Rep Paulino Salvador “Doy” Leachon was originally scheduled to deliver a privilege speech calling for an investigation into misleading stem cell procedures being conducted in the Philippines.
In that speech, he was supposed to call for the resignation of Health Secretary Enrique Ona who said stem cell products may be administered for the sake of encouraging “innovation,” even without first going through clinical trials approved by the Philippine Food and Drug Administration (FDA).
He didn’t get to deliver the privilege speech, which was supposed to condemn the cure-all claims of certain stem cell transplant physicians who “take advantage” of a patient’s desperate situation.
The congressman told Rappler in a phone interview on Tuesday morning, “No offense to the President,” who appointed Ona and under whose party Leachon ran and won in May. “People’s lives are at stake here. If the advocacy of the [health] secretary will continue, I am calling for his resignation,” Leachon said.
Why was the speech not delivered?
Leachon was reminded by colleagues in the House, where he is a neophyte, of a standing rule: if members have filed at least 3 resolutions on a certain issue, a congressman may no longer deliver a privilege speech on it.
Stem cell therapy is a touchy issue, with Filipino doctors divided on its ethics and clinical applications. The legislator however said his stand remains unchanged with or without the speech.
Leachon reiterated in another phone call that Ona’s allowing stem cell treatment even for “unproven indications” makes him unfit for his job. A proven indication refers to a clearly indicated “therapeutic purpose” stemming from a clinical trial.
A clinical trial is a thorough process of drug testing that begins only upon FDA approval.
In a press conference, Ona said the administrative order (AO) he issued earlier this year on the accreditation of facilities offering stem cell treatment already regulates the therapy itself.
The AO lists the types of stem cell treatment that are allowed, prohibited, and restricted (i.e., allowed but with limitations) in accredited facilities.
Ona added that the list of accredited facilities will be released by August 31.
“Our guidelines [were] published as early as March of this year… But certainly, we will publish those [facilities] that we will approve. Ibig sabihin, kung wala doon sa listahan yung center or hospital na doing that, you should report it to us,” the health secretary explained.
(This means, if the center or hospital offering stem cell therapy is not listed, you should report it to us.)
The FDA however has yet to approve any stem cell or stem cell-based products to be used in the procedure. Not a single product has been registered, and neither are there pending applications for registration as of August 14.
Leachon said this is like putting the cart before the horse. “May facility, pero hindi na-approve yung gamot? It doesn’t make sense,” he added. (A facility but with no approved product to administer? It doesn’t make sense.)
While the FDA is part of the DOH, Leachon said the agency shouldn’t be beholden to the whims of a health secretary who has a “wrong viewpoint.” It should remain an independent institution with the sole power to approve drugs released in the market, Leachon said, adding that it should not be a mere rubber stamp that approves whatever guidelines are released by Ona.
Let patients pay?
On Saturday, August 10, about 21 medical organizations published a statement, urging practitioners not to use stem cell therapy for unproven indications and not to charge patients for the “experimental drug.”
In a speech two days after, Ona said medical institutions cannot afford to offer the therapy for free and that doing so would forever relegate the country to being a “marketing testing ground.”
Dr Anthony “Tony” Leachon, elder brother of Rep Leachon, has joined other physicians in calling for the suspension of “deceptive” stem cell transplant doctors.
Rep Leachon said no conflict of interest exists, as his and his brother’s stand against stem cell therapy for unproven indications is shared by other doctors’ groups.
“My brother is a practitioner. Minsan nagtatanong din ako sa kanya. Wala naman sigurong masama doon. Minsan nakakapag-supplement pa nga,” he said. (My brother is a practitioner. Sometimes, I also consult him. I don’t think there’s anything wrong there. Sometimes, it even supplements [my knowledge].)
Lives at stake
“People’s lives are at stake. It’s the obligation of any public official…[For me], public office is a public trust,” said Rep Leachon.
The 40-year-old lawmaker said the DOH, as “guardians” of public safety, must not allow the entry of unregistered drugs in the market.
He added that he would withdraw his call for Ona’s resignation if the secretary retracts his statement on stem cell therapy.
Leachon is the vice chairman of the House Blue-Ribbon Committee. It is his first term as a congressman, after being mayor of Calapan City. He is a lawyer by profession and was a Ten Young Outstanding Men awardee in 2011. – Rappler.com