Expert: No Miracle Drug Versus COVID; Distribution Of Ivermectin Violates FDA Law – Guevarra

No miracle drug has been approved to cure the coronavirus disease, an infectious disease expert said on Thursday, April 29.

In a virtual press briefing, Philippine Society for Microbiology and Infectious Diseases president Dr. Marissa Alejandria maintained that there is insufficient evidence showing ivermectin can be given for human consumption to stop the spread of COVID-19.

“There is no miracle drug that has been discovered at this point and we don’t think the management of COVID-19 will be effective with a single drug,” Alejandria said.

But Alejandria noted they are not discounting the possibility of using ivermectin as a treatment against COVID-19 in the future.

“What we are saying is that there is still insufficient evidence to give the drug to the general public,” she explained. “When there is insufficient evidence, you may or may not use the drug. But it is your responsibility to explain to the patient the status of the evidence.”

Alejandria stated they have made a “conditional recommendation” based on very low-quality evidence. There are 70 clinical trials on ivermectin.

Based on studies, Alejandria said ivermectin has shown no benefits in terms of COVID mortality reduction and clinical improvements.

“It’s really up to the public to decide,” she added.

Alejandria said the management of COVID-19 needs a bundle of treatment and interventions.

To determine if ivermectin can prevent the progression of COVID-19, she pointed out the government is launching a clinical trial.

Philippine Council for Health Research and Development executive director Dr. Jaime Montoya said a six-month clinical trial would be undertaken with 1,200 mild and moderate COVID cases in quarantine facilities in Metro Manila.

Montoya said they expect the clinical trial to start next month.

Amid the surge of COVID-19 cases in India, the Philippine government is looking for other sources of investigational drugs for treatment of the infection.

Health Undersecretary Maria Rosario Vergeire said the government is in talks with other suppliers of remdesivir and tocilizumab.

Vergeire said they have spoken to local suppliers of remdesivir since supply from India has been stopped.

“We are also talking to a major supplier of tocilizumab in Switzerland,” she said.

Vergeire said India had been one of the major sources of investigational drugs against COVID-19.

Dr. Rontgene Solante said the delivery of vaccines from India may be delayed.

Solante said the spike in COVID-19 cases in India has an impact on the Philippines in terms of vaccine and drug supplies.

“That is a difficult scenario because one of the reasons why these surges are happening in some countries is because of the low vaccine coverage,” Solante said in an interview with “The Chiefs” on One News / TV5 on Wednesday  night, April 28.

In a related development, Justice Secretary Menardo Guevarra said on Thursday that the distribution of ivermectin to cure COVID-19 is a violation of the Food and Drug Administration (FDA) law.

Republic Act No. 9711 or the FDA Act prohibits the importation, sale, distribution or administration of unregistered drugs or vaccines, according to Guevarra.

He said the FDA approved ivermectin for veterinary use and not for humans.

“So in the case of ivermectin, it’s not registered as a drug against COVID-19,” he said.

Guevarra noted that ivermectin may be used only when it is covered by a compassionate use issued by the FDA to hospitals or prescribed by doctors.

“But personally, I’m not sure whether these exemptions cited by the FDA have legal basis,” he said.

Guevarra made the statement after Anakalusugan party-list Rep. Mike Defensor and House Deputy Speaker Rodante Marcoleta distributed on Thursday free Ivermectin to residents of Barangay Matandang Balara, Quezon City.

Defensor said the “ivermectin pan-three” was coordinated with private entities Concerned Doctors and Citizens of the Philippines and Lifecore Bio-Integrative Inc.

Defensor added doctors have given the drug’s recipients prescriptions, adding that those who received the drug gave their “informed consent” and voluntarily went to the barangay hall to get their ivermectin pack.

Each recipient received 10 pieces of ivermectin capsules.

Guevarra said it is up to the lawmakers if they would consider using the FDA exemptions to defend themselves once a complaint is filed against them.