Clinical studies needed to assess ivermectin as COVID-19 treatment —pharma group

Clinical trials are needed to assess the benefits and risks of anti-parasitic drug ivermectin as a treatment for COVID-19 and to uphold regulatory standards in the pharmaceutical industry, a group of pharmacists said.

In a statement sent to GMA News Online, the Philippine Association of Pharmacists in the Pharmaceutical Industry (PAPPI) said they adhere to pertinent laws and regulations in the Philippines to ensure that its member-companies are providing safe and effective medicines to Filipinos.

“Some of our member companies continue to carefully examine the results of all available and ongoing clinical studies on the use of ivermectin for the treatment of COVID-19,” PAPPI said.

The association said there is still no concrete evidence on the drug's efficacy against COVID-19 and that it still lacks safety data in majority of the studies.

“If clinical data will progress to provide more concrete evidence on Ivermectin’s safety and efficacy in COVID-19 treatment, member companies are willing to provide our expertise in terms of assessing the benefits vs. risks and file registration to our [Food and Drug Administration] as needed,” it added.

Asked for their official statement on ivermectin’s use against COVID-19, the Pharmaceutical and Healthcare Association of the Philippines stood by the statement of its member-company Merck, a manufacturer of ivermectin.

In its official statement, Merck said there is “no scientific basis for a potential therapeutic effect [from ivermectin] against COVID-19 from pre-clinical studies."

Merck also said there is "no meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 and a concerning lack of safety data in the majority of studies."

"We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information," it continued.

Last week, the FDA granted a hospital’s application for "compassionate use" of ivermectin.

Despite the approval, the FDA said the drug's distribution is still prohibited, saying only the hospital that has the permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer.

The World Health Organization (WHO), the US Food and Drug Administration, the European Medicines Agency (EMA) have all said there is currently a lack of data on ivermectin's efficacy and benefits as a COVID-19 treatment.

Last week doctors debating the use of ivermectin acknowledged the lack of phase two trials on the appropriate dose of ivermectin, either to be given for patients who are being treated for COVID-19 or its use as prophylaxis.

Dr. Tess Lawrie, director of the UK's Evidence-Based Medicine Consultancy Ltd., urged the Philippines to do a study on ivermectin as a prophylaxis for health workers, saying that there were few serious adverse events (SAEs) recorded during studies on ivermectin as a COVID-19 treatment.

Dr. Jacinto Blas Mantaring III, who chairs the Department of Clinical Epidemiology of the University of the Philippines' College of Medicine, cited an international research initiative's ivermectin studies in cautioning that there could be as much chance that ivermectin causes harm as it could bring benefit to patients. 

Dr. Vicente Y. Belizario Jr., Dean of the UP College of Public Health, said there needs to be a consensus among doctors, as well as agencies such as the World Health Organization and the country's Food and Drug Administration, for its possible use against COVID-19. — BM, GMA News