Ivermectin approval hampered by red tape—ECOP

 

MANILA — The approval of the use of ivermectin as COVID-19 treatment is facing government red tape, according to Employers Confederation of the Philippines (ECOP) President Sergio Ortiz-Luis Jr, who also echoes the appeals of other business groups for the drug’s use.

Payag na nga sila sa isang hospital na pwedeng gamitin, e ‘di ibig sabihin pwede. Eh bakit binibigyan pa ng red tape eh maraming namamatay na Pilipino. Bakit hindi pa ibigay nang husto marami namang doktor ang humihiling na magreseta nito?” asks Ortiz-Luis in an interview.

The employers group will give ivermectin to their employees once the drug is approved by the FDA, as it is cheaper than other medicines studied for the novel coronavirus disease treatment.

On Thursday, the FDA granted a hospital’s application for “compassionate use” of ivermectin. Despite the approval, the FDA said ivermectin’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.

A number of physicians recommend the use of pharmaceutical-grade (or USP-grade) ivermectin for the prevention and treatment of COVID-19 that is seeing an unprecedented spike in the country. Several lawmakers clamor for the drug’s use to treat COVID-19 despite opposition of some health experts.
Heads of business groups and other organizations recently issued an open letter to President Duterte and the leaders of Congress, calling for “serious, urgent and immediate attention to ivermectin as an inexpensive drug to prevent and treat COVID-19 during this public health crisis.”

According to them, there is not enough evidence to prove that the drug can be a remedy for patients infected with COVID-19 despite articles and social media posts promoting Ivermectin as an anti-COVID-19 drug in Brazil, France, South Africa and South Korea.

 

There are ongoing trials, so wait for the results

It would be prudent to wait for results of clinical studies now being conducted in other countries on ivermectin’s efficacy and safety, says the Philippine Council for Health Research and Development (PCHRD) of the Department of Science and Technology.

“We are open to any possible drugs that could be used for COVID-19. We know that we need drugs that will help ease the suffering of our COVID-19 patients,” says Dr. Jaime Montoya, PCHRD executive director.

The council, tasked to oversee all clinical trials, including those for vaccines and drugs against COVID-19 and its complications, is the lead agency for health research and development in the country.

“We believe that we must wait for the results of the studies being conducted by different countries on ivermectin … and we can determine if it is useful,” Montoya says.

“If it is useful, I’m sure the FDA will look into this with a favorable outcome so that it can be approved [either for emergency or for general use].”

The World Health Organization (WHO), the US FDA, European Medicines Agency (EMA), and its manufacturer, Merck, have all stated there is lack of data and evidence of the efficacy and benefits for COVID-19 prevention and treatment. (JSM/JuanManila)

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