The Philippines Department of Health (DOH) announced it would conduct an independent assessment of the potential use of Remdesivir (Gilead), the first drug formally approved by the U.S. Food and Drug Administration targeting COVID-19. In an interesting move, the agency declared, “We are carefully reviewing the basis for the US FDA approval.” This comes in light of the recent World Health Organization (WHO) Solidarity Trial finding that the drug isn’t effective against COVID-19. The Philippines DOH is on record that it won’t let either the US FDA or the WHO findings dictate its own decision. Rather, they will seek an independent verification that the product can be a useful treatment targeting COVID-19.
Originally an antiviral drug developed to treat Ebola, the drug was first issued an emergency use authorization after a controversial change to a pivotal clinical trial endpoint. Then, just recently, the FDA finally authorized the use of the drug for COVID-19. Currently, it can only be given via intravenous injection in a hospital setting, although a recent study in the United States will evaluate the drug in an ambulatory setting.
On the remdesivir evaluation, the DOH recently declared, “Our Health Technology Assessment Council (HTAC) here in the country will also conduct an independent assessment of all available data (on Remdesivir) to come up with a good recommendation (on its use for COVID-19).”
As TrialSite recently shared, the World Health Organization’s Solidary Trial on COVID-19 Therapeutics reveals that at least based on interim results the product has little or no effect on COVID-19 patients. This leaves up in the air to some extent whether Remdesivir actually is effective or not.
Current Access in the Philippines
Presently, in the Philippines, the only way to access this drug is via the compassionate special permit from the local FDA according to a recent press account in PhilStar Global. A recent statement from the Philippine Society for Microbiology and Infectious Diseases suggests, “Remdesivir will continue to be available for compassionate use” until the guidelines are modified by DOH.
The local press emphasized that whether or not the Philippines DOH determines to accept Remdesivir or not has no connection to the recent WHO Solidarity Trial findings. Rather, that nation’s health apparatus will undertake its own independent analyses to determine whether to formally approve Remdesivir as an authorized drug for COVID-19.
Problems on the Vaccine Front
In other local news in the Philippines, it was disclosed that there are internal concerns shared about the Department of Trade and Industry (DTI) and its Philippine International Trading Corp (PITC) in procuring vital equipment and implementing critical projects, such as the COVID-19 vaccine effort. Identified as an incompetent bureaucracy, the nation’s population health is contingent upon the efficient and effective procurement of various health supplies including vaccines from the various makers in the East and the West.
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