With Spikes in COVID-19, Philippines DOST Secretary General Declares No Need for any New Ivermectin Trials

With Spikes in COVID-19 Philippines DOST Secretary General Declares No Need for any New Ivermectin Trials

In the Philippines, the Department of Science and Technology—Philippine Council for Health Research and Development (DOST-PCHRD) is an apex national body responsible for coordinating and monitoring research activities across this Southeastern Asian nation of 110.6 million people—the world’s 13th most populous country. Still considered a developing or low- and middle-income country (LMIC), this important organization associated with drug development there was formed in 1982 via an executive order. While an unprecedented spike in SARS-CoV-2 infections has spread across the nation, most recently DOST Secretary Fortunato de la Pena announced on Facebook that the DOST-PCHRD doesn’t see the need for any more clinical trials associated with ivermectin for COVID-19 in the Philippines, reported the Philippine News Agency. Citing the numerous completed trials (many with published results) and the dozens of ongoing studies based on ivermectin, indicating that plenty of data was, and will be available. New clinical trials taking months to years were not needed, declaring PCHRD “is of the position that there is no need to conduct another clinical trial in the Philippines.” Rather, “It would be appropriate to await the results of these studies that are already significantly advanced in terms of data collection and conducting interim analyses.” The Philippines Food and Drug Administration (FDA) has taken a position similar to the European Medicines Agency (EMA) that further clinical trials data is necessary to determine the efficacy of the cheap generic drug for use on early onset, mild to moderate cases of COVID-19. Most recently, the Philippines FDA issued a compassionate use special permit for a hospital to administer ivermectin to COVID-19 patients.

COVID-19 in Philippines

Of course, the most recent request for compassionate use was in response to the unprecedented spike in SARS-CoV-2 cases there. Despite its large population, the Philippines was relatively spared from the pandemic for much of the year. The first spike occurred in the summer of 2020, and at the worst moments, health authorities there recorded just under 7,000 cases per day. Of course, no one could be certain why this was the case—was it the youthful population or any other number of factors? But starting right in early March of 2021 (when there were about 2,000 cases per day), an ominous shift occurred: the total numbers of cases started rising and kept going up till April 5 where 8,347 estimated cases were registered in one day, shattering old records. Deaths are at an all-time high with the last seven day average at 189 per day.

Lockdowns

Consequentl,y by April 5, the government now has extended lockdowns by at least another week, reported US News & Work Report. The pandemic was now surging in the capital and outlying regions, overwhelming hospitals in the process.

Metropolitan Manila as well as four outlying provinces, a highly concentrated population of over 25 million, was placed on lockdown directly by President Rodrigo Duterte. A heavily Catholic nation, even the Roman Catholic leaders there shifted Holy Week and Easter events fully online.

Some major hospitals reported full capacity, such as the government-operated Lung Center of the Philippines, the largest hospital in Manila metro. It could no longer accept walk-in patients as its COVID-19 ward was full capacity while the emergency room was operating at double its capacity, reported spokesperson Dr. Norberto Francisco. While other hospitals had capacity, they were lacking in appropriate staff.  

Highest in Region

The Philippines has now been hit the hardest in the entire Southeast Asia with 864,868 reported cases and 14,945 deaths. In this region, Malaysia, with 32.7 million people, has reported 360,856 cases and 1,329 deaths.

Consequently, growing criticism has been directed to the outspoken, unorthodox and strong-handed president who has already received lots of criticism by the international community for overreaching and violating human rights during an aggressive war on drugs. This president took the nation down a very different path than previous presidents that had good relations with the United States for decades.

Now the administration of Duterte faces a growing chorus of disapproval for not handling the pandemic appropriately. The defense of Duterte came from spokesperson Harry Roque who declared to ABS CBN News that all in the nation were surprised by the March spike and the new variants. But this general excuse could be easily challenged as spikes were starting throughout the world as March approached.

Ivermectin Compassionate Use Authorized

Local media and TrialSite viewers recently sent in information about the Philippines FDA compassionate use approval for a specific situation where a health provider sought out and was able to secure the use of ivermectin.  Clearly, this move was contemplated given the urgent situation on the ground there. The FDA had previously taken a firm stance here in this nation that traditionally has been very aligned with the United States and its policies (the current president of course disrupted that general collegiality).

In association with the compassionate use acceptance, FDA Director General Eric Domingo shared in a Malacanang Laging Handa briefing that “Ivermectin is an investigational product and we know that there are ongoing clinical trials on its use for COVID-19.”

Interestingly, the FDA Director wouldn’t name the hospital that was given the permit, citing “patient privacy.” He noted in a Viber message, “The attending physician takes full responsibility for the use of the product.” TrialSite has received a number of communications emphasizing growing acceptance of the generic drug by physicians in the Philippines as the nation experienced an unprecedented spike in cases.

Responses

  1. So this isn’t a slow approach, it isn’t a fast approach, but it’s a bit more than a half fast approach. Wait and see, but on the studies already ongoing, instead of starting up your own study. And some compassionate use at at least one hospital. So overall, pretty good but still dragging the feet. And of course, one wing of their medical world says yes, one wing says no. People are the same everywhere.