June 17, 2024

The Food and Drug Administration and infectious diseases specialists from Baguio General Hospital and Medical Center are firm in their recommendation against using the Ivermectin in treating and preventing the virus that causes the Covid-19.

On the other hand, advocates of the controversial drug also continue to vouch for it efficacy sans government permit, as they commended the city council for opening discussions and considering ivermectin as a possible option in the city’s Covid-19 response efforts.

A proposed resolution filed by Councilor Benny Bomogao is pending at the city council and currently subject of deliberations.

During the council’s Nov. 29 session, FDA-Northern Luzon cluster head Gomer Clemente Gamuna said the regulatory agency dissuades the use of Ivermectin as a Covid-19 cure because there is currently no such thing as Covid-19 cure and the only current preventive measure there is, is injection or the vaccines.

Gamuna said while there are some testimonies as to the efficacy of Ivermectin as alleged cure for Covid-19, there is still no ample scientific data that would point to it as effective and should be used as part of Covid-19 protocols.

The Philippine FDA’s issuance of a warning against the drug, he said, is based on the issuances and studies made by the U.S. FDA that contradict the claims of Ivermectin advocates. 

The FDA confirms that Ivermectin is approved for topical purposes and as an anti-parasitic drug, but not for human consumption or for treatment of Covid-19.

“It is for topical purposes for skin diseases but as to the manner it would be ingested there is no standard yet as to milligrams (doses) and how frequent it will be taken by humans for it to be effective and efficacious in curing Covid-19. Those using Ivermectin use their own formulation, and that is why FDA is dissuading its use because there might be some adverse effect on unsupervised use of this drug. It is supposed to be under the ambit of a clinical trial that Ivermectin can be used,” Gamuna told council members.

He cited studies that suggest the notion for possible clinical translation and repurposing of ivermectin needs to be carefully addressed and any empirical statement with Ivermectin or its inclusion in therapeutic protocols is not scientifically justifiable.

Gamuna said FDA and even DOH are explicitly dissuading ivermectin use for Covid treatment because they themselves cannot defend that the drug is a Covid cure due to want of data to support it as of this time.

Dr. Bernard Demot, BGHMC adult disease specialist, said there is still lack of robust evidence suggesting the efficacy and safety of using Ivermectin for prevention and treatment of Covid-19.

“We stand by the Philippine Society for Microbiology and Infectious Diseases along with 40 other medical societies including the Philippine Medical Association that do not recommend this anti-parasitic medicine for Covid-19 treatment due to lack of scientific evidence for the use of the drug,” Demot said.

He said the World Health Organization also said its use should only be done in the context of a clinical trial, and since there are ongoing studies also on its feasibility, it is more prudent to await the result of these studies.

He added the country has to focus on proven and recommended treatment for Covid-19 and continue to intensify the vaccination rollout, strengthen the observance of minimum public health standards among citizens, and strengthen the capacity of local government units to avoid high health care utilization rate during case surges.

Demot said BGHMC also did not request for a compassionate special permit (CSP) for Ivermectin because up to now they do not see compelling evidence why they have to use it, and there are medicines they had asked CSP for, which have been reviewed and are compelling that are willing to vouch with their licenses that these drugs can be used for patients.

Dr. Allan Landrito, one of the most popular advocates of Ivermectin who consider it as a wonder drug, said the country could have done many things differently during the pandemic if it used Ivermectin and “we didn’t even have to use vaccine and the pandemic should have ended. We just have to give Ivermectin early.”

Landrito claimed to have treated thousands of patients using his self-made Ivermectin and noted high efficacy rate and prevented death.

“We are doing it even without approval, as we are saving a lot of people. I don’t think it’s wise to wait for that period (the clinical trial would entail) when we have it already in our hands,” he said.

He added what they are doing is not just based on assumption or experiment but based on empirical trials, experiences by doctors in different countries who looked into and shared their information, and arrived at proper protocols and standards how to use it.

The FDA, however, said saying because of the pandemic anybody could do things to mitigate the situation would be a dangerous proposition, because it will create chaos and disorderliness in the society.

Hindi puwedeng anybody could use any drug for any sickness na basta maibigan lang niyang gawin. We should accept responsibility that is a compassionate special permit may be issued for purposes of close monitoring of the patients. In the event of adverse reaction the doctor should be able to diagnose the correct medication to prevent death or any serious illness.

The FDA is sole regulatory agency that determines whether or not a particular drug is to be introduced and use in the country, through a process of validating by experts before it can be included in the list of allowed drugs. – Hanna C. Lacsamana