Doctors: ‘Ivermectin effective vs Covid-19;’ FDA opposes use

Baguio City Council probes efficacy 

By Jordan G. Habbiling

BAGUIO CITY -- The Food and Drug Administration and Baguio General Hospital and Medical Center (BGHMC) opposed the use of an FDA-approved antiparasitic drug called ivermectin as oral treatment for Covid-19 patients in the city.
    This, even as some Manila-based doctors testified to its efficacy against Covid-19, saying they healed hundreds of their patients with ivermectin during the city council session here on Nov. 29. 
    Councilor Benny Bomogao, in his resolution, invited representatives of the FDA and BGHMC to the city council’s regular session to inquire whether the drug can be prescribed to individuals infected with the virus.
    Gomel Gabuna, operating officer of FDA North Luzon, strongly warned against the use of ivermectin to prevent or treat Covid-19 outside of a clinical trial.
    Gabuna said the FDA prohibits use of ivermectin as a cure for Covid-19 on since there is not enough scientific data to prove the drug’s efficacy and safety when used for said purpose.
    “The FDA has approved the use of ivermectin but not for ingestion. It is only for topical purposes to treat parasites and skin diseases. There are no standards yet prescribing how it will be used as an oral medicine by humans,” he said.
    The FDA official warned there might be adverse effects of the drug when its consumption is unsupervised.
    He urged medical practitioners prescribing ivermectin to Covid-19 patients to obtain a compassionate special permit (CSP) from the FDA.
    A CSP is granted to physicians or hospitals for the use of investigational drugs that are not yet registered or in the process of registration here in the country for treating serious illnesses.
    The CSP holder must take full responsibility for the use of the requested drug.
    According to FDA guidelines, the CSP does not assure the product’s safety, efficacy, and quality.
    He warned the city council of legal implications of allowing the use of ivermectin as a Covid-19 treatment in the city without compelling medical practitioners or institutions who wish to prescribe or dispense ivermectin to obtain a CSP. 
    “If medical doctors are indiscriminately allowed by the city government to prescribe ivermectin, there is a possibility that any unscrupulous individual can easily claim that the death of a certain patient was caused by the use of ivermectin. The city government will open itself to lawsuits if it will allow the use of this untested drug,” the FDA official said. 
    He said despite advisories issued and several operations conducted against sale and distribution of ivermectin, the drug is still available in the market.
    Meanwhile, Dr. Bernard Demot, an infectious disease specialist at the BGHMC, told the council that the Philippine Society for Microbiology and Infectious Diseases, along with other medical associations in the country, does not recommend the use of the anti-parasitic drug to cure and prevent Covid-19 due to lack of enough scientific evidence.
    But he added a study on the efficacy of ivermectin as a Covid-19 cure is already being undertaken by the Dept. of Science and Technology (DOST) in quarantine centers of Ateneo de Manila University, De La Salle University, University of the Philippines Diliman, and Makati Science High School.
    He said it would be prudent for physicians to await results of the study.
    The country should continue focusing on the proven and recommended measures against Covid-19, the infectious disease specialist said.
    “We have to intensify the vaccination roll-out, strengthen the public’s adherence to minimum health standards, and strengthen the healthcare capacity of the city, so that we can avoid severe cases in times of surges,” he said.
    As opposed to the use of dexamethasone, remdesivir, tocilizumab, and baricitinib which underwent rigorous scientific processes and were approved by medical associations, there is no substantial and compelling empirical evidence supporting the efficacy of ivermectin in treating and preventing Covid-19, he said, thus he cannot recommend it. 
    Dr. Samantha Bartolo, another infectious disease specialist at BGHMC, cited the Ivermectin Treatment Efficacy in Covid-19 (ITEC) study recently done in Malaysia.
    The study showed there was no benefit in the use of ivermectin as Covid-19 treatment and that it may cause diarrhea.
    “As physicians, we follow the principle ‘Do not harm.’ Therefore, we will not advocate its use until there is further evidence,” Bartolo said.
    Two of the most prominent ivermectin advocates in the country also attended the council forum as resource speakers. 
    Dr. Allan Landrito, a medical officer in the City Health Department of Muntinlupa, said aside from having anti-parasitic properties, ivermectin is also an effective anti-viral drug.
    Citing studies conducted worldwide, Landrito said ivermectin improves the condition of severe Covid-19 cases by 96%.
    In his own study with 1,273 subjects, he concluded that ivermectin as a Covid-19 oral treatment is 95% effective.
Demot urged Landrito to publish his study so that other medical authorities could critique it.
    Asked if he is a CSP holder, Landrito replied, “After I get my certificate of product registration which I am currently applying for, why would I apply for a CSP? I will have to pay P500 for each patient and fill in a lot of forms which I have no time to do since I am seeing thousands of patients.” 
    “We are in an emergency situation. I have to give ivermectin to my patients right away,” he added.
    The Muntinlupa doctor said the country cannot afford to wait for the results of the clinical trial being undertaken by the DOST.
    “By the time the results are out, many people will have already died. Without their approval, we are prescribing ivermectin and are saving lives,” he said.
    Dr. Jose Oclarit, a scientist and professor in the scientific community, criticized mainstream doctors for dismissing the claim that ivermectin is anti-viral in nature and can “destroy the spike protein and viral material that causes Covid-19 infection.”
    “From the time I first encountered ivermectin, I have had more than a hundred patients that recovered from the Covid-19 infection by taking ivermectin coupled with Vitamin D3 at a rate of 5,000 units per day, Vitamin C at a rate of 12,000 mg per day, and zinc,” Oclarit said.
    In his final word, Gabuna said the FDA, as the concerned regulatory agency, cannot leave it to the discretion of citizens to decide whether or not to accept ivermectin as a Covid-19 treatment, stating possibilities of adverse effects and drug misuse. 
He said sale and distribution of ivermectin as a Covid-19 treatment is illegal.
    After hearing both sides, the council decided to refer the matter to the Sanggunian’s committee on health and sanitation, ecology and environmental protection to be further studied in aid of legislation.