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.
Read more...
