BY GERARD NAVAL and WENDELL VIGILIA
TWO more hospitals have been issued compassionate special permits (CSPs) by the Food and Drug Administration to use the anti-parasitic drug ivermectin as treatment for the coronavirus disease (COVID-19), bringing the total to five.
A CSP allows an institution or facility limited use of investigational drugs or unregistered drugs, such as ivermectin. The special permit does not guarantee the drug is effective, or that the FDA is recommending its use.
The issuance of permits to more facilities comes as the Department of Science and Technology is preparing to conduct clinical trials on ivermectin, as ordered by President Duterte, and amid debates on whether it should be used on COVID-19 patients.
Two party-list groups pushing for ivermectin use are set to distribute the drug today in Quezon City, along with three other groups.
The FDA Act of 2009 prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded.
The FDA allows those who want to use ivermectin for the treatment of COVID-19 patients to apply for a CSP.
Health Secretary Francisco Duque III said it would be best if everybody waits for the completion of studies on the efficacy of ivermectin.
The clinical trials could take about six months, the DOST has said.
“I’m just waiting for more data. The best provider of this data is the World Health Organization (WHO). We are guided by the WHO advisory on ivermectin,” he said in a TV interview.
“The DOST has already laid down the human trials for ivermectin. They need to prove the theory during clinical trials,” he added.
The World Health Organization last month recommended against using ivermectin for COVID-19 patients except for clinical trials, because of a lack of data to show its benefits.
The US Food and Drug Administration and the European Medicines Agency have also warned against the use of the drug.
The Philippine FDA has said any use of ivermectin veterinary products for the prevention or treatment of COVID-19 “should be avoided as the benefits and safety for this purpose has not been established.”
In an advisory last month, it also said registered ivermectin products in the country for human use are only topical formulations used to treat external parasites such as head lice and skin conditions.
It said registered oral and intravenous preparations of ivermectin are veterinary products.
The Anakalusugan party-list group of Rep. Michael Defensor and Sagip party-list group of Rep. Rodante Marcoleta will distribute ivermectin today, along with Lifecore Bio-Integrative Inc., Concerned Doctors and Citizens-PH, and Malayang Quezon City.
They said the initiative “endeavors to provide access to the poor to avail of the ivermectin drug in our fight against COVID-19.”
Marcoleta said their ivermectin tablets will be provided by a licensed compounding laboratory, Lifecore Bio-Integrative, Inc. He said doctors’ prescriptions will be given to the beneficiaries.
The event will be held at the Matandang Balara Barangay Hall park at 9 a.m. with doctors prescribing ivermectin to poor senior citizens of the barangay which has one of the highest cases of COVID-19.
“From this symbolic event we will pursue the distribution of ivermectin by giving access to the poorest of the poor in Quezon City. QC continues to be the number 1 area with the most cases of COVID-19 with a total of 87,727. Currently, there are 6,524 active cases with 1,188 deaths due to COVID-19,” Defensor said.
Defensor and Marcoleta said that under the “Ivermectin Pan-three” project, each beneficiary will be given a minimum of three ivermectin capsules or tablets for free.
They said they reached the decision after inquiries conducted by the committees on health and good government and public accountability “where both foreign and local experts were engaged on the potential use of ivermectin, we have decisively come to a critical decision to distribute ivermectin to those who are in dire need of this drug.”
