Clarify statements on Ivermectin
We believe that this is a life and death issue and therefore most decidedly in the public interest — and therefore, a public duty
A group of doctors has requested the Department of Health (DoH) to clarify and qualify its pronouncements that the promotion of the anti-parasitic drug Ivermectin as treatment for coronavirus in human beings is in “violation of the law.”
Dr. Benigno Agbayani Jr., president of the Concerned Doctors and Citizens of the Philippines (CDC Ph), made the request in a letter to Undersecretary Dr. Maria Rosario Vergeire, citing the fact that both the
Food and Drug Administration Director general and the FDA legal counsel have made public pronouncements that compounding of Ivermectin is perfectly legal.
“We believe that this is a life and death issue and therefore most decidedly in the public interest — and therefore, a public duty,” Agbayani said in his letter dated 8 April.
Compounding, according to Agbayani, is provided for by law under the Philippine Pharmacy Act of 2016.
“The physician’s history of both prescribing and compounding a patient’s medication themselves is a long one. More recently, compounding has been the way through which conscientious doctors have been able to prescribe Ivermectin to treat their Covid-19 patients for the sick to save themselves,” he told Vergeire in the letter.
The CDC Ph president expressed hope that the DoH will support this treatment option, considering the medical evidence and frontline experience not just in the Philippines but also around the world.
“We believe the Department will be able to look objectively at the medical merits of Ivermectin as this drug, which is in the Philippine and WHO Essential Medicines List for good reason, will be very helpful to frontline doctors facing enormous risks everyday,” he said.
“We believe the DoH can and will apply liberality and the balancing of interests in its interpretation of the rules to help our people,” he added.
License to operate
Dr. Allan Landrito, a member of the CDC Ph and the most popular Ivermectin proponent, has recently been granted a license to operate as a drug trader by the FDA, allowing him to sell his self-made Ivermectin.
He claimed to have treated at least 8,000 Covid-19 patients with the 15-mg Ivermectin capsule he compounded himself.
Landrito has sold 25,000 bottles across the country and found that his drug is almost 100 percent effective in preventing Covid-19.
None of his patients had experienced severe side effects, he claimed.
Underground market
Because of this, Anakalusugan Rep. Mike Defensor, who revealed that he had taken Ivermectin when he was recuperating from Covid-19, believed that this would help the country produce more human-grade Ivermectin to lower Covid-19-related deaths.
The CDC Ph president expressed hope that the Department of Health will support this treatment option, considering the medical evidence and frontline experience not just in the Philippines but also around the world.
Defensor told the Daily Tribune that this would “hopefully kill the underground market” that emerged due to sudden demand for Ivermectin.
The lawmaker earlier disclosed that the sellers underground have been dispensing the drug and overcharging consumers when it only costs P35 to P50.
Heed recommendations
Following questions raised on the use of Ivermectin, the Quezon City
Health Department (QCHD), in a related development, advised the public to heed the recommendations of regulatory agencies mandated to review and approve consumer products, including drugs and medicines, for general use.
QCHD stressed it is not distributing, nor has it endorsed or supported the use of antiparasitic drug Ivermectin as a preventive drug or cure for Covid-19, citing the joint official statement released by the DoH and the FDA.
“We will follow whatever is the stand of the DoH-FDA on the issue since this is very well under their jurisdiction, given their mandate to review consumer products. And if they don’t authorize the use of this drug for Covid-19, we will rely on their expertise. We are issuing this statement because it is a public health issue and our QCitizens’ well-being is our mandate,” said QCHD Chief Dra. Esperanza Arias.
Arias said the QCHD is one with the public in seeking fast measures to address the disease but she said this should not come at the expense of regulatory processes that test products and medicines for their safety and efficacy.
“There are also other factors we need to consider if we will use this, such as the correct dosage to get maximum benefit. Public health should never be compromised at any given time,” she said.
Await results first
Meanwhile, the Department of Science and Technology (DoST) refused to get involved in the controversy, saying that its most common involvement is the development of diagnostic kits, disease models, drugs and adjunctive therapies which include clinical trials.
The DoST said clinical trial projects will require a minimum of six months and can extend to years. Considering, however, that there are almost 20 completed and 40 ongoing clinical trials around the world as reported in clinicaltrials.gov exploring the use of Ivermectin formulations against Covid-19, the Philippine Council for Health Research and Development (DoSTPCHRD) is of the position that there is no need to conduct another clinical trial in the Philippines.
As most ongoing clinical trials have already been implemented since 2020, it would be appropriate, according to the agency to await the results of these studies that are already significantly advanced in terms of data collection and conducting interim analyses.