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‘Special permit for ivermectin per patient only’

Former Health Secretary Dr. Paulyn Ubial on Friday said the Food and Drug Administration’s compassionate use permit for anti-parasitic drug ivermectin should be issued per patient.

In an interview with Balitanghali, Ubial explained the permit issued to the hospital did not give them “blanket authority” to use ivermectin on other patients.

“The compassionate use application is per patient, and it is commonly issued to a hospital because the consideration is for every patient. It is not a blanket authority,” she said.

But Iloilo Rep. Janette Garin, a former Department of Health Secretary, said the Food and Drug Administration could be held liable for granting “compassionate use” of anti-parasitic drug ivermectin against COVID-19 to a certain hospital.

In a television interview, Garin mentioned Administrative Order 4, issued by the then DOH Secretary Juan Flavier, stating the guidelines on issuing compassionate special permit for restricted use of unregistered drug and device product or preparation.

“Definitely, yes. It actually started with Administrative Order 4. I think that was in 1992 or 1993, issued by Secretary Flavier. It was amended last year by [DOH] Secretary [Francisco] Duque,” Garin told CNN Philippines when asked if FDA could be held liable over its decision.

“It’s very clear in the guidelines.. the issuance of CSP for ivermectin is way beyond what is bounded in that...” she added.

In a related development, the effectivity of anti-parasitic drug ivermectin in treating COVID-19  is not backed by data, an infectious disease expert said on Friday.

“Ivermectin is very popular in South America where it is used for worms. A lot of countries started it using it out of desperation. Clearly, the controlled data, the data studies that are coming out really don’t show that it’s working,” Dr. Edsel Salvana told ANC.

“Early data showed that maybe it works in a Petri dish, maybe it works in certain subsets of patients, but when they did the big clinical trials with proper controls for any kind of bias, it turns out it doesn’t work,” Salvana said.

Several groups continue to advocate for its use.

However, the World Health Organization has warned against the use of ivermectin in patients with COVID-19 except for clinical trials because of inconclusive evidence.

The UN health agency’s recommendation followed the European Medicines Agency’s warning against the drug. The US Food and Drug Administration has also said it was not recommended for COVID-19 treatment.

In a separate message to reporters, Garin said a CSP was being granted to a specialized institution or a specialty society, adding there must be an ongoing Phase 3A trial in other countries or the country of origin before a CSP would be granted.

“It should also be clear if the CSP is for a clinical trial, who is the principal investigator, who are the subjects and what are the scientific basis of such and what does the trial intend to achieve/answer,” she said.

FDA Director General Eric Domingo earlier announced that one hospital’s application for compassionate use of the controversial ivermectin on humans with COVID-19 had been granted – but the hospital had not been named.

Domingo said only the hospital that had the permit for ivermectin’s compassionate use for humans would be allowed to import the drug through a licensed importer.

Garin said the hospital must be identified by the FDA for full transparency.

Meanwhile, business and civil society leaders have joined calls to allow the use of ivermectin to treat patients with COVID-19.

In a joint appeal, they called on President Rodrigo Duterte, Senate President Vicente Sotto III, and House Speaker Lord Allan Velasco “to give serious, urgent and immediate attention to Ivermectin as an inexpensive drug to prevent and treat COVID-19 during this public health crisis.”

They requested the President direct the Food and Drug Administration, Department of Health, and the Department of Science and Technology to:

Pro-actively look into the credible testimonial of a substantial number of Filipinos, including well-known members of Philippine society, and on the studies of several local and foreign medical researchers on the efficacy and safety of ivermectin in preventing and treating COVID-19 cases

Issue the appropriate permit or authority to persons, natural or artificial, to manufacture, compound, import, distribute and sell ivermectin

“We respectfully ask Congress to pass the appropriate legislation or resolution to expedite the availability of and easy access to ivermectin by the masses or our people,” they said.

The joint appeal was signed by Employers Confederation of the Philippines President Sergio Ortiz-Luis Jr., Chamber of Commerce of the Philippine Islands President Jose Luis Yulo Jr., Philippine Bar Association President Rico Domingo, Maritime Law Association of the Philippines President Ferdinand Nague, Sagot Kita Bayan President and former Senator Joey Lina, Philippine Chamber of Commerce and Industry Benedicto Yujuico, Federation of Philippine Industries Chairman Jesus Lim Arranza, Federation of Philippine Industries President Alberto Lina, PCCI Pasig City President Fernando Martinez, and Volunteers Against Crime and Corruption Chairman Cory Quirino.

Meanwhile, the Department of Health also said a systematic review of six randomized controlled trials showed that ivermectin did not significantly reduce the risk of mortality and duration of hospitalization among COVID-19 cases.

The registered oral and intravenous preparations of ivermectin are veterinary products, which are approved for use in animals for the prevention of heartworm disease and treatment of internal and external parasites in certain animal species, according to an advisory the FDA issued last month.

Salvana, a member of the technical advisory group that advises the Department of Health, cautioned against using ivermectin citing potential side effects.

 “The supposed anti-viral dose of ivermectin is about 5 times or higher that. So, I’m really concerned as a doctor if there will be toxic side effects because we do know that there are neurologic side effects of ivermectin if taken at higher dose or even in usual doses,” he said.

 Salvana lamented that non-medical professionals were promoting the drug despite a lack of data demonstrating its benefits.

 “Unfortunately, we also have, aside from a viral pandemic, we have a pandemic of misinformation where everybody thinks they can read journals, read the science when they’re not properly trained to do so,” he said.

“This is something we called epistemic trespassing where experts in some field feel that they can competently talk about something that’s not in their field and that’s really dangerous,” he added.

Topics: Paulyn Ubial , Food and Drug Administration , Janette Garin , ivermectin
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