In justifying his move to distribute free ivermectin, a drug intended to treat parasitic infestations, AnaKalusugan Rep. Michael “Mike” Defensor claimed that the United States (U.S.) allows it to be used “off-label” as a treatment for the coronavirus disease 2019 (COVID-19).
This is misleading.
STATEMENT
In an April 6 interview on ANC Headstart, the lawmaker said that health authorities such as the U.S. Food and Drug Administration (FDA), World Health Organization (WHO), and the Philippine Department of Health (DOH) have deemed the drug “safe.”
Defensor, whose party-list group advocates universal access to healthcare, went on to say:
“Safe siya (ivermectin). Wala siyang problema. Ngayon sa U.S., pinapayagan nila ‘yung off-label prescription. Kasi ‘yung sinasabi nila diyan, okay ito for the parasites, river blindness, so on and so forth. Pero pagka-COVID ba, pwede ka mag-prescribe [ng ivermectin]? In the U.S., it is allowed.”
([Ivermectin] is safe. It has no problems. Now, in the U.S., they allow off-label prescription [of ivermectin]. Because what they say about that is, it’s okay for parasites, river blindness, so on and so forth. But if it’s used for COVID, can they prescribe [ivermectin]? In the U.S., it is allowed.)
Source: ANC Official Youtube Channel, Headstart | ANC (6 April 2021), April 6, 2021, watch from 34:05 to 34:22
On April 5, Defensor announced on Facebook that his office is giving away free ivermectin to Quezon City residents, with priority to vulnerable sectors, specifically persons with comorbidities and senior citizens.
FACT
While the practice of prescribing off-label medications is, indeed, “legal and common” in the U.S., the country’s FDA has specifically warned against the use of ivermectin to treat COVID-19 patients.
In a March 5 advisory, the agency said ivermectin is currently approved for use in humans only at “very specific doses for some parasitic worms” and as topical (on the skin) formulations for head lice and some skin conditions. It has not been granted an emergency use authorization (EUA) for COVID-19 treatment.
The FDA is the agency responsible for “ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.”
The U.S. National Institutes of Health (NIH), on the other hand, has said there is still “insufficient data” to “recommend either for or against the use of ivermectin” as a treatment for COVID-19.
In its COVID-19 Treatment Guidelines, last updated on Feb. 11, the NIH, the country’s medical research agency, said:
“…results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.”
Off-label drug use is when a physician prescribes a patient with a drug that has been approved by the U.S. FDA to treat a condition that is different from what the patient has, as defined by the U.S. Agency for Healthcare Research and Quality.
Healthcare providers “generally” may prescribe or administer an FDA-approved drug for an unapproved use “based on their medical judgment, recognizing that the FDA has not assessed the safety or effectiveness of such use.”
However, the FDA warned that “taking a drug for an unapproved use can be very dangerous.” This is “true” for ivermectin, too, it said.
Meanwhile, WHO, in its Living Guideline on Therapeutics and COVID-19 released on March 31, has not recommended the use of the drug for COVID-19 patients except in clinical trial settings.
Citing results from a review of 16 randomized clinical trials (RCT) that had 2,407 participants, including both inpatients and outpatients with COVID-19, WHO said:
“The effects of ivermectin on mortality, need for invasive mechanical ventilation, hospital admission, duration of hospitalization[,] and time to viral clearance all remain very uncertain (all very low certainty evidence).”
Similarly, ivermectin manufacturer Merck has also cautioned against the use of the drug as COVID-19 treatment. In a Feb. 4 statement, it said an analysis done by its own scientists on “available and emerging studies” on the matter found that there is:
- no scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies;
- no meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease; and,
- a concerning lack of safety data in the majority of studies.
In the Philippines, DOH and the Philippine FDA issued a joint advisory on March 26 warning the public against the purchase and use of the veterinary version of the drug — which is the “commercially available and registered” version in the country — for COVID-19 patients.
Earlier that month, the Philippine COVID-19 Living Clinical Practice Guidelines Reviewers and the Philippine Medical Association, along with other national health and medical groups, likewise issued a joint statement, reiterating that they “do not recommend” the use of the drug on COVID-19 patients “based on current evidence.”
They said a “systematic review” of six RCTs showed that ivermectin “did not significantly reduce the risk of mortality among patients with mild to severe COVID-19 cases,” nor did it significantly reduce the duration of hospitalization.
On March 29, the FDA said there is currently “no registered ivermectin oral formulation for human use” in the country. So far, the drug has been approved only for:
- treatment of external parasites, such as head lice, in humans in topical form, as prescribed; and,
- prevention of heartworm and internal and external parasites in “certain animal species.”
Republic Act 9711 or 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.”
Any person found to have violated the law will face imprisonment of at least one year to 10 years, a fine ranging from P50,000 to P500,000, or both at the court’s discretion.
In a text message to reporters on April 6, Justice Secretary Menardo Guevarra said: “I am sure that as a lawmaker, [Defensor] knows the FDA law very well and that he is very much aware of what acts are allowed.”
On April 8, FDA director-general Eric Domingo announced that the agency had granted a compassionate special permit (CSP) to a hospital (without disclosing which one) to use ivermectin as a COVID-19 treatment.
A CSP allows limited use of an unregistered, investigational drug or product. It is different from a certificate of product registration (CPR), which allows the “manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and/or, where appropriate, the use, testing, promotion, advertising, or sponsorship of health products,” following the “evaluation and approval” of registration requirements.
In an interview with dzBB also on April 8, Domingo clarified that ivermectin is still not for general public distribution even with a CSP application granted, and that the permit is valid on a “per-doctor-per-patient” basis.
Apart from this, Domingo said there are two pending applications for a certificate of product registration (CPR) for the drug with the FDA.
Sources
AnaKalusugan Partylist Cong. Mike Defensor Official Facebook Page, Sagot ni Cong. Mike Defensor ang IVERMECTIN, April 5, 2021
House of Representatives, Hon. Michael T. Defensor, Accessed April 7, 2021
ABS-CBN News Channel Official Youtube Channel, Headstart | ANC (6 April 2021), April 6, 2021
U.S. Agency for Healthcare Research and Quality, Off-Label Drugs: What You Need to Know, Accessed April 7, 2021
U.S. National Library of Medicine, Off-Label Drug Information Regulation, Distribution, Evaluation, and Related Controversies, August 2009
U.S. National Library of Medicine, Ten Common Questions (and Their Answers) About Off-label Drug Use, October 2012
U.S. Food and Drug Administration (FDA), Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, March 5, 2021
U.S. Food and Drug Administration (FDA), FAQ: COVID-19 and Ivermectin Intended for Animals, Dec. 16, 2020
U.S. Food and Drug Administration (FDA), What We Do, March 28, 2018
National Institutes of Health, Ivermectin, Feb. 11, 2021
National Institutes of Health, Who We Are, Accessed April 9, 2021
US Food and Drug Administration (FDA), Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19, Oct. 22, 2020
US Food and Drug Administration (FDA), Understanding Unapproved Use of Approved Drugs “Off Label”, Feb. 5, 2018
World Health Organization, Therapeutics and COVID-19: living guideline, March 31, 2021
Merck, Merck Statement on Ivermectin use During the COVID-19 Pandemic, Feb. 4, 2021
Department of Health Official Facebook Page, DOH-FDA ANNOUNCEMENT ON THE USE OF IVERMECTIN FOR COVID-19 PATIENTS | 26 March 2021, March 26, 2021
Department of Health Official Facebook Page, The Philippine COVID-19 Living CPG Reviewers of the UP-NIH ICE and Consensus Panel Representative…, March 18, 2021
Philippine Food and Drug Administration, FDA Press Statement || Clarification on the purchase and use of Ivermectin 29 March 2021, March 29, 2021
Official Gazette of the Philippines, Republic Act No. 9711, Aug. 18, 2009
ABS-CBN News, Guevarra on ivermectin: Defensor should know what’s allowed, prohibited under FDA law, April 6, 2021
Philippine News Agency, Guevarra trusts solon won’t go against law on Ivermectin use, April 6, 2021
Manila Bulletin, Guevarra to Rep. Defensor: Hope he follows law on use, distribution of medicines, April 6, 2021
Radio Philippines Network DXKO Cagayan de Oro, LAGING HANDA PRESS BRIEFING 11:00 AM / 4-8-2021, April 8, 2021
Philippine Food and Drug Administration, Administrative Order No. 2014-0029, Sept. 8, 2014
Super Radyo DZBB 594khz Official Facebook Page, Super Balita Sa Tanghali, Nationwide | Lala Roque at Orly Trinidad, April 8, 2021
(Guided by the code of principles of the International Fact-Checking Network at Poynter, VERA Files tracks the false claims, flip-flops, misleading statements of public officials and figures, and debunks them with factual evidence. Find out more about this initiative and our methodology.)
