The debate over veterinary anti parasitic drug, ivermectin, for use as treatment to COVID 19 has reached the Supreme Court, with proponents—three legislators—asking the High Tribunal to compel the Department of Health and Food and Drug Administration to compel its use for Covid-19.
Defying the prohibitions made by health and food and drug authorities here and abroad, three law makers have filed a suit in the Supreme Court to compel regulators to allow the use of Ivermectin, a veterinary anti-parasitic drug, for Covid-19 cases.
Those that petitioned the Supreme Court to force the Department of Health and the Food and Drug Administration to approve the use of Ivermectin for human cases of Covid-19 are Sen. Francis Tolentino and Reps. Michael Defensor (ANAKALUSUGAN partylist) and Rodante Marcoleta (SAGIP partylist).
Joining the lawmakers as petitioners are Drs. Homer Lim, Maria Quinto and Rafael Castillo.
The use of ivermectin for Covid-19 treatment is still undergoing clinical trials. The Department of Health has so far said that "evidence has shown it does not give you any benefit in preventing, shortening the duration of hospitalization or the progression of your disease when you have Covid-19."
The US FDA and Centers for Disease Control and Prevention in fact had stated before that people had fallen ill after self-medicating with the drug, which is commonly used as veterinary medicine.
The US FDA even said “you are not a horse or a cow,” when it warned against Ivermectin usage. But locally,
President Duterte has refused to discourage Ivermectin to treat Covid-19 cases.
Writ of mandamus
Petitioners are seeking a writ of mandamus that would order government agencies to "immediately issue" a Certificate of Product Registration for ivermectin and to issue licenses to companies that will make and sell the drug.
They also want the Supreme Court to order the health department to allow "the use if Ivermectin as treatment for Covid-19."
Marcoleta and Defensor organized an event in April where they and members of Concerned Doctors and Citizens of the Philippines distributed ivermectin pills to residents.
No result from probe
Health authorities promised a probe into reported irregularities in the distribution of the drug but nothing has come of that and the local FDA has been largely helpless against the unauthorized use of medicines and vaccines during the pandemic.
Ivermectin, which is usually used on humans as a topical treatment, is covered by Compassionate Special Permits that the FDA issues to specific hospitals.
FDA has not allowed its use as a general treatment for Covid-19 for lack of evidence that it works.
Clinical trials on using ivermectin against Covid-19 have been scheduled in the Philippines, but the DOH will not endorse the drug until results are out.
President Rodrigo Duterte, bucking the advice of his health department, has declined from discouraging use of the drug.
"Kasi mahirap naman masisi na kung totoo talagang effective, tapos pipigilan mo (It would be difficult for me to be blamed if I stop it and it turns out to be effective)," he said last week.
US FDA on ivermectin
In its website, the US FDA said its principal job is to carefully evaluate the scientific data on a drug to be sure that it is both safe and effective for a particular use. In some instances, it can be highly dangerous to use a medicine for the prevention or treatment of Covid-19 that has not been approved by or has not received emergency use authorization from the FDA.
However, the FDA has received multiple reports of patients who have required medical attention, including hospitalization, after self-medicating with ivermectin intended for livestock.
The FDA has not authorized or approved ivermectin for use in preventing or treating Covid-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea.
Taking large doses of ivermectin is dangerous, the US FDA warned adding that “if your health care provider writes you an ivermectin prescription, fill it through a legitimate source such as a pharmacy, and take it exactly as prescribed. “
Never use medications intended for animals on yourself or other people. Animal ivermectin products are very different from those approved for humans. Use of animal ivermectin for the prevention or treatment of Covid-19 in humans is dangerous.
Even the levels of ivermectin for approved human uses can interact with other medications, like blood-thinners. You can also overdose on ivermectin, which can cause nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death.
For one thing, animal drugs are often highly concentrated because they are used for large animals like horses and cows, which weigh a lot more than we do—a ton or more. Such high doses can be highly toxic in humans.
Moreover, the FDA reviews drugs not just for safety and effectiveness of the active ingredients, but also for the inactive ingredients. Many inactive ingredients found in products for animals aren’t evaluated for use in people. Or they are included in much greater quantity than those used in people. In some cases, we don’t know how those inactive ingredients will affect how ivermectin is absorbed in the human body.
Ivermectin is a broad spectrum anti-parasitic agent, included in WHO essential medicines list for several parasitic diseases. It is used in the treatment of onchocerciasis (river blindness), strongyloidiasis and other diseases caused by soil transmitted helminthiasis. It is also used to treat scabies.
A guideline development group was convened in response to the increased international attention on ivermectin as a potential treatment for Covid-19. This group is an independent, international panel of experts, which includes clinical care experts in multiple specialties and an ethicist and patient-partners.
The group reviewed pooled data from 16 randomized controlled trials (total enrolled 2407), including both inpatients and outpatients with Covid-19. They determined that the evidence on whether ivermectin reduces mortality, need for mechanical ventilation, need for hospital admission and time to clinical improvement in Covid-19 patients is of “very low certainty,” due to the small sizes and methodological limitations of available trial data, including small number of events.
Dr, Bindu Balani, an infectious disease medical doctor, said wrote in Hackensack Meridian Health that reports from FDA showed people ingesting ivermectin doses in a past form that is designated for horses, and doctors prescribing the medication for Covid-19.
In a typical pre-pandemic setting, there are about 3,600 prescriptions filled for ivermectin in a year. From early July and August, the CDC reported over 88,000 prescriptions dispensed – that is a 2,344% increase.
“The stark increase in prescriptions for ivermectin is not a coincidence – this is an ‘off-label’ use of the drug. While ivermectin is approved for use in parasitic conditions, there has been no evidence or approval for use against Covid-19,” shares Dr. Balani.
Overdosing
The side effects of ivermectin overdose include: nausea, vomiting and diarrhea; confusion, hallucination, seizures, coma and death.
Darcy Jimenez, on April 19, 2021 wrote in Pharmaceutical Technology that until the ongoing research on ivermectin can determine its antiviral potential and safety profile with certainty, people desperate to protect themselves will continue to self-medicate with dangerous quantities and forms of the drug. But that doesn’t mean approving it is the answer.
The ivermectin debate has highlighted the disparity in access to Covid-19 vaccines and treatments for low- and middle-income countries. The consequences of global healthcare inequality are clear: if life-saving vaccines aren’t available, people will be driven to take matters into their own hands – with potentially catastrophic results.
Tags: #SupremeCourt, #Covid19, #Ivermectin, #clinicaltrials