Politics of Ivermectin

It is a worrisome day when politicians start dictating to bureaucrats charged with responsibilities that are supposed to be exclusively science-based. That’s what’s happening now with the Ivermectin case.

Last week, two congressmen distributed Ivermectin capsules to some 200 Quezon City residents, in clear defiance of our FDA which has not officially allowed public distribution of the drug. There were four doctors who were supposedly writing prescriptions they were not authorized to do outside the five hospitals allowed to use the drug.

FDA director-general Dr. Eric Domingo tried his best to assert the authority of his office and uphold the procedures for authorizing the use of drugs. Ivermectin is an anthelmintic, belonging to a group of antiparasitic drugs that expel parasitic worms (helminths) and other internal parasites from the body.

Ivermectin is only currently authorized to be used here for veterinary purposes. Using it for humans to treat COVID-19 requires rigid testing to determine safety, efficacy, and correct dosage. No such study has been presented to our FDA for its panel of experts to evaluate.

Supporters of Ivermectin here, including some doctors, say it is effective both as a prophylaxis against COVID-19 and as a means to reduce hospital stay in case of infection.

The effectiveness of the drug is supported only by anecdotal “evidence” that falls below what is required to allow any drug to be safely used.

Conspiracy theorists claim Big Pharma, including Ivermectin’s original manufacturer, is blocking its use against COVID to protect their economic interests. They also insist that the drug is safe based on experience of its widespread use in Africa as an antiparasitic drug.

If the problem is simply the lack of credible scientific evidence from a regular clinical trial, why doesn’t anyone do that? Ivermectin is now considered an orphan drug because its patent has expired. Doing a scientifically acceptable clinical trial will cost time and money.

Merck, which developed and marketed it for decades, issued a statement saying that their scientists continue to carefully examine the findings of all available and emerging studies of Ivermectin for the treatment of COVID-19 for evidence of efficacy and safety.

But Merck said they have found no scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies; no meaningful evidence for clinical efficacy in patients with COVID-19 disease, and; a concerning lack of safety data in the majority of studies.

Ivermectin’s advocates, however, point out that Merck is not interested in repurposing Ivermectin because they are working on a new antiviral drug that could be used for COVID. But two weeks ago, Merck announced it has stopped developing one medicine in hospitalized COVID patients and has given up completely on another COVID drug.

Merck has also dumped its own COVID vaccine effort, and instead has started to help manufacture the Johnson and Johnson vaccine.

Our FDA, through Dr. Domingo, tried to hold the line on the local use of Ivermectin for treating Covid, but the politicians intervened strongly.

House Speaker Lord Allan Velasco urged DOH and FDA to fast-track efforts to clear Ivermectin for emergency use authority. This was in reaction to an appeal of big businessmen to the Speaker, the Senate President and to Duterte to get FDA to decide on Ivermectin one way or another.

Senate President Vicente Sotto III admitted that he, too, is taking Ivermectin as a prophylaxis against COVID-19. Sotto advised health authorities to give more attention to treatment and prevention while the supply of COVID-19 vaccines is still scarce.

With the politicians taking the antiparasitic Ivermectin, we can at least be sure the only parasites left in Congress are those collecting outrageous allowances and pork funds.

There is also some social media support for Ivermectin as folks are worried when vaccines will be available and the cost of alternative anti-Covid drugs that hospitals are authorized to use. Ivermectin is their only hope.

Tocilizumab, supposedly used on some VIPs, costs $2621 per vial and must be imported yet. It is a repurposed rheumatoid arthritis drug. A number of studies show it helps critically ill patients survive, while others have shown otherwise.

Remdesivir supposedly costs P280,000 for the whole course in one major private hospital. Yet, WHO does not recommend use of remdesivir regardless of disease severity as there is currently no evidence it improves survival and other outcomes. So, why is FDA allowing its use?

Dr. Domingo is possibly strongly positioned to resist political interference because he is politically astute himself, definitely not a political virgin. He is the son of Andrea Domingo who chairs Pagcor. He got the UP Board of Regents to appoint him the director of PGH at a time when another had previously been appointed, making some of the hospital staff protest in favor of the incumbent.

To his credit, Dr. Domingo is trying hard to uphold FDA procedures, but he succumbed to political pressure anyway and granted five hospitals the authority for compassionate use of Ivermectin but only within their premises.

It is not clear if there was any scientific basis for his decision or if it was given in the context of conducting a clinical study. He was, after all, ordered by Duterte to conduct such a study. We have not heard from Dr. Domingo how he plans to comply with Duterte’s orders.

In the meantime, two Duterte congressmen out for political brownie points defied existing laws and openly distributed Ivermectin.

Justice Secretary Menardo Guevarra said that “on its face,” the distribution of Ivermectin is a violation of the FDA law, which prohibits the promotion of unregistered medical products in the country. But given their political influence in the administration, even the Justice Secretary would not say if they can be prosecuted for the violation.

Both the Philippine Medical Association and the Philippine Pharmacists Association have denounced the illegal distribution of Ivermectin by the congressmen. They want authorities to investigate and file appropriate charges.

But what can we expect of a “soft state” like the Philippines where laws are mere suggestions to be implemented at the discretion of the powerful elite? We continue to be a joke and that’s our tragedy.

Boo Chanco’s e-mail address is [email protected]. Follow him on Twitter @boochanco