Pragmatism needed to avert potential Indian variant outbreak

During a recent Congressional committee hearing on how we could more effectively address the pandemic, we shared some insights on how pragmatism, on the part of physicians, our health officials and our regulatory bodies like the Food and Drug Administration (FDA), could help address the multifaceted problem of the pandemic and also enhance policy making and good governance.

This is quite urgent in view of the looming threat of the more infectious Indian variant, which has ravaged India. At its peak, it infected around 400,000 new cases daily, killing more than 4,000 each day.

While we still have some time to prepare for it, we have to assemble the best preventive, therapeutic and supportive regimen we can under the current circumstances—not under ideal circumstances.

Potential next outbreak

It’s comforting to note though that the available vaccines—mainly AstraZeneca, Pfizer and Moderna—have been shown in a recent British study to be still effective, though slightly less, for the Indian variant. If we can ramp up vaccination of the vulnerable sectors of the population—the elderly and those with significant comorbidities like high blood pressure, diabetes, chronic lung or kidney disease, obesity—then we should have less hospitalizations and deaths despite this potential next outbreak.

The problem is that, as of last week, less than 10 percent of this vulnerable sector have been vaccinated. The Department of Health (DOH) and Inter-Agency Task Force for Emerging Infectious Diseases (IATF) should impose a strict deadline on themselves for completing the vaccination of the elderly and high-risk in the next three months, prioritizing those in known hotbed areas like Metro Manila and other key cities.

On a positive note, we’re glad that the DOH and the IATF are reckoning with the reality that mass vaccination at the rate it should be done is simply not feasible in our country, with the various constraints we’re confronted with. We should just opt for targeted vaccination of the vulnerable sector, preparing likewise to give them another round of booster doses after six months, as most likely, will be required.

The next question, though, is—since we could not mass vaccinate the population, how do we protect the majority of the population who cannot be vaccinated? This is where pragmatism is needed.

High-stakes wager

The difference in orientation between the pragmatist and idealist was highlighted during the recent surge in cases, which overwhelmed our health-care system, such that many highly symptomatic COVID cases spent hours looking for a hospital to take them in. Meanwhile, they were receiving no treatment.

Allowing or prohibiting ivermectin, shown in numerous studies to be effective in preventing and treating COVID-19, became a high-stakes wager for our regulators and health officials, as well as pro- and anti-ivermectin physicians, with human lives at stake.

So, the pragmatic physician focuses on the practical aspect: “How do we save lives despite the limitations?” He’s like an ambulance driver who risks breaking traffic rules to get his very sick patient quickly to the hospital. The idealist physician still stops at all red lights, and sticks to the allowed speed limit.

The pragmatic physician is not really a lawbreaker, but dares to break standard practices—like going against the guidelines recommended by expert societies and prescribing drugs off-label—because he believes it can help save his patient. He weighs carefully the risk vis-à-vis the benefit of treatment. In our real-life setting, it can fill a big gap in preventing and treating COVID-19.

Recently, with the COVID surge in France, 1,500 doctors wrote a strong letter to their health minister requesting for an immediate emergency use authorization for ivermectin. They explained in detail the efficacy and safety data, showing it’s even safer than commonly used drugs like paracetamol.

The French doctors have previously requested their FDA for a temporary authorization for ivermectin to be given to some local companies, but this was turned down. They wrote that the “refusal represents a serious threat to public health.”

Such a strong statement virtually indicts the French health agency of a grave dereliction of duty or sin of omission or inaction, which, in times of emergency, is considered a grave offense for government officials. We don’t want a similar indictment of our DOH and FDA to happen here.

New therapeutic measures

The Declaration of Helsinki of the World Medical Association emphasizes that “doctors have the right to use new therapeutic measures if it offers hope of saving lives or alleviating suffering.” It does not say when the evidence is already very strong. Our DOH and FDA may be unwittingly violating the rights of both the patient and the doctor with their undue suppression of ivermectin.

In times of pandemic, good governance mandates combining best available evidence, including real-world evidence, with sound clinical judgment and a big dose of pragmatism. Real-world data is now playing an increasing role in drug regulation, policy making and health-care decisions.

Speaking of real-world data, there are now numerous success stories of ivermectin distribution campaigns in various countries. Let’s talk about the success story in Uttar Pradesh, because we believe it is a good model for the Philippines.

Uttar Pradesh is the most densely populated state in India, with a population of more than 230 million—that’s more than twice the population of the Philippines. With such density, one would expect that the recent surge would have severely affected it. On the contrary, it had one of the lowest positivity and death rates at the peak of the surge, and its government confidently shared that the timely use of ivermectin was their secret.

We tried to compute based on published figures how Uttar Pradesh fared at the peak of the Indian surge in the first three weeks of April. Though they were still affected by the outbreak, they had 72 percent less new cases of COVID-19 compared to the rest of India. They also had 62 percent less deaths. This reduction in transmission and deaths is similar to the data given in randomized controlled trials.

This just highlights the fact that real-world evidence can reinforce the findings of well-designed clinical trials, and public health officials, guideline drafters and regulators like our FDA should also consider real-world evidence. Such evidence is more pragmatic because it’s where the rubber meets the road.

The Indian health ministry must have recognized the success of a few states like Uttar Pradesh, such that on April 28, it revised its national guidelines and recommended the antiparasitic drug for COVID-19 treatment. It made this bold move, which defied the recommendations of the World Health Organization (WHO) and the country’s experts.

More liberal use

Is it just coincidental that three weeks after initiating a more liberal use of ivermectin, new cases in India have dropped by nearly 50 percent?

It may be worthwhile for Health Secretary Francisco Duque III to give the young and strong-willed health minister of India a call and compare notes. It might change Duque’s outlook.

Some people have been telling us, too, that at the height of the recent outbreak in Metro Manila and other key cities, around 3 million tablets or capsules of ivermectin were illegally sold here by well-meaning traders. And this somehow helped play a part in reducing the number of cases, aside from other measures the DOH/IATF implemented. Well, all’s well that ends well, but we hope it remains well despite the increasing numbers of the Indian variant here.

It’s good that we already have a registered ivermectin product available in the market, but as House Deputy Speaker Bernadette Herrera-Dy appealed to the expert societies and drafters of our anti-COVID living guidelines, they should not maintain their hard line of strongly recommending against ivermectin, which many doctors still follow. The doctors and their patients should be given the freedom to consider it as an option, despite the perceived low quality of its efficacy evidence by the experts. It’s a contract or agreement between the patient and his/her doctor, and we should give them the freedom to decide on it, appealed Herrera-Dy.

We hope that the next time we’re told about the “still insufficient evidence on ivermectin,” we’d consider the robust body of real-world evidence that indicates it could save thousands of lives in the population, prevent infection, likely avert health-care exhaustion, help salvage the economy, and probably help restore normalcy in a country.