Thursday, January 21, 2021

What it takes to crush a pandemic by Johanna Benesty

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My son was born in January 2020, shortly before the lockdown in Paris. He was never scared of people wearing masks, because that’s all he knows. My three-year-old daughter knows how to say “gel hydro-alcoolique www.snowtown.in.th

” That’s the French word for hydroalcoholic gel. She actually pronounces it better than I do. But no one wants to be wearing a mask or wash their hands with hand sanitizer every 20 seconds. We’re all desperately looking at R and D to find us a solution: a vaccine.

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It’s interesting that in our minds, we keep thinking of the vaccine discovery like it’s the Holy Grail. But there are a couple of shortcuts here that I’d like to unpack. I’m not a doctor, I’m just a consultant.

My clients focus on health care biopharma companies, providers, global health institutions — and they’ve educated me. We need to find the tools to fight COVID, and we need to make them accessible to all.

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First, one single vaccine will not get us out of this. What we need is an arsenal of tools. We need vaccines, we need therapeutics, we need diagnostics to make sure that we can prevent, identify and treat COVID cases in a variety of populations.

Second, it’s not just about finding a tool. What do you think will happen when one of those clinical trials demonstrates that the tool is effective? Do you think we can all run to the pharmacy next door, we get the product, we take off our masks and we go back to French kissing? No.

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Finding an effective tool is just one step in this big fight, because there is a difference between the existence of a product and access to that product. And now you’re thinking, “Oh — she means other countries will have to wait.

” Well, no, that’s not my point. Not only others may have to wait, but any of us may have to. The humbling thing about COVID is that because of its speed and magnitude, it’s exposing all of us to the same challenges and giving us a flavor of challenges we’re not used to.

Remember when China got into lockdown? Did you imagine that you would be in the same situation a few weeks after? I certainly didn’t. Let’s go to the theoretical moment when we have a vaccine.

In this case, the next access challenge will be supply. The current estimate of the global community is that by the end of 2021 — so that’s over a year after the discovery of the vaccine — we would have enough doses to cover one to two billion of the eight billion of us on the planet.

So who will have to wait? How do you think about access when supply is short? Scenario number one: we let the market forces play, and those who can pay the highest price or be the fastest to negotiate deals will get access to the product first.

It’s not equitable at all, but it’s a very likely scenario. Scenario number two: we could all agree, based on public health rationale, who gets the product first. Let’s say we agree that health care workers would get it first, and then the elderly and then the general population.

Now let me be a bit more provocative. Scenario number three: countries who have demonstrated that they can manage the pandemic well would get access to the product first. It’s a little bit extrapolated, but it’s not complete science fiction.

Years ago, when the supply of high-quality second-line tuberculosis drug was scarce, a special committee was established to determine which countries had health systems that were strong enough to ensure that the products would be distributed properly and that patients would follow their treatment plans properly.

Those select countries got access first. Or, scenario number four: we could decide on a random rule, for instance, that people get to be vaccinated on their birthday. Now let me ask you this: How does it feel to think of a future where the vaccine exists, but you would still have to wear a mask and keep your kids home from school, and you would not be able to go to work the way you want because you wouldn’t have access to that product? Every day that passed would feel unacceptable, right? But guess what? There are many diseases for which we have treatments and even cures, and yet people keep being infected and die every year.

Let’s take tuberculosis: 10 million people infected every year, 1.5 million people dying, although we’ve had a cure for years. And that’s just because we haven’t completely figured out some of the key access issues.

Equitable access is the right thing to do, but beyond this humanitarian argument that I hope we are more sensitive to now that we’ve experienced it in our flesh, there is a health and an economic argument to equitable access.

The health argument is that as long as the virus is active somewhere, we’re all at risk of reimported cases. The economic argument is that because of the interdependencies in our economies, no domestic economy can fully restart if others are not picking up as well.

Think of the sectors that rely on global mobility, like aerospace or travel and tourism. Think of the supply chains that cut across the globe, like textiles or automotive. Think of the share of the economic growth that is coming from emerging markets.

The reality is that we need all countries to be able to crush the pandemic in sync. So not only is equitable access the right thing to do, it is also the smart thing to do. But how do we do that? Let’s make sure we’re on the same page in terms of what “access” means.

It would actually mean that the product exists; that it’s working sufficiently well; that it’s been approved by the local authorities; that it is affordable; but also that there is evidence that it works in all the populations that need it, and that can include pregnant women or immunodepressed people, or children; that it can be distributed in a variety of settings, like hospitals or rural clinics, or hot climate or cold climate; and that we can produce it at the right scale.

It’s a very long checklist, I know, and in a non-crisis situation, we would likely address these issues one after the other in a sequential way, which takes a lot of time. So what do we do? Access is far from being a new challenge, and in the case of COVID, I have to say, we’re seeing extraordinary collaboration of international organizations, civil society, industry and others to accelerate access: working things in parallel, speeding up regulatory processes, engineering supply mechanisms, securing procurement, mobilizing resources, etc.

Yet we are likely to face a situation where, for instance, the vaccine would need to be constantly stored at, let’s say, minus 80 Celsius degrees; or where the treatment would need to be administered by a highly specialized health care worker; or where the diagnostic would need to be analyzed by a sophisticated lab.

So what more can we do? Pushing further the logic that the global health community has advocated for for years, there is one additional thing I can think of that might help. There is a concept in product development and manufacturing that’s called “design to cost.

” The basic idea is that the cost management conversation happens at the same time as the product being designed, as opposed to the product being designed first and then reworked to bring the cost down.

It’s a simple method that helps ensure that when cost has been identified as a priority criteria for a product, it’s made a target from day one. Now, in the context of health and access, I think there is untapped potential in R and D to access, the same way that manufacturers design to cost.

This would mean that, instead of developing a product and then working to adapt it to ensure equitable access later, all of the items on the checklist I mentioned would be built into the R and D process from the beginning, and this would actually benefit us all.

Let’s take an example. If we develop a product with equitable access in mind, we might be able to optimize for scale-up faster. In my experience, drug developers often focus on finding a dose that works, and only after do they optimize the dosage or make adjustments.

Now imagine that we’re talking of a candidate product for which the active ingredient is a scarce resource. What if instead we focused on developing a treatment that uses the lowest possible amount of that active ingredient? It could help us produce more doses.

Let’s take another example. If we develop a product with equitable access in mind, we might be able to optimize for mass distribution faster. In high-income countries, we have strong health systems capacity.

We can always distribute products the way we want. So we often take for granted that products can be stored in temperature-controlled environments or requires a highly skilled health care worker for administration.

Of course, temperature-controlled environments and highly skilled health care workers are not available everywhere. If we were to approach R and D with the constraints of weaker health systems in mind, we might get creative and develop sooner, for instance, temperature-agnostic products or products that can be taken as easily as a vitamin or long-lasting formulations instead of repeat doses.

If we were able to produce and develop such simplified tools, it would have the added benefit of putting less strains on hospitals and health systems for both high- and low-income countries. Given the speed of the virus and the magnitude of the consequences we’re facing, I think we have to continue challenging ourselves to find the fastest way to make products to fight COVID and future pandemics accessible to all.

In my perspective, unless the virus disappears, there are two ways this story ends. Either the scales tip one way — only some of us get access to the product and COVID remains a threat to all of us — or we balance the scales, we all get access to the right weapons, and we all move on together.

Innovative R and D can’t beat COVID alone, but innovative management of R and D might help. Thank you.

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