A Mozambique spitting cobra, one of the deadly snakes whose bites can be treated with FAV-Afrique antivenom. Image: Stuart G Porter/shutterstock

The last supplies of an important snake antivenom just expired - and that's a problem

Uh oh.

KEVIN LORIA, BUSINESS INSIDER
6 SEP 2016
 

At the end of June 2016, the last remaining supplies of an important, safe, and effective antivenom expired. The antidote, known as FAV-Afrique, is what Doctors Without Borders (MSF) has relied on to treat snakebites in sub-Saharan Africa.

It can be used to treat bites from 10 venomous snakes, including some of the most dangerous in Africa. That’s particularly useful in the common cases where a person doesn’t know what type of snake bit them.

 

While other antivenoms exist, no one knows yet if any of these potential alternatives will safely be able to fill the hole left by an antidote that can be used against so many different types of snakebite. They will have to use alternatives anyway, hoping they work.

"It’s a shame that a product that all experts agree was good was abandoned," says Julien Potet, policy advisor for neglected tropical diseases at MSF. "We’re putting the lives of some patients at risk."

The dire situation is no surprise - MSF, the World Health Organisation (WHO), and others have known that Sanofi Pasteur had stopped producing FAV-Afrique years before.

MSF had hoped to convince the pharmaceutical company to accelerate the transfer of their technology to another company and to continue producing antivenom in the interim period, but that still hasn’t happened.

Even if they find someone else willing to produce the treatment, Potet says it will take a couple of years for a new company to get production going and to get antivenom distributed.

In a statement emailed by a representative of Sanofi, the company explained that they ceased production of FAV-Afrique after lower cost products led to a "steep drop in orders" for their antivenom.

 

The statement added: "Sanofi Pasteur regrets the worldwide situation with respect to the supply of anti-venom immunoglobulins and is studying options that would enable the transfer of know-how to other biologicals producers who would be willing to take over the production."

But the fact of the matter is, finding someone who wants to produce antivenom is not an easy task. A recent Nature News story explains that many pharma companies have stopped producing antivenom and only five of the 35 companies or governments who make antivenom make products for sub-Saharan Africa.

"In the absence of medicines, snakebite victims have been known to drink petrol, electrocute themselves or apply a poultice of cow dung and water to the bite," Carrie Arnold writes.

More than anything else, this situation is just an illustration of a much more serious global problem with regard to access to treatment for venomous bites.

A larger and growing problem

The patients encountered by Doctors Without Borders are just a fraction of those affected by snakebites, both in Africa and around the world.

"Every five minutes, somebody dies from snakebite," Leslie Boyer, the founding Director of the VIPER Institute at the University of Arizona, tells Business Insider. "Ten to twenty thousand Africans lose limbs to amputation each year from snakebite, with lifelong impact on their ability to work and take care of families."

According to recent estimates, more than 100,000 people die each year after being bitten by cobras, vipers, and other venomous snakes, and many others suffer debilitating injuries. More than 400,000 people have limbs amputated or rendered useless.

That’s far more than was previously thought, and it’s possible the number could be higher still, since most bites don’t occur in places where they are necessarily reported. Antivenom shortages are a problem the world over - it’s not just about FAV-Afrique.

"Snakebites are a growing public-health crisis," according to Nature News.

The loss of FAV-Afrique is a blow to those that MSF is able to treat now. But far more patients in Africa never make it to an MSF facility after being bitten.

Last year in the journal BMJ, David Williams of the Australian Venom Research Unit wrote that gaps in the global antivenom supply "have cumulatively cost millions of lives, maimed millions more, and contributed to the burden of poverty and disenfranchisement that lingers heavily over many nations" - all for something that he writes is "eminently treatable".

"Snakebite is the most neglected of the ‘Neglected Tropical Diseases," according to Boyer.

Snake oil treatments

Well-tested and approved products like FAV-Afrique are not cheap, with an average cost of around US$120 a vial, according to Potet (and many venomous bites must be treated with more than one vial).

That amount of money is more than some citizens of countries like Chad, South Sudan, and Ghana - all places FAV-Afrique was helpful - make in a year.

So in the late 2000s, when companies popped up offering antivenom at far cheaper rates, ministries of health jumped at the opportunity. But there are lots of ways that an antidote can be screwed up, according to Richard Clark, the Medical Director of the San Diego Division of the California Poison Control System and a professor of toxicology at UCSD.

Manufacturers may not use the right antibodies or they may not properly treat the antidote to remove components that cause negative reactions.

The companies making these cheaper antivenoms seemed to have these problems. Adopting a new antivenom in Chad caused fatality rates from bites to go from 2.3 percent to 15 percent. Ghana saw a similar change. These products were "low-cost, low-quality", says Potet.

But the change in market share was enough for Sanofi to decide it was time to get out of the business.

Most venomous snakebites happen in parts of the world that aren’t high income, meaning that making antivenom isn’t particularly profitable.

"It’s really all a cost-benefit analysis," says Clark. And that’s led to antivenom shortages everywhere, he says.

Compounding the issue is the fact that expensive treatments rarely make it to individuals in most of sub-Saharan Africa (or rural India, Bangladesh, or Pakistan, other places where snakebite is a serious issue). When bitten, people seek out traditional healers, who can’t do much to counteract a venomous bite.

Boyer explains that, according to the African Society of Venimology, this creates a vicious cycle. People don’t expect good treatment in a hospital, so they don’t go until they are desperate. Once they do, they’re too sick for treatment to be effective. And existing trust issues were worsened in places that used less effective antivenoms.

The search for a solution

There’s no easy answer when it comes to figuring out how to deal with what’s known as the global burden of snakebite.

Potet does say that the World Health Organisation (WHO) seems to recognise now that snakebite is a bigger issue that needs to be dealt with (though there are still criticisms of the WHO’s efforts).

That international organisation is now assessing alternative products that might be used in sub-Saharan Africa, and there are hopes that at least one product might be a viable alternative for FAV-Afrique. Some of those products could even be more shelf-stable (less prone to spoil), which is important if an African health ministry wants to order a large quantity.

But there are major debates over how to handle the problem. Some groups in Costa Rica and Brazil are working on new safer types of universal antivenoms, according to Nature News.

But it could be years before these are ready to use and they may cost tens of thousands of dollars for each dose when they first become available. Meanwhile, people are dying and becoming disabled every day because of something that we have the technology to treat.

The biggest challenges are still financial, as is frequently the case when dealing with drug prices and companies working in both the developing and developed world.

As Boyer explains it, the solution isn’t going to come from a place like the US, where her research shows a 1,000-fold markup between the cost to make antivenom and the cost a patient pays.

It’s more likely that a Latin American or Spanish product might prove to be effective, safe, and affordable, she says.

Along with working on new antivenoms, researchers in Costa Rica, Brazil, and Mexico do have other more conventional antivenoms in the works that could be effective in Africa. Even so, ensuring it gets to patients in need will be a challenge.

"As long as [antivenom] is user fee driven, people will only have access to low-cost, low-quality products," says Potet. "There is definitely a need to subsidise quality antivenoms."

This article was originally published by Business Insider.

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