A Poisonous Shortage

by Jenna Frawley

I am standing at the stat hood, handing the pharmacist a second vial of Cro-Fab that we need to dilute. Since when did Virginia have rattlesnakes? I knew of the venomous copperheads. Yet somehow, when I thought of rattlesnakes, I thought of the Old West movies, not the backyard of some poor Leesburg teenager who was now a patient in our ER. Nevertheless, here I was, the technician, learning to make the antivenom. I would have to use this skill again a few weeks later when a man would decide to stick his hand into a nest of baby copperheads living in his log pile.

I work at Loudoun Hospital in northern Virginia, and every summer we get a handful of snakebite victims. These injuries are challenging to treat as the antivenom is expensive (up to $9,000 a bottle) and the patient needs repetitive doses of four to six vials, followed by two more every couple hours until the doctor is sure the venom is out of their system. When this treatment protocol is followed, only 5 out of 8,000 snakebite victims die every year in the United States. While we do not usually keep enough vials for more than one patient at a time, it is easy enough to borrow from any of three surrounding hospitals. Not everywhere in the world is this lucky, however.

As of 2016, the worldwide supply of FAV-Afrique antivenom (used primarily in Sub-Saharan Africa) is set to expire. FAV-Afrique is favored due to its high level of efficacy as antivenom with the least number of adverse reactions. It also covers the broadest spectrum of snakes native to the area. While snakebites tend to take a backburner in people’s minds relative to HIV, diabetes and other more prominent health crises, snakebites are responsible for up to 100,000 reported deaths every year, a third of which occur in Sub-Saharan Africa. Now, with the antivenom running out, that number could skyrocket.

How could a drug so critical just get taken off the market? Back in 2014, Sanofi Pasteur, the pharmaceutical company that produced the antivenom, ended production because the drug was unprofitable. It cost up to $500 to receive the treatment, which is several years’ salary for many families in the countries that use it. The company had issued warnings as far back as 2010 that they wanted to pull the drug, claiming that they were being outcompeted by other less effective, but easier to produce antivenoms, which were heavily advertised to doctors who were not necessarily trained to correctly pick them out. Since they ended the product, Sanofi Pasteur has offered to sell their production methods and technology. Unfortunately, no other company has taken up the offer.

Antivenom is produced by harvesting snake venom, diluting it and then injecting it into an animal such as a horse or a sheep. The antibodies produced by the animal in response to the venom are then extracted from their blood and used as the antivenom. FAV-Afrique uses the venom from ten different species of snakes in the Elapidae and Vipidera families. This can be a rather expensive process. On top of that, because it is a biological agent, there must be strict measures on its transportation and storage. For example, it generally requires steady refrigeration and extra precautions. In my hospital, I generally have to walk the IV bag in which it is made down to the ER room, as we cannot risk getting it shaken up in the tube transport system. These precautions limit how the antivenom can be distributed, which makes it difficult for many people in rural areas of Africa to receive the treatment.

An alternative to FAV-Afrique is not scheduled to be available until 2018. In the meantime, there are a few alternative antivenoms, but these do not always cover the correct species of snakes. Additionally, patients that receive these alternatives are more prone to adverse reactions. In the meantime, there is a precedent for extending the expiration date of antivenoms in the United States. The FDA found that expired samples of the antivenom were still good a few years after their expiration date. A similar approach may be possible for the FAV-Afrique shortage.

These issues of antivenom shortages are not a novelty to the world. The primary problem is that the countries currently concerned are not equipped to deal with these impending shortages. In the United States, the regular citizen cannot afford the cost of medical care, and so the government must subsidize the product for it to be a viable option. Many developing nations in Africa lack the political stability and economic means to compensate for the high cost of antivenom in this manner. Furthermore, in accordance with Sanofi Pasteur’s own statement, many doctors simply do not have the knowledge to pick out the right product, which contributed to the downfall of FAV-Afrique.

Africa has had issues with antivenom shortages for decades. Only now, when it has reached a crisis level, are international organizations like Doctors without Borders and Medicines Sans Frontieres beginning to address the shortage. If anything, the impending shortage represents how citizens of developing countries are put at unnecessary risk, simply because they do not have the means to pay for a life-saving treatment.

The next time you think about the big health issues facing the world, such as cancer and cardiovascular, it might be worthwhile to consider the huge effect that drug shortages and underproductions can potentially have on giving rise to critical life-threatening situations from something like a snake bite.