Antivenom Shortage

A good look at a pit viper pupil

 

Coral Snake

Well, according to the front page of MSN, the bite from a coral snake could either cost you your life or a lot of expensive hospital care to recover from it. Why? 

There are several reasons but first, a little background on the snakes.  

Arrowhead shaped head of a pit viper

 The coral snake is not as aggressive as its cousins the pit vipers (rattlesnakes and cottonmouth are a couple). But what it lacks in aggressive behavior, it makes up for with neurotoxicity.  

First off what is a pit viper? Pit vipers get their names from the pit between their mouth and eye. This is a heat-sensing organ and makes it possible for the snake to accurately strike a warm-blooded victim, even if it cannot see the victim. 

They have a triangular or “arrowhead” shaped head. 

The pit viper has fangs that drop down and forward from its jaw and the fangs work as hypodermic needles to pump venom from a sac. A bite from a pit viper can be extremely painful. 

Pit vipers have an elliptical pupil (like a cats’ eye) and all other snakes (usually non-venomous) have a round pupil. The highly poisonous Coral Snake has a round pupil. 

The coral snakes’ habitat is mostly in Florida, parts of Alabama, South Carolina, Louisiana, Texas and Arizona and there are only about 100 bites per year. Unlike the moveable, long fangs of pit vipers, the coral snake has small, fixed teeth and in order to inject venom into a victim, it has to ‘chew’ on them for a while. (Much like a gila monster – a venomous, “beaded” lizard does.) The victim will have very little pain to indicate a bite but within a few hours symptoms such as tingling sensations in the arms, fingers, toes (the extremities), slurred speech and droopy eyelids begin to show. Then the victim’s lungs shut down. The venom acts as a neuromuscular blockage to the lungs, effectively paralyzing them so that artificial respiration is needed or the victim will die. 

There is only one antivenin commercially available, and after October 31 of this year the existing vials of Micrusrus fulvius, the only antivenin approved by the Food and Drug Administration, will no longer be available. 

Why? 

Wyeth, now owned by Pfizer, had the antivenin approved for sale in 1967 when the regulations were less stringent. Wyeth kept up production of coral snake anti venom for almost 40 years, but due to the rarity of coral snake bites, it was hardly a profit making proposition. The company shut down the factory that made the anti venom in 2003. Wyeth worked with the FDA to produce a 5 year supply as a stop gap measure while other options were pursued. After that period, the FDA extended the date on existing stock from 2008 to 2009 and then once again from 2009 to 2010. 

No new manufacturers’ have stepped forward. Not surprisingly it all comes down to money. However, there is a coral snake anti venom produced by the Mexican drug manufacturer Instituto Bioclon that researchers believe could be even more effective and safe than the soon to expire Wyeth product.  There is a fly in the ointment. The drug, Coralmyn, is not currently licensed for sale by the FDA. The tests required to get it licensed would cost millions of dollars. In other words, because of the rarity of coral snake bites it does not, at this time, justify the expenditure of millions of dollars. It would take decades for Bioclon to make its money back. 

Antivenom shortages are not that rare of an occurrence. The state of Arizona ran out of antivenom for scorpion stings after Marilyn Bloom, an envenomation (The injection of a poisonous material by sting, spine, bite, or other similar means.  From http://dictionary.com) specialist at Arizona State University retired in 1999. She had been single-handedly making all scorpion antivenom for state hospitals. 

In another instance, Merck & Co, the only FDA-licensed producer of black widow antivenom, has cut back distribution because of a production shortage. The World Health Organization has listed worldwide envenomations as a “neglected public health issue.” 

New scorpion and black widow antivenoms are in the pipeline, thanks to the efforts of several poison-control associations to speed foreign drugs into the market through FDA research programs. 

The bottom line is that it is quite possible that if these antivenom drugs are not approved costs will skyrocket when doctors will have no other choice but to intubate coral snake bite victims on ventilators for weeks until the effects of the toxin wear off which potentially could cost hundreds of thousands of dollars per bite as well as the cost of human suffering. 

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