Man v. Snake v. Government Bureaucracies

Man wins, at least against the snake. Pit viper bites can be really nasty, and it sounds like Dave got hit by a big one. Rattlesnake venom is hemotoxic, meaning it destroys tissue. This makes a bite from a members of the pit viper family extremely painful, and visibly damaging to the surrounding area. In high enough doses it’s lethal. It looks like reasonably prompt treatment with antivenin managed to save his life. While I think we all can agree getting bitten by a snake is a remarkably bad run of luck, the specific type of snake here, the pit viper, is responsible for enough bites of man and beast each year to create a viable market for antivenin, and overcome the hurdles the FDA throws at people making the stuff.

To understand that, you have to understand a bit about antivenin. What is generally done is to inject snake venom into a horse, which causes the horse to produce antibodies against the venom. Those antibodies can be separated from the horse’s blood, purified, preserved, and eventually injected into the victim of a snake bite. The horse antibodies then go to work neutralizing the venom. It sounds great, and it is. The only problem is, there are a significant number of people who are allergic to equine proteins, and who will go into anaphylactic shock as a result of the treatments, never mind the snake bite.

So clearly if you’re dying of a snakebite, we can’t take the risk that you might be allergic to the antivenin. Better that you die of the snake bite, lest anyone blame an FDA bureaucrat for approving it. Fortunately for Dave, the FDA has approved an antivenin for pit viper bites that’s sourced from sheep, rather than horses, which fewer people are allergic to. Enough people and animals get bitten by pit vipers each year to make it economical. But what if you get bit by something else?

Something else, like a Coral Snake. Coral Snake have a venom is a neurotoxic, meaning it attacks the nervous system. The victim of a Coral Snake bite might not feel much in the way of pain, not have limbs bloody and blow up like balloons. In that sense, a bite from the Coral Snake is not as dramatic as bites from species that produce hemotoxic venom. But the victim does stand a very good chance, untreated, of dropping dead a few hours later from respiratory and cardiac arrest, as the venom goes to work on the central nervous system. If you happen to be unlucky enough to get bitten by a Coral Snake, which fortunately are rare, since they are not an aggressive species, you’re pretty much shit out of luck. Why? Well, the last US stocks of existing equine derived Coral Snake antivenin are scheduled to expire, right about now actually. The market for antivenin for that species is too small for there to be an incentive for a pharmaceutical maker to get it approved by the FDA. There are stocks in other countries, like Mexico, but they aren’t of a variety that is approved by the FDA, and no one wants to pay for the studies to prove it’s safe. Like I said, better to let you die of the snake bite.

So there you have it. If you get bit by a snake, make sure it’s from a species our government protectors have deemed we may be saved from, or get bit in Mexico. This chapter in government regulation was brought to you by the letter “H” and “C.”

17 thoughts on “Man v. Snake v. Government Bureaucracies”

  1. For what it’s worth, I would call it antivenom. Until Dave’s post, and God’s grace and speed to him, I had never heard or seen the word antivenin. I actually thought that his use of the word “antivenin” was a typo due to the fact that he was doped up. This, having spent over 40 years studying and practicing first-aid and wilderness/emergency medicine. I can’t recall a single instance of having seen the word antivenin in a Western text/publication. Even when I went to the Thai Red Cross center for producing antivenom in Bangkok in 1995, I don’t recall seeing the word “antivenin” there. From Wiki;

    The name “antivenin” comes from the French word “venin”, meaning venom, and historically “antivenin” was predominant around the world. In 1981, the World Health Organization decided that the preferred terminology in the English language would be “venom” and “antivenom” rather than “venin/antivenin” or “venen/antivenene”.[2]

  2. That’s quite a bigoted post – do you have any source for thinking that the FDA is incompetent or mean-spirited, or conspiring against the public? Is it more likely that a company unable to produce a safe and effective product, having wasted investment capital and needing to raise more capital in the face of their own failure, would exercise it’s right to free speech and whine for political help (and investment capital), or is it more likely that scientists thoroughly protected from any consequences (good or bad) would want to screw Americans? Remember that FDA isn’t supposed to fight back in the news; they can’t talk about confidential business information (such as why an antivenom wasn’t approved).

    A competent company would make fully human monoclonal antibodies for antivenom, and produce them in cell culture (such as CHO cells). Producing polyclonal antibodies in a horse or sheep is old, old technology. It’s amazing that they can claim to meet good manufacturing practices (GMP). It would be so easy to get a monoclonal antibody approved; their is a specific set of regulations (the ‘Animal Rule’) that would grant approval based on testing in rats and dogs (instead of longer clinical studies).

  3. And to claim their isn’t a market to support developing a life saving drug is an outrageous ignorant lie. Read a little about the Orphan Drug Act, and the taxpayer money available as grants to encourage development of drugs to treat rare diseases. Companies have suscessfully developed replacement enzymes to treat congential diseases that only afflict a few dozen babies worldwide per year. Sure, it costs hundreds of thousands of dollars for a course of treatment, but that’s to cover the cost of developing a brand new molecular entity.

    Second generation antivenom would only cost 1% of what it costs to develop a new drug.

  4. I don’t think it’s conscious mean spirited, like people at the FDA want people to die, I’m speaking more organizationally. I just think the incentives are bad, and the FDA has gotten entirely too — organizationally — cautious. That has prevented drugs from getting to market that would help people because no one wants to approve the next Vioxx.

    Maybe it’s a matter of the market just being too small for much research to go into it, but the regulatory hurdles are going to be a big part of the decision not to do the research.

    I’m not an abolish the FDA type, and nor am I arguing for no regulation whatsoever. But it seems that when dealing with diseases or conditions that have a high likelihood of lethality, the burden of proof on safety ought to be much lower than, say, a hair loss drug. To a large degree it is already, but is it enough to encourage research into really niche markets?

  5. Some rattlesnakes have neurotoxin based venom, others have hemolytic toxins, and there are those which have a mix of the two. Mojave Greens have “mojavetoxin” which is population selective (within the same species) for any of the above. Bad juju anyway you look at it.

  6. Bureaucracies have a built-in bias toward keeping themselves safe. Safe means not taking chances. People might die from antivenom shots. This could cause problems for the FDA. So better the FDA denies license/throws up roadblocks to the manufacture of antivenom.
    Soon coming to obumble/democrap healthcare. And people WILL die for the above reason.

  7. Some of your information may be out of date, Sebastian. Most pit viper bites in the US these days are treated with Crofab antivenom, which is ovine (sheep-based) rather than the older Wyeth antivenom, which was indeed equine (horse-based). Crofab is a much better antivenom than Wyeth, with less chance of allergic reaction/anaphylactic shock. Wyeth is no longer manufactured, but it is still stocked in some places.

  8. If the FDA approves a drug, and it accidentally kills a few people, they get blamed for it.

    If the FDA stops a drug from being produced, and they lack of the drug kills THOUSANDS of people a year, they get no blame at all. Their families don’t know that they could have been saved, except for gov interferance.

    The FDA has incentives to prevent the release of drugs, even if they could save lives.

  9. Are you seriously willing to take untested medicine from a developing country for a life-threatening illness? Do you think insurance companies should pay for the drug?

    Right now, between 20 and 40% of drugs coming from Mexico are fake. Not the homeopathic cures and stuff approved in Europe but not the US, but rather medicines approved in the US that are cheaper in Mexico. The more expensive the drug, the more likely it is to be fake. Which is easier: to make an antibody against venom, or an antibody against a cancer epitope, or to package up some proteins at the right consistency and pretend it’s product? Pateints can tell if a narcotic isn’t working, but they can’t tell in a timely fashion if the anti-cancer therapy is (especially if they are old and sick, and take the pills at home because they can’t afford daily visits from a health care professional). You’ll be lucky if the emergency room doc has experience with snake bites and can tell that the drug is or isn’t working before you die. Whose responsibility is it to track whether or the not imported drugs are working as hoped? Wyeth declined to track patient outcomes for their coral antivenom (one pathway FDA proposed to show that it still works). Wyeth declined to demonstrate activity in animals. What do you think FDA’s general approach should be – to force Wyeth, or to have the government take over? FDA did what it could – gave Wyeth a heads up, and gave other companies opportunity to step in.

    Why should FDA be allowed to extend the expiration date on coral snake antivenom? The Supreme Court recently ruled (Wyeth v Levine, 2009) that it is the company who gets screwed, not FDA. Why should Wyeth (coincidentally the maker of the coral snake antivenom) be forced to make product available without experimental data to protect them from a lawsuit?

  10. I’m generally of the opinion that if you take a drug from a third world country, which you know not to be FDA approved, you get whatever is coming to you.

    Generally speaking I don’t have a problem with the FDA process conceptually. Unlike most government agencies, most of what the FDA does is based on science rather than politics. In my view the FDA’s role is essentially to prevent fraud. In other words, that what you’re selling is actually medicine rather than poison, and that it does what you say it does. In that sense, it more properly regulates sellers.

    Where I start to have issues is when the FDA regulates buyers. If I decide European drug standards are enough for my own purposes, why shouldn’t I be able to import the drug and take it? If someone advertises a Mexican approved patent medicine that kills people or is basically diluted alcohol, go after the advertiser for fraud. I don’t care much whether the advertiser is a drug company, a doctor, or whoever. I would have no problem in such a regime if FDA required doctors to inform patients of risks associated with unapproved medicines, and held them liable if they did not.

    So I’m not saying so much that FDA should do something about the antivenin situation in regards to Coral Snakes, so much as it shouldn’t have the power to interfere with someone’s decision as to what can an can’t go into their own bodies.

  11. So in Wyeth v Levine a physician’s assistant preformed an action (which consisted of a improperly preformed injection) that there was a specific warning against and the company is still found liable. I fail to see how upon reading the “Inadvertent Intra-arterial Injection” warning a medical professional could not conclude that it would be safer to use a IV drip than a push. Why do you even require medical professionals if no application of their skills and judgment are necessary?

    On a related note it seems that I have not been adequately informed of the risks of treatments administered to me.

  12. What bothers me the most about the FDA is that they can outright ban things they decide are bad for us. Take Vioxx, for example. Once it’s known to cause heart attacks, shouldn’t those with severe arthritis be free to choose if they want lesser pain–possibly less enough that they can actually do things now–and accept the fact that, by doing so, they may be taking ten years off their life by increasing their heart attack risks?

    The same should go for the anti-venom. If it’s produced in horses instead of sheep, the FDA doesn’t have to approve it–but why can’t someone bitten by a coral snake decide to take the risk that he may be allergic to horse proteins?

    And, if someone dies in either case, how should the FDA be blamed? Couldn’t they just say, “See, we told you so!”?

  13. I spent a lot of time in the Army training in the swamps around South Georga, Ft. Stewart and some places in South Carolina. We were taught that Coral snakes did not bite, specifically because their venom was a nerve agent they had to chew on a small portion, like between your fingers or your nose for their venom to take affect. I don’t suppose it would make any difference to the one being “venomed” to death.

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