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Why Snakebites Are About to Get a Lot More Deadly

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  • Why Snakebites Are About to Get a Lot More Deadly

    Why Snakebites Are About to Get a Lot More Deadly

    The cure for bites from North American coral snakes is about to disappear. Find out why an unprofitable antivenom may end up costing lives.

    By Glenn Derene

    As venomous snakes go, the coral snake is a clumsy biter. Unlike pit vipers such as rattlesnakes and cottonmouths, which have gruesomely efficient fangs that articulate forward during a strike and inject venom like hypodermic needles, the brightly colored coral snake has small, rear-facing fangs that guide venom into a wound. This process doesn't always work well — experts estimate that 25 percent of coral snake envenomations are dry bites — which is perhaps why the coral is so unaggressive. The snake is found throughout Florida, as well as in parts of Alabama, South Carolina, Louisiana, Texas and Arizona, but there are generally only about 100 or so bites each year.

    What the coral lacks in belligerence, it makes up for in neurotoxicity. Unlike bites from pit vipers, which cause immense pain and swelling at the wound site, coral snake victims usually report little pain after being bitten. But the effects begin to show within hours, with symptoms such as tingling sensations in the extremities, dysarthria (slurred speech) and ptosis (droopy eyelids). Then a victim's lungs shut down. "The venom acts as a neuromuscular blockade to the lungs," University of Florida professor of medicine Craig Kitchens says. "Without antivenom, you need artificial respiration or you die."

    Unfortunately, after Oct. 31 of this year, there may be no commercially available antivenom (antivenin) left. That's the expiration date on existing vials of Micrurus fulvius, the only antivenom approved by the Food and Drug Administration for coral snake bites. Produced by Wyeth, now owned by Pfizer, the antivenom was approved for sale in 1967, in a time of less stringent regulation.

    Wyeth kept up production of coral snake antivenom for almost 40 years. But given the rarity of coral snake bites, it was hardly a profit center, and the company shut down the factory that made the antivenom in 2003. Wyeth worked with the FDA to produce a five-year supply of the medicine to provide a stopgap while other options were pursued. After that period, the FDA extended the expiration date on existing stock from 2008 to 2009, and then again from 2009 to 2010. But as of press time, no new manufacturer has stepped forward.

    Antivenom shortages are a surprisingly common occurrence. The entire state of Arizona ran out of antivenom for scorpion stings after Marilyn Bloom, an envenomation specialist at Arizona State University, retired in 1999. Bloom had been single-handedly making all the scorpion antivenom for state hospitals. Recently, Merck & Co, the only FDA-licensed producer of black widow antivenom, has cut back distribution because of a production shortage of the drug. In a 2007 report, the World Health Organization listed worldwide envenomations as a "neglected public health issue."

    New scorpion and black widow antivenoms are currently in the pipeline, thanks to efforts by several poison-control associations to speed foreign drugs into the market through FDA research programs. There is also a coral snake antivenom produced by Mexican drug manufacturer Instituto Bioclon that researchers believe could be even more effective and safe than the outgoing Wyeth product. But that drug, Coralmyn, is not currently licensed for sale by the FDA. The tests required for licensing would cost millions of dollars, and for such a rare treatment (there are 15 times as many scorpion stings per year as coral snake bites), it could take decades for Bioclon to make its money back.

    Envenomation experts express exasperation and disbelief at the situation. "It's ridiculous that we're losing a technology that we already have," says Joe Pittman, a snakebite treatment specialist at the Florida Poison Information Center in Tampa. "It's even more ludicrous that we have a product that's available, and we have to jump through so many hoops to get it approved." In July 2009, an FDA advisory board determined that Coralmyn qualified for an accelerated approval process, but there is still no one with the estimated $3 million to $5 million to pay for the required studies.

    "Nobody in this situation is being a bad actor," says Eric Lavonas of the Rocky Mountain Poison and Drug Center. "We just don't have a system set up to deal with it." With no adequate replacement for coral snake antivenom, hospitals are likely to appeal to local zoos, many of which maintain small stocks for their staff. But zoos are under no obligation to provide the medicine.

    If and when shortages do occur, many hospitals will have no other option but to intubate coral snake bite victims on ventilators for weeks until the effects of the toxin wear off — potentially costing hundreds of thousands of dollars per bite. "It's probably going to end up costing us far more not to deal with this than to deal with it," Lavonas says, "both in human suffering, and in dollars and cents."
    The all-wise government regulations to the rescue...

    Why Snakebites Are About to Get a Lot More Deadly - The Bigger Picture - Your Life - MSN Lifestyle
    "Only Nixon can go to China." -- Old Vulcan proverb.

  • #2
    Won't Obamacare take care of this? I mean, it is health related, and Obamacare fixes all the problems with the health care system. Give Obama a call, I'm sure he'll get on this, top priority
    Meddle not in the affairs of dragons, for you are crunchy and taste good with ketchup.

    Abusing Yellow is meant to be a labor of love, not something you sell to the highest bidder.

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    • #3
      Originally posted by bigross86 View Post
      Won't Obamacare take care of this? I mean, it is health related, and Obamacare fixes all the problems with the health care system. Give Obama a call, I'm sure he'll get on this, top priority
      Is Obama responsible for those regulations? Why mention him because of existing regulations that preceded him in office?
      And it is ridiculous that it costs so much to get something certified that could save lives.

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      • #4
        You can't have it both ways. The drugs that are used to save lives should circumvent all the safeguards that the FDA put in place in order to save lives. Remember Thalidomide?
        Meddle not in the affairs of dragons, for you are crunchy and taste good with ketchup.

        Abusing Yellow is meant to be a labor of love, not something you sell to the highest bidder.

        Comment


        • #5
          Originally posted by bigross86 View Post
          You can't have it both ways. The drugs that are used to save lives should circumvent all the safeguards that the FDA put in place in order to save lives. Remember Thalidomide?
          That's a bad example to use since it wasn't approved by the US for sale. The company is the one that is the holdup, since they don't want to pay for testing. Should the US taxpayer be the one to foot the bill for a private company?

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          • #6
            Originally posted by ZekeJones View Post
            The company is the one that is the holdup, since they don't want to pay for testing.
            Why should they pay millions for gov't mandated testing when they will never recover the money?
            Originally posted by ZekeJones View Post
            Should the US taxpayer be the one to foot the bill for a private company?
            We do it all the time. We gave Duke Energy $200 Million for "green energy" projects.
            "We will go through our federal budget – page by page, line by line – eliminating those programs we don’t need, and insisting that those we do operate in a sensible cost-effective way." -President Barack Obama 11/25/2008

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            • #7
              Originally posted by bigross86 View Post
              You can't have it both ways. The drugs that are used to save lives should circumvent all the safeguards that the FDA put in place in order to save lives. Remember Thalidomide?
              Exactly. People would also be outraged if the FDA took shortcuts to approve drugs and didn't discover some lethal side effect.
              "There is no such thing as society" - Margaret Thatcher

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              • #8
                There's no need to come out with a new antivenom, and there's no need to setup mass production for such a small amount.

                The simple solution would be to assign one of the various alphabet agencies like NIH or CDC (both of whom have the labs and personnel already in place), to just make a short run of the Wyeth antivenom- say 500 doses.

                Then stock it at CDC in Atlanta for when it's needed. In 5 or 6 years, you can do it again if needed.
                "We will go through our federal budget – page by page, line by line – eliminating those programs we don’t need, and insisting that those we do operate in a sensible cost-effective way." -President Barack Obama 11/25/2008

                Comment


                • #9
                  Originally posted by highsea View Post
                  There's no need to come out with a new antivenom, and there's no need to setup mass production for such a small amount.

                  The simple solution would be to assign one of the various alphabet agencies like NIH or CDC (both of whom have the labs and personnel already in place), to just make a short run of the Wyeth antivenom- say 500 doses.

                  Then stock it at CDC in Atlanta for when it's needed. In 5 or 6 years, you can do it again if needed.
                  That's a good alternative.

                  Comment


                  • #10
                    ^^It's just a stopgap measure.

                    The problem with clinical trials on coral snake antivenom is the scarcity of patients. There aren't enough people bitten each year, you can't recruit patients in advance, and when they do show up to referrral centers, a lot of the time they have already been treated. So you have to use animal studies and allow it's use on humans on a closely monitored basis. Back when that Wyeth antivenom got approval, standards were a lot looser than they are today.

                    The US has an Orphan Drug Act that subsidizes studies on drugs that can't make it on their own due to the low levels required. The Bioclon antivenom could qualify for this subsidy. It also has the advantage of working on scorpion and black widow bites, and some other non-native exotic snakes that we currently have no antivenom for. Scorpion antivenom is only available as an investigational drug.

                    So there's potential for an excellent antivenom that can treat multiple types of bites, if the company can just get it through the FDA. The frustrating thing is that this is a problem the FDA has known about for years, and just ignored it.
                    "We will go through our federal budget – page by page, line by line – eliminating those programs we don’t need, and insisting that those we do operate in a sensible cost-effective way." -President Barack Obama 11/25/2008

                    Comment


                    • #11
                      The FDA system, aka the strong arm of the pharmaceutical industry, has been set up this way for quite some time. Less competition for the big players and only the big money maker potential drugs get tested. Saving lives is not the issue. Making gobs of money is the only driving force so it is no wonder our over all health is getting worse and we are now on the verge of taking a step backwards.
                      Removing a single turd from the cesspool doesn't make any difference.

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                      • #12
                        Hmm. I don't think our overall health is declining, it seems to me that life expectancies are getting longer, and people are generally more healthy and active much later in life than ever before. And we're on the cusp of a whole new generation of biotherapies that will revolutionize the way medicine is practiced.

                        I wish Kams was still around- he works for a Canadian pharmaceutical company, his perspective would be useful.

                        I can't blame the pharmaceutical companies- when it takes several years and millions of dollars to get through the multiple phases of new drug trials, you have to expect them to try to recover the investment. They have shareholders and boards to answer to.

                        The FDA, like all federal regulatory agencies, is a revolving door between themselves and the industry they are charged with regulating. Nothing new about that...
                        "We will go through our federal budget – page by page, line by line – eliminating those programs we don’t need, and insisting that those we do operate in a sensible cost-effective way." -President Barack Obama 11/25/2008

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                        • #13
                          The FDA (and its international equivialents) only requires that the companies do testing that drug companies should be doing on new drugs for human use anyway. It takes time and costs money, and basically people have to just deal with that. However, the reality is that we have thousands of very good drugs so the fact that it takes time and money for new ones to get approved doesn't mean that we are going backwards in our health outcomes. It just means that we get drugs at a slower rate than we would in a completely deregulated market, but our health outcomes may in fact be better because the system helps reduce the number of lethal side effects.
                          "There is no such thing as society" - Margaret Thatcher

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                          • #14
                            Originally posted by bonehead View Post
                            The FDA system, aka the strong arm of the pharmaceutical industry, has been set up this way for quite some time. Less competition for the big players and only the big money maker potential drugs get tested. Saving lives is not the issue. Making gobs of money is the only driving force so it is no wonder our over all health is getting worse and we are now on the verge of taking a step backwards.
                            If you're so caring and want to help the human race, why don't you form a company that will invest millions of dollars into new drugs while not seeking a return?

                            Or you don't even have to go through all those troubles of research. Just solicit donations from those who believe in what you do, and pay the fees to get this coral snake anti-venom through the FDA bureaucracy. Come on, it's worth your entire life-savings even if it saves only one life.
                            "Only Nixon can go to China." -- Old Vulcan proverb.

                            Comment


                            • #15
                              According to the CDC there are only 15-25 coral snake bites per year in the United States. In only about 40% of them does the snake release venom.

                              They account for less than 1% of all reported snake bites.

                              So I don't know where the writer gets his 100 or so number or his 25% dry bite numbers from.

                              They are native to my area. And its nothing to see them curled up the concrete on your porch in the morning. They are about the most non aggressive snake around.

                              So its not like lots of people are going to be dropping dead from coral snake bites because of a lack of antivenom
                              Last edited by Gun Grape; 13 Jul 10,, 02:16.

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