Get bit by a coral snake and die

[Itchrelief]

well.


that pretty much sucks.

You mean it bites?

 

[TheWart]

If you get bit, just get to Mexico as fast as you can since they have lots of anti-venom apparently!

At least that is what the article taught me...

 

[IHateMyJob2004]

The gov't needs to step in and tell Pfizer that they will start making it again.

 

[mrjminer]

Where in the article was that implied?

If you'd like to make antivenom, I can tell you how, lots of people could. Just be ready to invest a lot of money on startup, and expect very low sales volume.

As there are obviously no vials being made and one "longtime manufacturer" mentioned, it is implied that the product being manufactured was owned by Wyeth Pharmaceuticals. Wyeth was bought by Pfizer, who would then own the manufacturing rights to the product. The article then specifically points out that they have no plans to make the product, attempting to highlight that Pfizer, who would now own the rights to produce the product, is not doing so, thus resulting in the likely incapacitation and/or death of someone getting bit.

To solidify this point, the article later states that a Mexican company makes the drug, but is not cleared by the FDA to sell it in the U.S., implying that, indeed, the formulas are different, and, therefore, indicating that the formula for the anti-venom is a product able to be made uniquely.

This makes the formula a product with a copyright... at least that's how I made the determination.

 

[Mike Gayner]

So glad we don't have snakes down here.

 

[ahenkel]

Worst I've seen is garter snakes around here. I did have a boa as a pet but it got out and went for a ride in the dryer.

 

[Nebor]

The gov't needs to step in and tell Pfizer that they will start making it again.

Why doesn't the government just step in and pass a law against getting bitten by coral snakes?



Anyway, back in the free world, why doesn't Pfizer just charge enough for the anti-venom to make it profitable? If you've been bitten by a coral snake, you'll pay $2,000 for the anti-venom. I realize it's very low volume, so they need to adjust the price upwardly to compensate. I imagine this is more a case of opportunity costs for Pfizer though.

 

[Oceanas]

Looks like nobody is willing to pony up the $ to get the Mexican drug approved with the amount of time likely needed to recoup the investment.

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.

Also..

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."

http://www.popularmechanics.com/science/health/snakebites-about-to-get-more-deadly

Anyway, back in the free world, why doesn't Pfizer just charge enough for the anti-venom to make it profitable? If you've been bitten by a coral snake, you'll pay $2,000 for the anti-venom. I realize it's very low volume, so they need to adjust the price upwardly to compensate. I imagine this is more a case of opportunity costs for Pfizer though.

Looks like it already costs way more than that.. and this info is from 2004..

An aside: the average number of vials of antivenom to treat a snake bite is 20, 12-40 is common and over 100 is possible. The cost of the antivenom is $2000 – $3000 per bottle (bad news). Each bottle has a gram of protein that goes right into your bloodstream (more bad news) and this can cause shock that can be as deadly as the snake bite (yet more bad news). Furthermore, there are some patients who, after surviving the initial treatment, have an episode of serum sickness where the immune system tries to reject the horse or sheep serum from the antivenom (not the last of the bad news). This happens ten or so days after leaving the hospital (ok, this is the last of the bad news).

http://www.biochem.arizona.edu/CatalystWebsite/Fall04/Feature2.html

 

[SearchMaster]

Yep. AFAIK, anti-venom is actually made from the real venom. While it sucks, always remember.

"Red on yellow, kill a fellow.
Red on black, good for jack."

There were three variants of this rhyme in this thread. If one of these fuckers ever bites me, my head will assplode before the venom gets me as I try to remember it.

 

[Linflas]

Why doesn't the government just step in and pass a law against getting bitten by coral snakes?



Anyway, back in the free world, why doesn't Pfizer just charge enough for the anti-venom to make it profitable? If you've been bitten by a coral snake, you'll pay $2,000 for the anti-venom. I realize it's very low volume, so they need to adjust the price upwardly to compensate. I imagine this is more a case of opportunity costs for Pfizer though.

Actually the government does have a Constitutionally defined role in this. Per Article I, Section 8, Clause 8 Congress has the power to control this:

To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.

They could simply modify the law controlling copyrights and patents to cover situations like this.

 

[Nebor]

Wait, it takes 20 bottles at $2000 per bottle? Sweet baby jesus!

 

[Gibsons]

As there are obviously no vials being made and one "longtime manufacturer" mentioned, it is implied that the product being manufactured was owned by Wyeth Pharmaceuticals. Wyeth was bought by Pfizer, who would then own the manufacturing rights to the product. The article then specifically points out that they have no plans to make the product, attempting to highlight that Pfizer, who would now own the rights to produce the product, is not doing so, thus resulting in the likely incapacitation and/or death of someone getting bit.

To solidify this point, the article later states that a Mexican company makes the drug, but is not cleared by the FDA to sell it in the U.S., implying that, indeed, the formulas are different, and, therefore, indicating that the formula for the anti-venom is a product able to be made uniquely.

This makes the formula a product with a copyright... at least that's how I made the determination.

There's no copyright issue. They can't patent injecting a sheep with a toxoid and purifiying the antibodies. That's all there is to it.

The Mexican treatment is made using the same technology, it's virtually the same thing. The only thing stopping them is getting it through trials and FDA approval of facilities and methods. Pfizer can't stop the Mexican manufacturer from submitting to the FDA, nor stop the FDA from approving it. Getting past the FDA is no joke however. It's an expensive pain in the ass, and the Mexican manufacturer might know that they won't pass inspection.

 

[bignateyk]

The problem here is the FDA. Sorry, but if i'm dying of a snake bite, I don't give a flying fuck if the anti venom is licensed by the FDA or not. Fuck them.

 

[Oceanas]

Wait, it takes 20 bottles at $2000 per bottle? Sweet baby jesus!

I found a copy of an article from 2002 posted on another forum, where a 4 yr. old needed 44 vials. (can't find the original article anymore)

each of Emma's 44 vials cost $2,400, hospital officials confirmed, bringing the antivenin costs alone to $105,600.

http://www.herpsofarkansas.com/forum/topic/9/massive-antivenom-infusion-saved-girlgreat-article/

 

[gorcorps]

I found a copy of an article from 2002 posted on another forum, where a 4 yr. old needed 44 vials. (can't find the original article anymore)


http://www.herpsofarkansas.com/forum/topic/9/massive-antivenom-infusion-saved-girlgreat-article/

Jesus... and that's a 'low profit' anti-venom? I know the volume of sales would be very low, but still.

 

[tk149]

First, copyright law does not apply to drugs.
Second, any patent is probably expired already.

So what is the problem here?

The FDA regulates the hell out of medical device and drug manufacture (which is where my expertise lies), distribution, labeling, post-market activities, etc. I can only assume that they require the same for anti-venom.

The bottom line is that it is very expensive to manufacture and sell an FDA-regulated product in the U.S. if you want to stay in compliance. You have to get pre-market approval from FDA (including expensive clinical trials), and then set up a GMP facility, and do post-market monitoring as well. It's good for safety, but it ain't cheap.

If a product is unprofitable (or has a very low profit margin), why would a company produce it? They can use that money to produce something else with a higher margin.

It sucks, but unless FDA wants to compromise its standards, or people are willing to pay more for the antivenom, that's the way it is.

Found this on FDA's site:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm155092.htm

Expiration Date Lot 4030026 - North American Coral Snake Antivenin (Micrurus fulvius) (Equine)

Important Notification
This is to provide you with important information regarding Antivenin (Micrurus fulvius) (Equine), commonly referred to as North American Coral Snake Antivenin. Antivenin (Micrurus fulvius) (Equine) is indicated for treatment of envenomation by Micrurus fulvius fulvius (Eastern Coral Snake) and Micrurus fulvius tenere (Texas Coral Snake). This product was manufactured by Wyeth Pharmaceuticals.
FDA has extended the expiration date on this lot of Antivenin (Micrurus fulvius) (Equine). The extension is based upon FDA evaluation of stability data, which determined that this lot of product will maintain stability and potency for an additional year.
Wyeth Pharmaceuticals no longer manufactures Antivenin (Micrurus fulvius) (Equine). There is no alternative product licensed in the U.S. for coral snake envenomations. Lot 4030026 is labeled with an expiration date of October 31, 2008. Because this lot has a new expiration date, you may continue to maintain the product in your inventory and keep it available for use until October 31, 2010. The manufacturer is updating the current labeling through a Dear Health Care Provider Letter.
Lot 4030026 continues to be available. Wyeth is closely managing their inventory, and will supply product only to direct customers.

 

[Garet Jax]

The gov't needs to step in and tell Pfizer that they will start making it again.

Why force Pfizer to lose money? Why not have the government step in and force you to start making it at a loss? Companies want to make money not lose it.

The problem here is the FDA. If I am dying of something, then I want to be able to use drugs and treatments that might be able to save me. A government agency shouldn't be able to stop me and thereby sentence me to death.