While it's done a lot of good for making things safe to eat and is a necessary public service I'm going to have to say that currently:
...The FDA sucks...
You need millions in legal/preparation fees just to get your foot in the door and the level of bureaucratic bullshit you have to deal with still blows my mind.
My company has had a lot of experience in this sorry to say.
Again. Going to reiterate here: The FDA sucks and needs to be completely overhauled. Lots of PhDs and government bureaucrats spending too much time behind a desk with no real world experience and dictating arcane rules to the rest of us - that's the FDA I know.
I don't think the FDA is the real problem on this one. There is a known treatment whose patents have expired, however for now nobody is willing to manufacture it.
It's just not profitable to manufacture the currently known solutions.
If someone discovers a new, better antivenin you would still have to spend millions of dollars and wait years to pass the FDA guidelines. That alone probably destroys the profitability margins of most discoverable solutions due to the small demand.
You know, when you boil it all down, most things in life are about the approval process. Money has become the defacto standard for approval. If the FDA requires millions of dollars to be approved, then the people, law, and pharmacies believe that organization getting approval must be approve worthy.
If you are a guy in a shed with a couple thousand bucks and a cancer cure, ... hmm... you're just a guy in a shed. If you were smart enough to cure cancer, obviously you'd have more than a couple thousand bucks -- right?
So that's how society works. A series of gate keepers who have become persuasive enough to acquire "convincing wealth". Wealth is all you need to convince others that whatever you have and whatever you may have in the future is worth buying into, either in thought, or as a product. Many times, this convincing is as easy as an advertisement on television or some clever lawyers who can figure out that all you have to do is change the name of your product and market it to another segment to extend your patent.
While I can agree that jumping through hoops to meet regulations sucks, the cost of failure and the potential for unintended consequences justifies the high market entry costs. To be fair, the FDA is constantly making decisions (with regards to approval) that ethicists have struggled with for millenia. Furthermore, its not readily apparent what constitutes an effective drug in many cases due to the placebo effect.
For an example of the FDA's good work, if you have the chance, take a look at the FDA's 483 for the McNeil plant that recently got shut down (the children's Tylenol, Benadryl, etc. recall). Its kind of horrifying: http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORA...
Perhaps a more relevant example would be the case of United States v. Caputo (7th Cir. 2008). Caputo had gotten clearance to sell a small sterilizer of surgical equipment without tubes or hinges. His customers, being satisfied with that equipment, requested a larger sterilizer instrument that could sterilize equipment with tubes or hinges. Caputo, meaning well, and believing that the changes between the two equipments were trivial (as it would seem at first glance) produced what his customers requested and sold and marketed it. Turns out that one of the opthalmic instruments being sterilized had brass joints that reacted to the peracetic acid being used to sterilize. It resulted in numerous people being blinded. Of course, he later failed to report the cases of blindness to the FDA, which resulted in further problems. But I still believe that the point can be made that the possibility for unintended consequences and the high costs of mistakes justifies the high barrier to entry that the FDA imposes.
In the case of the snake antivenin, its a long process to produce antivenin in general. Its made by injecting a sheep or horse (older antivenins used horses, newer ones tend to use sheep) with the venom and then gathering and purifying the antivenin that the sheep or horse produces in response (Animal rights groups have historically protested in locations where antivenin is made). Hopefully the government or some public interest organization will fund further production of the antivenin, its unfortunate that antivenin is not more durable.
It seems ridiculous to me that the FDA prevents scientists and doctors from getting known, proven anti-venom products back in the market, whereas the rich corporations can get drugs on the market that still aren't proven to be much more effective than a placebo, but with worse side effects.
My view is that people should be allowed to opt out of FDA regulation if they wish to do so. It's my body; I should be allowed to put anything I want into it.
It took 10 years for the first beta blockers to be approved in the US after they were in use in Europe. In that amount of time, thousands of Americans died for lack of the drugs. It's hard to distinguish this from mass murder, or at least mass manslaughter.
It's not that simple. If they allow the sale of non regulated drugs then you'll have a 10x increase in commercials on TV trying to sell you an untested and unregulated "purple pill".
The fine print will say "this drug has not been tested and is not approved by the FDA. It may cause death or create an uncontrolled viral outbreak..."
The drug will sell like hotcakes though because the commercials will have lots of happy-smiley people and the distributor will get a healthy 80% profit margin on the sales.
There's some comfort in knowing that a non-profit agency is looking into the safety of a drug before it goes out to the public for consumption.
There's some comfort in knowing that a non-profit agency is looking into the safety of a drug before it goes out to the public for consumption.
What's so awesome about non-profits? They have their very own perverse incentive structures. Proposed replacement or supplement: Any company wishing to sell Drug X to the public must be insured against patient lawsuits. Insurance companies are quite capable of hiring people to assess risk and wouldn't have the same biased weighting of risk and benefit.
Why not make getting these non-approved drugs conditional on getting X% of the questions on a MCT correct, where said test is a quiz on the effects, side-effects, toxicity etc. of the desired drug? If I was implementing this I'd mandate that the source material for said test be publicly available at a centralised registry, that you need to get 100% of the answers right that the questions be randomly drawn from a test bank and that the test cost say half a day's median wage. Have authorisation lapse after three months so you need to take the test again.
Informed consent has just been assured, and people can now make their own decisions but they need to really want the drug.
FDA is a federal agency, paid for by the government. It is not a nonprofit because it doesn't have to seek funding whatever the govt't gives it is what it works with.
BTW, bribing a government official will usually result in one or both of you doing time in a federal (not a country club) prison.
Ah, good point, my mistake. So if I've got it right, the common usage would be "government official" for administrative positions, and "politician" for elected?
That's welll over 97% of the meaning[0] but for some reason I must say more. I'd be very surprised if anyone described am elected judge in America as a politician, even though they're elected.
The US already has that situation in the supplements industry and while heavily-advertised weight-loss/muscle/hair supplements are annoying, it's not that bad. The cost of not getting valuable drugs is underestimated since people only hear about it in rare cases such as this one, whereas dangerous treatments generate a lot of media coverage.
Right, weight loss supplements are OK because hypertension and cardiomyopathy (along with the occasional sudden death) are no problem? At the end of the day, the FDA needs to carefully regulate the market not because dumb people need them to, but because smart people such as most HNers do.
"There's some comfort in knowing that a non-profit agency is looking into the safety of a drug before it goes out to the public for consumption."
You're kidding right? At least with a for profit corporation I know their motives. With a government agency I have no idea if they are returning a favor, taking money, or simply like the person. With that said, the FDA still requires a large profit motive since no one would spend the millions required to get approved unless they expected some return.
I wonder how many possible working drugs for esoteric diseases are floating around that will never be released because of the expense of getting through the FDA.
That's the thing, I fully expect for-profits to accept bribes and would act accordingly. Assuming that the FDA is some high and mighty agency that only approves safe drugs is the problem.
What do you mean you would act accordingly? You would ignore any recommendations they make? So then you are left trusting the original drug developer to have properly done and analyzed the safety trials?
And require a signed waiver and prescription from a doctor? Presumably (most) doctors are smart enough not to prescribe cyanide as a cure for insomnia.
OK, so now the doctor has to come up with the millions of non-FDA approved drugs that are about to come onto the market, because there will be lots of these drugs.
Personally, if you are stupid enough to go for the non-FDA approved drugs, you are too stupid to help anyway. Unless you are going by some other approval system, for example whatever they use in Canada, UK or Australia. But if you are just going by what you read on the website, you are a fool.
Arguably, that is the crux of the 1st Amendment issue -- government regulation of speech - including that of "evil" or "unpopular" drug companies -- is a slippery slope.
The past few years seem to indicate that we're slipping up the slope, then, as what was once prohibited is now allowed, both in the case of prescription drug advertisements and corporate political speech.
Compare with the following phrases:
Prohibiting forgery strays dangerously close...
Prohibiting defamation strays dangerously close...
Prohibiting Ponzi schemes strays dangerously close...
I can accept that regulation of speech is inherently suspect, but not that it's inherently bad. The reasons for regulating this kind of advertising are pretty clear to me.
Prohibiting slander, libel, and inciting imminent lawless action are also technical violations of the first amendment. Society tolerates these rules because they provide even greater value than the freedom of speech alone.
In this case, I agree that prohibiting advertising is a first amendment violation. Instead, we should simply disallow all outdoor advertising and advertising that is broadcast on the publicly-owned radio spectrum.
Even so, the advertising aspect seems relatively minor to the whole picture. Hospitals are the ones who need to worry most about FDA and non-FDA. Would a hospital be able to acquire the funding it needs if it ever allowed the prescription of any non-FDA approved drugs? What would insurance companies think? It opens up too many liabilities to try any experimental drugs--that is, drugs not approved by a mandating organization--for any large organizations to consider doing it. Then we're back where we started--we need something like the FDA, though definitely in a more efficient form.
And when people finally quit looking at medication as a cure-all, because we've had the FDA around to "prove" things are safe?
Of course, they've never made mistakes, oh no, not them. Approved medications aren't dangerous in the least degree. And no "medications" are sold which aren't FDA approved. Not supplements, not energy drinks, nothing. McD's approves their fries, so does your corner diner.
I think the solution may be to have multiple standards bodies, the FDA being one of them. If bodies A, B, and Q approve a drug, and they have a good track record, people can choose. If a drug is experimental, bodies X and Y agree with research Z and not Q because someone ate a peanut, so take your pick based on your circumstances. At least then there would be other options.
Allowing advertising for drugs is a problem in and of itself. I think the United States is pretty unique in allowing direct to consumer drug advertisement.
I always find watching US tv bizarre because of that. You have all the usual crap car/cellphone/food ads and then all of a sudden they're diving into surreal craziness about cholesterol levels and brain chemistry that I suspect 99%+ of viewers can't possibly critically evaluate.
If that's really your concern, then why not at least let college graduates opt out? Or people holding PhDs? My suspicion is that many people would oppose this because it disadvantages the uneducated, but of course you can't have it both ways. Either regulation is good for the uneducated or it is not.
"It's my body; I should be allowed to put anything I want into it."
It is my understanding that many drugs are not entirely metabolized/naturalized by the first person they enter. So the presupposition you are working with isn't entirely true.
When you measure only the costs of one side and only the benefits of the other, the conclusion is predetermined, and of no value.
How about you engage the question of whether the costs and benefits of our current policy outweigh the costs and benefits of a looser policy directly, instead of just tossing a rhetorical hand grenade into the debate ("look! mangled babies!") and running away? It would look something like this:
"The number of thalidomide birth defects estimates range from 10,000 to 20,000 according to Wikipedia. Given the rate of cancer death in this country, a net one year delay applied across all effective therapies compounded across many years almost certainly outweighs your one example. Excessively liberal medicine policy may kill and maim, but so does excessively conservative policy; it's not a pure win by any means. Are you so sure that our policy is really the best policy?"
This isn't a question you can actually determine the best answer to with a series of anecdotes. You have to actually do a statistical analysis. I have not done this statistical analysis, so all I can say is something like "I'd bet money we're being too conservative", or "My libertarian leanings lead me to say we should have a more liberal acceptance policy on the grounds of personal freedom", but just screaming about deformed babies with no other analysis like this is an emotional tactic that should be replaced with something better. Too many people's lives are on the line for this debate to be shut down with "won't someone please think of the babies?"
It's also effectively a non-issue. Why not slap a big "THIS IS NOT TESTED TO BE SAFE FOR PREGNANT WOMEN" label on the thing? I mean doctors don't recommend ibuprofen for pregnant women, but mostly because there are no studies on the effects of ibuprofen on unborn babies. We don't out-right ban ibuprofen just because we don't know how it will effect women/babies during pregnancy.
If there was no FDA, you'd basically need to slap a label on that said - "This is not tested to be safe for anything", since it's the FDA that mandates all the safety testing.
No, it's not, but your point definitely is irrelevant. You see, it's my body, so I can put whatever I want in it, be it aspirin, heroin, thalidomide or cyanide. And yeah, I may wish to make an educated choice about that, but then again, I don't have to.
True, but when you're talking medicines, you may not have a choice in the matter. e.g. You come into the emergency room unconscious, what medicines should the doctors be allowed to use?
Basically, if someone is going to make a decision affecting my body while I'm unconscious, I'd rather have someone I picked for that job to do it (like, I don't know, my doctor or my wife or my dad or my friend or even my insurance company) than some bureaucrat in FDA.
But that's not quite the issue in question, eh? My understanding is, you can't get the unapproved anti-venom even if you are conscious and you are about to die without it anyway, by doctors opinion.
I realize that you still can't get it when you are conscious. I'm just saying that 'personal choice' isn't the only weighing factor here. If you come into the emergency room and you are unconscious, who says that you are with someone (wife,friend,etc) or that there is enough time to try and get in touch with your doctor?
I personally think that the FDA approval process is bogus too. I'm just trying to expand the discussion a bit.
I was just trying not to drift too much into complicated parts of the problem, since the society is obviously unable to fix even the most obvious and simple parts of it.
Yeah, maybe there should be some rules about corner cases like that (what to do with you if you are unconscious and there is nobody to ask about what you'd want to be done to you). And maybe one way to get those rules written and enforced is to have people on government payroll for that. Or maybe we should just leave it to the ER folks. But, frankly, I think it would be nice to fix the obvious big wrongs first, and worry about all this stuff later.
Since you include heroin and cyanide, would you have some kind of provision that prohibits people from taking certain substances if they've demonstrated by their behavior that those substances would cause them to harm other members of society? In other words, should we allow susceptible people to become junkies if they end up doing something really really bad while they're under the influence?
I'm not sure there is a one-size-fits-all solution to that. But, in general, I think that what matters is the real damage done. I mean, if you do harm others, you should be punished/restricted, and if you do harm others repeatedly under the influence of some substance (be it snorted cocaine or internally produced adrenaline), you should perhaps be punished/restricted more.
But the punishment/restriction should always be a response to the harm done to others, not to whatever the person does to her own body.
Millions of people have died because the government has banned certain drugs. Whereas the number of people who have died because of a drug not being banned is zero. It seems like a clear tradeoff to me.
http://en.wikipedia.org/wiki/Fen-phen had a body count before it was banned. Such cases are rare, but that means the system is doing at least part of its job.
People died because they took a dangerous drug. They didn't die because the drug wasn't illegal.
If you want to cut down the number of people taking dangerous drugs, ban doctors from prescribing non FDA-approved drugs and ban companies from marketing them. However, I have only contempt for people who want to put their fellow citizens in jail for making their own medical decisions.
It seems like this would be an instance where the government should provide the funding. It's in the public's best interest to have at least one anti-venom product available. It makes no sense to tell people "tough luck" when they get bitten just because it's too expensive to pay for the studies to get government approval.
Well, until it has been tested, it is neither tried nor proven. And here is but a single reason http://en.wikipedia.org/wiki/Thalidomide for such testing requirements.
Edit: to be clear, I was attempting to respond to the parent's parent post. I apparently suck at internet.
The use case for an antivenom based on known working precedents, where the untreated alternative is death, is somewhat different to sedatives used generally to treat colds, coughs, morning sickness, etc.
No. Read the article -- in the example used, the alternative is weeks on a ventilator. Which we know works. Until these drugs are known to be efficacious with tolerable side effects, they are still a second best treatment.
What if you are too far away from a facility that can provide that for you? Having a syringe of anti-venom with you can be the difference between life and death.
There is no facility you will encounter that has the anti-venom but does not have a ventilator. This is not like an epi-pen or some other OTC med that a backpacker will carry with them, it is a hospital-dispensed, fucking expensive dose of medicine (e.g. rattlesnake anti-venom is around $4K/bottle.) But why let reality get in the way of a good rant I guess...
How could you classify my comment as a rant? I realize that 'tone' doesn't really translate well through text and you might read my comment as an attack (which it wasn't), but how can a couple of sentences be a 'rant?' I would think that a rant would have to be at least a few sentences or more (or some sort of absolute character/word limit in the case of large run-on sentences).
If you felt it was made in anger or hate, I would think it would classify as a retort or something similar.
> Edit: to be clear, I was attempting to respond to the parent's parent post. I apparently suck at internet.
Something weird happened. When I originally posted, your comment was a sibling post to mine (and was already a child of the root of this thread after the page reload from submitting my comment). I was surprised when I came back to this thread to see your comment a child to my comment.
Or simply revoke the patent for these antivenoms so that companies that don't have the same opportunity costs can enter the niche.
I think it would solve a lot of other problems (e.g. submarine patents) if patent holders were required (within defined bounds) to offer their patented products for sale on the open market in order to retain the patent.
As much as you may be against software patents, there can be no current patent restriction on the production of coral-snake antivenom if it was approved in 1967.
The problem described in the article is simply that so few bites occur, the effort to make antivenom is not interesting to anyone with the skills or equipment to make it. This includes individual pharmacists, university scientists, and corporations; all of who can but do not provide antivenom.
That's a good point; I didn't make the connection with the 1967 date and focused on the article referencing that one company as the only source of antivenom.
Is it possible for pharmacists to synthesize anti-venom on demand? Coral snake bites may be rare, but if you were, for example, the operator of an Everglades tour group, your probability of encountering a bite might be a bit higher, and the antivenom would be good to keep around.
you'd probably want an organic synthesis chemist, not a pharmacist. and you wouldn't have time for him to have the appropriate glassware fabricated, and synthesis equipment setup. so he'd have to leave a room with it all step up properly.
...which sounds like the sort of thing you might do if you were just manufacturing it.
..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..
Granted, the antivenom situation is ridiculous, but the quote above exposes yet another, much larger ridiculous issue: why is it OK to charge "hundreds of thousands of dollars" for a few weeks of hospital stay?
Is it because lung vent. machines are $1 billions apiece, or what? How do they come up with those ridiculous bills? Are they really riding 1000% profit margins there or what's going on?
"So… in terms of the real economy, this was an $83 transaction, equivalent to what you might spend on dinner for two. But instead of being paid with a credit card swipe, there were apparently multiple clerks involved at the doctor’s office and the insurer. Negotiations happened behind the scenes. A paper invoice was printed and put into an envelope by hand. A check was mailed through the U.S. mail"
The idea behind health insurance is spending other people's money. If health insurance provides no benefit over just putting money in your savings account, people will just do that instead. Then the system collapses.
(Pooling the money is more beneficial than keeping it to yourself, because the insurance companies can invest it better than an individual can. Think of the interest you get on $1000 vs. what you get on $1,000,000. One buys you a cup of coffee, the other supports you for life. When the insurance companies leverage your premiums in this way, it means that the actual money the spend is nearly free. It's a pretty good deal.)
My high deductable plan doesn't cover anything until I spend $1.5k on health costs in a year. (Except preventive health stuff, that's all covered.) After you pay 1.5k they cover everything. My company and I pay a premium for this coverage (it's not nearly as high as the co-pay and HMO plans available).
Really, when I got to the doctor once or twice a year, for a whopping grand total of about $70/visit, then spend MAYBE $100 on prescriptions/other medications with my prescription discount card, it's really not worth that extra $30 every two weeks.
I don't want to pay for my hypochondriac neighbor's daily doctor visits, or for their kid's sniffles. The way I (and a lot of other Americans) see health insurance is that it should pay for things that would bankrupt you, I can handle the small stuff.
The best part about HSAs is that they are pre-tax accounts, so they help with your income tax costs. This also has the effect of making medical things cheaper because you didn't lose 30%+ on that money before having to spend it. I'm just hoping Congress doesn't cut the usefulness of HSAs with their new health care garbage...
It's only tax-free if your contribution is less than the standard deduction. I don't spend $7500 on healthcare per year, so I can't even deduct it. Maybe if I buy a house I can't afford, then I'll have some deductable interest to push me over...
(If your employer handles the FSA/HSA, then it's pre-tax no matter what. I'm W2, but my employer simply doesn't offer that benefit because it costs them too much money.)
I don't want to pay for my hypochondriac neighbor's daily doctor visits, or for their kid's sniffles.
Well, that's what the co-pay is for. $20 every time you visit the doctor adds up if you visit unnecessarily -- the real cost that the doctor bills the insurance company isn't even much higher than that. Insurance companies aren't losing money on people who see the doctor every week.
(Why do I like the current system? Because the premium I pay is almost exactly matched to my monthly health maintenance cost. And I have protection in the case of disaster, or generally expensive medical procedures.)
Maybe, but only if that forced a real market in healthcare, with transparent and advertised prices and no tying between different services and specialists, so one could actually shop around. Right now, it's damn near impossible to get a rate sheet out of a doctor's office or a hospital, and they don't much like giving quotes on the phone either. Even auto mechanics are more transparent than that (they'll at least give you a quote or estimate if you insist on one). Why can't I go to five different doctors' websites and see five different rate sheets for what they charge for a range of common things, like standard office visits or vaccinations? Why won't a hospital tell me up front how much a surgery will cost, in total after all the different fees (surgeon, anesthesiologist, materials, etc.) are included?
If you actually think that the UK's financial problems have anything at all to do with NHS, well there's probably an extreme right wing party waiting for you.
Thats not a very constructive comment, but taking the trollbait - there are examples of other countries around the world (my own for example) that have public option health cares who's economies aren't in the tank.
Just to clarify: all of the industrialized world (except for the US) has universal health care.
As for the troll, a couple of points:
1. Britain has government-controlled health care, not just government-funded health care. In Canada, where I live, the government is the single payer but health care itself is provided by a wide variety of small and large businesses, including doctors' offices, walk-in clinics, testing labs, and so on.
2. Among industrialized countries, Britain is at the very low end of the spectrum for health care expenditures, either per capita or as a percent of GDP. Government-funded and -controlled health care in Britain has done a phenomenal job of containing costs.
Exactly. The effort required to meet insurance and then government regulations for a doctor or hospital to get paid is through the roof. I was at the doctor not long ago and noticed a sign at the desk that if you paid in full with cash or credit he would give you a price that was close to or below many people's rising co-pays.
* why is it OK to charge "hundreds of thousands of dollars" for a few weeks of hospital stay?*
Sigh... I've been a critical care nurse for years, and here is the answer:
When a person is in the ICU on life support, it's not just "staying in the hospital for a few weeks on a ventilator" it requires 24/7 care on a 1:1 or 1:2 nurse patient ratio. That is, every hour, on the hour a highly trained nurse goes in to your room, takes your vital signs, observes you for any minute changes in condition, documents those changes, monitors how much you've peed in the last hour. A person on life support is also probably on a myriad if IV drips that each have to be controlled with a separate pump.
I've cared for patients on death's door that have easily had 25 separate medications slowly dripping into the patient at rates of 3-5 cc's per hour, and any number of those medications in the wrong doses could kill the patient. Each of those medication rates are changed, and titrated from minute to minute or hour to hour depending on the patient's changing condition.
That's just nursing care, not to mention a Pharmacist with a Phd that's awake 24/7 to double check the safety, concentration and contraindications on each of those 25 drips. They have to be ready to send me a replacement does within minutes of my requesting it.
Not to mention having at least one doctor that's an intensivist. That is, she's gone to school for 15 years to learn how to manage cases like coral snake bites that they might only see once or twice in their entire career. They have to be on call 24/7. Not to mention a toxicologist, perhaps a cardiologist *(12-14 years of school) or a neurologist (easy 12-14 years of school) on call 24/7 in case the person develops a worsening neurological or cardiac symptoms.
And, you need to have a system in place to handle the dozens or hundreds of lab tests this patient is going to need on an on going basis. A lot of those results need to be made available on a "STAT" basis, which is, I need those results within 1 hour or less.
Plus all the added infrastructure: specialized beds to prevent pressure sores, IT infrastructure or organize those lab test and doctors orders.
I could go on.
Not to mention, antivenom is incredibly expensive to purchase. I worked in LA, 5 miles outside of Hollywood. We had a patient bit by rattle snakes in Griffeth park. Each vial of horse serum (rattle snake anti-venom) costs around $3000 each to manufacture. We gave this person 25 vials of antivenom in the first 24 hours, and he needed 25 vials a day for the next week. We indeed had to call the local zoo and all the area hospitals to obtain extra vials.
And, by the way, most hospitals work on a profit margin of 0.5 - 1.5% if they make money at all.
Health care costs a lot, because we demand a lot from our system, like forcing every hospital in LA to maintain a stock of 6 vials of rattle snake anti-venin, so that when one drunk ass hat tries to catch a rattle snake in Griffeth Park in Holly wood, we can save his arm from going necrotic.
Note that they call it "horse serum" because antivenom is produced by putting venom into horses in tiny amounts over long periods and then extracting antibodies from them.
> I'm curious... why is it that so much antivenin was required? If that much is needed, why do hospitals only stock six vials apiece?
Because odds are they won't need it. They stock to buy time until they can get enough for a single patient.
To put it another way, if there's an average of one patient/year in an area with 10 hospitals, what's the right amount for each hospital to stock? Remember - they have lots of other things that they could stock with comparable odds.
The dose is based on the extent of envenomation, weight of the person, and ongoing symptoms.
Horse serum is actually a giant pain in the ass to deal with. It's a crystalline structure that is really hard to dissolve. And, when it gets dissolved, it tends to foam terribly. It generally takes at least 1/2 an hour of slow mixing to dissolve the crystals and get them to stop foaming.
So, to compensate for the difficulty in mixing the horse serum, they don't put as crystallized serum into a vial, and the dose requires multiple vials. The standard adult dose is 4-6 vials depending on the size of the person.
Hospitals don't stock too much of the stuff (unless you're in an area where rattlesnake bites are endemic) because of cost and infrequency of use.
Whew, this article was a real eye-opener. I didn't know we had anti-venom shortages, my assumption being that you can go to a hospital after a bite in time you'll be easily cured.
Just last week a family friend was bitten by a huge copperhead and was in real bad shape. My mother, a nurse for 40 years and the director of protocols for a string of hospitals in southwest Missouri, took him to the hospital for care. They were very hesitant to give him the anti-venom, but after about 20 hours and a move to the ICU, they gave him the ONLY dose they had at the hospital. He's a big burly bastard, and they decided he needed another dose. They had to put him in an ambulance and take him an hour to the next hospital to get another dose.
My mother, after seeing everything first hand, launched into a review of their snake-bite procedures. She came to find out after speaking with the head pharmacist, that the anti-venom our friend needed was $64,000 - and they have a short shelf life! This was the reasoning for only having one dose at the hospital they went to.
Our friend is fine, and has a good story to tell. My mother called a 'meeting of the minds' for the hospitals she oversees to try to find a solution.
All that to say, yes, there are indeed problems with anti-venom!
The second hospital was a larger hospital in Springfield. The doctors at the first recommended they move him instead of the anti-venom because they said the docs at the larger hospital were more experienced in snakebites, and he was plenty stable. However, according to my mom, their procedures weren't any better.
whereas in reality, "The cost of ... antivenom is $2000 – $3000 per bottle" [1] and you should hope that your health insurance covers it. I've heard of anti-venom which is more like $10k per bottle, but can't find a link.
oh, and you'll hope that there's a location in-state, otherwise you're going to rely on the fastest courier to get one to you, once you've been approved.
> you should hope that your health insurance covers it.
I don't think that the choice between thousands of dollars of debt and death is a hard one to make... Even in this case where without the anti-venom you could 'wait out' the venom on breathing apparatus, it will cost your $100K+ (according to the article). You don't really have many choices. It basically comes down to: death or debt. I know which one I choose.
That leads into a whole other debate. Death vs. Debt is straightforward when you're 30 or 40 and looking at $100k to cure a snakebite. It's an entirely different issue when you're 70 and looking at a $2m cancer treatment, the only problem is then you know that your debt will be payed for by the government.
> Death vs. Debt is straightforward when you're 30 or 40 and looking at $100k to cure a snakebite. It's an entirely different issue when you're 70 and looking at a $2m cancer treatment, the only problem is then you know that your debt will be payed for by the government.
That may be, but this entire discussion is around snakebites and anti-venom which is a lot different than a (possibly) terminal condition like cancer. You're completely changing the frame of reference when you compare 2 different types of health issue and two different age brackets at the same time...
Good point but even if the 70y.o. had a snakebite that would cost $100k to cure it's still a debate. My point wasn't that you shouldn't go into debt to cure a snakebite. I was just trying to show that your point was over-simplified and is a debate not a given.
My first thought reading the article: Could something like the Bill & Melinda Gates Foundation step in to make life-saving but unprofitable drugs available?
This seems like a very legitimate problem that might be worthy of attention from some non-profit, but maybe it just effects too few people?
Maybe it is just too expensive to keep producing these drugs, when they are not needed. As horrible as it is to say, there is a price on a human life. If those millions can be better spent elsewhere, surely we should be doing that.
Interesting. Being an Aussie it makes me wonder what the situation regarding anti-venoms are here, because lets face it everything over here is either poisonous or venomous which with the small population and the large distances makes it potentially a worse problem.
Going by rumours I've heard from snake fanciers, Australian doctors don't like anti-venom as much as they used to. Besides being expensive, it's quite dangerous. They've gotten so good at keeping people alive that it's often safer to let the victim recover naturally.
The large distances don't matter as much as you'd think, because first aid management of snakebite is very effective. If you're bitten by a snake, and there are country people or bushwalkers around, you can spend many hours getting to hospital, or even days.
I can belive that. What worries me is if you do need it that they cant get at it quickly enough.
As for distances though im not sure if I would care to be waiting hours following a Taipan bite considering how neurotoxic the venom is and how much they can inject.
Lost in all these borderline hysterical comments is that very few people get bitten by coral snakes - so few - that the remaining stock is expiring on the shelves.
Technically, it's small demand about to become no supply.
If bureaucracy is the only thing standing between a victim and treatment, a certain passion is understandable. People have a tendency to recognize injustice whether, rationally or statistically speaking, they shouldn't care about it.
Adam Smith showed that some regulations lead to smuggling (he spoke of gold and silver mainly).
Doesn't this antidote situation == instant black market, via internet-based mail-order from countries where it isn't banned?
Though it probably wouldn't be delivered fast enough for when you need it; and organizations that would sensibly keep a stock of it (hospitals, zoos) are not in a position to buy from a black market; and if you're going to pay thousands for something and inject it, you probably want more assurance than a dodgey website can give. Unless you're dying.
I think the US should fund the NiH to do drug studies for potentially good, but uneconomic (usually because no patent is possible, but also if they isn't a high demand) drugs.
Give it say 40 million a year, and they should do as many studies as they have money for. I think that's enough for about 4-10 per year.
Just make it part of the science research grants they give out. I'm sure there are some scientists out there who love to work with venom and anti-venom :)
It appears that anyone who could quickly provide the Mexican variant of the coral snake antivenin would be in a position to profit. Isn't there some room here for an entrepreneur/arbitrageur ("your money or your life!")?
Fascinating. I had no idea that anti-venoms make for such a great example of regulatory failure: a completely strangled market and the resulting dangerous shortages.
My read of the article makes this sound more like a natural failure than a regulatory one. The anti-venoms are very expensive to make and very rarely needed.
I see no reason that these drugs should get a pass on FDA testing that other drugs are held to, so it doesn't seem like a regulatory failure. It seems like some body acting for the general good (ie, government or nonprofit, maybe some life/health insurance?) should pay for the FDA trials to help get the alternative drugs to market.
Fascinating. I had no idea that government regulation is the force which drives companies to stop manufacturing products which are expensive to manufacture and for which there's little demand in the market. You've truly opened my eyes to this hitherto-unseen lurking evil.
The article clearly states that Coralmyn would have been on the market, except for FDA approval. The demand is low, I agree, but regulatory overhead made the difference between producing something and producing nothing.
But without regulation there would be chaos! All corporations are evil and want to kill you and the government is perfect and only has your best interests at heart!
Actually, that's exactly true. Without regulation there _would_ be chaos. It's not hard to look back a hundred years[1], before there was an FDA. Instead of real, effective cures the market was dominated by patent medicine, most of which was harmless (aside from not curing you) but much of which was actually dangerous. The FDA was set up not as a silly, unnecessary regulatory layer but to solve a very real problem that was actually killing and sickening people.
It's easy to decry regulation today, when we have never personally seen the world before that regulation. But if you read your history, you would realize today's world is much more pleasant to live in.
I see your point and I think I mostly agree with you.
However, I don't think crediting the FDA with all of the benefits of the rise of medicine as a scientific discipline through the late 19th and early 20th century is entirely warranted. Were snake oil salesmen sidelined because of the FDA or because doctor's started developing medicines that actually, and obviously, worked (such as aspirin, sulfa drugs, etc)?
The point is, without the FDA there would be no way to tell the difference between actually effective medicines and snake oil. Since snake oil is a lot cheaper to research and make, economics would dictate that it would come to dominate the market. And ordinary people, left to their own devices, are spectacularly bad at differentiating between the two. This is clearly demonstrated by the contemporary anti-vax movement (with its attendent "alternative" cures) and the alternative medicine movement, which is almost entirely snake oil.
I contend that without the FDA we would merely have different ways of telling the difference between actually effective medicines and snake oil (for example, the advice of a doctor). Indeed, how do we determine the difference in effectiveness between various FDA approved medicines today? Most medical research is not done at the behest of the FDA.
Clearly only the government is capable of scientific research. This is why we cannot tell the difference between different computer hardware, because there is no regulating government agency to do their magic for us.
...The FDA sucks...
You need millions in legal/preparation fees just to get your foot in the door and the level of bureaucratic bullshit you have to deal with still blows my mind.
My company has had a lot of experience in this sorry to say.
Again. Going to reiterate here: The FDA sucks and needs to be completely overhauled. Lots of PhDs and government bureaucrats spending too much time behind a desk with no real world experience and dictating arcane rules to the rest of us - that's the FDA I know.