Why Snakebites Are About to Get a Lot More Deadly
popularmechanics.com
popularmechanics.com
...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.
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.
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.
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.
Edit: to be clear, I was attempting to respond to the parent's parent post. I apparently suck at internet.
If you felt it was made in anger or hate, I would think it would classify as a retort or something similar.
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.
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.
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.
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.
...which sounds like the sort of thing you might do if you were just manufacturing 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.
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 personally think that the FDA approval process is bogus too. I'm just trying to expand the discussion a bit.
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.
I'm sure this is a debatable 'fact'/statistic.
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.
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?"
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.
In which fields? You are entering a mine field.
> Either regulation is good for the uneducated or it is not.
There could be different kinds of regulation.
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.
Prohibiting advertising strays dangerously close to the 1st Amendment.
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.
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.
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.
I wonder the same thing. And it's not like the people in the non-profit agencies aren't paid, and can't accept bribes.
Not that anyone bribes the FDA, of course. They're non-profit, what possible gain could there be?
BTW, bribing a government official will usually result in one or both of you doing time in a federal (not a country club) prison.
If bribed with cash, maybe, unless it can fall under "campaign finance". Sports tickets, dinners, and gifts are generally accepted though.
Cheers for pointing that out.
[0]Ain't spurious exactitude great?
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.
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.
The FDA should have a rule that any drug approved by any of the following agencies is automatically approved for use in the USA.
Yet Europe has drug regulation. Maybe the problem isn't regulation as such, but the way regulation works in the US.
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.
Or would you rather prescribe them yourself too?
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"
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.
England public debt: 59.9% of GDP
New Zealand public debt: 29.3% of GDP
United States public debt: 86.3% of GDP
(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.)
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...
(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.)
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.
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.
It's cheaper to spread out the vials, see which hospital needs it, then re-collect them when you have an actual patient.
If they would see a patient every day, I'm sure they would stock more.
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.
If you're interested in learning more about it, there's a good article here: http://emedicine.medscape.com/article/771455-overview
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.
[1] http://www.biochem.arizona.edu/CatalystWebsite/Fall04/Featur...
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 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...
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!
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?
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.
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.
No Demand = 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.
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.
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.
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.
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.
[1] OK, technically 104 years
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)?