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US Patients Battle EpiPen Prices And Regulations By Shopping Online (cnn.com)
"The incredible increase in the cost of EpiPens, auto-injectors that can stop life-threatening emergencies caused by allergic reactions, has hit home on Capitol Hill," reports CNN. Slashdot reader Applehu Akbar reports that the argument "has now turned into civil war in the US Senate":
One senator's daughter relies on Epi-Pen, while another senator's daughter is CEO of Mylan, the single company that is licensed to sell these injectors in the US. On the worldwide market there is no monopoly on these devices... Is it finally time to allow Americans to go online and fill their prescriptions on the world market?
Time reports some patients are ordering cheaper EpiPens from Canada and other countries online, "an act that the FDA says is technically illegal and potentially dangerous." But the FDA also has "a backlog of about 4,000 generic drugs" awaiting FDA approval, reports PRI, noting that in the meantime prices have also increased for drugs treating cancer, hepatitis C, and high cholesterol. In Australia, where the drug costs just $38, one news outlet reports that the U.S. "is the only developed nation on Earth which allows pharmaceutical companies to set their own prices."
Time reports some patients are ordering cheaper EpiPens from Canada and other countries online, "an act that the FDA says is technically illegal and potentially dangerous." But the FDA also has "a backlog of about 4,000 generic drugs" awaiting FDA approval, reports PRI, noting that in the meantime prices have also increased for drugs treating cancer, hepatitis C, and high cholesterol. In Australia, where the drug costs just $38, one news outlet reports that the U.S. "is the only developed nation on Earth which allows pharmaceutical companies to set their own prices."
Ban drug ad's like most developed nations do!
You're aware that the senator whose daughter is CEO of Mylan is a Democrat, right? Greed isn't a left nor right issue. It's not a conservative nor liberal issue, it's a people issue.
Epi-pen dosage is 0.3 mg of epinephrine. One dose from a Primatene mist inhaler releases 0.22 mg of epinephrine, exactly the same active ingredient as an Epi-pen. There are over 60 doses per Primatene mist inhaler. at a cost of about 50 cents per dose. Several years ago Primatene Mist was removed from the market. Our health care system is now fully controlled by corporations that don't give a rat's ass if we live or die as long as their profits continue to skyrocket, at any cost. Health insurance companies could fight back. But they don't appear to care, as they just raise their rates to cover the excessive and escalating cost of life saving prescription drugs. Having asthma, and having worked with suppliers of delivery mechanisms during my career, I estimate the cost of goods sold per Epi-pen is about $2 to $3 each. Any figures beyond that are profit. Any higher CGS presented by Mylan, should they choose to do so, are likely accounting techniques where they move ongoing R&D costs onto old and fully paid for products. The retail price of Mylan's Epi-pen is legalized theft such that Al Capone would be proud.
Epipen has no domestic competitors because the FDA (government) says so. It can't be bought from abroad because the government (FDA) says so. The solution isn't to mandate pricing, it is to streamline the process of delivering a well understood drug (adrenaline) at a well known dose, in an exactly known situation. It would be trivial to bring generic competitors to market if this were a reasonably governed area, and there would be no price gouging allowed because they couldn't sell it at even what the price was before the jacked it up. (Adrenaline aka epinephrine is trivially cheap, and the injector is quite cheap to make as well.)
Arguably "the same drug" will be the same everywhere, but if you're ordering online drugs from somewhere outside the FDA inspection regime, you don't know what your chances are that it's in fact actually "the same drug". Really, you don't know what you're getting.
That's still a possibility here, of course, but when a US producer commits fraud you'd better believe you'll have an army of lawyers beating down your door to help sue them into oblivion for it. Random Joe Bob's Discount Drug Shack operating in Singapore? Good luck.
Secondly, the FDA approval process itself. For better or for worse, having a complex medical trial and many layers of approval is probably better that not having it, in terms of protecting US consumers from unsafe foods and drugs. There's a fast-track process for promising drugs and devices to prevent dangerous conditions, and there registered experimental treatments, but all other things being equal, I'd prefer to know that some basic level of testing was done.
Drug IP process. People in other countries like to point out that they can purchase drugs for $20 that are charged higher processes here. You can thank us (the American Consumer) for that. Not everyone gets to be a marginal consumer.. and part of the reason we're paying full price for drugs is so that the market incentive allows those drugs to be developed in the first place. Without market incentive, you're only going to proceed in research as fast as centrally-planned authorities dictate you will. Or you're a charity, funded by donations.
None of those things directly deal with device IP, but to be honest cases like this (where someone is being an abject douchebag) are rare, and tend to get discovered, highlighted, and corrected through social pressure. (EMT's have been talking about the cost of EpiPens for years, and there were already initiatives under way to allow EMT's to inject Epi directly: http://thesouthern.com/news/local/govt-and-politics/new-state-law-will-allow-emts-to-inject-epinephrine/article_42dbddd9-a035-509b-b99a-7f720c7411b0.html
If there's a justifiable reason for a price hike, it'll become public as well. Often there is. E.g., a critical component has restricted availability.
Hire a Linux system administrator, systems engineer,
There's no market when only one company is allowed to sell the good.
The creatures outside looked from Alt-Right to Antifa; but already it was impossible to say which was which.
Since there seems to be a lot of confusion in the media about the real issue here, the EpiPen problem (1) has nothing to do with drug patents, and (2) has relatively little to do with patent protection in general.
IIRC doesn't the patent in this case apply specifically to the mechanism? And yes, epinephrine, for those who don't know, is commonly called adrenaline, which is the name brand of synthetic (but is chemically identical to the endogenous source, and thus no different from it) epinephrine.
And indeed, in many cases when there's a drug monopoly, it doesn't involve a patent. Because I have stage 4 CKD, I have problems with gout. The only medication that effectively treats it in my case is a drug called colchicine. That particular drug has been in use for a few centuries now, but a company presently has market exclusivity. Why? Well, when the Food and Drug Act was passed in 1934, any drug made from that point forward had have its efficacy proven before it could be prescribed, however old medications were "grandfathered in" until a few decades ago (I don't remember the exact year) when the FDA said they needed to pass scientific scrutiny, go through clinical trials, etc, to have their efficacy empirically proven. Colchicine was one of these drugs, and before this happened it was about 10 cents a pill, until the company that put it through its paces was granted market exclusivity as part of their efforts to prove that it works. They then trademarked it under the name Colcrys and raised the price to about $6 per pill.
And again, there is no intellectual property involved here, just the FDA granting market exclusivity. And to a point, I agree with this; they put in the effort to make sure that a drug that's actually by all definitions of the word toxic (it comes from a highly toxic plant) actually works and won't kill you, which isn't a cheap thing to do, they should be able to see a return on investment. But allowing them to raise the price of a drug that is super cheap to produce to a price that's just flat out extortion is ridiculous.
About the only rationale I can figure for avoiding the syringe issue is people's fear of needles
Actually believe it or not I'm less scared of a syringe than an autoinjector. Why? Because in the Army we were issued an autoinjector in case of exposure to some kind of gas (I don't remember which one) which you were supposed to inject into the muscle in your butt cheek. The scary part was how I saw one of these stick right through a 2x4 piece of wood. Imagine if you accidentally stuck your hip bone or your hand...oww...I'll stick with the syringe, thanks.
It's not just an exclusive license. They passed laws requiring schools to buy them.
Heather Bresch, Mylan's CEO, whose father is a congressman, managed to get Congress to pass a law effectively requiring every school in the country to stock an automatic injector, of which EpiPen is the only one readily available.
...[Y]our real problem in this world isn't actually the FDA, it's the insurance industry. The FDA may be able to shut down businesses which don't comply, but, by and large, they let an awful lot of stuff get through. It's the insurers who are deciding what actually gets used in our medical system...
Tell me about it. My mother has cancer. Her physician-recommended treatment isn't covered by insurance because they consider it "experimental", despite the fact that it seems to have worked quite well for Jimmy Carter.
Il n'y a pas de Planet B.
1. The school nurse and teachers were trained to use the EpiPen, not your homebrew syringe kit, when your kid has an emergency reaction to errant peanut butter in the lunch area.
Syringes are just as easy to use with 5 minutes of training. Particularly a licensed school nurse should certainly be able to handle that without extra training.
2. Syringes are typically controlled medical supplies here in the United States because they can also be used to inject illegal drugs. They don't just sell empty syringes over the counter and most schools here in the US would probably freak out over "drug paraphernalia" if they spotted your kid with a bag of pre-filled syringes.
Most states do in fact sell syringes over the counter, e.g., for diabetics. Some do put limits on sales to prevent drug use. But all of this is solved by -- ya know -- a prescription, just like you'd get for an EpiPen.
By the way, I guess you just proved my point. Our insane "war against drugs" nonsense is likely why we want to suck hundreds of dollars out of families for no good reason to force them to get the "EpiPen" while refusing to tell them about a cheap, reasonable alternative. Or, worse yet -- the families who go without an EpiPen because of expense or hope that an expired one still works... how many kids are we willing to kill or rush to the hospital with a severe allergic reaction because "ACK NEEDLES!!"
3. Emergency medical personnel are not troubled by the first two problems, but they aren't there when your kid needs them.
If you need someone to actually withdraw a dose from an ampule or vial, be sure to get the proper dose, be sure there's no air bubbles, etc. -- sure I'd agree that paramedics with experience will be better at it in a tense scenario.
But you put a pre-filled syringe in a kit, and it's ready to go. There are some things you need to know (e.g., do NOT inject into a blood vessel, but that's true of EpiPens too), but again that can be covered in 5-10 minutes of training... not significantly more than an EpiPen.
Unfortunately they didn't say that. Those were just lab tests of stability and sterility. In order to be convinced, I'd have to see a study of actual patients who successfully learned to do their own epinephrine injections. That would be a hard study to do, since anaphylaxis is relatively rare.
I never claimed my links said that. They only proved that pre-filled syringes are a viable choice for those people who claim "We can't use syringes because of dosage concerns or worries that people won't fill them correctly or they'll lose time in doing all that for people inexperienced with them." Those things are the reasons always trotted out for why syringes aren't a reasonable alternative, but most of them are solved with a pre-filled syringe... which my links note is a viable way to store the drug until use.
Anyhow, you seriously want a STUDY showing normal people can successfully do an injection?? There are THOUSANDS of diabetics who inject themselves every day in the U.S.
(The other problem was that ephinephrine degrades after 3 months, while the EpiPen lasts 12 months.)
No, do you think the epinephrine in the EpiPens is "magic" or something? It doesn't degrade as fast because it's sealed. Epinephrine in a sealed vial or ampule would generally also last 12 months. Trained medical personnel who are used to drawing syringes quickly in emergency scenarios would have no problem with that stuff. So yes, putting in a pre-filled syringe cuts down the guaranteed stable lifespan. Anyhow, it's easy enough to swap out the syringes on a schedule. Is it less convenient and possible people will forget? Sure. But I think it's also likely some other people are more prone to forget to get a new EpiPen every year, since there's a much longer time between replacements.
My basic reaction to your post is, you can't know that something is going to work until you've done a well-designed study in the real world.
I never said it was guaranteed to be BETTER than an EpiPen -- and for that, I agree it would require a proper study. What I'm saying is that it's a reasonable, inexpensive, and reliable alternative that should be offered to patients who might want to consider alternatives.
Obviously an EpiPen -- used properly -- is probably less fuss and easier. However, I think it's irresponsible for physicians, pharmacists, and the news media to not mention the cheap, simple alternative that is clearly available.
(You also mentioned something about a media source claiming syringes require "extensive medical training" or something... I call BS. Again, diabetics deal with this all the time. There are some precautions, but most are similar to EpiPens, and the additional warnings can easily be explained in a few minutes. You also may want to check into the credentials of that medical professional -- I've seen some media quotes in stories in the past few days saying similar, but it turns out they work for allergy societies that get a huge amount of support from the manufacturer of EpiPens, which at a minimum presents a significant conflict of interest. Please note that many of the major allergy societies have been relatively silent in the past weeks as the EpiPen controversy has grown -- they get a lot of funding from the EpiPen company, so they haven't really been speaking out about what is clearly a patient advocacy issue. Horrifying all around.)