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."

Comments

Logic Says It Should Be Legal

[pubwvj]

It should be legal to order the same product from another country. They're both made by the same company. Stupid trade protectionism.

Re:Logic Says It Should Be Legal

[ArmoredDragon]

Your resident crazy libertarian here:

Indeed there doesn't seem to be any good reason to prevent importing anything from international editions of books (save money for college students) to pharmaceuticals. There may be some merit to that argument for places like Mexico where quality controls are quite poor, however that should be a judgement call left up to the consumer. Likewise, I think the idea of tariffs, embargos, and other forms of mercantilism ultimately cost a domestic economy much more than they supposedly preserve.

Nevertheless, I don't think that's quite the root of the problem. This isn't, by any definition whatsoever, a free market. This is in fact a government granted monopoly. You cannot have both a free market AND a monopoly in most cases. That said, I don't quite understand why we give i.e. patent holders, copyright holders, etc free reign on how, when, where, and how much they can charge for anything with the sky being the limit. There probably should be some system in place whereby if they opt for government protection, then they must follow certain pricing and trade rules in order to keep that protection.

Re:Logic Says It Should Be Legal

[jenningsthecat]

Many on the left love protectionism...except when they don't.

Many on the right hate protectionism...except when they don't.

Corporations just love having unfettered access to other markets for their products. They also love unrestricted access to supplies of (cheaper) materials and labour in other countries; but let their customers demand the same, and all of a sudden the hypocritical bastards lobby for protectionism, and start spreading FUD about the supposed dangers of products from other countries. Their idea of a 'free market' is really a 'captive market' - one that is kept captive by the legislation they buy, the lies they spread, and the dirty deals they strike with their counterparts in other countries.

Re: Logic Says It Should Be Legal

[Anonymous Coward]

When my wife was on a particular medication, we used CanadaDrugs dot com to get it vastly cheaper than we could through any USA based pharmacy. The funny thing was, the drug was made in the USA and shipped from a USA warehouse.

The medication was never outside the US borders at all -- but the only way to get a good price was to order it via an international pharmacy.

Re:Logic Says It Should Be Legal

[AthanasiusKircher]

This isn't, by any definition whatsoever, a free market. This is in fact a government granted monopoly. You cannot have both a free market AND a monopoly in most cases. That said, I don't quite understand why we give i.e. patent holders, copyright holders, etc free reign on how, when, where, and how much they can charge for anything with the sky being the limit.

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.

Just to be clear, the drug here (epinephrine) has been around for many decades and is patent-free. You can easily get a dose of it for a few cents: hospitals directly inject the generic all the time. And the EpiPen is basically out of patent protection. There apparently is still an active patent for some aspect of the device, but the manufacturer settled a lawsuit already that would allow generic manufacture.

So what's the real problem here? There are two. The first is the FDA. Epipens fall under the category of both "drugs" and "medical devices" for approval purposes, and the byzantine set of processes necessary for approval take forever. They also require standards for effectiveness that are probably impossible to meet in this case, because of the high rate of EpiPen (and generic autoinjector) user error. There were supposedly 26 incidents of "incorrect dosage" from Auvi-Q before the recall, but none were actually confirmed and the devices involved did not seem to be malfunctioning. So why the wrong dose?

This is the dirty secret of this whole autoinjector business -- people actually screw up using them quite a bit. (The second issue.) The most common user errors: (1) forget to take safety cap off, (2) use wrong end, (3) don't inject for adequate time (usually recommended for 10 seconds). You introduce a slightly different procedure (with another cap, oh gosh!) and that makes alternatives like Adrenaclick even more likely to be misused.

This whole discussion in the media, to my mind, has been highjacked by people who want to draw attention to the high prices of drugs in the U.S. And that's a very noble goal, because it is ridiculous.

But in this particular case, there is a simple, viable, CHEAP alternative -- a syringe with epinephrine. The primary objections are that people could draw up the wrong dose in a panic or whatever -- but this is solved simply. Have your syringe prefilled by a doctor, nurse, or pharmacist. You'll also hear misinformed doctors saying, "But it isn't guaranteed to be sterile" or "it will degrade." Again, we have research on this issue -- see here and here. Basically, as long as the syringe is stored in darkness (e.g., in a simple tube or something), it's sterile and stable for at least 3 months.

And guess what -- you don't have any of those annoying problems with people screwing up using their autoinjectors. (1) forgot to take safety cap off? Nope -- you actually see the drug go in, so if there's some sort of safety put on the needle to prevent accidental discharge, it'll be clear if you didn't take it off. (2) Used the wrong end? Nope -- even a 4-year-old knows which end of the syringe has to go in. (3) Don't inject long enough? Nope -- again, you see the stuff go in. You push the needle until the pre-measured dose is completely out.

Giving yourself or someone else an injection is not rocket science, and with pre-filled syringes it's probably less error-prone than "autoinjectors." And here's the best part: the total cost is probably about $5 for one (including the syringe and the pre-filling to correct dose). If you were willing to buy syringes and a larger bottle of epinephrine yourself, you could make it even cheaper, but we're already down to $20/year with replacements every

Re:Logic Says It Should Be Legal

[Zontar The Mindless]

That sort of globalisation is intended to provide for unrestricted movement of capital while keeping labour and consumers locked down as tightly as possible.

Re:Logic Says It Should Be Legal

[AthanasiusKircher]

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.)

Ban drug ad's like most developed nations do!

[Joe_Dragon]

Ban drug ad's like most developed nations do!

Re:Ban drug ad's like most developed nations do!

[Anonymous Coward]

I left the US right about when they were starting to be allowed. Now when I go back it's pretty disconcerting, bordering on revolting, to see how much tv space is taken up with drug ads.

There is no reason for drug ads. Period. Drugs should be allowed by efficacy and safety, priced honsetly and prescribed by qualified unbiased doctors for the conditions they treat best. None of that is true in the modern US of A

Hooray for overseas mailorder

[glomph]

My Telmisartan (technically generic now, but Big Pharma is delaying it) is 6x cheaper overseas. Fuck the corporate kleptocracy and their politcal enablers with a rusty rake.

Re:Free market

[Anonymous Coward]

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.

Re:Free market

[JaredOfEuropa]

This is not a free market. In a free market you'd be free to buy from overseas companies.

All these pharma/insurance stories

[fustakrakich]

And still insufficient demand for universal health care. And don't blame the politicians. With the upcoming 95% reelection rate (and 100% republican/democrat monolith), there is no incentive for them to change anything. The only issue monopolizing the media is *he who shall not be named*

Epinephrine cost per dose in about 50 cents

[ITRambo]

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.

Re:Epinephrine cost per dose in about 50 cents

[Dorianny]

The biggest problem is that Medicare the largest insurer in the country is bared from both negotiating prices with Drug manufacturers as well as weighing its cost when considering approval of medication

Re:Epinephrine cost per dose in about 50 cents

[JBMcB]

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.

Primatene Mist was banned by the FDA in 2011 because it contained CFCs.

http://hubpages.com/health/Wha...

Do you have evidence that Primatene wanted the FDA to pull their product off the market?

Re:IP law has nothing to do with logic.

[Calydor]

No one said the company isn't allowed to turn a profit - but as a patient, do you want the sole supplier of medication that keeps you alive to suddenly realize they are the ONLY REASON YOU ARE ALIVE and bumping your daily expense up to a million dollars?

Re: IP law has nothing to do with logic.

[Anonymous Coward]

Um. Dude. You might want to look around, this site is largely due to the existence of free software. FREE. People do it and give it away for FREE.

You just can't fathom value being non-monetary which makes your economic-fu weak. Homo econicus ain't no fool, Homo Economicus has gradients of preferences, in relation to and driven by a variety externalities, which regardless of your mental capacity to comprehend them exist. Right now. In you, your inner homo economicus, is erupting with complex value calculations that you are probably to ignorant to clearly understand.

You should stop being so hung up on money, and let your inner homo economicus run free. Enjoy all your preferences, not just the ones society shows you will satisfy you.

A big secret I learned a long time ago, that sort of makes this all work, is that by helping each other (think free shit) we get along better in the universe. It actually makes us happy and fulfilled. What?! That is our most selfish center is, is best satisfied by caring about helping other humans?

That sounds fucked up. Real fucked up... But shit that does make some fucking sense. It's probably our evolutionary edge, because there ain't no fuckin way we out predator'd everything else on this planet lone wolfing it for a few million years... That and thumbs.

Thumbs are no fucking joke.

Re:Conflating several issues here

[thegarbz]

Random Joe Bob's Discount Drug Shack operating in Singapore? Good luck.

Random Joe would be bound by the inspection rules of the Singapore Health Sciences Authority (HSA) which serve a similar purpose as the FDA as well as be registered with the Singapore Pharmacy Council (SPC). Now if these sound like shady organisations it's because the FDA has a formed a joined working group with the HSA to ensure that all drugs available in Singapore and the USA meet the requirements of both countries as required by the trade agreement that is in place. i.e. Your government's agency charged with protecting you think that their government's agency charged with protecting them are equally capable and do the same job.

I'm glad you chose Singapore. It shows both your prejudices against the east as well as your complete ignorance of the pharmaceutical industry outside of the USA where, not only are the drugs of comparable quality but people are less likely to die as they can afford them too.

Re:IP law has nothing to do with logic.

[JoeMerchant]

Well, libertard (please take that in fun, as it was intended) your 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 - drugs, devices and procedures they are willing to pay for are widely used, those they do not are relegated to a tiny fraction of the market. FDA doesn't actually "approve" anything, they give "permission to market." It's insurers that "approve reimbursement," and insurers who have built up a system so corrupt that when it is studied in history, people will not believe the ratios between private pay price and insured reimbursement. It simply won't make sense that a society that supposedly had a free and open competitive market, with laws against monopolistic behavior, could ever allow billing $15 for a 500mg Tylenol pill, or $15,000 for a device with 30 year old technology inside that costs $500 to make.

The only other time I ever encountered "prices" that were so crazy was in former East Germany, just after the wall fell 1990: Bread: $0.05 per pound, nice 3 bedroom flat in town: $12 per month, bicycle (luxury item) $15,000, color TV $45,000. It turns money into a sick joke. Just like in the USA today, when you get really sick, the money involved is beyond crazy, all you can do is laugh and shake your head, oh, and pay the man if you want a chance to live.

Re:IP law is not involved in this case

[nbauman]

The solution: Change the FDA. Make it cheap and fast for a drug manufacturer to get approved to make any drug if they can prove that they are using industry-standard (or better) processes for quality control and if they are producing a chemically-identical product.

And exactly how do you propose to change that? Do you want FDA employees to work longer hours? Or do you want them to work twice as fast in the same hours? Can you speed them up like a tape recorder?

Actually, the FDA does a pretty good job right now. They approve drugs faster than European regulators. They had a backup several years ago when Congress (actually, Republicans) thought it would be a great idea to cut taxes and cut the budgets of government agencies.

I remember the CEO of a biotechnology company (I think Centicor) complaining that the FDA inspector couldn't come to his plant because they didn't have the budget for the train fare on Amtrack.

FDA regulation has little to do with why drugs cost so much money. More important is the Republicans refusing to let the government negotiate prices with the drug makers. https://en.wikipedia.org/wiki/...

In the UK, they have an agency, NICE, which decides how much the drugs are worth, which is often half or a third as much as the US price.

Re:IP law has nothing to do with logic.

[nbauman]

As an example, my wife's kidney dialysis sessions are billed out at $3,925 each, for a total of about $600,000 per year. The insurance company's "real price" is $290 per session.

Well, the original intention of Congress was to have free market competition in kidney dialysis, to bring the price down, but that didn't work. There were a lot of small providers but a couple of big companies took over the industry and turned it into a monopoly. You can't negotiate prices with a monopoly.

It seems that in the modern economy, the free market doesn't last long as many industries turn into monopolies. Amazon is a book-selling monopoly. Google is an internet advertising monopoly.

If we must have a monopoly, we might as well have the government running it.

Re:IP law has nothing to do with logic.

[Zontar The Mindless]

...[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.