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.
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.
...[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.
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.)