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from the better-mousetrap-trapped-in-limbo dept.
AlterNet reports
The [EpiPen], which millions of Americans depend on, was invented in the 1970s by engineer Sheldon Kaplan[PDF], who died seven years ago in modest surroundings amid obscurity. But Kaplan's patent made its way into [the] Netherlands-based drug maker Mylan, which, since 2007, has jacked up the price of the spring-loaded injector from $57 a shot to $300.
[...] The high price [...] caught the attention of Dr. Douglas McMahon. The 38-year-old allergy specialist in St. Paul, Minnesota, has been thinking about how to improve on the EpiPen and to do so in a way that's affordable.
[...] McMahon saw that the EpiPen device was not only overpriced for what it does but also was too big to be easily carried in a pocket. For the past couple of years, he has been tinkering with injection-device components in his lab. And the result of his work is AllergyStop [1], an injection prototype that's small enough to fit on a key chain. McMahon claimed his device is as effective as the EpiPen and can be marketed and sold for about $50.
But, even though McMahon's device has been production-ready for the past two months, the steps he must take to get the device approved will cost him about $2 million and it will potentially take him years to go through all the hurdles required by the U.S. Food and Drug Administration for possible approval of his invention.
[1] All content is behind scripts. archive.li will run those for you.
Previously:
EpiPen's Price Increased 400% since 2008
(Score: 2) by Zinho on Monday September 12 2016, @02:23PM
Dunbal, can you comment on this a bit more?
From what little there is on the website, it sounds like a bunch of the money is going to verification of sterility; sounds like the FDA is worried that the process of filling the syringes would introduce pathogens.
How viable would it be for a consumer to DIY something like this by purchasing the syringes, ampoules, and carrying case on the open market and pre-fill their own syringe to carry around? I'm asking specifically about the sterility issue. Usually a diabetic patient is injecting immediately after measuring, here there would be a delay and some risk of contamination during storage.
I imagine that this inventor feels about the same as you do on this topic; comparisons to the injection of insulin to treat diabetes seem justified, and given that context the costs/requirements on sterile delivery must seem burdensome.
"Space Exploration is not endless circles in low earth orbit." -Buzz Aldrin
(Score: 3, Informative) by Dunbal on Monday September 12 2016, @02:36PM
Dunbal, can you comment on this a bit more?
The questions you are asking are the questions that would interest lawyers. So a company like Epi-pen will invest a lot of money in making sure they can't be sued if anyone gets infected by their product because "oh we have this process, and that system, and such and such, and these studies..." - which is understandable but 100% MARKETING. Pay attention to this further comment:
ALL MEDICAL PROCEDURES INVOLVE RISK. ALL OF THEM. NO EXCEPTIONS. INCLUDING INJECTING YOURSELF WITH AN EPI-PEN.
You can infect yourself with the DIY system. You can infect yourself with an Epi-Pen. You might have an increased chance of infection if you do it yourself with a plain old needle. The chance of any wound being infected normally is around 7%. If the most cautious anti-septic and aseptic procedures are followed, it drops to around 1%.
A course of antibiotics and a walk in clinic doctors' visit is still cheaper than a $600 epi-pen. Of course you could be the unlucky one that not only got infected but got infected by a resistant strain, got complications, and died. It happens. It's not likely. Heck heroin addicts inject themselves far more often, with far dirtier things (both the needles and the tainted, "cut" drugs they shoot themselves with) and not all of them drop dead on the spot from infection.
And at the end of the day - you did it to yourself with a needle you loaded yourself. Who are you going to sue? You were explained how to do it properly, and you were made aware of the risk. But Epi-pen, well of course they have to cover their backsides. They are a magnet for lawyers.
(Score: 2) by Zinho on Monday September 12 2016, @03:02PM
The questions you are asking are the questions that would interest lawyers. So a company like Epi-pen will invest a lot of money in making sure they can't be sued if anyone gets infected by their product because "oh we have this process, and that system, and such and such, and these studies..." - which is understandable but 100% MARKETING. . .
And at the end of the day - you did it to yourself with a needle you loaded yourself. Who are you going to sue? You were explained how to do it properly, and you were made aware of the risk. But Epi-pen, well of course they have to cover their backsides. They are a magnet for lawyers.
Yeah, that's what I suspected. The regulatory hoops AllergyStop is jumping through sound exactly like lawyerproofing instead of actual treatment requirements. Unfortunate, and a side-effect of the "shift responsibility to someone else" culture we've developed.
"Space Exploration is not endless circles in low earth orbit." -Buzz Aldrin
(Score: 3, Insightful) by Dunbal on Tuesday September 13 2016, @01:22AM
Unfortunate, and a side-effect of the "shift responsibility to someone else" culture we've developed.
You hit the nail on the head. Of course this culture exists for a reason, and that is financial gain. The lawyer will advise you to sue because he and his profession have a vested interest. They get paid. And they let you have a cut, too. So it becomes a game of find the most vulnerable target as opposed to actually caring about medicine and patient welfare. Of course the lawyer will deny this, and will tell you about how punitive damages provide a service to health-care by offering consequences for the unethical. But that's not the whole truth. At the end of the day, they will go wherever the money is.
I get US TV stations where I live, and I am constantly seeing ambulance chasing advertisements from law firms for things like Mesothelioma. It's all they seem to talk about. Is mesothelioma a serious problem? It's cancer, but not really. There are far worse and far more aggressive types of cancer. Is it a common illness? No, it's extremely rare. Then why the disproportionate advertising - you'd think everyone in the US was dying of mesothelioma. Ahhh - because it is one of the most EASILY MISSED diagnoses. A lawyer with a mesothelioma patient can go through the file and be pretty much guaranteed to find some sort of evidence, IN HINDSIGHT, that points to a missed early diagnosis. It's pretty much a guaranteed payout - and a BIG payout, after all, you get to go in front of a jury and tell them you are dying of CANCER because of Dr. So and so. But does the lawyer actually care about the patient? No. Does it improve the prognosis of mesothelioma? No. Does it cause doctors all over the country to order inappropriate tests to defensively rule out mesothelioma just to lawyer-proof the patient file, wasting time, money and resources? Yes. But such is the world we live in now.
(Score: 1) by segwonk on Tuesday September 13 2016, @05:31AM
"Then why the disproportionate advertising....Ahhh - because it is one of the most EASILY MISSED diagnoses."
I haven't looked into this very much, but I was under the impression that Mesothelioma is sought after by ambulance chasers because of the disease's link to asbestos. And I also have this dim memory that there is a fund set aside by some chemical companies as a result of some class action settlement for Mesothelioma.
But I could be wrong. Anyone know?
.......go til ya know.
(Score: 3, Interesting) by sjames on Monday September 12 2016, @07:57PM
It seems to me that sterility goes out the window when you inject someone through their pants leg.