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Reverse Voxsplaining: Drugs vs. Chairs[Content note: this is pretty much a rehash of things I’ve said before, and that otherpeoplehaveaddressedmuchmoreeloquently. My only excuse for wasting your time with it again is that SOMEHOW THE MESSAGE STILL HASN’T SUNK IN. Pitching this as “market” vs. I am overly simplistic sometimes then it will sink in better.]Epi. Pens, useful medical devices which reverse potentially fatal allergic reactions, have recently quadrupled in price, putting pressure on allergy sufferers and those who care for them.

Vox writes that this “tells us a lot about what’s wrong with American health care” – namely that we don’t regulate it enough: The story of Mylan’s giant Epi. Pen price increase is, more fundamentally, a story about America’s unique drug pricing policies. We are the only developed nation that lets drugmakers set their own prices, maximizing profits the same way sellers of chairs, mugs, shoes, or any other manufactured goods would. Let me ask Vox a question: when was the last time that America’s chair industry hiked the price of chairs 4.

When was the last time that the mug industry decided to charge $3. When was the last time greedy shoe executives forced most Americans to go barefoot? And why do you think that is? The problem with the pharmaceutical industry isn’t that they’re unregulated just like chairs and mugs.

The problem with the pharmaceutical industry is that they’re part of a highly- regulated cronyist system that works completely differently from chairs and mugs. If a chair company decided to charge $3. When Mylan decided to sell Epi. Pens for $3. 00, in any normal system somebody would have made their own Epi. Pens and sold them for less. It wouldn’t have been hard.

Its active ingredient, epinephrine, is off- patent, was being synthesized as early as 1. Epi. Pen- load. Why don’t they? They keep trying, and the FDA keeps refusing to approve them for human use. For example, in 2.

Teva Pharmaceuticals announced a plan to sell their own Epi. Pens in the US. The makers of the original Epi. Pen sued them, saying that they had patented the idea epinephrine- injecting devices.

Teva successfully fended off the challenge and brought its product to the FDA, which rejected it because of “certain major deficiencies”. As far as I know, nobody has ever publicly said what the problem was – we can only hope they at least told Teva. In 2. 01. 0, another group, Sandoz, asked for permission to sell a generic Epi. Pen. Once again, the original manufacturers sued for patent infringement. According to Wikipedia, “as of July 2. In 2. 01. 1, Sanoji asked for permission to sell a generic Epi. Watch The Black Balloon Online Iflix on this page.

Pen called e- cue. This got held up for a while because the FDA didn’t like the name (really!), but eventually was approved under the name Auvi- Q, (which if I were a giant government agency that rejected things for having dumb names, would be going straight into the wastebasket). But after unconfirmed reports of incorrect dosage delivery, they recalled all their products off the market. This year, a company called Adamis decided that in order to get around the patent on devices that inject epinephrine, they would just sell pre- filled epinephrine syringes and let patients inject themselves. The FDA rejected it, noting that the company involved had done several studies but demanding that they do some more.

Also, throughout all of this a bunch of companies are merging and getting bought out by other companies and making secret deals with each other to retract their products and it’s all really complicated. None of this is because Epi. Pens are just too hard to make correctly. Europe has eight competing versions. But aside from the Epi. Pen itself, only one competitor has ever made it past the FDA and onto the pharmacy shelf – a system called Adrenaclick. And of course there’s a catch.

With ordinary medications, pharmacists are allowed to interpret prescriptions for a brand name as prescriptions for the generic unless doctors ask them not to. For example, if I write a prescription for “Prozac”, a pharmacist knows that I mean anything containing fluoxetine, the chemical ingredient sold under the Prozac brand. They don’t have to buy it directly from Prozac trademark- holder Eli Lilly. It’s like if someone asks for a Kleenex and you give them a regular tissue, or if you suggest putting something in a Tupperware but actually use a plastic container made by someone other than the Tupperware Corporation.

Epi. Pens are protected from this substitution. If a doctor writes a prescription for “Epi. Pen”, the pharmacist must give an Epi. Pen- brand Epi. Pen, not an Adrenaclick- brand Epi. Pen. This is apparently so that children who have learned how to use an Epi. Pen don’t have to relearn how to use an entirely different device (hint: jam the pointy end into your body). If you know anything at all about doctors, you know that they have way too much institutional inertia to change from writing one word on a prescription pad to writing a totally different word on a prescription pad, especially if the second word is almost twice as long, and especially especially if it’s just to do something silly like save a patient money.

I have an attending who, whenever we are dealing with anything other than a life- or- death matter, just dismisses it with “Nobody ever died from X”, and I can totally hear him saying “Nobody ever died from paying extra for an adrenaline injector”. So Adrenaclick continues to languish in obscurity. So why is the government having so much trouble permitting a usable form of a common medication? There are a lot of different factors, but let me focus on the most annoying one.

Epi. Pen manufacturer Mylan Inc spends about a million dollars on lobbying per year. Open. Secrets. org tells us what bills got all that money.

They seem to have given the most to defeat S. Preserve Access to Affordable Generics Act”. The bill would ban pharmaceutical companies from bribing generic companies not to create generic drugs.

Did they win? Yup. In fact, various versions of this bill have apparently failed so many times that FDA Law Blog notes that “insanity is doing the same thing over and over again and expecting different result”. So let me try to make this easier to understand. Imagine that the government creates the Furniture and Desk Association, an agency which declares that only IKEA is allowed to sell chairs. IKEA responds by charging $3. Other companies try to sell stools or sofas, but get bogged down for years in litigation over whether these technically count as “chairs”. Watch Today`S Special Online Full Movie.

When a few of them win their court cases, the FDA shoots them down anyway for vague reasons it refuses to share, or because they haven’t done studies showing that their chairs will not break, or because the studies that showed their chairs will not break didn’t include a high enough number of morbidly obese people so we can’t be sure they won’t break. Finally, Target spends tens of millions of dollars on lawyers and gets the okay to compete with IKEA, but people can only get Target chairs if they have a note signed by a professional interior designer saying that their room needs a “comfort- producing seating implement” and which absolutely definitely does not mention “chairs” anywhere, because otherwise a child who was used to sitting on IKEA chairs might sit down on a Target chair the wrong way, get confused, fall off, and break her head.(You’re going to say this is an unfair comparison because drugs are potentially dangerous and chairs aren’t – but 5. Britain alone and as far as I know nobody has ever died from an Epi. Pen malfunction.)Imagine that this whole system is going on at the same time that IKEA spends millions of dollars lobbying senators about chair- related issues, and that these same senators vote down a bill preventing IKEA from paying off other companies to stay out of the chair industry.