Ep-Ep-EpiPen

Scott’s article about the EpiPen pricing debacle, REVERSE VOXSPLAINING: DRUGS VS. CHAIRS, is going hugely viral having been shared thousands of times on Facebook and posted many times on Reddit. Scott argues that FDA regulation, and possibly lobbying by maker of the EpiPen, Mylan Pharmaceuticals, is preventing the production of cheaper alternatives to the EpiPen. By contrast, the production furniture such as such chairs and tables are unregulated, and that’s why IKEA chairs cost $40 instead of $400, because the furniture industry is perfectly competitive. Overall, it’s a good argument, reminiscent of one Milton Friedan would probably make if he were alive.

However, there are a couple problems with Scott’s reasoning: namely, that an EpiPen, which is an emergency device, is much more complicated and has a much smaller margin of error for functionality than household furniture, so the analogy may not be apt; second, the suffix ‘pen’ belies its complexity, because some assume it’s like a Bic pen and that if Bic pens are cheap and simple, so should Epinephrine pens. An EpiPen, more specifically, an Epinephrine autoinjector, is a fairly complicated device. It has to work with nearly 100% consistency, for a wide range of ages and body weights, and for a wide range of potential allergens. It has to inject the right about of Epinephrine every time – too much may cause death and too little may be ineffective. The auto-injecting technology must work consistently, too, and not jam-up, break, or leak. And the whole thing has to be designed in such a way that a person with no medical experience can administer it correctly. All of this requires a considerable amount of testing and engineering.

The problem is, when people die from drugs or have very adverse side-effects, patients (or their families) tend to sue, both the FDA, doctors, and drug companies. It doesn’t even have to be drugs; for example, the FDA got sued over shellfish poisoning. And here’s a lawsuit over genetically engineered salmon. And then a suit that alleges former FDA chief suppressed danger of ‘deadly’ drug for sake of profit. So here we have two extremes: either the FDA being too cautious (in the case of approving EpiPen alternatives) or being callous. Given that the spectre of litigation is always hovering, this necessitates erring on the side of caution. As a commenter notes:

Therefore the FDA tends to err on the side of not approving things. If you have a population of near-term terminal patients they’re more likely to approve stuff quickly, e.g. for late-stage cancer patients with little hope, because the headline risks to the agency are again low. But for anything where the advantage is just an issue of money or convenience, a new drug with even slightly iffy safety or efficacy relative to the state of the art is going to get slow-rolled into oblivion.

Another thing that’s amazing is how big the pen is. When I first heard about this story, I assumed the pen was something that could fit in a shirt pocket, but it’s actually much bigger:

On a related note, there’s a common misconception that the FDA is blocking experimental potential cures for deadly cancers, but this is not true; rather, the FDA is blocking the production of treatments that are completely ineffective (and in the case of terminal cancer, the bar is pretty low, with a ‘successful’ drug often costing tens of thousands of dollars and only adding a few months of additional life for the patient). Refractory cancer patients are often referred to clinical trials as a last-ditch measure, but very seldom do these trials produce successful treatments.

Mylan spent $1.5 million lobbying in a given year, but that is still nowhere near the top.

Then, as other people have pointed out, the issue is also insurance companies only covering EpiPen and not its cheaper alternative, Adrenaclick.

But also, the article went viral because the headline itself invokes curiosity: ‘What do chairs have to do with drugs?’, so people are enticed to click to find out. This is a technique used by the authors of Freakonomics, for example, in the chapters ‘What Do Schoolteachers and Sumo Wrestlers Have in Common?’ and ‘Why Drug Dealers Live With Their Moms’, where two seemingly opposite or random subjects are linked together in some way. The headline is probably the most important part of an article.