EpiPen Maker Mylan Tied Executive Pay to Aggressive Profit Targets
wsj.com
wsj.com
A company based in Netherlands, managed from Pittsburgh, by a person who lied about their credentials, is now modulating the rate of asthma deaths from anaphylaxis of American children. Yap. As Hunter S. Thomson said, "in a democracy you have to be a player". She is a good player...
Yet anyone dare mention nationalized medicine or price controls and that is met with pejoratives like socialism, anti-Americanism, and anti free market. "But you can't do that! You'll upset the free market Gods".
Somehow we manage to keep spending trillions on things like F-35, we manage to build tanks nobody needs (http://www.military.com/daily-news/2015/01/28/pentagon-tells...), send billions in foreign military aid to countries in the ME (Israel $3B+ and Egypt $1B). Yet anyone dare suggesting price controls for EpiPens -- and oh no, socialism will kill us all.
Uh, the US medical system is full of price controls on pretty much everything that is a "service" and not a product.
> Somehow we manage to keep spending trillions on things like F-35
Yes, these are a horrible and unconscionable waste of resources and blight upon the world. But the American left is just as much in favor of military excess as the American right.
Profits are what caused investors to create these companies in the first place, so without that we wouldn't have EpiPens.
In this particular case, there is an anti-trust argument to be made (after the generic got pulled), but drug development is a side-effect of investors seeking maximum returns. If anyone here thinks there is a better system for drug development, I think we'd all love to hear it.
In my opinion, most cases where you see one company able to charge outsized prices for their products, if you scratch the surface you'll find a government created monopoly, or near monopoly (wireless spectrum is an example of this) or regulation created situation that protects one company from competition.
At the very least you will not find a free market. Because in a free market, people will compete if anyone gives them even a small pricing umbrella. Even for things that require very highly refined manufacturing techniques, like drugs and electronics. Look at the cellphone market, nothing is more precisely built than a smart phone yet we have huge numbers of them in a wide variety at low cost, because the market is mostly unregulated.
However this time since it does not fits the optimal political pattern the outrage is far more silent.
They've been on it since the 23rd and have reported on it nearly every day:
https://www.google.com/webhp?sourceid=chrome-instant&ion=1&e...
And let's not forget that capitalism is people, not faceless, nameless machinery. Five people promised $82m between them had their greed overshadow anything else. This was spurred on by the greed of the board that would do anything to aggressively increase profits - but put the "how" on someone else for plausible deniability.
Greed is the part of capitalism that regulation stands in the way of. Too aggressively rid the system of regulation and greed will consume everything.
True if you mean the thing we call capitalism in the US.
The only reason the price of a $1 piece of plastic can possibly be so high is because of a very noncompetitive situation created by various cronies and abetted by regulators.
Let's call it what it is. It's not capitalism, it's simply a corrupt regulatory system and firms that have learned how to exploit it to their advantage. it's nothing like a market that allows competition, and the regulation is nothing like a fair referee that allows the best player to win.
Under actual capitalism, there would have been price competition and perhaps (gasp) a startup would have started selling epi pens for a reasonable price just as Google started offering massive email storage for a reasonable price, etc.
While I understand the emotional reaction that it is "essential for life" (I have family members who rely upon them), let's blame what is actually at fault, laws that allow firms to do this sort of thing and prevent solutions from emerging.
The first version of Soylent lacked iron because Rhinehart couldn't be bothered to Google basic nutrition requirements.
We've tried the no regulation medical market. The term "snake oil salesman" exists because of it.
Yet it is legal for someone to subsist only on Doritos. Why not regulate those too.
The point is that, iirc, Mylan has a government-granted monopoly on the EpiPen via a patent for the injection mechanism. That means Mylan is the only company that is legally allowed to manufacture it in the United States. In addition, it takes millions of dollars to bring a treatment through the slow FDA approval process (though it's not clear if this is necessary to compete with EpiPen), so even if someone was somehow able to circumvent and/or license any patents Mylan may hold, it'd still take herculean resources to bring a competitor to market.
That's what the grandparent is talking about. The EpiPen can be so expensive because no one else is legally allowed to sell a substantially similar device without Mylan's permission. When the consumer has only one option, especially for something as crucial as a life-saving medication, things are really bad, whether the economic system that consumer is living under calls itself "capitalism" or something else.
We've got to fix our intellectual property laws, both patent and copyright. A large part of the Fortune 500 is only there because of the excessive legal monopolies that we've granted through intellectual property (which means it'll be basically impossible to fix).
No, they don't. The EpiPen's patent is long expired. https://www.google.com/patents/US4031893
>Today that same tiny, lifesaving bolus of epinephrine — used mostly to treat severe allergic reactions — is delivered via sometimes elaborate devices called auto-injectors. Though the medicine itself hasn’t changed, the delivery devices have been protected by patents, enabling drug makers to charge ever escalating — sometimes prohibitive — prices for one of the oldest drugs in medical use.
It doesn't say which patents specifically may cover the EpiPen, but as far as I can tell, the consensus is that the device is patent protected. I would love to know if there's definitive evidence either way -- specifically which patents Mylan claims to be protected under, or whether this is in reality just a common assumption/myth.
[0] http://www.nytimes.com/2016/09/04/opinion/sunday/the-lesson-...
It's not like these decisions are being made purely on a scientific basis.
In reality the FDA is too conservative due to the incentive structure: people getting hurt from a drug approved too fast are very visible. People that get hurt due to a drug being approved too slowly are not. This is the core issue.
There are also companies making generics for Adrenaclick, they cost ~$140.
Yes there are various degrees of purity in capitalism across the world and one of the interestingly consistent things across history is that prosperity follows relative economic freedom, even if there is no purely free economy.
It's stupid to force competitors to invent a completely different method to do the same thing, and then have them try to get it through FDA approval, just because Mylar is unwilling to license the patent to competitors at a reasonable rate.
The fact that a company can just flat-out stop an idea from being implemented by anyone else for 20 years is insanity. There needs to be a mechanism that incentivises patents being licensed, rather than withheld and used as an anti-competitive bludgeons. Something like a means of finding a reasonable value for a patent (hopefully via some market mechanism) that takes into account the cost of invention, and then requiring the patent be licensed for that amount to anyone.
If you look at the situation with Microsoft and Android, it's crystal clear: the patents in question are pathetic, and yet they're being used to extort billions of dollars. It's such a massive distortion, and leads to huge duplication of effort and wasteful incompatibilities, and in this case lives at risk.
But for all its tradeoffs, patent protection does create an incentive for massive investment in R&D. It's difficult to imagine a meaningful counterfactual scenario.
Of course, bad patent office execution (leading to patent trolling, etc.) is parasitic and harms the system as a whole.
But what about the FDA? The FDA is notoriously overly risk-averse when it comes to approving new treatments. It simply should not be hard to get a competing delivery mechanism approved. It's easy to test, the test of whether the mechanism works can be repeated at nearly zero cost thousands of times, offering substantially more data than the typical drug approval process yields (when the question is whether a drug is safe long term).
If you are an FDA regulator, the only way you can really lose your job and pension is by approving a drug that should not have been approved. Nobody is keeping score of the suffering and loss of life caused by sluggish approvals.
And while I completely agree that those R&D billions should be compensated, when the go-to strategy for patents is to do a complete parallel re-invention rather than just pay the inventor, my stance is that the trade offs made by the current system are inefficient and damaging.
Isn't regulatory capture the most efficient and cost-effective way to maximize profits? Companies would have to be stupid not to do it. And not to rely on campaign contribution, lobbying, messing with local, state and national elections.
This is the real capitalism. We are in the middle of it.
> it's nothing like a market that allows competition
That is the market. The market includes the government. There is no such thing as government interfering with the market vs nice companies competing with each other, guided by the Adam Smith's hand. That world doesn't exist. It never will. We might as well be talking about the Star Trek universe here.
- Our system has many biases toward over-centralization, and the idea that we should have one Federal entity completely in charge of drug approvals is pretty absurd. Why not encourage many other groups to make recommendations. Why can't the FDA have its own list, as well as a list made by the AMA, major HMOs etc. Why not also consider the list used in the UK, etc.
When we a) combine effectiveness research with b) a public health mandate and c) risk-averse career burocrats, we end up with our current system. If our government weren't in the business of coordinating regulatory capture games, it would simply relinquish control of absolute authority, and allow respected third party institutions to have a voice.
If your doctor prescribes drug x simply because it's FDA approved, that is very much the wrong decision. The side-effect for Vioxx that led to it being pulled was well known to doctors (and applies to all NSAIDs), and so any doctor who let a patent suffer with Vioxx was at somewhat clueless if not negligent.
So yes, the government is yet another corrupt firm with a monopoly on certain things that it abuses for profit, harming all of us in the process.
> This is the real capitalism
Our economy contains some areas that are heavily corrupt and not very competitive, and others that are under the radar and are highly competitive.
That is a pretty good idea. It makes sense.
One instance where this happens is in Common Criteria Certification (the EAL levels). There is a mutual agreement between countries. And for example RedHat is going to Germany to get the EAL-4 certification for RHEL. Doing it in the US was too time consuming and expensive.
https://www.redhat.com/en/about/blog/red-hat-enterprise-linu...
But if my doctor wants me to take a drug that is whitelisted by only one of the lists and perhaps blacklisted by one, and gray-listed by others, I'd certainly want to dig a bit deeper and fully understand the tradeoffs I was getting into.
Some might say that is too much "work" for me as a patient. I'd certainly welcome the chance to have the chance to think about taking something that wasn't an obvious whitelist choice for all.
I think the desire on the part of many humans to simply put all their trust in one authority figure our institution comes from the same primitive drive that made our ancestors kneel before emperors and makes some wish to kneel before supernatural emperors.
> ...
> Mylan has been repeatedly protected from competition, and it has repeatedly (and predictably) increased the price of EpiPens in response. Allowing all of these companies to compete in producing epinephrine auto-injectors would be the best course for all of the many patients who want a cheaper solution for severe allergic reactions.
> One thing is for sure: capitalism is not to blame. Government regulations have choked this market and many others. What we need is a big dose of freedom.
src : https://mises.org/blog/lack-epipen-competitors-fdas-fault
And the drug isn't patented.
The question becomes, how small an improvement should we look at and decide that it warrants exclusivity?
It's a trickier question for something like the Epipen where there is benefit from widespread understanding of how to properly use it (so a change to the pen that requires different user training becomes a change that removes generics from the market).
I've seen multiple people try to figure out why there is no competition, and some consensus around the fact that while the drug is not patented, the particular delivery device design (or combination of it and the drug) is patented, and due to issues of needing to train people on multiple different delivery devices, there's no room to break into the market with an equivalent that evades the patent concern.
So in comparison to most of what Big Pharma spends money trying to bring to market, an epi pen is (in comparison) extremely easy.
My guess is that even if a patent were successfully filed for a new delivery device, the challenge lies in getting all the sweetheart deals that Mylan was able to get.
People forgoing medically necessary healthcare and medication is where the problem lies with aggressive profit seeking where demand is inelastic.
Now, if the US government would simply allow imports of equivalent medications and devices when this sort of rent seeking occurs (from other first world countries where the price is set through a single payer system), we wouldn't be having this conversation.
http://investors.morningstar.com/ownership/shareholders-majo...
Largest shareholder: Vanguard Health Care (5%) ... which is in turn owned by STAAR Alternative Catagories.
https://www.zacks.com/funds/mutual-fund/quote/SITAX
And STAAR Alternative Cats is managed by one J Andre Weisbrod.
The Vanguard Health Care Fund owns ~$1 billion of Mylan (out of $48.6 billion under management). SITAX manages around $2.7 million.
I don't see why SITAX and the guy that manages it matter to this story at all. The Vanguard fund having a big stake in Mylan certainly means that lots of people have a stake in Mylan though.