Scott Alexander: Reverse Voxsplaining – Drugs vs. Chairs
When Mylan decided to sell EpiPens for $300, in any normal system somebody would have made their own EpiPens and sold them for less. It wouldn’t have been hard. Its active ingredient, epinephrine, is off-patent, was being synthesized as early as 1906, and costs about ten cents per EpiPen-load.
Why don’t they? They keep trying, and the FDA keeps refusing to approve them for human use. For example, in 2009, a group called Teva Pharmaceuticals announced a plan to sell their own EpiPens in the US. The makers of the original EpiPen 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 2010, another group, Sandoz, asked for permission to sell a generic EpiPen. Once again, the original manufacturers sued for patent infringement. According to Wikipedia, “as of July 2016 this litigation was ongoing”.
In 2011, Sanoji asked for permission to sell a generic EpiPen 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.
From: Reverse Voxsplaining: Drugs vs. Chairs | Slate Star Codex
He has some good points about the patent system and maybe the FDA. He just completely ignores that drug prices are regulated in most countries in Europe. So his argument that regulation isn’t the answer doesn’t add up.
It would be interesting to know more about the FDA’s concerns about the pens that didn’t get on the market and whether they were serious or spurious.Report
It would be interesting to know more about the FDA’s concerns about the pens that didn’t get on the market and whether they were serious or spurious.
Can we use the fact that Europe has 8 different brands of epipen on the market as an indicator of anything?Report
If the FDA would approve alternatives, new regulations wouldn’t be needed. Your answer to a regulatory failure (one that is probably the result of capture) is more regulations?Report
I don’t know how good the FDA’s case for blocking the other pens was. It may be good and may not. It would be good to know instead of judging their actions based on generic stances on regulation.
I’d also be fine with reforming the patent system but that isn’t the FDA’s fault.
I didn’t actually say i was for more regulation in this case. Just that Alexander hadn’t made the case he thought he was. Across Europe drug prices are regulated. Also luckily for them they have more pens. So we could guess at some possible lessons.
Their greater number of regs isn’t a problem there but for reasons that are unclear.
Having more regs doesn’t necessarily lead to bad outcomes.
Somehow Europeans avoid the regulatory capture that may be part of this problem ( Following from that Americans are less efficient and easier to capture then Europeans)Report
Or maybe regulation as a whole isn’t always bad but the FDA in particular has an institutional mentality towards blocking new products by aggressively using the precautionary principle in the way that those wild and reckless Europeans don’t?Report
That is certainly possible. It has been noted americans are often easily scared and want super high levels of protection which does lead to problems.Report
Thalidomide.
I suspect that particular drug is still a very present memory in the FDA, and of the bullet they dodged by being cautious. I wouldn’t be surprised if that, and a few other similar cases, are pretty core to their institutional outlook.
There’s certainly enough recalled drugs with nasty side-effects, sometimes that showed up years or decades later, to bolster their conservatism. But nothing beats thalidomide for really knocking that viewpoint home.Report
Thalidomide was for the FDA what the 9/11 attacks were to the DHS.Report
That’s a very unfair comparison. DHS only exists because of 9/11. The FDA already existed for years when Thalidomide went on the market.Report
The FDA existed for years, but not as the absolute authority on what medications and medical devices may and may not be sold in the USA, and how they might be described and prescribed and advertised. It took Thalidomide for that to be justified.Report
Thalidomide was a serious win for the FDA.
There is a long series of them issuing approval for drugs and then having to do recalls because of massive side effects for serious adverse events.Report
I know, and Europe approved it and had to unapprove it.
That’s such a high profile, well known case (and not the only one) — I suspect the FDA might have a very institutional view of Europe as being too dangerously quick, as they were then. (And as a reflexive defense about stuff like Epipens and generics).
I would like to know, in this case, what problems arose with some of the alternatives. I would imagine that, since these drugs and delivery mechanisms are proprietary, that the lack of data is not solely due to government playing behind closed doors.
We might not know why Teva was rejected, because Teva doesn’t want us to — not because the FDA cares.Report
Teva still exists, and presumably they’re going to develop other drugs in the future. If they want those drugs to have any chance of approval, then they damn sure better not publish a final report that goes something like “the FDA provided no reason for refusing to approve other than vague statements about lack of confidence in the quality of our statistics”.
But hey keep on believing that there’s some Nefarious Reason. I know that epistemic closure is very important for you.Report
You clearly didn’t read carefully. Here, let me highlight it:
“We might not know why Teva was rejected, because Teva doesn’t want us to — not because the FDA cares.
Or do you think drug companies don’t have proprietary data? Or do you think it’s impossible Teva might want to keep the problems to themselves until they’ve fixed it? (For PR and sales purposes, if nothing else.)
I think your “epistemic closure” seems a bit projectionist, given that the part you labeled as “nefarious reasons” was a simple statement of fact: Teva might have reasons to not disclose the issues with their application, because “proprietary data” is an actual thing that exists. Or did you think the government is the only group that likes to keep thing secret?Report
You seem to have this idea that when you say “We might not know why Teva was rejected, because Teva doesn’t want us to”, you’re being entirely neutral and just presenting a possible scenario for us to entertain and not implying any particular interpretation whatsoever.Report
You seem to have this idea that pretending that trade secrets and proprietary data exists is being entirely neutral yourself.
I’m not sure why you’re choosing to grind this axe, but I find it hilarious you can accuse someone of “epistemic closure” for pointing out there are a number of other factors here we simply don’t know.
Goodness, that epistemic closure. Always talking about how we need more data.
Thank god we have open-minded fellows like yourself to assume all the details for us!Report
I think we need to go back and look at your original statement, which was:
“We might not know why Teva was rejected, because Teva doesn’t want us to — not because the FDA cares.”
Keep that in mind for further discussion.Report
If the FDA would approve alternatives, new regulations wouldn’t be needed. Your answer to a regulatory failure (one that is probably the result of capture) is more regulations?
More like: “Hey, if you want cutting edge drugs and treatments you gotta make it worthwhile for the developers!” Less regulation on an epinephrine injecting device is a slippery slope to less regulation overall, and the next thing you know people are stealing intellectual property and no one invests in research and development and the whole Big Pharma market comes crashing down.
Gotta prop up that market somehow, ya know?Report
Paging Megan McArdle, please pick the white courtesy phone
(It’s a joke)Report
yeah, me too. I’d REALLY like to know why the FDA rejected them — the FDA is a rather important organization, and if there’s problems I’d like sunlight to disinfect them and some sane Congress to adjust them. If there’s some weird incentive (legal or otherwise) that has the FDA keeping Mylan the sole source? That needs some hard looking at.
Now, I get why Auvi-Q recalled their stuff — when you need an epipen, you NEED an epipen. It’s life or death, and if they weren’t dosing correctly that’s…..well, that’s like recalling a car because the airbags didn’t deploy 15% of the time. People can die.
Now I notice unconfirmed is in the story for that — but they wouldn’t have voluntarily recalled and abandoned the market if they couldn’t confirm it at least internally.
Sadly, what I’m sure will happen is that instead of a targeted investigation to determine what happened and what should be done, you will hear calls for massive deregulation, the abolishment of the FDA, and blaming “government” for the high cost of every medicine ever.Report
“Well, you’ve completed the tests we requested, but the range of errors in your drug efficacy is greater than the range was on the comparator drug, so we’re not willing to approve. Sure, even at the low end the drug still meets all its performance requirements, but we don’t like how your error bars are bigger. Could you maybe re-do all the tests with more subjects to get smaller ranges of error?”
“No, we spent all our money doing the first series of tests that you told us were all we needed to get this drug approved.”
*shrug* *stamps NOT APPROVED on the final report* “Next, please!”Report
Yeah…yeah we could. And it would still be useful to know if the FDA had good or bad concerns.Report
How would we measure that, in the absence of the FDA providing such?
I would say that the bare minimum required to give the FDA the benefit of the doubt here in the face of such evidence as “Europe having 8 different brands” is for the FDA to say why their standards are higher than Europe’s. I mean, assuming that we’ve moved beyond any basic “let’s see what happens” period and there haven’t been a rash of people getting Hep C from a bad batch of epipens.
I can get saying “we have higher standards than Europe” about something that was invented yesterday, of course. Let Europe be the petri dish and let’s wait to see what happens.
Enough time has passed for us to say “okay, doesn’t look so bad”, right?Report
Jaybird, if you think that the government shouldn’t pay close attention to what Americans can safely put into their bodies, or stop industry from cutting corners and doing things cheap and making unsafe drugs in an unsafe manner, then I am sure that Somalia will welcome you with open arms.Report
At this point its conservatives who talk about Somalia more than anybody else except for actual Somalians.Report
In Somalia, at least you can drink as much soda as you want.Report
And own AKs!Report
Let’s take that as a given. Now explain to me why the FDA refused to accept test results/approved drugs from W. Europe as evidence of efficacy and insists that drug companies do trials in this country before approving the drug here.
And explain to me why the FDA refuses to let people take experimental drugs when they are terminal?Report
And explain to me why the FDA refuses to let people take experimental drugs when they are terminal?
If the drug is addictive, we don’t want children to have a bad example.Report
They do. They only declined 0.5% requests for experimental drugs.from 2010-2014.
http://www.raps.org/Regulatory-Focus/News/2015/02/04/21243/From-100-Hours-to-1-FDA-Dramatically-Simplifies-its-Compassionate-Use-Process/Report
Want to respond to the other question too?
And why don’t you show me the data for more than 4 years on experimental drug approval?Report
Different populations, perhaps. I find it hard to bitch about giving folks more data to make decisions on, even if some of it is rather blatant “make money for our researchers here”
It’s fucking hard to get an insurance company to approve a $60,000 treatment, Damon. If you hear stories about how someone won’t let you get your experimental treatment, it’s probably the fucking insurance company. Numbers not pulled out of my ass, either. I can also give you the number for what the drug costs once they have a production line.Report
Kimmi,
I’m not speaking to the cost of experimental. I’m speaking to the FDA not letting anyone take it.Report
@damon To the first, likely because different countries have different regulatory priorities. Also, how big a problem is lack of reciprocity? According to Derek Lowe, who has forgotten more about this issue than either of us ever have known, it’s a relatively minor.
I didn’t show more than 4 years because I don’t know where to find it and I’m not going to do your fishing homework. You claimed that the FDA does not (present tense) allow terminal patients take experimental drugs. I showed that for 99.5% of cases in the last 4 years, that is a false statement. Do you have evidence* that this is not allowed?
* Not counting anecdotes, since that anecdote may fall under the 0.5% that were denied.Report
My anecdotal info predates 2010 and as in news reports I read in the local paper. I don’t recall the drug, but it was something specifically approved in Europe and the FDA refused to clear it here for the reason that they wanted trials done here. The FDA may have since loosened their restrictions.Report
I don’t believe the law has changed since 2010. However, I believe the FDA does not allow a drug that has not even gone through Phase I trials to be taken experimentally. That is to limit snake oil.Report
Please note: anything that hasn’t gone through Phase 1 trials is pretty much “this may instantly kill you. We don’t know.”
I know people who have received toxins and poisons as part of medical treatment. These are all approved medical drugs.
Humira can basically (and does) kill a good percentage of the people who take it, nearly instantly. It’s blackboxed, but still okay to give to people.Report
“Other countries regulate drug prices and we don’t.”
“Yeah, but other countries have eight options to our one.”
“We shouldn’t be so quick to assume that we don’t have valid reasons for being different.”Report
Other countries have a combo of more and less regulations which works better in some ways. I can’t argue with that, but it doesn’t really say all that much.
This seems to be the kind of issue where we need more specific info on why the FDA did what it did to really judge whether they f’d up or not.Report
Except that if you look at how the FDA and the EU respectively are handling ecigarettes, you find that it’s not specific. I have objections to both and neither are exactly what I would like to see, but they indicate larger issues. I can elaborate, but basically the FDA wants fewer products while the EU wants products within tightly specified parameters.
So I suspect that the EU looks at an imitator epipen and says “This does basically the same thing” while the FDA looks at another specific model as another heartburn-inducing thing that they’re going to be responsible for. And so they throw up a lot of barriers and keep things ambiguous and discretionary.Report
That is possible. I, and none of us really, has enough info about the specifics of this case to know.
The euro area seems to be much more skeptical of GMO’s though which is unfortunate.Report
I wonder what the threshold is for having enough information to criticize the FDA.Report
Well people love their generalized criticisms so have fun with that. As i’ve said repeatedly, i’d like to know more about the issues Alexander glossed over. Maybe the epi pens that were rejected had serious issues. Beats me. It would be good to know if the FDA had good reasons for what they have done in this case. I don’t know and neither do you.
I’m more than happy to criticize the FDA if its warranted. I’m not a fan of what is happening with e-cigs ftiw.Report
“It’s utterly impossible that this is as dumb as it looks. There must be a secret reason why they’re acting this way“.Report
A couple years ago, I would have thought this. Which I guess gets to the root of where I disagree with others here. I simply give the FDA little to no benefit of the doubt.Report
Whatever conforms to your preexisting beliefs must be right.Report
You write this like it’s a rebuttal to what I wrote.Report
Oh look it’s Daraprim all over again.
But suddenly somehow “the FDA won’t approve generic manufacturers” is an argument we’ll listen to this time.Report
I am with Greg and Morat.
The FDA might be uniquely bad here but the fact is that other countries besides allowing more, also regulate/negotiate drug charges. I suspect that the right-wing is still opposed to this issue of allowing HHS to negotiate drug charges.
This seems to be one of those ideological battles where everyone insists on their solution without compromise. It seems to me that this is an area where bipartisanship can do something that makes everyone happy. We can reform FDA procedures to allow for more drugs on the market AND allow the government to negotiate for prices but it seems to me that the right just wants to stick with ideological anti-government purity.Report
Like I said, I’m happy to look into the FDA and figure out what’s wrong and how to fix it.
I’d like more data to go on to decide what to do than a snarky article that admits it lacks critical facts, but then again I’d prefer a fix not to use this to grind a partisan axe.
The FDA, even performing properly in a utopian world, is stuck balancing two contradictory concepts: To approve drugs and procedures for the sick as soon as possible, while also preventing drugs with subtle and nasty side-effects from getting to sick people — or at least making sure those side effects are known so informed choices can be made.
Too fast is just as bad as too slow, so even a perfectly functioning FDA is going to be constantly threading a moving needle.Report
Do other countries that handle the tradeoffs differently have unacceptably worse results?
Granted that the FDA is one of my least favorite government agencies right now, but when I look at this and other related matters, it very much cones across to me that their institutional interests diverge from the public’s, and they are given a benefit of the doubt as though that isn’t the case.Report
Well, I can think of a number of high profile recalls in the last decade or two.
Who knows? As I mentioned upthread, perhaps the most well-known drug case involved serious birth defects in Europe — but not the US.
With something like Epipens, I dunno. They’re really not used all that often, but when they have to be used they MUST work. (I say this as someone who has had to pay out the nose for those things, so I’m not exactly a big fan of Mylan right now. I remember when it was 80 bucks for a pair).
And given the proprietary nature of drugs and delivery mechanisms, I’m not even sure how much secrecy is the FDA itself and how much is companies wanting to keep it under wraps for competitive advantage. And that’s before getting into the fun games such companies have been known to play, like cherry picking research or burying it when need be.
To point to something closer to your own pet peeve — tobacco companies buried a LOT of nasty data for decades, hiding it from relevant regulatory bodies. I somehow doubt pharmaceutical companies are any less profit oriented, and IIRC, some of those recalls led to lawsuits that found exactly that — suspected side effects and dangers were downplayed, ignored, or flat out hidden.Report
“I’m not even sure how much secrecy is the FDA itself and how much is companies wanting to keep it under wraps for competitive advantage. ”
Competitive advantage is irrelevant for a drug (and a delivery method) that are both off-patent.
If there were some deficiency in Teva’s product that caused actual harm to users then the FDA would certainly not be keeping it secret!Report
I don’t even know what to say to that except “HA!”. And competitive advantage isn’t the ONLY reason to label information proprietary, not even close!
For instance, if Teva’s initial device had a flaw that wasn’t caught until the end-stage, they’d want to keep that quiet for simple PR reasons. (There’s no selling point like “Our last version was busted and we didn’t even notice! We’re pretty sure this one is good though!”) There’s also the fact that the internal mechanisms, designed usage, and the like can be used by competitors to predict production costs — which is NOT data you want competitors with entrenched market share to have when you roll-out.
That’s just two reasons off the top of my head.
Have you ever worked with proprietary business data? You’re not acting like it. I’ve got that crap across my desk all the time, and you’d be surprised what’s considered proprietary — but I’ll tell you this: Every single bit of design is proprietary, even if you’re making a knock-off, and everything that can be used to calculate manufacturing costs or predict price-points for sale is proprietary.
You DO realize that the FDA rejected Teva’s device. Therefore it was never on the market, therefore it literally could not have caused actual harm, right?
So why would the FDA disclose it?
At this point I’m not sure what you’re arguing, other than you think me pointing out that BOTH parties involved could have reason not to reveal details (and the FDA actually is, as noted elsewhere, legally required to keep a lot of stuff undisclosed in order to protect the proprietary data of companies submitting drugs or devices) as some weird sort of ideological blindness.
I find it hilarious that saying “Hey, it’s more complex and there’s a lot of missing information” is somehow a sign of close-mindedness in your world.Report
“Therefore it was never on the market, therefore it literally could not have caused actual harm, right?”
Adverse events are identified in the clinical trial phase. I’m surprised I have to explain that to you, given how much you’re telling us you know about this stuff.
“if Teva’s initial device had a flaw that wasn’t caught until the end-stage”
uhhhh if the device had a flaw that made it not work then Teva wouldn’t have got all the way to Phase III trials before uncovering it.
“I find it hilarious that saying “Hey, it’s more complex and there’s a lot of missing information” is somehow a sign of close-mindedness in your world.”
It’s interesting that you’re totally ignoring the possible scenario regarding statistical confidence that I posted, in favor of some 9-11 Troofer-style “well I’m just asking questions” riff.Report
Auvi-Q’s actually made it through Phase III trials and past the FDA, only to be recalled (voluntarily, and not via FDA fiat) for not reliably delivering the correct dosages. A counter example that is stated outright in the original post, but one you just asserted could never happen.
For someone so certain of the truth, you seem to be quite busy making factual mistakes.
If you’d like another:
Let me point you to the FDA’s own compliance guide:
I also helpfully bolded the mention of confidentiality.
You know, the bit you just called “Trooferism” because I dared to suggest Teva might not want certain details published, as they’d be proprietary data.
If you’d bothered typing in “FDA” and “confidentiality” or “proprietary data” you wouldn’t have gone down that path. Or if you’d stopped to think for a second, you’d have realized that any FDA trial — whether for a new drug or a generic — requires a company to submit a lot of information that would be very, very valuable for competitors — and that the FDA would clearly have rules in place to prevent (successfully or not) leakage of such data. (Indeed, you can find their regulations and policies on line).Report
At this point I’m not sure what you’re trying to say here, because you float raised-eyebrows comments about how Teva isn’t saying anything because of Mysterious Proprietary Data, I point out that this reeks of conspiracy theory, and you get Very Upset and produce an inaccurately-highlighted post about how the FDA doesn’t release proprietary data and so it isn’t Teva’s decision after all?
And you still ignore my post regarding statistics, I guess because it doesn’t fit your preferred narrative about companies working to protect that sweet, sweet proprietary data about their thing that doesn’t work.
“Auvi-Q’s actually made it through Phase III trials and past the FDA, only to be recalled…”
Haw. Recalled with no evidence of actual malfunction, no ability to reproduce the described failure mode, and the actual devices that supposedly failed were not returned and therefore couldn’t be investigated. (Oh, and the number of failures was actually one-third that of Mylan’s EpiPen.)
I guess you’re correct that no actual recall order was issued, but I’m surprised that someone who knows everything about clinical trials and drug regulation thinks that a post-Vioxx FDA wasn’t going to issue one if Sanofi had not.Report
The FDA like the FAA or even USCIS suffers from the dual contradictory mandate problem in ways that many other government agencies do not.Report
The Fed just ignores their employment mandate, by and large. 🙂Report
Isn’t it stealing a base to call patent protection a “regulation”? Is Scott calling for an end to patent protection? I’m pretty sure if you went to a drug company and offered either price controls or no patent protection they’d take price controls in a New York minute.Report
Patents aren’t the source of blockage, for the most part. It could be some of the ancillary issues are caused by what patents won’t let them do, but Europeans also have patent protection. So it’s not really a question of whether we do or don’t have patents.Report
I need a lawyer over here!
Here’s a line from the post:
The makers of the original EpiPen sued them, saying that they had patented the idea epinephrine-injecting devices.
It seems to me that you can patent a particular mechanism for injecting epinephrine… but can you patent the idea of injecting epinephrine using a device?
I can see the argument that I should be able to patent a particular thing.
I can’t see the argument that I should be able to patent the idea of a thing that does a particular thing.
Please, explain to me what I’m not getting.Report
IANAL, but I have a handful of patents. They can patent the implementation, but not the idea. So let’s say you and I are both inventing things that fling. I design and patent a counterweight trebuche. If you then invent a spring loaded catapult, I will be unable to successfully sue you for inventing a thing that flings.
The big complaint about software patents is most of them are ideas rather than implementations. So it’s something like, “It slices, dices and makes Julienne fries with computers on a network,” and no regard to how you implement said slicing, dicing and Julienne frying.Report
This is what I thought. Thanks.Report
I have a patent that I don’t even put on a resume for fear somebody will look it up and read it.Report
@jaybird
I’m not a lawyer, but I play one in my successful TV series (and then I wake up)
In the USA there’s been a long tradition of patent granting in the grey zone between an abstract idea and a bona fide patentable subject matter. Lately (very lately) the Supreme Court has been ruling that you need more than a good idea and some gnomes underpants, but there are plenty of cases in which a patent has been granted on a new idea, or a new device, without tying it to any specifics.
The 2014 Alice Corp case (https://en.m.wikipedia.org/wiki/Alice_Corp._v._CLS_Bank_International ) is the classical example. Alice Corps basically patented “we will use software to implement a simultaneous transaction between two counterparties” but did not describe the software. When other people implemented software to electronically implement simultaneous transactions it was claimed that was a violation of Alice Corps’ patent.
Even though the SC ruled against Alice, you cannot patent abstract ideas, you must patent the human way to implement them, this just gives a general rule for judicial interpretation. You still have to litigate every single patent, possibly all the way to the SC. The likely problem is not that Mylan had a patent about “injecting epinephrine” (though they might), but they likely have a patent that says “foolproof injection device using compressed air (or whatever they use) so every dumb person can inject if in seconds without training”. Depending on the details or lack thereof of their patent(s) it might be difficult to circumventReport
By the way, though the case is about software,the Alice Corps ruling is general, and covers all subject matters.Report
@j_a The thing about Alice is that while it applies to all patents, it’s much harder to handwave away how something mechanical works. You have to show general diagrams and the like. So while they can patent using compressed air, that patent won’t cover a spring loaded version. On the other hand, with software, you don’t have to show code and there are multiple ways to crack a nut. Because of the reduced requirements, it’s easier to cast a much broader net with a software patent.Report
A good patent lawyer will ask you the question, “Is there an alternative to using compressed air?” and write the application so that compressed air and springs and any other method of storing energy that can be triggered to drive the syringe are covered. Often in a fancy form of “Compressed air is the preferred method, but other methods such as <long list of things including springs and rubber bands and whatever> are obvious to practitioners skilled in the art.” The PO might not give you something that broad, but the lawyer’s job is to go for as broad as possible.
The patent office gave me a ridiculously broad patent on a “method and system for testing real-time delivery of packets of data”.Report
Is this one of those things where one guy can use CO2, another can use N2O, another can use some weird hydro-fluorocarbon gas and each of them has a distinct method of application or is it one of those cases where, if it ain’t a liquid, and it ain’t a solid, and it ain’t a plasma, then it’s a gas and we’ve got a patent for that?Report
You’re way down in the weeds here, and it’s a “that depends” sort of situation. Suppose the first patent used compressed air, and included a variety of materials and complicated things to keep the oxygen in the air from leaking into the drug and causing problems (nasty stuff, oxygen). A subsequent design that used compressed argon and eliminated a bunch of parts because no one cares if a bit of argon leaks into the drug might be valid. Might not, depending on how the patent clerk (and subsequently, the courts) felt that day. If valid, then a manufacturer that wanted to use argon would have to license two patents, one for the general device and one for the argon simplification.
If you want to make the example more complicated, assume that the argon patent said “noble gases”, but that the materials used in the implementation were permeable to helium (helium’s tough stuff to keep penned up for long). Now someone comes along with a patent application using suitable materials and asserts “The noble gas patent as disclosed won’t work with helium, so it can’t cover that specific noble gas. My improvement does work with helium, so I should get a patent on the use of helium in this application.” If granted, a manufacturer that wants to use helium would need to license three patents to be safe.
Back in the day, when electronics were first being put in consumer devices, the big industrial labs (Sarnoff Labs at RCA, Bell Labs at AT&T, etc) all held a bunch of conflicting, overlapping, and critical patents. They did open-ended cross-licensing agreements with each other in order to stay out of court, and to keep new players from getting into their businesses.Report
Thank you for this detailed answer.
This is a mess.Report
You still have to litigate every single patent, possibly all the way to the SC.
This strikes me as being a grave injustice.Report
More fun: The Epipen injectable device is clearly derived from the Mark I NAAK, developed for the US Army.
Now while it’s not universal, one would think that if the US Army paid a company to develop something, the US Army would own the patents. Because the US Army paid for the time, research, and testing.
Which means the patent trolls are trolling on a patent that was developed solely with public funds, and frankly just be in the public domain. And for all I know is, because patent trolls are that blatant.Report
I would like to think that USG would tell the patent trolls to “pound sand”.
Why in the hell wouldn’t they?Report
What are you, a communist?Report
Since passage of the Bayh–Dole Act in 1980, the federal government policy is that the company doing the work has first opportunity to pursue patenting the invention (subject to some conditions which are relatively minor). The Act was intended to (a) provide a consistent policy (prior, some agencies kept the patent, some didn’t), and (b) solve the problem of government agencies sitting on patents without licensing them.
Even if your preferred policy is to have such inventions be freely available to all, there are a number of reasons for having the government obtain patents and “freely license” than to attempt to place the invention in the public domain. Pretty much the same arguments that apply to the GNU general license (“copyleft”), which is actually a set of licensing terms enforceable under copyright law.Report
I knew something had changed, but not when. My experience with government research was via NASA, which patented quite a few things over the course of it’s history, and generally opened them up to the public at one point or another. SpaceX would not be a going concern otherwise, since someone else would own all those patents that are kind of critical to making a rocket go.
I understand that, by and large, they’d prefer to license them but the government accounting is such that any proceeds from licensing patents or copyrights would go to the General Fund and not the NASA budget.
On the whole, I think I prefer making them available to the public rather than licensing them, and if they are licensed to go into the general fund — I think you’d get some perverse incentives otherwise.Report
On the whole, I think I prefer making them available to the public rather than licensing them…
The main reason I’d like them to go through the Patent Office, and then be freely licensed, is to avoid the situation where NASA says, “Here, this rocket engine design is now in the public domain” and someone comes along and says “That high-speed pump bearing design infringes on our patent.” Independent invention doesn’t count. If only there were some entity that could go through NASA’s claimed inventions, and determine which parts were actually available and which weren’t, so people knew what they were getting… oh, yeah.Report
Patent protections are a regulation, and broadly speaking a good one—I’d rather have our current patent regime than no patents. However, the specific way they’re executed is less than ideal. You’re not supposed to be able to patent something obvious, like a device for injecting a specific drug. The first guy who invented a device to inject a drug probably deserved a patent, but after that, using a different drug that needs to be injected is obvious and shouldn’t be patentable.
That said, patents are far from the only issue here, the other being the high regulatory bar imposed by the FDA. Note that the patent for epinephrine itself has already expired. The worst thing about these issues with generic monopolists is that a lot of people are conflating this issue with high prices for on-patent drugs—which are needed to get people to invest in developing them—and using the outrage over this to justify regulating prices on those. I’d happily accept price controls on generics if it kept the “Regulate the profits out of drug development” yahoos at bay.Report
“You’re not supposed to be able to patent something obvious, like a device for injecting a specific drug.”
But what if the device injects an exact amount of drug in a very specific way to a precisely-controlled depth under the skin? And it’s gone through extensive clinical trials to ensure that this actually does happen the way it’s supposed to, even when used by non-professionals outside a clinical setting (that is, you or me in the bathroom)?
There’s a lot more going on than “injecting is obvious”.Report
Having worked on the regulatory end of clinical research before engaging it from the medical side, I must say that the bigger the pharmaceutical company, the more fastidious they were about paperwork – both in terms of volume and insisting that it be completed “correctly”, which for all intents and purposes means: in the way most likely to prevent any competitors from taking a piece of our market.Report
Alexander has written one of those “Everything would be solved if we only did X” type of arguments that are like catnip for the ideologically minded.
In this case, his summary is that there is too much regulation, too much government power, and if only we had less of those, this wouldn’t have happened. Epipens would be like cheap Ikea chairs, and no one would be without.
But of course, he also angrily points out that Congress failed to enact regulation to prevent pharma companies from bribing other companies not to bring product to market.
And he notes that overcoming the patent lawsuit hurdle posed by Mylan is one of the biggest hurdles, aside from the FDA;
And what I didn’t see in his article but read elsewhere, was that Mylan lobbied to have the government use its power to prod or force schools to use Epipens.
Which gets to the nut of the “If only we did X” argument.
Who is this “we” and how do “we” do X?
His argument is one giant “Lets assume a can opener”;
Lets assume we live in a world where corporations are free to use bribery to manipulate the market, but powerless to influence government action;
Lets assume we live in a world where government has power to strongly protect property and patent, but only uses that power for good, never evil.Report
That is the complete opposite if what he did. He wrote a piece criticizing the Voxarticle for suggesting that everything would be solved if we just had more government.Report
The simple argument would be that if we regulated drug prices then epi pens wouldn’t be expensive. In most/all of Europe drug prices are regulated so more good regs would lead to cheaper epi pens. While you may disagree with that, the logic of the vox article is …well…logical.
He also pointed at Europe as a place with less regs and therefore its better because of many cheaper epi pens.
To sum up, Europe is a place with both more and less regs and has cheaper epi pens. There are things we can learn from that but not exactly what Alexander was suggesting.Report
Follow Scott’s logic; what would be his suggested remedy?
What is the opposite of “more regulation?” and how could it have been applied here?Report
Not only the Vox article say that, but it didn’t even consider the possibility that this was an outcome of FDA regulation. Maybe someone who dived into each decision could’ve said they were all reasonable and worth the trade-off, but it’s pretty telling that the topic wasn’t even broached.
Edit — oops, was supposed to be a reply to J R.Report
Chip, did you actually read Alexander’s article? It’s not rocket science — if multiple companies were selling the same product, then a single producer couldn’t just fix a price wherever they wanted, because a competitor would undercut them.Report
If the multiple companies weren’t bribed to sit on their product, you mean.
If Mylan weren’t able to bribe Congress to force schools to purchase their product, you mean.
If Mylan weren’t able to extort smaller companies into submission with patent lawsuits, you mean.
Yeah, if we had all those can openers, Epipens would be cheap as toasters and sold at Walmart.Report
You seem determined to make an opposing view ridiculously extreme. Are you saying that the FDA’s rulings had no impact on Mylan’s pricing power?Report
These are things Scott talked about as a big part of the problem in the post you’re criticizing.Report
But libertarians are agreeing with him!Report
I just got like 200 bucks from a price-fixing settlement that says you’re wrong.
Turns out — fun story here — companies will HAPPILY collude and set prices. Sometimes to drive someone else out of business, sometimes because it pads their own pockets.
Go figure.Report
There is the problem. You’re not reacting to Alexander’s post. You’re reacting to what you think he might be saying/implying.
The post isn’t suggesting anything. It’s taking Vox to task for taking a complex issue with multiple lines of causality and trying to simplify it down to a rote ideological position. And it is attempting to offer a better and more complete account of what is going on with prescription drug prices.Report
OK OK, maybe I am overreacting to Scott’s article.
Maybe its because I read not only his article, but followed his links to:
The Mises Institute,
The Washington Examiner:
Laissez Faire Books:
Seriously, c’mon now.Report
You aren’t saying they’re wrong, sir. But you’re writing as though you think you are.Report
Upthread, Trumwill notes that certain types of regulation are good and some types are bad. And surely the epipen/Mylan situation brings the claim into high relief. Eg, “section 121.3-4a requires epinephrine delivery devices to be sterile”, vs “No, no competition for Mylan on this one”.
he also angrily points out that Congress failed to enact regulation to prevent pharma companies from bribing other companies not to bring product to market.
Preventing monopolies, even those resulting from buying up the competition, is a good idea. Opening up the market is a good idea since. Common sensical – or at least less-than-insane – regulation is a good idea. Don’t you think?Report
Dont’ know if anyone else pointed this out but…
Mylan’s CEO’s father is Joe Manchin, i.e. the senior US Senator from West Virginia.
He’s on the Committee on Commerce, Science, and Transportation. One of that Committee’s subs is Consumer Protection & Product Safety. Among other things they get to haul in the FDA for questioning.
This would be the same FDA which has systematically prevented any of her competitors from introducing a competing drug.
And yes, this is not “proof”.Report
but um um like Europe has regulations and Epipens are cheap, therefore regulations are not the problem because shut up you’re wrong.Report
It would be stronger evidence of corruption if the FDA weren’t already known for being like this in general.Report
The problem with the “proof” is none of us know how good the FDA’s reasons for not allowing the other epi pens were. They could be good ( really unsafe, ineffective, etc) or bad( reg capture, excessive risk aversion). We. Don’t. Know. Most of the rest of the threads have been ideological posturing.Report
Very true! So why was your initial reaction toward price controls?
In this case, a better regulation would be for the FDA to make public the rationale for not approving alternatives.
If you must have price controls, then simply have a regulation that a drug or device can not have it’s price rise above the rate of inflation, absent an external (& uncontrollable*) change in the supply of a production material or facility*.
Of course, I can see all sorts of first & second order effects from this, many of them not good, but that is the risk of price controls.
*You can’t collude to limit the supply of a necessary chemical or material, nor can you shutdown a production line that makes a significant amount of the product just to limit the supply.Report
Hmm I didn’t say i was for price controls. They have PC’s in europe which is one explanation why epi pens, and other drugs, are be cheaper there. Also that Alexander was pointing at how they are doing things better in Europe AND complaining about bad regulations. Well they have more regs in Europe so regulation in general doesn’t sound like the problem. Maybe its what the FDA has done specifically here but there is also the patent issue so it wasn’t’ exactly what Alexander was thinking.Report
As has been said by many hereabouts (myself included), the issue isn’t necessarily too many regulations, but bad regulations.
Hrmm, upon review, now that I am back at a PC (and navigating is easy again), you are correct. I withdraw that claim.Report
@oscar-gordon
As much as my heart cries for the FDA to reveal why they rejected the Epi-pens alternatives, my head tells me that Regulators of any sort making public proprietary information of the companies that they oversee is a terrible idea.
Let’s assume that Pens by Gordon’s application is rejected because the pens get contaminated with bacteria if left in a damp place. How long until all of Pens by Gordon’s competitors in all kinds of products start advertising that the FDA says that ALL of Gordon’s products carry a heavy risk of infection?
The “trust” that companies have that their Regulators will keep their information confidential (very limited most of the time) is a key element of any regulatory system. Without it, companies would hide from the regulator as much as they couldReport
Funny, I just got accused of “epistemic closure” by stating that very thing.Report
Fair point. Still, the FDA has some explaining to do, because they’ve again allowed a single company to become the sole supplier of a pretty significant product, and that company has chosen to leverage that advantage in a pretty nasty way.Report
“a better regulation would be for the FDA to make public the rationale for not approving alternatives.”
They already do that. See the bit in the article about “the FDA identified ‘certain major deficiencies'”? That’s all the reason you should need, right?Report
So, like, let’s say that one of the eight companies that sells epipens in Europe tries to sell their product in the US.
Let’s say (not unreasonably) that the FDA fails to okay their particular epipen for “certain major deficiencies”.
Ought Europeans who use this particular epipen say something to the effect of “holy crap, we need to buy one of the other seven brands!”?Report
In the absence of knowing what their reasons are, why should we err on the side of assuming that the reasons are really good rather than err on the side of assuming that there’s some regulatory capture going on?
Do we have reason to believe that Europe’s FDA-equivalent is slipshod? This is a serious question, by the way.Report
Europe’s FDA equivalent? I don’t know enough to say. I doubt any of us do. I’ve heard a bit about how they do things differently but the legal regime is very different there. I don’t think they are across the board more lax on regs because the EU has a metric butt ton of regs but they are also down on GMO’s.
It could get pretty technical pretty darn quick regarding drug trials if they are done differently over there. There may be actual reasons why the trials they do aren’t applicable over here…Again i don’t really know.Report
Here’s a wiki page.
Out of curiosity, is your skepticism surmountable?
I mean, is there any amount of evidence that would get you to change your mind or is this going to be a Young Earth Creationism kind of thing?Report
Huh? I’ve said a few times the FDA could have been wrong and a problem. Or they could have done a good job. I don’t know and neither does anybody here from what i’ve seen. Or some of what they did could have been good and some bad. Beats me. I haven’t made up my mind at all on the great epi pen debacle.
I could only skim the wiki page quickly because of blasted work but it looks interesting and i’ll read it better later. Could be allow drugs quicker than the FDA does, most likely. Do i trust pharma companies completely, no, very much no. Does europe do a better job? Very possibly , but i also think they do a better job with their universal health care systems and i know where those arguments have gotten me.Report
See, I’d be willing to believe that, out of the eight epi-pens available in Europe, only four would cut the mustard in the US due to how much more freaking awesome the United States is than Europe.
I think it strains credibility to say that only one would.
Like, above and beyond any “I don’t know and you don’t either” skepticism.
Add to that the relationships between the regulators and the regulated and we’ve got ourselves enough evidence for skepticism that regulatory capture is not happening rather than merely maintaining enough evidence that the FDA cares more about Americans than the European Medicines Agency cares about Europeans.Report
So you’re taking my ” i really don’t know enough about the specific details of this” as somehow denying that the FDA might have F’d up. How many times have i said the FDA might have F’d up. Okay one more time. The FDA might have F’d up.
I think you are seeing a fixed position where there isn’t one.Report
Alexander’s thesis isn’t that it’s all about regulation. He is arguing that it’s about a lack of competition. Too much regulation, bad regulation, and a paragraph devoted to the lack of a regulation.Report
If there is a lack of competition its due to regs though so if he is correct then regs are the problem. If regs are the problem it is bad regs. Yeah has anybody denied that.Report
Vox, which he is responding to, didn’t seem fit to mention anything but price regulations. And a lot of the arguments here hinge on the notion that they’re responding to an article that focused unidimensionally on “too many regs.”
Instead of the larger case he made that regulations, in its various forms, is a big part of the problem. Regulations that are too harsh, regulations that are misapplied, and a key regulation that isn’t there but should be.
Maybe not. But most of the people here seem to be arguing against a unidimensional “too many regulations” argument, which is not the one that Alexander made. He does suggest that regulatory hold-up is a part of the problem. He also suggests that some regulation is misapplied. And he argues that something congress should regulate isn’t being regulated.
Granted, some of this is because of the portion that I chose to excerpt, but I can’t excerpt the whole thing.Report
Maybe the problem started with reading Vox. I do a little of voxing but they are not the best source of much of anything.Report
I wrote that this article was catnip for the ideological minded, because it frames the situation entirely in structural and systemic causes and effects.
Mylan was not a bad actor abusing a reasonable system and needs to be punished;
The FDA is not led poorly by incompetent people and needs better leadership;
Congress is not a bunch of feckless fools susceptible to lobbyist money and we need to elect better people;
No, Mylan, the FDA, and Congress were simply passive actors playing out the roles given to them by the system.
What is needed, Scott suggests, is a different structured system whereby the drug monopoly doesn’t exist, where competitive products are easier to produce, then the system will solve the problem.Report
There will always be greedy, incompetent, and feckless fools in positions of power, so what is wrong with trying to imagine a system that gives acceptable outcomes despite that?Report
If the right people were in power, we wouldn’t *HAVE* to.Report
Because there will always be greedy incompetent and feckless fools who act to block that system.
This yearning for a system that can produce good outcomes without needing good actors is the essence of Marxist thought; that individuals merely follow the prescribed pathways through the system like rats in a maze, and if you want the rats to arrive at a different destination, you need to reconfigure the pathways.
These feckless Congressmen- will any of them lose an election because of this?
Or will voters, the very same voters who are so outraged about Epipen prices, vote for them again and again?
Will the heads of the FDA be called to account for their sluggish and cronyish behavior? Or will they be given raises and promotions?
Will the stockholders of Mylan fire the guilty parties, or reward them?
If you want to see the “system”, here it is.
Focusing on the regulatory apparatus allows everyone involved to escape accountability for their voluntary willful conduct. None of the actors were forced to make the choices and decisions they made, and we as citizens and stockholders are forced to make the decisions we do.
This is where I believe the Facebook shaming is actually a good thing; everyone involved in this should be publicly identified, named, and shamed.Report
Sure. But billionaires can just cry into the piles of money that they presumably sleep in as they console themselves with paid help who smile and nod and tell them that everything will be okay for $400/hour.
If you want to change the system, you need an FDA that will loosen up until it’s as loosey-goosey as the one found in, say, Germany.Report
So damned if we do, and damned if we don’t.Report
Its only a conundrum if we accept the premise.Report
Which premise?Report
The premise that an unvirtuous citizenry will exist and cannot improve.
We could demand more honest Congressmen, we could demand corporations act virtuously, and demand that the FDA be more efficient in its mission.
These are the willful choices I spoke about above, decisions that each and everyone of us makes that shapes the environment in which Epipens are made and sold.Report
Ah, OK, I understand. Absolutely agree, 100%!
Now there are 2 of us, only 100 million more to convince…
ETA: When I look at this:
And I think about why we don’t, I envision an academic, somewhere, saying it isn’t realistic or fair to demand such things, and we just have to accept flaws because humans, and jobs, and…
Then I think back to my time in the service, where perfection wasn’t expected, but damn if there wasn’t an expectation of being better than your most basic impulses, and those who couldn’t, would suffer for it.Report
I think your stealing a base or two here. Your saying ‘demand’ which I am not completely sure how that is provoked. You can voice at the top of your lungs that you want a social construct to change but it doesn’t have to.
It takes believable threat of or actual divestment from a sizable portion of those involved, to create change in a social construct.
Even divestment is not an effective strategy, if in the end your just going to build another social construct that will get captured in the same way.
The flaw in Marxist thought is to replace the management in social constructs. If any measure of the repeated corruption of the vanguards is any indication, it is a flawed premise.
It’s the possibility of divestment that should keep social constructs in good behavior. Knowing if they don’t provide the socialistic service/product that they should, they face divestment and collapse.
The problem with the divestment model is few have any sense of the possibility of producing robust individual constructs enough to handle social construct divestment for extended periods of time.Report
The flaw in Marxist thought is to replace the management in social constructs.
Heh. “The” flaw.Report
Ha, you got me.Report
“Focusing on the regulatory apparatus allows everyone involved to escape accountability for their voluntary willful conduct.”
Considering that the FDA is under the Executive Branch, the only way that I as a citizen can exert any authority over that organization is by voting for President. Which only happens once every four years, and “regulatory issues with the generic equivalent of Epipens” is not exactly a priority item in that decision.Report
Looking closer, it seems like you’re right—the article was badly worded. Here’s the patent, and here’s the complaint (PDF). The patent in question is actually for a specific autoinjector, and doesn’t mention epinephrine at all. So apparently it doesn’t necessarily cover any device for injecting epinephrine. That seems more reasonable, and I should be even more skeptical of secondary sources.
The patent was granted in 2008, and automatic epinephrine injectors have been in use for much longer than that. So why can’t anybody manufacture the old, off-patent versions?Report
“why can’t anybody manufacture the old, off-patent versions?”
Explained in the article. If it’s a drug (or a device intended to have a medical effect) then not only the drug (or device design) but the actual manufacturer has to be approved by the FDA, because Thalidomide, and the FDA has thus far refused to approve any manufacturers other than Mylan despite several efforts.Report
That’s..incorrect. They approved Auvi-Q, which recalled it’s own injector. I know, because that’s the one I had about three or four years ago. (It’s also listed in the article).
I don’t know WHY Auvi-Q recalled it, except that it was supposedly about not delivering enough of the drug, and Auvi-Q yanked them ALL voluntarily.
Not via FDA order. And then they abandoned the market, which is pretty strange, but has jack-all to do with the FDA.Report
So let’s say we come down like a hammer on this CEO and this company.
Above and beyond the whole “let’s have a rally and chant ‘hey hey ho ho epi pens have got to go!’ and then post it to youtube!” solution, we should have people whose job it is to boo whatshername whenever she leaves the house for the rest of her life, we could actually pass a law saying “Sorry, the price of the pen is capped at $82” and that’s it. It immediately reduces the price of the pen and we’re good.
Except, next year or maybe the year after, we will find ourselves, once again, in a situation where the FDA has, somehow, denied all but one company the ability to distribute Correctital and we’re going to be asking ourselves why we’re paying 800% more for Correctital than Germany is (where 6 companies distribute Correctital).
The FDA is too strict and goes too far. Swing the pendulum back a bit.
Europeans are, to my knowledge, medically identical to Americans. They might be skinnier, I dunno.
We should be able to pool our medical knowledge somewhat.Report
Like I said; we had this conversation about Daraprim, and we’d had it before about colchicine, and we’ll have it again in the future when it turns out that–somehow, unexpectedly–the FDA has created a monopoly on some drug or other.Report
Whack-a-mole yesterday.
Whack-a-mole today.
Whack-a-mole forever.Report
A close family member of mine has a condition that requires relatively frequent monitoring. The EU has a device that lets you do it from home. The FDA hasn’t approved it. I asked a friend in Finland to buy it with money I wired to her, and she shipped it here and it’s been very helpful and to my knowledge hasn’t resulted in any birth defects for anyone.
At any rate, it’s nice to have money and friends in other countriesReport
It’s only a matter of time before it decapitates her.Report
Champions of the FDA, should Vikram’s family member be worried that the device in question has not been approved by said FDA?
Because my immediate thought is some variant of “hey, good for Vikram.”
Which tells me that the FDA does not have a particular moral authority here.
I mean, let’s all imagine some sort of weird situation where the people who need epipens all suddenly have a non-FDA approved connection in Germany and they get their epipens shipped to them for cost plus a bottle of something, you know, for the trouble.
Are the people in my above example putting themselves and/or their loved ones in harms way by using devices that have not been approved by the FDA? Are these people being foolish?
Because, from where I’m sitting, they’re pretty smart and pretty lucky to have a connection in Germany.
Which, as thought experiments go, leads me to the conclusion that the FDA is messing up.
Those of you out there who also go through this thought experiment: have you reached a different conclusion?Report
Heh. I’m imagining someone saying “well, see, you *can* get medical innovations in a country with a single-payer healthcare system!”Report
The FDA doesn’t want you getting your drug prescriptions filled in Canada because of safety concerns. (They said something about not being able to monitor the supply chain.) So, I suspect they’d like your getting drugs from a friend in Germany even less.
Edit: The FDA does go after those who seek to import drugs from Canada, including US-manufactured drugsReport
Oh, I would assume that the FDA would say “HEY HEY HEY WE DIDN’T APPROVE THOSE!!!!” for anything/everything *INCLUDING* US-manufactured drugs being reimported from foreign countries EVEN IF THEY ARE APPROVED IN THE US.
Which, of course, strikes me as being nutzo. But, as has been established, I’m one of the crazy people on the board.
I’m asking the people who are the champions of the FDA this question and wondering if their immediate response is to say “Yay Joe Patient Getting His Epipens And Sticking It To The Man!” or “Joe Patient Is A Fool For Trying Products That Have Not Been Vetted By The FDA”.Report
“I’m asking the people who are the champions of the FDA this question and wondering if their immediate response is to say “Yay Joe Patient Getting His Epipens And Sticking It To The Man!” or “Joe Patient Is A Fool For Trying Products That Have Not Been Vetted By The FDA”.”
Heh. As we see in this thread, it’s possible for it to be both! “This guy reimported epipens from Canada, he’s awesome! This other guy tried to get his epipen approved in the US but the FDA refused, he’s a dangerous lunatic who must be cutting corners somehow!”Report