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> ...EpiPen’s original cost of around $50 per injector in 2007. That year, Mylan bought the rights to EpiPen and then raised the price more than 400% in the yea
by paulintrognon 7y ago
> ...EpiPen’s original cost of around $50 per injector in 2007. That year, Mylan bought the rights to EpiPen and then raised the price more than 400% in the years that followed. The authorized generic is essentially triple the price of what two injectors used to cost.
This is outrageous. Nothing new, I know, but every time I read about this I'm outraged. I trully think there should be a law on maximum margins at least for life saving drugs, or some kind of regulations preventing this phenomenon.
- haroldp 7y agoOr maybe we should REMOVE the laws that give companies a monopoly on producing drugs?
- manjana 7y agoBut it's a tricky thing because we don't wanna remove the incentive to invent new drugs.
- serpix 7y agoHow about saving lives for an incentive? Pharmas don't exactly have a good track record for doing the right thing with the current incentive of becoming filthy rich. This argument is so worn out it has become a cargo cult parroted response.
- johnisgood 7y agoHow about becoming rich from saving lives, and losing money for failing to do so?
- sansnomme 7y agoBetter way: Have the federal government bare the cost of certification and human testing. Extend this to other products too like wireless devices in electronics to be consistent. Instead of outsourcing to external labs or running own experiments that cost tremendous amount of money, the common trial-and-error type drugs (i.e. not a wildly advanced/theoretical treatment, those can be done the old fashioned way) testing should be fully State funded. This makes it easy for generics/functionally similar drugs to enter the market. New pharma startups would only have to bare R and D manpower and material costs (which according to YC at least, is plunging), the most expensive human testing is fully done by third-party i.e. government. It democratises drug development. There is a serious problem with the pharmaceutical and healthcare industry on the supply side. Shortage of drugs, difficulty of building and approving new hospitals, shortage of residencies and medical school intake restrictions. These all can be dealt with in one sweep if the FDA changes its regulatory process and restructures the healthcare industry. Almost every bio grad I know is going into software and CS. We have people who have spent years studying life sciences only to give up all their knowledge and choosing to do web dev/data science because they see no future in their own industry. It's basically med school (or worse, nursing), pharmaceutical or academia. All with tremendous amount of regulatory capture or extreme shortages. A proteomics PhD's highest calling shouldn't be too fiddle with Webpack configs so that React can interop with Vue. Just as the Soviet apparatchiks are responsible for mass famine due to incompetent central economic planning among other things(despite their economists inventing Linear Programming), modern policy makers need answer as to why a premed student would choose to work in DevOps instead of a wet lab. People complain about cancer drugs not hitting the market or breakthrough research that never seem to be commercialised. It's not the poorly paid scientists you ought to hold responsible, it's the people who set the rules in the first place. Sure YC just released a post on how Biotech investment is going to magically be the next software industry. But biotech has been hyped for years and there has been no real progress on the regulatory side. Only under the current US Presidential administration did the Right to Try become legalised. Unlike aerospace(a similarly bureaucratic domain) where the worst outcome of a long time to market for a plane is a less comfortable/fuel efficient plane, the opportunity cost in medicine and pharmacy is paid in human lives.
- eesmith 7y ago"These all can be dealt with in one sweep if FDA changes its regulatory process." That is not true. For one, the FDA has little influence on the degree of difficulty in building and approving new hospitals. You'll note too that one of the problems is that existing medical facilities are disappearing from poorer and rural areas. For another, the "shortage of residencies and medical school intake restrictions" is due to the Balanced Budget Act of 1997, which "capped the number of residency slots the federal government would fund ... The shortfall-what is not covered by the Federal government-is paid for by the hospitals where residents train. While it is possible to increase the number of residents they train, to do so, hospitals must fund the entire cost of those training positions." - https://thehill.com/blogs/congress-blog/healthcare/266610-shortage-of-residency-slots-may-have-chilling-effect-on-next https://thehill.com/blogs/congress-blog/healthcare/266610-sh... . The FDA has nothing to do with that.
- sansnomme 7y agoYou are correct. The exact detail of my comment is inaccurate, but the point still stands that it is up to the federal government. The buck has to stop somewhere. Continuously blaming the insurance industry for high costs is popular but there are a lot of other factors too which the media conveniently seem to neglect to mention. It helps no one if brilliant minds would rather go work on a "data analytics" healthcare startup (think fancy wearables) using "machine learning" that is purely dry lab (the bio academia preferred term for data science) without a single bit of wet lab physiology research that contributes to drug cures because commercialisation is too difficult, takes too long, too regulated.
- eesmith 7y ago"which the media conveniently seem to neglect to mention" What? No. These are well-known structural problems that are mentioned often. I mentioned one related to funding residency programs. Another which has come up is the lack of public pricing information. Eg, "how much does it cost to give birth at your hospital if there are no complications?" - https://www.vox.com/2016/5/5/11591592/birth-cost-hospital-bills https://www.vox.com/2016/5/5/11591592/birth-cost-hospital-bi... . (I believe this information is now required to be public.) A third is how Medicare is prohibited from negotiating for better drug prices. The exact details of your comments are important because if you don't know the source of the problems - which in part are due to the same federal government that you pin your hopes on - then you are at a high risk of being manipulated by the same mistaken views that have perpetuated this broken system. Take your final statement, "takes too long, too regulated". That is a common talking point pushed by those who want to sell "drugs" that haven't been proven to actually work, and by those who are philosophically opposed to government regulations. Quite simply, the US isn't the only country developing new drugs. Other countries have their own, different regulations, and if it were a simple matter of the US being "over regulated" then we see companies elsewhere doing significantly better. Or, look at all the people who, desperate for treatment, go to another country with weaker regulations to seek an experimental treatment which not only doesn't work, but drains them of money, and sometimes makes things worse.
- reallydontask 7y agoThis is a complicated area but given: The relative spend on R & D vs Marketing The fact that the taxpayers already funding a lot of the research (university grants mostly, I believe) The fact that lifestyle drugs are much more likely to be developed. It would seem hardly any new antibiotics are being developed (I'm not saying none) despite the so-called superbug crisis I'm just not sure the current system works for most people.
- _Wintermute 7y ago> The fact that the taxpayers already funding a lot of the research (university grants mostly, I believe) I see this argument a lot, but most people don't realise the amount of research, work and vast amounts of money that goes into turning an academic finding into an effective drug on the market. Identifying a cellular pathway involved in a disease, or even going as far as presenting a hit compound that targets that pathway in a paper is such a small step towards a useful drug. There are hundreds of things that are yet to be considered and any one of them could result in the entire project being scrapped, and that is of course assuming the work published by academia can actually be replicated.
- ldng 7y agoR&D is costly yet pharmas make margins only second to ad tech industry. Maybe I'm stupid but I can't reconcile the two...
- refurb 7y agoThe best Pharma you’re looking at are the ones that are successful, not the ones that go under. And margins have to be high - what other investor would risk hundreds of millions on a 1:10 bet unless high margins.
- coredog64 7y agoCialis and rogaine (two “lifestyle drugs”) are actually failed heart disease treatments. In the first case, patients asked to stay on it despite lack of efficacy in treating the main condition. I’m the second, female patients complained about the side effects. Preemptively, I’ll take on the other talking point: “Me too” drugs are actually important. All meds come with side effects, either from the active ingredients or the inactive ingredients. Having options allows patients to choose something that works for them. Multiple treatments also means competition and lower costs.
- krageon 7y agoIt can be profitable without being outrageously profitable. This sort of reasoning reads to me like the news articles saying there is "nothing to be done" about all the shootings in the US, even though it's obvious to everyone what could be done. It's excusing bad behaviour because of cargo-cult beliefs without a good practical foundation and it has to stop.
- pergadad 7y agoDeveloping and getting approval for a new drug takes two decades and costs hundreds of millions. Part of that surely is patent cost buy the main parts are testing, animal and human trials and the approval process. The 'innovation' lie in telecomms (that you need high margins to assure innovation and investment) is surely not true but pharmaceuticals really are expensive to get from R&D to market. Companies with a big seller where the patent protection runs out, and that didn't succeedem to get another big drug to market, often sell themselves as they expect to go bankrupt or have to sell off their half-developed portfolio, which amounts to the same thing. Of course all a bit different for the big drug makers. So maintaining the current system without patents seems difficult. But an option would of course be to shift the system - public investment for research and promising trials and then the result is free to use (or protected only for a short period).
- epmaybe 7y agoI went to a talk by a VP of development at a prominent pharmaceutical company, and nowadays it's taking around 7 years from basic studies to animal studies to human trials to approval. This is especially true for biologics (antibody drugs), as they can test and find good candidates for human trials quickly. I'm sure it's still expensive, though, and many companies like you said go bankrupt.
- mrhappyunhappy 7y agoI was once told by someone who owns lots of guns that every time there is a mass shooting in US of A, the sales of weapons go through the roof. Apparently the fear of regulation triggers a buying spree. True or not, I found it interesting and somewhat ironic how these shootings could be helping gun sales.
- lawlessone 7y ago>But it's a tricky thing because we don't wanna remove the incentive to invent new drugs. What incentive is there to produce new drugs when they are making plenty of money gouging people on price with the old drugs?
- ImprovedSilence 7y agoRight? Along the same lines, why invent a cure, when you could instead invent a lifelong treatment?
- replicatorblog 7y agoThis sentiment drifts dangerously close to a conspiracy theory. The existence of the vaccine industry demonstrates there is a market for a cure. As do immunotherapies. Where cures are possible, they are commercialized.
- wayneftw 7y agoSo? Corporations, governments and other people conspire to rip off customers all the time. Off the top of my head: Planned obsolescence is a thing. Whole companies of people in India calling your house trying to trick you into buying computer-virus protection is a thing. Entire nations conspiring to steal industry secrets from other countries is a thing. Operation Mockingbird was/is a thing. General corruption is a thing and people working together when they have common goals is a thing. So what's your point in saying that something sounds like a "conspiracy theory" when there are clearly many, many people conspiring to do wrong all the time? And the existence of the vaccine industry does not prove that cures are always commercialized when possible.
- pygy_ 7y ago> And the existence of the vaccine industry does not prove that cures are always commercialized when possible. For once, the health industry works on planning its own obsolescence (as it should, generally), and a major conspiracy theory pops up countering the trend... Another domain you didn't mention: imagine the crisis in the food and distribution industry if everyone started having a healthy diet overnight... While those sectors may not have started the obesity epidemics deliberately, they now rely on its expansion for growth.
- srean 7y agoIf protection from market is predicated on testing and research being expensive, it pretty much ensures that they will do their best to keep them that way to enjoy the profitable protection.
- thaumasiotes 7y ago> But it's a tricky thing because we don't wanna remove the incentive to invent new drugs. That's covered by the patent system. The barriers to selling an existing, out-of-patent drug (remember that mention upthread of an "authorized generic"?) are covered by the FDA; they're totally unrelated.
- amelius 7y ago> But it's a tricky thing because we don't wanna remove the incentive to invent new drugs. Let universities and government institutions invent them. Why does everything need to be run by corporations these days?
- Frondo 7y agoThis is absolutely true -- you don't see drug researchers on yachts. The people actually doing the work aren't rich as avarice, it's the people who turn their work into a "business". People doing groundbreaking work are motivated to do the work for whatever reason, and it's seldom money. There are more important things to them, whether it's simply doing Good, or status, or it fascinates them, or whatever. The guy who invented insulin sold the patent for a dollar. New drugs and therapies are often developed outside these big companies anyway, and they just buy them, run them through the certification, and then sell them at incredible markup. The money's not in development, it's in the business side of things. We've (some of us, at least) so bought into the argument that the world needs to be this way that we totally ignore these things actually get done.
- bazooka_penguin 7y agoTechnically the certification is part of the development and iirc quite expensive and high risk since it can make or break a drug. But I dont think its unreasonable to either loosen standards a bit or simply slow down the development of new drugs (in the US).
- LargeWu 7y agoThis is a good argument for nationalizing drug production and research.
- eesmith 7y agoHow would that help here? These are generic, so there is no monopoly beyond the Hatch-Waxman Amendments, which is only 180 days. Now, if we got rid of trademarks, which gives a company the monopoly on the trade name, then it would of course be much easier for generics to start selling EpiPen-labeled injectors.
- coredog64 7y agoThe generic makers have already got that figured out. The box includes the text “The same active ingredients as X” and “Not manufactured by (maker of X)” is enough to inform consumers while not falling afoul of trademark law.
- lonelappde 7y agoThe problem with EpiPen is that you can only get an alternative if your doctor prescribees it. epipen is patented on the user interface so patients can't get the alternatives on an EpiPen prescription (which you will recall from Oracle v Google and others is usually not allowed, but pharma gets to do it).
- eesmith 7y agoI mean to use EpiPen here in the same generic sense that https://en.wikipedia.org/wiki/Epinephrine_autoinjector https://en.wikipedia.org/wiki/Epinephrine_autoinjector uses in sentences like "Teva Pharmaceuticals filed an ANDA to market a generic EpiPen" and "Sandoz submitted an ANDA to sell a generic EpiPen". Since "The first modern epinephrine autoinjector, the EpiPen, was invented in the mid-1970s at Survival Technology in Bethesda, Maryland by Sheldon Kaplan[10][11] and was first approved for marketing by the FDA in 1987", at least those patents have expired. And this article is, after all, talking about generics - authorized generics, certainly, but still generics. However, you are right - the "Epipen" is a trademark for an epinephrine autoinjector. As such, it can be applied to many things, eg, "Sudafed" packages might not contain pseudoephedrine as they once all did.
- sokoloff 7y agoI don't see what getting rid of trademarks will do to help consumers. It's not like people who need an epinephrine auto-injector are confused and think that only Epipens exist in that market. Hell, I don't need one and I'm well aware. If you want an Advil, I think you should be able to buy Advil. If you want 200mg ibuprofen, you can also shop for that, but if you happen to know that you prefer the outer pill smoothness and taste of genuine Advil, you are harmed by having the generic ibuprofen (without that same outer coating) be able to be advertised as "Advil" (rather than merely as "the same active ingredient as Advil").
- deleted 7y ago[deleted]
- 8bitsrule 7y agoThat law would be the 'Medicare For All' law. The government could then determine the maximum price for life-saving everything. And the predatory bastards could go find an honest job (if they know what that means).
- TomMarius 7y agoIn my country we tried this "government could determine the maximum price for (some category) everything" and it ended up with tons of dead people. Not even Germany with their socialized Healthcare does that, why would the US do?
- NicoJuicy 7y agoI call bullshit, give me facts somewhere where I can read about it ( trustworthy source). Because here in Europe, multiple countries are fine with it.
- TomMarius 7y agoI don't know a single EU country that would set maximum prices. Can you share which one do you mean? Aren't you confusing it with insurance company tariffs (pre-determined prices for treatments etc), which are set by the insurance companies, not government? https://en.wikipedia.org/wiki/Healthcare_in_Germany https://en.wikipedia.org/wiki/Healthcare_in_Germany
- wjnc 7y agoUhm, the Netherlands does? In Dutch [1]. There are a few mechanisms. One is a maximum price based on a basket of comparable countries. Two is a maximum insured price based on comparable medicines with mandatory co-payments above the average. Three is insurers bargaining with apothecaries. Four is government bargaining for orphan medicines. Five is sometimes allowing apothecaries to create licensed medicine by themselves. Many of these are totally opposite the US-system afaik, with Medicare not being allowed to negotiate prices being the most glaring one. [1] https://www.rijksoverheid.nl/onderwerpen/geneesmiddelen/betaalbaar-houden-van-geneesmiddelen https://www.rijksoverheid.nl/onderwerpen/geneesmiddelen/beta...
- rayiner 7y ago> I trully think there should be a law on maximum margins at least for life saving drugs, or some kind of regulations preventing this phenomenon This is exactly the opposite of what you want. Investment goes where the margins are. That’s why huge amounts of money gets invested in stuff like Facebook. Making it relatively unprofitable to create lifesaving drugs just ensures that investment won’t flow into that area. Apple makes about the same profits as the total US pharma industry, and that amounts to a tiny fraction of US healthcare spending. Too much profit is not the problem.
- indalo 7y agoUnderstandable, but something like an EpiPen and a lot of other very well established things like say, insulin. They're well within the realm of a stable generic that can be managed as to maximize the amount of lifes it improves. Right?
- sxg 7y agoRegarding insulin, we’ve made huge progress in so many ways, and there is still room for improvement. We have different forms of insulin with different lifespans that we can use to create insulin regimens for different kinds of diabetics. For example, we have lantus, which is a long acting insulin that helps give 24 hour coverage. We combine that with short acting insulin lispro at mealtimes. Lantus is a relatively new form of insulin that wasn’t available a few decades ago. Different bodies also respond very differently to all the different kinds of insulin available. There is room for further improvement as the typical lantus/lispro regimen isn’t perfect for everyone.
- rayiner 7y agoThe epi-pen auto injector is tricky to do right, so it took a few tries to make a good generic. But they’re on the market now: https://www.consumerreports.org/drugs/epipen-shortage-continues-but-new-low-cost-options-are-available/ https://www.consumerreports.org/drugs/epipen-shortage-contin... Insulin is hard to manufacture. The older versions are now generic, but the new, patented ones have measurable advantages. Because most people have insurance coverage, there is a limited market for the older, generic insulin.
- jaclaz 7y agoHere in Italy, the self-injecting adreanaline same as the Epipen in the US is normally "free" (its cost except maybe a "ticket" of 4 € is paid by the equivalent of the NHS in the UK) if prescribed by an authorized doctor or in the hospital. But any doctor can prescribe it and the "full" price is around € 80 for the single pack or 140 for the two pack, so it is around 1/4th if the US $600 cited in the article. BTW here a "normal" adrenaline 0.5 mg vial is around 1 or maybe 2 €, so all the prize must be in the auto-injection mechanism and not in the actual drug.