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but but but it's in FA so it must be necessary!
'Clinton Proposes $250 Monthly Cap on Prescription Drug Costs'
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but but but it's in FA so it must be necessary!
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@PL198 : Well, actually, it's pretty good drug for demonstrating metabolic pathways. The developer of it based her investigation into it off of exploiting human vs. microbial biochemistry, so it makes sense to use it as a teaching point. I have had a patient with toxo, and treated them with pyrimethamine and sulfadiazine. Only one, so yes, the very definition of a rare disease. The ID team as all aflutter about it.
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Thanks for clearing that up. After reading about it, most of the patents associated with it are for its use as a pro-drug for other drug delivery systems. Cheers, that was helpful.
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Not all prices are unknown after care. There are labs and physicians who clearly post fees. It's not like most of healthcare occurs in an emergency room.
And any other costs you pass on to the patients, just like in any other free market system.
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To me, this is probably one of the more interesting stories in the news lately. Not Mrs. Clinton's $250 cap necessarily, but Turing Pharmaceuticals' price hike of Daraprim. So, it turns out, the FDA grants exclusivity for 7 years to manufacturers of orphan drugs, under the Hatch/Waxman act. This is distinct from a patent, even though it serves primarily the same purpose, but the rule granting body is the FDA, not the US patent office. This is what Turing was presumably actually buying from Impax, who bought it from someone else, who bought it from GSK.
So, the article in Vox isn't really telling the whole story. It's just not the economics of the situation, although that is very important. If someone else with the means of production wanted to start making pyrimethamine, first of all, they would need approval from the FDA for an abbreviated new drug application, and would need to demonstrate bioequivalence. This means, that whatever the formulation, whether it's an ester, or a salt, or whatever, as long as the blood levels in about 30 young healthy volunteers demonstrate a similar time to therapeutic level, it has demonstrated a close enough bioavailability, and the FDA will OK it. This is not an insurmountable obstacle. Small molecule drugs do not require extensive reverse engineering, so that is also not a huge obstacle. This part of the process is what prevents any private party from buying pyrimethamine by the truckload from a manufacturer in mainland China, purchased with a few mouse clicks via AliBaba, compounding it, and selling it.
But an FDA ANDA is not really worth buying for millions of dollars. Most of these drugs aren't really worth making anyway, especially if only about 2000 people per year actually consume it. The Orphan Drug act exclusivity provides an incentive and a measure of protection for a manufacturer to produce a pharmaceutical, since it assures that someone else can't get an ANDA and undercut them.
In recent years, small pharma companies have been buying the rights to orphan drugs, and raising the prices. Cardiac drugs, colchicine, progesterone, etc. It's a small niche market, so its an opportunity to make some quick cash.
The real question here, is why Turing would pay $55 million for Daraprim? After all, if only 2000 people a year take a fixed course of medication, a you'd have to charge about, say, $750 a tablet to turn a profit. Ouch. Good luck with that.
Who'd buy that? Only people who really need it. Which is what the uproar is all about. Apparently, although I could not find a link to support this, it was reported that Turing agreed to be a Medicaid 340B participator with Daraprim, which means that certain clinic approved by Medicaid can buy it at a discount, allowing in theory, needy people to get the drugs they need. Still, if Daraprim just increased in price by 5000%, and if 340B works by a percentage discount, it still sounds like a losing proposition for the public.
Apparently, Turing announced that they will decrease the retail price, in response to the public outcry. That means, in essence, Turing really just bought $55 million worth of hot horse----.
Winners: Impax, who sold Daraprim to Turing after a mere $1 to $13 price hike, for $55 mil. Losers: Turing Pharmaceuticals, the taxpaying and insurance buying public, and anyone with toxoplasmosis.
So, the article in Vox isn't really telling the whole story. It's just not the economics of the situation, although that is very important. If someone else with the means of production wanted to start making pyrimethamine, first of all, they would need approval from the FDA for an abbreviated new drug application, and would need to demonstrate bioequivalence. This means, that whatever the formulation, whether it's an ester, or a salt, or whatever, as long as the blood levels in about 30 young healthy volunteers demonstrate a similar time to therapeutic level, it has demonstrated a close enough bioavailability, and the FDA will OK it. This is not an insurmountable obstacle. Small molecule drugs do not require extensive reverse engineering, so that is also not a huge obstacle. This part of the process is what prevents any private party from buying pyrimethamine by the truckload from a manufacturer in mainland China, purchased with a few mouse clicks via AliBaba, compounding it, and selling it.
But an FDA ANDA is not really worth buying for millions of dollars. Most of these drugs aren't really worth making anyway, especially if only about 2000 people per year actually consume it. The Orphan Drug act exclusivity provides an incentive and a measure of protection for a manufacturer to produce a pharmaceutical, since it assures that someone else can't get an ANDA and undercut them.
In recent years, small pharma companies have been buying the rights to orphan drugs, and raising the prices. Cardiac drugs, colchicine, progesterone, etc. It's a small niche market, so its an opportunity to make some quick cash.
The real question here, is why Turing would pay $55 million for Daraprim? After all, if only 2000 people a year take a fixed course of medication, a you'd have to charge about, say, $750 a tablet to turn a profit. Ouch. Good luck with that.
Who'd buy that? Only people who really need it. Which is what the uproar is all about. Apparently, although I could not find a link to support this, it was reported that Turing agreed to be a Medicaid 340B participator with Daraprim, which means that certain clinic approved by Medicaid can buy it at a discount, allowing in theory, needy people to get the drugs they need. Still, if Daraprim just increased in price by 5000%, and if 340B works by a percentage discount, it still sounds like a losing proposition for the public.
Apparently, Turing announced that they will decrease the retail price, in response to the public outcry. That means, in essence, Turing really just bought $55 million worth of hot horse----.
Winners: Impax, who sold Daraprim to Turing after a mere $1 to $13 price hike, for $55 mil. Losers: Turing Pharmaceuticals, the taxpaying and insurance buying public, and anyone with toxoplasmosis.
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The ACA is purposefully structured to collapse. Harry Reid has directly stated this (not implied ---> see google). It will collapse and then we will be making a nationalized health service unless there is a major political change towards economically sensible policy (not going to happen)
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Look again, prices are not being targeted. what patients are expected to pay is being targeted. Somebody will still pay for the $750 a pop pill, just not the patient.
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Off topic, but there is a new elapidae anti-venom working its way through the process. Until then, just keep using the expired stuff.
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Yeah, they're testing it in Florida last I heard. Still sucks though.
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I think a lot of people are very confused here....
The $250 cap is an AWFUL idea... it just increases the consumer's (patient's) moral hazard. It doesn't in any way address the actual problem of price gouging. The biggest insurance company in the US is the US government so guess who's going to be stuck with the bill for the $700 pill at the end of the day - the American tax payer. Same thing is happening with the Hep C drugs... at the end of the days the drug companies are just robbing the american tax payers. We need real solutions and bold ideas....not some tired pander from a career politician like Hillary Clinton.
The $250 cap is an AWFUL idea... it just increases the consumer's (patient's) moral hazard. It doesn't in any way address the actual problem of price gouging. The biggest insurance company in the US is the US government so guess who's going to be stuck with the bill for the $700 pill at the end of the day - the American tax payer. Same thing is happening with the Hep C drugs... at the end of the days the drug companies are just robbing the american tax payers. We need real solutions and bold ideas....not some tired pander from a career politician like Hillary Clinton.
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Politicians from both parties are awful...
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Turing doesn't get FDA protection under the Orphan Drug Act for the drug that already exists. There's no patent or manufacturing restriction on this drug from the sale of it from one company to another. The drug is an "orphan drug" only in the sense that market competitors have left the scene and Turing now has a de facto grey market monopoly on the drug.
The prescription pharmaceutical market is not a free market. There is way too much legislation and there are way too many middle-men for it to ever be a truly free market. Bringing a generic drug to market isn't like making widgets. Turing paid $55 million for Daraprim because it knows two things: (1) It controls most of the supply line which will delay/discourage any competitors from trying to establish another generic, and (2) Even if another drug company WERE interested in developing a generic to compete with their drug, the FDA backlog on ANDA approvals currently stands at roughly 48 months. So, even if Generic Company X had a viable generic in its hands at this moment (which we know none of them do), it would take around 4 years to get their ANDA approved. So Turing has a de facto monopoly on this drug and has decided to do what monopolists do: charge the price at which buyers are willing to buy the profit-maximizing quantity. Turing also knows that when it comes to valuing your own health, the "price the buyer is willing to pay" is likely to be something stratospheric. It's not like deciding between purchasing a Lamborghini and walking. A guy definitely doesn't "need" a Lamborghini, but he probably needs to have the use of his body parts. Which is what makes Turing's (and other drug profiteers') actions so gross, given the fact that they did none of the initial investment in developing the drug to begin with.
Turing hasn't announced what they will be "decreasing" the price to, either. It won't be $13 a pill, I can guarantee you that. I seriously doubt they'll take a loss.
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Thanks for writing back. I am confused about the orphan drug exclusivity, since it seems that it would have expired by this time anyway. Maybe it isn't applicable in this case, although the drug was listed as such by the FDA. I am confused about a lot of things here, since they don't really make a lot of sense, and neither do the cursory explanations that are provided.
Disregarding all of the moral aspects of this situation, I still think that Turing severely overvalued the purchase. It seems to me that what they bought was the opportunity to sell a certain number of pills to a captive market within a limited time period. According to one article I read, only 2000 people a year need the treatment. The duration of treatment is 6 weeks, and you need 50 mg daily (plus a 200 mg loading dose) or 75 mg if you are >60kg. so if each pill is 50 mg, and for the sake of argument everybody weighs over 60 kg, and it will take 4 years for a competitor to gain approval, this is roughly the sale of 500K pills. If you just bought the opportunity to sell these 500K pills for 55 million, you need to sell each pill for around $100. That seems like the best case scenario, with heavy patients not seeking alternative treatments, of which there are some.
The only toxo patient I've ever seen was a Medicaid player. Someone who ignored their symptoms until they couldn't anymore, and then became admitted to the hospital to discover that their CD4 count was less than 50. So the payor mix here might not be optimal.
So yes, they have room to come down from $750 without taking a loss, but that's not a sure thing.
It's a risky move, and it seems that the result of this, it will inevitably be more expensive for everyone.
One possible way to prevent this from a legislative point of view, would be to allow the sale from international sources of WHO essential medicines that are non-innovator drugs, in conditions of scarcity, or to expedite the approval process.
Anyway, thanks for taking the time to think about it. I appreciate you sharing your insights.
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yeah and where in the magical world do you think that money will come from chief
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This is without a doubt the most pragmatic approach to this.
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Big Pharma will NEVER let that happen.
some one has to stand up to the insurance companies I'm a practicing internist. I think all generic drugs should be covered by all insurance companies (or they should not get any CMS contracts) Why do I have to play a guessing game to write a generic medication
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deleted480308
That's not your job...let the patiebt be an adult and pay for their generic meds
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We should take away mansions from rich people, I mean why should they have nicer houses than poor people? Equal everything for everyone
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I have to say, it amazes me that people think they are entitled to medications.
I worked in R&D at a pharmaceutical company before medical school, and saw firsthand failure after failure, million spent after million spent, before coming accross a remotely successful drug. The industry is so risky, that you can hardly fathom it unless you experience it. Literally 100's of PhD scientists careers dedicated to each of these drugs... 100's of others dedicated to more numerous failed efforts. The industry is graveyard for scientists. To me, it's no surprise that they demand huge prices in exchange for thier (increasingly rare) successful endeavors.
Pharma has been in a downward spiral since the 80's, off-shoring innovation to China/India and downsizing US research efforts. If you think your patients are entitled to xarelto or januvia or whatever new drug you please, then you should support these price limits I suppose. But if this happens, don't expect any innovative therapies to emerge in the foreseeable future. There needs to be a large reward to compensate for the incredible risks taken by this industry. This proposal is asinine and would bring drug discovery in the private sector to a halt.
You'd still have drug discovery in the academic sector, but time and again they've demonstrated they have no fuggin clue what they're doing in this area.
I worked in R&D at a pharmaceutical company before medical school, and saw firsthand failure after failure, million spent after million spent, before coming accross a remotely successful drug. The industry is so risky, that you can hardly fathom it unless you experience it. Literally 100's of PhD scientists careers dedicated to each of these drugs... 100's of others dedicated to more numerous failed efforts. The industry is graveyard for scientists. To me, it's no surprise that they demand huge prices in exchange for thier (increasingly rare) successful endeavors.
Pharma has been in a downward spiral since the 80's, off-shoring innovation to China/India and downsizing US research efforts. If you think your patients are entitled to xarelto or januvia or whatever new drug you please, then you should support these price limits I suppose. But if this happens, don't expect any innovative therapies to emerge in the foreseeable future. There needs to be a large reward to compensate for the incredible risks taken by this industry. This proposal is asinine and would bring drug discovery in the private sector to a halt.
You'd still have drug discovery in the academic sector, but time and again they've demonstrated they have no fuggin clue what they're doing in this area.
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Can you go into more depth how academic sector drug discovery is less effective? I have seen some very cool ideas and drug discovery research come out of my school. Drug manuafacturing obviously can't be done by a university but discovery can....
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No, everyone should be able to have equal access to healthcare. When there aren't enough resources, financially or otherwise, for everyone to receive a good or service it has to be rationed somehow. Ideally everyone would get free healthcare while physicians would remain highly compensated for the extensive work put in just to be able to see a patient. That's just not how it works though, and it can't work that way in the U.S. Idealism is fine, but useless when not practical.
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Why? Resources are already getting stretched. And the problem is not that everyone has access but that a small minority is eating up the majority of resources with dubious benefit.
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deleted480308
Economics works that way, finite resources means price elevates to equalize demand with supply
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Academic drug discovery is considered a joke for a variety of reasons, but the primary reasons are 1) no actual expertise in academia developing drugs in any species beyond rats and 2) inability to conduct clinical trials that would appease the FDA's standards. There are exceptions, but they are exceedingly rare and often involve collaboration with the private sector.
In the private sector of drug discovery, no one takes your molecule seriously unless its demonstrated efficacy AND safety in a higher order species (sheep, non-human primate, or even low-dose early human trials overseas). In the academic sector, once you can make a tumor shrink in mice it gets you tenure and an article in Science. It's absurd. If only the scientific community knew how many times the private sector has cured Alzheimer's/ lung cancer/ asthma/ hypercholesterolemia in rats... the problem is that efficacy and safety in rats very, very, very rarely translates to efficacy and safety in humans.
Also, clinical trials are multi-million dollar, risk-laden endeavors that academia cannot afford. Because they never do clinical trials, they don't have an accurate internal "risk" compass. And because of this, all sorts of bat **** crazy ideas from academia are billed as the next big thing in XYZ disease, while the pharmaceutical industry just watches and collectively rolls their eyes.
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That was actually a good explanation. Thanks for the insight!
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I'm not how that was a response to my post but undergraduate economics do not reflect what things are like in the real world. Also, in healthcare demand is fairly inelastic and price does not change with demand. Also, patients don't really participate in the market and their preferences are more or less irrelevant as the difference in knowledge keep them from controlling much of their care
It's not like you're going to only accept an mri if it costs less than 1000 dollars. You just have things done to you and then you get a bill at the end
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deleted480308
If we stopped the lunacy of not making people pay for their care that's exactly how it would work...
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I'm assuming you're asking about the equal access to healthcare. I'm not saying that everyone should receive healthcare, I'm saying that assuming they can pay for a given service they should be able to have access to that service. I understand that resources will dictate who can actually be treated, but I don't feel that any given person "deserves" to receive treatment over another.
Personally, I'd prefer a tiered system like Australia has. Their first tier is a universal system called Medicare which is somewhat similar to our medicaid. Every citizen can utilize it, and it is relatively cheap and inexpensive to the population (CHIP tax of 2% flat tax to everyone in the population, only those well below poverty threshold can obtain an exemption from the tax). This covers yearly check-ups, cheap lab tests (dipsticks for example) and cheap prescriptions (I believe it's anything under $8 for what would be 30 days worth of treatment). It doesn't include specialist visits and patients can only utilize public clinics/hospitals or private providers which accept Medicare, but it provides the basic needs to everyone to help prevent exacerbation of conditions in a large percent of the population. The second tier is private insurance, which can either be complete coverage or just a wrap-around plan to supplement their Medicare. It's essentially a similar system to the private insurance we have here, and covers pretty much everything at some level. This way, less available resources are rationed to individuals who can pay for them and those who want to pay more can choose to see providers in a more timely manner.
Yes, in that system everyone would still be paying a small amount of their money to support others, but your tax dollars wouldn't be going to pay for the quadruple bypass or other expensive procedure that would put huge burdens on the system. It's the closest thing I've seen to providing for everyone in a cost effective manner while ensuring limited resources are able to be replaced and not exhausted by a small percentage of people who cannot pay for them.
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This will probably not be a popular opinion, but if grandma is terminally ill and will not have long term benefits from those treatments, then she should receive palliative care (which, btw, has been shown to have better outcomes and be cheaper than most other treatment forms) instead of some expensive treatment that will briefly extend her life. I think a huge problem in the U.S. is our never-give-up attitude about death. At a certain point we need to ask ourselves if the benefits are really worth the risk/expense, otherwise we end up paying exorbitant amounts of money for treatments with little to no long-term benefit to the patient.
Edit: Watch the film "How to Die in Oregon". It makes a pretty compelling argument for allowing patients to die along with addressing the generally attitude in the U.S. that if we aren't trying to keep out patients alive for as long as possible, then we're failing at our jobs.
Edit: Watch the film "How to Die in Oregon". It makes a pretty compelling argument for allowing patients to die along with addressing the generally attitude in the U.S. that if we aren't trying to keep out patients alive for as long as possible, then we're failing at our jobs.
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The world as you want it will NEVER exist... and you know it. Telling someone sorry the system can't afford to pay for your Cx treatment will never happen here for a multitude of reasons
In my opinion, I think it would be better to have an insurance system that cover major surgeries, hospitalization, meds etc...--things that cost 1000s of dollars... Any thing outpatients i.e. check up, labs etc... should be paid out of pocket.
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It's easier for someone to pay for something that cost a $1000 than.... 20k.
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Medi care/caid can cover these things...
Edit: It probably won't work... I was just proposing a solution for the private sector. I guess we are approaching a nationalized system.
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my proposal was directed toward the middle class and the private health insurance market...
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deleted480308
That's the point no one wants to admit....either you have no right to make your neighbors buy your care or you have infinite right
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Let say we have mess, but once the middle class can no longer afford premiums, I think it will be easier to nationalize the system...
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So then if major things are going to be paid for by the gov, what's the difference between paying for smaller things (1-2k) and just paying insurance? I really don't see where you're going with this...
Now I see where you were going with this.
I disagree with the infinite right part. By using a system which pays for the basics (yearly check-up, cheap antibiotics, etc) it allows us to cheaply treat the poor while avoiding major expenses that would occur from untreated chronic conditions or unnecessary exacerbations of acute ones. You can do a lot of good by utilizing education and cheap preventative medicine even if you're not going to provide the major, expensive treatments and procedures.
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deleted480308
How do you articulate a right for me to take my neighbors property to pay for my care.....but not "really expensive" care, just care that falls below an arbitrary number?
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If you're going to put it in the perspective of rights, then I could easily make an argument that it doesn't matter because rights are merely societal constructs set in place to create structure and prevent collapse of an established populace. Nature doesn't abide by the concept of rights, society does.
It completely depends on how you define "rights" though. In this situation, I'd articulate it as a law established in order to reflect the values of the majority of the populace which are effected by such statute. To a certain extent, I think one has to consider a utilitarian view as the "all or nothing" argument lacks practicality on many levels. It's the same principal as taxes. You pay taxes, you have the right to receive benefits or utilize the programs those taxes fund, like having adequate roads or a functional police/firefighting force through the law established in response to the expressed needs of the overall population.
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deleted480308
Rights are not dependant on laws or slavery would not have been wrong while legal
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Rights are dependent on societal constructs and views. Many people did not consider slavery wrong, both before and after it was made legal. However, those slaves were not given rights until they were freed. So yes, it was dependent on the law. Once again, it depends on how you define the idea of 'rights'. Since I have no idea what your definition is I can't really answer your question.
