Who gets scarce drugs?
February 14, 2016 8:35 PM Subscribe
While Martin Shkreli's decision to raise the price of a cancer drug by a factor of more than 50 has attracted some bad press, another problem plagues patients: drug shortages are forcing doctors to ration access.
Letters to the editor go into some of the details.
A panel of doctors and regulators discuss how to handle shortages of children's cancer drugs.
Letters to the editor go into some of the details.
A panel of doctors and regulators discuss how to handle shortages of children's cancer drugs.
Stop making it illegal for third parties to produce goods.
posted by effugas at 9:09 PM on February 14, 2016 [3 favorites]
posted by effugas at 9:09 PM on February 14, 2016 [3 favorites]
(And don't approve drugs that don't have published and tested fabrication routes.)
posted by effugas at 9:09 PM on February 14, 2016 [3 favorites]
posted by effugas at 9:09 PM on February 14, 2016 [3 favorites]
So from what I can tell, drug shortages happen when safety issues occur in companies that manufacture patented drugs. I take a medication that does not have a generic version available, and I pay a premium for it. I continue to be appalled that my health condition is making someone a shit ton of money. I mean, I'm also a socialist who believes that good health is a basic human right, so what do I know?
posted by Ruki at 9:54 PM on February 14, 2016 [4 favorites]
posted by Ruki at 9:54 PM on February 14, 2016 [4 favorites]
I haven't seen this previously on Mefi, but before this thread is hopelessly detailed by our 3-minutes of hate for "pharma bro", the New Yorker's recent piece that Everyone Hates Martin Shkreli. Everyone Is Missing the Point should be required reading.
As far as the drug shortage part of the FPP, it's shameful, and heartbreaking, but until there's some plan that doesn't grant an exclusive patent while simultaneously still incentivizing spending $2.6 billion to get a new drug approved (according to a 2014 Tufts study), are things really going to be able to change?
posted by fragmede at 9:57 PM on February 14, 2016 [19 favorites]
As far as the drug shortage part of the FPP, it's shameful, and heartbreaking, but until there's some plan that doesn't grant an exclusive patent while simultaneously still incentivizing spending $2.6 billion to get a new drug approved (according to a 2014 Tufts study), are things really going to be able to change?
posted by fragmede at 9:57 PM on February 14, 2016 [19 favorites]
I continue to be appalled that my health condition is making someone a shit ton of money. I mean, I'm also a socialist who believes that good health is a basic human right, so what do I know?
This doesn't make any sense. How do you expect to convince people to make create drugs for you? How do you convince people to go to medical school and treat you?
posted by esprit de l'escalier at 10:02 PM on February 14, 2016 [8 favorites]
This doesn't make any sense. How do you expect to convince people to make create drugs for you? How do you convince people to go to medical school and treat you?
posted by esprit de l'escalier at 10:02 PM on February 14, 2016 [8 favorites]
We need to find a better way to test drugs than a $2.6B testing regime. And the answer is probably going to be drug discovery leaving the US.
posted by effugas at 10:05 PM on February 14, 2016 [6 favorites]
posted by effugas at 10:05 PM on February 14, 2016 [6 favorites]
As far as the drug shortage part of the FPP, it's shameful, and heartbreaking, but until there's some plan that doesn't grant an exclusive patent while simultaneously still incentivizing spending $2.6 billion to get a new drug approved (according to a 2014 Tufts study), are things really going to be able to change?
That's a great article you cited. However, patents have nothing to do with it. The drug Shkreli repriced is not patented. Anyone can make the drug, but they have to go through an expensive and difficult FDA approval process. The article suggests that streamlining this process would increase competition.
Personally, I think there need to be some more regulations. Even a very efficient market like the rental market has price regulations. Just because you have the freedom to move, we still don't let your landlord can't jack up the prices by 100% randomly because moving takes at least a few days. Similarly, a 1000% increase in drug price might eventually create competitors, but there's a delay. So I would say that something like drug price increases should be limited to three times inflation barring extenuating circumstances (or something like that).
posted by esprit de l'escalier at 10:07 PM on February 14, 2016 [4 favorites]
That's a great article you cited. However, patents have nothing to do with it. The drug Shkreli repriced is not patented. Anyone can make the drug, but they have to go through an expensive and difficult FDA approval process. The article suggests that streamlining this process would increase competition.
Personally, I think there need to be some more regulations. Even a very efficient market like the rental market has price regulations. Just because you have the freedom to move, we still don't let your landlord can't jack up the prices by 100% randomly because moving takes at least a few days. Similarly, a 1000% increase in drug price might eventually create competitors, but there's a delay. So I would say that something like drug price increases should be limited to three times inflation barring extenuating circumstances (or something like that).
posted by esprit de l'escalier at 10:07 PM on February 14, 2016 [4 favorites]
I haven't seen this previously on Mefi, but before this thread is hopelessly detailed by our 3-minutes of hate for "pharma bro", the New Yorker's recent piece that Everyone Hates Martin Shkreli. Everyone Is Missing the Point should be required reading.
Nah. This is a "why not both?" situation.
I mean, I get the article's point that Shkrelli is a minor, ultimately inconsequential symptom of a deeply broken system and hating on him won't solve any if the real problems with it, but he's still human garbage.
posted by Sangermaine at 10:19 PM on February 14, 2016 [11 favorites]
Nah. This is a "why not both?" situation.
I mean, I get the article's point that Shkrelli is a minor, ultimately inconsequential symptom of a deeply broken system and hating on him won't solve any if the real problems with it, but he's still human garbage.
posted by Sangermaine at 10:19 PM on February 14, 2016 [11 favorites]
> This doesn't make any sense. How do you expect to convince people to make create drugs for you? How do you convince people to go to medical school and treat you?
ooh ooh ooh okay for the first one let's go with "state-funded research."
and with the second one we can go with "I dunno people go to medical school in most western countries with socialized medicine so we can prolly figure it out here too."
posted by You Can't Tip a Buick at 10:21 PM on February 14, 2016 [40 favorites]
ooh ooh ooh okay for the first one let's go with "state-funded research."
and with the second one we can go with "I dunno people go to medical school in most western countries with socialized medicine so we can prolly figure it out here too."
posted by You Can't Tip a Buick at 10:21 PM on February 14, 2016 [40 favorites]
Whether the state pays them or whether they are paid by the private sector, someone has to pay them Buick. So someone will be "making money" off illnesses.
posted by esprit de l'escalier at 10:29 PM on February 14, 2016 [6 favorites]
posted by esprit de l'escalier at 10:29 PM on February 14, 2016 [6 favorites]
This doesn't make any sense. How do you expect to convince people to make create drugs for you? How do you convince people to go to medical school and treat you?
Ah, see, here's the rub. Without my medication, I cannot be a productive member of society. As a productive member of society, I am not using the government disability benefits that I would otherwise need. In fact, I work for, and make money for, a Fortune 500 company. While I personally believe that healthcare should be a universal right, in a capitalistic society, a healthy worker is a productive worker. Yes, we all need to get paid, but if pharmaceutical companies are more concerned about their own profits than the well being of the people their drugs treat, the prohibitive cost of medicine results in less productive workers. If one cannot afford the medicine one needs to thrive, they cannot be a productive worker. And the overall economy loses for that.
posted by Ruki at 10:29 PM on February 14, 2016 [17 favorites]
Ah, see, here's the rub. Without my medication, I cannot be a productive member of society. As a productive member of society, I am not using the government disability benefits that I would otherwise need. In fact, I work for, and make money for, a Fortune 500 company. While I personally believe that healthcare should be a universal right, in a capitalistic society, a healthy worker is a productive worker. Yes, we all need to get paid, but if pharmaceutical companies are more concerned about their own profits than the well being of the people their drugs treat, the prohibitive cost of medicine results in less productive workers. If one cannot afford the medicine one needs to thrive, they cannot be a productive worker. And the overall economy loses for that.
posted by Ruki at 10:29 PM on February 14, 2016 [17 favorites]
spending $2.6 billion to get a new drug approved (according to a 2014 Tufts study)
That Tufts study is funded by the pharmaceutical industry. It is horseshit. Stop quoting it as if it has any bearing on the truth. The pharmaceutical industry spending more money on marketing -- advertising and bribes for physician testimonials -- than it spends on research.
posted by JackFlash at 10:33 PM on February 14, 2016 [16 favorites]
That Tufts study is funded by the pharmaceutical industry. It is horseshit. Stop quoting it as if it has any bearing on the truth. The pharmaceutical industry spending more money on marketing -- advertising and bribes for physician testimonials -- than it spends on research.
posted by JackFlash at 10:33 PM on February 14, 2016 [16 favorites]
Hey, I agree with you Ruki, but we still have to pay pharmaceutical companies to do what they do. I don't see any way around that.
What we can do is socialize the cost of medicine so that we all pay for everyone. It might also be possible to have some price controls on drugs in such a way that innovation is not stifled. That's the big question is how to maintain innovation while preventing gouging. A person who doesn't want to die is in a desperate situation, and so we don't want to make it so that situation is exploitable. On the other hand, we want to maximize the efficiency of the market so that the drugs are created in the first place. We wouldn't people to die because there were insufficient incentive to drive the companies to take risks on creating new drugs either.
posted by esprit de l'escalier at 10:34 PM on February 14, 2016
What we can do is socialize the cost of medicine so that we all pay for everyone. It might also be possible to have some price controls on drugs in such a way that innovation is not stifled. That's the big question is how to maintain innovation while preventing gouging. A person who doesn't want to die is in a desperate situation, and so we don't want to make it so that situation is exploitable. On the other hand, we want to maximize the efficiency of the market so that the drugs are created in the first place. We wouldn't people to die because there were insufficient incentive to drive the companies to take risks on creating new drugs either.
posted by esprit de l'escalier at 10:34 PM on February 14, 2016
I'm no Econ expert, but scarcity drives prices up, typically?
At some point we're going to be better off with fully stocked stores of generic drugs than selectively rationed unstable supplies of under patent drugs and generics.
posted by RobotVoodooPower at 10:34 PM on February 14, 2016 [1 favorite]
At some point we're going to be better off with fully stocked stores of generic drugs than selectively rationed unstable supplies of under patent drugs and generics.
posted by RobotVoodooPower at 10:34 PM on February 14, 2016 [1 favorite]
Also, prosecute pay for delay as the collusion that it is.
posted by RobotVoodooPower at 10:38 PM on February 14, 2016 [2 favorites]
posted by RobotVoodooPower at 10:38 PM on February 14, 2016 [2 favorites]
This doesn't make any sense. How do you expect to convince people to make create drugs for you? How do you convince people to go to medical school and treat you?
I mean, I'm sure plenty of people go into medicine for the paycheck, and it is, at least in certain specialities, a lucrative profession, but it's also one that generally requires dropping $200,000+ on medical school (not counting undergrad costs), and 3-4 years or more of residency at a not particularly lucrative salary (I think maybe $40,000 is standard, but I'm sure it varies and this may be off.) Not to mention the hours, which for many specialties (ex: Emergency Medicine) can be grueling even after residency. So I'm pretty sure the money isn't the primary draw for a lot of people.
(I say this as someone who hopes to enter medical school in the not so distant future. I'm doing it because I really, really, really want to be a doctor. I hope I earn enough to pay off my student loans before I retire. I do like that it's a profession where I'll probably never have to worry about not being able to find a job, but that's not remotely why I'm choosing to pursue this career path.)
and with the second one we can go with "I dunno people go to medical school in most western countries with socialized medicine so we can prolly figure it out here too."
If you could get a medical degree for the same tuition as you would in the countries with socialized medicine, I bet that would be a pretty big help.
So someone will be "making money" off illnesses.
Okay, but there's making money and then there's charging $750 a pill, which is the number quoted in the New Yorker piece linked above.
My vote is for allowing doctors (and everyone else!) to get an education that won't be equal to most people's mortgages, some sort of restrictions on the staggering prices of some drugs, and federal/state funded research to hopefully push drug companies towards producing and discovering the drugs we need the most, as opposed to the drugs that they think will make them the most money.
posted by litera scripta manet at 10:38 PM on February 14, 2016 [12 favorites]
I mean, I'm sure plenty of people go into medicine for the paycheck, and it is, at least in certain specialities, a lucrative profession, but it's also one that generally requires dropping $200,000+ on medical school (not counting undergrad costs), and 3-4 years or more of residency at a not particularly lucrative salary (I think maybe $40,000 is standard, but I'm sure it varies and this may be off.) Not to mention the hours, which for many specialties (ex: Emergency Medicine) can be grueling even after residency. So I'm pretty sure the money isn't the primary draw for a lot of people.
(I say this as someone who hopes to enter medical school in the not so distant future. I'm doing it because I really, really, really want to be a doctor. I hope I earn enough to pay off my student loans before I retire. I do like that it's a profession where I'll probably never have to worry about not being able to find a job, but that's not remotely why I'm choosing to pursue this career path.)
and with the second one we can go with "I dunno people go to medical school in most western countries with socialized medicine so we can prolly figure it out here too."
If you could get a medical degree for the same tuition as you would in the countries with socialized medicine, I bet that would be a pretty big help.
So someone will be "making money" off illnesses.
Okay, but there's making money and then there's charging $750 a pill, which is the number quoted in the New Yorker piece linked above.
My vote is for allowing doctors (and everyone else!) to get an education that won't be equal to most people's mortgages, some sort of restrictions on the staggering prices of some drugs, and federal/state funded research to hopefully push drug companies towards producing and discovering the drugs we need the most, as opposed to the drugs that they think will make them the most money.
posted by litera scripta manet at 10:38 PM on February 14, 2016 [12 favorites]
This is sort of tangential to the article, but I feel like it's the other side of this same coin.
There's this drug, Nudexta, which is prescribed for "Pseudobulbar Affect" aka uncontrollable laughing and crying. I first saw this drug in a TV ad*. As far as I can tell, the condition this drug is supposed to treat is actually quite rare. However, I did a bit of internet research, and from what I can tell, the hope is that they'll eventually be able to market it for other conditions. After all, why put this much money and effort into a drug that treats a condition most people would never of heard of and not very many people need treated? I also found some reports of the manufacturers getting flack for charging exorbitant prices for this drug, which pretty much just combines to pre-existing, very cheap medications (dextromethorphan aka the thing that's in cough medicine you buy at CVS, and quinidine.)
The whole reason I spent time researching this med is because it was prescribed to a family member who does not have anything resembling Pseudobulbular Affect. It was prescribed to her for treatment of neuropathic pain. After reading up about this drug, I also looked up the prescribing physician, and found that in 2015, this doctor was visited by Avenir, the drug company that markets Nudexta, at least once a month during the last year.** The money declared for each visit was about enough to buy a meal, but it's hard not to imagine that there might be a connection between this off label prescription and the drug company visits.
Basically, this is a severely broken system, like the rest of US healthcare. I'm not saying there's an easy or quick fix, but clearly it's not the only option, as evidenced by the many other countries that seem to have found a different way to go about things.
*I also vote for not allowing drug companies to run ads for their drugs.
**I also think this kind of shit shouldn't be allowed.
posted by litera scripta manet at 10:50 PM on February 14, 2016 [11 favorites]
There's this drug, Nudexta, which is prescribed for "Pseudobulbar Affect" aka uncontrollable laughing and crying. I first saw this drug in a TV ad*. As far as I can tell, the condition this drug is supposed to treat is actually quite rare. However, I did a bit of internet research, and from what I can tell, the hope is that they'll eventually be able to market it for other conditions. After all, why put this much money and effort into a drug that treats a condition most people would never of heard of and not very many people need treated? I also found some reports of the manufacturers getting flack for charging exorbitant prices for this drug, which pretty much just combines to pre-existing, very cheap medications (dextromethorphan aka the thing that's in cough medicine you buy at CVS, and quinidine.)
The whole reason I spent time researching this med is because it was prescribed to a family member who does not have anything resembling Pseudobulbular Affect. It was prescribed to her for treatment of neuropathic pain. After reading up about this drug, I also looked up the prescribing physician, and found that in 2015, this doctor was visited by Avenir, the drug company that markets Nudexta, at least once a month during the last year.** The money declared for each visit was about enough to buy a meal, but it's hard not to imagine that there might be a connection between this off label prescription and the drug company visits.
Basically, this is a severely broken system, like the rest of US healthcare. I'm not saying there's an easy or quick fix, but clearly it's not the only option, as evidenced by the many other countries that seem to have found a different way to go about things.
*I also vote for not allowing drug companies to run ads for their drugs.
**I also think this kind of shit shouldn't be allowed.
posted by litera scripta manet at 10:50 PM on February 14, 2016 [11 favorites]
From The Letters to The Editors linked to in the FPP:
There is no justifiable reason for a country with the resources of the United States to have a situation in which a sick child or any other patient lacks access to lifesaving drugs because of shortages.
This pretty much encapsulates what makes this whole situation so disturbing and sickening. We can and should be doing better than this.
For example, maybe requiring drug companies to continue producing less profitable but still medically necessary drugs in order to be allowed to produce their big money drugs, or any drugs at all. Or providing federally funded incentives to make those drugs.
And yeah, doing whatever it takes to make it easier for other companies to manufacture generic versions of these drugs.
posted by litera scripta manet at 11:04 PM on February 14, 2016 [1 favorite]
There is no justifiable reason for a country with the resources of the United States to have a situation in which a sick child or any other patient lacks access to lifesaving drugs because of shortages.
This pretty much encapsulates what makes this whole situation so disturbing and sickening. We can and should be doing better than this.
For example, maybe requiring drug companies to continue producing less profitable but still medically necessary drugs in order to be allowed to produce their big money drugs, or any drugs at all. Or providing federally funded incentives to make those drugs.
And yeah, doing whatever it takes to make it easier for other companies to manufacture generic versions of these drugs.
posted by litera scripta manet at 11:04 PM on February 14, 2016 [1 favorite]
The death panels and rationing for health care are evidently just peachy when it's all about money.
posted by fifteen schnitzengruben is my limit at 11:35 PM on February 14, 2016 [13 favorites]
posted by fifteen schnitzengruben is my limit at 11:35 PM on February 14, 2016 [13 favorites]
For those of us who read about this awful bullshit and wish karma would happen to people like Shkreli, he may have just been scammed out of 15 million dollars.
posted by Feyala at 11:43 PM on February 14, 2016 [7 favorites]
posted by Feyala at 11:43 PM on February 14, 2016 [7 favorites]
The most expensive medication I regularly take is a blatant cash grab. As generic for tenex it was a ten dollar a month generic, but as Intuniv it is ten dollars a day. It was once a day for blood pressure, but totally needed an extended release version for the ADHD children! But my drug coverage does not cover the cheap version and does cover it as Intuniv. Sorry, taxpayers. But price hikes and cash grab dodges are a relatively minor issue when compared with actual shortages, because these are often the treatments that save lives in hospitals.
The larger problem in shortages is that the big pharmaceutical companies have bought up most of the little medication manufacturers and so there is no one out there to steadily manufacture those old basics (not patentable) and staples that aren't very profitable. Like parenteral nutrition products and vitamins, potassium and calcium injectables, atropine... FDA Drug Shortage list, ASHP Current Shortage list.
Over the past 6 weeks I have had 3 procedures done under general anesthesia and needed IV antibiotics for each, as well as for an infection that otherwise might have killed me and certainly would have cost me a kidney. I just hope that the several vials of Zosyn they used on me doesn't leave them short for someone else.
posted by monopas at 1:02 AM on February 15, 2016 [4 favorites]
The larger problem in shortages is that the big pharmaceutical companies have bought up most of the little medication manufacturers and so there is no one out there to steadily manufacture those old basics (not patentable) and staples that aren't very profitable. Like parenteral nutrition products and vitamins, potassium and calcium injectables, atropine... FDA Drug Shortage list, ASHP Current Shortage list.
Over the past 6 weeks I have had 3 procedures done under general anesthesia and needed IV antibiotics for each, as well as for an infection that otherwise might have killed me and certainly would have cost me a kidney. I just hope that the several vials of Zosyn they used on me doesn't leave them short for someone else.
posted by monopas at 1:02 AM on February 15, 2016 [4 favorites]
As someone with health anxiety, I am wondering if perhaps I should not have read this... for my own health.
posted by gloriouslyincandescent at 1:21 AM on February 15, 2016
posted by gloriouslyincandescent at 1:21 AM on February 15, 2016
What do other socialized countries do to deter shortages? I would guess allow importing of the active ingredient from India, checking its purity, then making your own formulation for almost nothing.
posted by benzenedream at 1:24 AM on February 15, 2016 [1 favorite]
posted by benzenedream at 1:24 AM on February 15, 2016 [1 favorite]
The whole reason I spent time researching this med is because it was prescribed to a family member who does not have anything resembling Pseudobulbular Affect. It was prescribed to her for treatment of neuropathic pain.
The flip-side of this is that (as I understand things) neuropathic pain is one of things that’s really difficult to treat effectively - ordinary painkillers don’t always work & even if they do they probably only work for a relatively short period before they become ineffective. Once a patient has burnt through the existing treatments & either found that they don’t work for them or reached the point (eh with opiates) where the side effects outweigh the desired painkilling effect, doctors start reaching for the off-label prescriptions that they’ve heard about because, well, what else are they going to do? They have a patient in severe pain right in front of them & if there’s anecdotal evidence that a drug that’s already well characterised as being reasonably safe has some beneficial effect on neuropathic pain, then prescribing it off-label seems like a totally reasonable thing to do & indeed is something that happens with lots of drugs.
Of course, this can get really, really shady - anything in pharma seems to have that potential - but the fundamental principle is not shady at all.
posted by pharm at 1:50 AM on February 15, 2016 [2 favorites]
The flip-side of this is that (as I understand things) neuropathic pain is one of things that’s really difficult to treat effectively - ordinary painkillers don’t always work & even if they do they probably only work for a relatively short period before they become ineffective. Once a patient has burnt through the existing treatments & either found that they don’t work for them or reached the point (eh with opiates) where the side effects outweigh the desired painkilling effect, doctors start reaching for the off-label prescriptions that they’ve heard about because, well, what else are they going to do? They have a patient in severe pain right in front of them & if there’s anecdotal evidence that a drug that’s already well characterised as being reasonably safe has some beneficial effect on neuropathic pain, then prescribing it off-label seems like a totally reasonable thing to do & indeed is something that happens with lots of drugs.
Of course, this can get really, really shady - anything in pharma seems to have that potential - but the fundamental principle is not shady at all.
posted by pharm at 1:50 AM on February 15, 2016 [2 favorites]
What do other socialized countries do to deter shortages? I would guess allow importing of the active ingredient from India, checking its purity, then making your own formulation for almost nothing.
Even in the US, I believe it’s still possible for a pharmacist to make up drugs from scratch from imported ingredients like this on a case by case basis.
This doesn’t work if the drug isn’t stable or has other weird chemical properties that require special handling of on sort or another, but I believe it has been a workable solution for some people if they can find a source of the drug somewhere & a willing pharmacist.
posted by pharm at 1:56 AM on February 15, 2016
Even in the US, I believe it’s still possible for a pharmacist to make up drugs from scratch from imported ingredients like this on a case by case basis.
This doesn’t work if the drug isn’t stable or has other weird chemical properties that require special handling of on sort or another, but I believe it has been a workable solution for some people if they can find a source of the drug somewhere & a willing pharmacist.
posted by pharm at 1:56 AM on February 15, 2016
I also vote for not allowing drug companies to run ads for their drugs.
Yes. IIRC the only countries that currently allow drug ads are the US and New Zealand, and I think both should ban that practice. It adds to existing bad incentives.
Also, seconding effugas' remark that drug discovery should probably leave the US. The current state of affairs is ridiculous and in 2016 we should be doing better than this.
posted by iffthen at 5:36 AM on February 15, 2016 [1 favorite]
Yes. IIRC the only countries that currently allow drug ads are the US and New Zealand, and I think both should ban that practice. It adds to existing bad incentives.
Also, seconding effugas' remark that drug discovery should probably leave the US. The current state of affairs is ridiculous and in 2016 we should be doing better than this.
posted by iffthen at 5:36 AM on February 15, 2016 [1 favorite]
Even in the US, I believe it’s still possible for a pharmacist to make up drugs from scratch from imported ingredients like this on a case by case basis.
Yes. They are called compounding pharmacies...
posted by jim in austin at 5:38 AM on February 15, 2016 [1 favorite]
Yes. They are called compounding pharmacies...
posted by jim in austin at 5:38 AM on February 15, 2016 [1 favorite]
Addendum, full disclosure and FWIW: the current clusterfuck of bad incentives for Big Pharma, stupid drug laws, and trade issues directly impacts my own ability to contribute to the economy. At best and at great difficulty I can access drugs that allow me to contribute at a level approaching 100% of self-considered potential. (These drugs are scheduled and raise eyebrows in various quarters.) At worst, I either remain dysfunctional or resort to illegal means. Needless to say, I consider un-fucking the aforementioned three problems to be directly in my own personal interest. Bias warning.
posted by iffthen at 6:27 AM on February 15, 2016
posted by iffthen at 6:27 AM on February 15, 2016
We wouldn't people to die because there were insufficient incentive to drive the companies to take risks on creating new drugs either.
I hardly think the medical community is lacking sufficient incentive to keep people from dying. Show me a doctor/epidemiologist/biomedical researcher who loses interest in the field purely because there isn't enough money to be made and I'll show you a really shitty person.
It's the investors who always pouting about incentives.
posted by RonButNotStupid at 6:34 AM on February 15, 2016
I hardly think the medical community is lacking sufficient incentive to keep people from dying. Show me a doctor/epidemiologist/biomedical researcher who loses interest in the field purely because there isn't enough money to be made and I'll show you a really shitty person.
It's the investors who always pouting about incentives.
posted by RonButNotStupid at 6:34 AM on February 15, 2016
It's strange how the article frames drug shortages as more or less a natural law that has to be reckoned with, and only the AHA's letter to the editor frames it as a problem to solve.
posted by RobotVoodooPower at 6:38 AM on February 15, 2016 [1 favorite]
posted by RobotVoodooPower at 6:38 AM on February 15, 2016 [1 favorite]
In discussions of economic issues, one will hear the advocates for a free market bring up the concept of a moral hazard. Incentives that are caused by regulation that lead to adverse results. Why don't we hear about moral hazards when the regulation enables rent seeking?
Copyright that leads to generations of otherwise productive citizens living on a guaranteed paycheck they don't work for somehow isn't the same sort of moral decay as need based food stamps. Medical regulatory capture is somehow seen as a fact of life, an inevitability, while we fight over the elderly having a livable income...
posted by idiopath at 7:05 AM on February 15, 2016 [4 favorites]
Copyright that leads to generations of otherwise productive citizens living on a guaranteed paycheck they don't work for somehow isn't the same sort of moral decay as need based food stamps. Medical regulatory capture is somehow seen as a fact of life, an inevitability, while we fight over the elderly having a livable income...
posted by idiopath at 7:05 AM on February 15, 2016 [4 favorites]
That Tufts study is funded by the pharmaceutical industry. It is horseshit. Stop quoting it as if it has any bearing on the truth. The pharmaceutical industry spending more money on marketing -- advertising and bribes for physician testimonials -- than it spends on research.
It's nontrivial to determine how much it costs to produce a new drug. At any given time, multiple drug candidates are being developed by a company. Most of those candidates will fail. The development time for a drug is around 14 years. Costs fluctuate from year to year (usually up). So the cost of developing one successful drug has to include the cost of developing many failed drugs over many years, with lots of variation from year to year. Some people have argued that the $2.6 billion figure is high. If so, it's not by much. A more conservative estimate I've heard is $1.8 billion. It's an absurd amount of money either way.
It's true that companies spend more on marketing than on R&D, but marketing is a net generator of revenue. Meaning that the company makes more money as a result of marketing than it spent on said marketing. That's really the whole point, right? You could take all that money and pour it into R&D, and you'd probably get a bump (many years later) in newly approved drugs. But that would occur alongside a slump in revenue that would ultimately necessitate slashing R&D and leave the company worse off than when it started. I promise you these numbers have been crunched many times by many people. Big Pharma are notorious twiddlers when it comes to strategy and operations.
Even in the US, I believe it’s still possible for a pharmacist to make up drugs from scratch from imported ingredients like this on a case by case basis.
Pharmacists are only allowed allowed to compound a drug formulation that is not commercially available from a manufacturer.
posted by dephlogisticated at 7:47 AM on February 15, 2016 [3 favorites]
It's nontrivial to determine how much it costs to produce a new drug. At any given time, multiple drug candidates are being developed by a company. Most of those candidates will fail. The development time for a drug is around 14 years. Costs fluctuate from year to year (usually up). So the cost of developing one successful drug has to include the cost of developing many failed drugs over many years, with lots of variation from year to year. Some people have argued that the $2.6 billion figure is high. If so, it's not by much. A more conservative estimate I've heard is $1.8 billion. It's an absurd amount of money either way.
It's true that companies spend more on marketing than on R&D, but marketing is a net generator of revenue. Meaning that the company makes more money as a result of marketing than it spent on said marketing. That's really the whole point, right? You could take all that money and pour it into R&D, and you'd probably get a bump (many years later) in newly approved drugs. But that would occur alongside a slump in revenue that would ultimately necessitate slashing R&D and leave the company worse off than when it started. I promise you these numbers have been crunched many times by many people. Big Pharma are notorious twiddlers when it comes to strategy and operations.
Even in the US, I believe it’s still possible for a pharmacist to make up drugs from scratch from imported ingredients like this on a case by case basis.
Pharmacists are only allowed allowed to compound a drug formulation that is not commercially available from a manufacturer.
posted by dephlogisticated at 7:47 AM on February 15, 2016 [3 favorites]
Pharmacists are only allowed allowed to compound a drug formulation that is not commercially available from a manufacturer.
Unless the legal details outlined in the wikipedia article are completely wrong (which is of course possible) this isn’t true, nor does it match the anecdotal evidence I’ve seen. Shorter version: it’s a bit more complicated than that?
posted by pharm at 8:31 AM on February 15, 2016 [1 favorite]
Unless the legal details outlined in the wikipedia article are completely wrong (which is of course possible) this isn’t true, nor does it match the anecdotal evidence I’ve seen. Shorter version: it’s a bit more complicated than that?
posted by pharm at 8:31 AM on February 15, 2016 [1 favorite]
Section 503A of the Federal Food, Drug, and Cosmetic Act
(1) Licensed pharmacist and licensed physician.--A drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician--
...(D) does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product.
There's an exemption for a given change in formulation "which produces for that patient a significant difference". So, for example, if someone has difficulty swallowing, a compounding pharmacist could reformulate a solid dosage form into a liquid dosage form. But you could not get a compounding pharmacist to whip up a batch of Viagra tablets from raw imported sildenafil just because it's cheaper.
posted by dephlogisticated at 8:55 AM on February 15, 2016
(1) Licensed pharmacist and licensed physician.--A drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician--
...(D) does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product.
There's an exemption for a given change in formulation "which produces for that patient a significant difference". So, for example, if someone has difficulty swallowing, a compounding pharmacist could reformulate a solid dosage form into a liquid dosage form. But you could not get a compounding pharmacist to whip up a batch of Viagra tablets from raw imported sildenafil just because it's cheaper.
posted by dephlogisticated at 8:55 AM on February 15, 2016
We wouldn't people to die because there were insufficient incentive to drive the companies to take risks on creating new drugs either.
I hardly think the medical community is lacking sufficient incentive to keep people from dying. Show me a doctor/epidemiologist/biomedical researcher who loses interest in the field purely because there isn't enough money to be made and I'll show you a really shitty person.
It's the investors who always pouting about incentives.
Research costs money — not just interest. The research that pharmaceutical companies do is paid for by investments. Investments are motivated by returns. It has nothing to do with "shitty people" (which is ridiculous sputtering).
posted by esprit de l'escalier at 9:26 AM on February 15, 2016
I hardly think the medical community is lacking sufficient incentive to keep people from dying. Show me a doctor/epidemiologist/biomedical researcher who loses interest in the field purely because there isn't enough money to be made and I'll show you a really shitty person.
It's the investors who always pouting about incentives.
Research costs money — not just interest. The research that pharmaceutical companies do is paid for by investments. Investments are motivated by returns. It has nothing to do with "shitty people" (which is ridiculous sputtering).
posted by esprit de l'escalier at 9:26 AM on February 15, 2016
I have been prescribed a drug from a compounding pharmacy. Basically, it's a drug the insurance company won't cover because my case is an off-label use, and it's too expensive to get it out of pocket even though it is a generic compound that is easily available as an ingredient. So my doctor prescribes a combination of this drug with a common vitamin, and sends the prescription out to the compounding pharmacy, and therefore I get the drug for $70/month out of pocket instead of thousands.
I have tried it twice and it was useless, but at least I got to try it...
posted by elizilla at 9:32 AM on February 15, 2016 [1 favorite]
I have tried it twice and it was useless, but at least I got to try it...
posted by elizilla at 9:32 AM on February 15, 2016 [1 favorite]
Back in my first job out of college I worked in drug research. It was stunning what things cost. They paid me $17K per year to use up a million dollars worth of pipette tips. Seriously, a million dollars for pipette tips!
There is a whole supply chain of overpriced supplies and equipment, layered under the overpriced drugs.
The hospital seems to be a similar thing. Layers and layers of other entities, whose gravy train is based on what the hospital pays them. Supplying hospitals or Big Pharma is probably more lucrative and less stressful, than being a hospital or Big Pharma.
posted by elizilla at 9:39 AM on February 15, 2016 [1 favorite]
There is a whole supply chain of overpriced supplies and equipment, layered under the overpriced drugs.
The hospital seems to be a similar thing. Layers and layers of other entities, whose gravy train is based on what the hospital pays them. Supplying hospitals or Big Pharma is probably more lucrative and less stressful, than being a hospital or Big Pharma.
posted by elizilla at 9:39 AM on February 15, 2016 [1 favorite]
In my old job I used to go to a meeting where the director of the pharmacy division of the hospital where I worked would talk about shortages. It was always the most gripping part of the meeting, because there is this whole dramatic process of drug hoarding and gray-market sales [I should say that my hospital explicitly refused to participate in the gray market], and you never knew what was going to be in short supply. A lot of the more surprising shortages (IV acetaminophen) seemed anecdotally to be due to aging manufacturing infrastructure that was making cheap generics.
The most surprising one for me was normal saline, which is just sterile salt water. It turns out that a lot of hospitals depended on compounding pharmacies to make and sell individually packaged sterile syringes of normal saline for IV flushes and things, and after the great meningitis scandal of 2012 nobody was buying from compounding pharmacies anymore due to concerns about contamination.
posted by The Elusive Architeuthis at 10:01 AM on February 15, 2016
The most surprising one for me was normal saline, which is just sterile salt water. It turns out that a lot of hospitals depended on compounding pharmacies to make and sell individually packaged sterile syringes of normal saline for IV flushes and things, and after the great meningitis scandal of 2012 nobody was buying from compounding pharmacies anymore due to concerns about contamination.
posted by The Elusive Architeuthis at 10:01 AM on February 15, 2016
If a company cannot produce a patented drug, or ever refuse sale of the drug to a legitimate customer, they should lose the patent to the public domain. Perhaps they should be allowed a few months grace, perhaps not.
I also think there's a strong case to be made for direct government/hospital networks directly commissioning generic contract labs for already approved drugs. Put the single payers or perhaps insurers in the driver seat on supply for non-property drugs. Formalize and expand the compounding system.
posted by bonehead at 10:08 AM on February 15, 2016 [4 favorites]
I also think there's a strong case to be made for direct government/hospital networks directly commissioning generic contract labs for already approved drugs. Put the single payers or perhaps insurers in the driver seat on supply for non-property drugs. Formalize and expand the compounding system.
posted by bonehead at 10:08 AM on February 15, 2016 [4 favorites]
IV acetaminophen is a great object lesson. The active drug is dirt cheap and has been around for ages. A pharmaceutical company got a branded IV formulation approved and began selling it for $18 a vial. Then another company bought the rights and doubled the price.
At the hospital where I'm working, pharmacists have pushed hard to get the doctors to stop using the IV formulation so much, given the obvious cost savings with oral APAP. The doctors have resisted. They think there's a clear benefit from the IV formulation (and admittedly there is some data to support this). They also have no particular incentive to reduce costs; it simply doesn't affect them, and some doctors are offended by the notion that cost should even factor into medical decisions. This has resulted in long, heated arguments in the P&T meetings.
Meanwhile, it's the patients that ultimately pay for the drug, either directly or via health insurance premiums, and they don't get any choice in the matter. They get whatever drug the doctor orders and receive a bill for it later.
posted by dephlogisticated at 10:41 AM on February 15, 2016
At the hospital where I'm working, pharmacists have pushed hard to get the doctors to stop using the IV formulation so much, given the obvious cost savings with oral APAP. The doctors have resisted. They think there's a clear benefit from the IV formulation (and admittedly there is some data to support this). They also have no particular incentive to reduce costs; it simply doesn't affect them, and some doctors are offended by the notion that cost should even factor into medical decisions. This has resulted in long, heated arguments in the P&T meetings.
Meanwhile, it's the patients that ultimately pay for the drug, either directly or via health insurance premiums, and they don't get any choice in the matter. They get whatever drug the doctor orders and receive a bill for it later.
posted by dephlogisticated at 10:41 AM on February 15, 2016
the New Yorker's recent piece that Everyone Hates Martin Shkreli. Everyone Is Missing the Point should be required reading.
Just because there's a lot of others that we don't know by name doesn't mean we shouldn't set the ones we do know about on fire.
posted by Hoopo at 11:33 AM on February 15, 2016 [2 favorites]
Just because there's a lot of others that we don't know by name doesn't mean we shouldn't set the ones we do know about on fire.
posted by Hoopo at 11:33 AM on February 15, 2016 [2 favorites]
And then what? The world has no shortage of assholes.
posted by fragmede at 6:35 PM on February 15, 2016
posted by fragmede at 6:35 PM on February 15, 2016
That's the least compelling reason I can think of to not go after any particular asshole.
posted by Etrigan at 6:58 PM on February 15, 2016
posted by Etrigan at 6:58 PM on February 15, 2016
Back in my first job out of college I worked in drug research. It was stunning what things cost. They paid me $17K per year to use up a million dollars worth of pipette tips. Seriously, a million dollars for pipette tips!
Each tip costs around $1 (or $0.3 for nonsterile tips) to buy with no discount and not in bulk, and can only reliably be used once. Yes, that's expensive, but I wonder what the margins on pipette tips actually are. A 20uL pipette tip, for example, needs to be manufactured to be accurate and precise enough to dispense within 100pL of the volume it's set to, it needs to be made from a plastic that compounds aren't going to adhere to, and it usually needs to be sterile.
posted by Thoughtcrime at 3:23 PM on February 16, 2016
Each tip costs around $1 (or $0.3 for nonsterile tips) to buy with no discount and not in bulk, and can only reliably be used once. Yes, that's expensive, but I wonder what the margins on pipette tips actually are. A 20uL pipette tip, for example, needs to be manufactured to be accurate and precise enough to dispense within 100pL of the volume it's set to, it needs to be made from a plastic that compounds aren't going to adhere to, and it usually needs to be sterile.
posted by Thoughtcrime at 3:23 PM on February 16, 2016
It was a little over a year ago my good friend was okayed for a treatment on a curable infection. Actually it took until the fourth time before he was okayed to get the treatment. The prior three times he was denied because the 12 week treatment comes close to six figures; the cost per pill is over a grand each. Someone somewhere along the line got the idea that he needed those drugs to cure him. I'm sure they meant well. He died a week later. I've mostly worked through the grief, but the bitterness over his death and this whole topic keeps a little fire going in the pit of my stomach.
I'm much too empathetic to be able to give, have any inclination for, or want of, violence towards anybody. But if I did, I think I would start by punching the taste out of Shkreli's contemptuously smirking mouth.
posted by P.o.B. at 4:01 PM on February 17, 2016
I'm much too empathetic to be able to give, have any inclination for, or want of, violence towards anybody. But if I did, I think I would start by punching the taste out of Shkreli's contemptuously smirking mouth.
posted by P.o.B. at 4:01 PM on February 17, 2016
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He's the villain that we deserve
posted by schmod at 9:07 PM on February 14, 2016 [3 favorites]