Cancer drug rationing
June 21, 2023 7:57 PM Subscribe
US doctors are rationing lifesaving cancer drugs amid dire shortage The drug shortage could lead to preventable deaths, and it's unclear when it will end.
The stunning inspection report, released in January, leaves no doubt as to why the plant was shut down. In addition to various manufacturing violations, including laboratory and quality control problems, inspectors reported finding a truck 150 meters from the facility loaded with plastic bags full of shredded and torn documents. When the inspector dug into the documents, they realized they were quality control documents and analytical weight slips.
I realize that this is only a short article, but this point immediately made me question the initial problem of rationing explained by a doctor upstream in the piece:
But "If we reduce her doses to extend our drug supply, we risk reducing the chance of response, and that could mean missing a chance at potentially curative surgery," Rice wrote. "If her scan after that third cycle isn’t what we hope, the first question she will ask is: 'What if I had received the full dose? Would it have made a difference?'"
So if the patient had received a full dose of the cisplatin (or other platinum-based chemotherapeutics), but it was not QCed, then it seems possible that patients — in general — may run the risk of remaining sick anyway, because the medications had not been made to specification in the first place. Who knows what dosage they are really getting?
While the FDA cannot manage supply chains, the parent federal government could presumably contract to purchase needed medications in bulk — just as it did by way of emergency measures for Covid vaccines and treatments like Paxlovid and remdesivir — enforcing safety and QC measures by means of contract law.
And, in any case, this is the sort of thing that countries with single-payer healthcare systems already do: buy medications in bulk, so as to avoid supply chain, quality, cost, and other problems related to free market inefficiencies.
posted by They sucked his brains out! at 8:13 PM on June 21, 2023 [6 favorites]
I realize that this is only a short article, but this point immediately made me question the initial problem of rationing explained by a doctor upstream in the piece:
But "If we reduce her doses to extend our drug supply, we risk reducing the chance of response, and that could mean missing a chance at potentially curative surgery," Rice wrote. "If her scan after that third cycle isn’t what we hope, the first question she will ask is: 'What if I had received the full dose? Would it have made a difference?'"
So if the patient had received a full dose of the cisplatin (or other platinum-based chemotherapeutics), but it was not QCed, then it seems possible that patients — in general — may run the risk of remaining sick anyway, because the medications had not been made to specification in the first place. Who knows what dosage they are really getting?
While the FDA cannot manage supply chains, the parent federal government could presumably contract to purchase needed medications in bulk — just as it did by way of emergency measures for Covid vaccines and treatments like Paxlovid and remdesivir — enforcing safety and QC measures by means of contract law.
And, in any case, this is the sort of thing that countries with single-payer healthcare systems already do: buy medications in bulk, so as to avoid supply chain, quality, cost, and other problems related to free market inefficiencies.
posted by They sucked his brains out! at 8:13 PM on June 21, 2023 [6 favorites]
This is people committing manslaughter.
...aaand they're based in a foreign country. Good luck getting any mileage out of that lawsuit.
posted by aramaic at 8:18 PM on June 21, 2023 [2 favorites]
...aaand they're based in a foreign country. Good luck getting any mileage out of that lawsuit.
posted by aramaic at 8:18 PM on June 21, 2023 [2 favorites]
The FDA has since tried working with other manufacturers to boost production of the cancer drugs and is exploring temporarily importing drugs from China to ease the shortage... It's also unclear how much the imported drugs will help.
I mean ... it will help by getting more drugs? I'm confused because we already import like 80% of our pharma products from China, and the problematic plant was in India.
posted by credulous at 8:40 PM on June 21, 2023 [2 favorites]
I mean ... it will help by getting more drugs? I'm confused because we already import like 80% of our pharma products from China, and the problematic plant was in India.
posted by credulous at 8:40 PM on June 21, 2023 [2 favorites]
I'm not clear how buying medications in bulk would prevent quality problems, since it's the exact same company making the medications and presumably would need to be audited in a similar manner (and would still be shut down).
posted by meowzilla at 9:14 PM on June 21, 2023 [2 favorites]
posted by meowzilla at 9:14 PM on June 21, 2023 [2 favorites]
OH MY GOD
My partner was treated for stage four nasopharyngeal carcinoma at the height of the pandemic, and the chemotherapy part of her treatment used cisplatin (one round, with two more scheduled that her docs canceled when her tumors responded well to radiation). She’s been in remission for a couple of years and her doctor seems pretty confident that she’ll stay healthy, but I keep thinking about what if she had to be treated now in the midst of these shortages?
This is ENRAGING and I feel so awful for the people who will needlessly suffer because of these careless, soulless motherfuckers
posted by donatella at 9:46 PM on June 21, 2023 [33 favorites]
My partner was treated for stage four nasopharyngeal carcinoma at the height of the pandemic, and the chemotherapy part of her treatment used cisplatin (one round, with two more scheduled that her docs canceled when her tumors responded well to radiation). She’s been in remission for a couple of years and her doctor seems pretty confident that she’ll stay healthy, but I keep thinking about what if she had to be treated now in the midst of these shortages?
This is ENRAGING and I feel so awful for the people who will needlessly suffer because of these careless, soulless motherfuckers
posted by donatella at 9:46 PM on June 21, 2023 [33 favorites]
It's not just the manufacturers; it's the fucking PBMs who make it a money-losing proposition to produce these drugs without cutting corners.
posted by Ickster at 9:51 PM on June 21, 2023 [13 favorites]
posted by Ickster at 9:51 PM on June 21, 2023 [13 favorites]
the fucking PBMs
The only group of people related to the health care system that I loathe more than insurance companies and even the particularly abusive for profit hospitals.
posted by wierdo at 10:10 PM on June 21, 2023 [5 favorites]
The only group of people related to the health care system that I loathe more than insurance companies and even the particularly abusive for profit hospitals.
posted by wierdo at 10:10 PM on June 21, 2023 [5 favorites]
The only psych med production facility in Mexico got shut down last November for similar reasons. Ironically a lot of people started getting their supply from India instead.
Can’t win for losing.
posted by Tell Me No Lies at 10:32 PM on June 21, 2023 [2 favorites]
Can’t win for losing.
posted by Tell Me No Lies at 10:32 PM on June 21, 2023 [2 favorites]
I have someone undergoing cancer treatment right now (not in USA) so now i have to dig into their sources. Csn people not just do their fucking jobs and do them as well as they can?
posted by Iteki at 11:19 PM on June 21, 2023 [2 favorites]
posted by Iteki at 11:19 PM on June 21, 2023 [2 favorites]
"Shortages of medicines are also not unique to Ireland, and there is no evidence that shortages disproportionately impact patients in Ireland compared to other countries, it said."
posted by BobTheScientist at 11:47 PM on June 21, 2023 [1 favorite]
posted by BobTheScientist at 11:47 PM on June 21, 2023 [1 favorite]
who make it a money-losing proposition to produce these drugs without cutting corners
Is it really a money-losing proposition at wholesale pharmaceutical prices, can anyone in the industry say more? (Or is it positive-margin but manufacturing execs look good squeezing out more profits even if it blows up on the company later?)
There's a long way between the U.S. cash retail price of cisplatin -- hundreds of dollars per gram -- and the marginal cost of producing a gram purely as chemical engineering. Even with the price of platinum! Process and compliance costs in most industries are more as setup cost than per-unit cost, but I don't know pharmaceutical process.
posted by away for regrooving at 12:39 AM on June 22, 2023 [2 favorites]
Is it really a money-losing proposition at wholesale pharmaceutical prices, can anyone in the industry say more? (Or is it positive-margin but manufacturing execs look good squeezing out more profits even if it blows up on the company later?)
There's a long way between the U.S. cash retail price of cisplatin -- hundreds of dollars per gram -- and the marginal cost of producing a gram purely as chemical engineering. Even with the price of platinum! Process and compliance costs in most industries are more as setup cost than per-unit cost, but I don't know pharmaceutical process.
posted by away for regrooving at 12:39 AM on June 22, 2023 [2 favorites]
And, in any case, this is the sort of thing that countries with single-payer healthcare systems already do: buy medications in bulk, so as to avoid supply chain, quality, cost, and other problems related to free market inefficiencies.
I can't speak for other countries, but in the UK the NHS is far from immune to drug shortages, which have been increasing dramatically in recent years. Drug supply in the UK follows a fairly standard wholesale distribution model handled by for-profit private companies, even though we are basically single-payer as you put it. I have worked in the UK pharmaceutical supply chain for over two decades and we have been affected by these kinds of issues far more frequently in the past few years.
I suspect that how a national healthcare system is funded is largely irrelevant with regard to pharmaceutical supply, because pharma is a global industry that has basically always been a private, for-profit enterprise. There is no practical way that even a large, rich nation like the UK could make every single drug it needs locally. Even if you make every other component of your healthcare non-profit or whatever, if you want to offer patients the full spectrum of modern treatments you will still have to buy many drugs from international companies that ultimately need to make a profit to continue to exist. Some of those companies will get the balance between making profit and supplying drugs safely wrong, leading to shortages at best, and tragic consequences at worst. I think that can't be fixed by national healthcare policy, only by some sort of international effort to regulate pharmaceutical manufacturing globally.
posted by tomsk at 12:50 AM on June 22, 2023 [2 favorites]
I can't speak for other countries, but in the UK the NHS is far from immune to drug shortages, which have been increasing dramatically in recent years. Drug supply in the UK follows a fairly standard wholesale distribution model handled by for-profit private companies, even though we are basically single-payer as you put it. I have worked in the UK pharmaceutical supply chain for over two decades and we have been affected by these kinds of issues far more frequently in the past few years.
I suspect that how a national healthcare system is funded is largely irrelevant with regard to pharmaceutical supply, because pharma is a global industry that has basically always been a private, for-profit enterprise. There is no practical way that even a large, rich nation like the UK could make every single drug it needs locally. Even if you make every other component of your healthcare non-profit or whatever, if you want to offer patients the full spectrum of modern treatments you will still have to buy many drugs from international companies that ultimately need to make a profit to continue to exist. Some of those companies will get the balance between making profit and supplying drugs safely wrong, leading to shortages at best, and tragic consequences at worst. I think that can't be fixed by national healthcare policy, only by some sort of international effort to regulate pharmaceutical manufacturing globally.
posted by tomsk at 12:50 AM on June 22, 2023 [2 favorites]
To add to tomsk's statement, this being a generic manufacturer in India does not mean this only happens in India. In all of Europe right now, bupropion is unavailable and will continue to be for the foreseeable future. GSK found a fault in their manufacturing and halted all production in December. I had to go to the US to refresh my supply, made, interestingly enough, by an Indian generics company. (Bupropion is theoretically only prescribed in the UK and EU for smoking cessation, so no one is worried. All antidepressant use is off label.)
Drug shortages happen because there are so few places manufacturing any particular one. There are steps that can be taken to sure up supply lines, like having a backup producer of stockpiling enough medication that it does not run out while a new factory is spooled up, but in the end, this unfortunately happens. In a rich country with a functional health care system (unlike the US or the UK), this might be possible.
All this is to say that this is exacerbated by the US system, but, for as messed up a system as it is, it is not the sole cause.
posted by Hactar at 3:26 AM on June 22, 2023 [5 favorites]
Drug shortages happen because there are so few places manufacturing any particular one. There are steps that can be taken to sure up supply lines, like having a backup producer of stockpiling enough medication that it does not run out while a new factory is spooled up, but in the end, this unfortunately happens. In a rich country with a functional health care system (unlike the US or the UK), this might be possible.
All this is to say that this is exacerbated by the US system, but, for as messed up a system as it is, it is not the sole cause.
posted by Hactar at 3:26 AM on June 22, 2023 [5 favorites]
I personally would be dead without cisplatin. It saved my life literally. I was in treatment with several older people who would probably have been sacrificed to get the cisplatin to me, in a triage situation.
posted by kittens for breakfast at 4:20 AM on June 22, 2023 [7 favorites]
posted by kittens for breakfast at 4:20 AM on June 22, 2023 [7 favorites]
Generic drugs should be manufactured by the government (and I mean actually BY the government, at factories owned by the federal government and staffed by folks on the General Schedule) and distributed at cost.
posted by rockindata at 4:37 AM on June 22, 2023 [20 favorites]
posted by rockindata at 4:37 AM on June 22, 2023 [20 favorites]
Fuuuuuck. My kiddo received cisplatin for osteosarcoma in 2020-2021. His cancer came back in 2022 (and again this year) and now I wonder. Definitely going to reach out to the sarcoma team and ask.
posted by kokaku at 5:10 AM on June 22, 2023 [4 favorites]
posted by kokaku at 5:10 AM on June 22, 2023 [4 favorites]
Generic drugs should be manufactured by the government (and I mean actually BY the government, at factories owned by the federal government and staffed by folks on the General Schedule) and distributed at cost.I’d also accept the regulated utility model with a modest guaranteed profit margin but also executive accountability and a salary cap. There’s no way you couldn’t get a competent administrator for a decent non-superyacht salary - I’d think the odds might be better because you’d filter out the finance weasels who’d be focused on juicing stock prices.
posted by adamsc at 5:54 AM on June 22, 2023 [4 favorites]
There is no practical way that even a large, rich nation like the UK could make every single drug it needs locally.
The US, on the other hand, absolutely could make every single drug it needs locally, and probably help supply the rest of the world. We have just chosen to outsource all of our manufacturing to countries where workers can be paid less (and often where environmental and safety regulations are less stringent) because that's how the corporations make their money. A nationalized pharmaceutical industry is a thing the US could do tomorrow.
posted by hydropsyche at 6:07 AM on June 22, 2023 [9 favorites]
The US, on the other hand, absolutely could make every single drug it needs locally, and probably help supply the rest of the world. We have just chosen to outsource all of our manufacturing to countries where workers can be paid less (and often where environmental and safety regulations are less stringent) because that's how the corporations make their money. A nationalized pharmaceutical industry is a thing the US could do tomorrow.
posted by hydropsyche at 6:07 AM on June 22, 2023 [9 favorites]
Capitalism.
posted by AlSweigart at 6:38 AM on June 22, 2023 [2 favorites]
posted by AlSweigart at 6:38 AM on June 22, 2023 [2 favorites]
My father is fighting stage IV colon cancer, we just talked on Father's Day. He's on a second chemo treatment course because the first didn't have much effect. Probably because the stuff isn't up to standards after reading this article.
He told me he's been hit with this shortage. They're scrambling to find a new molecule to use. I'm preparing for the possibility that we've lost too much time.
posted by mookoz at 7:31 AM on June 22, 2023 [1 favorite]
He told me he's been hit with this shortage. They're scrambling to find a new molecule to use. I'm preparing for the possibility that we've lost too much time.
posted by mookoz at 7:31 AM on June 22, 2023 [1 favorite]
I'm confused because we already import like 80% of our pharma products from China, and the problematic plant was in India.
It's nowhere near 80% - India is also a major drug manufacturer. While our imports from China are a hair more than the imports from India by volume, the value of the pharmaceuticals imported from India are much higher - in general, India is the leader of manufacturing higher value but still generic drugs. Here's some data.
I do work somewhat adjacent to this, and I can say confidently that I don't think that the single-payer systems are any better off in cases like recalls and shortages. There are a lot of drugs where only a few companies make the drug, and even fewer companies synthesize the API. It's a big risk, and QA (or other) issues can have huge reverberations. Buyers are aware of this and do take active steps in market shaping but it's difficult to do when demand is limited and production only makes sense at a certain scale. While drugs are expensive from a consumer lens, margins for generic manufacturers are quite thin.
For those saying that US manufacturing would have solved it? Just look at the formula shortage last year, which stemmed from issues in a Michigan plant.
It certainly sounds like this facility was up to nefarious things and shutting down production was the right choice - even recognizing the severity of the consequences. I don't think it's fair to say that any part of this has easy or obvious solutions.
posted by mosst at 7:56 AM on June 22, 2023 [4 favorites]
It's nowhere near 80% - India is also a major drug manufacturer. While our imports from China are a hair more than the imports from India by volume, the value of the pharmaceuticals imported from India are much higher - in general, India is the leader of manufacturing higher value but still generic drugs. Here's some data.
I do work somewhat adjacent to this, and I can say confidently that I don't think that the single-payer systems are any better off in cases like recalls and shortages. There are a lot of drugs where only a few companies make the drug, and even fewer companies synthesize the API. It's a big risk, and QA (or other) issues can have huge reverberations. Buyers are aware of this and do take active steps in market shaping but it's difficult to do when demand is limited and production only makes sense at a certain scale. While drugs are expensive from a consumer lens, margins for generic manufacturers are quite thin.
For those saying that US manufacturing would have solved it? Just look at the formula shortage last year, which stemmed from issues in a Michigan plant.
It certainly sounds like this facility was up to nefarious things and shutting down production was the right choice - even recognizing the severity of the consequences. I don't think it's fair to say that any part of this has easy or obvious solutions.
posted by mosst at 7:56 AM on June 22, 2023 [4 favorites]
US manufacturing wouldn’t necessarily have solved this problem, but nationalized US manufacturing probably would. It just wouldn’t make as many billionaires.
posted by rockindata at 9:05 AM on June 22, 2023 [8 favorites]
posted by rockindata at 9:05 AM on June 22, 2023 [8 favorites]
Generic drugs should be manufactured by the government (and I mean actually BY the government, at factories owned by the federal government and staffed by folks on the General Schedule) and distributed at cost.
I don't see why that would necessarily solve the problem. What you need is an excess of capacity in ordinary times in order to ensure that if one plant gets shut down, there is no shortage. So just nationalising production doesn't solve it, you then need to take the next step of ensuring n-1 capacity. In some cases governments are able to do this but in many they are not.
Some kind of non-market mechanism which could be government ownership, regulated asset base, capacity based contracts, or something else is necessary as a precondition for excess capacity since the only market mechanism that would accommodate this (extreme shortage pricing) is not neither socially acceptable nor realistic. But it's a precondition, just having the mechanism isn't enough, you need to actually require the capacity as well.
posted by atrazine at 9:35 AM on June 22, 2023 [1 favorite]
I don't see why that would necessarily solve the problem. What you need is an excess of capacity in ordinary times in order to ensure that if one plant gets shut down, there is no shortage. So just nationalising production doesn't solve it, you then need to take the next step of ensuring n-1 capacity. In some cases governments are able to do this but in many they are not.
Some kind of non-market mechanism which could be government ownership, regulated asset base, capacity based contracts, or something else is necessary as a precondition for excess capacity since the only market mechanism that would accommodate this (extreme shortage pricing) is not neither socially acceptable nor realistic. But it's a precondition, just having the mechanism isn't enough, you need to actually require the capacity as well.
posted by atrazine at 9:35 AM on June 22, 2023 [1 favorite]
In this particular case though the plant was shut down because of production and record keeping irregularities presumably motivated by profit and/or corruption. Cases like water in Flint show governments aren't immune to those sorts of perverse incentives but the pressure is less.
posted by Mitheral at 9:51 AM on June 22, 2023
posted by Mitheral at 9:51 AM on June 22, 2023
Generic drugs should be manufactured by the government (and I mean actually BY the government, at factories owned by the federal government and staffed by folks on the General Schedule) and distributed at cost.
I don't see why that would necessarily solve the problem. What you need is an excess of capacity in ordinary times in order to ensure that if one plant gets shut down, there is no shortage. So just nationalising production doesn't solve it, you then need to take the next step of ensuring n-1 capacity. In some cases governments are able to do this but in many they are not.
Governments are terrific about hiring people over capacity just in case. The entire Department of Defense is over capacity just in case. They have huge organizations devoted to answering the question of "What do we do with these 18-year-olds to keep them out of trouble while they sit around and wait to be useful?"
posted by Etrigan at 10:22 AM on June 22, 2023 [5 favorites]
I don't see why that would necessarily solve the problem. What you need is an excess of capacity in ordinary times in order to ensure that if one plant gets shut down, there is no shortage. So just nationalising production doesn't solve it, you then need to take the next step of ensuring n-1 capacity. In some cases governments are able to do this but in many they are not.
Governments are terrific about hiring people over capacity just in case. The entire Department of Defense is over capacity just in case. They have huge organizations devoted to answering the question of "What do we do with these 18-year-olds to keep them out of trouble while they sit around and wait to be useful?"
posted by Etrigan at 10:22 AM on June 22, 2023 [5 favorites]
While overproduction of life-saving medicines by the government is important (or overproduction by those contracted by said gov't), distribution is just as important.
The United States had a supply of smallpox vaccine which was left underused — perhaps deliberately — when mpox broke out among the MSM community this same time last year. It took an immense effort of reminding the public about the early days of HIV to get the ball rolling on immunization, which thankfully succeeded in helping control the spread, along with early and persistent communication within the MSM community.
Returning again to the evidence-based example of Covid, it is possible for a government to mobilize private industry to make and distribute safe medicines, even with some early quality control problems with vaccine manufacturing by some contractors in 2021 and 2022. But moving the process forwards does require pistons in the engine to fire mostly in sync.
posted by They sucked his brains out! at 3:37 PM on June 22, 2023
The United States had a supply of smallpox vaccine which was left underused — perhaps deliberately — when mpox broke out among the MSM community this same time last year. It took an immense effort of reminding the public about the early days of HIV to get the ball rolling on immunization, which thankfully succeeded in helping control the spread, along with early and persistent communication within the MSM community.
Returning again to the evidence-based example of Covid, it is possible for a government to mobilize private industry to make and distribute safe medicines, even with some early quality control problems with vaccine manufacturing by some contractors in 2021 and 2022. But moving the process forwards does require pistons in the engine to fire mostly in sync.
posted by They sucked his brains out! at 3:37 PM on June 22, 2023
>Generic drugs should be manufactured by the
> government (and I mean actually BY the
> government, at factories owned by the
> federal government and staffed by folks
> on the General Schedule) and distributed at cost.
I don't see why that would necessarily solve the problem.
I don't think it would solve it, but it would cut down on the drug-produced-in-another-country-stops-coming-or-doesn't-meet-standards problem.
posted by Tell Me No Lies at 4:22 PM on June 22, 2023
> government (and I mean actually BY the
> government, at factories owned by the
> federal government and staffed by folks
> on the General Schedule) and distributed at cost.
I don't see why that would necessarily solve the problem.
I don't think it would solve it, but it would cut down on the drug-produced-in-another-country-stops-coming-or-doesn't-meet-standards problem.
posted by Tell Me No Lies at 4:22 PM on June 22, 2023
This story reminded me a lot of a book I read early in the pandemic: Bottle of Lies: The Inside Story of the Generic Drug Boom, by Katherine Eban. Right down to the "and they ran around hiding evidence of the falsified reports while the FDA inspectors were en route" kind of talk.
As a chronically ill person with a long list of prescriptions, mostly generic, the book and this story terrified me. It's one of those things I have to not think about. Fortunately my medications are mostly for maintenance so even if I get a bad bottle, it probably won't kill me, unlike the cancer patients.
posted by gentlyepigrams at 4:38 PM on June 22, 2023 [1 favorite]
As a chronically ill person with a long list of prescriptions, mostly generic, the book and this story terrified me. It's one of those things I have to not think about. Fortunately my medications are mostly for maintenance so even if I get a bad bottle, it probably won't kill me, unlike the cancer patients.
posted by gentlyepigrams at 4:38 PM on June 22, 2023 [1 favorite]
MSM is an initialism for "men who have sex with men" in case anyone else is wondering. It's well known by people in public health spaces (how I heard of it but I still had to look it up to be sure) but not really used outside that context.
posted by Nec_variat_lux_fracta_colorem at 6:28 AM on June 23, 2023
posted by Nec_variat_lux_fracta_colorem at 6:28 AM on June 23, 2023
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In another instance, the inspection report notes that an employee, upon learning the FDA inspectors were walking through the quality control lab, ran to the balance room and "immediately rushed and tore apart balance printouts along with Auto Titrator spectrums and threw the torn pieces into the small trash container located next to the balance. Later, he threw [redacted] acid solution inside the same trash in an attempt to destroy the evidence." The bag of torn, acid-soaked reports was later found stuffed under a staircase.
"The killing of a person without malice aforethought, but in the commission of an unlawful act that leads to an unintended death" is the definition of manslaughter.
This isn't "going to lead to preventable death". This is people committing manslaughter.
posted by mhoye at 8:07 PM on June 21, 2023 [15 favorites]