Students make pricey drug for 2 bucks per pill; pharmabro has tantrum
December 2, 2016 7:59 AM Subscribe
A group of Australian high school students have managed to recreate a life-saving drug that rose from US$13.50 to US$750 a tablet overnight after an unscrupulous price-hike by former hedge fund manager Martin Shkreli. The Sydney Grammar students reproduced the drug, Daraprim, used to treat a rare but deadly parasitic infection, in their high school laboratory with support from the University of Sydney and global members of the Open Source Malaria consortium.
They succeeded, making the drug for a mere $2 a pill. The story went global overnight, with headlines such as “High schoolers punch Martin Shkreli in the face, figuratively” in Forbes and “Sydney high school students ‘show up’ Martin Shkreli” in the Washington Post. On Twitter Shkreli dismissed what the students achieved, saying “how is that showing anyone up? Almost any drug can be made at small scale for a low price”.
Previously and previously.
They succeeded, making the drug for a mere $2 a pill. The story went global overnight, with headlines such as “High schoolers punch Martin Shkreli in the face, figuratively” in Forbes and “Sydney high school students ‘show up’ Martin Shkreli” in the Washington Post. On Twitter Shkreli dismissed what the students achieved, saying “how is that showing anyone up? Almost any drug can be made at small scale for a low price”.
Previously and previously.
Well, he's not wrong. The vast majority of a drug's cost is normally clinical trials, then compound development. Most simple molecules cost pennies per pill to make.
That said, Shkreli's drugs are expensive because he's taking advantage of regulatory loopholes. The R&D expenses were paid off decades ago.
posted by Orange Pamplemousse at 8:08 AM on December 2, 2016 [29 favorites]
That said, Shkreli's drugs are expensive because he's taking advantage of regulatory loopholes. The R&D expenses were paid off decades ago.
posted by Orange Pamplemousse at 8:08 AM on December 2, 2016 [29 favorites]
How was the $2 cost calculated?
Does it take into account the capital cost of machinery, the labor needed to create, pack, warehouse and ship the goods, quality control, regulatory compliance, cost of the building etc?
The article doesn't say exactly but I am guessing that they just based it on the cost of the chemicals which are only one component of a cost.
Figuring out the cost of manufacturing a good is far more complicated than anyone thinks - especially when you get into overhead calculations.
posted by nolnacs at 8:16 AM on December 2, 2016 [9 favorites]
Does it take into account the capital cost of machinery, the labor needed to create, pack, warehouse and ship the goods, quality control, regulatory compliance, cost of the building etc?
The article doesn't say exactly but I am guessing that they just based it on the cost of the chemicals which are only one component of a cost.
Figuring out the cost of manufacturing a good is far more complicated than anyone thinks - especially when you get into overhead calculations.
posted by nolnacs at 8:16 AM on December 2, 2016 [9 favorites]
This is not hard stuff. Even easier, buy 20kg of active ingredient from India, which has fantastic scale up chemists, safety test it, and supply the US for 2 years to bankrupt Shkreli's company. But but socialism etc etc
posted by benzenedream at 8:17 AM on December 2, 2016 [9 favorites]
posted by benzenedream at 8:17 AM on December 2, 2016 [9 favorites]
To elaborate further, my company's system has 4 different types of costs depending on which factors you do or do not want to consider when pricing an item.
posted by nolnacs at 8:19 AM on December 2, 2016
posted by nolnacs at 8:19 AM on December 2, 2016
Thanks for the link to a good piece I missed, Celsius1414. Yeah, I think the journalists got it wrong, not the students. That said, it was interesting to read Shkreli's twitter tantrum. He even made a video. He and Trump appear to share certain traits, including the inability to tolerate criticism. So that was fun to notice. Um, not really.
posted by Bella Donna at 8:20 AM on December 2, 2016 [9 favorites]
posted by Bella Donna at 8:20 AM on December 2, 2016 [9 favorites]
What a lot of people don't realize is that it's not the drug that Skreli has the lock on. It's the distribution of the drug, and that's only because he had the infrastructure already in place for it.
And the fact that he's a super-sized grand-mal prick.
posted by prepmonkey at 8:21 AM on December 2, 2016 [13 favorites]
And the fact that he's a super-sized grand-mal prick.
posted by prepmonkey at 8:21 AM on December 2, 2016 [13 favorites]
Celsius1414's link is spot on, and explains exactly why the reporting on this was kind of annoying. What the kids did was a fantastic example of how to teach chemistry well, especially how they demystified the scientific process by showing their missteps along the way, but it has no impact on the legal loopholes that let Shkreli and his ilk be horrible. Manufacturing Daraprim on a commercial scale is relatively simple.
posted by Wretch729 at 8:22 AM on December 2, 2016 [7 favorites]
posted by Wretch729 at 8:22 AM on December 2, 2016 [7 favorites]
omg my high school is in the nooz
What I'm most interested in is how these 'global members of the Open Source Malaria consortium' helped out. Are there some logs of the interactions between the students and the OSM members somewhere I could potentially peruse?
posted by Panthalassa at 8:22 AM on December 2, 2016 [2 favorites]
What I'm most interested in is how these 'global members of the Open Source Malaria consortium' helped out. Are there some logs of the interactions between the students and the OSM members somewhere I could potentially peruse?
posted by Panthalassa at 8:22 AM on December 2, 2016 [2 favorites]
QFT
That said, Shkreli's drugs are expensive because he's taking advantage of regulatory loopholes. The R&D expenses were paid off decades ago.
The cost of drug synthesis - much less GMP level manufacture - is a red herring.
This is Shkreli being scum hacking a the FDA's bad regulatory structure and gloating about it - with human misery as the externality.
See in the pipeline for reasonable analysis.
posted by lalochezia at 8:23 AM on December 2, 2016 [15 favorites]
That said, Shkreli's drugs are expensive because he's taking advantage of regulatory loopholes. The R&D expenses were paid off decades ago.
The cost of drug synthesis - much less GMP level manufacture - is a red herring.
This is Shkreli being scum hacking a the FDA's bad regulatory structure and gloating about it - with human misery as the externality.
See in the pipeline for reasonable analysis.
posted by lalochezia at 8:23 AM on December 2, 2016 [15 favorites]
"By attempting to levitate the Pentagon, the yippies have muddied the issue, it was never about paranormal powers, it's a problem with international politics and the legacy of colonialism"
posted by idiopath at 8:26 AM on December 2, 2016 [13 favorites]
posted by idiopath at 8:26 AM on December 2, 2016 [13 favorites]
"This" to the above comments.
One thing that needs (sadly) to be emphasized time and time again is that, with pharmaceutical drugs, you're not just paying for the active ingredient. You're paying for the FDA regulations that guarantee (in theory) that the active ingredient isn't contaminated with a dangerous impurity, that it's present in the desired concentration (and only in the desired concentration), that the release profile is acceptable ... in short, that the drug behaves exactly the way you want it to.
If all I cared about was the active ingredient, I'd buy meth rather than taking taking ADD medication.
posted by steady-state strawberry at 8:26 AM on December 2, 2016 [12 favorites]
One thing that needs (sadly) to be emphasized time and time again is that, with pharmaceutical drugs, you're not just paying for the active ingredient. You're paying for the FDA regulations that guarantee (in theory) that the active ingredient isn't contaminated with a dangerous impurity, that it's present in the desired concentration (and only in the desired concentration), that the release profile is acceptable ... in short, that the drug behaves exactly the way you want it to.
If all I cared about was the active ingredient, I'd buy meth rather than taking taking ADD medication.
posted by steady-state strawberry at 8:26 AM on December 2, 2016 [12 favorites]
Figuring out the cost of manufacturing a good is far more complicated than anyone thinks - especially when you get into overhead calculations.
It is reasonably complicated to guess your costs, but c'mon. Most small molecules have a cost per dose of pennies, unless the synthesis is really exotic, in which case it may be a few dollars before markup.
Just do open CRO bids for the manufacture and safety testing of a large stockpile. That's the actual cost.
posted by benzenedream at 8:26 AM on December 2, 2016 [1 favorite]
It is reasonably complicated to guess your costs, but c'mon. Most small molecules have a cost per dose of pennies, unless the synthesis is really exotic, in which case it may be a few dollars before markup.
Just do open CRO bids for the manufacture and safety testing of a large stockpile. That's the actual cost.
posted by benzenedream at 8:26 AM on December 2, 2016 [1 favorite]
The exact regulatory and legal exploit used is somewhat unique to this case, but it's very similar to the overall strategy behind the raises in many drugs in the US, including epinephrine and diabetes drugs recently. Find a protected or difficult to enter niche, exploit it.
I think it's past time that people, regulators and lawmakers, start doing exploit analyses on regulatory regimes, much like security audits are done. There's a great deal of naivety that the market will always produce good faith results. But any ecosystem has niches that allow parasites and other value-destroying colonies.
posted by bonehead at 8:29 AM on December 2, 2016 [5 favorites]
I think it's past time that people, regulators and lawmakers, start doing exploit analyses on regulatory regimes, much like security audits are done. There's a great deal of naivety that the market will always produce good faith results. But any ecosystem has niches that allow parasites and other value-destroying colonies.
posted by bonehead at 8:29 AM on December 2, 2016 [5 favorites]
All music should be free. Afterall it costs nothing to download a copy!
(The difference here being pharmaceuticals save people's lives and perhaps should not be treated to the same artificial scarcity regime we give other intellectual property.)
posted by Nelson at 8:31 AM on December 2, 2016 [1 favorite]
(The difference here being pharmaceuticals save people's lives and perhaps should not be treated to the same artificial scarcity regime we give other intellectual property.)
posted by Nelson at 8:31 AM on December 2, 2016 [1 favorite]
I think the STEM/STEAM folks need to add a Science/Medical Journalism and News Outreach component, because this is a problem that keeps getting worse and worse.
posted by Celsius1414 at 8:34 AM on December 2, 2016 [4 favorites]
posted by Celsius1414 at 8:34 AM on December 2, 2016 [4 favorites]
The major difference is that licensed music is priced pretty much exactly as intended by the lawmakers, and so can be argued to be "fair".
I don't think a significant number of legislators could be convinced to produce a regime where profits on drugs necessary for voter survival were essentially uncapped.
posted by bonehead at 8:35 AM on December 2, 2016
I don't think a significant number of legislators could be convinced to produce a regime where profits on drugs necessary for voter survival were essentially uncapped.
posted by bonehead at 8:35 AM on December 2, 2016
Just do open CRO bids for the manufacture and safety testing of a large stockpile. That's the actual cost.
No, that is your cost to purchase the good. That is not at all the same thing as the cost to actually manufacture the good.
The people providing those quotes will be considering all the factors I detailed to figure out what price they can provide you that will cover all their costs AND provide them with an acceptable level of profit. As not all companies are equally efficient or set up to do the same sorts of processes, the manufacturing costs they have will vary.
posted by nolnacs at 8:39 AM on December 2, 2016
No, that is your cost to purchase the good. That is not at all the same thing as the cost to actually manufacture the good.
The people providing those quotes will be considering all the factors I detailed to figure out what price they can provide you that will cover all their costs AND provide them with an acceptable level of profit. As not all companies are equally efficient or set up to do the same sorts of processes, the manufacturing costs they have will vary.
posted by nolnacs at 8:39 AM on December 2, 2016
lalochezia's link to in the pipeline is very cogent to deflating the insane news coverage of this.
I am by no means defending Shkreli’s actions, but I like Derek Lowe's metaphor about cars. A somewhat competent High School shop class could make a small combustion engine, I would hope.
This is entirely different from saying that the Ford or Toyota motor companies are morally bankrupt and defrauding people. The problem of making 100,000 combustion engines and delivering them to consumers in a wide variety of frames across the world-- all within differing regulatory frameworks-- are entirely different classes of problems.
posted by mrdaneri at 8:44 AM on December 2, 2016
I am by no means defending Shkreli’s actions, but I like Derek Lowe's metaphor about cars. A somewhat competent High School shop class could make a small combustion engine, I would hope.
This is entirely different from saying that the Ford or Toyota motor companies are morally bankrupt and defrauding people. The problem of making 100,000 combustion engines and delivering them to consumers in a wide variety of frames across the world-- all within differing regulatory frameworks-- are entirely different classes of problems.
posted by mrdaneri at 8:44 AM on December 2, 2016
Just do open CRO bids for the manufacture and safety testing of a large stockpile. That's the actual cost.
Assuming you know which molecule to make. Most people just don't realise how hard drug design is to do. For every project that is able to successfully bring a molecule to a phase I trial they have probably made well over 10k new molecules. None of these molecules have ever existed before they were made and the entirety of chemical space is such that it wouldn't be possible to make one miligram of everything possible given the entirety of the mass in the universe. The sheer cost of making each of those samples also isn't even remotely the only cost in development, there is all of the testing, testing and more testing.
The syphilitic boil was given a monopoly because they paid for a really minor amount of testing, because the compound had already passed through safety studies. All that was needed was to prove efficacy and those studies are relatively easy to run, provided your compound actually does something that can be monitored easily. The fault for the increase lies with the laws that grain the boil exclusive rights for distribution for taking essentially no risk and doing no development other than running a test to prove what was already known.
posted by koolkat at 8:48 AM on December 2, 2016 [1 favorite]
mrdaneri: I am by no means defending Shkreli’s actions, but I like Derek Lowe's metaphor about cars. A somewhat competent High School shop class could make a small combustion engine, I would hope.
This is entirely different from saying that the Ford or Toyota motor companies are morally bankrupt and defrauding people. The problem of making 100,000 combustion engines and delivering them to consumers in a wide variety of frames across the world-- all within differing regulatory frameworks-- are entirely different classes of problems.
It's still a good thing to demonstrate. Because at some point, the companies and framework really can be so dysfunctional that they're actually counterproductive. If cars cost fifty million dollars each, having shop classes throw together engines might actually be the more practical option.
posted by Mitrovarr at 8:48 AM on December 2, 2016 [5 favorites]
This is entirely different from saying that the Ford or Toyota motor companies are morally bankrupt and defrauding people. The problem of making 100,000 combustion engines and delivering them to consumers in a wide variety of frames across the world-- all within differing regulatory frameworks-- are entirely different classes of problems.
It's still a good thing to demonstrate. Because at some point, the companies and framework really can be so dysfunctional that they're actually counterproductive. If cars cost fifty million dollars each, having shop classes throw together engines might actually be the more practical option.
posted by Mitrovarr at 8:48 AM on December 2, 2016 [5 favorites]
“High schoolers punch Martin Shkreli in the face, figuratively”
While I would normally applaud students aiming high, I think it's a mistake in this case.
posted by Kirth Gerson at 8:53 AM on December 2, 2016 [8 favorites]
While I would normally applaud students aiming high, I think it's a mistake in this case.
posted by Kirth Gerson at 8:53 AM on December 2, 2016 [8 favorites]
Being able to make an out-of-patent drug with a well-established use is almost beside the point. Any contract lab, in the US or China, could make it in volume, to medical standards pretty trivially for almost no cost. The thing Shkreli owns that has value is the right to sell that drug elusively.
posted by bonehead at 8:53 AM on December 2, 2016 [3 favorites]
posted by bonehead at 8:53 AM on December 2, 2016 [3 favorites]
There is a political solution lurking behind this though : We need many nation to develop their own native genetic pharmaceuticals industries by invalidating patents or simply never admitting foreign patents in the first place. AIDS treatments only became affordable because Brazil ignored the patents.
posted by jeffburdges at 8:53 AM on December 2, 2016 [9 favorites]
posted by jeffburdges at 8:53 AM on December 2, 2016 [9 favorites]
It's not even a "loophole" in the FDA regulatory system. It's just the ordinary difficulty of the approval process that's keeping other companies out for the time being.
Pyrimethamine (the active ingredient in Daraprim) has been on the market for a long time: it was first sold in 1953, back when the FDA didn't require pre-approval to sell drugs. Later on, after the regulatory regime tightened up to require pre-approval testing, Burroughs and the FDA went back and established that it was effective. There aren't any patents on it, so all anyone needs to do to sell pyrimethamine to treat toxoplasmosis is design a dosage form and do some moderate (by FDA standards) testing to show that their form delivers the right quantities of pyrimethamine to the body. That testing, plus the process of submitting the results for FDA review and approval, would take a couple of years and a couple million dollars.
What Shkreli realized when he bought Daraprim (i.e., that line of business plus the existing regulatory approval for it) was that it was the only approved form of pyrimethamine for toxoplasmosis. Anyone else who wanted to compete would have to go through the testing and FDA review process. At $13.50 a pill, that would be completely unprofitable, so no one had bothered. At $750 a pill, of course there'd be intense interest, but (a) Shkreli would have a long head-start, so even a couple of years would be highly profitable, and (b) once someone else was approved, he could cut the price again and make it unprofitable for the new competitor -- which would also tend to deter anyone from even trying.
The FDA does have some tricks it can use to deter this kind of abusive pricing, like looking the other way if compounding pharmacies start suddenly filling a lot of special orders for pyrimethamine. But there's no weird "loophole" here that can be closed without affecting anything else in the drug-regulatory system.
posted by grimmelm at 8:56 AM on December 2, 2016 [16 favorites]
Pyrimethamine (the active ingredient in Daraprim) has been on the market for a long time: it was first sold in 1953, back when the FDA didn't require pre-approval to sell drugs. Later on, after the regulatory regime tightened up to require pre-approval testing, Burroughs and the FDA went back and established that it was effective. There aren't any patents on it, so all anyone needs to do to sell pyrimethamine to treat toxoplasmosis is design a dosage form and do some moderate (by FDA standards) testing to show that their form delivers the right quantities of pyrimethamine to the body. That testing, plus the process of submitting the results for FDA review and approval, would take a couple of years and a couple million dollars.
What Shkreli realized when he bought Daraprim (i.e., that line of business plus the existing regulatory approval for it) was that it was the only approved form of pyrimethamine for toxoplasmosis. Anyone else who wanted to compete would have to go through the testing and FDA review process. At $13.50 a pill, that would be completely unprofitable, so no one had bothered. At $750 a pill, of course there'd be intense interest, but (a) Shkreli would have a long head-start, so even a couple of years would be highly profitable, and (b) once someone else was approved, he could cut the price again and make it unprofitable for the new competitor -- which would also tend to deter anyone from even trying.
The FDA does have some tricks it can use to deter this kind of abusive pricing, like looking the other way if compounding pharmacies start suddenly filling a lot of special orders for pyrimethamine. But there's no weird "loophole" here that can be closed without affecting anything else in the drug-regulatory system.
posted by grimmelm at 8:56 AM on December 2, 2016 [16 favorites]
I'm not the kind of person who wishes someone ill, no matter how awful they are. But if Martin Shkreli woke up tomorrow to find his asshole stuffed with lit dynamite, it would be a challenge for my better nature to admit there was anything suboptimal about that.
posted by DirtyOldTown at 9:03 AM on December 2, 2016 [10 favorites]
posted by DirtyOldTown at 9:03 AM on December 2, 2016 [10 favorites]
We keep making a lot of noise about fake news and conservatives here on the blue, but somehow we keep falling for it. These kids have done nothing new, nothing remotely interesting, and provided no meaningful critique of anything.
posted by Blasdelb at 9:07 AM on December 2, 2016 [10 favorites]
posted by Blasdelb at 9:07 AM on December 2, 2016 [10 favorites]
There's so many people to hate these days, or at least, people that are genuinely worthy of hate. The big escape-artist trick of the next four years is getting out of them with your heart intact.
posted by newdaddy at 9:08 AM on December 2, 2016
posted by newdaddy at 9:08 AM on December 2, 2016
As much as I want Martin Shkreli to fall into an open sewer manhole, after my experience making insulin bulk API, I'm not sure I trust high school students to meet SISPQ. FDA GMP is ridiculously Byzantine, but some of those rules are actually useful for keeping patients from getting killed or injured.
posted by double block and bleed at 9:11 AM on December 2, 2016 [3 favorites]
posted by double block and bleed at 9:11 AM on December 2, 2016 [3 favorites]
I see this more as a case study for the future black market in healthcare meds that we will be turning to when we all lose our healthcare here in the good 'ol USA.
posted by emjaybee at 9:35 AM on December 2, 2016 [9 favorites]
posted by emjaybee at 9:35 AM on December 2, 2016 [9 favorites]
Future? I already get life-saving medications from the grey market. Have needed to for years. We've been a Blade Runner (no, the other one) society for a while.
posted by byanyothername at 9:45 AM on December 2, 2016 [1 favorite]
posted by byanyothername at 9:45 AM on December 2, 2016 [1 favorite]
All the "Um, Actually" in the first comment and many that follow seems to miss the point to me:
This is whole exercise is a really smart piece of propaganda on the side of good; it's not intended to be a scalable model of drug production and distribution.
These high school students are publicly shaming a horrible person who is emblematic of the reason why medicine and health must be divorced from capitalism. That has massive value. We need headlines that say, "High School Students Prove That Capitalist Dick Bag Is, In Fact, A Bag of Dicks" because we need to be the ones framing this discussion. Popular opinion and imagination matters. I don't see how it forwards the cause of justice to be like, "Duh, the FDA and other regulatory bodies say Shkreli is a-OK". I mean, we know that, and we must exert pressure on our law makers to change these policies, and part of exerting that pressure is gaining popular support for the idea that the current laws allow pieces of human waste like Shkreli to act this way.
posted by latkes at 10:03 AM on December 2, 2016 [33 favorites]
This is whole exercise is a really smart piece of propaganda on the side of good; it's not intended to be a scalable model of drug production and distribution.
These high school students are publicly shaming a horrible person who is emblematic of the reason why medicine and health must be divorced from capitalism. That has massive value. We need headlines that say, "High School Students Prove That Capitalist Dick Bag Is, In Fact, A Bag of Dicks" because we need to be the ones framing this discussion. Popular opinion and imagination matters. I don't see how it forwards the cause of justice to be like, "Duh, the FDA and other regulatory bodies say Shkreli is a-OK". I mean, we know that, and we must exert pressure on our law makers to change these policies, and part of exerting that pressure is gaining popular support for the idea that the current laws allow pieces of human waste like Shkreli to act this way.
posted by latkes at 10:03 AM on December 2, 2016 [33 favorites]
I mean, Shkreli is just the worst and most obvious example, but drug companies claim the need to charge astronomical prices for their drugs. This is a headline-grabbing argument that they don't.
posted by latkes at 10:04 AM on December 2, 2016 [3 favorites]
posted by latkes at 10:04 AM on December 2, 2016 [3 favorites]
These kids have done nothing new, nothing remotely interesting, and provided no meaningful critique of anything.
It's not new information in the Claude Shannon sense, but it does tell a story that many people might not otherwise understand – the products that Turing makes so much money off of are sometimes simple and cheap to make. So simple and so cheap that high school trained chemists can do it.
posted by zippy at 10:05 AM on December 2, 2016 [8 favorites]
It's not new information in the Claude Shannon sense, but it does tell a story that many people might not otherwise understand – the products that Turing makes so much money off of are sometimes simple and cheap to make. So simple and so cheap that high school trained chemists can do it.
posted by zippy at 10:05 AM on December 2, 2016 [8 favorites]
Wait, so punching punch Martin Shkreli in the face literally is off the table?
“You're paying for the FDA regulations that guarantee (in theory) that the active ingredient isn't contaminated with a dangerous impurity,”
Yeah! The drug companies don’t sell safety as much as the idea of safety. You have to protect people from their fears. For money.
Did we know the drug Phalanx wouldn’t work against zombie infection? Hey, all they said was it worked against rabies and it did, and everyone was calling it “African rabies” so…. er…What was the problem again?
Oh, right, regulatory tricks and greed.
I mean, did I miss where the plain, simple idea here is that they’re maximizing profits at the expense of other people’s pain and risk to public health?
That’s rather obvious isn’t it? Am I missing something that isn’t complexifying bullshit?
This pill or its analogue(s) costs, what, a buck in Canada?
Pretty sure I don’t want the secondary disease effects of parasitic infection spreading through my neighborhood just so some schmuck can buy another boat.
So why, student chemistry aside, is Shkreli not constantly taking clouts in the chops?
He should be running from his car to office dodging dead cats and rotten fruit. He should wear a cup all day because of the increasingly likely chance someone tries to boot his winkies.
There’s no “but” here. The system creates Shkrelis. They’re one and the same. Dissembling is defending the status quo.
Because the people behind this, and the attendant parasitic system, is the Kansas City Shuffle. It's like an ephemera cyborg. Thought-borg. I dunno. But the system and khazers like Shkreli are symbiots that work healthy (in this case literally) systems into unhealthy ones.
This particular mindfuck, the Kansas City Shuffle works because we all know we’re being conned. But we’re being tricked into spending time arguing as to “how.” Because they know we’re going to be too smart for our own good.
Who cares whether students do what or where as it pertains to major economic and pharma-regulatory systems. We KNOW those are rigged.
We know the students are doing science.
That it’s just science reveals all the other bullshit to be a scam to make money on human suffering.
See how much money the students need to profit off human suffering in order to do science? Oh, me neither.
Perhaps then it’s our system that’s fucked and not the clearly very basic science that’s too mystifying or “socialism” that’s too politically dangerous or basic human compassion that’s too expensive.
Whatever it is, it's not the "ooh, but science and economics are big and too hard for you commoners to understand" song and dance they like to trot out.
/on preview - what latkes and zippy just sed.
posted by Smedleyman at 10:15 AM on December 2, 2016 [5 favorites]
“You're paying for the FDA regulations that guarantee (in theory) that the active ingredient isn't contaminated with a dangerous impurity,”
Yeah! The drug companies don’t sell safety as much as the idea of safety. You have to protect people from their fears. For money.
Did we know the drug Phalanx wouldn’t work against zombie infection? Hey, all they said was it worked against rabies and it did, and everyone was calling it “African rabies” so…. er…What was the problem again?
Oh, right, regulatory tricks and greed.
I mean, did I miss where the plain, simple idea here is that they’re maximizing profits at the expense of other people’s pain and risk to public health?
That’s rather obvious isn’t it? Am I missing something that isn’t complexifying bullshit?
This pill or its analogue(s) costs, what, a buck in Canada?
Pretty sure I don’t want the secondary disease effects of parasitic infection spreading through my neighborhood just so some schmuck can buy another boat.
So why, student chemistry aside, is Shkreli not constantly taking clouts in the chops?
He should be running from his car to office dodging dead cats and rotten fruit. He should wear a cup all day because of the increasingly likely chance someone tries to boot his winkies.
There’s no “but” here. The system creates Shkrelis. They’re one and the same. Dissembling is defending the status quo.
Because the people behind this, and the attendant parasitic system, is the Kansas City Shuffle. It's like an ephemera cyborg. Thought-borg. I dunno. But the system and khazers like Shkreli are symbiots that work healthy (in this case literally) systems into unhealthy ones.
This particular mindfuck, the Kansas City Shuffle works because we all know we’re being conned. But we’re being tricked into spending time arguing as to “how.” Because they know we’re going to be too smart for our own good.
Who cares whether students do what or where as it pertains to major economic and pharma-regulatory systems. We KNOW those are rigged.
We know the students are doing science.
That it’s just science reveals all the other bullshit to be a scam to make money on human suffering.
See how much money the students need to profit off human suffering in order to do science? Oh, me neither.
Perhaps then it’s our system that’s fucked and not the clearly very basic science that’s too mystifying or “socialism” that’s too politically dangerous or basic human compassion that’s too expensive.
Whatever it is, it's not the "ooh, but science and economics are big and too hard for you commoners to understand" song and dance they like to trot out.
/on preview - what latkes and zippy just sed.
posted by Smedleyman at 10:15 AM on December 2, 2016 [5 favorites]
Who cares whether students do what or where as it pertains to major economic and pharma-regulatory systems. We KNOW those are rigged.
We know the students are doing science.
"Doing science" is meaningless at best. They're practicing organic synthesis. They might even be learning retrosynthesis (a solid skill). If the teachers are good, they're learning analytical chemistry, too. But none of those things are pharmacology.
Shkreli is an asshole and deserves to be hit with a bus of lobsters. And his behavior clearly shows that we need to modify FDA regulations to make them less easy to hack. But that has nothing to do with what pharmaceutical companies do in general, either.
posted by steady-state strawberry at 10:37 AM on December 2, 2016
We know the students are doing science.
"Doing science" is meaningless at best. They're practicing organic synthesis. They might even be learning retrosynthesis (a solid skill). If the teachers are good, they're learning analytical chemistry, too. But none of those things are pharmacology.
Shkreli is an asshole and deserves to be hit with a bus of lobsters. And his behavior clearly shows that we need to modify FDA regulations to make them less easy to hack. But that has nothing to do with what pharmaceutical companies do in general, either.
posted by steady-state strawberry at 10:37 AM on December 2, 2016
It has everything to do with what pharmaceutical companies do in general. He is an extreme example, but what is the real difference between him and the epi-pen scandal or the bulk of overpriced essential medicines we never hear about? Let alone how drug companies devote their resources to unnecessary but money making drugs and don't even do antibiotic development anymore and starve other life-saving drug development ?
posted by latkes at 10:46 AM on December 2, 2016
posted by latkes at 10:46 AM on December 2, 2016
Was there ever a question that making Daraprim was inexpensive? I mean, that's why it used to be $13.50. The science hasn't changed.
posted by maryr at 11:06 AM on December 2, 2016 [1 favorite]
posted by maryr at 11:06 AM on December 2, 2016 [1 favorite]
None at all, for anyone who cared to look, I would think.
There's a value to doing public demonstrations to emphasize a scientific point. I've done 'em and changed the conversation about the issue as a result. Stunt or, perhaps better, activist science can be really valuable if done right. It gives deniers less wiggle room and clears the air. I live in hope that some bright young (or old) thing can figure out how to do this for climate science, for example.
I don't think that's really what happened here. These kids didn't show that it was cheap to do human trials or get a drug on an FDA list. It was a great benefit to them, but to society at large, as Blasdelb says above, it's a trivial result. I don't think it changes the conversation being had about the issue, or excises any of the lies being told by the companies exploiting these loopholes. It's always added costs that are the problems, not the production cost.
We went through the same arguments over the epinephrine injectors where it was clear that the drug cost itself was less than $1 a dose.
posted by bonehead at 11:18 AM on December 2, 2016 [3 favorites]
There's a value to doing public demonstrations to emphasize a scientific point. I've done 'em and changed the conversation about the issue as a result. Stunt or, perhaps better, activist science can be really valuable if done right. It gives deniers less wiggle room and clears the air. I live in hope that some bright young (or old) thing can figure out how to do this for climate science, for example.
I don't think that's really what happened here. These kids didn't show that it was cheap to do human trials or get a drug on an FDA list. It was a great benefit to them, but to society at large, as Blasdelb says above, it's a trivial result. I don't think it changes the conversation being had about the issue, or excises any of the lies being told by the companies exploiting these loopholes. It's always added costs that are the problems, not the production cost.
We went through the same arguments over the epinephrine injectors where it was clear that the drug cost itself was less than $1 a dose.
posted by bonehead at 11:18 AM on December 2, 2016 [3 favorites]
maryr: Was there ever a question that making Daraprim was inexpensive? I mean, that's why it used to be $13.50. The science hasn't changed.
It eliminates the idea that there needed to be a huge capital investment in order to make the stuff.
posted by Mitrovarr at 11:35 AM on December 2, 2016
It eliminates the idea that there needed to be a huge capital investment in order to make the stuff.
posted by Mitrovarr at 11:35 AM on December 2, 2016
> the right to sell that drug elusively
You saw it of MeFi first: All we need to do to fix the FDA permanently is remove that pesky little "xc" from our current law.
This is going to change everything--and in a really good way . . .
posted by flug at 11:38 AM on December 2, 2016 [4 favorites]
You saw it of MeFi first: All we need to do to fix the FDA permanently is remove that pesky little "xc" from our current law.
This is going to change everything--and in a really good way . . .
posted by flug at 11:38 AM on December 2, 2016 [4 favorites]
Wow, Smedleyman, that is some straight up Hakim Bey stuff right there! Very nicely put.
posted by booksarelame at 1:32 PM on December 2, 2016
posted by booksarelame at 1:32 PM on December 2, 2016
And the fact that he's a super-sized grand-mal prick.
The only good thing that could possibly have come out of the results of the 2016 US Presidential election was the general release of Once Upon A Time in Shaolin courtesy of Shkreli, and of course he isn't going to do it. Last I heard it was allegedly because of rights issues, because of course it is. I guess it would become monotonous to only embody the most obnoxious aspects of IP law in one field all day every day.
posted by No-sword at 5:07 PM on December 2, 2016 [1 favorite]
The only good thing that could possibly have come out of the results of the 2016 US Presidential election was the general release of Once Upon A Time in Shaolin courtesy of Shkreli, and of course he isn't going to do it. Last I heard it was allegedly because of rights issues, because of course it is. I guess it would become monotonous to only embody the most obnoxious aspects of IP law in one field all day every day.
posted by No-sword at 5:07 PM on December 2, 2016 [1 favorite]
The FDA does have some tricks it can use to deter this kind of abusive pricing, like looking the other way if compounding pharmacies start suddenly filling a lot of special orders for pyrimethamine. But there's no weird "loophole" here that can be closed without affecting anything else in the drug-regulatory system.
IANAL, but from my corporate training - and many case studies we looked at - Australian law gives judges specific latitude when dealing with cases like these, classifying them as "Unconscionable Conduct" - basically, there's no specific law that stops you from from doing this, but you're being an asshole, so stop.
Link to ACCC site Unconscionable conduct does not have a precise legal definition as it is a concept that has been developed on a case-by-case basis by courts over time. Conduct may be unconscionable if it is particularly harsh or oppressive. To be considered unconscionable conduct it must be more than simply unfair—it must be against conscience as judged against the norms of society.
posted by xdvesper at 5:21 PM on December 2, 2016
IANAL, but from my corporate training - and many case studies we looked at - Australian law gives judges specific latitude when dealing with cases like these, classifying them as "Unconscionable Conduct" - basically, there's no specific law that stops you from from doing this, but you're being an asshole, so stop.
Link to ACCC site Unconscionable conduct does not have a precise legal definition as it is a concept that has been developed on a case-by-case basis by courts over time. Conduct may be unconscionable if it is particularly harsh or oppressive. To be considered unconscionable conduct it must be more than simply unfair—it must be against conscience as judged against the norms of society.
posted by xdvesper at 5:21 PM on December 2, 2016
Shkreli is an asshole and deserves to be hit with a bus of lobsters.
He deserves punishment, but consider the lobsters.
posted by Jon Mitchell at 6:44 PM on December 2, 2016 [4 favorites]
He deserves punishment, but consider the lobsters.
posted by Jon Mitchell at 6:44 PM on December 2, 2016 [4 favorites]
This would be more impressive if the high school students found a loophole in patent law to allow a $2 version of the drug.
Because it's always been about the legal burden, not the chemistry.
posted by rokusan at 11:05 PM on December 2, 2016
Because it's always been about the legal burden, not the chemistry.
posted by rokusan at 11:05 PM on December 2, 2016
maryr: "Was there ever a question that making Daraprim was inexpensive? I mean, that's why it used to be $13.50. The science hasn't changed."But thats the thing, its hilariously far from doing that. Production to the cGMP standards that are and absofuckinglutely should be necessary to sell drugs requires silly amounts of capital investment. They haven't eliminated a damn thing that is actually relevant to the conversation. The reasons why the regulatory environment designed to keep drugs safe is vulnerable to Shkreli fucking the system are complex, and this kind of fake news designed to convince us that the solutions are simple is deeply fucking dangerous.
Mitrovarr: "It eliminates the idea that there needed to be a huge capital investment in order to make the stuff."
Particularly when liberal places like this are so easy to convince that we don't ever fall for bullshit like this.
posted by Blasdelb at 2:27 AM on December 3, 2016 [2 favorites]
I'm a bit conflicted. I appreciate rigor and I believe it is important to understand the broader context for things. I am deeply frustrated by misleading oversimplifications like comparing the budget of the US government to that of a typical household. Reality is complex and the solutions to complex problems rarely come in the form of silver bullets.
On the other hand, critical thinking skills and the willingness to pay attention to the the things that will have the most impact on our lives and planet are clearly in short supply. Serious people can have serious discussions with each other as much as they want, but they're still at the mercy of the rest of the world. I think it could be argued that there is enough substantive discussion of most issues, amongst those motivated to engage in it.
I think we desperately need ways to engage a broader slice of humanity. Undoubtedly this has to involve some simplification, while also remaining true to the deeper complexities of each issue. Probably it involves the development of narratives to tell the story of the issues rather than list facts. In some cases, the stories that reach out to people and pull them in the right direction may be frustratingly incomplete to more knowledgable individuals. Some cases may straddle the line between accessible and misleading, but critiquing all expression as if it were submitted to a peer-reviewed academic journal doesn't seem like it solves any serious problem to me.
As a side-note, it is also really difficult/impossible to control how the media will interpret/misinterpret/present something. I wouldn't presume to know how the students/teacher presented what they did based on how the press covered it.
posted by snofoam at 6:21 AM on December 3, 2016
On the other hand, critical thinking skills and the willingness to pay attention to the the things that will have the most impact on our lives and planet are clearly in short supply. Serious people can have serious discussions with each other as much as they want, but they're still at the mercy of the rest of the world. I think it could be argued that there is enough substantive discussion of most issues, amongst those motivated to engage in it.
I think we desperately need ways to engage a broader slice of humanity. Undoubtedly this has to involve some simplification, while also remaining true to the deeper complexities of each issue. Probably it involves the development of narratives to tell the story of the issues rather than list facts. In some cases, the stories that reach out to people and pull them in the right direction may be frustratingly incomplete to more knowledgable individuals. Some cases may straddle the line between accessible and misleading, but critiquing all expression as if it were submitted to a peer-reviewed academic journal doesn't seem like it solves any serious problem to me.
As a side-note, it is also really difficult/impossible to control how the media will interpret/misinterpret/present something. I wouldn't presume to know how the students/teacher presented what they did based on how the press covered it.
posted by snofoam at 6:21 AM on December 3, 2016
snofoam, here's the press release.
Long story short, they did some pretty neat chemistry & the uni did a press release. It was worthy of a story in the local paper, where they'd have made it clear that this wasn't going to change the world. Got picked up by the nationals, then globally, so it turned into "these kids did the impossible, but easy".
People said "err, that's not the issue" so the backlash started, and everyone's more confused about medicinal chemistry and "big Pharma" than they were before.
But now the public know not to trust anyone. Except the papers, because the fact that they set such an untruthful narrative is as invisible to the writers as it is to the readers. And the whole narrative became untruthful without one single lie being told.
Which is to say I agree with your last paragraph, but would phrase it much more emphatically: Always assume that when someone's work is sensationalized, they know full well the context in which it's relevant.
(Does not apply to politicians)
posted by ambrosen at 6:56 AM on December 3, 2016
Long story short, they did some pretty neat chemistry & the uni did a press release. It was worthy of a story in the local paper, where they'd have made it clear that this wasn't going to change the world. Got picked up by the nationals, then globally, so it turned into "these kids did the impossible, but easy".
People said "err, that's not the issue" so the backlash started, and everyone's more confused about medicinal chemistry and "big Pharma" than they were before.
But now the public know not to trust anyone. Except the papers, because the fact that they set such an untruthful narrative is as invisible to the writers as it is to the readers. And the whole narrative became untruthful without one single lie being told.
Which is to say I agree with your last paragraph, but would phrase it much more emphatically: Always assume that when someone's work is sensationalized, they know full well the context in which it's relevant.
(Does not apply to politicians)
posted by ambrosen at 6:56 AM on December 3, 2016
Upon reading the press release and re-reading the Guardian article from the post, I genuinely have no objections to either. Synthesizing the drug does highlight the fact that other forces are causing/allowing it to be so expensive, and neither piece presents itself as an overview of all the factors that contribute to drug costs. Regardless of whether anything new was proven, it was clearly an effective way to remind people about issues with pharma pricing. Its a topic that should be part of a broad public conversation, and this is the kind of media exposure that helps get it there. Like all content that is accessible to a broad audience, there is plenty of room for beanplating, and that beanplating is mostly a self-absorbed waste of time.
posted by snofoam at 8:51 AM on December 3, 2016 [1 favorite]
posted by snofoam at 8:51 AM on December 3, 2016 [1 favorite]
Anyone want to help me do the same thing with Feliway?
posted by exogenous at 10:02 AM on December 3, 2016
posted by exogenous at 10:02 AM on December 3, 2016
It seems like the mostly useful outcome of this is a thousand snotty articles like the ars one that say "WELL ACTUALLY those kids didn't build a clock they just took one apart and put it in a box; it's corruption that makes drugs expensive!"
The conclusion is the same regardless of whether your thought process is:
"Hurr Hurr they showed him drugz that high school kids make should be cheap"
or
"ACTUALLY there are a lot of other costs involved and regulating drugs is complicated and expensive and we need to factor in demand and also the need to have the drugs available to people who need them even when there aren't that many people so maybe the cost of the drug is more accurately reflected by factoring all of those costs in but in the end the drug's price is much higher than any of those considerations would warrant because it is exploiting limitations of the US's regulatory regime that can't be fixed because too many people have vested interests in maintaining them and not enough people will die from lack of this medicine to generate the public outcry neccessary for change"
posted by ethansr at 12:05 PM on December 3, 2016 [1 favorite]
The conclusion is the same regardless of whether your thought process is:
"Hurr Hurr they showed him drugz that high school kids make should be cheap"
or
"ACTUALLY there are a lot of other costs involved and regulating drugs is complicated and expensive and we need to factor in demand and also the need to have the drugs available to people who need them even when there aren't that many people so maybe the cost of the drug is more accurately reflected by factoring all of those costs in but in the end the drug's price is much higher than any of those considerations would warrant because it is exploiting limitations of the US's regulatory regime that can't be fixed because too many people have vested interests in maintaining them and not enough people will die from lack of this medicine to generate the public outcry neccessary for change"
posted by ethansr at 12:05 PM on December 3, 2016 [1 favorite]
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Does not change pharmabro's shitty moral bankruptcy, but.
posted by Celsius1414 at 8:04 AM on December 2, 2016 [19 favorites]