Synthesized. Not developed. Synthesizing medicines is easy. Developing them is extremely difficult.
That being said, they aren't running clinical trials or evaluating drug efficacy, which is another difficult part of drug development.
And while there is an argument to be made about how developing new medicine costs real money, the re-investment of profits into research is around 10%, we‘re talking about a deeply corrupt industry here. And while it‘s definitely still morally questionable to clone new drugs, the case is much more clear cut for substances like epinepherine or insulin, for which the patents have long expired. If pharma corporations keep these meds at insane prices with dirty tricks like biosimilars or application patents (the equivalent of „doing X on a computer“ software patents), that‘s at least as immoral. I for one welcome these hackers for some fresh air in the market.
Those things are worlds apart, in my view. Pharmaceutical companies add serious value to the world. They expend enormous amounts of money researching and testing drugs, and then shepherding them through the obscenely expensive FDA approval process.
Journal publishers like Elsevier do not fund research. They don't pay the authors of the articles they publish. They add literally zero value to the ecosystem. It's honestly a modern marvel that they still exist. They provide absolutely nothing of value to the world.
One is where are these immense sums going that they claim to spend on developing the drugs? I can understand that many prototypical drugs don't make it to market, most likely being found to be either unsafe or ineffective by FDA trials and other strictures that are the envy of and model of the rest of the world in terms of providing value to public health. I simply do not trust the accounting that makes up these amounts claimed spent on developing many of these medicines.
Scientists and engineers are not costing these companies millions each, yet its claimed that the current cost of bringing a drug to market is almost $3 billion. There simply must be synergies in drug development that are going unreported. Are development costs going to building research centers that will be used for later drugs? Further, what is being done to reduce the costs of developing these life-saving drugs (without allowing drug risk to rise) and is this even discussed or attempted by Big Pharma?
A second question regarding their net value is how they keep costs high and maximize their take by gaming the patent system in a number of ways to avoid losing sales to generics. AstraZeneca, in 2002 altered the molecule of an existing drug (prilosec) just enough to qualify for a new drug patent (Nexium). Another more recent example was how Allergan transferred their patent rights in Restasis to a New York indian tribe (St. Regis Mohawk) and licensed it back from them , all purely as a ploy. The tribe enjoys sovereign immunity and this will protect it in disputes against generic makers. These are just two simple examples of this type of abuse.
So, I'm less than sympathetic to Big Pharma's plight when the public's growing desperation for affordable medical care leads them to infringe on these patents.
Agree, although I was specifically here arguing against the notion that they are comparable to academic journals. Academic journals are the absolute economic scum of the earth. Literally beneath contempt. I don't think pharmaceutical companies are comparable, though I agree there is an argument that their net value add might be close to zero, or negative. Academic journals don't even have to be netted for their social value to go to zero.
> Scientists and engineers are not costing these companies millions each, yet its claimed that the current cost of bringing a drug to market is almost $3 billion.
Well, they do employ quite a few people. However, a big chunk of their cost is navigating the approval process. This means conducting large scale clinical trials. These get extremely expensive, and take a long time.
The overall transition probability from Phase I to approval is 9.6% . So that means to get one new drug approved, you have to get 10 to Phase I. Just getting a molecule to the point of Phase I trials is quite difficult, too. I don't know how to quantify that process, but I imagine it's akin to locating a needle in a haystack.
> A second question regarding their net value is how they keep costs high and maximize their take by gaming the patent system in a number of ways to avoid losing sales to generics. AstraZeneca, in 2002 altered the molecule of an existing drug (prilosec) just enough to qualify for a new drug patent (Nexium). Another more recent example was how Allergan transferred their patent rights in Restasis to a New York indian tribe (St. Regis Mohawk) and licensed it back from them , all purely as a ploy. The tribe enjoys sovereign immunity and this will protect it in disputes against generic makers. These are just two simple examples of this type of abuse.
Here's where you're approaching a more real issue, IMO. There's a very odd sort of anti-competitive thicket that's formed between regulators, pharmaceutical companies, and most importantly, doctors. The example of Nexium you cite, for instance. You're totally right that that pharmaceutical company did that. And in my view, there should be nothing wrong with them doing that. The question we ought to be asking is: why did anyone buy it? You have two drugs, prilosec and nexium that are nearly identical. Since Nexium is on-patent, it's going to be multiples more expensive, for efficacy improvements that are marginal at best. In a competitive market, this should not happen. The pharmaceutical company shouldn't even bother to get Nexium approved, because they should know that nobody would pay 10x the price for a drug that's only a little bit better.
But for some reason this does happen. Again and again. The reasons why, as best I can triangulate, are:
1. Heavy advertising to doctors, who are not paying for the drugs themselves, and therefore are not incentivized to compare on cost.
2. Side-effect smoothening, and extreme risk aversion on the part of the FDA, insurance companies, and doctors. I don't know much about Nexium, but if I had to guess, they probably purified a stereoisomer or made some other trivial tweak to the molecule that slightly improved its side-effect profile. What this means is that for a doctor to recommend Prilosec, they are essentially saying "Hey, patient, why don't you take on a bit more risk on this prior generation medicine so that you can save some money". The doctor doesn't save any money on that pill, but he does assume some malpractice liability for the side effects of his recommendations. Hence, he's strongly incentivized to choose the drugs that are the "safest" without considering whether going from .1% risk of headaches to .01% risk of headaches is worth $1,000/month to the patient.
And in fact, this is sort of the essence of the problem with pharma, right here. Because of this incentive thicket that we're stuck in, pharmaceutical companies are very strongly incentivized to innovate at the margins of what they already have, rather than develop bold new therapies. If going from Prilosec to Nexium gets you the same return as curing cancer, why bother with a cancer cure?
Movies are for fun & profit.
Medicine is for people's health / survival and profit.
You can live without the first but without the second you'll probably die soon and maybe painful as well (depending on the first fatal desease you contract).
If you want to help, they need someone to crack a rar file containing the Chematica data (which was acquired by Merck pharmaceuticals)
There is no need for an anarchist collective. You can just go to a third world country an import the drugs. Or you can start a pharma company. Or you can buy proper equipment and hire experienced people. The only reason for doing it yourself, and go to hacker conferences be applauded by people with no knowledge of the subject whatsoever, is to live a fantasy that can't exist if it is effective. And there is no way to loose because ignorant people will always say you did what you could in the face of Goliath even though anyone who was competent knew what would happen.
It is all fake. Just look at every other diy initiative to date that hasn't affected big companies in the slightest. "Hackers" are still perfectly happy about their "successes" while they make six figure salaries helping the oligopoly. Because there is always a new hacker conference, online forum or meetup you can visit to feel good about yourself by excluding people who know better.
These opinions can only exist in a place where the popularity of ignorance is favored over reason. And you'll deserve each other.
The problem with most libertarian ideas like this is externalities. If you take something made incorrectly and become incredibly sick, society has to either take care of you or let you die- and no one wants to let people just die. So instead, society foots the bill for taking care of you.
I'm not saying these guys aren't fighting a damn good fight. They're in the right, in my mind. But if they start a large enough movement with enough people then someone somewhere is going to eventually cut a corner or make a mistake and get someone killed or made seriously ill. And what then?
There is no reason why Epipens cost $300 other than the fact the FDA has a huge backlog  and other regulatory constraints. There are plenty of companies chomping at the bit to deliver that medication for cheaper.
Like you said, this alternative is less than ideal, these hackers weren't driven to this just for fun - it was born out of what they saw as a lack of other options, a necessity (same with their 'customers' who were pushed to the shadier/riskier option). This necessity is generated when the primary market is not delivering value properly/efficiently, creating a demand for it.
The more free the legal market, the more the black market will be far less lucrative. The same applies to drugs and many other markets which artificial controls/limitations.
This all must be factored into the balances of costs measured against the externalities it imposes on society. It's riskier than pure top-down/government intervention but sometimes it's a necessary risk when that option continually fails to reform/change and nothing else pushes the hand of the gov/industry to adapt.
Sure you could blame the black market, but the simpler solution would be to fix the original problem which caused the black market to exist.
Tell that to 100 years of American drug policies.
This was true years ago but not anymore. CVS sells a generic epipen two-pack for $109 . Still not cheap, but let’s not pretend that these cost $300 and are not even available. I wanted to like this article but when I read this it made me think either reading journalist didn’t check his facts or is more invested in the narrative than reality.
Edit: I posted this even though I figured it would attract downvotes. I’m curious if downvoters think my claims are untrue or don’t like the way I’ve phrased my comment.
To me, an article I can’t trust is basically worthless, which is why I pointed these inaccurate facts out.
Could they have made a few grams of nalaxone? Sure it’s pretty simple. Did they make enough to make a difference? No. Did they make sufficiently pure drug so that people don’t get poisoned? Probably not.
And did they make the AIDS drug? He’ll no. That synthesis is way more complicated than their mini lab can handle.
It makes for good VICE articles, but these guys are amateurs who are likely going to get someone killed.
Except that’s totally unrelated to why he’s in prison.
He brought attention to his tax evasion for other reasons... but is it difficult to acknowledge that the direct legal cause of his jail time was evasion?
cf: “A Simple and Convenient Synthesis of Pseudophedrine from N-Methylamphetamine”
I found it hard to keep reading after that. What's it called when people get so emotional about a cause they just start acting irrationally and doing more harm than good?
In the long term, bring drugs to people without thorough testing and regulations. It's one thing for e.g. stage 4 cancer. It's another to let a Vioxx get through.
Strict regulations around the development and testing of drugs exist because no human is capable of evaluating efficacy for themselves, absent stringently controlled testing processes.
We laugh about "snake oil salesmen", but given the amount of money in nutriceuticals, GNC, and the like... I'd say the only damn holding back the torrent on the unsuspecting is the FDA.
Look, I agree this isn't likely to be the scalable and safe solution that solves the cost crisis. But maybe we DO need someone to throw pills out for free just to show the absurdity of our current system. Because if it's something you need to live and the system is built to make something fundamentally cheap ultra-expensive, it's REALLY hard to see what this man could be doing wrong...
I am not suggesting this is the truth, or even a prediction. But I reject the emotionally charged language that people use to say there are no downsides.
There are always potential downsides; it is a dangerous way of thinking to be unable to see possible negativities and use that as certainty of a position. Otherwise, there's just no downside to Pascal's Wager, and we all must believe in God.
Perhaps they could get their point across while acting a bit more professional?
He can't be sure what will happen with pills that people accidentally carry out on their shoes or clothing. Any pills that don't get cleaned up from the venue could be eaten by children or animals at a later date.
We're talking about a drug that we don't even let sick people buy until they've talked to a doctor and a pharmacist. Maybe someone in the crowd wrongly believes that they need it or rightly believes that they need it but doesn't know how to take it properly.
Also, if you don't have sympathy for an adult who eats homemade pills and suffers from it, then you're pretty much arguing that this whole plan is irresponsible from the start.
I have plenty of sympathy for an adult who is forced to take homemade pills to save their life. An adult who swallows random pills a stranger threw at them, not so much.
It reinforces the point that this stuff is, in fact, extremely cheap and easy to make. The idea that prescription pills are expensive and precious is the scam that he's fighting.
They're talking about an encrypted file, right? If Merck just had this posted on "the dark web", constantly hammering them with bad passwords would probably clue them in. Incidentally, which did Merck value more, the database or the opportunity to keep it away from this group?
$ file .reaxys.tar
.reaxys.tar: Zip archive data, at least v2.0 to extract
Source: I was at the HOPE talk he gave and also talked to Michael at the conference about it too.
I was at his 2018 talk and the Vice article did an excellent job of summing it up. Usually the HOPE videos come online a few weeks after the conference (it was last weekend).
More like $574 billion dollars in FY2016.
While this is cool, it doesn't seem to generate attention in a way that could fix the underlying problem, except by dint of people who already know about it. Legislators are infamously subject to undue influence from medical companies that want to protect their oligopolies. A better hacking initiative might work to expose and excoriate those pharmaceutical and medical device companies which have abused the right to lobby in order to generate profits.
So, as an example, I'm on Stelara. It's $10,000/shot.
Their patient assistance program will, without any consideration to income, pay up to $20,000/year of my copays/deductibles.
Why? Because the marginal cost to them of producing the shot is probably $10, so by paying (for example) someone's $4k deductible (or even $13k, if I'm a family on a Bronze plan) they make the remaining $36k that year off insurance. That person might picked a cheaper option or not have taken the shots at all if they'd had to pay the $4k out-of-pocket.
It feels awesome as a patient, but that's because I'm insulated from the enormous cost. Over time, though, it's pushing my premiums up, but in a way that's totally disconnected (from my perspective as the patient) to the pharma benefit I'm getting.
Drug companies do give free drug and that doesn’t cause insurance premiums to go up.
Exactly what I would also say as pro capitalist but anti patent.
The article is not about anarchism. It is about not staying idle while people can't afford drugs. The methods may be questionable, like the partnership with dealers. But at least they try to do something.
I just hope there is a way for them to make money without legal risks
If the recipe is so secret, do not patent it. Some companies forgo patents for that reason.
Here nobody is compelling anyone. My anti patent point just means not letting the government enforce IP rights. In case like these, it is not just ideology - it is morally wrong as explained in the quote.
Forcing people to give up property that was legally acquired, to avoid a worse evil, seems more socialist than anything else to me
Here, I think the pro capitalist and socialist arguments are aligned. I quoted the argument because I felt taking the extreme of the opposing idea was quite good
Murder is also bad because a dead person no longer participates in the economy after the funeral. This is a loss for the economy as a whole. Even people completely lacking any morality can understand that.
If it's murder to apply intellectual property law and withhold drugs...what do we call the untold number of deaths that will result in the absence of a profit motive for developing new medicines? Is that murder?
The views of these people are childish and dangerous. I love their spirit, but their actual message here is just stupid and illiterate of basic economics.
One is a common hormone produced in the human body that was isolated over 120 years ago and has been used for medicinal purposes almost as long.
Another was discovered in 1952 and has been used in medicine since 1953.
Another was patented in 1961 and approved by the FDA in 1971.
The two related to abortion were developed in 1973 and 1980, respectively.
is not necessarily true. Expected future returns are already priced into stock of incumbents.
Now what? Well, on the one hand, everyone on earth will have cheap, timely access to every medicine that currently exists. That's pretty awesome. On the other hand, who's going to fund the development of new medicines? I'm certainly not going to invest in it, are you?
If pharma geniuses couldn't make a fortune in pharma, would they work for the government on the Federal wage scale, or would they go to coding bootcamp (which they could easily thrive at, based on the biochem->coding converts I know) and go work for Facebook?
They (and even our multi-payer system) already do. See: Public universities, NIH grants, etc.
But how much did it cost them to develop that drug? To get it through the FDA approval process? Their breakeven price on that drug is definitely in the tens of thousands per dose, before you get to any profit. Which means that at a minimum, they're charging $10,000/dose. In the case of movies, sure, i'll pay for netflix because it's more convenient than torrenting, because Netflix costs $10. If Netflix tried to raise their prices to $10,000/month, i'm going to start torrenting again.
I'd invest even if the only yield is longer/better life rather than $.
More $ - not terribly important beyond a threshold.
Longer/better life - yeah, that's important no matter how much money I have.
There are people in this thread who seem to be both decrying capitalism, and also asking that extremely rich venture capitalists fund the projects with their riches.
It's absurd. Capitalism has given us the most prosperous, longest living, most peaceful grouping of people in the history of mankind. The drugs these people are synthesizing exist BECAUSE of capitalism.
>After Four Thieves synthesized cabotegravir, it was just a matter of convincing at-risk populations to use it. According to Laufer, some Four Thieves affiliates began partnering with heroin dealers to cut their product with the cabotegravir.
I know nothing about chemistry/medicine, but this seems stupidly dangerous. There are good reasons to be patient and wait for drugs to go through the phase trials.
It also seems stupidly dangerous to allow uneducated/untrained people to make their own drugs at home by following directions. What if they unknowingly miss a step? For instance, the article is stating that opioids are needed to create Naloxone. That would be a costly mistake to make. They should never release this particular recipe.
These are truly brilliant people who probably have not spent a lot of time hanging around the average person. One reason governments and systems are in place is to prevent the non-well-rounded geniuses from giving an untrained mind an opportunity to make a devastating mistake.
EDIT: This reminds me of the guy who attempted to develop a nuclear reactor in his parents shed. https://en.wikipedia.org/wiki/David_Hahn
Making the drug and trying it on yourself is one thing. Sharing it with someone else who understands you and how you made it is somewhat similar. Convincing random people who don't know you to take it is crossing some sort of line, and setting up a situation where people are taking your homemade version of a non approved medication without even knowing it is just plain wrong. I know they are already taking heroin, but these are still people and not your lab rats. You shouldn't be making their decisions for them about what goes in their body.
In their do it yourself lab, what are they doing to remove stereoisomers?
How many unprosecuted crimes have been allowed in the course of war? Because it "had to be done"?
Prohibiting access to highly addictive narcotics? Makes some sense.
Prohibiting personal access to whatever you want to put in your body otherwise? Not such a strong argument.
If people want to risk killing themselves trying to cure their Hepatitis C infection, that's their business. In the same way we allow them to smoke, drink alcohol, drive vehicles, and own firearms.
Tobacco, alcohol, driving vehicles, and fire arms have all been regulated to limit use to prevent as much collateral damage as possible. It's no longer just their business when they're behind a steering wheel or holding a gun, or smoking/drinking in public.
Are you comfortable with telling a heroin user using dirty needles that "We can't allow you access to HIV retardants because we can't guarantee your safety"?
Concern for the public is valid, but it's a slippery slope that freedom often gets pushed down.
To answer your direct question though, yes, I am comfortable telling heroin users they cannot have access to HIV retardants until they have been proven safe, because you've made the false claim that this drug is actually an HIV retardant, when in reality it is untested.