https://motherboard.vice.com/en_us/article/43pngb/how-to-make-your-own-medicine-four-thieves-vinegar-collective
Meet the Anarchists Making Their Own
Medicine
The Four Thieves Vinegar Collective is a network
of tech-fueled anarchists taking on Big Pharma with DIY
medicines.
The first time I encountered Michael Laufer, he was
throwing thousands of dollars worth of homemade medicine into a packed
audience at Hackers on Planet Earth (HOPE), a biennial conference in New
York City.
“Does anyone here suffer from anaphylactic shock and not have access to
epinephrine?” Laufer asked the audience. A few hands went up and Laufer
stuffed a homemade EpiPen into one of them. “That’s one of the original
ones we made,” he said. “Use it well.”
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After a few minutes of gloating about
pharma bro Martin Shkreli “rotting at Fort Dix” for raising the price
of Daraprim, a lifesaving HIV medicine, from $13 to $750, Laufer grew
serious. “It’s been two years, but despite everything that’s happened,
the price of Daraprim hasn’t changed,” he said. He reached into his
pocket and produced a handful of white pills. “I guess I better hand out
some more,” Laufer said as he tossed the Daraprim into the audience.
With a shaved head, dark beard, and an ever-present camo jacket, Laufer
doesn’t look like the type of person you’d seek out for medical
advicebut that’s exactly his point. As the founding member of
Four Thieves Vinegar, a
volunteer network of anarchists and hackers developing DIY medical
technologies, Laufer has spent the last decade working to liberate
life-saving pharmaceuticals from the massive corporations that own them.
Laufer has no formal training in medicine and he’ll be the first to tell
you he’s not a doctor. In fact, from a regulatory standpoint he’s more
qualified to do mathematical work on nuclear weapons than treat patients.
But Laufer’s never really been the type to let rules and regulations
stand in his way.
I met Laufer at a bar across the street from HOPE after he finished his
talk on DIY medicine. He was meeting with his Four Thieves collaborators
who had flown in from all over the country to attend the conference and
unveil the new medical technologies under development by the collective.
Laufer kicked off the celebration with a toast.
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“A toast to the dead, for children with cancer and AIDS,” Laufer said,
raising a glass of bourbon and
quoting the hip
hop artist Felipe Andres Coronel, better known as Immortal Technique. “A
cure exists, and you probably could have been saved.”
In the last decade, Four Thieves has run afoul of the Food and Drug
Administration, billionaire pharma executives, doctors, and chemists at
some of the United States’ most prestigious universities. Indeed, Laufer
and his collaborators can’t stop pissing off powerful people because Four
Thieves is living proof that effective medicines can be developed on a
budget outside of institutional channels.
At the pharmacy, a pair of single use Mylan epipens can cost over $600
and the company’s generic version costs $300 per pair, but an ongoing
shortage means you probably can’t find them, even if you can afford them.
In response, Four Thieves published the instructions for a DIY epipen
online that can be made for
$30 in off-the-shelf parts and reloaded for $3. Shkreli drove the
price of the lifesaving HIV medicine Daraprim sells up to $750 per pill.
So Four Thieves developed an open source portable chemistry lab that
allows anyone to manufacture their own Daraprim for just 25 cents
apiece.
The pharmaceutical industry is valued
at
$446 billion in the US and its walls are tightly policed by
regulatory agencies like the FDA and Drug Enforcement Administration. By
freely distributing plans for medical devices and pharmaceuticals, a
loose collective of anarchists and hackers is threatening to pull the rug
out from under one of the most regulated and profitable industries in the
world. And they’re just getting started.
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FREE DRUGS
Four Thieves claims to have successfully
synthesized five different kinds of pharmaceuticals, all of which were
made using MicroLab. The device attempts to mimic an expensive machine
usually only found in chemistry laboratories for a fraction of the price
using readily available off-the-shelf parts. In the case of the MicroLab,
the reaction chambers consist of a small mason jar mounted inside a
larger mason jar with a 3D-printed lid whose printing instructions are
available online. A few small plastic hoses and a thermistor to measure
temperature are then attached through the lid to circulate fluids through
the contraption to induce the chemical reactions necessary to manufacture
various medicines. The whole process is automated using a small computer
that costs about $30.
To date, Four Thieves has used the device to produce
homemade Naloxone,
a drug used to prevent opiate overdoses better known as Narcan; Daraprim,
a drug that treats infections in people with HIV; Cabotegravir, a
preventative HIV medicine that may only need to be taken
four times per
year; and mifepristone and misoprostol, two chemicals needed for
pharmaceutical abortions.
Given the Trump administration’s
candidates for Justice Anthony Kennedy’s seat on the Supreme Court,
the collective feels an increasing sense of urgency to perfect its
abortion drugs. They fear that the federal government will soon allow
states to choose whether or not abortions can legally be offered and many
residents will be left without any recourse to abort a pregnancy. This
was a motivating factor for Tim Heilers, a former Navy sonar technician
from Louisville, to join Four Thieves last February.
“Kentucky is a very conservative state and I think we have a very real
possibility of becoming the first state with no abortion access
whatsoever,” Heilers told me. “Giving people the ability to make
mifepristone if they need it is something I think is very
important.”
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Although Four Thieves has successfully produced five drugs, so far only
the Daraprim is available for download on the collective’s website. This
is partly due to the disparities in how hard the various molecules are to
produce. Naloxone, for example, is particularly challenging because the
antidote to opiate overdoses uses the same precursors as the opiates
themselves. These precursors are controlled by the federal government and
only allowed to be possessed by approved labs in small doses. To get
around this issue, Laufer and his collaborators adopted a seemingly
counterintuitive protocol: They’d make medicine from poison.
Even though they couldn’t legally buy the Naloxone precursors, Laufer
realized that the opiates themselves are remarkably easy to obtain. After
obtaining oxycontin on the street, collective members were able to
perform a few chemical reactions to extract the necessary precursors from
the drug and used them to make the Naloxone.
"Would you rather break the law and live, or be a good upstanding
citizen and a corpse?”
“Some very clever drug dealers in the 90s discovered that you can do a
one shot reaction [with oxycontin] and get oxymorphone, which is
something like six times as powerful,” Laufer said. “You can make
Naloxone from oxymorphone in one step. It’s fairly easy and now you’ve
made medicine from poison.”
These sorts of unorthodox approaches to healthcare are the name of the
game in pharma hacking, where the goal is to help people at any cost.
There’s a drug called cabotegravir, for instance, which is a pre-exposure
prophylactic that has been demonstrated to
prevent
the spread of HIV through shared needles in macaques. Unlike other
pre-exposure prophylactics that need to be taken daily, cabotegravir may
only need to be taken
four times per
year to protect the user from HIV. Although the initial clinical
results with cabotegravir were extremely promising, Four Thieves grew
impatient with waiting for it to become commercially available. (The drug
is
currently undergoing Phase III FDA trials, which means it’s being
clinically tested on a large cohort of human subjects.) Moreover, based
on other pre-exposure prophylaxis drugs, cabotegravir would almost
certainly be sold at an exorbitant costTruvada, a comparable drug that
needs to be taken daily,
costs around $2,000 for a 30-day supply. So the group figured out how
to make it themselves.
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. This would ensure that users would receive
a regular dose of the preventative medicine every time they used heroin.
“Their heroin has a new side effect,” Laufer said. “You don’t get HIV
from it any more.”
Clearly, Four Thieves Vinegar Collective walks a fine line when it comes
to the legality of their enterprise. Although Laufer has turned
subversion of the medical industry into an artform, litigation remains a
perennial threat to his mission to liberate medicine. When a
pharmaceutical company manufactures a new drug, they own the patent on
the molecules that make the drug effective. Nevertheless, Laufer and his
colleagues are able to reproduce these molecules because they are
described in patent filings and often in academic journals. All it takes
is the right technology.
Since Four Thieves isn’t actually selling or distributing the medicines
made by its members, what they're doing isn’t technically illegal in the
eyes of the FDA, even though the agency has issued a public warning about
the collective’s DIY methods. Shortly after Four Thieves unveiled its $30
DIY epipen, the FDA issued a
statement to the media that said “using unapproved prescription drugs
for personal use is a potentially dangerous practice,” but didn’t refer
to Four Thieves by name. Ironically, only a few months later, the FDA
issued a warning letter to Pfizer for failing to investigate
“hundreds” of complaints about epipen failures, some of which resulted in
the death of the user. In May, the FDA
issued
another warning that declared a chronic epipen shortage.
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As for the DEA, none of the pharmaceuticals produced by the collective
are controlled substance, so their possession is only subject to local
laws about prescription medicines. If a person has a disease and
prescription for the drug to treat that disease, they shouldn’t run into
any legal issues if they were to manufacture their own medicine. Four
Thieves is effectively just liberating information on how to manufacture
certain medicines at home and developing the open source tools to make it
happen. If someone decides to make drugs using the collective’s guides
then that’s their own business, but Four Thieves doesn’t pretend that the
information it releases is for “educational purposes only.”
“The rhetoric that is espoused by people who defend intellectual property
law is that this is theft,” Laufer told me. “If you accept that
axiomatically, then by the same logic when you withhold access to
lifesaving medication that's murder. From a moral standpoint it's an
imperative to enact theft to prevent murder.”
“So yeah, we are encouraging people to break the law,” Laufer added. “If
you're going to die and you're being denied the medicine that can save
you, would you rather break the law and live, or be a good upstanding
citizen and a corpse?”
DOCTORS WITHOUT ORDERS
The catalyst for Four Thieves
Vinegar Collective was a trip Laufer took to El Salvador in 2008 when he
was still in graduate school. While visiting a rural medical clinic as
part of an envoy documenting human rights violations in the country, he
learned that it had run out of birth control three months prior. When the
clinic contacted the central hospital in San Salvador, it was informed
the other hospital had also run out of birth control. Laufer told me he
was stunned that the hospitals were unable to source birth control, a
relatively simple drug to manufacture that’s been around for over
half-a-century. He figured if drug dealers in the country were able to
use underground labs to manufacture illicit drugs, a similar approach
could be taken to life-saving medicines.
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Laufer started the collective shortly after he returned from Central
America, but its existence was only made public at HOPE in 2016. During
his first talk at the hacker conference, Laufer demoed the group’s $30
DIY “EpiPencil,” distributed some homemade Daraprim to the audience,
showed off an early prototype of the MicroLab, and gave Martin Shkreli a
call on stage (he didn’t answer.) When Four Thieves began, Laufer was
mostly working by himself. Now that it’s emerged from the underground,
the group is much larger, although Laufer said it’s impossible to know
its actual sizemembers come and go as they please, contributing as much
knowledge and time as they can.
Everyone I spoke with at Four Thieves comes from a technical background,
but none of them were medical professionals. Laufer, for instance, has a
background in nuclear physics and is the director of the math program at
Menlo College in Silicon Valley for his day job. The result of Four
Thieves’ diverse pool of technical expertise speaks for itself. The
collective now has independent biology, chemistry, data science,
programming, and hardware teams whose degree of collaboration is dictated
by the project at hand.
Four Thieves doesn’t sell anything, but the collective has two core
‘products.’ The first is open source hardware like the epipencil and
MicroLab chemical synthesizer, which can be made from off-the-shelf and
3D printed components. The second is the instructions for how to use
these tools to produce the drugs, which includes everything from how to
use the MicroLab to perform simple reactions to how to procure chemical
precursors.
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“I think it’s absolutely imperative that information about how to make
your own medicines should be as easily accessible as possible to everyone
who might have even a passing interest,” Laufer told me. “The goal of the
group is to make it possible for people to be able to do these things on
their own. The idea that someone could download the instructions, read
the list of materials, order them, read the instructions for how to
assemble it and program it, upload the code, order precursor chemicals,
and then manufacture medicine.”
All of Four Thieves’ tools were developed on a virtually non-existent
budgetthe only money the collective has is whatever its members supply
out of their own pocketsand so far the medicines they have produced
haven’t killed anyone. Yet some experts caution against taking medicines
produced by DIY tech that hasn’t been sufficiently vetted.
HARM REDUCTION
Eric Von Hippel, an economist at MIT that
researches “open innovation,” is enthusiastic about the promise of DIY
drug production, but only under certain conditions. He cited a pilot
program in the Netherlands that is exploring the
independent production
of medicines that are tailor made for individual patients as a good
example of safe, DIY drug production. These drugs are made in the
hospital by trained experts. Von Hippel believes it can be dangerous when
patients undertake drug production on their own.
“If one does not do chemical reactions under just-right conditions, one
can easily create dangerous by-products along with the drug one is trying
to produce,” von Hippel told me in an email. “Careful control of reactor
conditions is unlikely in DIY chemical reactors such as the MicroLab
design offered for free by the Four Thieves Vinegar Collective.”
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His colleague, Harold DeMonaco, a visiting scientist at MIT, agreed.
DeMonaco suggested that a more rational solution to the problems
addressed would be for patients to work with compounding pharmacies.
Compounding pharmacies prepare personalized medicine for their customers
and DeMonaco said they able to synthesize the same drugs Four Thieves is
producing at low costs, but with “appropriate safeguards.”
“Unless the system is idiot proof and includes validation of the final
product, the user is exposed to a laundry list of rather nasty stuff,”
DeMonaco told me in an email. “Widespread use [of Four Thieves’ devices]
would provide an entire new category for the Darwin Awards.”
Von Hippel and DeMonaco were in agreement that the ability to purify DIY
drugs and run quality control tests on the final product is paramount for
their safe use by patients. Von Hippel suggested that scientists with a
background in medicinal chemistry will be necessary to address these
issues in DIY pharma.
“I see Michael Laufer’s activities as a valuable form of social activism
that points the way to a promising future,” von Hippel said. “But I think
the equipment and the medicinal science issues have to be much further
developed before DIY medicine production will be safe.”
In a way, Four Thieves is just doing a small-scale version of what many
hospitals are doing already. Faced with rising drug prices and shortages,
many hospitals have
started to manufacture their own medicines on site to save costs. The
difference, however, is that these hospitals often have access to
sophisticated laboratories and trained medical personnel, which
significantly lowers the risk of something going wrong.
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Four Thieves isn’t naive about the risks of providing the documentation
to allow others to make their own medicine. It’s always possible that
someone follows the group’s instructions incorrectly and inadvertently
produces a toxic chemical. Yet there are ways to reduce the likelihood of
this happening and one of Four Thieves’ most significant contributions to
DIY medicine is prioritizing harm reduction in its research and
development.
There’s more than one way to produce a given molecule and some synthesis
pathways are simpler or allow for far greater margins of error than
others. Thus Four Thieves aims to discover synthesis pathways that lower
the risk of toxic reactions to the lowest possible level. When the
collective was first starting out, they had help doing this from a
startup called Chematica, which had collected 250 years of research on
organic chemical synthesis into a database and developed software that
used this data to predict and create new synthesis pathways to desired
molecules. With this database and software, Four Thieves was able to
create simple and safe synthesis pathways that would produce life-saving
drugs.
This worked great until
Chematica was bought by Merck, an international pharmaceutical giant,
last year. After the sale, Four Thieves lost access to the software and,
more importantly, the database. Laufer told me that the Four Thieves data
science team has created an open source version of Chematica’s software
and has even compiled a small database of organic chemicals to test it
on. The software is crude compared to Chematica’s, but Laufer said that
it works well enough. To improve the software, however, the collective
needs more data, which is now the property of Merck.
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But as any hacker knows, sometimes data “falls off a truck,” which is a
nice way of saying that Chematica’s database is currently posted on a
password protected website on the dark web. During his talk at HOPE this
year, Laufer implored the audience to help with cracking the password and
releasing the data into the world. Getting access to Chematica’s data on
synthesis pathways would blow open the door for a new suite of DIY
medicines, but until then it’s going to be pretty slow going.
THE FUTURE OF DIY MEDICINE
The most expensive drug on the
market is called
Glybera and is used to treat familial lipoprotein lipase deficiency,
a hereditary disease found in
only about 7,000 people worldwide. Lipoprotein lipase deficiency
prevents the normal breakdown of body fats, which results in abdominal
pains, acute pancreatitis, enlarged livers and kidneys, and the buildup
of fat deposits under the skin. Glybera helps treat these symptoms and is
critical to the quality of life of those with FLLD. The only catch is the
medicine costs each patient $1.2 million per yearif it’s even available
to them. In 2017, UniQure, the company that produces Glybera,
stopped selling the drug in Europe due to the extremely limited
demand. This means that the approximately
1,200 Europeans with FLLD are out of luck when it comes to treatment.
The situation is more or less the same for those afflicted with other
orphan diseases, which are defined as conditions that affect
fewer than 200,000 people worldwide. If a drug for the disease
exists, it is generally
prohibitively expensive to obtain. If the company doesn’t see enough
demand for its product, it will likely pull it from the market. So for
many rare diseases, a cure or palliative medicine may exist but is too
expensive for patients or not profitable enough to put on the market.
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In the future, Laufer wants Four Thieves to focus on manufacturing drugs
for orphan diseases so that those with rare conditions will never be
without their medicine. Yet these types of medicines come with their own
unique problems.
For instance, Laufer said that many of the medicines for orphan diseases
are made of biological material, such as fungus. Laufer said that Four
Thieves is working to create a BioTorrent site to distribute the organic
material need to manufacture orphan medicines. BioTorrent would be like a
normal file sharing site like the PirateBay, but instead of downloading
music and movies, people could download instructions for how to
synthesize their own medicine and share the organic material among one
another. Since biological cells are self-replicating, this would simply
require one user to grow a sufficient amount of cells for themselves
before shipping some cells to another user who would repeat the process,
similar to the way people ‘seed’ a media file on torrent sites.
The question, then, would be how to ship the biological material cheaply
and without getting caught. To this end, Four Thieves is investigating
the use of books and CD cases as grow media for biological precursors.
Mycelia are basically the ‘roots’ of many fungi and feed on cellulose,
which is found in abundance in the pages of a book. So Laufer and his
collaborators began injecting books with mycelium, which feed upon the
pages and grow out of the book. Similarly, compact discs are similar
enough to petri dishes that if they’re streaked properly they can be used
as a growth medium for bacteria and other biological precursors. The
advantage of this is that Four Thieves members using the BioTorrent site
could ship these cells using the cheaper
“media
rate” charged by the US Postal Service for items like books and
compact discs while avoiding scrutiny from law enforcement.
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In the meantime, however, Four Thieves is still mostly focused on
improving its MicroLab and synthesizing new medicines. Recently the
collective began producing its own custom circuit boards for the
MicroLab, which will make it even easier to set up the device at home.
Laufer said he plans to begin giving these circuit boards away as early
as next month. At the same time, the group is working on perfecting the
synthesis of Solvadi, a one-time treatment that can cure Hepatitis C.
This drug has been on the market for nearly five years, but its $84,000
price tag
makes it inaccessible to many people who need it. If Four Thieves has
its way, Hepatitis C will soon be a thing of the past for everyone,
regardless of their income.
At a time when many Americans lack even basic health care services,
Laufer’s ideas seem as intuitive as they are radical. His work is
predicated on the notion that too many critical decisions about our
health have been outsourced to private actors who care more about their
bottom line than their customers’ well being. For Laufer, Four Thieves is
as much about medicine as it is about the right to the free flow of
information and personal autonomy. As far as he's concerned, one cannot
exist without the other.
“Pursuing science is a human right,” Laufer said. “In fact, it’s the
human right from which all other rights flow. You have to be able to do
whatever you want to your body and to think the way you want.”