Meet anarchists who make their own drugs

Original author: Daniel Oberhaus
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The Acetic Group of Four Thieves is a network of anarchists who rely on technology and challenge the giants of the pharmaceutical industry with self-manufactured medicines.

I first met Michael Lofer when he was thrown into the audience of the hacker conference HOPE (Hackers on Planet Earth), held every two years in New York, with medicines for thousands of dollars.

“Has anyone present experienced anaphylactic shock without access to epinephrine ?” Asked Lofer from the audience. Several hands went up, and Lofer hurled an EpiPen ( homemade pen-like device for self-injection of adrenaline) into one of the people who raised their hand [ approx. trans. ]. “This is one of the first devices we made,” he said. “Use it wisely.”

A little bit gloating about how Martin Shkrelifrom a tribe of pharmaceutical giants raised the price of the drug daraprim , necessary for people suffering from HIV, from $ 13 to $ 750, Lofer became serious. “Two years have passed, but despite everything that happened, the cost of the drug daraprim has not changed,” he said. He reached into his pocket and took out a handful of white pills. “I think we need to give a little more,” said Lofer, and threw a gift to the audience.

With a shaved head, a dark beard and an eternal camouflage jacket, Lofer is not like a man who you would like to ask for medical advice - but that's the point. Having founded the Four Thieves Vinegar Vinegar Group of Thieves , a voluntary network of anarchists and hackers developing technologies for self-manufacturing of drugs, Lofer has spent the last ten years freeing vital drugs from the huge corporations that own them. Lofer has no medical education, and the first is ready to say that he is not a doctor. From the point of view of legislators, it would be more suitable for mathematical calculations on nuclear weapons than for treating patients. But Lofer never allowed the rules and regulations to block his path.

I met Lofer in a bar across the street from the hall where HOPE took place, after his speech on the manufacture of medicines with his own hands. He met with his fellow “four thieves” who had flown from all over the country to this conference in order to uncover the new medical technologies they were developing. Lofer began the celebration with a toast:

“Let's drink to the dead, for children with cancer and AIDS,” said Lofer, raising a glass of bourbon, and quoting hip-hop artist Felipe Andres Cornel, better known under the pseudonym Immortal Technique . "There is a cure, and you probably could have been saved."

In the past ten years, they have crossed the path to the FDA, billionaires - directors of pharmaceutical companies, doctors and chemists from the most prestigious universities in the United States. Lofer and his comrades do not stop infuriating influential people, because "four thieves" are living proof that effective medicines can be developed, keeping within a small budget.

At the [US] pharmacy, a pair of Mylan adrenaline syringes can cost you $ 600, a generic $ 300, but the continuing shortage almost guarantees that you won’t find them, even if you can afford them. In response to this, the "four thieves" published instructions on their website for the independent production of a syringe with medicine, which will cost you $ 30, moreover, it can be made from freely sold components, and then recharge for only $ 3. Shkreli brought the cost of life-saving medication for HIV-infected people, daraprima, to $ 750 apiece. Then the "four thieves" have developed a freely distributed chemical laboratory, allowing anyone to produce their own money for just 25 cents apiece.

The volume of the pharmaceutical industry in the United States is estimated at $ 446 billion , and its borders are actively protected by agencies like the FDA and the Anti-Drug Administration (DEA). By freely distributing medical device diagrams and drug manufacturing instructions, a handful of anarchists and hackers are threatening to shake the foundations of one of the most regulated and profitable industries in the world. And that they have just started to act.

Free medicine

“Four thieves claim successful production of five different types of drugs, and all of them are made with the help of MicroLab. This device should simulate an expensive device that can be found in chemical laboratories, while costing a small percentage of their cost, and using the available materials sold in stores. In the case of MicroLab, the reaction chamber consists of a glass jar that fits inside a larger jar, with a lid printed on a 3D printer, the drawings of which are available on the Internet. Several plastic hoses and a thermistor that measures the temperature are connected to the cap — fluid circulates through the device through the tubes, promoting the chemical reactions necessary to produce various drugs. The whole process is automated with a small computer, costing no more than $ 30.

Today, "four thieves" used this device to obtain drugs such as: naloxone , an antidote for overdoses of opioids, primarily heroin (known as Narcan); daraprim, a medicine that fights infections in people with HIV; Cabotegravir, an HIV preventive medicine that needs to be taken four times a year ; Mifepristone and misoprostol are two compounds required for pharmaceutical abortions.

Michael Lofer demonstrates MicroLab at the 11th HOPE Conference in 2016

Taking into account the new candidates for the US Supreme Court from the current administration, the anarchist team feels the need to rush to bring their drugs to abortion to perfection. They fear that the federal government will soon allow individual states to allow or prohibit legal abortions, and some of them will have no opportunity to have an abortion. This was the motivation for Tim Heilers (Louisville), a former sonar specialist from the US Navy, to join the “four thieves” last February.

“Kentucky is a very conservative state, and I think that there is a real possibility that we will become the first state where abortions are completely prohibited,” Haylers told me. “So I think it’s very important to give people the opportunity to produce their own mifepristone when needed.”

Although the "four thieves" managed to get five drugs, for downloading from the site so far only a manual for daraprim is available. This, in particular, is due to the very different complexity of obtaining different molecules. Naloxone is particularly difficult, since this antidote for opioid overdoses uses the same precursors as the opioids themselves. Their sale is controlled by the government, and they can be purchased only by approved laboratories, and then in small doses. To get around this problem, Lofer and his colleagues took, at first glance, a counterintuitive approach: they make medicine from poison.

Although they cannot legally purchase precursors to naloxone, Lofer guessed that opiates themselves were fairly easy to buy. Buying Oxycodone on the street(aka OxyContin), community members were able to conduct several chemical reactions, extract the necessary precursors from it, and use them to produce naloxone.

“Some ingenious dope dealers in the 90s found that it was possible to conduct a one-step reaction with oxycontin and get oxymorphone , a substance six times stronger,” Lofer said. “And then from oxymorphone, you can make naloxone in one step.” It's quite simple - and now you are already making medicine from poison. ”

Such unorthodox approaches to health are quite common in the process of hacking pharmaceutical giants, and their purpose is to help people at any cost.

For example, there is a drug cabotegravir , a prophylactic drug, proven to preventthe spread of HIV by sharing needles in macaques. Unlike other prophylactic medications that must be taken daily, cabogravir can be taken four times a year , and it will protect you from HIV. And although the first clinical trials of the drug were extremely promising, the “four thieves” were tired of waiting until this medicine was approved for widespread use. Currently, the drug is undergoing the third phase of the FDA's tests , that is, it is clinically tested on a large number of people. In addition, if you take into account the cost of other prophylactic drugs, then cabotegravir will most likely be sold at an exorbitant price. For example, the monthly supply of a similar drug Truvada , which must be taken daily,will cost you $ 2000 . Therefore, a group of hackers figured out how to make it yourself.

Cabotegravir is still in preclinical testing, but this did not stop the “four thieves” from trying to transfer a preventive drug to those who may need it. The group continues to experiment with the synthesis of its own version of the drug, and some of its members have already begun to purchase a commercially available preventive drug tenofovir , mix it with a buffer, and supply it to heroin sellers who can offer it along with their product as an “extra service” for customers . Customers who decide to take advantage of this service “will have side effects,” Lofer said. “With him, you won't catch HIV.”

The first prototype of the MicroLab is tubes tucked under the arm, a bicycle nipple and a glass jar.

“The vinegar group of four thieves”, obviously, runs along the edge when it comes to the legality of their actions. And although Lofer turned the overthrow of the medical industry into a kind of art, his mission to free medicine remains under constant threat of harassment from law enforcement. When a pharmaceutical company makes a new medicine, they also have a patent for the molecule that makes it effective. However, Lofer and his colleagues are able to reproduce these molecules, as they are described in detail in patents, and often in scientific journals. Only the right technology is needed.

Since the “four thieves” do not sell or distribute the drugs they have made, technically their actions are not illegal from the point of view of the FDA, although the agency issued an open warning about their initiative. Shortly after promulgating a syringe with adrenaline for $ 30, the FDA issued a warning to the press, saying that “using non-approved prescription drugs for personal use carries a potential hazard”, but did not mention the “four thieves” by name. Ironically, a few months before, the FDA issued a warning to Pfizer , which did not investigate "hundreds" of complaints about the failure of their syringes with adrenaline, some of which ended in death. In May, the FDA issued another warning.where chronic deficiency of these syringes was declared.

As for the DEA, none of the drugs produced by a team fall under the definition of “ controlled substances ”, so possessing them can be punished to the maximum according to the prescription drugs law. And a person suffers from a disease and he has a prescription for a medicine for him, he should have no problems if he produces this medicine himself. "Four thieves", in fact, simply release information about the production of certain drugs at home, and develop free tools for this. If someone decides to make prescriptions for their medicines, it will be his personal business, but the “four thieves” do not pretend to release information “for educational purposes only”.

“People who support intellectual property laws continue to call this theft,” Lofer told me. - If you take it as an axiom, then according to the same logic, keeping information about medicines that can save lives is with you called killing. From a moral point of view, you must steal to prevent murder. ”

“So, yes, we encourage people to break the law,” added Lofer. “If you are terminally ill, and you are denied a medicine that can save you, will you choose to break the law and survive, or remain a respectable corpse?”

Doctors without prescriptions

The catalyst for the creation of society was Lofer's trip to El Salvador in 2008, when he was still a student. Having visited the village clinic as one of the delegates of the mission documenting human rights violations in the country, he learned that contraceptives had ended there three months ago. When the clinic contacted the central hospital in San Salvador, she was informed that other clinics had the same problem. Lofer said he was amazed that hospitals could not provide people with access to contraceptives — a relatively simple-to-manufacture medicine that has been around for more than half a century. He thought that if drug dealers could use underground laboratories to produce drugs, then a similar approach could be used to produce life-saving drugs.

Lofer organized the community shortly after returning from Central America, but announced its existence publicly only in 2016 at the HOPE conference. During the first performance, Lofer demonstrated a homemade syringe with adrenaline for $ 30, distributed a hand-made daraprim among the audience, showed an early MicroLab prototype, and called from the stage to Martin Shkreli (he did not answer). At the beginning of the activities of the "four thieves" Lofer worked mainly by himself. Now, after leaving the underground, the group has grown strongly, although Lofer says that it is impossible to find out the exact number of members - people come and go, and share as much knowledge as they can.

Michael Lofer and a homemade syringe with adrenaline for $ 40

All people in the community have a technical background, but no one has a medical education. Lofer, for example, was engaged in nuclear physics, and manages the mathematical program at Menlo College in Silicon Valley. The results of the diverse technical experience of members of society speak for themselves. Now there are already independent teams in biology, chemistry, data studies, programming and equipment, the degree of involvement in which depends on the specific project.

The Four Thieves do not sell anything, but the group has two key “products.” The first is an open circuit of equipment, such as a syringe or a MicroLab synthesizer, which can be made from commercially available or printed components on a 3D printer. The second is instructions for using this equipment for the production of medicines, which includes everything from using MicroLab for the simplest reactions to ways to get chemical precursors.

“I believe that it is just necessary to provide easy access to information on how to make medicines on your own for everyone who has at least a little interest in this,” Lofer told me. - The goal of the group is to make it so that people can do all this on their own. The idea is that anyone can download the instructions, read the list of materials, order them, read the instructions for building and programming, download the code, order the precursors, and produce the medicine. ”

All the tools of the group were developed without any funding - all the necessary funds come from the pockets of the group members. So far, the medicines produced by them have not killed anyone. However, some experts warn against taking self-made drugs if they have not passed the approval procedure.

Harm reduction

Eric von Hippel, an economist at MIT who explores “open innovation,” is enthusiastic about the prospect of self-made drugs, but under certain conditions. He spoke about a pilot program in the Netherlands that studies the independent production of custom- made drugs for specific people as a good example of safe home-made production. These medicines are manufactured in hospitals by medical experts. Vaughn Hippel believes that it is dangerous for patients to take medicines made by them on their own.

“If you do not carry out chemical reactions with exactly maintained parameters, then along with the desired medication you can easily get dangerous by-products,” Hippel told me via e-mail. “It is hardly possible to carefully control the reaction conditions in such home-made reactors as MicroLab, offered freely by a team of hackers.”

His colleague, Harold Demonaco, who works at MIT, agrees with him. Demonaco suggested that a more rational approach to the voiced problems would be an option in which patients would work with pharmacies that produce mixtures themselves. They prepare medicines specifically for specific customers, and Demonaco says that they are able to synthesize the same medicines that the "four thieves" produced for little money, but with "appropriate security measures."

“If the system does not have a fool proof and is not able to evaluate the final product, then the user is endangered by a large list of unpleasant things,” Demonaco told me via e-mail. - The widespread use of devices from the “four thieves” will open a new category for the Darwin Awards .

Vaughn Hippel and Demonako agreed that for the safe use of drugs by patients it is absolutely necessary to clean home-made drugs and conduct tests on their quality. Vaughn Hippel suggested that solving these problems with homemade medicines would require scientists with experience in medical chemistry.

"Michael Lofer’s actions seem to me a valuable variant of social activism that points the way to a promising future,” said Hippel. “But it seems to me that before self-made medical products become safe, it is necessary to work out issues with medical science and equipment much better.

” “Four thieves” in a sense reproduce on a small scale what many hospitals are already doing . in the face of rising prices of medicines and their deficits, many hospitals began to independently produce their own medicines on the spot , in order to save. the difference, however, lies in the fact that these hospitals often have access to sophisticated laboratories and experienced persons lu, which significantly reduces the risk that something goes wrong.

“Four thieves” without naivety refer to the risks associated with distributing instructions that allow other people to make their own medicines. There is always the chance that someone will follow the instructions incorrectly and accidentally produce a toxic substance. However, there are ways to reduce the likelihood of such an event, and one of the most important contributions of “thieves” to homemade medicine is the priority of harm reduction in the research and development process.

There are several ways to produce a particular molecule, and some ways of synthesis turn out to be simpler, or give more room for deviations than others. Therefore, the "four thieves" seek to discover ways of synthesis, reducing the risk of toxic reactions to a minimum. At the very beginning of the community’s work, they were helped by the startup Chematica, which collected data on 250 years of research on the synthesis in organic chemistry into a database, and developed software that uses this data to predict and create new ways of synthesizing the necessary molecules. With such a database and software, “four thieves” were able to create simple and safe methods of synthesis, which result in life-saving drugs.

This scheme worked fine until last year Chematica was bought by Merck., international pharmaceutical giant. After the sale, the "four thieves" lost access to the software, and, more importantly, to the database. Lofer told me that their data mining team created an open source version of Chematica software, and even collected a small database of organic compounds for testing. Compared to Chematica's software, their program looks rude, but Lofer said that it works quite well. However, to improve it, you need to collect more data that now belong to Merck.

But, as every hacker knows, data sometimes “falls off the truck” - this is a polite way of saying that the database from Chematica was posted on a password-protected website on the “dark Internet”. During a report at the HOPE conference, Lofer asked the audience to help with password cracking and the release of this data into the world. Getting access to data from Chematica along the paths of synthesis would open the door to new versions of home-made drugs, but until then this situation will develop very slowly.

The future of homemade medicine

The most expensive medicine on the market is called " Gliber " and is used to treat a deficiency of lysosomal acid lipase, or Wolman's disease, a rare hereditary disease that affects only 7,000 people worldwide . The disease prevents the normal breakdown of fat, which leads to abdominal pain, acute pancreatitis, an increase in the liver and kidneys, and the accumulation of fat deposits under the skin. Gliber medicine helps with these symptoms and is critical for maintaining the quality of life of patients. The only problem is that this medicine will cost each patient $ 1.2 million a year - if they find it at all. In 2017, the drug-producing company UniQure stopped selling it in Europedue to extremely small demand. This means that approximately 1,200 Europeans suffering from the disease are not very lucky with treatment.

Approximately the same situation is with other rare diseases , which, by definition, affect less than 200,000 people in the United States. If a cure exists for such a disease, its cost is usually too high . If the company does not see a sufficiently large demand for products, it will remove it from the market. Therefore, for many rare diseases, a medicine or an emollient may exist, but it will still be too expensive for patients, or not profitable enough to sell it.

In the future, Lofer wants the “four thieves” to concentrate on the production of medicines for rare diseases, so that people suffering from them will not be left without medicines. However, these drugs have their own unique problems.

For example, Lofer said that many medicines for rare diseases are made from biological material, for example, from fungi. Lofer said that the “four thieves” are working to create a BioTorrent site that will distribute organic materials for the production of rare drugs. BioTorrent will work as a regular file-sharing resource, like The Pirate Bay, but instead of downloading music and movies, people will be able to download instructions for synthesizing homemade medicines and sharing organic materials with each other. Since biological cells are capable of reproducing themselves, one user will just need to grow enough cells for himself, and then send some cells to another, which will repeat this scheme - approximately the way people share files to each other on torrents.

The question then will be how cheaply and safely to send each other biomaterial. For this, the "four thieves" are exploring options with books and CD covers as a medium for biological precursors. Mycelium- this is something like the "roots" of many fungi, which feed on cellulose, which is easy to get from the pages of the book. Therefore, Lofer and his colleagues began to inject mycelium into books; it feeds on pages and grows up. Compact discs resemble Petri dishes, and if they are properly scratched, they can be used as an environment for the growth of bacteria and other biological precursors. The advantage of this approach is that using the BioTorrent website it will be possible to send these cells using a cheaper tariff for packages containing books and CDs, while avoiding the attention of law enforcement officers.

In the meantime, "four thieves" are mainly engaged in improving their MicroLab and the synthesis of new drugs. Recently, the group began producing its own MicroLab printed circuit boards, making it easier to assemble the device at home. Lofer said he plans to distribute these fees as early as next month. At the same time, the group is working to bring to perfection the synthesis of Solvadi , a one-time drug capable of curing hepatitis C. This medicine has been on the market for almost five years, but its cost of $ 84,000 makes it inaccessible to many in need. If the “four thieves” succeeds, hepatitis C will soon be a thing of the past for everyone, regardless of their income.

At a time when many Americans lack medical care, Lofer's ideas seem to be as intuitive, as radical. His work is based on the idea that too many critical health-related decisions were given to individuals who care more about their profits than their clients' health. For Lofer, the “four thieves” case concerns not only drugs, but also the right to freely disseminate information and personal independence. From his point of view, the one without the other can not be.

“Doing science is a human right,” said Lofer. - It is from this right that all other rights derive. “You should have the right to do whatever you want with your body and think the way you want.”

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