Hacker targets Big Pharma with homebrew meds

NEW YORK—What if Walter White, the manipulative methamphetamine maker from the AMC series Breaking Bad, decided to “break” a different way? What if he used his chemical-mixing genius to teach people how to safely make life-saving medication to which they wouldn’t otherwise have access?

That’s the question Michael Laufer asked a packed conference room of several hundred computer hackers Friday morning on the top floor of the Hotel Pennsylvania here in midtown Manhattan. The room exploded with applause as Laufer, who holds a Ph.D. in mathematics from City University of New York and is not a medical doctor, challenged his audience to question strict FDA rules and regulations, as well as the ostensibly unfair, high cost of medications major pharmaceutical companies impose on the people who need them.

“I hope people will be taking back control of their own health,” he said in an interview with The Parallax after his presentation. “Few people manage their own health, and that’s so antithetical to the hacker ethos.”

Laufer’s presentation at the biennial computer-hacking conference Hackers On Planet Earth, or HOPE, marked his first public discussion of a project he’s been working on for four years called the Apothecary MicroLab. Its objective: to short-circuit the medication-making process.

The project involves two distinct components that apply maker culture to medicine. The first part is a jerry-rigged hardware setup, a do-it-yourself version of expensive automatic chemical mixers called controlled lab reactors that produce new compounds. Laufer’s version consists of a cheap microcomputer (he’s using an Arduino) connected to an apparatus of motorized stirring rods, heating coils, plastic tubes, and lidded mason jars.

The second part involves providing recipes for desired drugs. In front of his HOPE audience, Laufer measured some white powder he said he’d synthesized using the Apothecary MicroLab and filled an empty gel capsule with it. The powder, he said, was a medication called pyrimethamine, an antimalarial commonly used to treat people infected with the toxoplasmosis parasite.

Risky business

The Apothecary MicroLab involves a risky challenge to accepted medical safety regulations. Laufer is seeking help from the hacker and medical communities to refine and freely distribute plans to convert accessible chemicals into medications. And he has partnered with Chematica, which he describes as the “Google of chemistry” but “cooler,” to form the drug recipes.

Laufer is well aware that distributing plans to build chemical-mixing hardware and synthesize medications at home could put him at risk of legal action from government agencies or pharmaceutical companies, respectively for violating regulations or patents. The project could, moreover, pose serious dangers to people who use the resulting homebrew drugs.

Suzannah Sundby, an attorney in Washington, D.C., who specializes in pharmaceutical intellectual-property patents, agrees that Laufer’s plan is dangerous.

“I would be very afraid for anybody who would do this and think they could treat themselves,” says Sundby, who as a cytogeneticist years ago helped map the genome of the fruit fly genus Drosophila. “I would worry about the public safety of others. It could be toxic. It could blow up. The chemicals that are involved in making some pharmaceutical products are toxic and have to be [disposed] of properly.”

Laufer “absolutely” acknowledges that his plan could harm or even kill the very people he intends to help. “But that risk is entirely outweighed by the potential benefit of people being able to live in the face of something deadly,” he says, “when the only thing that has disenfranchised them from medicine is legality and infrastructure.”

He includes on his list of targeted medicines the chemical compounds needed to make the equivalents of pyrimethamine; mifepristone and misoprostol, which are used to induce abortions in early term pregnancies; Naloxone, used to treat addiction to heroin and other opioids; Sovaldi, a drug currently costing $1,000 per pill that is used to treat Hepatitis C; and GSK744, which researchers believe could replace multidrug treatments for and inoculate people against HIV.

Most of those drugs’ manufacturers did not return requests for comment. But Abby Long, director of marketing at mifepristone maker Danco Laboratories, stressed an industry focus on safety.

“It’s in our interest and the FDA’s interest in getting women safe medication,” Long says.

Vincent Christiano, a pharmacist in Massachusetts with more than 30 years of experience, expressed support for Laufer’s goals but not his means.

“For someone to even think that they need to do this, it shows there’s an incredible need. It’s a good idea that you want people to get medication that is pure, affordable, and effective,” he says. “But drugs aren’t like growing lettuce. It’s a totally different animal. The processes are incredible. That’s why chemotherapy costs tens of thousands of dollars. Drug companies are held to an incredibly high standard; their medication has got to be analyzed and tested.”

A cure for price gouging?

Laufer isn’t alone in trying to make medication outside of heavily funded pharmaceutical companies. Counter Culture Labs in Oakland, Calif., is working on developing lower-cost human insulin. But so far, the Apothecary MicroLab appears to be the only domestic effort focused on helping people synthesize medication themselves.

It’s no accident that Laufer chose pyrimethamine, marketed as Daraprim in the United States, as the target drug for the Apothecary MicroLab’s public debut. The sole U.S. manufacturer of Daraprim, Turing Pharmaceuticals, last year raised the price of the drug 5,500 percent, from $13 to $750 per pill. The same pill is available from Canadian online pharmacies for about $2 per pill.

Responding to intense criticism, Turing’s founder, Martin Shkreli, said he had authorized the price hike to fund further research into combating toxoplasmosis. Currently under house arrest in Manhattan for securities fraud, Shkreli did not return a request for comment. He also did not pick up when Laufer, on stage at HOPE, revealed his phone number on a slide and called it, though Laufer said the two spoke the next day.

Laufer showed on another slide the chemical reaction he used to synthesize pyramethamine. Although he didn’t mention the chemical precursors by name he used in the synthesis process, they appeared on his presentation slides and are listed in the torrent file Laufer is distributing: acetonitrile, used as a solvent in spinning fibers and lithium batteries; ethyl bromide, a solvent used in anesthetics and gasoline; and cyano guanidine, used as a flame retardant, a dye fixer, and a coating in electronics.

He then threw the small white capsules he’d filled with the pyramethamine he’d synthesized into the audience—at the same time cautioning healthy people not to ingest them because of their serious side effects—and said he hopes that Apothecary MicroLab can help eliminate that kind of price gouging.

“To do nothing is to be complicit,” he says. “Every moment that we stand in inaction while people are dying because of intellectual-property laws, we’re complicit in their murder.”

Sundby says Laufer’s concerns that the companies he’s targeting will come after him in court are unfounded.

“From an intellectual-property stance, I don’t see how pharmaceutical companies would feel threatened by this,” she says. “If anything, I would hope that somebody would pursue legal action to protect the public.”

Laufer compares himself to the women’s health activist group Women on Waves and Dr. Rebecca Gomperts, who circumvented anti-abortion laws around the world by anchoring a ship in international waters that provided pregnant women with health services, including medication that would induce abortions. Diana Whitten, director of a 2014 documentary about Gomperts’ work called Vessel, filmed our interview.

Laufer’s plan, unlike Gomparts’, includes challenging the legitimacy of pharmaceutical companies themselves. And although he clearly will have to contend with many challenges ahead, including the safety of those who concoct and consume medications with Apothecary MicroLab formulas, Laufer feels that his project is on the right side of medical ethics.

The HOPE audience’s enthusiastic response to his newly revealed plans, he said, eyes watering, made him profoundly proud.

“I think that was the most satisfying moment of my life,” he said.

Update, July 25 at 4:40 p.m. PT: This story has been updated with clarifications, including the ingredients Laufer said he synthesized to create pyramethamine.