Biohackers Create Generics to Battle Rising Drug Prices

Alicia Ault

October 19, 2016

Public outrage over skyrocketing prices and the slow development of drugs and devices is driving discussions about whether reforms are needed, but some consumers aren't willing to wait years for policy makers to take action. Instead, some tech-savvy individuals are taking matters into their own hands, crafting their own solutions and sharing them via social media, websites, listserves, and word of mouth.

So far, these do-it-yourself (DIY) creations — such as home-brewed insulin and an EpiPen knockoff ― haven't come under fire from the Food and Drug Administration (FDA), in part because they fall into a somewhat gray area. But they are not escaping complete notice at the agency.

And it's not just regulators who are keeping a wary eye on the DIY community. Physicians and even some inventors say they are concerned with what might happen if homemade devices or drugs proliferate.

Without FDA regulation, "It's all a buyer-beware situation," David Rosen, a food and drug lawyer with Foley & Lardner in Washington, DC, told Medscape Medical News.

Crowdfunding "Home-Brewed" Insulin

The rising cost of insulin has become a source of anxiety, frustration, and fear among people with diabetes. According to GoodRX.com, a consumer site, the retail price for the standard package of five pens of the most popular insulin, Sanofi's insulin glargine (Lantus), is $381. And that price has risen steadily during the past 5 years. The price range for insulin is $146 to $541, according to the site.

Many patients may pay less than that through insurance coverage or discounts. But it's still a heavy burden, given the amount of insulin many individuals with diabetes require.

Despite having been on the market for almost 100 years, no generic insulin exists, and competition among brand manufacturers — and a growing market for the drug ― has done nothing to bring down the price. Analysts will be watching to see whether that changes in December, when Eli Lilly's generic version of insulin glargine, Basaglar, is expected to arrive on the market. That drug was approved by the FDA in December 2015.

The appearance of Basaglar is not going to stop Anthony Di Franco from pursuing his goal of synthesizing insulin in his small, all-volunteer laboratory in Oakland, California, and ultimately making the process available to all comers.

 
They want to prove that insulin can be easily produced. Anthony Di Franco
 

Di Franco, 33, has had type 1 diabetes for a decade. He said that he's been frustrated by the lack of low-cost therapies. "I'm reminded of it every day, many times a day," Di Franco told Medscape Medical News.

The Yale graduate — he holds a BA in computer science, math, and physics — is a cofounder of an Oakland-based biohacker space, Counter Culture Labs, which was started in 2011. The maker space aims to create and explore through the sharing of knowledge. By 2015, Di Franco and cohackers formulated the Open Insulin Project, with the idea that they could synthesize insulin out of Escherichia coli bacteria and show that it's possible to make insulin "in a simpler and cheaper way," Di Franco said.

The group launched an Internet crowdfunding campaign to get off the ground, raising $16,656 on Experiment.com from friends and strangers. They began lab work in early 2016 and still have much of their funding left, in part because it's an all-volunteer staff, said Di Franco. The project also has received some donations of equipment and supplies, he said.

So far, the lab believes it has produced proinsulin, but they "want to be really clear about what we're seeing and why" before making any sort of big announcement, said Di Franco. The next step will be to make insulin, which involves a combination of biological and chemical methods, he said.

"We're very far from the point where we could provide a pharmaceutical grade product to anyone," said Di Franco, noting that that was not the ultimate goal. Instead, they want to prove that insulin can be easily produced. "Hopefully we'll be able to contribute in some way, even if it's just demonstrating that it's possible and that the fundamental economics of it are sound," he said.

Another Bay Area scientist, Antonio Lamb, is attempting to make insulin from microalgae. Like the Open Insulin Project, the Algae Insulin Project began as a crowdfunding effort "to help generate traction for algae biotechnology and to demonstrate that algae is a promising expression platform for various therapeutic proteins," Lamb told Medscape Medical News. His company, MicroSynbiotiX, is ultimately seeking to develop a platform for aquaculture vaccines, he said.

The insulin project — which has raised $2277 — continues as an open effort that might ultimately be shared with others, said Lamb, who is cofounder and COO of MicroSynbiotiX.

Proinsulin has been successfully expressed in microalgae before, "but the yield has been disappointingly low in most cases," Lamb said. His project hopes to do better, but he isn't sure if that's possible. "If all goes as scheduled, we are hoping to confirm insulin expression from our construct by the end of December," he said, but added that he expected low yields.

Lamb and his colleagues "will likely not take the project beyond demonstration of the proof of concept," he said, but will try to find a way to share it with others, such as the volunteers at Open Insulin.

An EpiPen — for $30

Many individuals are looking for an alternative to the EpiPen (Mylan), an epinephrine autoinjector used to reverse anaphylaxis. The retail cost of the EpiPen is $600 for two pens. The generic alternative, Adrenaclick, retails for about half of that, but that's still a high price for many schools that need to stock the drug or for individuals who have large co-pays or who have fallen into the "donut hole" for Medicare's prescription drug coverage and have to bear the entire cost.

Complaints about the price of the EpiPen came to the attention of Michael Laufer, PhD, and colleagues at the Four Thieves Vinegar collective, a group dedicated to empowering people to take control of their own health.

Dr Laufer, who holds a doctorate in mathematics and is a lecturer at Menlo College in Atherton, California, decided that he could create an EpiPen alternative. He explains how to make the "EpiPencil" in a 5-minute video posted on YouTube. It involves an insulin injection device (AutoJect 2) coupled with a syringe and a needle. Dr Laufer said users can get epinephrine by obtaining a prescription from a physician.

In the video, he proves the device works by showing a clip of him injecting himself. In another clip, he shows the injector squirting liquid when a button is pushed.

Dr Laufer told Medscape Medical News that he's giving people an opportunity to make their own tools and that he has not heard anything from EpiPen manufacturer Mylan. He said he wouldn't expect to, "considering we're not in any related business and not even in any business," he said. As for the FDA, he believes he's within the law, "considering that we're not distributing anything."

When asked to comment on EpiPencil, FDA spokeswoman Theresa Eisenman said that "epinephrine autoinjectors require a valid prescription for dispensing to consumers, and only a pharmacy or medical practitioner licensed by the states may distribute prescription drugs to consumers pursuant to a valid prescription."

But Dr Laufer is not distributing or dispensing anything. Eisenman also noted, "It's essential to remember that epinephrine autoinjectors are lifesaving products, and it is critical that they are made to a high standard of quality so patients can rely on them to work safely and effectively."

Andrew Murphy, MD, FAAAAI, said that he gives Dr Laufer credit for his idea. "It's very creative," Dr Murphy told Medscape Medical News. "But I can't tell people to use that," said Dr Murphy, who practices at the Asthma, Allergy and Sinus Center in West Chester, Pennsylvania. He recommends the generic epinephrine injector to patients who can't afford EpiPen and will prescribe epinephrine and a syringe to those who can't pay for the generic. "That's fine," he says, especially "if the alternative is to not take anything."

The EpiPencil is a black box, though, he said. "If you're anaphylaxing, that's not the time to figure out if an interesting Internet hack is going to work," Dr Murphy said.

Whether it works when needed is a critical question, agreed Rosen, the attorney, who is also a pharmacist. He noted that epinephrine is unstable and can degrade with light, heat, or air.

Dr Laufer is claiming to only be trafficking in information, but he's giving instructions, said Rosen. And that should raise questions at the FDA, he said. "It would be very disconcerting if somebody got hurt," Rosen told Medscape Medical News.

DIY Insulin Pumps

Although Dr Laufer skirts the FDA, DIY developer Dana Lewis has developed a good relationship with the agency.

Several years ago, Lewis, who has type 1 diabetes, and her husband, Scott Leibrand, created a system to improve upon the alarms in her continuous glucose monitor (CGM). Initially, it was a "closed" system that required Lewis to physically change the insulin dose, based on the new alarms that she and Leibrand, a software engineer, had programmed. The system brought together a Raspberry Pi minicomputer, a Medtronic insulin pump with a Carelink USB, a Dexcom CGM system, and code written by Leibrand.

 
We are a reminder that it's not okay [to move slowly]. Dana Lewis
 

Lewis began sharing her excitement about the device at various gatherings of people with diabetes. By the middle of 2014, the FDA, having seen the device at one of those meetings, had taken an interest. According to Lewis, the agency told her that the system could be considered a regulated device under FDA rules. An official suggested that Lewis and Leibrand make the code widely available, to take them out of the role of device maker.

They did, and continued to enhance their system, with a goal of closing the loop—essentially going after the same “holy grail” target that device makers like Medtronic were spending millions of dollars to develop. Lewis and Leibrand succeeded in late 2014, creating what they called the OpenAPS (Open Artificial Pancreas System).

The DIY device automatically adjusts a pump's basal insulin delivery to keep glucose in a safe range overnight and between meals. According to Lewis, the device communicates with an insulin pump to obtain details of all recent insulin dosing, communicates with a CGM to obtain current and recent blood glucose estimates, and issues commands to the pump to adjust temporary basal rates as needed.

The instructions for making the device and the coding are widely available online, but potential builders have to be very tech-savvy. It is likely that that's limiting the uptake. Lewis said perhaps 120 people are using OpenAPS — a drop in the bucket, considering that about 1.25 million Americans have type 1 diabetes, according to the Juvenile Diabetes Research Foundation.

The FDA has so far been hands-off, said Lewis.

Technically, the OpenAPS "would fall within FDA's jurisdiction," said Courtney H. Lias, PhD, director of the Division of Chemistry and Toxicology Devices at the FDA's Center for Devices and Radiological Health. But, she told Medscape Medical News, "We haven't taken enforcement action."

In part, that's because the OpenAPS doesn't pose a risk to thousands or millions of others, said Dr Lias. Lewis is not distributing a product, but if she did, she would be subject to the same rules as any device maker, Dr Lias said.

The FDA is intrigued by the diabetes community's DIY creativity and is trying to foster interactions among manufacturers, patients, and the agency, she said. The FDA wants to "promote the development of products" so that patients "don't feel like they need to do it," Dr Lias said.

Patients Will Continue to Test Limits

As with many aspects of the American economy, technology is giving individuals more power to change their lives. Healthcare may be a little late to the party, but disruptive technology in the field may present some of the greatest challenges to corporations, regulatory bodies, and learned professionals.

Dr Laufer, the California mathematics lecturer, said he and his collective are deep in development of their "Apothecary MicroLab." The platform will allow patients to "share medication as easily as we share movies and music," Dr Laufer told an audience of hackers in July 2016.

The MicroLab will include instructions on how to make a pharmaceutical with off-the-shelf parts and some sophisticated coding. Organic chemistry know-how will be required. The Four Thieves Collective notes on its website that it will be extremely difficult work. But the collective aims to put out plans for making generic versions of pyrimethamine (Daraprim), the toxoplasmosis drug that drew fire after Turing Pharmaceuticals raised the price to $750 a dose; mifepristone (multiple brands) and misoprostol (multiple brands), used in chemical abortions; and sofosbuvir (Sovaldi, Gilead Sciences), the high-cost hepatitis C cure.

Laufer said he wants to bring much-needed medications to people who cannot afford them — whether in the United States or developing nations, such as El Salvador, where he spent time and where illicit drug laboratories were rampant, he said, but the medical clinic could not get access to pharmaceuticals.

Similarly, Lewis said she expects to keep building on her OpenAPS and that she's expecting the number of users to grow, despite the recent approval of Medtronic's 670G fully automated insulin delivery device. The 670G won't be available for at least 6 months, will be indicated for a limited number of patients with type 1 diabetes, and will cost as much as $8000 out of pocket, said Lewis.

Just the existence of a DIY community likely pushed Medtronic and the FDA to move more quickly, Lewis said. The community will continue to press for more options, more competition, and better and less expensive devices, she said. "We are a reminder that it's not okay" to move slowly, said Lewis.

For more news, follow Medscape on Twitter .

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....