On Oct. 17 local blockchainer Tristan Roberts livestreamed as he injected himself in the stomach with a treatment that is designed to fight HIV. It came with a warning for viewers not to try it themselves.
According to D.C.-based company Ascendance Biomedical, Roberts is the first person to try this particular treatment. And if it lowers his HIV viral load, the therapy could be available to the public as early as the first quarter of 2018.
Roberts, who has been HIV positive since 2011, joined forces with Ascendance Biomedical via a local biohacking group earlier this year. We’ve covered Roberts before – presenting at a meeting for the DCBlockchain Users Group and at an organizing event for hacktivist group Anonymous. Now he’s working with Ascendance Biomedical to test their HIV treatment, and also help them distribute the treatment using the blockchain.
How Does It Work?
The treatment Roberts tried is based on a gene therapy that was initially discovered by a team of NIH scientists. (However, the NIH was not involved in Roberts’ injection.) According to an announcement made in 2016, NIH researchers isolated an antibody produced by an HIV-positive patient called N6 which helped neutralize 98 precent of HIV strains. Although it isn’t the first antibody found to help combat the virus, NIH said N6 could be a game changer because it neutralizes more HIV strains, and more strain types. That’s why the goal has been to transfer N6 into people who don’t naturally produce it.
If transferring the N6 antibody worked, HIV positive people could potentially have more treatment options besides the expensive antiviral drug regimes used today. But finding a way to replicate N6 inside a new host has proved difficult, Roberts told me, and gene therapy is expensive.
This is where Roberts and Ascendance Biomedical come in.
“The therapy modifies a patient’s cells to produce N6,” Ascendance Biomedical wrote in a press release on how its version version of the treatment works. “This is done by replicating the gene for N6 and inserting it into plasmids, which can be ‘transfected’ into the patient’s cells.” (Plasmids are like a circle of DNA inside cells, capable of replicating themselves.)
As for the lowered cost barrier? That would be thanks to decentralization and the blockchain.
How Can the Treatment be Sold ‘At-Cost’?
Ascendance Biomedical CEO Aaron Traywick spoke to us over the phone about how his startup aims to distribute this gene therapy – for cheap. “We’re basically working with a model that’s a replication of the FDA’s Compassionate Access Program,” he said.
The FDA Program he referenced to (also called Expanded Access) allows seriously ill patients to try unapproved treatments. Traywick, 27, said he is concerned that the lengthy federal approval process slows down access to these treatments, and founded Ascendance with the idea that he could use the blockchain to give patients instant access.
“We make all our technology and all our treatments available to anyone who buys our Ethereum coins,” Traywick explained. The purchase of a coin enters the buyer into a contract relationship with the company. Traywick says this means Ascendance “will provide to you at the cost of production and materials, the treatment for research purposes only and not for human consumption.”
That last part is the sticking point.
Ascendance Biomedical is trying to skirt the FDA’s lengthy approval process by not marketing their treatment as medicine at all, but rather, a product you can research yourself. The company doesn’t – and can’t – recommend anyone inject themselves like Roberts did. Instead, Traywick plans to make materials, testimonials, and instructions publicly available through the blockchain.
In Traywick’s words, “Here’s the treatment, here’s what it’s doing, here’s how it’s done. And what you choose to do with it, is up to you.”
Traywick, who is originally from Alabama, now lives in Rockville, Md. Ascendance Biomedical, however, is an international affair.
“We have a network of clinicians, doctors, and researchers [in places] places all over the world,” Traywick said of his 15-person team. “We can deliver a cure for HIV at less than the cost of shipping it to you. That’s how low the cost is because of the way we’re operating.”
Not everyone is a fan. We spoke to Dr. Hank Greely, the Director of the Center for Law and the Biosciences at Stanford. He told us there’s a reason the FDA has a lengthy approval process, and strict regulations.
“These lower the chances that people will be directly harmed by their ‘treatments,’ will end up wasting their time and energy on useful ‘cures,’ or will avoid helpful treatments while chasing a pie in the sky panacea,” Greely wrote to us in an e-mail last week.
There’s also concern that Ascendance Biomedical could still be violating the Federal Food Drug and Cosmetics Act, which bans unapproved drugs. “It isn’t entirely clear that self-experimentation would violate the statute,” Greely said to us. “But the provision of the drug to someone else for their experimental use could.”
The Next Steps
Roberts told us that even though he injected in two sites in his stomach, Ascendence Biomedical has a different dosage goal. “Our goal is to have a ‘one injection is a cure for life’, or at least a few years,” Roberts told us during a phone call. Success will be measured in a reduction of his HIV viral load. “That’s what we’re seeking to find with the lab results. It should be an undetectable viral load.”
In addition to being lab rat, Roberts is also helping design Ascendence Biomedical’s blockchain framework.
Traywick explained the blockchain will be used to provide quality conrol. “It will be used to certify the scientific team behind each treatment and the individual contractor who decide to receive the treatment and test it out on themselves,” he said.
Ascendance Biomedical will also be using the blockchain to record “attestations” or testimonials from the people who test out the gene therapy. Hank Greely, the bioethicist at Stanford, shared his concerns about using the quality of attestations as proof of successful treatment.
“In a word, crap,” Greely said. “Single, uncontrolled anecdotes can prove very little.”
For now the only testimony is Roberts – who reported to us last week that his injection sites showed no sign of allergies. He said he’s cautiously optimistic about the results.
“I would still say it’s a functional cure rather than a complete cure because there will still be fragments of HIV genetic material very deep within my cells,” Roberts said. “But at any point when they surface and start to reproduce they won’t be able to do anything – they’ll just get destroyed by an antibody. That’s the hope.”
Greely on the other hand, is less optimistic about the treatment, or Ascendance Biomedical in general.
“To me, folks who want to make money by selling desperate people unproven cures or treatments for dread diseases belong somewhere in Dante’s Inferno. If your treatment is good, prove it!” Greely said. “And if it’s that good, don’t tell me you can’t find the money, or the partner, to prove it with.”-30-
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