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from the how-do-you-test-its-effectiveness? dept.
"Biohackers" are growing bolder with their self-experimentation:
Aaron Traywick, 28, who leads biotech firm Ascendance Biomedical, used an experimental herpes treatment that did not go through the typical route of clinical trials to test its safety. Instead of being developed by research scientists in laboratories, it was created by a biohacker named Andreas Stuermer, who "holds a masters degree and is a bioentrepreneur and science lover," according to a conference bio. This is typical of the Ascendance approach. The company believes that FDA regulations for developing treatments are too slow and that having biohackers do the research and experiment on themselves can speed up the process to everyone's benefit. In the past, the company's plans have included trying to reverse menopause, a method that is now actually in clinical trials.
"We prefer to do everything before a live audience so you can hold us accountable in the days to come as we collect the data to prove whether or not this works," Traywick said before last night's spectacle. And, he added, "if we succeed with herpes in even the most minor ways, we can move forward immediately with cancer."
Despite specifying that he wanted "technical questions," someone in the audience asked whether Ascendance had received ethical permission for the experiment. Traywick said he didn't. Technically, everything has been officially labeled "not for human consumption," he said.
Also at The Scientist.
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(Score: 5, Insightful) by ledow on Wednesday February 07 2018, @11:33AM (2 children)
Self-experimentation has been done before. There are very famous examples of respected scientists doing exactly that (is it stomach ulcers that springs to mind? Someone gave themselves ulcers deliberately and then showed what caused them and thereby "cured" them?).
Guess what? You still can't give it to patients other than yourself without going through all the hoops that you're trying to avoid. And all you've done is prove that it didn't kill YOU and worked in YOU. Which is bog-useless to anyone hoping for it as a treatment. It's no better than anecdotal "Oh, well, honey and lemon REALLY cleared up my cold" kind of 'evidence'.
Rather than grandstand about something that experimenters have done before, and which is kind of useless in terms of medicine, get your stuff through the FDA approvals process which is how it is for a reason (the same as any other country's process): What doesn't kill you might well kill the next person taking it, even if you had no ill-effects. How many drug trials, even under the most controlled of circumstances, still come out as either "no medical benefit" or literally putting people into serious life-threatening conditions (people have had their kidneys destroyed by participating in late-stage drug trials, after the drugs passed all kinds of tests beforehand in other humans).
This achieves nothing, but marketing. And I don't use medicine from people who are more interested in marketing than patient safety.
(Score: 2) by HiThere on Wednesday February 07 2018, @05:33PM
The one that occurred to me was Yellow Fever, but, yeah, there's a long history. Many people ended up dead, but it was in a good cause. And this particular guy sounds as if he's well informed of the risks.
Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
(Score: 3, Insightful) by edIII on Wednesday February 07 2018, @08:07PM
This is because we've long ago moved away from evidence and fact-based truth to the full post-truth world. In that world, evidence is what a PR campaign says it is. Evidence is what the loudness of your Twitter followers contains, and remember, in the event of a dispute, liberally spread fake-news rebuttals across the Internet. It's Wild West old-timey medicine shows with the truth distribution system known as the Internet </sarcasm>.
To be fair, the FDA long ago lost any moral or scientific authority it had. So I can understand why these disruptive bio-hackers are giving the finger to the system. They know it's deeply flawed and corrupt, and unless you have billions and the right connections, you never get anywhere in that morass of an industry.
You're exactly correct. It doesn't matter if they live, if they're cured, what they find, etc. Whatever findings they produce must be replicated and understood using proper and unbiased science to give us the legal indemnities they would need to operate. Not to mention, it would be nice to know if it didn't kill us.
What I lament though is that truly proper and unbiased science doesn't exist. So I either get innovation in health care from the corrupt greedy fuckers that see deaths as percentages, or Wild West dreamers enjoying their bio-hacking civil disobedience. Either way, the medical system is poorer for it.
Technically, lunchtime is at any moment. It's just a wave function.