Nowhere in the article do these critics actually explain how doing an offshore trial like this is unethical. There's no suggestion that this activity happening on Saint Kitts is in violation of local law.<p>So what's the problem? Are they suggesting that US law should apply to every other sovereign country on the planet? That US entrepreneurs should be categorically banned from financing foreign (e.g. EU or Chinese) medical research unless it conforms to US regulation?<p>The cherry on top is the epitome of lazy journalism of not contacting the Saint Kitts and Nevis authorities and getting their take on this. I assume they disagree that Saint Kitts and Nevis is categorically unsuitable for medical research due to their supposedly unethical regulations.
I'm a hypochondriac who also likes sex with randos so I've read up on this extensively.<p>I'm just glad that herpes vaccines are being developed. Even though a lot of people argue that they're just a minor skin condition with more social stigma, they're still pretty scary. You can do everything right but unless you're having sex in latex boxer shorts you're at risk.<p>If you ever read the Reddit r/herpes boards or other herpes boards, you can see how much hope is riding on Rational vaccines. It doesn't justify being careless with ethics or precautions, but i felt that was worth mentioning.
The issue here is the lack of IRB (Institutional Review Board), and what looks like an intentional effort to conduct trials in a neighboring country to avoid that requirement.<p>An IRB is not run by the FDA. They are independent bodies affiliated with research organizations like universities. The use of IRBs grew in response to research done in Tuskegee and Nazi Germany, and has been the standard for decades. Rather than make an organization like the FDA screen all human subject studies, IRBs are empowered to review and manage studies instead.<p>So no one is saying this research study needs to monitored by the FDA -- that's not how it works. There are also international standards for IRBs, this isn't just an American concept.<p>The investigator is at SIU, which has plenty of experience managing IRB studies [1]. It does seem odd that they would set this study up in this way, unless everyone involved is an extreme libertarian trying to thumb their noses at the notion of ethical review and monitoring, or the researcher has had past conflicts with an IRB at SIU. I wonder how many at SIU are aware of this study and if they will distance themselves from the study or the researcher, if this gets more press.<p>[1] <a href="http://ospa.siu.edu/_common/documents/human-subjects-forms/hsc-guide-%205-4-2012.pdf" rel="nofollow">http://ospa.siu.edu/_common/documents/human-subjects-forms/h...</a>
It's expensive to develop drugs and vaccines in the US. This could be viewed as a US market failure caused by the current regulatory environment.<p>(Before you downvote, note that I am not making a normative judgment here)
> “There’s a reason why researchers rely on these protections. People can die.”<p>People can die even with those protections. They do all the time.<p>Use your influence to get an exemption from your government's waste. Way to go Peter Thiel.<p>And this is definitely more about the company actually doing it, than one of the investors in the company.
Good.<p>Fuck the current medical system.<p>It's archaic, full of encumbrance and moves at a snails pace.<p>It's human lives at stake. These self preserving anti risk taking measures kill people.<p>The entire system needs a shake up and if this is the only way, so be it.
Let me see if I get it straight:<p>According to the article, majority of participants in the trail were Americans who already had herpes? They were flown to some island to get a vaccine that had a chance of "curing" them?<p>Are the same people complaining about it complaining about drugs from Canada? How about medical tourism?