7 ms·

s/FDA/regulatory agency with similar standards as the FDA/ An IRB is an institutional review board, not a government agency. It's basically an independent chec

• avar 9y ago
  > s/FDA/regulatory agency with similar standards as the FDA/ That's more reasonable but not the argument the article is making, which could be paraphrased as "it's not being done the way we do it in the US, so it must be bad". > it's sketchy as hell to have a drug that's > likely intended to be marketed in the US > not clinically trialed in the US or[...] You can't trial a drug in some supposed banana republic and then market it in the US. Here's a nice overview of the hurdles the FDA puts on foreign-developed drugs, even those from mature developed markets like the EU and Australia: http://healthaffairs.org/blog/2014/02/14/if-a-drug-is-good-enough-for-europeans-its-good-enough-for-us/ http://healthaffairs.org/blog/2014/02/14/if-a-drug-is-good-e... So the concern is not that FDA rules are being evaded for the purposes of marketing to US consumers, but rather that someone's running preliminary medical trials outside of the US. Presumably to test basic viability, or perhaps to initially target markets in other countries than the US. > This could kill, and it's unethical to > attempt to sidestep strong protections[...] Herpes is already killing hundreds (if not thousands) annually, although it seems nobody has good numbers on this as the countries disproportionately affected are usually really poor [1][2][3]. > [...]for the sake of some minimal extra cash. A lot has been written about how insanely expensive medical research is these days, and how big drug companies tend to focus on expensive drugs they can keep selling you at the cost of something like vaccines. It's pretty telling that we're talking about Peter Thiel funding Herpes vaccine development at all, the fact that he's not a joke in that space being out-competed by big pharmaceutical companies should tell you something. So this supposed trolley problem of "if we allow cheap research people might die" becomes less clear. People are dying right now, and apparently basic research to solve that problem has become too expensive for anyone to bother in major developed nations like the US and EU. 1. http://www.sciencedirect.com/science/article/pii/S0022347615002516 http://www.sciencedirect.com/science/article/pii/S0022347615... 2. http://www.who.int/reproductivehealth/topics/maternal_perinatal/estimates-neonatal-herpes-cases/en/ http://www.who.int/reproductivehealth/topics/maternal_perina... 3. https://www.ncbi.nlm.nih.gov/pubmed/28153513 https://www.ncbi.nlm.nih.gov/pubmed/28153513
  • nimish 9y ago
    >You can't trial a drug in some supposed banana republic and then market it in the US. Here's a nice overview of the hurdles the FDA puts on foreign-developed drugs, even those from mature developed markets like the EU and Australia: http://healthaffairs.org/blog/2014/02/14/if-a-drug-is-good-e.. http://healthaffairs.org/blog/2014/02/14/if-a-drug-is-good-e.... That's my point: they are end-running around FDA equivalent rules to get a sketchy study done so they can market it somewhere with lax rules. That's not exactly ethical. Regulatory arbitrage is dubiously ok when there's no real harm, but not with medication and drugs. People don't die from genital herpes, and while it's a terrible condition having a false medication is arguably just as bad, but not for Thiel & Co's wallet. >A lot has been written about how insanely expensive medical research is these days, and how big drug companies tend to focus on expensive drugs they can keep selling you at the cost of something like vaccines. There's a reason trials are expensive, and that's because there is a long history of sham and garbage medications being sold before we decided that drugs have to be safe and effective. Seriously, look at thalidomide or any of the myriad of disasters that were sold before the Food and Drug Act. This is a false dichotomy here: it's possible to have a safe, effective and economical drug trial process but it doesn't involve sending people to a wild west jurisdiction like St Kitts and not undergoing peer-review.
    • avar 9y ago
      > [...]they are end-running around FDA > equivalent rules to get a sketchy study > done[...]. I haven't read anything to suggest that they research being done there is actually sketchy, just that people are complaining about the lack of US oversight. There's quotes in the article to the effect that all appropriate safety precautions are being taken, and no suggestion that the actual activities in St. Kitts are sketchy in in of themselves. Of course that's harder to ascertain without an IRB, but given Thiel's politics I'd be just as willing to believe that this is all on the up & up and he's just giving the FDA the middle finger out of some libertarian grandstanding as the possibility that he's running some offshore Mengelean medical lab. > [...]so they can market it somewhere with lax > rules. That was just a throwaway theory of mine as to what they could be doing, they could also just be trying to save money in phase 1 trials on what they see as a needless bureaucracy. > That's not exactly ethical[...] I think this entire line of thinking, aside from this specific case, is highly arrogant and US-centric. You're assuming that more regulation is automatically an improvement, and that e.g. India, China, Saint Kitts and Nevis or some other country is inherently incapable of running ethical medical trials just because they aren't doing it as some "the FDA's way or the highway" cheerleaders think they should be doing it. If they're actually doing something unethical that behavior warrants criticism. The line of argument that the US needs to be involved in everything is fallacious. > People don't die from genital herpes. Yes they do. Unless you don't consider newborns people. Maternal genital herpes transmitted at birth is the primary cause of neonatal herpes simplex, which can be fatal. A herpes vaccine could eliminate this transmission vector and save lives. Whether Thiel or his supposedly sketchy research comes up with that vaccine is another matter. > sending people to a wild west > jurisdiction like St Kitts My main beef with this article is the lazy journalism, and its assumption (and seemingly yours too) that St. Kitts is some wild-west jurisdiction allowing unethical medical trials. Maybe that's the case, but e.g. some quick googling finds that there's a medical school there[1], it seems lazy in the extreme to not e.g. contact them, or someone from the St. Kitts government to get their take on this. We're just left with something that seems like lazy hit-piece. > [...]not undergoing peer-review. Peer-review would happen once they're ready to publish something in a medical journal would it not? The supposedly unethical behavior here is that they're not volunteering to US-style oversight. 1. https://en.wikipedia.org/wiki/Windsor_University_School_of_Medicine https://en.wikipedia.org/wiki/Windsor_University_School_of_M...