3 ms·

No IRB, no oversight by the FDA. Medical trials aren't beta apps, they can seriously hurt or kill people even in well regulated jurisdictions. Just because it'

• avar 9y ago
  > No IRB, no oversight by the FDA Yes of course domestic US agencies don't oversee or regulate medical trials in other countries. The article explains that these agencies would need to be involved if this research yields a drug destined for the US market. > Just because it's legal in a nowhere > medical destination like St Kitts > doesn't mean it's ethical. It doesn't make it unethical either. My primary beef is with the lazy way the article is written. Maybe this trial is unethical, maybe it isn't. But the argument put forward in the article would equally apply if this research were done in the EU. I.e. that it's somehow inherently bad that US regulatory agencies aren't involved in medical research that happens abroad. > they deliberately chose to evade strong oversight. Maybe they did. Companies selectively choose legal jurisdictions based on regulations all the time. E.g. EU food regulation is stricter than US regulation. Would you say that it's unethical for a EU company to fund food startups in the US for that reason? The article quotes Thiel as saying "you would not be able to invent the polio vaccine [in the US] today". I don't know if that claim is true, but if it is (or even if today the vaccine's introduction to the market were delayed compared to the 1950s) this whole question of "unethical" trials v.s. overly strict regulations becomes much more complex.
  • nimish 9y ago
    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 check on the trails. The unethical bit is that there is no independent oversight and 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 equivalent jurisdiction in terms of ethical oversight. The FDA is cool with international drug trials as long as they are done to equivalent standards and the have an office that will go and check out other countries' compliance. Again, this is not a beta app or some new frontend framework that has no meaningful impact on people. This could kill, and it's unethical to attempt to sidestep strong protections for the sake of some minimal extra cash.
    • 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.