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Peter Thiel Funds ‘Unethical,’ Offshore Herpes Vaccine Trial

30 points by rm2889 9y ago

aaron695 9y ago
Good. Fuck the current medical system. It's archaic, full of encumbrance and moves at a snails pace. It's human lives at stake. These self preserving anti risk taking measures kill people. The entire system needs a shake up and if this is the only way, so be it.
- andriesm 9y ago
  Exactly. The FDA is a major impediment to progress. Often times treatments already approved in other jurisdictions get delayed for YEARS without good reason other than bureaucracy and paperwork. I also hate the bs about how trial participants are taken advantage off - people can freely choose to participate. If the FDA really cared, they could just mandate that people are properly informed of risks, rarher than try to mandate that people aren't allowed to participate in trials.
  - JudasGoat 9y ago
    Do these people really understand the risks? This is scary as hell.
    - patrickaljord 9y ago
      What's so scary? People making their own decision of how to use their own body? Land of the free, home of the brave they used to say...
- zimpenfish 9y ago
  It's "full of encumbrance and moves at a snails pace" PRECISELY BECAUSE "human lives [are] at stake". A quick look at medical history will show you what happens when people cut corners.
avar 9y ago
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. 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? 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.
- nimish 9y ago
  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's legal in a nowhere medical destination like St Kitts doesn't mean it's ethical. Hell if they had funded it in the EU nobody would care, but they deliberately chose to evade strong oversight. See the Northwick park TGN1412 trials for what can happen.
  - 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.
notyourday 9y ago
Let me see if I get it straight: 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? Are the same people complaining about it complaining about drugs from Canada? How about medical tourism?
hammock 9y ago
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. (Before you downvote, note that I am not making a normative judgment here)
fatjokes 9y ago
I'm a hypochondriac who also likes sex with randos so I've read up on this extensively. 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. 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.
ringaroundthetx 9y ago
> “There’s a reason why researchers rely on these protections. People can die.” People can die even with those protections. They do all the time. Use your influence to get an exemption from your government's waste. Way to go Peter Thiel. And this is definitely more about the company actually doing it, than one of the investors in the company.
skue 9y ago
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. 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. 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. 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. [1] http://ospa.siu.edu/_common/documents/human-subjects-forms/hsc-guide-%205-4-2012.pdf http://ospa.siu.edu/_common/documents/human-subjects-forms/h...

30 points by rm2889 9y ago

Good. Fuck the current medical system. It's archaic, full of encumbrance and moves at a snails pace. It's human lives at stake. These self preserving anti risk taking measures kill people. The entire system needs a shake up and if this is the only way, so be it.

andriesm 9y ago
Exactly. The FDA is a major impediment to progress. Often times treatments already approved in other jurisdictions get delayed for YEARS without good reason other than bureaucracy and paperwork. I also hate the bs about how trial participants are taken advantage off - people can freely choose to participate. If the FDA really cared, they could just mandate that people are properly informed of risks, rarher than try to mandate that people aren't allowed to participate in trials.
- JudasGoat 9y ago
  Do these people really understand the risks? This is scary as hell.
  - patrickaljord 9y ago
    What's so scary? People making their own decision of how to use their own body? Land of the free, home of the brave they used to say...
zimpenfish 9y ago
It's "full of encumbrance and moves at a snails pace" PRECISELY BECAUSE "human lives [are] at stake". A quick look at medical history will show you what happens when people cut corners.

avar 9y ago

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. 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? 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.

nimish 9y ago
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's legal in a nowhere medical destination like St Kitts doesn't mean it's ethical. Hell if they had funded it in the EU nobody would care, but they deliberately chose to evade strong oversight. See the Northwick park TGN1412 trials for what can happen.
- 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.

notyourday 9y ago

Let me see if I get it straight: 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? Are the same people complaining about it complaining about drugs from Canada? How about medical tourism?

hammock 9y ago

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. (Before you downvote, note that I am not making a normative judgment here)

fatjokes 9y ago

I'm a hypochondriac who also likes sex with randos so I've read up on this extensively. 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. 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.

ringaroundthetx 9y ago

> “There’s a reason why researchers rely on these protections. People can die.” People can die even with those protections. They do all the time. Use your influence to get an exemption from your government's waste. Way to go Peter Thiel. And this is definitely more about the company actually doing it, than one of the investors in the company.

skue 9y ago

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. 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. 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. 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. [1] http://ospa.siu.edu/_common/documents/human-subjects-forms/hsc-guide-%205-4-2012.pdf http://ospa.siu.edu/_common/documents/human-subjects-forms/h...