
Peter Thiel Funds ‘Unethical,’ Offshore Herpes Vaccine Trial - rm2889
http://www.thedailybeast.com/peter-thiel-funds-unethical-offshore-herpes-vaccine-trial
======
avar
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
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

        > 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
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

        > 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-e...](http://healthaffairs.org/blog/2014/02/14/if-a-drug-is-good-enough-
for-europeans-its-good-enough-for-us/)

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/S0022347615...](http://www.sciencedirect.com/science/article/pii/S0022347615002516)

2\.
[http://www.who.int/reproductivehealth/topics/maternal_perina...](http://www.who.int/reproductivehealth/topics/maternal_perinatal/estimates-
neonatal-herpes-cases/en/)

3\.
[https://www.ncbi.nlm.nih.gov/pubmed/28153513](https://www.ncbi.nlm.nih.gov/pubmed/28153513)

~~~
nimish
>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

        > [...]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_M...](https://en.wikipedia.org/wiki/Windsor_University_School_of_Medicine)

------
fatjokes
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.

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

------
hammock
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)

------
ringaroundthetx
> “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.

------
aaron695
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
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
Do these people really understand the risks? This is scary as hell.

~~~
patrickaljord
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...

------
notyourday
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?

