At one of my companies we were encouraged by our investors to do Phase I (and some Phase II) clinical trials in the Dominican Republic, Mexico, Angola, and other such places.
Back then we did do device studies in Germany because the regulations were at the time quite lax (basically you just needed a German MD to decide it was OK and to actually use the device). They've since tightened up the rules.
Interestingly, in the device case, people who were squeamish about doing studies in poor countries with poor IRBs and such were perfectly happy to do the device studies in Germany. Not sure what to make of that.
Isn't it obvious? Germany is a respected western country, what goes there must be OK, even if not according to other western country's laws. And surely there are sanity checks at place there. Angola, on the other hand, is a poor developing country in third world and that just signals that something nefarious is going on. The participants probably felt doing stuff there would have no such sanity checks and it would also taint their reputation.
Doing trials on people who don't have the protection of strong consent laws feels pretty unethical as it's got a good chance of doing direct harm to those people.
Testing a device in Germany has only indirect harm, if those substandard devices go on to hurt people later.
Ignoring ethical standards compromises the validity of any evidence and resulting claims: if we know that the author is willing to ignore ethical principles, we have no reason to believe that they aren't lying about their data/results. The baby goes out with the bathwater.
There are plenty of journals (and websites) that will publish junk research, but that's all it is -- junk.
There are classified journals that are used to publish classified scientific results from the intelligence, defense, and national security communities. This is what came to mind when you mentioned “dark journals,” although I initially interpreted dark as invisible to the public. Who knows what ethical standards they have? I presume some pretty unethically acquired results could be published in them, say, on the effectiveness of different weapons systems or “enhanced interrogation techniques” in the field.
Journals don't establish the validity of results. That's established by the community through things like replication and building on top of the results. If you don't abide by ethical standards, the community won't validate your work.
I was practicing at a medtech company in high school and the team really wanted to conduct tests in China, since the best product testing would be to shoot live pigs from a cannon into a concrete wall for treatment with the device afterward.
To my knowledge it never happened, because adhering to local ethics requirements would be better for seeking investments. But I also think the company went under because of lacking real world results in the limited trials that could be done.
Of course this has been happening for a while. When I was a child, I recall reading this in the newspaper when it was revealed that Johns Hopkins dodged normal process by testing drugs in India. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1121689/
Interesting that you could simply test on people in India without establishing safety on animals first.
The history of the Tuskegee syphilis experiment along with others shows that you don’t need to leave home to disregard ethical practices. At home or abroad, the rule is that abusive people and companies will target groups without a voice. It’s the same reason people can be tortured or killed by police and jailers, and the public only pays lip service to reform. The only thing that really changes is who has no voice or power, and then becomes victims.
This is the dark side of globalism and it’s not just testing, it’s every aspect of capitalism where it touches countries in the developing world. Everything from the food you buy to the clothes you wear is the result of horrific exploitation.
[+] [-] gumby|7 years ago|reply
Back then we did do device studies in Germany because the regulations were at the time quite lax (basically you just needed a German MD to decide it was OK and to actually use the device). They've since tightened up the rules.
Interestingly, in the device case, people who were squeamish about doing studies in poor countries with poor IRBs and such were perfectly happy to do the device studies in Germany. Not sure what to make of that.
[+] [-] effie|7 years ago|reply
[+] [-] fwip|7 years ago|reply
Testing a device in Germany has only indirect harm, if those substandard devices go on to hurt people later.
[+] [-] scarejunba|7 years ago|reply
[+] [-] woodruffw|7 years ago|reply
There are plenty of journals (and websites) that will publish junk research, but that's all it is -- junk.
[+] [-] smadge|7 years ago|reply
[+] [-] daveFNbuck|7 years ago|reply
[+] [-] bookofjoe|7 years ago|reply
[+] [-] tapland|7 years ago|reply
To my knowledge it never happened, because adhering to local ethics requirements would be better for seeking investments. But I also think the company went under because of lacking real world results in the limited trials that could be done.
[+] [-] _Schizotypy|7 years ago|reply
[+] [-] dasanman|7 years ago|reply
[+] [-] scarejunba|7 years ago|reply
Interesting that you could simply test on people in India without establishing safety on animals first.
[+] [-] Pharmakon|7 years ago|reply
[+] [-] lsiebert|7 years ago|reply
[+] [-] nmz787|7 years ago|reply
[+] [-] neonate|7 years ago|reply
[+] [-] empath75|7 years ago|reply
[+] [-] aaron695|7 years ago|reply
The examples in the article were stopped/got in trouble due to ethics or were not dumps.
But I wish it was common, the millions who die each year due to overly convoluted delays in testing and high prices it creates is a travesty.
People creating fake issues like "Ethics dumping" are the real villains in this world.
[+] [-] eye_rack|7 years ago|reply
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