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Viral Genetics, a Californian biotechnology company, was criticised for failing to explain adequately to participants that they were taking part in a trial rather than receiving a proven medicine. Others question whether it was right that, while some patients were given its test VGV-1 compound, the rest received a placebo instead of antiretroviral therapy, long accepted in the west as the most effective treatment. The company declined to comment.
The trial complied with current international standards and a Chinese investigation concluded that there was “no serious violation of ethical principles”. Even so, such practices highlight both the rapid growth in clinical trials in the developing world and the tensions caused by this latest form of globalisation.
What controls? Two meds I have taken are no longer sold in the US and look at the strange outcome from the ENHANCE study, (thank God they had good end points) with Vytorin! If that is not human testing in the US I do not know what is.
Testing on humans where ever they are is always done with highly scrutinized protocols, which are supervised by the sponsor or the contract research organization conducting the clinical trial. Clinical trials have been held overseas for many years. One reason is that there is a larger population having the disease to be studied. Many of the diseases have no effective treatment or the current treatment maybe outdated and the clinical trials must be run in order to measure the safety and effectiveness of the treatment. Without clinical trials it would be a crapshoot trying to determine whether a treatment or drug candidate actually works or not. Would you want to take a drug that was tested on a few select volunteers?
I used to supervise clinical studies. We would NEVER have approved a testing protocol that included a placebo of “no treatment.” Outrageous.
#2
Perhaps these trials were done very well, but do you really expect trials that fail or those with bad outcomes to be reported or reported in a timely manner? ENHANCE sure was not nor do we see that in many drugs. My real concern is that a majority of these trials today can be terminated but what about gene therapy or stem cells. How the hell do you stop those in case of bad end points?
This is nothing new
Much of the work on birth control pills was done in the Philippines
If not for this work there would have not of been the release of the varieties of medications referred to as “the pill”
I once attended a medical conference
One whole presentation was of an American medical research group whose whole talk was on the procedure to get a clinical investigation approved and how they were stopped in their tracks
The next group presenting was a Brazilian ( third world) group who had completed the exact research
#5, Medical Studies,
How much faith can be put on studies that fail to pass protocol in western countries yet are readily done in third world countries? I don’t have any inside information, but I do wonder if these foreign studies don’t cut more than a few corners.
Maybe the first group you listened to should have spent more time preparing to do a proper study than wasting time after the fact crying because they couldn’t pass protocol. If that drug does end up on the market and something happens, this will count as a serious black mark against the drug manufacturer.
Drug companies cutting corners on testing? I’m shocked! Shocked, I tell you! Why next, you’ll be telling me there’s corruption in the US government! It’s unheard of!
-Sarcasm OFF-
The phrase “Primum non nocere” (First, do no harm) no longer has relevance. Money drives research not hope.
I can think of two places I would encourage this kind of research: prisons and DNC headquarters.
DNC headquaters? Oh–you mean experiment on people you disagree with.
Wow, thats fuunnneeee!
Know any knock-knock jokes?
You start.
Hey, ya gotta find humor where you can….
#9 pedro
“But if you ask “J”, he will say that this is bull nad that those trials can be done safely in any third world country.”
pedro once again you are wrong I completly disagree with that type of thing.
#12 TheGlobalWarmingNemesis
I got the humor and I am very liberal. Needless to say I even laughed but Get smart made me laugh more
#12–Ok==I apologize.
But it kinda reminds me of that joke about the guy with shit on his lip. He was looking for love in all the wrong places==like humor from mechanical set-ups, or creating humor with the same process that creates political analysis?–neither one is fuunnee!
Oops. I forgot I was apologizing.
(Now, I’m laughing. More lame humor at our own cleverness, a private affair.)
I’m sure the Japanese would join in on the experimentation… 😛 (From Hei Tai Yan 731, which is about the Japanese Unit 731.)
Puh-lease, the drug companies already own the FDA PLUS it’s a lot easier in the USA to “test” experimental drugs on people than to test them on dogs (the boo hoo poor doggies have stricter regulations that the meanie hyoomans.)
#13, “J”,
I got the humor…
I thought so.
One of the four fluids of the body, blood, phlegm, choler, and black bile, whose relative proportions were thought in ancient and medieval physiology to determine a person’s disposition and general health.
Physiology
a. A body fluid, such as blood, lymph, or bile.
b. Aqueous humor.
c. Vitreous humor.
http://www.thefreedictionary.com/humor