Quality Control

If the intention of the Drug Manufacturers is wholeheartedly pure, this may be the only way some of the people being treated may get quality, first rate medical care. My only concern would be the quality of control by those administering the trial drugs. We've already seen instances where tests were performed and results were altered or pertinent information or warnings were ignored. This happens in many companies, not just pharmaceutical.

Off course it is not right, but it is a way to circumvent the American rule-set.

And because there are no governing body that controls these trials we do not know what those people are going through.

I think only PETA is pleased with this, no Animals were harmed during our trial.

Lots of issues around the monetary incentives in medical research. Not only the issue of tempting volunteers into risky trials by paying the volunteer, check out this peer-reviewed article by Lemmens and Miller, "Regulating the Market in Human Research Participants" which is focused on the money being paid to the doctors (not the volunteers) in exchange for getting the patients involved in trials. Here in Canada and USA. $1000 a head kickbacks documented here....imagine.

As for the risks involved, a clear idea of the magnitude of risk for the volunteer can be found in the FDA report "Innovation or Stagnation" . Scroll down the Executive Summary to "Negotiating the Critical Path" and read the stats: Only 8% of drugs in Phase I clinical trials were successfully approved, down from 15% - which is still not great, if you are the volunteer hoping for a cure. Your chances of being cured with acceptable levels of damage are a whopping 8 to 15%..... Many of these drugs are not approved because they cause unacceptable levels of damage to the liver, kidneys and what have you... The companies are unable to predict failure in human treatment on the basis of animal trials.

The report says a ten percent improvement in identifying the "failures" would decrease development costs by $100 million per drug. So tell me, how many third world volunteers can you buy for $100 million? to identify "failures" and then walk away.

For even less liability, how many unknowing unconsenting subjects can you buy right here in North America for testing, in the criminal human trafficking market, for that kind of cash value to industry? I'm guessing you can pretty much get what you want for a million dollar bill... especially if there's no risk of getting caught.

They did drug trials at the AZ state prisons for a while. Too bad they forgot to tell the prisoners. Their ethics are money. I wonder how much money it cost them to get the FDA to limit their liability if the FDA approves the drug even if the FDA was not given the real facts? Original article, CR4 thread

Brad