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gy66 replied to the topic Right to Try Law in the forum Clinical Research Basics 6 years, 8 months ago
I believe the new Right to Try law is a good move for the most part for the obvious reasons. The best case-scenario is that the patient recovers with the help of an investigational treatment and that company attains validation for their product. Validation for drugs and medical treatments take an incredible amount of time and resources to ever reach human trials so having the ability to bypass those steps even for a few human trials is extremely beneficial, even if the patient does not recover. However, I do see how this may cause potential problems down the line. First off, it is important to understand that just because an individual takes a drug, does not mean only that individual is affected. We all naturally release and leave behind bodily fluids, dead skin, and hair. Not to mention we exchange our bodily fluids with others in various different ways every day. With that said, how can anyone be certain that the trace amounts of a particular drug, found in our bodily fluids, skin, and hair, will not have an impact on others? This is particularly important if the drug consists of nanoparticles. I’m sure this may be far-fetched but these are things that should be considered when exposing any drug outside of a controlled and contained environment.