posted
I think it is crazy that drugs can be marketed with specific claims about their efficacy without first having been tested fully.
Where an “off label” use is completely different to that registered I think trials should have to be submitted and evaluated before it can be marketed. This is a clear case where regulation should be used instead of market forces.
If this treatment works, then it is a great step forward. However, I don’t think government and insurance companies should pay for this until the trials are completed. The only way to force companies to complete the necessary testing in the absence of strong regulation is if they have no market without the proper studies.
Posts: 169 | Registered: Aug 2005
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posted
I thought of you right away, CT....among others, of course.
I have some specific knowledge about the drug testing process that very few people have due to my experiences at USAMRIID.....I drafted specific changes into their drug testing protocols regarding informed consent and compensation. Those protocols are considered worldwide to be the highest standard if informed consent, and are used as a model for other countries programs.
Most of the informed consent stuff wasn't mine, it had been in place for years and included direct Congressional oversight among other things.
I will chime in more later, but I wanted to give myself more time to think about this.
Also, I am heading to work right now and don't have the time to type it all out.
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