Why I (sometimes) hate the FDA

[Flavio]

Gene therapy for ED shows great promise, but the new treatment still has to undergo the bureaucratic hell of the FDA. This is very frustrating. We all know that FDA rules are meant to protect consummers, but by creating so many obstacles to a treatment that we all know that works, I think they’re actually doing more harm than good.

Here’s a brief summary of what lies ahead (adapted from Wikipedia):

Phase I

Phase I trials are the first stage of testing in human subjects. Normally, a small group of healthy volunteers will be selected. This phase includes trials designed to assess the safety of a drug.

In the case of gene therapy for ED, Phase I trials are now over (the treatment was tested on animals and 11 men and there were no side effects) and Phase II is now under preparation.

Phase II

Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients.

Phase III

Phase III studies are aimed at being the definitive assessment of how effective the drug is. Because of their size and comparatively long duration, these trials are the most expensive, time-consuming and difficult trials to design and run.

So, there’s still a long, long way to until gene therapy for ED becomes available – maybe years! And the current world economic crisis won’t help, either.

Nevertheless, let's be optimistic: it really works!

For more on this:

Ion Channel - Gene Transfer Therapy

[eddie]

Yeah it is allot of stuff to go through but this is standard and any pharmaceutical company that wants to get FDA approval needs to go through all these phases!!!! I have read allot about this online and while I do agree with you I am glad the FDA takes precautions and requires allot of detail for new therapies to get approved..