I posted this to the Clincial Trials subsection, but not to this part of the board. I am moving this to the primary board so that Perry's comments can be seen.

Below are comments from Perry Cohen about Sham Surgery. Any replies to his comments?

This is another example of sham surgery for placebo control plus additional risk for study participants from gene therapy, an unknown risk. Carolyn, do you know how long the control patients are under anisthesia? Are there provisions for crossover to treatment for patients who receive the placebo? Is that follow-on guaranteed by the company? Were the FDA Patient consultants asked to represent patient views in the design decisions?

These are a few of my questions to the FDA and the company based on our pipeliner experiences with many clinical trials. We have asked FDA to consider participation in a round table discussion on the issues around sham surgery, The question in this case is what is the value of the data gained by a burr hole and exposure to anesthesia as designed to trick the patients into uncertainty about whether they got the treatment. On the face of it, to me this design would undermine the therapeutic impact for those who got the treatment as well. In order to think through the logic of the designs carefully, we need to hold this workshop as soon as possible, with FDA and scientists. I expect that PDF will sponsor the meeting this fall. In meantime I would like to hear responses from PWP who are eligible for this study what factors they consider important in entering this clinical trial.

Lets get the discussion started to find out how PWP perceive the risks and benefits, to let them know how we and other PWP feel. Then we can either endorse the practice or condemn it. If we do nothing they will continue to ask for this risk to be taken on by volunteers desperate for relief.

Perry