John, I certainly hear you and understand that sense of urgency. Frankly, I really do agree with most of your points. In particular, I have been an advocate and am in full agreement that new research is needed at the PD subtype level. You certainly may be correct in suggesting that we are averaging out study results across subtypes and may well be missing out on possible drug efficacy in many situations. And, no, I don't necessarily think that the Isradipine trial will find THE answer.

However, where we disagree is that I believe that a properly designed and controlled cllinical trial is more likely to provide us with useable information about the efficacy of a drug than your suggestion of three month uncontrolled individual studies. In addition, even if you were able to find interesting information as a result of your study, it would never move the science forward because it would only be considered anecdotal, at best. Like it or not, we live in the world of the FDA and EMA. If we want treatments that will benefit all of us now and our children down the road, we have no choice but to follow the rules and get the proper government agency approvals. I am all for finding every possible way to speed this process up, but to avoid it will not help in providing long term treatments for all of us.

So, as my original posts pertained more toward this specific drug and trial, I guess we disagree as to the best course of action. Keeping in mind that the hypothesis behind Isradipine and PD is that it may be neuroprotective and not provide symptomatic relief, I don’t see where a three month, uncontrolled, individual study will give any of us much useful information. Is three years too long, I don’t know. But I certainly believe three months is way to short to test out any neuroprotective drug.

I would like to add that I appreciate all of your posts. Although I may not always agree, I think they are thought provoking and provide for interesting debates. In many other situations I think that your shorter term individual study suggestions would be quite useful. I'm just not sure it will help in this specific case.


Thanks,

Gary