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>>>her replies are between arrows here, like this<<<Dear Dr. Ruwalt, As I understand it from reading your letter to President Bush, you are proposing a cerification process in addition to or in place of the current FDA approval process. You also seem to be adocating a mechanism through which 'terminally-ill' patients could opt out of approval. Both of these do seem like goals worth investigating and pursuing, but I fail to see how they would alleviate the current dificulties faced by those of us who suffer from ibs and know that there are medications available which could alleviate our suffering, either because they have in the past or they might in the future. I also fail to see how you proposals would lead to further research and development of treatments in this important area. To be more specific, I'm not sure how certification, while an interesting proposal, would do anything more than add another layer of bureaucracy.>>>Certification would replace current regulations, not add new ones. The FDA could review manufacturer data on drugs and give a Seal of Approval, but pharmaceutical firms wouldn't need the Seal in order to market their products. The patients would be able to buy a drug, even if the FDA held back it's approval. The final decision would rest with the person who was suffering.<<< As far as opting-out is concerned is concerned, as I see it there are two major problems even though we are in agreement on the general importance of individualized decisions made by informed patients and doctors in the context of a doctor-patient relationship . The first problem is that ibs is currently seen as a 'vexing inconvenience' rather than a terminal illness. I don't here at all intend anything disparaging toward people with other problems, only to assert that ibs can be very serious and life-altering.>>>Conversion to a certification system is a multi-step process. First, we let the terminally ill "opt-out" to show that the sky doesn't fall when consumers are given freedom of choice. The next step is to extend this freedom to everyone.<<< The second problem with opting-out is is one that we might be able to explore further to arrive at a mutually acceptable concept. As I understand it there are in place already mechinisms for opting-out. The problem seems to be that they are not working as efficiently as they could.>>>They don't work well because they were not designed to help large numbers of people, such as those suffering from IBS. However, they are a good starting place for letting individuals "opt-out."<<<
 
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