Added benefit of subset analysis insufficient for keeping safe drug from patients with no alternative Jan 17. 2013 | Comments (41)
An FDA "no" to Ampligen would significantly slow down investment in chronic diseases in general. They voted it safe. They're not contesting its effectiveness per se, they mainly insist on knowing which subset is affected more than others. We're not saying this doesn't belong in an efficacy profile, we're saying its added benefit doesn't outweigh the tremendous human and financial cost. It's an insufficient justification for keeping a potentially life-saving drug from bed-ridden patients with no alternative. Authorities in Canada and Brussels approved it 2 decades ago. Do you really think they're less diligent? Respect our right to decide with our doctors and provide incentive for sponsors to give drug companies the means to get those subsets refined. We already know the subset that matters most. They're called ME/CFS patients.