Giving terminally ill patients the 'Right-to-Try'
"Right-to-try" legislation billed as making it easier for terminally ill patients to obtain experimental drugs and devices is currently making its way through Congress. The new legislation, which proposes to increase the availability of investigational treatments that are currently off limits under FDA regulations, is being met with varying reactions. While advocates argue that individuals of sound mind should be the final arbiters of what they put in their bodies, opponents including the American Society of Clinical Oncology say that such legislation puts patients at risk of exploitation and does little to facilitate patient access to such therapies. Manish Shah, M.D., was one of several doctors interviewed by MedPage Today about his view. Read the full article here.
To what extent do current regulations make it too difficult for patients who have exhausted conventional therapies to gain access to experimental treatments? (Patients who are very sick and/or extensively pretreated are often ineligible for formal clinical trials.)
I think the major impediment is insurance -- most insurance companies will not pay for treatment that hasn't demonstrated a treatment benefit. If federal guidelines state that this should be considered an option, then insurance companies may follow suit, then allowing more patients to get such options.