To The Editor. —An article 1 in the Dec 11 issue of JAMA emphasized patients' safety and payment for drugs as major issues in the implementation of the (use of investigational new drugs [INDs] to treat patients with serious or immediately life-threatening illnesses). Making promising new therapies available to the desperately ill is a worthy goal. Ms Monaco and Ms Gottlieb indicate that only time will tell whether the treatment IND will achieve this goal or only subvert the clinical trial process so that drug efficacy can never be adequately demonstrated. I believe that is a critical issue. If patients have the option of either buying experimental drugs under a treatment IND or entering a clinical trial where they don't pay but perhaps have a 50% chance of receiving an investigational drug and a 50% chance of receiving a placebo, will their consent for the trial be forthcoming?