Dr. Jenkins–
I have seen your recent comments on providing REMS programs for opioids. Since you are the director of OND, I was hoping to give you some feedback on these programs, and to alert you to the adverse effect on patient care that they can have.
I am a clinical hematologist and oncologist. I have to contend with many drugs under these programs, including Promacta, Nplate, Thalomid, Tysabri, and Revlimid. Looks like opioids are next on the list.
My first exposure to these programs was with the Thalomid STEPS program as a fellow. The paperwork, telephone surveys, and faxes were onerous. The counseling of 80 year old women and men not to become pregnant or share their medicine with women of childbearing age was absurd, to say the least. But we complied with the program, and continue to do so.
Then we had the TOUCH program for Tysabri. In my opinion, this program was a failure, since there were still reports of PML even after its implementation, and because the drug company used the REMS program in this case as an opportunity to do marketing of their product. Rituximab has reports of PML also, yet FDA does not mandate a REMS program for it. Why? Read the Full Article on interactmd.com