Alloway Speaks at FDA Forum on Transplant Medication Therapy

CINCINNATI—It’s a general misconception that once a transplant patient receives a healthy organ and their body accepts the organ that the patient is discharged from the hospital and goes on about their merry way. Treatment, however, doesn’t stop once the patient is wheeled out the hospital doors. There’s often a lifetime of autoimmune medication therapy that accompanies the transplant.

"A transplant is only successful as long as the patient adheres to the immunosuppressive regimen,” says University of Cincinnati transplant researcher Rita Alloway, PharmD, who spoke at the U.S. Food and  Drug Administration’s (FDA) "Public Meeting on Patient-Focused Drug Development for Patients Who Have Received an Organ Transplant" in Washington, D.C., Sept. 27.

But just like the patient who has an acute illness and either doesn’t get their prescription filled, takes it erratically or stops taking their medications once they feel better, some transplant patients struggle with the commitment to taking the very medications that prevent the transplanted organ from rejecting, says Alloway.   

"There are a variety of factors which result in a patient being non adherent, most of which are best understood by the patient,” she says of the meeting which brought representatives from federal agencies, academia, industry partners and patients together to help clinicians obtain a better understanding of patients’ perspectives on the severity of their disease.

Alloway, a research professor in the division of nephrology and hypertension who has been active in transplant immunosuppressant drug clinical research for over 25 years and is helping to refine today’s immunosuppressive regimen, says the patient’s perspective on long-term immunosuppression is vital for transplant success. She noted, "It doesn’t matter how good prescribed immunosuppressive regimens are if patients do not or cannot take them.”

Clinicians, she says, have historically been very paternalistic when attempting to identify causes of non-adherence, assuming that if a patient were fortunate enough to receive a lifesaving transplant, the patient would comply with a complex medication regimen.

But that’s not always the case, she says, and thus the reason for the FDA-initiated meeting, which Alloway helped organize, to review available therapies and to facilitate novel drug development in transplantation.