Tenapanor protests target FDA & politicians with offal
Federal Drug Administration (FDA) and politicians reportedly receiving whole kidneys in the mail after decision debacle over dialysis drug.
Outrage at an unexpected FDA rejection last month of drug Tenapanor as a phosphate binder for dialysis patients has morphed into a nationwide ‘mail-them-a-kidney’ campaign led by patient advocates, nephrologists and butchers.
The rejection was widely panned as “baffling”, “inconsistent” and “possibly corrupt” by clinicians and kidney disease sufferers. Now reports are coming in from across the country that whole kidneys - possibly sourced from pigs - are being packed in salt, boxed up and delivered to the offices of the drug regulator, Senators and Congressmen as part of a direct action campaign by chronic kidney disease sufferers.
One butcher’s store in Silver Spring MD has reportedly sold more pig’s kidneys in the past week than at any time during its 22 years in business. The store offers free local delivery of small meat orders and is located nearby the FDA’s Center for Drug Evaluation & Research headquarters in Maryland, the unit responsible for the rejection decision.
Tenapanor acts in the gut to reduce the absorption of sodium and phosphate and was already approved for the treatment of irritable bowel syndrome. The manufacturer Ardelyx sought expanded use to treat dialysis patients with phosphate overload, and FDA approval had been almost universally anticipated by healthcare professionals after large-scale clinical trials successfully met all endpoints. Ardelyx is appealing.
