Kidney Foundation Retracts Allegations About Medication

November 26, 2004

THE Costa Rican Kidney Foundation(FUNCORE) has retracted its charge thatthe public health-care system’s switch togeneric medicine for kidney transplantpatients may have caused some deaths.FUNCORE announced in a statementlast week that it had complied with therequest of the board of directors of theSocial Security System (Caja) to retractits allegations, but attributed the affair to a“misunderstanding,” saying it had “neverestablished a direct connection betweenthe deaths of patients and the use of thegeneric drug.”The foundation released a statementlast month titled “Five Kidney PatientsDied Who Used Generic Cyclosporin and16 Lost Their Transplants,” that allegedlycited a Caja study of the immunosuppressive(anti-rejection) drug (TT, Oct. 29).The Caja reacted with a press conferenceattended by doctors, officials, scientistsand a patient who uses the genericversion of the drug, who is also a Cajadoctor, to address the claims.“None of the kidney transplantpatients who have died, died because ofcyclosporin,” Executive President of theCaja Alberto Sáenz said.Abott Laboratories, the U.S.-basedmanufacturer of the drug, released a statementshortly after saying “use of genericcyclosporin does not have any relation tothe deaths of five kidney patients.”It pointed out that the same informationFUNCORE sent in its statement –excerpts of the Caja study – demonstratesthe generic drug is as safe, percentagewise,as the original version.The rate of kidney rejection amongCaja patients is around 25%, which isabout the same as worldwide rates, saidDr. Manuel Cerdas, a nephrologist (a doctortrained in kidney diseases, transplantation,and dialysis therapy) with the publicHospital México. Most of those whorejected their transplants were rescued, hesaid.“Concerning the deaths of patients,they were given autopsies and the causeof death was cardiovascular problems andinfection,” Cerdas said. “An exhaustiveanalysis of these cases didn’t show anylink between the deaths of the patientsand use of the medicine in question.“There is no link, and it’s importantthat that is clear,” he added.The Caja has administered the genericversion of the drug to kidney transplantpatients who began treatment in January2003; those who began treatment beforewere given the original version, and mostof them continue taking it – only a fewhave switched to the generic, according toAlbin Chaves, the Caja’s director of pharmaceuticaltherapy.The Caja buys 10,200 bottles ofcyclosporin annually at a cost of about$2.1 million, according to informationfrom the four public hospitals that dealwith kidney transplants – the NationalChildren’s Hospital, Hospital México,Hospital Calderón Guardia and HospitalSan Juan de Dios.

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