State Asked to Improve Generic Drug Tests

October 22, 2004

DRUG industry and health officialsare calling for stricter control of genericdrugs after reports last week that defectivemedicine for blood clots may have causedthree deaths last year.Three people with mechanical valvesin their hearts died in May 2003 and anotherperson suffered severe complicationswith blood clots after taking a batch ofWarfarin, an anticoagulant, which waslater proven to be defective.According to government officials,every batch of every prescription drug istested by officials of the Social SecuritySystem (Caja) according to proceduresoutlined in U.S. and British NationalFormulary manuals.Dr. Yalile Araya, director of the Caja’sdrug quality laboratory, told The TicoTimes the defective batch of blood-coagulantpills passed a test in February 2002,but after the tragedies occurred the pillswere retested in August 2003.The second test revealed that the pillsdid not dissolve properly, Araya said,which could affect how the medicine isabsorbed into the body. They were thenrecalled from pharmacies and the sellerwas notified.“WE don’t know what could havechanged,” Araya said. Because the medicineis sensitive to light, she suspects itwas damaged by humidity and heat whilein storage at the pharmacies.An investigation carried out by thedaily La Nación from July to Septemberrevealed that the chief of the Caja’s departmentof pharmaceuticals, Albin Chaves,received 31 reports from doctors warningabout problems with the medicine inFebruary 2003, four months before thetragedies occurred.Neither patients nor their families weretold of the defective pills – all of themfound out during interviews with LaNación reporters this year. The daily AlDía reported some family members of thedeceased are planning to sue the Caja,including those in charge of buyingWarfarin.The pills are a generic version of theoriginal drug Coumadin, made by NewYork-based Bristol-Myers Squibb.AFTER the news reports broke, Dr.Rodolfo Lambour, president of the CentralAmerican Federation of PharmaceuticalLaboratories (FEDEFARMA), called onthe government to publish and enforce adecree that requires generic drug makersto submit their products to bio-equivalencytests. The tests would ensure the medicineperforms the same way as the name brandversions.Public Health Minister María Sáenz ispushing for new drug testing rules, thoughnew rules have been on the HealthMinistry’s agenda since at least 2000,Araya said. The daily La Prensa Librereported last week that Sáenz delivered apreliminary bill to health institutions forfeedback.Lambour, however, said Costa Ricaalready has good laws in place, it needsonly to regulate and enforce them andexpand the list of drugs that require testing.Seven drugs are now on the testinglist, but even those drugs are not testedbecause the bio-equivalency tests decreehas not been published, he said.HE also criticized the Caja, which provideshealth care for most Costa Ricans,for letting price dictate its purchases to theexclusion of quality.“A lack of resources should not justifythe purchase of medicines of poor quality,”Lambour said.He emphasized that the drug laboratoriesshould pay for the tests, which would meanthe government would not foot the bill.Caja executive president Alberto Sáenz“categorically denied” the charge, saying hisinstitution takes factors beside price intoaccount, La Prensa Libre reported.FEDEFARMA represents multinationaldrug companies including Bayer,Pfizer and Bristol-Myers Squibb, most ofwhich produce original drugs, not genericversions. However, Lambour said “wehave nothing against the concept of genericmedicine,” and stressed that they arelegitimate, less-costly alternatives whenthey are tested properly.The risk to patients is real when genericdrugs are not tested properly, he said.He listed a variety of generic medicinesfrom antibiotics and epilepsy treatmentsto Viagra knock-offs and anti-cholesterolmedicine available on the marketthat have not passed equivalency tests andtherefore present health risks.

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