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Accfocus: Drug-Trial Cases Spark Call For Acc Coverage


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Posted 14 May 2016 - 06:06 AM

Two patients injured in clinical trials have fought with international drug companies for compensation, sparking a call for a return to cover by the Accident Compensation Corporation. One of the men was in a trial for people with gout, comparing the medicine lesinurad with another gout drug. The other man was in a diabetes trial. Both cases were in 2012. Lesinurad was then supplied by Ardea Biosciences, an American company later taken over by AstraZeneca. It is not known what happened to the patients.

"A claim was made in relation to a NZ trial sponsored by a company subsequently acquired by AstraZeneca," Astra told the Weekend Herald.
"No causation was ever established between the drug and the alleged injury. A confidential settlement was reached between the parties involved".
The company testing its diabetes drug did not respond to Herald inquiries. The dispute from that trial was heading to mediation, according to a brief outline by the National Ethics Advisory Committee.
Patients in drug company-sponsored clinical trials were removed from ACC cover in 1992 because of fears the no-fault scheme could attract higher-risk trials to New Zealand.
Ethics committee chairwoman Victoria Hinson told Associate Health Minister Peter Dunne in a 2014 report made public this year that the two cases could undermine New Zealand's clinical trials system.
"There is a risk that, if the public becomes aware of the difficulties faced by these participants, it could affect future participation in, and conduct of, clinical trials in New Zealand."

Herald


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