by Enligt en studie över myndigheters roll i godkännandet av nya läkemedel, i det här fallet statiner, framgår det enligt en ny studie, att de myndigheter som reglerar läkemedel, och som har till uppgift att oberoende säkerställa att nyttan överväger riskerna, inte själva analyserat datan som låg bakom godkännandet.
”Globally, drug regulators have approved statins for the prevention of cardiovascular disease (CVD), although their use in primary prevention has been controversial. A highly publicised debate has ensued over whether the benefits outweigh the harms. Drug regulators, which are legally required to make independent judgements on drug approvals, have remained silent during the debate. Our aim was to navigate the decision-making processes of European drug regulators and ultimately request the data upon which statins were approved. Our findings revealed a system of fragmented regulation in which many countries licensed statins but did not analyse the data themselves. There is no easily accessible archive containing information about the licensing approval of statins or a central location for holding the trial data. This is an unsustainable model and serves neither the general public, nor researchers.”
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