Recent changes to clinical trial rules in Europe, an emerging controversy over Food and Drug Administration (FDA)-approved anemia drugs, and heated debate over the bird flu moratorium are all in the mix in this week’s Research Ethics Roundup.
Europe proposes revision of clinical trial rules: The European Commission has formally adopted proposals for new rules to replace the controversial Clinical Trials Directive. Experts predict that these changes will reduce some of the red tape that has resulted in bloated insurance costs and a reduction in the number of clinical trials being conducted in the EU since the inception of the directive.
Free access to British scientific research within two years: According to The Guardian, the British government plans to make “research papers that describe work paid for by the British taxpayer free online for universities, companies and individuals to use for any purpose, wherever they are in the world." The goal is to implement this policy by 2014.
Anemia drugs made billions, but at what cost?: Researchers have uncovered a growing body of evidence that indicates that FDA approval for several popular anemia drugs may have resulted from the drugs’ benefits being overstated and their potentially lethal side effects being downplayed. According to The Washington Post, “the multibillion-dollar rise and fall of the anemia drugs illustrates how the economic incentives embedded in the U.S. health-care system can make it not only inefficient but also potentially deadly.”
Bird flu researchers to meet about research moratorium: What was to be a 60-day, voluntary moratorium on work with contagious, lab-altered forms of bird flu has now reached its sixth month anniversary. Researchers will meet in New York next week to discuss whether the high risk of a bird flu epidemic should impact scientists’ decision to conduct research in order to minimize the chance of an outbreak, or if it should motivate researchers to learn more about the virus in general. Concerns have also been raised over the limited involvement of nonscientific stakeholders, and the lack of transparency of these risks in the media.