Have Questions? Call Us Toll Free (877) 880-5251

Red Tape Blamed for Blocking Scientific Study

Back in 2006, the National Eye Institute approved funding of a clinical study to compare the effectiveness of two drugs, Avastin and Lucentis in treating wet AMD. However, the study didn't actually launch until early 2008 and just reached its patient capacity in late 2009. What was trying to be determined was whether Avastin was as effective as Lucentis in treating wet AMD. Lucentis is the only FDA approved drug to treat wet AMD but it costs $2,000 for a monthly dose. Ophthalmologists were opting instead to use Avastin which is only $50 per dose and appeared to be just as effective. The first delay in the study occurred when trying to determine who would pay for the drugs since there was no drug company to sponsor the research. Medicare policy prevented payment for the drugs back in 2006 but made a policy change back in 2007. The next roadblock occurred with the issue of co-payments and trying to recruit patients who would be in the costlier Lucentis group. Congress eventually passed a bill in late July 2008 which was too late for the Avastin/Lucentis study which finally began back in early 2008. The delayed study meant that doctors were left to make decisions about their patients' care without important information regarding safety and efficacy. Researchers involved with this study stressed the need for significant changes to be made within the federal infrastructure for comparative effectiveness research to be carried out effectively.* Andrea Schumann Staff Writer

Search VisiVite