GERN- Can the FDA be bought off ?
FDA said they don't think there is much efficacy for GERNs drug Imtelstat. In addition, they don't think the risk of the side effects(specifically Cytopenias and Nuertopenias) are worth the benefit the drug gives to so few. The Advisory Committee told the FDA on March 14 that there is huge efficacy for Imetelstat, and it met primary and secondary end points in phase 3. They also said the side effect of Cytopenias can be well managed, and the beneifts of the drug far outweigh the risks. They said that around 40% of the patients taking the drug have much improved lives, and are either totally transfusion independent or take far fewer transfusions, even after e year. They said overall hemoglobin levels are much higher for these 40%, and patients just feel much better. They said that being there is just about no treatment for these patients that have MDS(a deadly anemia), the Imetelstat is an option well worth taking, despite the fact that 60% were non respondent, and had to endure side effects while on the drug.
My fear is that there was no logical reason for the FDA to have been so negative in light of a 12 to 2 vote as a suggestion to the FDA to approve the drug. I am concerned that big pharma was swaying their view on Imetelstat, and that if they still are, that FDA approval may not be given on June 16, despite that fact that 97% of time the Advisory Board has a major consensus, the drug gets approved.
