This spring’s outbreak of a virulent form of Escherichia coli in Germany and France provoked a rapid response from public health authorities and the research community. Not only did the response represent a triumph of global collaboration in rapidly characterizing the Shiga toxin–producing strain but it also prompted an on-the-fly clinical trial of one of the world’s most expensive biotech drugs—Alexion’s humanized monoclonal antibody Soliris (eculizumab)—previously approved for the rare disease paroxysmal nocturnal hemoglobinuria (PNH). As thousands fell ill with the enterohemorrhagic E. coli (EHEC) strain O104:H4 from eating tainted food—a substantial fraction developing potentially fatal hemolytic uremic syndrome (HUS)—German and then French doctors turned to Soliris, which prevents the cleavage of complement component 5 (C5) and activation of the hemolytic cascade.
Continue reading E. coli crisis opens door for Alexion drug trial
Companies seeking approval for new biotech crops can now prepare their own environmental study or hire an outside contractor to do so. The new options, announced by the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) in April, are part of a two-year voluntary pilot program designed to speed up document preparation, although critics argue such self-reporting is inevitably biased. Currently, genetically modified (GM) crops can take years to approve, as the agency faces a backlog of nearly two dozen petitions, according to APHIS deputy administrator Michael Gregoire. Before a crop can be deregulated, the law requires a preliminary environmental study, followed by a more comprehensive environmental assessment conducted by APHIS (the regulatory arm of the US Department of Agriculture (USDA). The environmental assessment costs the petitioner $75,000–$100,000, although the USDA may decide a crop warrants a more detailed environmental impact statement, which can cost over a million dollars. 