The fallout from the scandal over the TeGenero drug trial in London continues. The trial left all six men in the early-stage trial with weakened immune systems, conditions that are likely to plague them for life. Little by way of compensation has been made to the victims. And initial reviews indicate that regulators in the U.S. and Europe may significantly tighten rules for studies that involve testing drugs in humans for the first time. Dr. John K. Jenkins of the F.D.A. tells The New York Times that the main lesson from the fiasco is that any time regulators see a new molecule with a novel mechanism, they need to take a new approach.
- take a look at the article on the regulatory response from The New York Times