Thursday, August 26, 2010
More pediatric clinical trials going overseas
Back in January 2009 I reported that the Court of Appeals for the Second Circuit revived a claim filed under the Alien Torts Statute by Nigerian citizens against Pfizer claiming the company subjected their children to medical experimentation without their consent during a 1996 meningitis outbreak. The opinion is available here. The Supreme Court then rejected an appeal by Pfizer. Interestingly, today Pharmalot is reporting that "[a] new study in Pediatrics finds more pediatric trials are going overseas - 65 percent conducted under the pediatric exclusivity provision, which offers drugmakers six months of patent extension for running safety and efficacy studies - used overseas sites. More than one-third, or 38 percent, enrolled patients in a developing country, including one-third of trials testing infectious disease, cardiovascular and allergy and immunology meds. And 11 per cent only used sites outside the US (here is the abstract)." The study suggests there are potential benefits to the globalization of pediatric research, such as reducing the cost and time line for drug development, fostering global clinical innovation, and improving access to therapies and the health of children worldwide, but they also raise a number of troubling concerns such as whether research matches the needs of local populations, whether the meds would become available to children in these countries after the studies end and the issues related to the need for informed consent - which is the issue is the cases mentioned above. For more information go to Pharmalot.