The BMJ associate editor Peter Doshi, PhD, penned a feature article published by The BMJ in which he raises questions about the transparency of information surrounding the safety of GlaxoSmithKline’s Pandemrix vaccine used in 2009-2010. Doshi has been criticized in the past for his stance regarding flu vaccines.
In this new feature, Doshi says that internal safety reports from 2009 (unearthed as part of a lawsuit) suggest that GSK and public health officials were aware of a variety of serious adverse events logged in relation to Pandemrix, “but it would seem neither GSK nor health authorities made the information public, either during the H1N1 outbreak nor in the eight years since.” In a release, Doshi says he learned of the reports from a colleague, Tom Jefferson, who was hired as an expert witness in a lawsuit alleging that Pandemrix caused the sleep disorder narcolepsy. The BMJ features states that the data are insufficient to draw cause-and-effect conclusions, but for Gillian O’Connor, the solicitor involved in the narcolepsy lawsuit, the disparity was “of such striking difference that any person contemplating taking the Pandemrix vaccine would be likely, if in receipt of this information, not to choose to have the Pandemrix vaccination.”
In many of the GSK reports, the company refers to having conducted “safety reviews.” The BMJ asked GSK for a copy of those reviews, but says GSK did not provide them. GSK told The BMJ it “continuously evaluated all available safety data and shared the data with the European Medicines Association (EMA) and other regulatory authorities where the vaccine was licensed so that the authorities could conduct their own independent assessments.”
The EMA told The BMJ that it “does not perform comparative benefit and risk evaluations between products approved in the EU, or between EU products and products approved or used outside the EU.”
These events raise fundamental questions about the transparency of information, writes Doshi.
