Update regarding 2010 Nature Medicine study
A GSK research paper published in 2010* that was found earlier this year to contain incorrect data has now been retracted by Nature Medicine.
The publication, on which several Shanghai-based GSK scientists were named authors, detailed preclinical, early-stage work investigating whether a signaling pathway within cells could be useful in the treatment of multiple sclerosis (MS). This was exclusively laboratory research that did not involve giving an investigational drug to any individuals.
In June we concluded an investigation of the publication and, regretfully, established that certain data were indeed misrepresented. We shared our conclusion with Nature Medicine and recommended that a retraction was appropriate.
An early clinical study in which healthy volunteers were receiving an investigational drug targeting the same signaling pathway** was also stopped in June as a precautionary measure. This study had been intended to lay a foundation for eventual testing in MS patients but given the misrepresented data, MS is no longer a focus and no clinical studies are taking place at the moment. GSK still believes the investigational drug and the signaling pathway may have potential in other disease states.
Following the investigation GSK took appropriate action. Five R&D employees who were among the named authors of the publication have left GSK.
GSK is committed to the highest ethical and scientific standards, in light of this data misrepresentation a broader scientific data review team was established. The team, overseen by an independent chair from outside GSK (Professor Sir Patrick Sissons, Emeritus Regius Professor of Physic, University of Cambridge), was asked to examine the integrity of data generated in our Shanghai research centre and review any decisions based upon these data. The review team reported that:
- There was no evidence that patient safety had been compromised and found no reason to suspend or stop any clinical research.
- Data misrepresentation was found in only one publication – the retracted Nature Medicine article.
- Two other unpublished manuscripts, involving the same small research group that drove the Nature Medicine publication, contained potentially purposeful misrepresentation of data.
- Opportunities exist to further strengthen our existing culture and processes around data management.
- The recommendations of the review team are being fully implemented and will be embedded as standard practice.
“I am deeply disappointed by this unacceptable breach of scientific integrity”, commented Patrick Vallance, President, Pharmaceuticals R&D. “This robust review was actively encouraged by our scientists - I am pleased at how open and collaborative they have been throughout. We remain committed to research in China and our work in neurosciences. Our recent appointment of Professor Min Li as Senior Vice President, Neurosciences to be based in Shanghai, is a signal of our commitment to patients in this area.”
* The published research paper is "Crucial role of interleukin-7 in T helper type 17 survival and expansion in autoimmune disease," originally published in Nature Medicine, 2010, 16: 191-197.
** Protocol excerpt from the early clinical study that has been stopped “The proposed study consists of three parts. Part A will evaluate single ascending doses of GSK2618960 in healthy volunteers; Part B will evaluate repeat ascending doses of GSK2618960 in healthy volunteers; Part C will evaluate repeat doses of GSK2618960 at a single dose level in RRMS patients. The purpose of Parts A and B is to provide safety and tolerability data in humans which supports progression to Part C.”