GSK Pauses Ph I MS Trial and Sacks China R&D Chief

In the study the authors claimed that interleukin-7 plays a 'crucial' role in stimulating the multiplication of a subset of white blood cells - T helper 17 cells- which are thought to be involved in the development of MS in some patients.

However, according to GSK spokesman David Daley, some of the data on which this conclusion was based may have been faked. 

He told us that data characterised as the results of studies on cells donated by MS patients were either derived from tests carried out on healthy donor samples or from experiments that “cannot be documented at all, suggesting that they may well have been fabricated​.”

Daley stressed that Baylor Medical College in Texas, US where the MS cell tests were carried out had not played a role in misrepresenting the data and added that the firm believed the fraud was not reflective of a systemic problem.

“What happened was unacceptable but it is an isolated event. We are committed to the highest ethical and scientific standards and employees, regulators, physicians and patients can have confidence in the research we carry out. In this instance our standards were compromised.”​

Impact​

What impact the discovery of the fake data will have on GSK’s MS development programme in the long-term is unclear, but in the short-term it has prompted the UK firm to temporarily halt an early stage clinical trial, as Daley explained.

“The research has contributed to the development of an early stage asset but it has not been pivotal. There’s an independent body of evidence that the receptor under examination in that paper, interleukin-7, is a valid target for a variety of auto-immune disorders.​

“We’re going to pause the current PhI clinical study in MS but we have no plans to discontinue the asset at the moment. We’re also going to continue with existing plans to conduct a proof-of-concept study in another autoimmune indication for which external supportive data exist. That will be used to guide any decisions on whether we study the asset in other indications​.”

GSK’s contention about interleukin-7’s role in MS is indeed supported by other research, however the focus on T helper 17 cells suggested by the Zhang paper may not be.

The results of a Pfizer-sponsored study published in 2011 ​suggest that interleukin-7 “is neither necessary nor sufficient for the induction or expansion of T(H)17 cells​," but “can greatly enhance both human and mouse T(H)1 cell differentiation​." 

China syndrome? No says GSK​

One thing that is clear is that the discovery of fake data is not going impact the role research conducted in China plays in GSK’s development programmes.

Daley rejected the suggestion that the issue had arisen because the work had been conducted at a distance from the firm’s base in the UK.

“Throughout GSK we have strong codes of conduct and have put into practice our commitment to conducting our business openly and transparently. These ways of working reflect our commitment to the highest standards​.”