NYT: GlaxoSmithKline's China R&D audit found ethical breaches

GlaxoSmithKline has been unable to escape the glare of the global spotlight on its operations in China, where officials are investigating the company's alleged bribery of doctors in a position to prescribe its drugs. In the latest blow to its China operations, The New York Times has ferreted an internal audit from two years ago that found significant ethical breaches at the London-based drug giant's R&D center in Shanghai.

Among a crowd of multinational drugmakers with fast-growing China operations, Glaxo ($GSK) has encountered problems in its efforts to keep high standards for drug research there. As the Times article noted, the audit from November 2011 found that Glaxo researchers in China failed to report the findings of animal studies for an experimental therapy that was already being tested in humans. And auditors questioned flat-rate payments to Chinese hospitals as clinical trial sites regardless of the amount of services they provided.

Though GSK says that a later audit came back more favorable, the report builds on a growing stack of bad press about its activities in China, where the company and others have banked on benefiting from the rapidly expanding pharmaceutical sector. GlaxoSmithKline has recently fired its head of R&D in China after learning that he co-authored an article in Nature Medicine with erroneous data from pre-clinical experiments, prompting the company to halt an early human study of a therapy associated with the data. But the company has contended with additional problems.

In one "critical" breach cited in the two-year-old audit, GSK researchers in China failed to report 6 mouse experiments of an experimental therapy called ozanezumab before the company began testing the drug in humans, the Times reported. After GSK's leader for the program learned about results from the mouse studies, the company halted human testing for the therapy in multiple sclerosis but continued trialing the candidate for Lou Gehrig's disease or ALS.

"If that's true, it's a mortal sin in research requirements," said Arthur Caplan, the head of the division of medical ethics at NYU Langone Medical Center, who has advised GSK on bioethics, as quoted by the NYT. "No one could approve human trials without having that information available, scientifically or ethically. That's kind of a Rock-of-Gibraltar-sized ethics violation."

It's unclear how much the research breaches can be blamed on poor oversight of staff practices versus conscious flouting of proper procedures. On the commercial front, Glaxo issued a statement yesterday that its executives appear to have broken laws in China, where officials are investigating the company's and other pharma groups' sales activities. Clearly, GSK has some work to do on its research operations in the country as well.  

- get more in the NYT article