The Glaxo China Scandal – Bribes, Hidden Study Results and More
July 24th, 2013 // 1:12 pm @ jmpickett
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There are serious signs that the R&D operations in China for GlaxoSmithKline are a complete train wreck. The latest story is that researchers were failing to report animal study results on drugs that were being tested in humans, and employees failed to monitor clinical studies and they paid hospitals in bribes, The New York Times reported this week. This is in addition to the bribery scandal that is engulfing GSK operations in China.
An audit in 2011 of the R&D facility noted that the results of six studies for ozanezumab were not reported, even though early human trials had started.The project leader learned later about the study results for three sets of mice. Ozanezuab is a monoclonal antibody that is being made to treat multiple sclerosis and Lou Gehrig’s disease.
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This audit noted that patient safety was not an issue, but the lapses were very serious, and warned that patients might be exposed to risk that was unnecessary. An audit later stated that GSK took several steps to boost compliance, and no more problems were noted.
The Times then wrote that auditors noted that GSK employees in China were not recording if clinical study participants were signing new consent forms during the trial. They also failed to document if participants took the right drug dosages, or if they were following up when they discovered that study participants were not following protocol.
If these practices are true, Arthur Caplan, who heads medical ethics at the NYU Langone Medical Center, told the Times that Glaxo had committed mortal sins in research. No one would be able to approve a human trial without having that information. He noted that this is a Rock of Gibralter-sized violation of ethics.
GSK told the Times that after it had reviewed the whole range of data from the clinical studies, GSK determined that efficacy would not be good enough to continue on. The trial for ozanezumab was ended.
This is not the first time that GSK oversight at this R&D center in China has been scrutinized. Last month, we reported that a research paper in Nature Medicine had faked data and one of the authors of the paper was fired.
These episodes indicate that the failure of GSK execs in the United Kingdom, where the drug maker is headquartered, to properly oversee China operations were much more extensive than the current bribery scandal indicated.
GSK CEO Andre Witty is expected this week to talk about the bribery scandal during a quarterly earnings report. So far, GSK has admitted that bribery occurred and law in China was violated.
At this point, four GSK executives in China are being held on bribery charges. The firm is alleged to have paid out hundreds of millions of dollars to doctors and travel agencies to get fake invoices for conferences. Sexual favors were offered to some GSK employees. One law enforcement person in China called GSK the Godfather of crime in China.
