Executives at the British drug maker GlaxoSmithKline were warned nearly two years ago about critical problems with the way the company conducted research at its drug development centre in China, exposing it to potential financial risk and regulatory action, an internal audit found.
The confidential document from November 2011, obtained by The New York Times, suggests that Glaxo?s problems may go beyond the sales practices that are currently at the centre of a bribery and corruption scandal in China. They may extend to its Shanghai research and development centre, which develops neurology drugs for Glaxo. The failings, some experts said, underscore the problems that can arise when major drug companies export their scientific development to emerging markets like China.
Since 2006, 13 of the top 20 global drug makers have set up research and development centres in China, according to a report by McKinsey & Co. ?It?s cheaper to do research there,? said Eric Campbell, a professor of healthcare policy at Harvard Medical School. However, ?I have absolutely no doubt that with cheaper research comes greater risk.?
Auditors found that researchers did not report the results of animal studies in a drug that was already being tested in humans, a breach that one medical ethicist described as a ?mortal sin? in the world of drug research. They also concluded that workers at the research centre did not properly monitor clinical trials and paid hospitals in ways that could be seen as bribery. Last year, Glaxo said, a more favourable audit found the concerns had been addressed. But several outside experts said the problems outlined in the initial audit were grave and painted a picture of an organisation that failed to keep tabs on a crucial research centre as it expanded both in size and scope.
And it indicates that the problems there were more extensive than were reported in June, when the company fired the head of research and development in China after discovering that an article he helped write in the journal Nature Medicine contained misrepresented data.
In a statement, Glaxo said it was committed to conducting ?robust? audits of its business practices, and in this instance, ?the process worked exactly as intended?. It added, ?Patient safety is paramount and the audit reports do not show that this was compromised.?
In all, company officials said that appropriate steps were taken to address the issues outlined in the audit. ?It is good that they detected problems and vowed to fix them,? Dr Avorn, a professor at Harvard Medical School said, ?but this report shows what can happen when a drug company rapidly expands its clinical research programmes overseas without adequate quality controls.?
