U.S. Citizen Detained as Pharma Probe Spreads (Updated)

An American has been detained in China as part of a probe into multinational pharmaceutical companies that previously led to bribery charges against GlaxoSmithKline executives earlier this month. From Reuters:

The unnamed American is the first U.S. citizen to be detained in connection with the investigations, and the second foreign national, after a British risk consultant linked with GlaxoSmithKline was held last week.

[…] “We are aware that a U.S. citizen has been detained in Shanghai. We are in contact with the individual and are providing all appropriate consular assistance,” U.S. embassy spokesman Nolan Barkhouse said on Tuesday, when asked about the involvement of U.S. citizens in the widening probe.

He declined to say which company the individual was associated with. [Source]

Problems with bribery are not specific to GlaxoSmithKline, according to Rob Schmitz’s report for Marketplace:

“It’s a systemic problem. It’s certainly not a GlaxoSmithKline problem,” says Shaun Rein, author of The End of Cheap China.

[…] “Foreign pharmaceutical brands are caught in a conundrum,” says Rein. “In order for them to sell into China, they have to give bribes. Because that’s what the Ministry of Health and that’s what hospital administrators and doctors are forcing them to do. If you don’t give a bribe, you can’t expand here.” [Source]

Two employees from drug maker AstraZeneca in Shanghai were also detained on Tuesday after a sales representative was questioned by police last week. Malcolm Moore at The Telegraph reports:

On Friday, police visited AstraZeneca’s main sales office in central Shanghai and detained one employee, a Chinese national, for questioning.

That person has now been released, but two more senior employees, both thought to be district sales managers, were taken away by police on Tuesday. AstraZeneca said both were line managers of the individual detained on Friday.

The move will raise fears that AstraZeneca could become embroiled in an investigation into its sales practices. [Source]

At The New York Times, however, Katie Thomas writes that GlaxoSmithKline’s issues in China extend beyond faulty sales practices to its drug research and development operations:

Glaxo’s research and development center opened in 2007 with lofty ambitions not only to help the company’s drugs get approved in China, but also to serve as one of its primary research hubs. The center grew quickly, expanding from one employee in 2007 to 460 in 2011, according to the audit. But as it grew, supervisors did not always ensure that the work done there was of high quality, auditors found.

One of the most troubling lapses — a problem the report labeled “critical” — involved a drug known as ozanezumab, which was being developed to treat patients with multiple sclerosis and Lou Gehrig’s disease.

The report revealed that the drug’s project leader belatedly learned the results of three studies of ozanezumab in mice. During their investigation, auditors came across six studies whose results had not been reported, even though early trials in humans were already under way.

Reporting such information is crucial, ethicists said, because animal studies can identify safety risks and are among the main factors drug companies use to decide whether to pursue human trials. [Source]

Update: GSK has responded to the Times report, saying that these and other issues have since been addressed.

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