Monday, September 21, 2015

China Probes Ex-Official Who Oversaw Clinical Trials for Bribery/ Bloomberg

Drugs and devices licensed in the US often rely on data generated overseas for FDA approval.  It should come as no surprise that FDA oversight of foreign clinical trials may be weak or nonexistent, and that drug/device approvals today seem more and more likely to be based on data whose reliability is far from assured...especially when the stakes are so high.  The cost of doing business for big pharma has included fines of billions of dollars, when they are occasionally found out.  

From the point of view of a physician, prescribing newly licensed drugs to patients is a nerve-wracking activity, as I have no assurance they are as safe and effective as claimed.  And they are assuredly more expensive than the old standards.  From Bloomberg

Chinese prosecutors announced a bribery investigation into a former national health official who for at least a decade oversaw clinical drug trials and implemented hospital policies. Wang Yu, the former director of the National Health and Family Planning Commission’s bureau of medical administration, has been arrested and is being investigated by prosecutors in the southwestern province of Sichuan, China’s Supreme People’s Procuratorate said on its website Tuesday. Bloomberg News reported earlier this month that Wang was suspected of violating Communist Party discipline, according to a person with direct knowledge of the matter, who asked not to be named because the probe wasn’t public.
Before retiring last year, Wang was responsible for supervising trials of drugs and medical devices, as well as drafting policies for medical institutions. The prosecutor’s statement Tuesday provided no details about bribery allegations against him.
The health industry is facing greater scrutiny in China, with the government in September fining British drugmaker GlaxoSmithKline Plc 3 billion yuan ($484 million) for paying bribes to win customers in the world’s most populous country. Authorities also last year started a preliminary probe into the business practices of foreign medical-equipment makers, people familiar with the matter said earlier this month.

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