Monday, October 12, 2015

Updates on the GVK story

Earlier this year, I'd posted some quick links about GVK Biosciences, a Hyderabad-based clinical research organization which was accused of falsifying clinical trial data on a massive scale, ultimately leading to 700 generic drugs tested by GVK being banned in the European Union pending further investigation.

Since then, the story has gotten murkier. First, this investigative report claims that the entire situation was precipitated by an affair between two employees, a married executive and his subordinate. The two eloped, the police were called in, and as they searched the executive's email, found that he had sent emails "to every major drug regulatory authority in the world raising doubts about the quality of clinical research conducted at GVK Biosciences."

These emails were apparently sent as retaliation after his employment was terminated by the organization. While the company claims to have conducted an internal investigation of the employee and went so far as to file a police complaint against him, what remains unclear is how this issue popped up on the radar of European regulatory authorities, triggering the subsequent investigation. Were the employee's emails enough to trigger alarm bells? Right now, there isn't a definitive account of the chain of events leading to the eventual ban.

The second twist is courtesy of a six-member expert panel set up by the government of India to investigate the case against GVK. They claim that, after extensive data analysis, "no data manipulation has been found." What's more, they say that several EU regulators, including the US FDA, had examined the ECG data which was supposedly falsified, and didn't report any issues.

The Indian government has also come out strongly in favour of GVK, cancelling a meeting with the EU's chief trade negotiator (and bringing to a standstill negotiations around the proposed free-trade accord between the EU and India). They have also indicated a willingness to take the matter to the World Trade Organization if the EU refuses to lift the ban. The whole situation raises several questions. Was it this single whistle-blower who set the entire investigative machinery in motion, or is there more to the story? Was data truly falsified or not? Is the EU ban really justified? Is this a case of genuine misconduct, or are there other forces at work here?

However the story may play out, one thing's for certain - the image of the Indian generics industry has taken a major hit when it comes to quality control issues, and it's going to need some hard work to restore reputations and rebuild global confidence that our home-grown pharma companies are worthy players on the global stage.

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