In October this year, a national newspaper in India ran a front page news item with the headline “A love story that cost GVK its international reputation”.
The story spoke of a former GVK Biosciences employee turned whistle-blower, and of a chain of unintended consequences that resulted in the European Medical Agency (EMA) cancelling the marketing authorisation of 700 drugs previously approved for sale in the EU on the basis of data generated at GVK Bio. This in turn caused India to cancel scheduled talks on the Indo-EU Free Trade Agreement (FTA).
That former employee must have caused an unbelievable amount of consternation in GVK’s offices. In May of 2012, he forwarded a detailed list of accusations, with data to back them up, about manipulation of clinical data (which GVK performs under contract) to the WHO and to drug regulators in the US, France, the UK, the Netherlands and Turkey. Ten days later, he copied GVK management, and I can only imagine the scene.
Dinesh Thakur, the author of this new article, was the whistleblower who started off the big Ranbaxy scandal a few years ago. (And yes, I realize what it sounds like when I keep writing text string that consist of “[big Indian biopharma player] scandal”). Thakur is in a position to say that the story about this latest affair in The Hindu, linked to above, appears to be quite wrong about some key points.
All sorts of stories were flying around about who the whistleblower was in this case, how he might have been tracked down, and what his motivations were. The Hindu would have it that GVK’s reputation was ruined, and the the reputation of India’s entire biopharma sector dragged through the mud as well, because of a “love affair gone wrong”. But that’s not true. GVK ruined themselves by systematically falsifying data on a large scale in order to make studies come out the way that their clients wanted. The newspaper goes on about illicit affairs, as if that changes anything (even if true), and manages to get in some good old conspiratorial thinking, too:
G.N. Singh, Drug Controller-General of India (DCGI), confirmed that he knew about the whistle-blower. “We do not know why the whistle-blower — if that was his intention — did not approach the Indian regulators first. Having said that, one must understand that there is a bigger game being played out here. I have repeatedly stated that multinational pharmaceutical companies constantly use incidents like this to bring disrepute to Indian generic drug makers,” he said.
With all due respect, G. N Singh can stick it in his ear. Allow me to clear up a couple of points for him – not because I’m so clearsighted, but because any intelligent adult should be able to do the same. The whistleblower in this case did not go the Indian regulatory authorities because he did not trust them to do the right thing. Was that so hard to understand? And as far as foreign drug companies using “incidents like this to bring disrepute” to Indian drug companies, words fail me. Well, almost: what if there were no such incidents, eh? The Indian drug sector has (on several occasions) brought disrepute on itself. Muttering about a “bigger game being played” is fatuous, and if this is what the Drug Controller-General of India reaches for in a situation like this, the country is going to have problems for a long time to come. Grow up. Don’t fake results. And don’t go around blaming other people when the fakery gets discovered.
Update: here’s Thakur’s follow up piece, and he’s coming pretty close to sounding like I was in that last paragraph. And with good reason. The Indian government and its drug industry are not handling this well at all.