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Getting the Indian Drug Scandals Straight

An old colleague of mine sent along this story from India. It’s about the problems that GVK Bio had in 2015, which led to all sorts of consequences:

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.

31 comments on “Getting the Indian Drug Scandals Straight”

  1. anonymous says:

    Real life stories in Indian companies mimics Bollywood! What else can one say?

    1. Daniel says:

      Endemic corruption has been popping back out from under the policy rug off and on for well over a century in India, and this is just more of the same.

  2. Hap says:

    It’s not like history hasn’t show that lots of people will behave similarly (our and China’s diethylene glycol-for-glycerol switches, for example) when you let them get away with it. If you would prefer no disrepute come to Indian pharma, then perhaps you should consider making it less profitable for it to do disreputable things.

    A cynical alternative strategy would be to make sure India’s drug enforcement agency employees get only drugs from Indian manufacturers – either they’ll fix the problem, or they’ll go away.

    1. loupgarous says:

      The Chinese are getting the idea, though. “Put melamine in our milk, will you? Stand right here.” (action: walks behind toxic milk marketer and draws out a pistol)

      “Now, before I go any further, do we have your family’s current mailing address? I need to know where to send the invoice for this pistol cartridge… “

  3. watcher says:

    And this is exactly why I don’t trust generics from third world countries….but it’s a problem when insurance insists on them instead of brand name drugs.

  4. tally ho says:

    Derek – good to see you coming back online, complete with your pre-virus chutzpah (hope you didn’t catch whatever got ahold of J. Michael Pearson). However, this most recent news item makes me ill.

  5. Anon says:

    Only a defensive psychopath would blame the whistleblower without taking the responsibility (and oppurtunity) to rectify one’s own faults. The people responsible for denial are as much to blame and should be fired, period. In fact, the whole sorry affair reminds me of Sepp Blatter at FIFA.

    1. Pennpenn says:

      It was my understanding that almost everyone in a position of power who gets “whistleblown” will either blame the whistle-blower or try to discredit them (or both) as an automatic reaction.

  6. Anon says:

    Another question is whether the firms who contracted GVK knew of the fabrication of results. I can’t see any other reason why GVK would fabricate its results. If your client didn’t know the assumption would be that any CRO would give the same result…

    1. NJBiologist says:

      It’s possible that clients knew of fabrication (there are study monitors, after all), but it’s also possible that we’re just seeing the results of differential scrutiny. As a preclinical CRO biologist, I’ve seen more of the latter than the former. If I produce results that surprise the client, I get a lot more questions than if the results are in line with expectations. Judging from the comments here, I’m not the only person to have found this.

  7. I wonder if Ted Cruz & his co-author have thought about what would happen in their scheme if EMEA (or similar) revokes authority? Does that then revoke authority in the U.S. if granted under their bypass the FDA model?

  8. Emjeff says:

    It seems that the Indian drug industry, like the Palestinians, never miss an opportunity to miss an opportunity. With its highly-educated work- force, and huge market potential, India could have become a world leader in the pharmaceutical industry. Instead, the industry is dying, and its scientific talent is leaving for the EU and the US. Too bad…

  9. Anon says:

    Emjeff, why do you have to drag the Palestinians into this? You’re inviting a response that has nothing to do with the GVK Bio or the Indian regulatory situation, one that could start a storm of hate-filled invectives. Please stop.

    1. Emjeff says:

      No, I won’t stop.

      1. johnnyboy says:

        Spoken like a true troll.

        1. Emjeff says:

          Go into your safe space, johnnyboy, and ask Derek to put up trigger warnings on the site so your widdle fweelings don’t get hurt.

  10. Bagnar says:

    When I was working in a Big Pharma I won’t name here, we outsourced production of starting materials at GVK.
    I remember how angry my colleague in charge of this partnership was, when it was time to control what was produced. False NMR data, bad product quality etc.
    At the end, we spend more time to re-purify compounds, supposed to be pure, than simply synthesize them. Since this time, sorry for that generalization, I do not trust any CRO of the “third-world countries”.

    Sure, this is less important than false clinical trials data, but it shows that cheating is everywhere.

  11. Slava Bernat says:

    This is exactly why being a whistleblower sucks. One gets a huge amount of stress with no prospect of physical reward, while there is always an arrogant high-level manager with better access to the media claiming whatever BS he can come up with.

  12. Dylan says:

    Am I misunderstanding some of the facts in this case? My understanding is that the whistleblower passed along this information to several regulatory agencies and several agencies inspected GVK’s facilities, but only the ANSM found issues. The FDA and other inspectors didn’t find any problems. And GVK’s response to the ANSM report was sufficient to get everything except the echocardiogram issues thrown out. And the FDA as well as some independent consultants said that the echocardiogram data could have been falsified in a few cases, but might not have been, that there just wasn’t anyway to tell for sure?

    It doesn’t seem that Dinesh Thakur’s piece disagrees with any of these statements, but instead focuses on how the whistleblower has been portrayed in the press? I agree that some of the accusations on how GVK apparently tracked down the whistleblower are disturbing, even to this American in the post-Snowden era, but that doesn’t mean that the actual work they did was bad. If I’m misunderstanding some of the facts and allegations I’d appreciate a correction, but to me this seems like it should have been much less of a scandal then what happened at Ranbaxy.

    1. Dylan,

      It is true that the US FDA has publicly said that they did not find problems with GVK Bio’s clinical unit, but the story is not over yet. It still remains to be answered why the US FDA revoked (if my understanding is accurate) preliminary approval for Wockhardt’s Felodopine. Stay tuned.

      Also, ANSM confirmed that the ECG data was falsified in 9 different studies, not just a few. I had included a link to the original and final ANSM reports, I think you would find that there were several other questionable practices if you do decide to read them. Given the limitation of the piece I wrote, I had to pick one to illustrate my point.

      1. Dylan says:

        Dinesh,

        Thank you for the response. I have gone through the final ANSM report that you linked to and am still a little confused by the conclusions. My understanding is that there was no evidence supporting or disproving the most serious allegations of sample substitution, and it couldn’t be proven either way because of deficiencies in the SOP, which have now been updated. Then there is this section, which seems to be the meat of the objections that caused 1000 drugs to get banned from Europe?

        “The results of the review of the data of trial 145-08 are fully consistent with the information received and give them strong credit. Information on sample substitution provided as part of the allegation is considered as highly credible in the case of trial 145-08. It is however noted that no similar pattern was seen when reviewing the data of 17 other trials submitted to ANSM. Trial 145-08 was not submitted to ANSM.”

        The rest of the issues appear to be some sloppy SOPs, not great, but the kinds of issues that seem to be pretty standard worldwide. Maybe Ranbaxy just desensitized me too much to bad actions among Indian pharma…but the allegations here and the level of evidence seem pretty weak compared to the reaction.

        1. Dylan,

          You have to look at the ANSM action in the context of two successive investigations, not just the most recent one, where they continued to see data falsification. In addition, ANVISA, which was a partner with ANSM for the most recent investigation, cancelled GVK Bio’s license to submit BA/BE data to Brazil based on studies they audited specific to that market. Unfortunately, I have not been able to secure the inspection report from ANVISA.

          My experience with Indian generic manufacturers and CROs is that sloppy SOPs are the first indicator of data falsification. Intentional loopholes are designed to provide leeway for their managers to take liberties with data integrity when the results dont show what they want to see.

          1. Daniel says:

            Dinesh,

            Are you referencing the “Relatório de Inspeção Internacional 003/CETER/GGMED/ANVISA” cited in the doc linked in my nick? If so, I can try to obtain it through our equivalent of the FOIA, if you think it could help (i.e., if that was not precisely what you’ve already tried),

  13. smatphone says:

    in general, CRO outfits in Hyderabad and Bangalore are suspect. you work with them AT YOUR OWN RISK !! leo pharma works with GVK.

    falsification of data to compensate for the “lack of scientific skill” – that just about describes GVK and Syngene.

    this is how business is done in India.

  14. Insilicoconsulting says:

    As it inevitable the mud slinging has begun. I admit some cro’s may be sloppy, some studies may indeed be falsified.

    But just look at the comments section. If this is not country bashing and stereo typing, what is?

    Clients often put enormous pressure on both clinical and preclinical cro’s in the name if productivity. Given that its a buyers market and indian companies have limited capital, there comescan inflexion point when things get desperate.
    But still. What’s the benefit that would accrue to the vendor by falsifying as a matter of habit? Were these studies milestone based ?

    It is indeed true that we could have been a pharmaceutical super power, but lack of that is due to lack of a risk taking attitude and an internal well oiled market like the US rather than just a propensity for fudging data.

    1. Hap says:

      If India’s institutions (government and press) cover up for the drug companies who cheat, then the successful companies are going to be the ones who cheat (because it’s cheaper and easier to be successful by cheating than to do so honestly), and then India is going to get a reputation for low-cost crappy drugs (which it seems to be getting, unfortunately).

      It’s like baseball and steroids – since baseball and its players decided that the quick way to hitting home runs was acceptable, and hitting home runs paid well and made spectators happy, lots of people took steroids to hit. Now everyone (almost) from that era who hit home runs has to face the scrutiny of “He hit home runs. Was he juicing?” If you don’t fix it early instead of burying it, then that’s what happens.

      1. smutphone says:

        You are absolutely right Hap. BUT DO NOT EXPECT THIS TO CHANGE.

        Unfortunately this is cultural and essential modus operandi in India. honest effort is NEVER rewarded in India. Corruption is rampant. In our culture, shortcuts are appreciated.

        remember the indian chemist who fudged reactions in Ron Breslow’s lab !!!
        remember how the indians cheated Daichi Sankyo into plunking down billions of dollars for RANBAXY !!!

        Buyer BEWARE.

    2. loupgarous says:

      You’re protesting far too much. The US is usually transparent on the issue of drug scandals, because we have a very active adversarial legal system in which such transparency can be lucrative to law firms. The checks and balances in our government aren’t foolproof, and can be evaded by unscrupulous politicians and their sponsors in finance and industry, but eventually the truth comes out.

      There’s no special incentive for us to bash India in this blog. If India had relatively strong controls over fraud in regulatory drug filings, many in this country would welcome the news, for it would mean we had a very inexpensive source for quality pharmaceuticals of known quality, and in this country we like competition.

      Moreover, we do discuss our own drug scandals (price gouging by Mylan and Turing Pharmaceuticals which appear to have occurred with at least some FDA connivance, for example) with asperity and venom. GVK Bio barely gets any mention at all here compared to Mylan and Turing.

  15. Observer says:

    This article on the topic in the Financial Times may be of interest

    http://www.ft.com/cms/s/0/de0ca3f4-5581-11e5-97e9-7f0bf5e7177b.html#axzz3x9qO86fV

    The article quotes the former general counsel for Cipla that indeed it is a cultural problem: “Indians don’t like to give bad news and so test results always have to come out good…”you know what the test is supposed to say and you try to show that”.

    This has been 100% my experience working with our Indian R&D department. There is no tradition of scientific rigour and open discussion. Nobody in the organization trusts their results. The verifying effort is huge. The department costs way more than it’s worth.

  16. Nishi Dutta says:

    Very nice post, thanks. I have checked a site, which has a great drug database about generic & branded drugs, with therapeutic class and ICD codes, please check it, it is very useful for everyone. https://mediklik.com/main/knowledgebase/drugsearch

  17. loupgarous says:

    Unfortunately, we’re moving closer to India on drug scandals. Dr. Margaret Hamburg leaves the FDA, where she was Commissioner, under a cloud of scandals in February 2015. In March of 2016, President Obama announced he’s re-appointing her as FDA commissioner. April 2016 saw this posted. The Daily Caller posted this here, and no one but the conservative press has touched the story, yet,

    Still, we’re not hearing denials in the rest of the press. We’re hearing silence on the accusation that FDA covered 5,000 drug-related deaths up to keep stock prices for a Big Pharma firm in which the hedge firm where Dr, Hamburg’s husband was co-CEO had millions of dollars of stock. And, coincidentally, an accusation “on information and belief” that Dr. Hamburg and her spouse showed much love to the Clinton Foundation immediately before she was appointed Commissioner of the FDA in 2009.

    If the Daily Caller‘s wrong, or just clutching at a story they know will drive their eyetracks way up, that’s just as relevant to the topic of drug scandals as it being a plausible story.

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