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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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June 11, 2013

More on the GSK Shanghai Scandal

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Posted by Derek

The accusations of data fabrication at GlaxoSmithKline's China research site are quite real. That's what we get from the latest developments in the case, as reported by BioCentury, Pharmalot, and the news section at Nature Medicine. Jingwu Zang, lead author on the disputed paper and former head of the Shanghai research site, has been dismissed from the company. Other employees are on administrative leave while an investigation proceeds, and GSK has said it has begun the process of retracting the paper itself.

As for what's wrong with the paper in question, BioCentury Extra has this:

GSK said data in a paper published in January 2010 in Nature Medicine on the role of interleukin-7 (IL-7) in autoimmune disease characterized data as the results of experiments conducted with blood cells of multiple sclerosis (MS) patients "when, in fact, the data reported were either the results of experiments conducted at R&D China with normal (healthy donor) samples or cannot be documented at all, suggesting that they well may have been fabricated."

Pharmalot and others also report that GSK is asking all the authors of the paper to sign documents to agree that it be retracted, which is standard procedure at the Nature Publishing Group. If there's disagreement among them, the situation gets trickier, but we'll see what happens.

The biggest questions are unanswered, though, and we're not likely to hear about them except in rumors and leaks. How, for one thing, did this happen in the first place? On whose initiative were results faked? Who was supposed to check up on these results, and was there anything that could have been done to catch this problem earlier? Even more worrying - and you can bet that plenty of people inside GSK are thinking this, too - how many more things have been faked as well? You'd hope that this was an isolated incident, but if someone is willing to whip up a batch of lies like this, they might well be willing to do much more besides.

The involvement of the head of the entire operation (Jingwu Zang) is particularly troubling. Sometimes, in such cases, it turns out that the person at the top just had their name on the paper, but didn't really participate much or even know what was going on. But he's the only person so far in this mess who's been outright fired, which suggests that something larger has happened. We're not going to hear much about it, but you can bet there are some rather worried and upset people digging through this inside GlaxoSmithKline. There had better be.

Comments (30) + TrackBacks (0) | Category: The Dark Side | The Scientific Literature


COMMENTS

1. blueman on June 11, 2013 7:02 AM writes...

This has to be unique - is there anyone else with a warning letter from the FDA and a paper retraction in Nature to their name ?

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2. Anonymous on June 11, 2013 7:17 AM writes...

Wow. I was working at GSK when they first took this guy on, to great fanfare. Embarrassing doesn't begin to cover it!

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3. Anonymous on June 11, 2013 7:28 AM writes...

Yes! He was a friend if Moncef apparently. I wondered why a known liar would be recruited in the first place ....

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4. Anon2 on June 11, 2013 7:34 AM writes...

Included in the fanfare when first being established was the policy that GSK China would be a totally independent entity from the rest of GSK R&D.

Another association that has not been lost on many folks is that the hiring of JZ in setting up GSK China was a decision made by Witty and Slaoui. The purchase of Sirtris was the decision of Slaoui and Witty. Two of the the most worst and embarrasing investments in the Pharma industry for the past 10 years. It is a self evident truth that both should be relieved of their positions.

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5. Nick K on June 11, 2013 7:36 AM writes...

Perhaps they should also take a careful look at the screening results generated there.

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6. a on June 11, 2013 7:54 AM writes...

Sometimes a race to the bottom actually gets you there.

Oh wait; this is just a LOCAL minimum.

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7. Anonymous on June 11, 2013 7:59 AM writes...

#3 - you answered your own question: "friend of Moncef"

What is it they say about "birds of a feather..."?

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8. emjeff on June 11, 2013 8:33 AM writes...

I think we've only seen the tip of the iceberg here. If the head of the group was involved, you can bet a lot more than the authors of this paper were involved. This is a disaster of truly epic proportions.

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9. processchemist on June 11, 2013 8:40 AM writes...

I remember when the Shangai CEDD was established. Slaoui promised major advancements in field of neurodegeneratives diseases in 5 years....

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10. anonie on June 11, 2013 9:07 AM writes...

9: Yes, and Slauoi still has little clue as to what it takes to do true inventive Discovery through to Phase 1 in an area as tough as the neurosciences. Yet, the pressure must have been felt by the China site to show that they would be productive toward the assigned purpose.

I'm afraid, too, that emjeff (8) could be right. This disclosed incident demonstrates a lack of data validation, review, accountability that would satisfy other's standards. Why would "the problem" be limited to a single event, a single manuscript?

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11. pc on June 11, 2013 10:04 AM writes...

The rumor has it that Zang met with the first two authors in a hotel right after GSK notified him about initiating the investigation and informed him to stay put (for interviewing/questioning maybe). The mitbbs site has quite a bit of meat over there on this whole thing.

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12. exGlaxoid on June 11, 2013 10:08 AM writes...

Having worked at GSK R & D until it fell apart under the great leadership of Moncef Slauoi, I can say that he was the worst R & D leader I have ever seen. GLaxo Wellcome had been doing great until the merger with SKB. After JP took over and put Moncef and many other SKB leaders in charge of research, the path of R & D started going downhill. I actually think that Witty is still trying to clean up the mess that Moncef and JP created. He might have had some say in those bad decisions, but most appear to have started before or shortly after he was put in charge.

There were many bad decisions, in addition to the ones that made the news, spending money on many overpriced wild goose chases with Affymax, Praecis, Sirtris, R&D factories, Shanghi, etc. If those miltimillion dollar mistakes had not been made, R & D could have been left alone, and the company would likely still have some reasonable pipeline. Not to say that there would not be challenges still, but at least GSK would have had a fighting chance.

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13. Brett on June 11, 2013 10:13 AM writes...

This doesn't surprise me, considering the accounts I've heard about rampant research fraud in China.

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14. Anchor on June 11, 2013 10:19 AM writes...

It is very sad, what is unfolding. Recently on a trip to for a conference, I was impressed with some fascinating work carried out in clinical research (optical imaging) by some academicians in the US university in the mid-west. The work was funded by NIH and other foundation based here in the USA, but surprisingly their collaborators where from PRC. I am seething with anger as to why there are no rules to to straighten out these defeciencies in funding mechanisms.

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15. ElMatador on June 11, 2013 10:33 AM writes...

Dear Moncef and Patrick,
is it getting dark or is that just a flock of chickens coming home to roost?
I'm surprised that anyone is surprised by this!

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16. pgwu on June 11, 2013 11:02 AM writes...

According to John P. A. Ioannidis, most published research findings are false. This is probably an overly pessimistic view. But still there are quite a few publications/blogs on the topic. Had this been a paper from an academic lab with no commercial interest, it might have been just like a tree falling in a forest. Research in biology is hard enough with sample heterogeneity, paucity of samples, and tracking. The rush to monetize a new finding without prudent confirmation causes all problems. When the rubber meets the road and things are not they seem to be, finding a scapegoat is in order. Not to defend the fired person, but like the blog said, there seems to be more to the headline.

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17. Hap on June 11, 2013 11:17 AM writes...

As with crimes, though, the key to what happens is intent. There are lots of bad results, but not that many of them are due to actual fraud (although some meet pretty similar levels of dishonesty - pick one result out of ten or so that you did, for example, and report only that result).

People who make honest errors can be taught to do things correctly. People committing less-than-honest errors might be rehabilitated, but probably not. People who commit fraud probably can't be rehabilitated in a useful way - even if the person who committed fraud tries to go straight, people aren't likely to trust their work without substantial verification, ever. Since the person accused was the head of a major pharma's Chinese research division (and not just a lower level researcher), it seems bigger than usual. In cases of fraud, though, there is almost never transparency, so there will be plenty we don't know, some of which might make this look better and some not.

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18. pc on June 11, 2013 11:51 AM writes...

The first author has issued a statement

http://www.bio360.net/news/show/5594.html

Basically claiming it's an honest mistake instead of faking the data intentionally. If the statement is indeed from him then it seems like he is willing (or maybe instructed to ?) to take the fall for Zang. Again pure speculation.

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19. Chemjobber on June 11, 2013 12:51 PM writes...

Where have you gone, Agilist, a comment section turns its lonely eyes to you...

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20. Hap on June 11, 2013 1:43 PM writes...

If it gets really embarrassing, someone (or some entity) might decide to really send a message about what happens when you get caught falsifying research results. I've liked my bosses, but there isn't a one I think I'd be willing to take the needle for.

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21. alig on June 11, 2013 2:17 PM writes...

It used to be GSK policy that every piece of data in a paper had to be referenced to a notebook page. Part of the vetting process before the paper was allowed to be submitted was the internal GSK reviewers were supposed to check that the notebook pages actually existed. Not sure how many reviewers took the time to check, but I bet they will now.

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22. pete on June 11, 2013 4:48 PM writes...

@ 21 alig
Agree that internal peer review & independently checking the congruency of figure data & notebook entries is an important preventive.

Unfortunately, the determined fraudster can still blow right by that: e.g., surreptitiously substituting (& mislabeling) one cell line for another.

Quite easy for me to imagine how even the most astute colleagues can get blindsided, especially when the badness starts at the top.

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23. KissTheChemist on June 12, 2013 2:58 AM writes...

It takes a long time to build up a good reputation and a heartbeat to destroy it. The only way for GSK China to salvage any credibility here is a very thorough and public investigation and punishments of those at fault.

Oh, and is anyone buying the "oops, I made a mistake" line of one of the authors? Please.

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24. Previous Insider on June 12, 2013 9:12 PM writes...

Typically, it seems Zang as corresponding author did not know the details of the paper, but the mistake is from the first authot who wrote the paper.
please follow the link for newest update:
http://blogs.nature.com/spoonful/2013/06/gsk-inquiry-reports-signs-of-possible-data-fabrication-in-multiple-sclerosis-paper.html

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25. Previous Insider on June 12, 2013 9:13 PM writes...

Typically, it seems Zang as corresponding author did not know the details of the paper, but the mistake is from the first authot who wrote the paper.
please follow the link for newest update:
http://blogs.nature.com/spoonful/2013/06/gsk-inquiry-reports-signs-of-possible-data-fabrication-in-multiple-sclerosis-paper.html

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26. Previous Insider on June 12, 2013 9:21 PM writes...

And the mistake is not kind of fabricating data, but of describing error due to manuscript updating, as declared by the real first author. Intersting!
like to hear more about the investigation.


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27. Anonymous on June 13, 2013 7:07 AM writes...

Ture was Zang instructed this project personally! Everyone in gsk China knows it.

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28. Hap on June 13, 2013 8:00 AM writes...

From the Nature website here:

Submission to a Nature journal is taken by the journal to mean that all the listed authors have agreed all of the contents. The corresponding (submitting) author is responsible for having ensured that this agreement has been reached, and for managing all communication between the journal and all co-authors, before and after publication.
The editors at the Nature journals assume that at least one member of each collaboration, usually the most senior member of each submitting group or team, has accepted responsibility for the contributions to the manuscript from that team. This responsibility includes, but is not limited to: (1) ensuring that original data upon which the submission is based is preserved and retrievable for reanalysis; (2) approving data presentation as representative of the original data; and (3) foreseeing and minimizing obstacles to the sharing of data, materials, algorithms or reagents described in the work.
Authors are required to include a statement of responsibility in the manuscript that specifies the contribution of every author. The level of detail varies; some disciplines produce manuscripts that comprise discrete efforts readily articulated in detail, whereas other fields operate as group efforts at all stages.

From this:

1) The corresponding author is responsible for knowing the details of the paper (he has to take responsibility for the paper and also verify that the data therein are representative). "I wasn't really paying attention" is not an appropriate response.

2) I am assuming that the "Contributions from Authors" did not include "I'm the head of research and my name gets on the paper whatever I do" (which is generally a violation of journal's authorship rules, anyway), and if so, he wasn't being honest there, either.

I'm sure the "the grad student/postdoc/peon did it" explanation would solve a lot of problems for some people, but I don't think I'd put much stock in that explanation if I were at GSK.

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29. Chemist18 on June 14, 2013 8:08 AM writes...

I was an Analytical Chemist at GW. When SKB took over (and that's what it was) the focus on doing the right thing became the focus on cutting costs.

Management was so out of touch from what we did day to day, a VP actually suggested we could save salary costs by hiring temps to "cut out our peaks".

I was proud to work for GW, that pride quickly eroded after the takeover, it evaporated completely after the condition of the Cedra site became known.

blueman asked about warning letters, etc. I know of a generic company (starts with an 'H') that has averaged one warning letter per year since 2009.

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30. Charles on December 30, 2013 3:00 PM writes...

Hmm it looks like your site ate my first comment (it was super long) so I guess I'll just
sum it up what I wrote and say, I'm thoroughly enjoying your blog.
I as well am an aspiring blog writer but I'm still new to everything.
Do you have any helpful hints for beginner blog writers?
I'd genuinely appreciate it.

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