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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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In the Pipeline

« Getting Smarter Already? | Main | Quick Note »

April 18, 2008

Cut It Out. Cut It Out Now.

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Posted by Derek

File this under “does no one any good”. As many of you will have seen, JAMA just published a report on various studies that Merck has conducted and published over the years on Vioxx. The conclusion was that the company basically wrote the papers, and then went shopping for well-known academic names as authors. No, this one isn’t going to be good for anyone involved.

There seems little doubt that this practice does go on. I’ve never been in a position to see it happen, but it’s been reported for years. There are whole companies whose business is “scientific writing and communication”, and some of these seem to be in the business of turning studies into manuscripts, with no mention of their work in the final version. (The JAMA article found evidence of this sort of thing as well).

Scientific authorship is a messy business, true, and there are a lot of journal articles whose entire list of authors might have trouble with a pop quiz on the details of the paper. It is, in my mind, perfectly acceptable for one or two people on the author list to do most of the writing, with everyone else contributing suggestions and revisions. That’s how every paper I’ve been on (or written) has been done. But the worst of these Merck cases look like a search for a lead author or co-author, which is just unacceptable.

At least one of the authors named in the article is disputing its conclusions. Stephen Ferris of NYU says that he was no figurehead, and calls the JAMA paper “egregious” for having done no follow-up with the people it names. I suspect that there will be others in his category – the JAMA offices are getting a lot of testy e-mails this week, I’m sure. Of course, even the guilty are going to be sending them, since no one wants acquiesce to the label of “paid shill for publication”.

And that’s the problem. I can believe that the JAMA authors (Joseph Ross of Mt. Sinai et al.) could have cast their net too widely as they dug through the piles of discovery documents from the Vioxx litigation. But, unfortunately, I can’t believe that all their examples are mistaken. Enough chicanery goes on with authorship in purely academic settings – I can well believe that it happens in industry/academic collaborations.

But that’s the problem right there: the idea behind such a collaboration is, at least partly, to lend credence to the study’s results. Rightly or wrongly, industry studies on marketed drugs are perceived as needing the help. It’s the money involved, of course. When an industrial group publishes a paper on cell physiology or on a new method for cleaning up palladium-catalyzed reactions, no one doubts the results. But when it’s something that might have a direct and immediate effect on millions of dollars in revenue, doubts naturally set in. They always will, even if the research is beyond reproach.

And that’s why this ghostwriting business just makes the problem worse. I haven’t seen anyone suggesting that the Merck studies themselves are bogus – they had damn well better not be – but by playing games with the external author list, the company invites suspicion. I’m willing to bet that many people outside our industry who have just read the headlines on this story have assumed that the results were cooked up, just like the authorship. This is not what the industry needs. It never has been, and we need it less now than ever.

If we’re going to win back the trust of the general public – which we’ve lost, in case anyone hasn’t noticed – we’re going to have to cut out the shortcuts, stop the doubletalk, and act as if what we’re doing (drug discovery) is something to be proud of. Sure, this is a business – we sell improved health for money, and since it sure costs money to do it, there’s nothing in that transaction to be ashamed about. So why are we acting as if the only way to do business is under the cover of darkness?

We’re not going to have much of a business if these practices keep going on. Want price controls, real industrial-strength ones? Want lots and lots of marketing restrictions? Want the FDA to raise the bar for approval to levels never before seen? Want flocks of lawyers beating their wings, circling around our every move? Just keep it up, just keep this stuff up. We’ll get all that and more.

Comments (19) + TrackBacks (0) | Category: The Dark Side | The Scientific Literature | Why Everyone Loves Us


COMMENTS

1. milkshake on April 18, 2008 8:28 AM writes...

I ended up on one paper of which I did not know the content before it was published - it was a biology/PK group writeup on our clinical candidate that ended-up shelved as a backup. (I worked on the series but did not make the actual final compound and no SAR or chemistry was discussed in the paper, just the PK/activity profile). This happened after the site was closed so the communication between all people on the paper was more complicated. But at least the first author on the paper should know whats in it and how the numbers were obtained. Ghost-writing papers becomes deadly serious when it concerns the interpretation of the clinical studies.

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2. sroy on April 18, 2008 8:29 AM writes...

I thought that supressing data that Vioxx was linked to a 3 fold increase in mortality (as opposed to placebo) in AD patients was the bigger news.

Ghostwriting is dishonest, but hardly dangerous as long as what is reported is close to the truth. Supressing damaging mortality data on the other hand- is not just bad science, but legally problematic.

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3. MTK on April 18, 2008 8:49 AM writes...

While I agree that this looks terrible and is yet another black eye for the industry and Merck in particular, my initial thought as somewhat of a scientific insider was "Keep moving. Nothing to see here." All of us know plenty of instances where the asterisked name had little or nothing to do with a paper or grant, either in conception, planning, execution, or writing. Their sole contribution was their name and the credibility (and money) it brings. Many of us know first hand of groups where the advisor isn't much more than a figurehead and spellchecker.

I'll admit, however, that some of the examples cited here clearly cross the line of acceptability. I think it's one thing to write something and have your advisor sign his name to it, it's a completely other thing to go on a PI fishing expedition. But it happens. The sad part is that none of this would have come to light if things had not gone so awry. Usually, it's a no harm, no foul attitude. (Another instance where things went bad is the case of Dr. Gerard Schatten who was a senior co-author of Prof. Hwang's fabricated stem cell work.)

It's one of the dirty little secrets of science.

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4. NHchem on April 18, 2008 9:02 AM writes...

I went to a small school and was the first in my family to go to college thus the first to go to grad school. I had no idea of the politics in chemistry. My published papers could have been increased by a factor of 5 if my adviser took the route that most labs do which is to publish letters and divide the papers up.

I saw many instances where people are added to the authorship and they did nothing. I have also experienced being completely left off of publications (such is life when you leave a company....).

Add to that highly respected scientists whose students shared with me information regarding similar projects and was told that his boss informed him NOT to report an observation that I spoke about since it ruined their "story".

Chemistry is way too political as far as pedigrees and such. It is sad......

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5. CMC guy on April 18, 2008 9:41 AM writes...

It is a pretty poor practice to be sure when one of the authors have little or no actual contribution to a paper. I have also seen it happen on Patents where a Lab Head gets added although had no real scientific involvement or a person who did related work that was unsucessfull got put on as a reward. Makes me think that just like clincial studies that don't work there is a tendency for chemists to not publish experiments that did not work out which is unfortunate as those can be most interesting or value to others.

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6. CMC guy on April 18, 2008 9:54 AM writes...

A second thought on Patents is that maybe I mayself have been guilty of having a lawyer ghostwrite since after all the legal jargon and other verbage is put in it can be hard to recognize the lab work ;)

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7. MTK on April 18, 2008 11:16 AM writes...

CMC,

I'll absolve you on the patents. You're not claiming authorship, just inventorship.

NHChem, I hate to break it to you, but what you're observing isn't chemistry specific. It's called life. Anytime more than 3 people are involved in anything, there's politics. Don't despair, however, I firmly believe you can't keep talent down.

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8. milkshake on April 18, 2008 12:23 PM writes...

Talent grows like weed in the corporate hothouse: you don't want to keep it down - you uproot it as soon as you find it, before it ruins your whole crop of flowcharts.

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9. anon on April 18, 2008 12:48 PM writes...

NHchem,

"...boss informed him NOT to report an observation that I spoke about since it ruined their "story"..."

Do you not think that this is more indicative of a publish or perish academic environment? Also, it's difficult to publish results where nothing worked!!! In fact we tend to call these failures rather than results, less interesting but true nonetheless.

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10. NHchem on April 18, 2008 3:15 PM writes...

Politics are everywhere and that is life but to be told that your work is good but you don't have the right pedigree is a tad disheartening. That said, you are absolutely correct that talent does rise and fate has a wonderful way of working itself out.

As to publish or perish, all I can say is that noting that a compound decomposes within two weeks when stored in glass as opposed to nalgene is something that any decent chemist would put forth. It does not hurt the story. Then again, high powered types don't care about the technical details that help other chemists- now, that, is just life as well ;-)

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11. S Silverstein on April 18, 2008 4:25 PM writes...

So why are [some] acting as if the only way to do business is under the cover of darkness?

Greed, ego and other character flaws.

Permalink to Comment

12. geoffrey barton on April 18, 2008 7:53 PM writes...

Ironic that this data hits the news the same day as the Rand Corporation "study" on mental health problems for returning vets. I looked up who is on the board at Rand and saw Rumsfeld and Rice and other lesser luminaries. Then I saw the Major Client" listing included several pharmaceutical giants like Eli Lilly (Prozac and antipsychotics). Of course the co-athor of the "study" was Lisa Jaycox, a long time apologist for the drug companies who pushes pills whenever and where ever she can. They've wrung out our tears to get us to pay for drugging our school children and now they're after the next huge cash-cow, our veterans. I'm certain this "study" included data from ghost-written studies by the usual cast of suspects. I think these entire drugging, lying, falsification and obfuscation tactics are the just tip of the Enron sized iceberg.

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13. SRC on April 18, 2008 9:09 PM writes...

Thanks for the "analysis," Geoff.

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14. drug_hunter on April 19, 2008 8:40 AM writes...

I am not familiar with Lisa Jaycox's work. Is this the person? Can you point to a specific example of her long-time apologism?

rand.org/media/experts/bios/jaycox_lisa.html

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15. biohomber on April 20, 2008 12:10 AM writes...

Derek,
From what I understand from some follow-up of the JAMA article, the authors of the article seem to have some self-serving association with trial lawyers involved in litigation against Merck. Is this a little bit of the "pot calling the kettle black" in the JAMA article? Merck issued a response- http://www.merck.com/newsroom/press_releases/corporate/2008_0415.html - which if correct, suggests that lawyers have used JAMA in much a similar mode as they are accusing Merck of doing...

And in addition, does not some of the responsibility also lie with the MDs that went along with the authorship of articles written by unacknowledged authors?

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16. Terry Finley on April 21, 2008 7:13 PM writes...

That's what happens in
a publish or perish society.

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17. tgibbs on April 22, 2008 4:13 PM writes...

I have some ethical concerns about the article itself. I certainly would not consider it to be any kind of scientific publication. We are basically asked to take the authors' word about how substantial the contributions of the various listed and unlisted authors might be--and the authors of the paper have a past financial relationship with plaintiff's lawyers, and presumably can look forward to further such work in the future if their employers are happy with them. No metrics are provided, and there are "absence of evidence equals evidence of absence" statements such as "we found scant documentary evidence that the recruited authors were involved in the design or conduct of the study or made substantive contributions to the manuscript beyond minor editing." What was the criterion for "substantive?" Number of changes? How many changes constitute substance? And the way the authors use loaded words such as "ghostwriting" or "guest authorship" seems to come very close to assuming the conclusion.


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18. Know what amine? on April 24, 2008 11:25 AM writes...

Would this be a candidate:

doi:10.1016/j.bmc.2008.02.040

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19. WEL on September 29, 2008 3:16 PM writes...

MAXIDEX WARNING

I had eye surgery and in the post-op pack was MAXIDEX(dexamethasone) drops by ALCON LABS.

Two days later I was BLIND

Use Google and enter EPOCRATES MAXIDEX REACTION to verify

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