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Who authors drug studies?
A disturbing article in the most recent issue of JAMA (The Journal of the American Medical Association) suggests that the practice of ghostwriting medical studies is widespread. How it works is that a big drug company writes a study touting the merits of its latest drug. Then the company hands off the study to a prestigious researcher who agrees to be listed as the author. This adds a veneer of scientific credibility to what is basically corporate propaganda.

The dupes in this entire process are the patients who are convinced to shell out big bucks for medicine that's either worthless or actually harmful (such as Vioxx).

The drug companies, of course, claim this isn't how it works at all. The International Herald Tribune notes:

Merck acknowledged Tuesday that it sometimes hired outside medical writers to draft research reports before handing them over to the doctors whose names eventually appear on the publication. But the company disputed the article's conclusion that the authors do little of the actual research or analysis.

I wonder, do the drug companies expect anyone to believe them anymore?
Health/Medicine
Posted by The Curator on Thu Apr 17, 2008


With all the "side effects" of todays pharmaceutical drugs, i.e. ED, Why would ANYBODY take a prescription drug these days??? My brother started with ONE medication for blood pressure, and after all the side effects of "this and that", he's taking six meds... PLUS one for ED (Viagra)... Screw the meds, I'd prefer to "die of NATURAL causes"...
Posted by Christopher  in  Warm, sunny Florida...  on  Thu Apr 17, 2008  at  07:07 PM
I know that "blame the drug companies" is in vogue right now, but your post comes off as horribly ignorant. There might be problems here and there but "ghostwriting" technical documents is common and practical.

Clinical trials necessarily involve a collaboration between a pharamceutical company and doctors. Doctors feed back summarized results to the company, who pass them on to technical writers. The job of the technical writer is to organize the information into formats required by various journals or disciplines - a doctors' time is better spent on other things. The draft is passed back to the doctor(s) in charge of the research who add their name to the publication as a stamp of approval, usually following substantial revision.

If, in fact, a doctor attaches his name willingly to research with which he has no involvement, professional ethics would find fault with the individual doctor and not the drug company.
Posted by Irene  in  Beaverton, OR  on  Thu Apr 17, 2008  at  07:09 PM
Note that the technical writer's name is not attached to the document because he/she made no material contribution to the research therein. Otherwise the practice is little different than the near universal practice of grad students/post-doctoral fellows writing papers on behalf of their professors.
Posted by Irene  in  Beaverton, OR  on  Thu Apr 17, 2008  at  07:10 PM
Irene said:

"I know that 'blame the drug companies' is in vogue right now, but your post comes off as horribly ignorant. There might be problems here and there but 'ghostwriting' technical documents is common and practical."

So, the fact that it's common makes it ethical? Two wrongs (or a hundred or a thousand) make a right? No one is questioning how "common" or "practical" this is (shady techniques are usually practical which is why they're employed). We're questioning the ETHICS here.

"If, in fact, a doctor attaches his name willingly to research with which he has no involvement, professional ethics would find fault with the individual doctor and not the drug company."

So, it's unethical to TAKE money for pretending to have written a scientific paper but perfectly ethical to PAY money to that same person to do that? Fascinating.

Irene, which pharmaceutical company do you work for?
Posted by Cranky Media Guy  on  Thu Apr 17, 2008  at  08:47 PM
Hey, Cranky... You're good...
Posted by Christopher  in  Warm, sunny Florida...  on  Thu Apr 17, 2008  at  09:11 PM
Irene, my first job was actually as a pr agent for the biotech industry. And that experience gave me enough of a window onto the industry to convince me that Big Pharma executives are the lowest form of life on this planet. I find it very hard to give Big Pharma the benefit of the doubt in this case.

Luckily, I got out of that racket and am now making a more honest living writing about hoaxes and the odd things scientists do. wink

Anyway, if you read the IHT article, you'll see that in some cases the Pharmaceuticals hadn't even decided whom to farm out the articles to after the articles were written. So it doesn't seem to be a case of collaboration between pharmaceuticals and doctors. It's a case of scientists rubber-stamping dodgy research. And patients pay the price.
Posted by The Curator  in  San Diego  on  Thu Apr 17, 2008  at  09:29 PM
To Cranky -

I am a Ph.D. scientist working in the electronics industry. We use technical writers to write our patent applications which we then attach our names to. The technical writers receive no credit because they were not materially involved in the research. This is roughly equivalent to the sinister plot that you accuse the pharmaceutical companies of.

Why don't I write the things myself? Simple economics: my time is worth too much. A decent technical paper or patent can take thirty to fifty hours to prepare plus time spent formatting and revising in response to peer review. This sort of time-intensive work is best left to cheap labor e.g. graduate students or technical writers. Instead of spending fifty hours of my time prepping a paper I spend two hours revising it. At the end of the day it's my name on the patent, not theirs. Ethical? Sure it is. It's my idea and my data. These folks just organize it to make it presentable.

IF it were implied that the doctors listed as authors were either (a) listed without their permission, (b) paid exorbitant sums to "look the other way" or the like we'd have an ethical issue on our hands. But that's just not the case. Of the doctors interviewed in the IHT article, all three emphatically stand behind the research that bears their name while admitting that they did little of the grunt work of writing.

I'm not saying that pharma companies are some shining example of ethics, but I think you're barking up the wrong tree on this one.
Posted by Irene  in  Beaverton, OR  on  Thu Apr 17, 2008  at  11:56 PM
To Alex -

I think that the article is talking about principal authorship, meaning which of the contributors is listed as the primary contact for the research. This is always a dicey question, even in academia, especially in cases where multiple professors or otherwise "principal investigators" are concerned.

I've published a dozen papers or so in my day and with each one I struggled with who to include and who not to include as an author. In the realm of scientific publications authorship means something different than "the guy who did the writing". A list of authors includes folks who made real, material contributions to the research with regards to novel ideas, experimental design, or data analysis. Science being a largely collaborative effort, whether to include someone as an author or not is completely subjective, as is who to designate as the principal author or contact. Practices vary widely among different institutions and disciplines.

In the case of clinical trials there might be several dozen doctors involved over the course of several years. It's not customary or practical to include them all and choosing which of these physicians to include as the "principal" author is necessarily arbitrary.

Are there potential problems with this? Sure. The pharma company might lure physicians with lots of money or do some sort of "venue shopping" to find a pharma-friendly doctor but there's no evidence in the IHT article that this is taking place. It's not even implied. The only accusation is that the guy whose name is on the paper isn't the guy who actually keyed it into the computer.

Put differently, the reason that Reuters finds this practice sinister and that you mistakenly classify it as a hoax is because few people outside of the sciences have little insight into how these things actually work. If you want to go after direct-to-doctor marketing tactics or design flaws in specific clinical trials be my guest. But, like CMG, you're barking up the wrong tree with this one.
Posted by Irene  in  Beaverton, OR  on  Fri Apr 18, 2008  at  12:08 AM
If any one was saying to me: hey, Raoul, take the drug test, okay? I would say, No, the dog ate my home work. That would not be good. I would have to say, Hey, my dog is sick, he took the drugs. And then Raoul would be in the trouble. That is not fair to me, okay? First the moles, now the dogs. What it is up with it, Yo? That sounds cool, right? Rrrraoul
Posted by Raoul  on  Fri Apr 18, 2008  at  01:50 AM
I am with Irene to some extend. She is right in what she says about how a list of authors comes to be established and that they can have had very different roles from writing.

(I am shocked however that she says 30 to 50 hours investment in writing a paper is "best left to cheap labor e.g. graduate students or technical writers" because her "time is worth too much". That is certainly not the spirit of my own field of science. A paper is the ultimate outcome of your work as a scientist, therefore it deserves investment just like the actual research does)

I think a much more serious problem is how pharmaceutical companies influence what is and what is not published because many scientists doing drug research can do so only by grace of the money from pharmaceutical companies - there is an unhealthy dependance there.
Posted by LaMa  in  Europe  on  Fri Apr 18, 2008  at  02:20 AM
Actually, I believe it is The Biological Accord Demonstrating Medical Advances Magazine And Journal of the American Medical Association (or BADMAMAJAMA)that has been involved in the testing and grading of the tetr- oh, wait, no sorry, that's something else. My bad. Carry on
Posted by Hairy Houdini  on  Fri Apr 18, 2008  at  04:21 AM
Irene said:

"I am a Ph.D. scientist working in the electronics industry. We use technical writers to write our patent applications which we then attach our names to. The technical writers receive no credit because they were not materially involved in the research. This is roughly equivalent to the sinister plot that you accuse the pharmaceutical companies of."

I think that's a false analogy, Irene. In the case of your industry, the tech writers essentially summarize the work produced by other people.

In the case of the pharmas, the docs who pretend to "author" the papers had NOTHING to do with the work. Basically, it's the opposite of what you say goes on in your industry.
Posted by Cranky Media Guy  on  Fri Apr 18, 2008  at  04:36 AM
Rather than rely on Reuters or the Herald Tribune, I invite people to read the JAMA article here:

http://jama.ama-assn.org/cgi/content/full/299/15/1800

In at least some cases it looks like CMG is right when he says 'the docs who pretend to "author" the papers had NOTHING to do with the work': from the article:

'When publishing their own clinical trials (designed, conducted, and sponsored by Merck), ... Merck scientists often work[ed] to prepare manuscripts and subsequently recruit[ed] external, academically affiliated investigators to collaborate on the manuscript as guest authors. For instance, trial 078 ... was designed and conducted principally by scientists at Merck... [T]he trial itself and the analyses were complete before the academically affiliated investigators were involved in the manuscript.'

Also:

'Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support.' (my emphasis)

So not only was there (allegedly) a practice of ascribing work to external doctors post hoc, but those doctors failed 'in 50% (36 of 72) of review articles [to publish] either a disclosure of Merck sponsorship or a disclosure of whether the author had received any financial compensation from the company.'.

Also:

<i>'The first author of [one] study [told] a New York Times reporter in 2005, "Merck designed the trial, paid for the trial, ran the trial . . . Merck came to me after the study was completed and said,
Posted by outeast  on  Fri Apr 18, 2008  at  05:15 AM
Didn't this happen in House? Someone asked him to support a drug that did exactly the same as another drug for twice the money, and he refused?
Posted by Nona  on  Fri Apr 18, 2008  at  07:38 AM
Anyone who knows about the drug industry will recognize the paid trolls who enter into the debate (some above).

Vioxx research was faked. The problem is that these authors are signing their name to fake studies about which they know nothing and have had no control, with missing data, altered statistics and selective findings (the bad ones left out). It is not just a problem of technical writing, which can be OK (sometimes).

This is a good blog that discusses some of these problems
http://scientific-misconduct.blogspot.com

(it is also worth reading about the background to this blog writer)
http://www.thejabberwock.org/wiki/index.php?title=Actonel_Case_Media_Reports
Posted by Carol Prince  in  NJ  on  Tue May 06, 2008  at  06:15 PM
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