Wednesday, August 19, 2009

Ghostwriting Stays in the Spotlight

With Natasha Singer's article on ghostwriting appearing in the Health section of today's New York Times, this underhanded method of drug promotion is in the public spotlight as never before. Medical ghostwriting leaches out the confidence we have in the authenticity of medical research, because the articles are conceived and written by drug company marketers and their surrogates. But when they are published in the top journals, they look like serious reports of medical science, complete with the names of prestigious doctors who are dubbed "authors."

After you read the New York Times article, I suggest you read this very clever article by William Heisel, a two time Pulitzer finalist, who blogs on Reporting on Health, a project of the Annenberg School for Communication at USC. Heisel's focus is on the self-deluded ways doctors are rationalizing their partipation in medical ghostwriting. For example, Dr. Leon Speroff, a former professor of obstetrics and gynecology at Oregon Health Sciences University who allowed DesignWrite to put his name on a paper he didn't write, defended his bad behavior by saying that it was then "standard practice" to not disclose a drug company's involvement.

Comments Heisel:

Why is it when these researchers are caught with a drug company's hand playing them like a puppet, they pull the "standard practice" line? Standard for whom? Certainly not for the patients taking the pills and presumably not for the journal editors accepting the articles for publication. Perhaps this is something Sen. Charles Grassley, R-Iowa, should ask in a hearing. Speroff told the Journal Sentinel he had nothing to apologize for:

"There is nothing dishonest about it."


Speroff was quoted in this excellent investigative report on medical ghostwriting at University of Wisconsin written by--who else?--the incomparable John Fauber and Meg Kissinger of the Milwaukee Journal Sentinel, both of whom should be on the short list at the next awards meeting of the Pulitzer committee.

14 comments:

Gina Pera said...

Has there been any research done examining the amount of fallacious statements or "sins of omission" in these papers?

Isn't that an important factor here?

If this has not been done, why the outrage? Seems outsized to me.

Anonymous said...

I recall reading one study in the ophthalmology literature that compared industry-supported studies to nonindustry-supported studies in glaucoma. They found that the abstracts of the industry-supported often misrepresented the actual results of the study in some way (even though they were often accurately reported in the body of the paper). This is important because often abstracts are screened to determine if the paper is relevant to the searchers needs, and disturbing because it provides evidence of the collusion of journal editors in the corruption of the medical literature. While journal editors claim to be "shocked, shocked I tell you" every an example of industry manipulation of the medical literature comes forward, they can't possibly be so innocent. This is an aspect of the problem that deserves more attention.

Bernard Carroll said...

If it’s fallacious statements you’re looking for in ghostwritten articles, you need look no further than the ones with Charles Nemeroff’s name on them. Here is a well known example.

In 2006, Dr. Nemeroff pimped the drug Risperdal (risperidone) for treatment resistant depression in his own journal. Several KOL cronies were co-authors, along with employees of Janssen. The article made claims about the benefit of Risperdal that were later retracted under pressure from me and others. You can read about this episode at the urls given at the end of this comment.

Dr. Nemeroff and all his co-authors dodged responsibility for the false claims in this publication. It was as though these false claims arose by Immaculate Conception. Whatever. Nemeroff plainly did not do due diligence as “author” in identifying the fabricated claims that appeared under his name. These false claims stood out like a sore thumb to any reader who was awake. That tells you about Dr. Nemeroff’s standards of tradecraft. The appearance was that Janssen wrote the paper and the academics signed off on it.

Where is the harm in this behavior? The scientific literature is tainted. Depressed patients are fleeced for high priced drugs that give them insignificant benefit. And these patients are exposed to unnecessary risk of Risperdal-related side effects like weight gain, akathisia, and tardive dyskinesia.

http://hcrenewal.blogspot.com/2008/01/antipsychotic-drugs-for-depression.html

http://clinpsyc.blogspot.com/2007/12/key-opinion-leader-provides-false.html

Rich said...

I'm a physician and a medical "ghostwriter." I began my descent into sin when a colleague who couldn't put words on paper to save his life asked me to "look over" a review paper he was trying to write.

Well, doctors tend to be "picture straighteners" by nature. I took his original work - which was worthwhile and necessary but hopelessly unreadable - and bashed it into lucidity suitable for publication. Not hard.

But then I found out that one could get paid for doing this sort of stuff. Well, if HCFA (now CMS) wouldn't pay me what I'm worth for treating patients, I might as well get paid for doing something else at which I have an aptitude.

In more than a decade of functioning as a medical writer, I've never once "ghosted" anything, or saw anything ghosted at all. I've been asked to recommend particular authors for pharma companies strategic publications plans, and I've done so. I've also been steered by pharma companies to authors they'd like to see publishing on their products - almost always clinical investigators who've done work on those products and who are therefore eminently qualified to put their experience and thought in front of their colleagues by way of publications in the clinical literature.

The interaction between those of us who work as medical writers - many of us physicians, nurses, pharmacologists, and people with doctorates and other advanced degrees in the sciences - and the authors whose names rightly belongs on those articles and textbook chapters we help to complete - is anything but "here, I'll write this, and you sign off when it's done."

I've pestered the authors with whom I've worked, and they've plagued me in return. The interaction is sometimes heated, even argumentative.

Well, hell. If you've ever had to sit through a hospital medical staff meeting, you know how it is. Raging ego meets delusions of grandeur. These authors put genuine skull sweat into every one of these manuscripts. They're the ones with the smarts; us medical writers are just the ones who know how to make the smarts show up on paper. But enough of that.

Remember, the people making the noise about this non-scandal are, respectively, professional politicians like Sen. Grassley and the editors of The New York Times.

Bear in mind that these congresscritters don't even read the bills they vote upon, much less write them themselves.

And as for The New York Times.... Well, can the reader remember a fellow named Jayson Blair?

Steven said...

Thanks for aggregating these articles. Most of us who read research articles don't have the time or inclination to verify their authors or assertions. The best we can do is wait for additional findings in support. We choose to trust or not. Whether or not the content can be trusted, the methodology illuminated here makes it easier to doubt, to embrace a broadly projected cynicism. Medical science writing becomes business propaganda labeled as scholarship.

Michael S. Altus, PhD, ELS said...

“It is therefore pertinent to look at an especially egregious ethical violation—the ghostwriting [actually, ghostauthoring] of research publications.” Brody H. Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry. Lanham, Maryland: Bowman & Littlefield Publishers, 2007, page 130.

Why did I change ghostwriting to ghostauthoring? Please read on.

Definitions:
(with enduring thanks to Tom Lang [for example, see www.amwancal.org/events/lang.html])

Author: One who has made substantial contributions to the CONTENT of an article and takes public responsibility (guarantorship) for it by being named on the byline.
For example, per the highly regarded and widely cited International Committee of Medical Journal Editors (“the ICMJE” as it is referred to in the trade) Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication (www.icmje.org): Authorship credit should be based on 1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.

Ghostauthor: One who has made substantial contributions to the IDEAS and CONTENT of an article but who is NOT named on the authorship byline. The instances of ghostauthorship that have attracted widespread attention occurred when pharmaceutical companies worked with medical education and communication companies (MECCs) to develop articles that conceal (do not disclose) the participation of those who qualify to be named in the authorship byline.

Guest author: One who lends (or sells, when paid to do so) his or her name as a byline author to increase the likelihood of publication. In other words, a MECC shops an article to a key opinion leader (KOL) for signature as an author. (“We’ll write it; you’ll sign it”.) The KOL is given control over the article, but has not contributed in other ways, such as described by the ICMJE.

Writer (presenter): One who has worked with an author to present that author’s ideas and content but who has NOT contributed to developing those ideas and content, and who is NOT identified as an author but IS identified in the ACKNOWLEDGMENTS for this assistance. Writers ought to be acknowledged.

Ghostwriter: One who has done the work of a writer but who is NOT identified in the acknowledgments

COMMENT: Please note the essential distinction between “ghostAUTHOR” and “ghostWRITER”, an important contribution of Tom Lang. This distinction is based on the crucial understanding that CREATION of content (authorship) and PRESENTATION of content (writership) are, in the sciences, two separate tasks. That is, in the sciences, the creation (authorship) can be differentiated from the presentation (presentation). In contrast, in the humanities, as in poetry, for example, creator (author) of a poem is expected to have actually written it.

Defined in this way, the furor is all about ghost AUTHORing and guest AUTHORing, and less so about ghostWRITING. That is, a pharmaceutical company works with a MECC to develop manuscripts (ghostauthoring) and then shop for KOLS to sign on as authors (guest authoring). The role of the pharmaceutical company and MECC authors is deliberately concealed (not disclosed). It does not really matter who actually wrote the words, although the writers themselves should be included in the acknowledgments. Furthermore, the money trail, such as pharmaceutical company paying a MECC, and in the instance of a freelance writer, the MECC paying the freelancer, should also be acknowledged.

Michael

Michael S. Altus, PhD, ELS
Intensive Care Communications, Inc.®
Biomedical Writing and Editing
altus@intensivecarecomm.com
www.intensivecarecomm.com

Michael S. Altus, PhD, ELS said...

Bernard Carroll wrote:
If it’s fallacious statements you’re looking for in ghostwritten articles, you need look no further than the ones with Charles Nemeroff’s name on them.

Dr. Carroll,

Would you please provide evidence that any of Charles Nemeroff’s articles were ghostwritten or ghostauthored?

Thank you.

Michael

Michael S. Altus, PhD, ELS
Intensive Care Communications, Inc.®
Biomedical Writing and Editing
altus@intensivecarecomm.com
www.intensivecarecomm.com

Anonymous said...

Dr. Altus:
Dr Carroll provided evidence in his prior post. See the link.

Bernard Carroll said...

No problem, Michael. Start with the infamous Cyberonics Vagus Nerve Stimulator (VNS) review that Nemeroff published in his own journal, Neuropsychopharmacology, in 2006. Sally Laden was the ghostwriter. Then you could look to the article I mentioned in my earlier comment, also published in Neuropsychopharmacology. That one is filled with ghosts, all desperate to become invisible when someone had to take responsibility for the false claims that appeared under their names. That’s just off the top of my head.

Anonymous said...

The ghost-writing tempest has been wonderful entertainment. We will now have less tendentious medical publications and a reordering of the medical universe as those less skilled at written expression will have less influence creating a vacuum for new talent.
Pity that Senators and Representatives only hold physicians to an ethical standard. Can you imagine a politician even reading their ghost-written legislation, much less contributing any prose to it?

Michael S. Altus, PhD, ELS said...

Dr. Carroll,

For those who would benefit of having background, I note the following: Vagus nerve stimulation (VNS) therapy refers to the implantation of a device into the chest to stimulate the vagus nerve. About 80% of the fibers in the vagus nerve transmit impulses from various parts of the body into various parts of the brain, including those that affect mood. VNS therapy, which was FDA-approved in 1997 to reduce seizures that are unresponsive to antiepileptic medications, was FDA-approved in 2005 for treatment-resistant depression.

An article, “VNS Therapy in Treatment-Resistant Depression: Clinical Evidence and Putative Neurobiological Mechanisms” (Nemeroff CB and eight others. Neuropsychopharmacology. 2006; 31:1345-1355) became the subject of considerable media attention during the summer 2006. The reason is that the article failed to cite 8 of the 9 authors' ties to Cyberonics, manufacturer of the VNS therapy device. The 9th author was a Cyberonics employee.

This Neuropsychopharmacology article included the following acknowledgment: “We thank Sally Laden for editorial support in developing early drafts of this manuscript. We maintained complete control over the direction and content of the paper. Preparation of this report was supported by an unrestricted educational grant from Cyberonics Inc.”

Because Sally Laden was identified in the acknowledgments for her editorial support, she was NOT, by definition, a ghostwriter. The acknowledgment should have noted that Ms. Laden was supported by Cyberonics. Regardless, I am unaware of any evidence that ghostwriting or ghostauthoring occurred in the development of this article. If there is any evidence, then I want to learn about it.

Now to the second article, Rapaport MH and 11 others, including Nemeroff CB. Effects of risperidone augmentation in patients with treatment-resistant depression: Results of open-label treatment followed by double-blind continuation.
Neuropsychopharmacology. 2006 Nov;31(11):2505-13.
ERRATUM in Neuropsychopharmacology 2006;31(11):2514 and in Neuropsychopharmacology 2007;32(5):1208.
COMMENT (by Carroll BJ) in Neuropsychopharmacology 2008;33(10):2546–2547
RESPONSE to Dr Bernard Carroll (by Rapaport MH) in Neuropsychopharmacology 2008;33(10):2546–2547

You wrote, “The appearance was that Janssen wrote the paper and the academics signed off on it.” Unfortunately, this appearance remains only your inference. It does not provide any evidence whatsoever for ghostwriting in which Janssen authored the article and the named authors signed off on it. I am unaware of any evidence that ghostwriting or ghostauthoring occurred in the development of this article. If there is any evidence, then I want to learn about it.

The problem with confirming an instance of ghostauthoring is that ghostauthoring is concealed, making it difficult to detect. “Smoking-gun” the evidence for ghostauthoring comes when documents in lawsuits against pharmaceutical companies are unsealed by the court.

One such instance providing evidence for ghostauthoring is summarized in a flowchart “Ghost Medical Writers, Working for Wyeth” (www.nytimes.com/interactive/2009/08/04/health/20090805-ghost.html). The “smoking-gun” documents themselves are available at “Documents: A Case Study in Medical Writing” (http://documents.nytimes.com/design-write-medical-writing#p=1)

Although we might disagree on definitions of ghostauthoring and other “g” words, and on whether or not ghostauthoring or ghostwriting took place in a particular circumstance, “.... all of us should take part in discussions of authorship ethics.”
Source: Witte FM. Authorship ethics: a clash of cultures. In: Witte FM, Taylor ND, eds. Essays for Biomedical Communicators: Volume 2 of Selected AMWA Workshops. Bethesda MD: American Medical Writers Association; 1997:93-101. (Available for purchase from AMWA at [www.amwa.org/default.asp?id=182].)

Michael S. Altus, PhD, ELS
Intensive Care Communications, Inc.®
Biomedical Writing and Editing
altus@intensivecarecomm.com
www.intensivecarecomm.com

Anonymous said...

The REAL scandal is that the legislation introduced by Senator Grassley and his cronies is routinely ghost written by lobbyists hired by corporations with an explicit interest in the legislation.

The hypocrisy is stunning.

I think that this area should be cleaned up. However, we need to distinguish between biomedical writers whose disclosed contributions make the literature more readable, and the uncredited, hired guns who "seed" the literature with "key messages" as part of an overall marketing plan and seduce academics looking to pad their CVs in hopes of academic promotion (publish or perish!) into participating.

I still find it interesting that no one wants to discuss the apparent collusion of journal editors in allowing this to happen. They can't be that naive.

Bernard Carroll said...

Hell, Nemeroff WAS a journal editor!

Anonymous said...

Nice rejoinder, Dr. Carroll. Your turn Dr. Altus!