“It’s rampant,” said Jim Szaller, a Cleveland lawyer who uncovered the evidence of ghostwriting in his work representing 8,400 women who are suing the drug company Wyeth for misrepresenting the benefits of hormone drugs. “This particular practice has to be stopped. It can’t continue, because patients are going to suffer.”

Paul Hebert, editor-in-chief of the Canadian Medical Association Journal, agrees. He estimates that he rejects between five to 10 pieces per year after discovering they have been secretly ghostwritten and paid for by pharmaceutical companies.

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“Just three days ago, I got a request to be the author of a ghostwritten article about the effectiveness of a cholesterol-lowering drug,” Dr. James H. Stein, professor of cardiology at the University of Wisconsin School of Medicine, said this month. “This happens all the time.” He declined to attach his name to the paper.

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Alison Bass visits the ghosts of Paxils past.

Excerpts from the comment thread of a New York Times article about ghostwriting among medical school professors.

Launch budgets can easily exceed $300 to $500 million. Madison Avenue firms write the ghost articles, drug reps target regional physician ‘opinion leaders’ who are compensated in creative ways to put their names on the articles. Later the drug reps coordinate numerous speaking opportunities for the ‘opinion leaders.’ A single rep might in a two to three day event usher the ‘opinion leader’ through 10 or so physician offices to speak directly to the ‘script writers’ in the rep’s territory. During the evening hours the ‘opinion leader’ addresses large gatherings of ‘script writers’ at dinners.

The really interesting thing is that the ‘opinion leader’ generally reads from a pre-written script and a deck of PowerPoint slides with which he has almost no familiarity. It is supposed to be his research. I have literally witnessed ‘opinion leaders’ read directly from the slides prepared in advance by the drug maker, then not be able to answer reasonable questions based on what he has read.

What is most striking is that no one in the audience seems to be shaken by this.

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Most physicians are barely literate and could not write a grammatical paragraph if their lives depended on it. As one friend of mine has said, “If you take out the writers, the medical literature would be gibberish.”

They also don’t have the time to do much writing. Medical writers are just writers — much like corporate or political speechwriters — who help the author get the words on the paper.

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Regardless of their technical brilliance, many medical and scientific professionals are poor writers. They need help to write well-organized, comprehensible journal articles.

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When a professor is handed a manuscript and they make a few phone calls or minor corrections, they have not met the standard of ownership. Placement of their name on the paper, and in some of these papers as the only name, is claiming property rights that have not been earned and is a form of plagiarism. It is up to their university to enforce the rules on academic misconduct and take appropriate action. If a few full Professors were stripped of their tenure, you would see this malignant process grind to a quick halt.

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That this could be considered acceptable and even the norm in academic medicine is an indication of the depth of corruption of the medical schools in the U.S.

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From the Associated Press:

Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.

… Known as the CASPPER program, the paper explains how the company can help physicians with everything from “developing a topic,” to “submitting the manuscript for publication.”

The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.

… According to ghostwriting expert Dr. Leemon McHenry, Glaxo’s program was unusually intertwined with its internal sales and marketing department.

“We know that GSK has engaged in ghostwriting for many years,” said McHenry, who works as a research consultant for Baum Hedlund. “But to create an internal ghostwriting program and have the gall to name it after a cartoon ghost demonstrates their juvenile attitude and careless disregard for patients.”…

What an irritable, judgmental remark on the part of McHenry. The man has no sense of humor.

America’s newspaper of record, and a high-profile senator, keep up the pressure.

But still nothing. And we need, once again, to ask why that is.  Why universities refuse to do anything about professors on their faculties who ghostwrite in medical research journals.

The New York Times has published yet another, even longer, exposé of faculty who do no work on articles to which they sign their name.  The true authors of the articles are drug companies who both shape the content of the articles and place them in journals read by prescribing physicians. 

The ghost professor essentially does nothing at all.  Nothing.  That’s why she’s called a ghost. She takes money from the company in exchange for allowing it to float her name over the article.  She often has little notion of what’s in the article. 

If she took the time to look, she’d find a whitewash.  An argument for the obvious superiority of the company’s drug over all competing drugs.  She’d find not a scientific article, but a commercial.

… [M]any universities have been slow to recognize the extent of the problem, to adopt new ethical rules or to hold faculty members to account.

Those universities may not have much longer to get their houses in order before they find themselves in trouble with Washington.

With a letter last week, a senator who helps oversee public funding for medical research signaled that he was running out of patience with the practice of ghostwriting. Senator Charles E. Grassley, an Iowa Republican who has led a long-running investigation of conflicts of interest in medicine, is starting to put pressure on the National Institutes of Health to crack down on the practice.

… “How long does it have to go on before it actually is stopped? One way to stop it would be if the actual authors were punished in some way,” said Dr. Carl Elliott, a professor at the Center for Bioethics of the University of Minnesota. “But the academics who are complicit in it all never seem to be punished at all.”

… [B]ioethicists said that medical schools must take responsibility for faculty members whose publications do not explicitly acknowledge the work of writers receiving industry support. Such subsidized articles allow pharmaceutical companies to use the imprimatur of respected academics — and by extension, the stature of their institutions — to increase sales of certain drugs, ultimately skewing patient care, they said.

… [T]he medical school of a single university, Columbia, is home to three professors who were authors of Wyeth-financed articles.

… Dr. Michelle P. Warren, [is] a professor of obstetrics and gynecology at Columbia. Her article was published in The American Journal of Obstetrics and Gynecology in 2004, when women feared that Wyeth’s brand of hormone drugs could be causing particular problems. The thesis of the article was that no one hormone therapy was safer than another.

The published article acknowledged help from four people. But it did not disclose that DesignWrite employed two of those people and the other two worked at Wyeth. Court documents show DesignWrite sent a prepublication copy to Wyeth for vetting and charged Wyeth $25,000 for the article, information not disclosed in the paper.

In a phone interview, Dr. Warren said the article was intended to clear up confusion over the risks of hormone drugs. She said she worked on the project in phone conversations and in meetings… [Way to publish scientific research, honey. Over the phone and in meetings. Hi, it’s Michelle! How much for putting my name on the article? … Sounds good. Go ahead. Presto -Warren’s 155th article this year. Raise and promotion for research productivity coming up.]

 … A new policy at Columbia took effect in January. It prohibits medical school faculty, trainees and students from being authors or co-authors of articles written by employees of commercial entities if the author’s name or Columbia title is used without substantive contribution. [Lots of wiggle room in substantive, so that’s worthless.]  The policy, which does not retroactively cover articles like Dr. Warren’s, requires any article written with a for-profit company to include full disclosure of the role of each author, as well as any other industry contribution.

But Dr. Elliott, the bioethicist, said universities should go further than mere disclosure, prohibiting faculty members from working with industry-sponsored writers. Policies asking only for disclosure “allow pharmaceutical companies to launder their marketing messages,” he said.

No, the laundry will continue to get done; the whitewashing will go on as always. A multi-billion dollar industry can afford a lot of detergent.

An Oregonian editorial about ghostwritten medical articles evokes the university subculture that produces professors with no compunction about taking money in exchange for having their names put on studies written not by them, but by corporations selling pills.

There’s seldom any indication that these ghosts have read the articles they’re pretending – in exchange for money from the pharmaceutical company – to have written.

The practice is widespread and will, UD predicts, never really end. An entire subsidiary industry — the businesses that actually write the ghostwritten article and then chase down corrupt professors to pretend authorship — has evolved to serve pharma’s need to give new drugs the appearance of scientific legitimacy. As long as journals play along, how will we ever be able to stop it?

A commenter on the editorial writes:

It is certainly unethical to add your name to a ghost written paper. Unfortunately, it really isn’t that rare – especially in these sorts of fields – to have everyone on the research team, from the post-docs to the Principal Investigator to all put their names on a paper, even though it would be physically impossible for all of them to have actually contributed to the writing (and implausible for them to have personally contributed to the research). So you often end up having a dozen or more authors and vitaes with a couple of hundred publications.

I recall that when I was a grad student I questioned my advisor adding his name to my paper. I got the response that I was lucky he was allowing me to keep my name on it. I didn’t ask any more questions after that.

Get the picture?

The Oregonian editorial adds:

A pharmaceutical company pays a writer to write a report touting a drug’s benefits, with the author “TBD” (to be decided). Then the company shops for a prestigious researcher to sign off on it and pump up the findings with institutional credibility. The results, published in a respected medical journal, often are widely disseminated in newspapers, magazines and medical blogs. If the news reverberates long enough in this echo chamber, the drug’s supposed benefits can become conventional wisdom.

… “This is actually putting your name on something without any firsthand knowledge about it,” explains Dr. Susan Tolle, director of Oregon Health & Science University’s Center for Ethics in Health Care.

The good news, Tolle says, is that this practice is being cleaned up. OHSU and other research institutions have cracked down on it. The bad news is that it continues to infect the journal literature that is still in circulation and has entered the mainstream of medical lore.

Prestigious researchers who loan their names — for a fee — to drug companies for such articles not only wind up duping patients but also other doctors and ultimately cast doubt on reports that are perfectly legitimate…

The editors call for an end to the practice, but again UD asks: How? The drug companies won’t end it — especially given the noises people are making lately about ending direct-to-consumer advertising of prescription drugs — and the journals are always going to be amiable dunces who understand where their advertising revenue comes from.

That leaves the universities whose halls the ghosts haunt. The universities who boast of professors who flit from industry-compromised continuing medical education outings, to undisclosed hawking of pills and devices, to the prostitution of their integrity in industry-compromised research journals.

We know from the farce of campus conflict of interest management that universities too will do nothing. How, precisely, can they crack down? Has any ghost lost her job? Suffered any penalty? Even been acknowledged – after her exposure in the press – as a ghost by her university?

That leaves the consumer.

Feeling her way alone, in the dark.

“These articles contributed to widespread prescription of hormones to women who did not need them, but who were put at risk of blood clots, breast cancer, and other adverse effects,” said Adriane Fugh-Berman, associate professor of physiology and biophysics at Georgetown University Medical Center, a pharmaceutical industry critic.

Adriane’s pissed because Wyeth, maker of the often unnecessary and sometimes dangerous hormones in question, wrote five articles, which reached hundreds of thousands of doctors, praising its own hormones.

Great hormones, if I do say so myself…

I mean, of course Wyeth didn’t reveal in the articles that it was praising its own hormones. That’d be nuts. People would dismiss the findings as advertising rather than science. Nor did the professors of medicine Wyeth paid to put their names on the articles reveal that they didn’t write a word of them. That’d be nuts too. Their reputations as scientists of integrity would go up in smoke.

These are polite people, these ghosts, and, like Gloria Bachmann, another Wyeth ghost, they went out of their way to thank the ghostwriting firm Wyeth paid to write the articles the ghosts didn’t write. (To clarify: The distinction here is between ghosts, who simply float about, and ghostwriters, who put the ghosts’ names on things the ghostwriters have written.)

Leon Speroff, one of the ghosts, wrote the following to his ghostwriters about the article he got paid to pretend he wrote:

“You did a super job of writing this paper – succinct and makes the points very well.”

Leon’s mother taught him to say thank you when he got a gift.

Leon’s mother forgot to tell him not to steal.

James Stein, a [University of Wisconsin] cardiologist, said he was approached twice in the last week to put his name on educational material for different drug companies. He said he turned down both offers because, “frankly, it’s plagiarism.”

“If an undergraduate did this, he would be expelled,” Stein said.

When a drug company puts a doctor’s name on an article that actually was written by a professional writer, it is able to present a more biased and promotional version of an issue as though it were coming from an independent source, Stein and others say.

The company’s ultimate goal is to sell more drugs, said Steven Miles, a physician and professor at the Center for Bioethics at the University of Minnesota Medical School.

“These ghostwritten articles are advertising masquerading as scientific reviews,” he said. “It’s dishonest.”

Forgot to tell him not to lie too.

Never too late to learn. Maybe Speroff is reading this.

My blogpal Bill links me to this New York Times article about professors who allow drug companies to put their names on articles the professors haven’t written.

The practice is immoral and dangerous, but no one seems to care.

… In 1997 … DesignWrite, a medical communications company in Princeton, N.J., proposed to Wyeth a two-year plan that would include the preparation of about 30 articles for publication in medical journals.

The development of an article on the treatment of menopausal hot flashes and night sweats illustrates DesignWrite’s methodology.

Sometime in 2003, a DesignWrite employee wrote a 14-page outline of the article; the author was listed as “TBD” — to be decided. In July 2003, DesignWrite sent the outline to Dr. Gloria Bachmann, a professor of obstetrics and gynecology at the Robert Wood Johnson Medical School in New Brunswick, N.J.

Dr. Bachmann responded in an e-mail message to DesignWrite: “Outline is excellent as written.” In September 2003, DesignWrite e-mailed Dr. Bachmann the first draft of the article. She also pronounced that “excellent” and added, “I only had one correction which I highlighted in red.”

The article, a nearly verbatim copy of the DesignWrite draft, appeared in 2005 in The Journal of Reproductive Medicine, with Dr. Bachmann listed as the primary author. It described hormone drugs as the “gold standard” for treating hot flashes and was less enthusiastic about other therapies.

The acknowledgments thanked several medical writers for their “editorial assistance,” not disclosing that those writers worked for DesignWrite, which charged Wyeth $25,000 to generate the article.

Dr. Bachmann, who has 30 years of research and clinical experience in menopause, said she played a major role in the publication by lending her expertise. Her e-mail messages do not reflect contributions she may have made during phone calls and in-person meetings, she said.

“There was a need for a review article and I said ‘Yes, I will review the draft and make sure it is accurate,’ ” Dr. Bachmann said in an interview Tuesday. “This is my work, this is what I believe, this is reflective of my view.”…

This filthy practice incorporates just about everything people rightly revile about some precincts of academia: Plagiarism. Fakery. Arrogance. Laziness. Cynicism (Wyeth was promoting drugs that turned out to be dangerous.).

People make fun of postmodernists by talking about the Postmodern Generator, a program that automatically generates articles full of obscurantist rhetoric. But that’s only generating words. Ghosting whores among our medical faculties are generating real sickness.

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Bachmann-Wyeth Overdrive.

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Still uncertain why this is filthy? Read Daniel Carlat’s post.

Alas, poor ghost!

Pity me not, but lend thy serious hearing
To what I shall unfold.

Speak; I am bound to hear.

So art thou to choler, when thou shalt hear.

What?

I am big pharma’s mouthpiece,
A paid tool of some drug’s maker,
A walking shadow, a money’d player
That smiles and signs his name upon a page.

I was forbid to tell the secrets of my counting-house,
But now good Grassley has them out. List, list, O, list!

O God!

… [A]nybody looking for a measure of [Ruth Madoff’s] integrity might do well to take a peek at her cookbook, The Great Chefs of America Cook Kosher. Published in 1996, the book lists Madoff and her friend Idee Schoenheim as executive editors. In truth, however, the work was done in its entirety by Karen MacNeil, a food expert who has been quoted as saying that Madoff “was interested in having her name on something that would allow for some sort of fun.” McNeil is listed as an editor.

In the grand scheme of things, claiming authorship of a ghost-written book is a minor offense, the kind of thing that will get one a window seat in an outer, more pleasant, circle of Hell; certainly, it pales beside the crimes of Ruth’s husband. However, a case could be made that someone who will lie about the small things may be inclined to lie about the big ones, and that someone willing to take credit for another person’s work has exploitative tendencies…

Ruth’s approach to publication has much in common with the approach of thousands of American medical school professors. They too are interested in having their name on something that would allow for some sort of fun.