Medical ghostwriting and the role of the 'author' who acts as the sheet.

This week the New York Times reported on the problem of drug company-sponsored ghostwriting of articles in the scientific literature:

A growing body of evidence suggests that doctors at some of the nation's top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies -- articles that were carefully calibrated to help the manufacturers sell more products.

Experts in medical ethics condemn this practice as a breach of the public trust. Yet many universities have been slow to recognize the extent of the problem, to adopt new ethical rules or to hold faculty members to account.

The last time I blogged explicitly about the problem of medical ghostwriting, the focus on the coverage seemed to be on the ways that such "authorship" let pharmaceutical companies stack the literature in favor of the drugs they were trying to sell. Obviously, this sort of practice has a potential to deliver "knowledge" that is more useful to the health of the pharmaceutical companies than to the health of the patients whose doctors are consulting the medical literature.

This time around, it strikes me that more attention is being paid to the ways that the academic scientists involved are gaming the system -- specifically, putting their names on work they can't legitimately take credit for (at least, not as much credit as they seem to be claiming). When there's a ghostwriter in the background (working with the company-provided checklist of things to play up and things to play down in the manuscript), the scientist who puts her name on the author line starts moving into guest author territory. As we've noted before, guest authorship is, at its core, a deception.

Deception, of course, is at odds with the honesty and serious efforts towards objectivity scientists are supposed to bring to their communications with other scientists.

Back to the New York Times article:

Like many of the universities, N.I.H. appears reluctant to tackle the issue. A spokesman said the agency was committed to maintaining objectivity in science. But he added that in the case of ghostwriting allegations, universities and other institutions that employ researchers are responsible for setting and enforcing their own ethics policies.

"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."

It's an interesting question how useful an agency's commitment to maintaining objectivity in science when, faced with a publishing practice that is actually happening and that arguably poses a significant risk to objectivity in the scientific literature, that agency can't be bothered to do something about the researchers it funds who participate in this practice. Passing the enforcement buck to universities and other employers seems like a pretty weak commitment. (And yes, I understand that at the moment the NIH is strapped for cash, but don't you think universities are, too?)

But what do we know about the medical ghostwriting in question this time around? Again, from the New York Times article:

The documents offer a look at the inner workings of DesignWrite, a medical writing company hired by Wyeth to prepare an estimated 60 articles favorable to its hormone drugs. In one publication plan, for example, DesignWrite wrote that the goal of the Wyeth articles was to de-emphasize the risk of breast cancer associated with hormone drugs, promote the drugs as beneficial and blunt competing drugs. The articles were published in medical journals between 1998 and 2005 -- continuing even though a big federal study was suspended in 2002 after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer and heart disease.

Wyeth has changed its policy in the years since the hormone papers were published, according to Douglas Petkus, a company spokesman, and now requires that scientific articles acknowledge any participation by Wyeth or a Wyeth-sponsored writer. Some leading medical journals have also beefed up their disclosure policies for authors.

Some of the authors of the Wyeth hormone articles played significant roles in the work, while others made minor changes to drafts that were prepared for them, the documents show. But, in the main, the articles did not disclose that they had been drafted by outside writers paid to advance the drug company's views.

In a nutshell, we have scores of articles in the scientific literature masquerading as the objective reports of authors committed to communicating what their research actually demonstrated, not what they (or their corporate funders) wish it had demonstrated. The lack of disclosure here makes it much harder for the people reading these papers to suss out the kinds of bias that might be affecting the authors' reports here. Indeed, the folks reading these papers don't even have an accurate read on who participated in writing the papers.

This practice thus hobbles the scientific communication on the reader's end of things. Plus, to my eye it looks a lot like cheating on the part of the authors attaching their names to the paper without doing all the work that typically goes along with authoring a scientific paper. Since the scientific papers you author are part of what is tracked to "keep score" of your job performance at a university, universities whose faculty members are participating in this sort of practice have an interest in cracking down.

Not that these universities are necessarily moving to deploy the resources necessary to crack down, at least until someone calls them on their lack of concern:

In December, for example, Mr. Grassley released documents indicating that DesignWrite had drafted an article that was published under the name of a gynecology professor at New York University School of Medicine.

Eight months later, a spokeswoman said the school had not looked into the matter.

"If we had received a complaint, we would have investigated," said Deborah Bohren, the vice president for public affairs at New York University Langone Medical Center. "But we have not received a complaint."

She added N.Y.U. never condoned ghostwriting and was now drafting a written policy to that effect. Faculty members, however, are responsible for the integrity of their own work, she said.

NIH says universities are responsible for setting and enforcing their own ethics policies. The NYU vice president for public affairs says faculty members are responsible for the integrity of their own work. Isn't it interesting how the assumption is that somehow, someone else in the chain will make sure bad things aren't happening? The tiny flaw in that assumption is that a faculty member who has something to gain by cheating -- and who has ample reason to believe the chances are good that she can get away with this kind of cheating -- might not be the best guarantor of the integrity of her own work.

Not that the "authors" who play the role of the white sheet to the pharmaceutical company ghostwriters would necessarily characterize their own behavior as cheating:

In one measure of the extent of the problem, the medical school of a single university, Columbia, is home to three professors who were authors of Wyeth-financed articles. The three are also recipients of N.I.H. grants, according to the letter from Mr. Grassley.

A spokeswoman for Columbia said that Dr. Lee Goldman, the dean of the medical school, who is not among the professors linked to Wyeth articles, was not available for an interview because he was out of the country. She did not answer a query seeking comment from Columbia.

One of the authors discussed in DesignWrite documents is Dr. Michelle P. Warren, 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 -- contributions not reflected in the court documents, she added. She said that it was a mistake not to have disclosed the writers' payment and affiliations in the acknowledgment; articles published today involve more detailed disclosures, she said.

DesignWrite scoured the scientific literature on hormone therapy for the article, she said. "I would never undertake this without some help," said Dr. Warren, who is the Wyeth-Ayers Professor of Women's Health at Columbia. "It's too much work. I am not getting paid for it."

Perhaps Dr. Warren has forgotten that the academic scientists who create much of the scientific literature are not getting paid specifically for the tasks that are a normal part of writing a good scientific paper. They don't have a standard billing rate for their literature search, nor designated charges for proofreading or answering reviewers' questions about their submissions. They are employed as academic scientists, and contributing to the literature in their field is part of their job. If a particular piece of research and writing is "too much work" relative to the expected return (in terms of credit towards retention, tenure, and promotion, the help it is expected to give in making the case for funding, raising their profile in their professional communities, etc.), academic scientists are well advised to take a pass on the project.

I'm guessing, though, that Dr. Warren felt she was getting something by being listed as an author on this article, even though she did not do the work that an author normally does (and thus could not vouch for that work having been done honestly and objectively). If someone offers you a relatively big reward for a relatively small effort on your part, it might be worth asking what they are getting out of your involvement. Otherwise, you risk offering yourself up as a tool to further their agenda.

If that agenda amounts to misleading other members of your scientific community about what we know and with what confidence, your relatively big reward may not be enough to compensate for the loss of credibility you, the willing tool, may experience if you're caught.

And, as I've written before, ghost written articles in the scientific literature cannot be presumed to be a minor thing:

Let's be clear: There are articles in respected medical journals whose content has been spun by authors who didn't do any of the research but did get paid by drug companies with a financial stake in the research outcome reported. And, the names of these authors don't appear on the papers whose substance they have materially altered. Which means, of course, that it's really hard to hold these authors responsible for the content, since they are invisible to the other scientists relying on these published articles as sources of reliable information. ...

Scientific knowledge is only as good as the scientists who stand behind it. Ducking behind it is usually a bad sign.

I do hope scientists in the relevant fields are keeping track of the authors of record on these ghostwritten papers. Even if funding agencies and universities are unwilling or unable to deal with enforcing ethical standards on the scientists they fund or employ, other members of the scientific community can surely communicate to their peers that this kind of dishonesty is a problem, and that people who participate in it are hurting their own credibility and that of their scientific discipline.

Otherwise, I reckon this kind of thing will keep happening until the government and the public have lost all their faith in the scientific literature and the scientists who create it.