[Infowarrior] - Senator Moves to Stop Scientific Ghostwriting

[Richard Forno]

August 19, 2009
Senator Moves to Stop Scientific Ghostwriting
By NATASHA SINGER
http://www.nytimes.com/2009/08/19/health/research/19ethics.html?hp=&pagewanted=print

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.

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.

That is significant because the N.I.H., a federal agency in Bethesda,  
Md., underwrites much of the country’s medical research. Many of the  
nation’s top doctors depend on federal grants to support their work,  
and attaching fresh conditions to those grants could be a powerful  
lever for enforcing new ethical guidelines on the universities.

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.”

The full scope of the ghostwriting problem is still unclear, but  
recent revelations suggest that the practice is widespread. Dozens of  
medical education companies across the country draft scientific papers  
at the behest of drug makers. And placing such papers in medical  
journals has become a fundamental marketing practice for most of the  
large pharmaceutical companies.

“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.

Allegations of industry-sponsored ghostwriting date back at least a  
decade, to scientific articles about fen-phen, the diet drug  
combination that was taken off the market in 1997 amid concerns that  
it could cause heart-valve damage. But evidence of the breadth of the  
practice has come to light only gradually, most recently in documents  
released in litigation over menopause drugs made by Wyeth.

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.

Many universities have been slow to react to evidence about the extent  
of the practice. 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.

But bioethicists 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.

“To blow this off is not acceptable,” said Dr. Ross McKinney, the  
director of the Trent Center for Bioethics at Duke University Medical  
Center. Duke has a policy that prohibits ghostwriting and advises  
faculty to keep records of their participation in preparing scientific  
articles.

“Our ultimate responsibility is to provide good care, and research is  
the foundation of that care,” Dr. McKinney said. “Presenting  
information where the bias is not made clear is inconsistent with our  
mission.”

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.”

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. 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.