The Ghostwriters, the Doctors and the NIH: Putting an End to Medical Articles Written to Sell Drugs

Last week we presented Stephen Colbert’s hilarious send-up of the not-so-hilarious news that Wyeth pharmaceutical company had hired ghostwriters to write 26 scientific papers about hormone replacement therapy.

These articles, which emphasized the benefits of taking HRT and de-emphasized the risks, appeared in medical journals between 1998 and 2005. No coincidence that sales of Wyeth’s hormone drugs, Premarin and Prempro, soared, reaching nearly $2 billion in 2001. Usage began to drop in 2002, when the Women’s Health Initiative, a study of postmenopausal women, found surprisingly higher risks of heart problems and breast cancer in women taking hormone drugs.

More than 8,000 women have since sued Wyeth, claiming the hormone drugs caused them to develop illnesses. Lawyers for the women uncovered the ghostwriting documents, which were made public after a request in court from PLoS Medicine, a medical journal from the Public Library of Science, and The New York Times.

Natasha Singer broke the Wyeth story in Times, and in an excellent follow-up she focuses on a connected problem: doctors at medical schools attaching their names to articles written on behalf of drug companies.

“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,” writes Singer. “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.”

Court documents (above) include a description of DesignWrite’s plans for developing, writing and placing articles commissioned by Wyeth.

The practice has attracted the attention of Sen. Charles Grassley (R-Iowa), who has led investigations into conflicts of interest in medicine.

Grassley wrote a letter to Raynard Kington, the acting director of the National Institutes of Health, a federal agency that invests more than $30 billion in medical research each year, most of which is awarded through competitive grants to researchers at universities, medical schools and other research institutions.

In the letter, which was obtained by The New York Times, Grassley identifies researchers at Columbia University and University of Maryland who were recipients of NIH grants and who have signed on to ghostwritten publications. The senator asks the NIH to clarify its current policy on ghostwriting with regards to NIH-funded researchers and institutions.

Singer writes that with many of the nation’s top doctors depending on federal grants, “attaching fresh conditions to those grants could be a powerful lever for enforcing new ethical guidelines on the universities,” but NIH has, up to now, taken the same hands-off stance as many universities:

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.

These revelations are startling, especially considering how rigorous, independent scholarship is at the very core of a university’s mission. Here’s another example:

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.”

Singer notes that Columbia instituted a new policy in January prohibiting “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.” It also 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.”

Smart steps, but Columbia is late to make amends. The impact of years of medical professionals and patients relying on biased data is unknown.

Go read the full article, which includes comments from bioethicists understandably alarmed by how all this affects the reputation of respected academics and institutions. Kudos, too, to artist Minh Uong, for the wonderful graphic of medical research in air quotes. It’s a sad but fitting metaphor for the lack of trust.