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.”