Papers that bear academic scientists’ names as authors, but are ghostwritten by for-profit companies, may be disturbingly common in medical journals, a new study indicates. Some of the scientists accused of being involved in that practice deny any wrongdoing, but journal editors are already outlining measures to prevent future breaches of academic integrity.
In the new issue of The Journal of the American Medical Association,four scientists have published the results of a search of court documents related to the anti-inflammatory drug Vioxx, which has been withdrawn from the market because of concerns about its safety, and which has been the subject of hundreds of lawsuits.
The search revealed mentions of many articles that were published under academic researchers’ names but appear to have been written by others. And those others were employees of Merck & Co. Inc., which is the developer of Vioxx, or of medical publishing companies.
In one example, the JAMA authors compare the draft and published version of a paper about a clinical trial; the draft lists only Merck authors along with “External author?” as first author. The published paper has three external authors: one from the University of California at San Diego, one from New York University, and one from a contract research organization. (The Chronicle was unable to reach the New York University scientist, Steven H. Ferris; the researcher from San Diego, Leon J. Thal, died last year.) An e-mail message from one Merck scientist to another said, “I think you should be the first author since you have done virtually all of the writing.”
In an editorial accompanying the article, Catherine D. DeAngelis and Phil B. Fontanarosa, the editor in chief and executive deputy editor of JAMA, respectively, call researchers’ guest authorship “unprofessional and demeaning to the medical profession and to scientific research.”
The JAMA researchers, led by Joseph S. Ross, an instructor in geriatrics at Mount Sinai School of Medicine, searched a database of millions of documents provided by Merck for two Vioxx product-liability cases. (All four of the researchers had served as consultants to the plaintiffs in the cases.) Dr. Ross then analyzed individually each of the 20,000 documents that came up relating to authorship.
The researchers examined 96 articles that had been discussed in internal Merck documents before they were published. They found that papers reporting the results of clinical trials or reviewing data from multiple studies sometimes appeared to be written by employees of Merck or of publishing companies, and only later were given the names of academic authors.
In another instance, an e-mail message from Scientific Therapeutics Information, a medical publishing company, to Merck, lists eight manuscripts the publisher was preparing, “intended” external authors, and the journals the manuscript would be sent to. Dr. Ross and his colleagues identified seven published review papers that matched the list of eight, all with just one author listed. And, in each case, that author was from academe.
The Chronicle attempted to contact the seven authors; two responded, and both denied lending their names to a ghostwritten article.
One, A. Mark Fendrick, a professor of internal medicine at the University of Michigan, said that he worked with the medical publishing company to develop the outline but did the writing himself. He said he had no contact with Merck.
The other, Noor M. Gajraj, a doctor at Sherman Pain Care, in Texas, who used to be on the faculty of University of Texas Southwestern Medical Center, said in an e-mail message: “The article was written solely by myself, certainly without any help by a medical publishing company.”
Dr. Ross, however, called these explanations “hard to believe” in light of the documents he turned up. He added that he did not intend to impugn any single researcher or even Merck. “This is a widespread practice,” he said. “These just happen to be people whose behavior we had witness to because of the litigation documents. The point is that physicians in the scientific community need to come together and agree, This is wrong; this is not how science is conducted.”
(Another article in JAMA used the court documents to demonstrate that Merck produced data analyses suggesting higher death rates than the company revealed to the Food and Drug Administration or in published papers.)
In their editorial about the two Vioxx-document studies, Dr. DeAngelis and Dr. Fontanarosa call for “drastic action” including:
- Journals should require each author to specify the role he or she played in the research and writing, a requirement JAMA already has in place.
- Clinical-trial registries should include the name of the principal investigator.
- For-profit companies that sponsor research should not be primarily responsible for collecting and analyzing data, or for writing the manuscript.
- Any author who does not disclose financial conflicts of interest should be reported to his or her department chair or dean.
“Ensuring, maintaining, and strengthening the integrity of medical science,” the two editors conclude, “must be a priority for everyone.”