Updated from 6:59 a.m. EDTAn Alzheimer's disease research paper published last year in a prestigious medical journal failed to disclose the financial ties one of the co-authors had to Elan ( ELN) and Wyeth ( WYE) as a paid consultant to the drugmakers. The paper in the September 2007 Archives of Neurology, a journal published by the American Medical Association, describes the use of a new test -- the neuropsychological test battery (NTB) -- to measure the memory and mental status of patients with Alzheimer's disease. John Harrison, the consultant, was paid by Elan and Wyeth to create the NTB as a new cognitive test for the company's experimental Alzheimer's drug, bapineuzumab. As previously reported by TheStreet.com, Elan and Wyeth are seeking to convince regulators here and in Europe that the NTB should be used as the basis to approve bapineuzumab. The NTB, the companies have argued, is a superior alternative to the ADAS-cog test, the most well-known and widely used measure of cognition in studies of mild to moderate Alzheimer's patients today. To help make their point, Elan and Wyeth have cited the Archives of Neurology paper, titled "A Neuropsychological Test Battery for Use in Alzheimer Disease Clinical Trials," as independent, scientific proof that validates the NTB. Harrison is the lead author of that NTB paper, but his role as a consultant paid by Elan and Wyeth to create the test is not disclosed in it. Harrison is the only author of six listed in the paper's conflict-of-interest statement as having no financial conflicts with Elan and Wyeth. Harrison's five co-authors are all employed by Elan or Wyeth. "The drafts of our manuscript specifically included reference to the fact that I had received payment from both Elan and Wyeth, though for some reason this disclosure does not appear in the published manuscript," said Harrison in an email response to questions. "This is clearly worthy of further investigation, and I will seek to discover why this statement was omitted," he added.
Cindy Kuzma, spokesperson for JAMA/Archives, the publication arm of the American Medical Association, said the medical group was not aware of Harrison's financial connection to Elan and Wyeth. The Archives of Neurology's author guidelines state that the medical journal's "policy is one of complete disclosure of all relevant financial interests." The journal requires all authors to "to report potential conflicts of interest, including specific financial interests relevant to the subject of their manuscript..." Kuzma said JAMA/Archive editors, including JAMA editor-in-chief Catherine DeAngelis, would not comment publicly about the Harrison issue and said that a formal investigation into the matter could not be launched unless AMA/Archives received written documentation that Harrison was a paid consultant to Elan and Wyeth. Last month JAMA was forced to publish a correction about another case of unreported financial disclosures in its pages involving authors of lung cancer research who failed to disclose patents and pending patents related to CT scans.