An Alzheimer's disease research paper published last September inArchives of Neurology failed to disclose the financial ties that one co-author had to Elan and Wyeth as a paid consultant to the drugmakers, TheStreet.com reports.
The paper describes the use of a new test - the neuropsychological test battery (NTB) - to measure memory and mental status of patients with Alzheimer's disease. John Harrison was paid by Elan and Wyeth to create the NTB as a new cognitive test for their experimental Alzheimer's drug, bapineuzumab. You may recall that TheStreet previously noted that the drugmakers hope to convince regulators here and in Europe that NTB should be used as the basis to approve the med.
Wyeth and Elan have argued that the NTB 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. And to help make their point, TheStreet writes, the drugmakers 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, according to Adam Feuerstein, TheStreet's columnist. 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," Harrison wrote in an email to TheStreet. "This is clearly worthy of further investigation, and I will seek to discover why this statement was omitted."
One of the criticisms of Elan and Wyeth's efforts to push the NTB as a new approval standard for Alzheimer's drugs is that the drugmakers created the test specifically for use with bapineuzumab. Elan and Wyeth, therefore, have financial involvement not only in developing the med, but also in the test being used to evaluate bapineuzumab and in the research study that purports to show that the NTB is better than the widely validated ADAS-cog, TheStreet writes.
An Elan spokesman was asked to provide all independent research that validates the use of the NTB in Alzheimer's clinical trials, especially since the NTB has never before been used as the basis to approve an Alzheimer's drug. The only research cited by the Elan spokesman, however, was the Archives of Neurology paper, which concludes, "The psychometric properties of the NTB suggest that it may have particular utility in evaluating drug efficacy in clinical trials in which patients with mild Alzheimer disease are included."
There's much more, so please keep reading...