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Elan and Wyeth Had Ties to Study's Authors

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.

Another Alzheimer's Test

Dr. Lon Schneider, an Alzheimer's disease expert and a professor at the University of Southern California's Keck School of Medicine, calls the omission of Harrison's financial connection to Elan and Wyeth a "nitpicking detail" because "everyone knows that Elan and Wyeth paid for the study."

Schneider believes that Elan and Wyeth are doing the right thing by trying to use the NTB as the test for their Alzheimer's drug bapineuzumab. The NTB is probably a more sensitive measure of cognition than the ADAS-cog, he says, and regulators, including the U.S. Food and Drug Administration, will be open to its use.

Given the novelty of the NTB, however, Schneider did say that Alzheimer's researchers will be more comfortable with bapineuzumab results from upcoming clinical trials that produce a positive signal on both the NTB and the ADAS-cog.

A positive result on the former but not the latter "would be a problem," says Schneider, because the data would be hard to conclude that patients are receiving real clinical benefit from the drug.

Last week, Eli Lily & Co. (LLY) announced the start of a large phase III study of its Alzheimer's drug, LY450139, which will use the ADAS-cog test as one of two co-primary endpoints.

Dr. Richard Mohs helped to invent the ADAS test in the late 1970s and early 1980s while working as a researcher and an expert in aging and Alzheimer's at Mount Sinai School of Medicine and the VA Medical Center in New York. Today, Mohs works as a neuroscience researcher for Lilly and is helping to oversee the company's LY450139 program.

"We chose to use the ADAS-cog for our cognitive primary endpoint because it has a long history of tracking the progress of disease in mild and moderate Alzheimer patients," said Mohs. "There is a lot of information out there about it, and it's the one instrument that is acceptable to all regulatory bodies."

Did Lilly choose to use the ADAS-cog test over the NTB because Mohs was one of its co-inventors?

"My first priority is to do the best study that we can," said Mohs. "If there was a good chance that something else was better than the ADAS-cog, we would be happy to use it."

Know What You Own: ELN operates in the pharmaceutical sector of the healthcare industry, and some of the other stocks in its field include Novartis (NVS), Pfizer (PFE), Johnson & Johnson (JNJ) and Merck (MRK). These stocks were recently trading at $50.80, -2.53%, $21.29, -0.28%, $65.59, -0.21% and $41.01, +2.52% respectively. For more on the value of knowing what you own, visit TheStreet.com's Investing A-to-Z section.

Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
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