Did ties to Alzheimer's test maker sway NIH report?

Athena Neurosciences Inc. scored a coup last April, when an expert panel convened by the National Institutes of Health suggested that one of its tests for Alzheimer's disease was superior to rivals' tests in diagnosing the dementing illness. Athena wasted no time trumpeting the results to thousands of physicians.

The report "has been very, very good for us," says David Hanak, a product manager at Athena, noting that sales of the genetic test are up 28 percent this year.But in a flap that underscores the often-close ties between the pharmaceutical industry, government and academia, some Alzheimer's researchers are crying foul. Five of the panel's eight members had financial or research ties to Athena, a South San Francisco, Calif., unit of Ireland's Elan Corp. PLC. The panel's "consensus report," published in the journal Neurobiology of Aging, doesn't disclose these relationships. Some medical ethicists consider this a glaring omission.

In addition, Athena provided a $100,000 grant to fund the study and played a behind-the-scenes role in launching it. The company's unrestricted grant was disclosed in the report. But the nonprofit Alzheimer's Association, which used the funds to organize the panel on behalf of the NIH, now says it regrets accepting Athena's financial support.

"It interferes with the perception of the credibility of the statement," concedes William Thies, vice president for medical and scientific affairs at the Alzheimer's Association.

While agreeing that Athena's ties to the panel should have been disclosed, Dr. Thies, NIH officials, the editor of Neurobiology of Aging and several panel members all insist that each panel member was aware of the others' ties. They also stress that the views expressed in the report are scientifically solid and not biased in favor of Athena.

The NIH, while noting that its policies forbid product endorsements, says it has no jurisdiction over how Athena uses the report in its marketing.

The report wasn't an unqualified recommendation of Athena's test. It emphasized that there still is no way -- short of an autopsy -- to definitively diagnose Alzheimer's, which afflicts an estimated four million Americans.

Still, the report did single out Athena's test as one that "can add confidence" to diagnosis in symptomatic, late-onset patients. For families desperate for answers -- even imperfect ones -- that distinction can be a strong selling point.