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.

Doctors don't routinely use diagnostic Alzheimer's tests made by Athena or any other company, even though they have been available for years. Experienced neurologists can correctly diagnose the disease at least 70 percent of the time -- mainly by ruling out other conditions. Tests specific to Alzheimer's seek to increase that degree of certainty, and at an earlier stage. Of the roughly 250,000 Alzheimer's diagnoses made annually by one estimate, fewer than 10 percent involve the $225 Athena test.

None of the handful of Alzheimer's tests on the market is especially reliable. Athena's genetic test produces false or inconclusive readings about one-third of the time, a recent study showed.

Even more importantly, there still is no cure or even effective treatment for the disease -- though several drugs on the market can temporarily improve memory in a fraction of patients. Thus, many doctors feel that achieving 100 percent certainty in diagnosis is inconsequential.

"At the end of the day, unless you can tie this sort of diagnostic to a therapeutic, it's not clear where the value of testing is," says Walter Moos, chairman of MitoKor, a closely held San Diego company developing an Alzheimer's test, so far only for research purposes.

The Athena test spotlighted in the report is a blood test for a gene known as apolipoprotein E. The company says a faster, better diagnosis can improve physician care and potentially buy a patient time to prepare for the inevitable. But critics aren't persuaded.

"I strongly disagree with Athena that it's an appropriate diagnostic test," says Hank Greely, a Stanford University law professor who co-wrote a recent study on the ethical implications of genetic testing for Alzheimer's. He believes any benefits are outweighed by the test's cost and its potential for unduly alarming genetically similar family members.

The field of Alzheimer's testing has been dogged by other controversies. In late 1996 another test maker, Nymox Pharmaceutical Corp., Montreal, ran mass-media advertisements stating that its test could definitively rule out the disease. The Alzheimer's Association retorted that the company didn't have published evidence to support its "highly objectionable" claims.

Today, a Nymox spokesman says: "The only people calling our ads controversial are our competitors or those people with commercial affiliations to our competitors."

At around the time of the Nymox furor, while the Alzheimer's Association was pondering how to clear up public confusion over diagnostic testing, Athena came calling, recalls Zaven Khachaturian, an Alzheimer's research pioneer who directs the association's scientific programs as a paid consultant.

Athena suggested assembling a panel under the auspices of the association and the NIH. "They said they'd like to see a workshop done about the utility and scientific opportunity in diagnostic markers," Dr. Khachaturian says. "They gave an unrestricted gift of $100,000 with the understanding that they wouldn't control the meeting or have any say in who was invited or how it was conducted, and that's how the meeting was done."

Dr. Khachaturian, a member of the NIH panel, listed himself as an Athena consultant in an October 1997 article in the Journal of the American Medical Association. He did so, he says, because of indirect payments received by his firm for organizing the NIH Alzheimer's panel. But that affiliation wasn't listed in the panel's report, published six months later.

"There is an appearance of conflict," concedes Dr. Khachaturian. But the panel's purpose, he says, was to establish scientific criteria for evaluating Alzheimer's tests, not to promote a particular product. He adds: "I don't think in this case 1/8disclosure 3/8 is relevant, but I could be mistaken." He stresses that he didn't contribute to the panel's written report.

Also on the panel was Teresa Radebaugh, Dr. Khachaturian's partner and, like him, an Alzheimer's Association consultant. Ms. Radebaugh says she acted merely as an administrator to the group and didn't contribute to its report.

Two other panel members had more direct financial stakes in Athena. Harvard researcher Dennis Selkoe is a board member and shareholder of Elan, Athena's parent. Allen Roses, a vice president at Glaxo Wellcome PLC and a professor at Duke University, was a consultant to Athena until mid-1997. He holds a patent on Athena's genetic test, and collects limited royalties.

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A fifth panel member, John Trojanowski, had agreements with Athena in 1995 enabling him to receive proprietary research materials -- including special strains of mice -- from the company. Dr. Trojanowski says that because his Athena collaborations weren't financial, he sees no need to have disclosed them.

In retrospect, Drs. Selkoe and Roses both now say that their affiliations should have been disclosed in the report. They both say that during the workshop they informed panel chairman John Growdon about those ties.

Dr. Growdon, a Harvard neurologist with no connection to Athena, calls the Athena ties of panel members "irrelevant." He adds, "Everyone had their academic hats on, not their company hats. The report is fair, honest, and not biased by any company affiliation."

Some medical ethicists disagree. "There is no doubt in my mind that you have to fully disclose what the ties are," says Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, citing the increasingly pervasive connection between medical research and drug companies that stand to profit. "I don't believe the ties are necessarily distorting or necessarily bad, but people have a right to know what they are."

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