http://www.nytimes.com/aponline/health/AP-Alzheimers-Vaccine.html
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February 23, 2002 Illness in Alzheimer's Vaccine Study
By THE ASSOCIATED PRESS
Filed at 6:43 p.m. ET WASHINGTON (AP) -- Twelve Alzheimer's patients injected with an
experimental vaccine are suffering serious brain inflammation. The vaccine's manufacturer halted the experiment last month when it
discovered that the first four patients, all from France, were suffering the
encephalitis-like reaction. Since then, doctors have discovered eight more people with the apparent
side effect, which can be hard to distinguish from worsening Alzheimer's,
said Bill Thies of the Alzheimer's Association. All 12 are stable or
improving, he said. But the reactions raise serious questions about the future of Elan Corp.'s
vaunted vaccine. Elan excited researchers in 2000 when it discovered that in mice, the
compound could ward off and even reduce brain-clogging plaques that are a
hallmark of Alzheimer's disease. Initial safety tests in British patients showed no signs of serious side
effects. But because the vaccine works by inducing the immune system to
attack the protein that makes up those plaques, called beta amyloid, some scientists
had warned that brain inflammation was a potential serious side effect. Thus,
participants in the latest 360-patient study were warned about the potential
risk, Thies said. Elan spokesman Max Gershenoff wouldn't discuss the cases but said they are
under review by an independent scientific panel appointed to oversee the
research. The study might be able to continue if there were some way to identify who
is at highest risk of the reaction, Thies said, but Elan's oversight panel
and government regulators would have to agree. Shares in Elan, Ireland's largest pharmaceutical company, fell Friday on
the news. Elan was trading down 5 percent at $13.06 a share in early trading
on the New York Stock Exchange. It's the latest bad news for the firm, which already has seen its stock
value slashed by two-thirds in recent weeks. Earlier this month, the
Securities and Exchange Commission began investigating Elan's accounting
practices after The Wall Street Journal reported the company appeared to be
concealing losses in joint ventures, an Enron-style practice that Elan chiefs
vehemently denied. |
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