Alzheimer's drugs fail to deliver

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Thomas Finucane, a geriatric specialist, tells his Alzheimer's patients and their relatives not to get their hopes up when he prescribes Pfizer Inc.'s Aricept and similar drugs.
“In 10 years we are going to be embarrassed that we were sending billions of dollars to the drug companies for a pill that patients can't distinguish from a placebo,” said Finucane, a professor of medicine at Johns Hopkins University School of Medicine in Baltimore.
Alzheimer's medicines generated $2.16 billion last year, according to IMS Health Inc. Approved in 1996, Aricept became the world's top-selling drug for the disease even amid doubts about its effectiveness and that of similar pills. Today, in one of the largest reviews of clinical data on Alzheimer's drugs, researchers found that all medications in the same class as Aricept, known as cholinesterase inhibitors, offered the same small improvement in mental functioning.
The study by the U.K.-based Cochrane Collaboration analyzed data from 18 clinical trials involving 9,200 patients. Patients taking Alzheimer's drugs showed an average 2.5-point improvement on a 70-point scale measuring cognitive function and activities of daily living compared with those taking a placebo.
The analysis found that 29 percent of patients dropped out of the trials because of side effects, such as nausea, vomiting and diarrhea.
'Don't Expect Miracles'
“The average benefit is very small. It might escape notice,” said lead researcher Jacqueline Birks, a medical statistician for Cochrane's dementia and cognitive impairment group at University of Oxford. “Don't expect miracles.”
“All the current drugs only treat the symptoms, they don't get at the underlying disease process,” Morris said.
Previous clinical trials have shown that more than half of patients show no improvement, and for those that do, the degree of benefit is small, according to the Alzheimer's Association. Findings presented today at the International Conference on Alzheimer's Disease and Related Disorders in Madrid will do little to sway opinion on either side of the debate.
'Not ultimately Satisfying'
“It's not ultimately satisfying to anyone, and I think the manufacturers would agree with that,” said William Thies, vice president of medical and scientific relations for the Chicago-based Alzheimer's Association. “If you put all these studies together you do get a consistent effect. It's modest.”
The marginal efficacy of Alzheimer's drugs also raises the debate about cost effectiveness. A month's supply of Aricept pills costs about $150, according to Drugstore.com. Razadyne costs about $160 per month, and Exelon costs about $170.
Last year, the U.K.'s National Institute for Clinical Excellence, which evaluates a drug's cost against its benefits for the country's National Health Service, recommended against prescribing the drugs, saying they weren't worth the expense.
'No Clear Evidence'
“The reason there is such a dispute is that there is no clear evidence that they have an important clinical benefit or that they make a difference in the lives of patients,” Sidney Wolfe, director of the Washington-based Public Citizen's health research group, said in an interview.
Public Citizen has kept Aricept on its list of “worst pills” since 1999. Exelon and Razadyne are also on Public Citizen's list of medications to be avoided. The group accuses drug makers of playing on the “hope, fear and guilt” of Alzheimer's patients and their caregivers through advertising.
Eli Lilly & Co., based in Indianapolis, is developing drugs to both block the secretion of amyloid and improve the body's ability to clear it out of the brain. Dublin-based Elan Corp. and Wyeth, based in Madison, New Jersey, are developing a similar treatment to remove amyloid deposits, while Switzerland's Novartis is refining a vaccine that would prompt the body's own immune system to destroy the plaque.