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FDA Helps Companies Exploit Patients With Alzheimer’s Disease

May 2012

Sidney M. Wolfe, M.D.

For the second time in less than two years, the Food and Drug Administration (FDA), at the behest of companies seeking to exploit the large market for Alzheimer’s disease, has approved a product with little proven benefit and documented risks.

The first of these two unwarranted FDA approvals of Alzheimer’s disease products occurred in July 2010, when the FDA approved a new, high-dose version of Pfizer/Eisai’s top-selling but patent-expired Alzheimer’s drug Aricept (Aricept 23). The agency approved the drug over the objections of most of its scientists, who noted that the drug did not improve overall functioning but caused considerably more side effects than an older, lower-dose version of the drug.

The most recent example is a dye, Amyvid, which is injected into patients with possible Alzheimer’s disease and, on the basis of a subsequent brain scan, is used to detect amyloid plaque in the brains of such patients. A brain scan finding involving amyloid plaque is related to Alzheimer’s disease.

After the FDA recently approved this dye, despite strong opposition from several experts in brain imaging and from Public Citizen, the manufacturer, Eli Lilly, hemmed and hawed in a statement about some of the test’s limitations, while cheering its approval.

The ifs, ands and buts in the Lilly press release failed to obscure the fact that this is an inaccurate test, subject to serious physician interpretation differences. The test has been shown to detect amyloid plaque in some patients who do not have Alzheimer’s disease and to fail to detect the plaque in some patients who turn out to have the disease. Clearly a financial boon for Lilly, the approval sends another blow to Alzheimer’s patients and those who love them.

Approving a diagnostic test that can falsely suggest that someone has Alzheimer’s disease can obviously result in considerable anxiety for patients, their families and friends. Considering this decision along with the dangerous FDA decision to approve Aricept 23, the agency’s and the drug industry’s priorities toward the well-being of Alzheimer’s patients seem to be taking a backseat to the well-being of companies such as Lilly and Pfizer/Eisai.

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