The American Food and Drug Administration is being pressured to approve a supposed wonder drug to treat Alzheimer’s disease, despite evidence of dangers, such as liver damage.
A recent editorial in the Wall Street Journal attacked the FDA for dragging its feet on the drug tetrahydroaminoacridine, or tacrine, and called for swift approval.
The reason for the FDA’s hesitation is an interim report on the drug published in the New England Journal of Medicine which was considered uncontrolled and poorly designed.
The FDA’s panel also based their decision on two studies of 300 Alzheimer’s patients. In one such French study, published in the British Medical Journal last year, low doses of tacrine did not improve symptoms of Alzheimer’s and also were suspected of causing hepatitis, although there were some questions about the design of this study.
In the meantime, Warner-Lambert claims that it is submitting additional data to the FDA which it feels will clinch its case.