Marcel Brasey recently emailed to tell me about a video called “Fortunately” that the French Alzheimer’s Association planned to air on television and on their web site. The video seems to show people with very advanced dementia in dire situations.
A woman urinates in the grocery store, another stares blankly into the camera with blood running down her face, a man eats dog food, etc. Dark music plays in the background. At the end, the words on the screen say “Fortunately, they won’t remember.”
Summary: The FDA’s “Expanded Access to Investigational Drugs for Treatment Use” rule provides a way for patients who can’t participate in clinical trials to gain access to potential treatments not yet approved by the FDA. Despite optimistic headlines about Alzheimer’s cures and breakthroughs, many drugs currently in trial seem to have only incremental benefits. This may keep demand for expanded access to potential Alzheimer’s treatments low.
Over the past few months, I’ve received several emails from people diagnosed with Alzheimer’s or their caregivers asking how they can get access to Alzheimer’s drugs still in clinical trials. Most of these inquiries were about Dimebon, Rember or potential “Alzheimer’s vaccines” such as Bapineuzumab.
In each case, someone saw an optimistic media report about the promise of a drug in clinical trials (an “investigational drug”), and wanted access to it before trials were completed and it could be approved for the U.S. market.
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