BBC Propaganda on behalf of Big Pharma (Eli Lilly)
A Clinical Trial reported in New England Journal of Medicine
Excellent Article by Alan Feuerstein
Excerpt:
In an extended analysis of two large but negative clinical trials, Lilly scientists conclude that mild Alzheimer's patients who start treatment with sola early lose cognition and function at a slower rate than similar patients who start taking the drug later. The inability of "delayed-start" sola patients to catch up to early sola starters suggests the drug is having a positive, modifying effect on Alzheimer's, Lilly says.
Using a delayed-start trial design to assess the potential for a drug to slow disease progression has been tried before, but the sola results are the first time it's been used successfully with Alzheimer's patients, says Hong Liu-Seifert, the Lilly scientist who led the EXPEDITION-EXT study.
"The results support the potential benefit of starting treatment with solanezumab earlier rather than later in disease progression, and suggest there is persistence of treatment effect after the delayed-start patients are given the drug," said Dr. Paul Aisen, director of the Alzheimer's Therapeutics Research Institute at the University of Southern California, in a statement.
But not all Alzheimer's experts share Lilly and Aisen's optimistic view of the sola delayed-start data. An Alzheimer's doctor at the AAIC conference, who asked not be named because he didn't want to criticize colleagues publicly, views the small differences in measurements of cognition and function between early- and delayed-start sola patients to be clinically meaningless.
He also believes Lilly leaned heavily on extensive "modeling" of the raw data and unproven but generous statistical methods to reach its positive conclusions. "What we're seeing here is not a disease modifying effect," he says.
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