It was a travesty that the FDA ignored its commission’s advice and approved this drug. It was at very best and debatably only mildly effective in mild Alzheimer’s cases, and it was approved for ALL Alzheimer’s patients with no end in sight in use. The FDA approval forces Medicare to cover the drug (and this insurances companies who always follow their lead when Medicare covers a drug), and the drug is priced at $55,000 a cycle with no limit on cycles except that expensive MRI’s and follow up monitor testing is required. Given the gigantic number of Alzheimer’s patients, this move would cripple Medicare funding.
The approval last month was a shock since the FDA had always followed the advice of its panel assigned to evaluate the drug, and Biogen’s stock shot through the roof.
This past week, in an effort to back up and limit their damage slightly, the FDA restricted the use of the drug to mildly affected patients only (which was actually the only subset of patients ever studied), but this still represents a massive number of patients, and the results were not clearly clinically beneficial. The serious problem still exists.
Well, now it appears that the clamor has triggered an investigation into the relationship between FDA members and Biogen
Link: https://www.newsmax.com/health/health-news/biogen-fda-probe-alzheimers/2021/07/09/id/1028095/
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Link: https://science.sciencemag.org/content/372/6549/1371
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...the drug is only for mildly-affected patients...
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