29 days ago, I emailed you about Public Citizen’s emergency response to the Food and Drug Administration’s approval of a new Alzheimer’s treatment called aducanumab.
We demanded that the FDA revoke its approval because there is nowhere near enough evidence that aducanumab is effective.
This morning — following intense pressure from Public Citizen and allies — the FDA narrowed its prescribing recommendations for this unproven medication.
But we still think the FDA should revoke its approval of aducanumab altogether. Because:
- Geriatric experts and the FDA’s own independent advisory committee strongly urged the agency NOT to approve the medication.
- Public Citizen even called for an investigation of the inappropriately close collaboration between the FDA and Biogen — the pharmaceutical company that developed aducanumab — in analyzing clinical trial data.
- Beyond insufficient evidence of effectiveness, aducanumab has potentially serious side effects. For example, 40% of people who took it in clinical trials had swelling and bleeding in their brains.
- What’s more, Biogen is planning to charge an average of $56,000 per patient per year for the treatment. (And that doesn’t even include potentially tens of thousands more per patient in screening and monitoring costs.)
- That price tag is so exorbitant that it might single-handedly jack up insurance premiums across the board and drain tens of billions a year from Medicare.
Public Citizen has been standing up to Big Pharma and keeping ineffective, unsafe drugs off the market for half a century.
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Thank you!
For health and safety,
- Robert Weissman, President of Public Citizen
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