On Monday, the Food and Drug Administration approved a new medication for the treatment of Alzheimer’s disease.

But — as Public Citizen has noted — there is nowhere near enough evidence that the drug, aducanumab, is effective.

• In fact, 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 Big Pharma 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 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.

Here’s what Dr. Michael Carome — director of Public Citizen’s esteemed Health Research Group — said in a statement to the national media:

“The FDA’s decision shows a stunning disregard for science and eviscerates the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.”

Tell the FDA:

Aducanumab has not been shown to be effective and you know it. What’s more, Biogen is planning to charge such an absurd amount that it could overwhelm Medicare. Meanwhile, millions of Alzheimer’s patients and their families will be given false hope. And the development of other treatments may be delayed or shelved altogether. Revoke your approval of aducanumab immediately or risk permanent damage to the FDA’s credibility in the eyes of the American people.

Add your name.

Thanks for taking action.

For health and safety,

- Robert Weissman, President of Public Citizen

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