I've joined colleagues petitioning the FDA to withdraw Biogen's license for aducanumab, a drug that hasn't demonstrated benefit to patients & poses major safety issues (brain bleeds/swelling). Besides being case of regulatory capture, Biogen's marketing has been deeply cynical...
After receiving startling approval last June (again, for a drug that doesn't appear to work & has already been linked to deaths), Biogen set the price at $56k annually, despite initial projections of $3k-$8k. This doesn't even factor in cost of PET scans, clinical infusion, etc.
They then unveiled a direct-to-consumer marketing plan, including a website w/ a memory loss screener. No matter how a user answers they get geo-linked via zip code to provider locations that also happen to be infusion sites for the drug (which is an anti-amyloid antibody).
The company also bought a slick "paid post" in the NY Times that looked deceptively like a legit feature. It told the emotional story of a family's trauma around mild memory loss. At the end, the ad also linked users to Biogen's proprietary website w/ the memory test
Meanwhile, Biogen pushed plan to "help patients access" the drug, focusing on "equity/disparities" & targeting underserved pts of color more likely to receive AD diagnoses. Partnered w drug store chains to reach these populations & provide cog screenings leading to drug infusion
When sales of the drug tanked this fall w/ increasing reports of serious side effects, we started seeing industry puff pieces about how, actually, women are driving innovation at companies like Biogen. #BelieveWomen, even when it comes to drugs that are dangerous and ineffective
(Fascinating to see the ease with which Biogen assimilated the dominant identitarian discourse of this era into their marketing strategy...)
Anyhow, we are now asking the FDA to immediately withdraw Biogen's license to market aducanumab & thus protect aging Americans who could be harmed by this ineffective Tx. If people feel inclined, they can sign a citizen's petition to keep the pressure on rightcarealliance.org/call-for-the-a…
Overall this situation further exposes deep problems at FDA which, since Prescription Drug User Fee Act of '92, has received massive % of budget from industry user fees. Inspector general & other investigations are currently digging into alleged inappropriate links b/t Biogen/FDA
Factor in their mishandling of opioids in the '90s & the massive loss of life & suffering that has wrought, & it is no surprise there is such deep distrust in our regulatory institutions (not to mention public institutions more broadly). Good related read: nytimes.com/2021/12/03/opi…
I'm honestly not sure how we fix/reverse any of this rot. We are in pretty deep, our political system captured. But what we can try to do in this era is be truthful & diagnose problems as they exist in the world. Succeeding in the withdrawal of aducanumab wld be one small victory
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