As Biogen and Eisai await an FDA decision for Alzheimer’s candidate aducanumab, it’s got celebrities Samuel L. Jackson and Kimberly Williams-Paisley on its side.
Through an Alzheimer’s Association advocacy campaign, that is. The actors are two of the celebrities supporting the group’s “More Time” campaign in personal (and unpaid) social media posts, along with real patients and their loved ones.
The goal? Highlight the benefits of having an approved drug that might slow an Alzheimer's patient's decline.
“We felt that it was a great opportunity for the association to not only make the general public aware of our position and support of the approval of aducamunab, but also create a grassroots engagement campaign to ensure families impacted by Alzheimer’s can raise their voices in support of what this could mean to them,” Michael Carson, chief marketing officer at the Alzheimer’s Association, said.
Advocacy group support for drug approvals isn’t new—remember the “Even the Score” grassroots push for female libido drug Addyi and the Duchenne muscular dystrophy families who championed Sarepta’s Exondys 51 a few years ago? Still, Biogen’s aducanumab results, the pharma’s close association with the FDA through the process and recent advisory committee rejection make the associations’ campaign support notable.
And not everyone is in favor of the advocacy ads. Vanderbilt University Medical Center professor Matthew Schrag wrote earlier this year that the Alzheimer’s Association advocacy and its statements that aducanumab "would potentially change the progression of Alzheimer’s" are cause for concern.
Pushing for approval when the trials showed conflicting results and "high rates of potentially dangerous side effects" won't change the reality that aducanumab has not been proven to work, Schrag said in an email to Fierce Pharma on Thursday. Rather, the approval would instead simply "transfer the cost and the risk to our patients and compromise the rigor of future studies."
He'd prefer that advocacy groups direct energy elsewhere.
"I hope the Alzheimer's Association and other advocacy groups will join the chorus of physicians and scientists advocating for a new, complete clinical trial to be conducted as soon as possible," Schrag said "This is the solution that serves the best interests of patients."
A tumultuous history
Researchers like Schrag and advocates like the Alzheimer's Association have long been divided on aducanumab.
Alzheimer’s patients and families, advocacy groups, the drugmaker and some devotees inside the FDA generally argue that a stake in the ground for Alzheimer’s is needed, and while aducanumab may not be a wonder drug, at least it’s a start.
On the other side are physicians, other drugmakers with Alzheimer’s candidates and many members of the FDA advisory panel that reviewed aducanumab—experts who said they understand the desperate need for a solution, but that the drug just doesn’t work well enough to make a difference for Alzheimer’s patients.
Aducanumab failed its November advisory committee review, earning a resounding thumbs-down on whether the phase 3 trial provides “strong evidence that supports the effectiveness” of the drug as a treatment for Alzheimer’s, with two voters abstaining.
It was the latest in a string of literal back-and-forth results beginning with two phase 3 studies, dubbed EMERGE (aka Study 301) and ENGAGE, that tested aducanumab in patients with early-stage and mild Alzheimer’s, along with a phase 1b study where discrepancies surfaced—and continue to muddy the results.
Patients in the EMERGE trial who got the highest dose of aducanumab, for example, had a statistically significant improvement on a clinical dementia scale, but the same patient group in the ENGAGE study did worse than placebo patients on that same measure, as well as on a test of cognitive function.
When the phase 3 program flunked a futility analysis in March 2019, Biogen initially pulled the plug on the entire program. But in a surprise about-face eight months later, Biogen insisted that analysis was “incorrect.” It argued it was based on a smaller data set with fewer patients who received high-dose aducanumab.
By Biogen's estimation, additional data did show that aducanumab reduced clinical decline, so it decided to file for approval—where it now awaits an FDA decision in June, after being pushed back three months from an initial March date.
The association’s argument
The Alzheimer’s Association disclosed that it received $275,000 from Biogen and $250,000 from Eisai in 2020, although Merck, Genentech and Eli Lilly each donated more at $855,706, $331,000 and $323,791, respectively.
The “More Time” campaign ran for five days, kicking off May 6 with full-page print ads in The Wall Street Journal and USA Today. The ads were open letters from Alzheimer’s Association CEO Harry Johns and included three personal stories from patients and loved ones.
The ad copy mentions aducanumab's clinical studies but homes in on a single result that "reported a 22% reduction in cognitive and functional decline compared to placebo."
If a drug could slow Alzheimer’s giving me more time with my mom, I would have read to her more. Join me & @alzassociation in supporting #MoreTime for people with Alzheimer’s:https://t.co/2LX3JjNy89. #ENDALZ— Samuel L. Jackson (@SamuelLJackson) May 8, 2021
On Instagram, Facebook and Twitter and in unpaid advocacy, some patients and families—along with celebrities such as Jackson and Williams-Paisley who were affected by Alzheimer’s in loved ones—spoke out about what “More Time” would mean to them. Google search and display ads along with websites in English and Spanish were also part of the effort.
The association’s paid ads were posed as questions on Twitter asking things like “If a drug could slow Alzheimer’s, what would it mean for you?”
Jackson posted on Twitter: "If a drug could slow Alzheimer’s, giving me more time with my mom, I would have read to her more." He also invited people to support the association and its #MoreTime effort. It got 2,845 likes and 312 retweets.
And people were paying attention campaignwide. The grassroots effort nabbed 92 million impressions overall, five million engagements with the digital and social ads and more than 1 million people who affirmed support in petitions for the need for Alzheimer’s treatments, Carson said.
While the paid ads are over for now, the Alzheimer’s Association will continue its grassroots effort and amplify patients' and family members' support on social media.
“With an approval, without an approval—I mean we certainly hope there is an approval—we will still continue to do what the association does in terms of providing information to families of those diagnosed and continue to raise awareness,” Carson said.
He added, “There is a pipeline. Science builds upon itself and this is not dissimilar to other fatal diseases, certainly in cancer, and so we will continue to do what we do today if there’s not an approval tomorrow.”