The nation's most prominent Alzheimer's advocacy organization convened its policy team the day after Medicare officials announced a preliminary decision to sharply limit coverage of the controversial new Alzheimer's medication Aduhelm.
The fight against Medicare's proposal is on the agenda.
According to recordings obtained by The New York Times, Robert Egge, the association's chief public policy officer, said that this was their top priority.
On the next day, the chief executive told the entire staff that they could count on him being relentless.
Many Alzheimer's experts and other doctors welcomed the proposal to pay for Aduhelm only for participants in randomized clinical trials. They say it would protect patients and families who might try anything if they are desperate.
The Alzheimer's Association and other groups strongly object to Aduhelm. The first drug approved for Alzheimer's in 18 years, Aduhelm, should be covered for anyone with mild Alzheimer's-related cognitive decline and usage decisions should rest with patients and their doctors, they say.
The association argues that discrimination against everyone with Alzheimer is caused by the restriction of coverage of Aduhelm.
With Medicare's final decision due by April 11, the group has organized ads on social media and websites, as well as emails directed at President Biden.
It has orchestrated over 400 meetings in which people with Alzheimer's, their family members or supporters have urged their members of Congress to press the Centers for Medicare and Medicaid Services to cover the drug. The officials suggested that people say versions of phrases like "I have a fatal disease and I want more time with my family" and "how access to F.D.A."
Beth McMullen, senior director of grassroots advocacy, told people to submit comments in ways that weren't scripted. She said that employees cannot submit as staff members of the Alzheimer's Association.
The push reflects growing activism by advocacy groups involved in various diseases, which sometimes campaign for therapies despite medical experts' concerns about insufficient data. Some are funded by pharmaceutical companies. The Alzheimer's Association received $1.6 million from manufacturers in fiscal year 2021.
UsAgainstAlzheimer is one of the Alzheimer's advocacy groups. The government would consign millions of Americans to inevitable decline and death, with no possibility of appeal, and it has run television ads featuring patients.
The Alliance for Aging Research led a rally of about 100 people outside the Department of Health and Human Services, which houses C.M.S.
The Food and Drug Administration approved Aduhelm in June despite conflicting scientific results. Patients in a nearly identical trial didn't seem to benefit from the slight slowing of cognitive decline that participants in one clinical trial experienced. About 40 percent of patients on the dosage later approved experienced brain swelling or brain bleeding. The council of senior F.D.A. officials and the independent advisory committee said there wasn't enough evidence for approval.
Questions about the approval and whether the F.D.A. worked too closely with Biogen have prompted investigations by congressional committees, the Health and Human Services department, the Federal Trade Commission and the Securities and Exchange Commission. The Cleveland Clinic is one of the major medical centers that has declined to offer Aduhelm.
Dr. Lee Fleisher, the agency's chief medical officer, said that their main goal was to protect beneficiaries from harm from an intervention without known benefits.
C.M.S. received 9,957 comments, some of which were organized by advocacy groups on both sides of the debate.
The Alzheimer's Association, with revenue of $400 million, runs an international conference, provides research grants and publishes a journal.
Association officials didn't mention Aduhelm's safety risks in recordings of the staff meeting and two prep sessions.
The risks are real, but they are not worse than treatments that are covered, according to the chief executive. Many experts say that wouldn't be enough to evaluate the drug.
Maria Carrillo, the association's chief science officer, spoke at the staff meeting about whether Aduhelm works.
Some patients enthusiastically back the association's efforts, but its stance troubles some longstanding supporters, including a retired neurologist.
He was 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 800-273-3217 He considers Medicare's proposed restrictions to be appropriate.
He will stop donating to the Alzheimer's Association except for his local chapter.
Several members of the association's scientific and medical advisory group said the drug shouldn't be approved yet. The association pushed for approval.
The F.D.A. acknowledged the unclear benefit when it greenlighted Aduhelm under accelerated approval, which allows authorization of unproven drugs for serious diseases with few treatments if the drug affects a biological mechanism in a way.
The agency's justification was that Aduhelm targets a amyloid that forms plaques in the brains of Alzheimer's patients. Years of data have not shown that reducing amyloid can slow cognitive decline.
In the staff meeting, Dr. Carrillo said that the experts who criticized Aduhelm were mainly anti-amyloid researchers.
Several scientists critical of Aduhelm's approval support the idea that targeting amyloid might help patients; they simply found Aduhelm's results unconvincing.
Mr. Egge said that it was not certain that the first treatment would work for everyone.
The Alzheimer's Impact Movement has spent hundreds of thousands of dollars on the campaign.
At the staff meeting, Mr. Johns addressed the issue of funding from the pharmaceutical industry.
He said that corporate contributions are very small, less than 1 percent of the total revenue.
One attendee asked if they should refuse to accept funding from the companies since the amount of funding they receive is so low.
It would have consequences, like preventing the organization from accepting corporate matching contributions for participants in association fund-raising walks who happen to work at pharmaceutical companies.
The explanations were echoed by Mr. Johns in the interview. I think some of our folks have had a conversation or more along the way with Biogen, and that's what I was asked if association officials had communicated with.
In the recordings, association officials told advocates that their annual meetings with local members of Congress would be different, and that they should request that lawmakers give a floor speech, write to C.M.S., or post on social.
A sample letter and social media posts should be given to congressional staff by advocates, according to one official.
Kate Johnson told advocates that if they don't know the answer to a question, they should always use our safest phrase.
She urged advocates to take photos of the congressional meetings and post them on social media to show the lawmaker that they are not giving up on the issues that they are passionate about.
Christopher Masak is the director of advocacy and was involved in a role-play.
My mom is living with a fatal disease, and the bottom line is, I want more time.
Medicare officials said that limiting coverage to clinical trial participants is important because Aduhelm is intended for people with early mild disease, who could potentially be sacrificing years of remaining function and quality of life if a drug outweighs any benefit.
The risk of the disease could be better tolerated later in the disease, but the milder early period is the time most people want to try to extend.
C.M.S. officials said that Aduhelm data isn't representative because most trial participants were white. Medicare wants new clinical trials to reflect racial and ethnic diversity.
The proposal by Medicare could have the opposite effect because people in underserved communities might not have access to clinical trial sites.
Some issues have been raised by those who don't oppose limiting coverage for Aduhelm. One is that, as currently worded, Medicare's decision would apply to all monoclonal antibodies for Alzheimer's, several of which are in late-stage trials and may soon be considered for F.D.A. approval.
It is denying access to all current and future F.D.A.-approved treatments targeting amyloid in those living with Alzheimer's disease.
C.M.S. was asked by the American Academy of Neurology to only cover patients in clinical trials.
C.M.S. plans to respond to new evidence as it becomes available.
The association wouldn't be satisfied if Medicare's restrictions were applied only to the agency, according to Mr. Johns, who attended three meetings with C.M.S. officials.
Efforts by advocacy groups have gotten some attention.
A bipartisan group of 40 House members wrote asking C.M.S. to provide broad coverage.
The Alzheimer's Association and Us AgainstAlzheimer's were quoted in a letter sent by 78 House Republicans. Both advocacy groups were described on Senator Susan Collins' website as supporting a letter she and another Republican wrote.
Some lawmakers, including Democrats, have posted a version of the association's language.
Legislators who chair committees investigating the F.D.A.'s approval of Aduhelm were praised by Medicare's proposal.
Mr. Johns didn't know if any lawmakers had switched from supporting to opposing Medicare. He said the association's congressional meetings have had positive outcomes even for people with different opinions. There is a different level of understanding.
There are people who are working against access to the campaign. We don't want to give them details of our tactical approaches. Outcomes that grant those with Alzheimer's disease access to current and future F.D.A.-approved treatments without unnecessary barriers will be measured.
All Rights Reserved © 2024
