By Arthur Allen
Doctors and scientists believe that FDA approved a drug on Thursday that shows the potential to slow down Alzheimer’s progress.
Although patient advocates celebrate the release of the new drug, some critics believe that it will worsen racial differences in the care of elderly people based upon a flawed understanding of how the disease is caused.
Last month, an FDA panel approved Eisai lecanemab with a 6-0 vote. A clinical trial compared the biweekly drug injections to placebos and found that the infusions slowed the progression of Alzheimer’s in some patients.
It will be necessary to carefully monitor the patients, and conduct brain scans, for many years. Lecanemab or Leqembi was found in a major study to have twice the risk of causing brain swelling and hemorrhaging compared with placebo. Three deaths have been attributed to Leqembi, a drug that strips away amyloid.
Eisai will market lecanemab for primary care physicians, who are the ones that treat dementia. However, critics have expressed their concern. Eisai is accused by some of selling false hope with its drug, lecanemab, for $26,500 annually. Low-income patients tend to get diagnosed later, which makes the drug less effective. They also receive their care at clinics that lack the equipment to deal with the restrictions of the drug.
Maria Glymour of Boston University, the Department of Epidemiology chair said: “This medication will divert attention and resource from providing basic supports to older adults with cognition impairment.” Instead of spending money on lecanemab and other expensive drugs, Glymour said it was better to focus resources and attention on diseases that cause dementia such as diabetes and high blood-pressure.
Lecanemab is approved by the FDA, but its approval has been complicated due to a lack of African Americans who participated in the testing.
Only 20 participants out of the 859 were Black. This shows how minority groups are often underrepresented in research. Carey Gleason a clinical neuropsychologist from the University of Wisconsin School of Medicine and Public Health pointed out that there was an additional obstacle to overcome in this study. She explained that many Black participants were “screened-out” because their PET scans indicated low amyloid concentrations in the brain – as lecanemab is able to remove such amyloid. Therefore, trial organisers excluded patients who had scans which came up negative no matter their symptoms.
Libby Holman is a spokesperson from Eisai. She said that the company enrolled a diversity of individuals, yet there were different amyloid concentrations based on racial/ethnic backgrounds. She continued, “If people do not show elevated levels of amyloid then they are not suffering from Alzheimer’s.”
In fact, lecanemab’s approval is a culmination of an idea formalized over 32 years ago that Alzheimer’s disease was caused by amyloid accumulation, the “trigger,” in conjunction with tau proteins, the “bullet.”
Most studies indicate that while blacks have twice the risk of developing Alzheimer’s as do whites, their levels of amyloid are similar. According to the hypothesis, Blacks may be more exposed to environmental stresses and have several health problems at once.
Lecanemab cannot be used to treat Alzheimer’s at an early stage in Blacks, or any other minority.
The two-tiered health care system in which we live means that people and groups who are marginalized don’t receive the same diagnostic services as those from more privileged backgrounds. For this reason, the drug should be given at the earliest stages of a disease.
Lecanemab still needs to be brought to the market but other avenues need to be explored.
The drug received a low rating from a group of 15 people appointed by Institute for Clinical and Economic Review (ICER) to evaluate lecanemab. According to the panel, this would worsen eldercare disparities by giving more access to wealthy patients who have greater resources and insurance.
Despite being aware of such risks, minority health advocates feel they can only combat these by pressing harder for drug availability. Carl Hill, Chief Diversity, Equity, and Inclusion Officer at the Alzheimer’s Association who is spreading the word through churches and grassroots organizations, says that there’s no proof the drug wouldn’t work on Black people.
Manly’s not convinced. She said that Alzheimer’s patients with African American ancestry tend to be more likely to suffer from vascular problems, such as hardening the arteries, than their white counterparts. If they were to take this drug, the risks of cerebral bleeds would increase. Since the trial didn’t take different ethnic and racial groups into consideration, it is not possible to guarantee that its results will be applicable for all of these groups.
She stated, “I am conflicted over equity.” “I’d love to see all families like mine have access to safe, effective Alzheimer’s drugs.”
Alzheimer’s expert disagrees that the risks of this drug require a careful selection by clinicians who are highly qualified and equipped with enough resources to detect any issues.
Karlawish recommended that FDA implement a Risk Evaluation and Mitigation Strategy, or REMS for short, in order to mitigate the risk associated with lecanemab while the drug is under medical supervision. In the current situation, REMSs are used to limit access for about 60 different drugs. This strategy, however, was not implemented with this drug’s authorization. FDA has issued warnings about blood-thinning drugs, but nothing about the use of REMS.
Lecanemab is an interesting drug that brings together safety and accessibility.
FDA approved Aduhelm as an early anti-amyloid therapy in 2021. Scientists who study Alzheimer’s disease believe that lecanemab is not the answer. But most doctors rejected lecanemab as unsafe and ineffective.
George Perry, professor of neurobiology at University of Texas at San Antonio has proposed that the buildup of amyloids and tau is caused by aging. This builds up plays a key role in maintaining brain health and not destroying it. Perry believes that the amyloid buildup in old people’s minds is a reflection of their body’s efforts to combat aging.
S. Ahmad Sajjadi said that in the future, cancer patients would receive targeted treatments.
Karlawish says that lecanemab may offer some hope, despite its potential risks. It has a 10% likelihood of slowing the disease’s progression for several months, or perhaps even years.
The Alzheimer’s Association and other patient groups, who have funded much of this research, are calling for lecanemab’s widespread availability. They oppose the Biden Administration’s proposal to pay only for lecanemab if Medicare patients agree to participate in post-marketing trials or a registry.
Joanne Pike is the CEO of Alzheimer’s Association. She noted that on average, lecanemab patients declined 5 months slower during their first 18-months on the drug. She added, “That’s a reason to celebrate.”
Perry questions, even though the Alzheimer’s Association has funded him, the organization’s support for this drug. This is despite the fact that the association promised its supporters and members to work towards a solution.
The amyloid has been pushed so far for the past 30 years that it is impossible to turn back.
