By Arthur Allen
According to scientists and physicians, the FDA approved on Thursday the first drug showing promise in slowing the Alzheimer’s disease progression.
Patients are happy, but critics fear that its rollout will lead to a racial imbalance in elderly care because of a faulty theory on the causes of the illness.
Lecanemab was approved by Eisai last month after a FDA advisory panel had voted 6 to 0. In a clinical study, the drug was given to nearly 1,800 Alzheimer’s patient biweekly, as opposed to those on a control group. It slowed down the progress of the disease.
Although it did not reverse Alzheimer’s disease symptoms, patients will need to be closely monitored for several years. Brain scans are part of this monitoring. Lecanemab – also known by the brand name Leqembi – was twice as susceptible to causing swelling of the brain or bleeding in comparison with a placebo. Although these incidents related to the drug stripping amyloids were usually minor, it is believed that three deaths could have been due to the drug.
Eisai has announced that it will begin marketing lecanemab in primary care to physicians treating most dementia cases. Eisai, who plans to charge $26,500 for the drug each year, is criticized by many as offering false hope. The drug is more effective for patients with low incomes who are diagnosed earlier. However, they are usually treated in facilities unprepared to administer the drug.
Maria Glymour of Boston University said, “This drug is likely to divert the attention and resources away from addressing support services for older people with cognitive impairment.” She said rather than spend on expensive drugs like the lecanemab that causes dementia, it’s better to tackle diseases like diabetes and high-blood pressure.
Lecanemab hasn’t been approved because of the lack of African Americans that participated in its tests.
The trial had only 20 Black participants, which is a sign of how often minorities are underrepresented in the research. Carey Gleason from the University of Wisconsin School of Medicine and Public Health said that this trial faced an added barrier. She claimed that many Blacks were “screened” out because of low amyloid level in their brains. Lecanemab, which removes amyloid from the brain, is effective. The organizers therefore did not accept patients whose PET scans returned negative results.
Libby Holman from Eisai said they enrolled a wide range of participants, however, there was a difference in amyloid level based on racial/ethnic background. “If there is no elevated amyloid in an individual, then that person does not suffer from Alzheimer’s disease,” she added.
The approval of lecanemab marks the culmination, 32 years after the formalization of this idea, that Alzheimer’s is caused amyloid buildup (the “trigger”) in combination with the tau protein.
While whites are more likely than blacks to have Alzheimer’s Disease, the majority of major studies found that levels amyloid were similar. Blacks, it is believed, are more susceptible to being stressed by environmental factors and suffering from multiple illnesses at once.
Lecanemab can’t be prescribed to early-stage Alzheimer patients because Blacks and minorities are more likely to have their disease diagnosed later.
As a result of our medical system’s two-tiered structure, people from marginalized groups and populations don’t have the same level of access to diagnosis as those in more privileged communities. That is why it is important that the drug be taken at an early stage.
Lecanemab remains a priority, but it is also important that we invest in alternative pathways.
A 15-member review panel, appointed by Institute for Clinical and Economic Review for the purpose of reviewing lecanemab received poor ratings. Panel members said that the drug would increase disparities between older and younger patients by favoring those with better insurance coverage, greater financial resources, or easier access.
They feel that the only way they can combat this is by pressing for greater access to the drug. Carl Hill of the Alzheimer’s Association’s chief diversity officer, equity and inclusion, said that there was no reason to believe the drug could not be effective in Blacks.
Manly does not share this opinion. She indicated that Alzheimer’s Patients of African American Descent tend to experience higher rates of vascular disorders like hardening of arteries in comparison to white patients. As the trial failed to take into consideration different ethnicities and races, the results cannot be guaranteed.
“I have mixed feelings about equity,” said she. I’d like for all families to be able to access a drug that is safe and effective to treat Alzheimer’s.
Alzheimer’s disease experts do not agree that due to the potential risks, patients should be carefully selected by well-trained doctors with adequate resources for monitoring any possible problems.
Karlawish suggested the FDA establish a Risk Evaluation and Mitigation Strategy(REMS) to lecanemab in order reduce the associated risks while it is being monitored by meds. The REMS strategy is currently used for 60 drugs, which restricts access. But in this case, no such strategy has been implemented. FDA released a warning regarding potential risks of blood thinners for people who are already using them, but said nothing on the implementation of a RM.
Safety and accessibility are at odds with each other.
FDA approved Aduhelm, an older anti-amyloid medication, in 2020. According to some Alzheimer’s experts, lecanemab’s low performance proves that amyloid alone is not enough. The majority of doctors however rejected it, citing its ineffectiveness and safety.
George Perry is a professor of Neurobiology at University of Texas at San Antonio. He hypothesized amyloid, tau, and other buildups are caused by ageing and help preserve the brain rather than destroy it. Perry says that amyloid accumulation in the brains of older people is the result of the body trying to battle aging.
S. Ahmad Sajjadi a clinical and neuroscientist from the University of California Irvine, believes patients can receive treatments that are as precise and as focused as cancer treatment.
Karlawish explained that lecanemab is currently offering a hint for hope for certain patients, in spite of its risk. Perhaps 10% of those who take it will be able to freeze the progression of their disease for months, or years.
Patient advocacy groups like the Alzheimer’s Association that funds the majority of research in this field are calling on Medicare to cover lecanemab only if participants participate in an after-marketing study or registry.
Joanne Pike from the Alzheimer’s Association stated that the average decline of patients taking lecanemab was five months lower in the first 18 months. It’s worth celebrating, she added.
Perry, who received funding from the Alzheimer’s Association questioned the group’s staunch support for the drug. The association had promised to assist in finding a cure to all its members.
“They can’t reverse their course after 30 years of pushing the amyloid.”
