\n\tArthur Allen<\/span><\/p>\n

This week the FDA is expected to approve what many scientists and doctors believe is the first drug to show promise of slowing the progression of Alzheimer\u2019s disease.<\/p>\n

But while patient advocates are celebrating, critics see it as the unfortunate triumph of a flawed theory of the disease\u2019s cause and predict the rollout of the drug will aggravate racial disparities in elder care.<\/p>\n

An FDA advisory panel last month voted 6-0 to support FDA approval of lecanemab, from the Japanese pharmaceutical company Eisai. In a clinical trial involving nearly 1,800 early-stage Alzheimer\u2019s patients, the drug slowed progression of the disease somewhat in those who got biweekly infusions, compared with those given a placebo.<\/p>\n

But the drug didn\u2019t reverse Alzheimer\u2019s symptoms, and it will require careful monitoring of patients for months or years, including many brain scans. Those receiving lecanemab, which carries the brand name Leqembi, were twice as likely as placebo recipients in the major trial to suffer hemorrhaging or swelling in the brain. These incidents, related to the drug\u2019s stripping away of amyloid proteins, were generally minor, but three deaths appear to have been caused by the drug.<\/p>\n

With the FDA poised to give full approval to lecanemab and Eisai set to promote it<\/a> to the primary care physicians who treat most dementia patients, critics are speaking out. Some say the drug, which Eisai plans to market for $26,500 a year, offers false hope. Others say any positive impact it has won\u2019t benefit lower-income patients, who tend to be diagnosed too late for the drug to be effective, and usually receive care in settings ill-equipped to handle the drug\u2019s stringent requirements.<\/p>\n

\u201cThe most likely consequence of this medication is to take resources and attention away from addressing basic supports for older adults with cognitive impairment,\u201d said Maria Glymour, chair of the Department of Epidemiology at the Boston University School of Public Health. The money spent on expensive drugs like lecanemab would be better invested in fighting diseases like high blood pressure and diabetes, which hasten dementia, and on community-based services for older adults, she said.<\/p>\n

The critique of lecanemab builds on another complexity of the drug\u2019s approval: Few African Americans were involved in testing it.<\/p>\n

Of the 859 people infused with lecanemab during the trial, only 20 were Black<\/a>. Minorities are often underrepresented in research, but this study had an additional barrier, said Carey Gleason, a clinical neuropsychologist at the University of Wisconsin School of Medicine and Public Health. Many Black volunteers in the trial \u201cscreened out,\u201d she said, because PET scans showed relatively low levels of amyloid in their brains. Lecanemab works by removing amyloid, so the trial organizers excluded patients \u2014 regardless of their Alzheimer\u2019s symptoms \u2014 if their PET scans were negative.<\/p>\n

Eisai spokesperson Libby Holman said the company worked to enroll a diverse population but that amyloid levels \u201cdiffered among racial and ethnic groups.\u201d She added, \u201cIf individuals do not have elevated amyloid, they do not have Alzheimer\u2019s disease.\u201d<\/p>\n

Indeed, lecanemab\u2019s approval marks the culmination of the idea, formalized 32 years ago<\/a>, that Alzheimer\u2019s disease can be understood as cognitive decline caused by amyloid buildup<\/a>, the \u201ctrigger,\u201d in combination with the \u201cbullet,\u201d a protein called tau.<\/p>\n

For example, Blacks are up to twice as likely as whites to be diagnosed with Alzheimer\u2019s, while showing equivalent levels of amyloid in most major studies. No one is sure why, but the hypothesis is that having multiple simultaneous health conditions and being exposed to environmental stressors put Blacks as a group at higher risk.<\/p>\n

Furthermore, Blacks and other minorities tend to be diagnosed at later stages, which automatically excludes them from use of lecanemab, which was designed and approved to treat early-stage Alzheimer\u2019s.<\/p>\n

\u201cThe drug has to be used in the very early window of the disease,\u201d Gleason said. \u201cIt\u2019s well documented that marginalized communities and people don\u2019t get access to diagnostic services as do more privileged populations, because our medical care is two-tiered.\u201d<\/p>\n

\u201cLecanemab should still come to market,\u201d she said. \u201cBut we need to be investing in other pathways.\u201d<\/p>\n

In its review of the costs and benefits of lecanemab, a 15-member panel appointed by the Institute for Clinical and Economic Review gave the drug low marks. Its rollout would aggravate elder care disparities, the panel said, by favoring wealthier patients who have more resources, better insurance, and an easier time getting to multiple appointments.<\/p>\n

Advocates for minority health care are well aware of these risks. But many feel the only response is to push harder for access to the drug. Black people whose conditions qualify them for the drug would do as well on it as whites, said Carl Hill, chief diversity, equity and inclusion officer for the Alzheimer\u2019s Association, which is raising awareness of the drug through churches and grassroots groups.<\/p>\n