By Arthur Allen
On Thursday, scientists and doctors believed that the FDA had approved the first drug to slow the progression of Alzheimer’s.
Critics predict that the launch of this drug, based on an incorrect theory about the cause of Alzheimer’s disease, will increase racial inequalities among elders.
A FDA advisory committee voted last month 6-0 to approve Eisai lecanemab. In a recent clinical trial, nearly 1,800 Alzheimer’s sufferers were treated with biweekly injections of lecanemab compared to those receiving a placebo. The drug was found to slow the progression of Alzheimer’s disease.
The drug does not reverse Alzheimer’s symptoms but it is still necessary to monitor patients over many years. This includes brain scans. Lecanemab (also known as Leqembi) was found to be twice as likely as placebos to cause swelling or hemorrhaging in the brain. The incidents were minor and related to lecanemab’s ability to strip away amyloid protein. However, three deaths may have been linked to this drug.
Eisai intends to sell lecanemab, once FDA approved, to primary care doctors who treat the majority of dementia patients. Critics are raising their concerns. Eisai plans to sell the drug for $26,500 per year. According to critics, it offers false hope. Patients with lower incomes are often diagnosed late, resulting in the medication not being effective. They are also treated at facilities that cannot handle its restrictions.
Maria Glymour is the chair of Boston University’s Department of Epidemiology. She said that this medication would divert resources and attention from basic support for older adults who have cognitive impairment. She said that rather than spend money on costly drugs such as lecanemab it is better to combat diseases like high blood pressure, diabetes and dementia.
Lecanemab approval is complicated because few African Americans took part in testing.
Only 20 out of 859 trial participants were Black, illustrating the lack of minorities in scientific research. Carey Gleason is a clinical psychologist at the University of Wisconsin School of Medicine and Public Health. She pointed out an additional barrier to this study. She said that since many Black volunteers’ PET scans revealed low levels of amyloid in their brains (lecanemab removes this amyloid), they were “screened out”. The trial organizers didn’t include patients with scan results coming back negative no matter how severe their symptoms.
Libby Holman said that Eisai enrolled a variety of people, and there are differences in the amyloid levels based upon racial or ethnic background. She said, “If an individual does not have high levels of amyloid they don’t have Alzheimer’s.”
Lecanemab is the result of a 32-year-old idea that Alzheimer’s Disease was caused by the accumulation of amyloid, or the “trigger,” and tau protein, which we call the “bullet.”
Most major studies have shown that amyloid levels are the same in blacks and whites. It is hypothesized that Blacks have a higher risk of being exposed to stressors in the environment and having multiple conditions.
Lecanemab is not approved to treat Alzheimer’s in its early stages for Blacks or other minorities.
Our two-tiered system of medicine means that marginalized populations and communities don’t get the same access to diagnostics as more privileged groups. This is why drugs must be administered in the early stages of disease.
Lecanemab is important, but there are other ways to improve the treatment.
Lecanemab was given a poor rating by a panel of 15 members appointed by the Institute for Clinical and Economic Review. The panel stated that it will exacerbate disparities in elder care by allowing wealthier patients to have better access, more insurance and better resources.
All of the advocates who are working to improve minority health care know about these dangers, but they still feel that the best way to counteract them is by pushing harder to make the drug available. Carl Hill is the chief diversity equity and inclusion officer for the Alzheimer’s Association. The Alzheimer’s Association is educating churches and local groups about the benefits of the drug.
Manly, however, isn’t convinced. She noted that Alzheimer’s sufferers of African American descent have higher rates for vascular diseases like hardening arteries than white patients. This could increase the risk of bleeding in the brain if these patients take the drug. The results of the study are not applicable to all racial or ethnic groups because the trials did not include them.
She said, “I’m conflicted on the issue of equity.” I would like to see every family have equal access to an effective and safe Alzheimer’s medication.
Alzheimer’s specialists disagree on the need for highly-trained clinicians to carefully select patients and have sufficient resources available to monitor problems.
Karlawish proposed that the FDA create a Risk Evaluation and Mitigation Strategy for lecanemab to minimize the risks of the drug under medical supervision. A REMS currently limits the access to about 60 drugs. However, this strategy wasn’t implemented in the case of lecanemab. FDA warned about possible risks to those who already take blood thinners but did not mention the REMS.
The paradoxical conflict that exists between lecanemab and safety is a major factor in its arrival.
FDA approved Aduhelm in 2021, an anti-amyloid drug that was available before. Lecanemab’s mixed performance is viewed by some Alzheimer’s researchers as proof that amyloid may not be the only answer. Most doctors, however, rejected the drug as being ineffective and dangerous.
Professor George Perry, a neurobiology expert at the University of Texas at San Antonio, hypothesizes that tau and amyloid buildup is a consequence of aging. They play a part in protecting and preserving brain tissue instead of damaging it. According to Perry, the accumulation of amyloid is due to the body’s attempt at fighting aging diseases.
S. Ahmad Sajjadi is a neuroscientist and clinician at University of California, Irvine. He believes that patients should receive treatment as specific and targeted as cancer treatments.
Karlawish stated that lecanemab, even with its risks, offers some hope to patients. There is a 10% possibility of stopping the progress of disease over months and years.
Patients’ advocacy groups such as Alzheimer’s Association who fund much of the clinical research on the subject are calling for lecanemab to be made available for all patients and rejecting Biden’s administration’s plan that Medicare would only pay for it if the patient participated in a post-marketing trial or registry.
Joanne Pike of the Alzheimer’s Association noted that, in average, patients who took lecanemab for the first 18 months saw their decline five months less rapid. She said, “This is a cause for celebration.”
Perry, despite receiving funding from Alzheimer’s Association questions its strong support of the drug given their promise to members and supporters that they would help to find a cure.
They can’t go back now that they’ve been pushing amyloid for so long.