The Dark Side of New Alzheimer’s Drugs: Genevieve Lane’s Tragic Story
Six years ago, Genevieve Lane, then 76, was still living an active life in Florida. Memory lapses began with forgetting her neighbors’ names and misplacing her keys. However, increasing periods of confusion and getting lost on walks led her to a nearby research center. There, a doctor diagnosed her with early Alzheimer’s disease and suggested she join a study testing a promising new drug, eventually yielding Leqembi. Initially, Lane and her housemate, Vicki Holmes, thought the drug was working. However, Lane was actually receiving a placebo, and when the trial concluded, she switched to the real drug. Six weeks later, Lane passed away, leaving her family with many questions.
Genevieve’s daughter, Yvonne Battaglia, demanded an autopsy, suspecting the drug may have played a role in her mother’s death. However, when both the research firm hired by the drugmaker and the hospital refused to conduct the examination, her family eventually hired an independent neuropathologist. The results were gruesome: Lane’s brain was littered with ruptured blood vessels, widespread inflammation, and dead cells. A second, independent autopsy confirmed: Severe cerebral inflammation, likely due to Leqembi, caused Genevieve’s death.
Despite Genevieve’s tragic story, the US Food and Drug Administration approved Leqembi in 2023, along with two other similar drugs: Aduhelm and Kisunla. These drugs aim to combat Alzheimer’s by eliminating amyloid plaques, a protein buildup in the brain thought to be behind the disease. However, the safety and efficacy of these medications remain highly questionable, raising serious concerns about their approval.
The Controversial Approval of Alzheimer’s Drugs
The journey of these drugs began decades ago with the “amyloid hypothesis,” which posits that Alzheimer’s is caused by amyloid plaque buildup. However, experts have long questioned the hypothesis. Recent investigations found that key studies supporting the theory had fabricated technical images. Even with this doubt, the pharmaceutical industry invested billions in developing drugs targeting amyloid.
Despite the overwhelming evidence of Aduhelm’s ineffectiveness, Biogen applied for accelerated FDA approval based on its ability to remove amyloid. This was unprecedented and generated significant controversy. Biogen and Eisai, the companies behind Leqembi, followed a similar approval process. Leqembi’s first clinical trial failed to demonstrate cognitive benefits, with the company using secondary effects like amyloid reduction to justify its approval. The FDA then relied heavily on a newly constituted advisory panel with financial ties to the drugmakers, leading to a unanimous approval.
While the FDA faces pressure to approve treatments for devastating diseases like Alzheimer’s, these approvals often neglect rigorous scientific standards. The Alzheimer’s Association, a major advocate for the approval, received substantial funding from drug companies, raising questions about conflicts of interest influencing their stance.
The Dangers of Leqembi and Similar Drugs
Leqembi, Aduhelm, and Kisunla share similar mechanisms and risks. They target amyloid plaques in the brain, leading to significant side effects in many patients. Brain swelling and hemorrhages are among the most severe adverse events, sometimes fatal. One of the most tragic cases was Monique, a woman in her late sixties who enrolled in a Leqembi trial. After receiving the drug, she suffered seizures, developed severe delirium, and rapidly progressed into dementia.
A similar fate befell Nicole Nicolle, a 70-year-old also part of the trial, who experienced massive cerebral hemorrhage and severe cognitive decline. These incidents highlight the serious dangers of the drugs. Neuropathologist Rudolph Castellani from Northwestern University warns that repeatedly administering these drugs could lead to long-term, severe brain damage.
Autopsy results from patients who died while taking Leqembi further highlighted the drug’s serious risks. One such case involved Genevieve Lane, whose death was attributed to severe cerebral inflammation.
Problems in Clinical Trials and FDA Oversight
Key issues in clinical trials and FDA oversight have raised concerns about the reliability of the drugs. The absence of comprehensive patient data and a lack of transparency in handling missing patients during clinical trials of Kisunla have cast doubt on the true effectiveness and safety of these medications. In the case of Kisunla, Eli Lilly initially failed to track 391 patients who dropped out of the trial, a practice that can make a drug appear safer than it is.
The FDA’s approval process has faced criticism, particularly with regards to the panels reviewing these drugs. In the case of Leqembi, the newly appointed advisory panel consisted of experts with strong ties to the drugmakers, raising concerns about possible bias. Independent researchers and neuronal pathologists continue to voice strong concerns about the unseen long-term effects of these drugs and the inaccurate portrayal of their benefits by manufacturers.
Efficacy and Ethical Concerns
The extent to which these drugs benefit patients is also a matter of debate. While drugmakers claim Leqembi and Kisunla slow cognitive decline, the evidence suggests minimal improvement. Studies relying on the CDR-SB test, a widely accepted cognitive assessment tool, showed negligible differences between groups receiving the drugs and those on placebo. Leqembi produced a difference of 0.45 points, while Kisunla showed a 0.7-point difference on the CDR-SB scale over a year and a half.
The Alzheimer’s Association, under pressure from funding sources, even lowered the standard for meaningful cognitive difference, which is widely criticized. Despite this, the FDA approved Leqembi in July 2023. This decision has been met with strong opposition from many independent experts.
International and Economic Implications
International reactions to these drugs have been mixed. Australia and the European Medicines Agency initially refused to approve Leqembi, citing insufficient benefits and unacceptable risks. However, following substantial pressure from Eisai, the European Medicines Agency approved Leqembi with restrictions. In contrast, the UK’s National Health Service rejected funding for Leqembi. Given the high cost and limited benefits of these drugs, widespread adoption could strain healthcare budgets globally.
Cost remains a significant issue. Medicare estimates spending $3.5 billion on Leqembi in 2025 alone. The effectiveness and safety of the drugs mandate stringent post-market monitoring, yet the current regulatory framework often fails to ensure this. In particular, the delay in final safety reports and the lack of public access to raw data hamper independent scrutiny.
Conclusion: Moving Forward
The controversy surrounding these new Alzheimer’s drugs underscores the need for more rigorous oversight and clearer communication about their benefits and risks. While the amyloid hypothesis remains prominent, alternative theories and treatment approaches need further exploration. The current focus on anti-amyloid drugs, driven by financial incentives and public pressure, may be diverting resources away from potentially more promising avenues in Alzheimer’s research.
Vanderbilt University’s Matthew Schrag emphasizes that patients should prioritize quality of life before embarking on high-risk treatment regimens. Encouraging patients to focus on meaningful activities during early Alzheimer’s stages could offer significant benefits. Despite the many questions and uncertainties, the healthcare community must continue to strive for treatments that truly improve patients’ lives without excessive risks.
“Patients taking these drugs are tethered to the hospital,” says Schrag:
“They have to undergo extensive testing, including a PET scan or spinal tap, to qualify for the treatment, then physically come to an infusion center every two to four weeks to receive the treatment and return multiple times in the first year for MRIs. If they develop side effects, which could range from headaches to disabling neurological symptoms, they may need even more testing.”
As the search for a true breakthrough in Alzheimer’s treatment continues, stakeholders must remain vigilant and demand transparency, rigorous scientific standards, and compassionate care.
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