The recent introduction of two new drugs, lecanemab and donanemab, has sparked significant debate among doctors and experts regarding their potential to revolutionize the treatment of Alzheimer’s disease. As the first therapies capable of slowing the progression of this debilitating condition, they have generated both hope and skepticism within the medical community.
Proponents of these drugs, including British biologist John Hardy, argue that we have “turned a corner” in Alzheimer’s treatment. Hardy, who has researched the disease since the 1990s, believes that lecanemab, marketed as Leqembi, and donanemab, sold as Kisunla, represent a significant advancement in medical research. However, critics like Rob Howard, a professor of old-age psychiatry at University College London, caution that these drugs may foster unrealistic expectations among patients and their families.
Lecanemab and donanemab were developed by pharmaceutical giants Biogen, Eisai, and Eli Lilly, respectively. Despite their promise, the controversy surrounding their effectiveness and approval has led to varied responses from different countries. The United States approved lecanemab in 2023 and donanemab earlier this year. In contrast, the European Union rejected lecanemab in July, casting doubt on donanemab’s approval prospects. The UK has taken a middle ground, approving lecanemab but not offering it through its National Health Service.
While both drugs are heralded as the most effective treatments for Alzheimer’s to date, their actual impact remains modest. Clinical studies indicate they may reduce cognitive decline by approximately 30% in patients at the onset of the disease. Critics argue, however, that these benefits are minimal and may be “practically invisible” on an individual level.
Another significant concern is the cost. Lecanemab, priced by Biogen and Eisai, could cost the European Union around 133 billion euros if administered to all eligible patients, according to a 2023 study. Critics emphasize that the potential side effects, including brain swelling or bleeding, do not justify such an expense.
Despite these concerns, advocates believe the drugs could provide patients with valuable additional months of autonomy, especially if administered earlier in the disease’s progression. Advances in diagnostic techniques may soon enable earlier detection, making early treatment more feasible.
The disparity in national drug approval policies raises concerns about equity in access to treatment. Hardy warns that wealthier individuals may travel to the U.S. to obtain these drugs, leaving poorer patients behind. This potential gap underscores the need for a more equitable healthcare approach.
The roots of this debate can be traced back to a pivotal 1992 article by Hardy that posited amyloid plaques as the primary trigger of Alzheimer’s disease. Over the decades, numerous drugs targeting these plaques have failed until the emergence of lecanemab and donanemab.
Skepticism surrounding the new drugs may also stem from the disillusionment with previous Alzheimer’s treatments, which were touted as breakthroughs despite their ineffectiveness. Critics like Christian Guy-Coichard have accused pharmaceutical companies and Alzheimer’s advocacy groups of being overly interconnected, raising questions about the motivations behind these new drugs.
On the other hand, organizations like France Alzheimer emphasize the pressure from patients’ families for new treatments, highlighting a desperate need for effective therapies. Benoit Durand, the deputy director of France Alzheimer, expressed frustration over the EU’s decision to reject lecanemab, fearing that such setbacks could deter pharmaceutical companies from investing in Alzheimer’s research.
While lecanemab and donanemab represent a potential turning point in Alzheimer’s treatment, their limited effectiveness, high costs, and varying international approval responses complicate the narrative. The ongoing debate reflects a broader struggle within the medical community to balance hope for new treatments with the realities of patient care and financial accessibility. As research continues, the quest for truly transformative Alzheimer’s therapies remains a critical and urgent challenge.
