The question of whether the FDA is approving Alzheimer’s treatments that don’t actually work is complex and has sparked significant debate. Several new drugs targeting Alzheimer’s disease have been approved in recent years, but their effectiveness and safety profiles have raised concerns among experts, patients, and caregivers.
Alzheimer’s disease is a progressive brain disorder characterized by memory loss and cognitive decline, affecting millions worldwide. For decades, treatments mainly focused on managing symptoms rather than altering the disease’s course. Recently, the FDA has approved a new class of drugs called anti-amyloid therapies, which aim to target amyloid plaques in the brain—believed to be a key factor in Alzheimer’s development.
The first of these, aducanumab, was approved amid controversy. It targets amyloid plaques but showed mixed results in clinical trials regarding whether it meaningfully slows cognitive decline. Some experts questioned if the benefits outweighed the risks, which include brain swelling and bleeding. The FDA’s approval was based on the drug’s ability to reduce amyloid plaques, but the evidence that this translates into clinical improvement remains debated. This has led to concerns that the FDA may have lowered its standards to approve a drug with uncertain clinical benefit.
Following aducanumab, two more drugs—lecanemab and donanemab—received FDA approval. These drugs also target amyloid plaques and have shown somewhat better results in slowing cognitive decline in early-stage Alzheimer’s patients compared to placebo or aducanumab. However, they come with significant risks, such as amyloid-related imaging abnormalities (ARIA), which include brain swelling and hemorrhages. The frequency of these side effects is notable, with some trials reporting brain abnormalities in up to 30% of treated patients. These risks require careful patient selection and monitoring, including expensive brain scans and genetic testing to identify those most likely to benefit and least likely to suffer harm.
Moreover, these treatments are costly, with annual prices ranging from around $26,000 to over $30,000, not including the additional costs of monitoring and managing side effects. This raises questions about accessibility and the overall value of these therapies, especially given that they are only approved for early-stage Alzheimer’s and are not suitable for all patients.
The FDA has responded to safety concerns by updating dosing guidelines to reduce risks, such as modifying donanemab’s titration schedule to lower the incidence of ARIA. These adjustments aim to balance efficacy with patient safety but underscore the challenges in developing truly effective and safe Alzheimer’s treatments.
In summary, while the FDA has approved several new Alzheimer’s drugs that represent a shift toward disease-modifying therapies, their actual clinical benefit remains modest and accompanied by significant risks and costs. The debate continues over whether these approvals reflect meaningful progress or premature endorsement of treatments that do not yet conclusively work. Patients and healthcare providers must weigh the potential benefits against the risks and uncertainties, and ongoing research is crucial to develop safer, more effective options.
