When the FDA approved Aducanumab, the world wasn’t watching. Most people weren’t even aware. The controversy surrounding this Alzheimer’s drug barely made a ripple in public consciousness. But within a small, devoted group of scientists, pharmacologists, and advocates, a wave of disbelief and betrayal spread quietly. These are the people who understand the high stakes of Alzheimer’s treatments, the tightrope of scientific rigor, and the desperate consequences of undermining regulatory standards. And they were the ones who watched, horrified, as the FDA took an unprecedented step that exposed the fault lines in a system meant to protect us all.
Act 1: A Dubious Approval and an Expert Outcry
Aducanumab, or Aduhelm, was supposed to be a breakthrough in Alzheimer’s treatment. The drug targets amyloid plaques in the brain, long seen as a hallmark of Alzheimer’s. But for all its promise, Aducanumab faced a problem: its clinical trials didn’t show that it improved cognitive outcomes. In fact, the trials were halted in 2019 due to a lack of clear benefits. Still, the FDA moved ahead, granting approval based on “surrogate endpoints”—namely, the reduction of amyloid plaques, even though the link between these plaques and cognitive improvement remains highly uncertain . Inside the FDA, tensions erupted. Three advisory committee members resigned in protest, calling the decision “a debacle” and “one of the worst” in the agency’s history. Dr. Aaron Kesselheim, one of those who resigned, minced no words: “This might be the worst approval decision that the FDA has made that I can remember.
But for the public, the shock and disappointment felt by this small circle of experts went largely unnoticed. This wasn’t a blockbuster headline; it was a distress signal from the people who understand just how far-reaching the implications of this decision could be.
Act 2: A System Under the Influence
The outrage over Aducanumab isn’t just about one questionable drug; it’s about the erosion of trust in a system that’s supposed to be unimpeachable. The FDA’s accelerated approval pathway, intended to fast-track life-saving treatments, was twisted here to push through a drug with unproven benefits. And for those within the regulatory and scientific community, the decision raised uncomfortable questions about the FDA’s independence from corporate influence. Biogen, Aducanumab’s manufacturer, stood to make $56,000 annually per patient —a stunning sum for a drug whose efficacy was far from proven. Biogen’s close ties with the FDA during the approval process prompted criticisms that regulatory capture—where a watchdog agency is compromised by the industry it oversees— had hit new lows. For those who understand the nuances, this wasn’t just a breach; it was a betrayal of trust in the very standards that safeguard public health.
Act 3: The Domino Effect on Global Trust
The FDA’s credibility matters beyond U.S. borders, especially in places like India, where regulatory bodies often lean on the FDA as a gold standard. India’s Central
Drugs Standard Control Organization (CDSCO) is underfunded and overburdened. For a country like India, relying on the FDA’s decisions as a shortcut in drug approval is tempting, almost necessary. But with the FDA’s judgment now under a cloud, who’s left to guide India’s regulatory decisions? This scandal leaves India vulnerable. Without a robust, independent infrastructure for drug approval, India risks inheriting the fallout from the FDA’s missteps, approving drugs whose benefits and safety are questionable. Patients, trusting in the CDSCO’s guidance, could unknowingly face the consequences of the FDA’s compromised standards. Here, the implications of Aducanumab’s approval move beyond scientific debate—they become matters of public health and safety.
Act 4: Opportunists on the Rise
The effects of the FDA’s missteps don’t just weaken regulatory standards; they embolden alternative medicine providers and conmen who thrive in an environment of eroded trust. With each questionable approval, the credibility of the FDA—and by extension, all mainstream medicine—wanes. In India, where traditional and alternative medicine already hold significant sway, the FDA’s compromised credibility fuels a ripe environment for unproven, often dangerous treatments. Snake oil salesmen seize this vacuum of trust, offering unregulated “miracle cures” that exploit patients desperate for solutions. For those who see the FDA’s approval as a green light, the real risk lies not in Aducanumab alone but in the creeping skepticism that leads patients away from scientifically vetted treatments.
Act 5: Rebuilding a Broken System
For those in the scientific community, Aducanumab’s approval is a stark wake-up call, a reminder that transparency, accountability, and rigorous scientific standards aren’t just ideals—they’re essentials. The FDA’s accelerated approval pathway, while useful in life-threatening situations, must be reformed to prevent further misuse. Closing the revolving door between regulatory bodies and the industries they’re meant to oversee is essential if the FDA wants to restore its standing as an impartial guardian of public health. In India and other developing countries, dependency on the FDA can no longer substitute for a strong, independent regulatory process. India’s CDSCO must strengthen its own infrastructure, enforce stringent post-approval studies, and adopt rigorous pharmacovigilance. The trust of the people isn’t a luxury; it’s the bedrock of effective healthcare. Each compromise by the FDA is a call for other nations to reconsider their reliance on its judgment.
Conclusion: A Crisis of Trust
Aducanumab’s approval wasn’t a front-page scandal, but it should have been. For those who understand the stakes—experts, scientists, advocates—it was a jarring, painful reminder of what’s at risk when regulatory bodies put corporate interests above patient welfare. The FDA’s influence, felt in every corner of the world, means that each misstep reverberates, reshaping global perceptions of medicine and opening the door to misinformation and exploitation. Aducanumab isn’t just a cautionary tale for the FDA; it’s a global wake-up call. If
the world doesn’t take notice now, we risk more questionable approvals, more resignations in protest, and ultimately, a future where trust in the entire
pharmaceutical system is the real casualty.