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Biogen Ends Controversial Alzheimer's Drug: An Examination of Ethics and Transparency in the Pharmaceutical Industry

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Ayanna Amadi
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Biogen Ends Controversial Alzheimer's Drug: An Examination of Ethics and Transparency in the Pharmaceutical Industry

Biogen Ends Controversial Alzheimer's Drug: An Examination of Ethics and Transparency in the Pharmaceutical Industry

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Pharmaceutical giant Biogen has recently made headlines by announcing the termination of the license for its controversial Alzheimer's drug, Aduhelm. This decision follows a scandal with the Food and Drug Administration (FDA) that significantly damaged public trust. The implications of this decision and the associated scandal go far beyond the FDA approval process and call for further investigation and exposure. This situation has sparked conversations about ethics and transparency in the pharmaceutical industry, as well as concerns about the impact on Biogen's profits.

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The Termination of Aduhelm

Biogen has decided to discontinue all development and commercialization activities for Aduhelm. This decision came after the drug, initially forecasted to bring in as much as $18 billion in annual revenue, returned disappointing results. Despite initially failing two Phase 3 trials, Biogen submitted its data to the FDA for approval. However, the FDA and independent advisers voted against Aduhelm's approval, citing concerns about the consistency of evidence and lack of compelling evidence of its treatment effect or disease slowing. This decision came at a significant cost to Biogen, with the company taking a financial hit of $60 million in the fourth quarter of 2023 to close out its work on Aduhelm.

The Impact on Biogen

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Aduhelm was the first new Alzheimer’s disease drug introduced in nearly two decades. Initially priced at $56,000 per year, the drug faced multiple challenges after its launch. These included weak evidence of slowing Alzheimer’s, limited insurance coverage, and strict limits from Medicare. As a result, Biogen will now book a charge of about $60 million for shutting down the Aduhelm program. The company has indicated that it will refocus its efforts on other treatments for Alzheimer’s and assist Japanese drugmaker Eisai in selling another Alzheimer’s treatment, Leqembi, which has full FDA approval.

Controversial Approval and Aftermath

Aducanumab, sold as Aduhelm, was approved for medical use in the United States by the FDA in June 2021. This decision was controversial due to ambiguous clinical trial results, the drug's high cost, and a high rate of serious adverse events. The drug was designed to reduce the buildup of aggregated forms of amyloid beta found in the brains of people with Alzheimer's disease. However, its approval was limited to people with mild cognitive impairment or mild dementia stage of the disease. Following the controversy, Biogen withdrew its application for marketing authorization of Aduhelm in April 2022.

Lessons Learned and the Future

The discontinuation of Aduhelm has sparked a debate between those who trust the science and those who believe in the hope of such treatments. This experience echoes past pharmaceutical scandals, reminding us that quackery is still prevalent and many people are susceptible to believing in miracle cures. However, it also serves as a stark reminder of the need for transparency and ethical conduct in the pharmaceutical industry. As Biogen and other pharmaceutical companies move forward, they must place the welfare of patients and the pursuit of scientifically sound treatments at the forefront of their operations.

Alzheimer's Disease Biogen
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