The FDA should not approve Aducanumab without further study.

is a claim about the FDA’s recent decision to approve an experimental Alzheimer’s drug for use despite a substantial rejection by its own scientific panel of experts on the subject.

Insufficient Evidence [edit]

There is insufficient evidence currently supporting its effectiveness; future study is needed [Tx9].

Future development [edit]

Current attempts to pursue drugs that target amyloid buildup (eg Aducanumab) have generally not born fruit, and are squeezing out funding for other approaches that may be more promising [TxF0]. Consequently, if this drug ultimately proves to be ineffective, or worse cause negative effects, then it will significantly impede the development of alternative medications in the future. [TxFF]

Undermining trust in the FDA [edit]

Patients, even when told about the problematic evidence, will still try the because they will assume there was a compelling reason it received F.D.A. approval. [Tx4]

Need does not outweigh scientific rigor [edit]

Alzheimer’s is a devastating disease without a cure, and has had no new medications approved for its treatment since 2003. Consequently, there is a significant amount of despair and hopelessness associated with its diagnosis. One argument offered for approval of Aducanumab at this juncture is that its potential benefits outweigh the lack of conclusive evidence since the need for any option is so great [FxB]. This undermines the scientific process, however, and will lower standards for future drugs, allowing them onto the market before experts in the field are convinced the benefits outweigh any safety risks. [Tx4] It is also not justified in this specific case since the potential benefits of the drug are insufficient to merit the undermining of scientific credibility.

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