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America’s approval of aducanumab, a drug to treat Alzheimer’s disease, will have a negative impact beyond the United States, especially in middle-income countries (“False positive”, June 12th). Regulators in these countries normally rely on decisions made by stringent regulatory authorities, including the Food and Drug Administration. The World Health Organisation considers such “reliance” to be good practice and a cornerstone of effective regulation. Unfortunately, the FDA undermines this concept by authorising medicines such as aducanumab without any evidence of the clinical benefit. Some argue that post-marketing studies will shed light on these benefits. However, conditional approvals are rare in middle-income countries and low enforcement makes withdrawing a drug unrealistic.
These countries also spend less on health care and their health systems are more vulnerable to financial pressures coming from expensive biologic drugs, including monoclonal antibodies such as aducanumab. The real costs to them of paying for these unproven medicines are huge.
Director of global health policy
Centre for Global Development
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