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cover of episode Are Your Medications Safe And Effective?, with Jerry Avorn

Are Your Medications Safe And Effective?, with Jerry Avorn

2025/6/26
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Jerry Avorn: 我认为患者理应认为医生开的药是安全有效的，医生们也认为药品的安全性和有效性是有保障的，因为有FDA的存在。但FDA在制药公司的压力下，对药物的批准变得过于宽松，有时只关注实验室指标的小幅变化。加速审批的初衷是为了应对艾滋病疫情，但现在却出现了一些问题，药品公司过度使用加速审批通道。现在，超过一半的新药通过某种形式的快速审查进入美国市场，这些审查使用的证据标准较低。即使药物未能通过后续研究，它们仍然留在市场上。例如苯肾上腺素是一种无效的感冒药，但仍然在市场上销售。只有一小部分通过加速审批的新癌症药物后来被证明可以延长患者的寿命，药物仅基于肿瘤缩小等替代指标获得批准，但从未证实可以延长总生存期。阿杜卡奴单抗（Aduhelm）是FDA的一个低谷，它并没有改善阿尔茨海默病患者的认知能力，甚至没有减缓病情恶化，而且可能会导致脑出血和中风，但FDA追溯性地批准了它，因为它降低了大脑中的淀粉样蛋白水平，但这从未作为评估的标准。我建议使用有条件批准来解决加速审批的问题，即在受监督的情况下提供药物，并在两年内评估其效果。如果药物尚未被证明有效，就不应该让公司普遍提供药物并收取全价。我们最终都在为那些无效的药物买单。 Jerry Avorn: FDA不测试药物的有效性和安全性，而是允许公司设计、支付、进行和解释研究结果，将药物测试留给制造商可能会导致他们设计研究以隐藏风险或夸大益处。美国允许制药公司随意定价，这是其他富裕国家所没有的。大量的药物开发费用来自公共资金，通过美国国立卫生研究院支付。例如Xtandi是一种转移性前列腺疾病的药物，完全由联邦资金开发，但美国人支付的Xtandi价格是其他国家/地区的两到六倍，尽管该药物的开发几乎完全由公共资金资助。特朗普总统声称要降低处方药的高价，但这可能只是空谈，他的想法是确定世界上某个国家，并迫使Ozempic的制造商以该价格向我们出售。欧洲国家通过说“我们认为这种药物不值得”来降低药价。我想为读者提供一些他们可以关注的东西，并问自己下次去看医生时应该怎么做。我建议患者进行“棕色袋子会议”，将他们正在服用的所有药物带到诊所，医生可以帮助患者识别重复的药物或可能导致副作用的药物。患者有权知道他们摄入的每种化学物质应该在他们的身体中做什么，应该询问药物的预期效果、治疗目标以及服用时间。患者还应该询问药物的费用、是否有仿制药或生物类似药。

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Chapters
This chapter explores Jerry Avorn's concerns about the FDA's drug approval process, particularly the Accelerated Approval Program. It discusses how this program, initially designed for life-threatening illnesses, has been applied more broadly, leading to the approval of drugs with questionable effectiveness. The chapter highlights the concerning trend of drugs remaining on the market despite failing subsequent studies.
  • The FDA approval process has become more permissive, approving drugs based on surrogate measures rather than proven patient benefit.
  • Over half of new drugs reach the market through expedited review with lower evidence standards.
  • Drugs often remain on the market even after failing follow-up studies.

Shownotes Transcript

For a more than a century, the Food and Drug Administration has worked to protect public health. In his research, Harvard University physician-researcher Jerry Avorn has examined how the FDA’s once-rigorous gold standard approval process has been affected by a powerful shortcut known as the Accelerated Approval Program—originally designed for desperate AIDS and cancer patients. He says that change in the 1990s has allowed more than half of all new drugs onto the market before drug companies have proven they actually help people.

In his new book Rethinking Medications: Truth, Power and the Drugs We Take, Avorn cites numerous examples: from a cold medicine that doesn’t de-congest to billion-dollar cancer treatments that only shrink lab results to the controversial Alzheimer’s drug Aduhelm—approved despite no clear cognitive benefits. In this episode, Avorn explores whether some prescriptions in your medicine cabinet are safe, effective and worth the money.