从肥胖和糖尿病到心脏病和肝病，自七年前Ozempic(semaglutide，司美格鲁肽)问世以来，GLP-1类药物 的应用不断扩展。如今，诺和诺德(NVO.US)正在测试该药物对阿尔茨海默症的效果。 诺和诺德计划在12月初圣迭戈的一场会议上公布两项涉及3,500多名轻度阿尔茨海默症患者的Ozempic试 验数据。如果遵循行业惯例，该公司可能会在数据分析完成后更早公布试验是成功还是失败。 目前已有的阿尔茨海默症药物主要是通过对抗淀粉样蛋白来起作用，这是一种在患者大脑中积聚的有毒 畸形蛋白。而使用司美格鲁肽的思路则不同。该药物模拟一种名为GLP-1的肠道激素，研究人员认为它 可能通过降低炎症并改变大脑使用糖的方式来发挥作用。多项研究显示，糖尿病患者更容易患上痴呆， 因此这一联系或许合理。 诺和诺德首席科学官Martin Holst Lange表示："这本身并不能作为确凿证据，但它确实引起了我们的注 意。"当时，诺和诺德已经在研究其更新的GLP-1药物是否能够帮助肥胖相关的心脏、肝脏和关节疾病 患者。受到这份丹麦数据分析(诺和诺德也参与发表)的推动，该公司决定同时测试这些药物对阿尔茨海 默症的疗效。 这些临床试验 ...

Core Viewpoint - A bipartisan group of over 80 U.S. lawmakers is urging the FDA to enhance regulation of the growing market for counterfeit and illegal weight loss drugs, citing rising safety concerns [2][4]. Group 1: Legislative Actions - Lawmakers have sent a letter to the FDA, expressing concern over the surge of illegal and counterfeit anti-obesity medications, particularly generics of GLP-1 drugs like Wegovy and Zepbound [2]. - The initiative is led by Representatives Richard Hudson and Herb Conaway, who are calling for stricter enforcement against illegal weight loss drugs, including monitoring of online retailers and compounding pharmacies [2][4]. - They have requested a written response from the FDA by July 30 to reflect the urgency of the issue [4]. Group 2: FDA's Response and Actions - An FDA spokesperson stated that the agency will work with the HHS to provide a comprehensive response to the lawmakers' concerns, emphasizing the importance of ensuring the safety of the U.S. drug supply [5]. - The FDA has acknowledged the rise of counterfeit GLP-1 drugs in the market and has previously allowed some pharmacies to compound these medications during supply shortages, but this permission has since been revoked as production capacity has increased [5][6]. Group 3: Market Concerns and Risks - Counterfeit drugs are often produced by unlicensed entities using illegally imported ingredients, posing significant health risks to patients [6]. - Some patients are resorting to purchasing raw materials online to compound their medications at home, which is highly risky [6]. - The FDA has confirmed that some hospitalizations may be linked to these counterfeit drugs, although adverse reactions may be underreported [6]. Group 4: Industry Response - Companies like Novo Nordisk and Eli Lilly have been urging consumers not to use compounded or counterfeit GLP-1 products and have taken legal action against telehealth companies providing these products [6]. - There is increasing pressure on federal regulators to balance the rising demand for GLP-1 drugs with the proliferation of counterfeit products, which is becoming a critical challenge for the FDA [7].