Drug Trials Often Do Not Include Overweight People

Drug Trials Often Do Not Include Overweight People

药物试验常常不包括超重的人群

【原文听力】

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　　By Gena Bennett

　　20 November 2023

　　More than 40 percent of American adults are considered obese, or medically overweight. But the medications many of these individuals take are rarely tested in bigger bodies.

　　Obese people are currently not required to be included in drug studies. Often, they are purposefully left out.

　　This is a problem because the amount of drugs an obese person should take to be safe is unknown, says Christina Chow. She is a researcher who has sought to bring attention to the need to include obese people in drug development and testing. "There's no real emphasis for them to be studied at all," Chow told The Associated Press.

　　Medications can work differently in people who are obese, but exactly how and at what amount is not clear. Research suggests this includes antibiotics and antifungal drugs, medications used to treat serious infections. It even includes ibuprofen, a commonly used painkiller that can be bought without a doctor's orders.

　　The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are the agencies that control and provide money for drug testing. At a gathering last year, FDA Commissioner Dr. Robert Califf noted a "deficit of evidence" about how medicines act in patients who are obese. The NIH now asks researchers to think about the results of not including obese people in their studies, an agency spokesperson said.

　　At a recent medical conference, Chow presented a review of more than 200 studies for new drugs in the U.S. last year. Nearly two-thirds of the studies failed to include weight or body mass index, a numerical value noting if a person is obese.

　　Historically, some populations have not been included in drug testing to avoid harm, including pregnant women and children. In the past, women, racial and ethnic minorities and aged people have also not been included.

　　Dr. Caroline Apovian is a researcher at Brigham and Women's Hospital in Boston. She is the co-author of Chow's study. Apovian told the AP there are many reasons people who are obese are not included in drug tests.

　　She noted that people who volunteer for trials are often thin and healthy and this does not effectively represent the general population. Obese individuals can have many health difficulties, and researchers often worry this will affect results of their work.

　　"Sometimes patients with obesity have many more comorbidities than others. They'll have more diabetes, more heart disease, more strokes," Apovian said.

　　But if drugs are not studied in a condition that affects 42 percent of the U.S. population, the real-world effects can be dire, experts say.

　　Some drugs remain in the body longer in obese people. That could result in harmful drug interactions if another medication is added too soon. There can also be less medication in the blood, leading to undertreatment, Apovian said.

　　Rexulti is a drug often used to treat people with schizophrenia or depression, Chow noted. Research has shown that in obese patients it may take much longer to reach the amount of Rexulti needed to be effective. As a result, many patients and their doctors may stop treatment too early or believe the drug does not work.

　　"Not treating or undertreating schizophrenia may be dangerous to themselves and the people around them," Chow said.

　　Even a drug as common as ibuprofen may not reduce pain in people at higher weights when taken as directed, research shows.

　　But without testing and clear directions, doctors won't know the amount of medicine needed for obese people, said Dr. Colleen Tenan. She is a board member of the Association of Clinical Research Professionals. Tenan said it is very hard to be a doctor and direct patients to take amounts of medication that have not been tested.

　　Change is coming, but progress is slow, said Dr. Alison Edelman. She is an obstetrician and researcher at Oregon Health & Science University. She told the AP that in 2019, the FDA suggested that researchers permit obese women in studies on birth control. Even though the suggestions are not required, they have already changed how she and other researchers structure their studies.

　　"Because unless we see representation in our study population, we don't end up with treatments that work well for individuals," Edelman said.

　　Apovian, from Brigham and Women's Hospital, said patients can ask their doctors about whether the usual amount of a medication is acceptable for their weight. Even if the doctors do not know, the question could start an important discussion about the most effective treatments.

　　"This is a big issue," Apovian said. "It can be important for patients to speak up."

　　I'm Gena Bennett. And I'm Bryan Lynn.

　　Jonel Aleccia reported this story for The Associated Press. Gena Bennett adapted it for VOA Learning English.

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　　作者：吉娜·贝内特

　　2023年11月20日

　　超过40%的美国成年人被认为是肥胖的，或者医学上的超重。但是，这些人群中的许多人所服用的药物很少在较大的身体中进行测试。

　　目前，肥胖人群并不需要参与药物研究。通常，他们被有意排除在外。

　　这是一个问题，因为肥胖人群应该服用多少药物才是安全的是未知的，Christina Chow说。她是一名研究员，一直在努力引起人们对将肥胖人群纳入药物开发和测试的需求的关注。"他们根本没有被研究的真正重点，"Chow告诉美联社。

　　药物在肥胖人群中的作用可能会有所不同，但具体如何以及需要多少量并不清楚。研究表明，这包括抗生素和抗真菌药物，这些药物用于治疗严重感染。甚至包括布洛芬，这是一种常用的止痛药，可以在没有医生的指示下购买。

　　美国食品和药物管理局（FDA）和国家卫生研究院（NIH）是控制和提供药物测试资金的机构。在去年的一次集会上，FDA局长罗伯特·卡利夫博士指出，关于药物在肥胖患者中的作用存在“证据不足”。NIH现在要求研究人员考虑不包括肥胖人群在他们的研究中的结果，一位机构发言人说。

　　在最近的一次医学会议上，Chow提交了对去年美国新药的200多项研究的审查。近三分之二的研究未包括体重或体质指数，这是一个数字值，用来指示一个人是否肥胖。

　　从历史上看，为了避免伤害，一些人群并未被纳入药物测试，包括孕妇和儿童。过去，妇女、种族和民族少数群体以及老年人也未被纳入。

　　卡罗琳·阿波维安博士是波士顿布里格姆妇女医院的一名研究员。她是Chow研究的合著者。阿波维安告诉美联社，肥胖人群未被纳入药物测试的原因有很多。

　　她指出，自愿参加试验的人通常都是健康的瘦人，这并不能有效地代表一般人群。肥胖个体可能有许多健康问题，研究人员常常担心这会影响他们工作的结果。

　　"有时候，肥胖病人的并发症比其他人多得多。他们会有更多的糖尿病，更多的心脏病，更多的中风，"阿波维安说。

　　但是，如果药物没有在影响美国42%人口的病症中进行研究，那么实际效果可能会非常严重，专家说。

　　一些药物在肥胖人群体内的停留时间更长。如果过早添加另一种药物，可能会导致有害的药物相互作用。也可能导致血液中的药物减少，导致治疗不足，阿波维安说。

　　Chow指出，Rexulti是一种常用于治疗精神分裂症或抑郁症的药物。研究已经表明，在肥胖患者中，可能需要更长的时间才能达到有效治疗所需的Rexulti量。因此，许多患者和他们的医生可能过早地停止治疗，或者认为药物无效。

　　"不治疗或治疗不足的精神分裂症可能对他们自己和周围的人构成危险，"Chow说。

　　研究显示，即使是像布洛芬这样常见的药物，如果按照指示服用，也可能无法减轻体重较高的人的痛苦。

　　但是，如果没有测试和明确的指示，医生就不会知道肥胖人群需要多少药物，克莱恩·特南博士说。她是临床研究专业人员协会的一名董事会成员。特南说，作为一名医生，指导患者服用未经测试的药物量是非常困难的。

　　变革正在进行中，但进展缓慢，艾莉森·埃德尔曼博士说。她是俄勒冈健康与科学大学的产科医生和研究员。她告诉美联社，2019年，FDA建议研究人员允许肥胖妇女参与避孕研究。尽管这些建议并非必需，但它们已经改变了她和其他研究人员设计研究的方式。

　　"因为除非我们在研究人群中看到代表性，否则我们最终得不到对个体有效的治疗方法，"埃德尔曼说。

　　来自布里格姆妇女医院的阿波维安表示，患者可以询问医生是否通常的药物量适合他们的体重。即使医生不知道，这个问题也可能引发关于最有效治疗的重要讨论。

　　"这是一个大问题，"阿波维安说。"患者发言可能很重要。"

　　我是吉娜·贝内特。我是布莱恩·林恩。

　　乔内尔·阿莱西亚为美联社报道了这个故事。吉娜·贝内特为美国之音学习英语改编了它。

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　　本故事中的词汇

　　emphasis –n. 特别重要

　　comorbidities - n. 患者的两种或多种疾病或医疗状况

　　dire – adj. 极其严重或紧急

　　schizophrenia – n.一种影响大脑处理信息方式并导致与现实脱节的疾病