“儿科”药物研究可能是医学研究史上最大的滥用。是律师介入的时候了。

IF 0.6 Q2 LAW Journal of Law and Medicine Pub Date : 2023-05-01
Klaus Rose, Jane M Grant-Kels, Pasquale Striano, Tanjinatus Oishi, David Neubauer, Earl B Ettienne
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引用次数: 0

摘要

随着美国和欧洲联盟儿科法要求/要求对18岁以下未成年人的疫苗和药物进行单独的临床研究,出现了一种新的研究类型。从生理上讲,未成年人在18岁之前就成熟了。医学治疗的是身体,而不是行政地位。许多“儿科”研究是在身体上不再是儿童的未成年人身上进行的,这使得它们毫无意义。传统的临床研究中的医疗事故诉讼涉及在临床研究中受到伤害的患者。在新型的“儿科”研究中,已知对人类有效的药物被重新测试,假装“儿童”是唯一不同的,这是不正确的。未成年人不是另一个物种。患者根本不接受治疗(安慰剂组)或低于标准护理(与过时的治疗相比)。儿科法律就是法律,但不是伤害病人的自由通行证。当“儿科”研究违反公认的医疗实践规范时,律师应该意识到医学和法律之间的这种挑战。
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"Pediatric" Drug Studies Might Be the Largest Abuse in Medical Research in History. It Is Time for Lawyers to Step In.

A new type of research has emerged with United States and European Union pediatric laws that request/demand separate clinical studies for vaccines and drugs in minors less than 18 years of age. Physiologically, minors mature before their 18th birthday. Medicine treats the body, not the administrative status. Many "pediatric" studies are performed in minors that bodily are no longer children, which makes them pointless. Traditional malpractice litigation in clinical research involves patients that were harmed in clinical studies. In the new type of "pediatric" studies, drugs known to work in humans are retested, pretending that "children" are uniquely different, which is incorrect. Minors are not another species. Patients are not treated at all (placebo group) or below standard-of-care (comparison to outdated treatment). Pediatric laws are the law, but not a free pass for harming patients. Where "pediatric" studies violate accepted norms of medical practice, lawyers should be aware of this challenge at the interface of medicine and law.

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