Joyce C R
J Med Ethics. 1976 Sep;2(3):112-7.
The tragic results for the babies of patients prescribed thalidomide, although they can indeed be termed "side" effects, hardly warrant so slight an epithet, and Dr Joyce in his paper would like the term to be dropped in favour of "additional" effects of drugs. Despite extensive clinical trials before drugs are put before the prescribing doctor, side effects cannot be entirely anticipated or eliminated, and indeed many are not harmful. However, it is important, Dr Joyce argues, for information to the doctor from the patient and from the doctor to the manufacturer to be collected and evaluated. Only in this way can effects of drugs other than those intended be drawn to the notice of the manufacturer. The commentary by two practising physicians emphasizes the ambiguities in the descriptive literature accompanying a new drug. Dr Herxheimer and Dr Higgs would like to see some sort of panel to be established to reassess drugs in the light of observations on their effects and "side" effects on patients, a task which the existing Committee on Safety of Medicines could not at the moment undertake. A medical need for a new drug should be established before it is manufactured, let alone offered to the general practitioner.
给服用沙利度胺的患者的婴儿带来的悲剧性后果,尽管这些后果确实可以被称为“副作用”,但这个词实在是太轻描淡写了,乔伊斯博士在他的论文中希望放弃这个词,而采用“药物的附加作用”。尽管在将药物提交给开处方的医生之前进行了广泛的临床试验,但副作用无法完全预测或消除,而且实际上许多副作用并无危害。然而,乔伊斯博士认为,收集和评估患者向医生提供的信息以及医生向制造商提供的信息非常重要。只有这样,制造商才能注意到药物的预期作用之外的其他作用。两位执业医生的评论强调了新药附带的描述性文献中的模糊之处。赫克斯海默博士和希格斯博士希望成立某种专门小组,根据对药物对患者的作用和“副作用”的观察结果重新评估药物,而现有药品安全委员会目前无法承担这项任务。在生产新药之前,更不用说将其提供给全科医生之前,应该确定对新药的医疗需求。