So patients suffer--it's for their own good!!!
So patients suffer--it's for their own good!!!
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所以病人受苦——这是为了他们好！
DOI：
10.1097/mjt.0000000000000155
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发表时间：
2015
影响因子：
4.2
通讯作者：
G. Jay
中科院分区：
文献类型：
--
作者：
G. Jay
食品和药物管理局（FDA）是负责批准治疗感染、癌症、肝脏问题和疼痛等药物的机构。不久前，有一个咨询委员会开会评估氢可酮缓释剂（ER）。令我惊讶的是，委员会并没有把重点放在药物上-好的，坏的，或者漠不关心，但本质上他们把时间花在了阿片类药物滥用上，这是一个重要而适当的话题，但不是在这个时间和地点。据报告，咨询委员会拒绝批准该药物，但FDA有能力推翻委员会的建议，行使了推翻程序并批准了该药物。因此，咨询委员会，这是谈判的问题，这种药物，而不是处理的问题，药物滥用和表达态度的使用阿片类药物，而不是事实资料的主题（药物）手头上。有很多这样的事情。在我的职业生涯中，在我的前25年实践中（我经营着一个三级护理跨学科疼痛和神经康复中心），我看到了超过35，000名患者。没有人，没有一个，过量或死亡。我感到专业的满足感，尽我所能帮助这些病人减轻疼痛，保持或改善功能。我不害怕使用有用和合适的药物。但那是过去，现在是现在：这是那些选择了对病人有利的立场的人的态度，不管他们的需要或对他们的需要没有反应。我不会进入PROP与PROMPT的竞争/关于如何治疗病人的相反观点。其中一个团体有它的斧头要磨，我对FDA处理这个问题的方式印象深刻并感到满意-它保持了患者获得阿片类药物的能力。
The Food and Drug Administration (FDA) is the agency responsible for the approval of medicationsfor infections, cancer, hepatic problems, and pain, to name a few. It was not too long ago that there was an Advisory Committee that met to evaluate hydrocodone extended release (ER). What surprised me was that the committee did not focus on the drug-good, bad, or indifferent, but essentially they spent their time focusing on opioid abuse, an important and appropriate topic, but not for this time and place. It was reported that the Advisory Committee denied approval of this drug but the FDA, which has the ability to override such committee recommendations, exercised the override process and approved the medication. So, the Advisory Committee that was to negotiate the issues of this drug, dealt instead on the issue of substance abuse and expressed attitudes about the use of opioids, not factual information on the topic (medication) at hand.There is a lot of that going around. In my career, in my first 25 years of practice (I ran a tertiary care interdisciplinary pain and neurorehabilitation center) I saw more than 35,000 patients. No one, not one, overdosed or died. And I felt professional satisfaction doing what I could to help these patients decrease their pain and maintain or improve function. I was not fearful to use medications that would be useful and appropriate. But that was then and this is now: It is the attitude of those who have chosen sides-what is good for patients-irrespective or irresponsive to their needs. I would not go into the PROP versus PROMPT rivalry/contrary views on how to treat patientshow to help patients-or not. One group had its axe to grind and I was impressed and gratified by how the FDA handled this issue-it kept the ability of patients to obtain opioids alive.