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Medical Marijuana Faces Fed's Catch-22
医用大麻面临第22条军规
Medical marijuana is now available in 28 states. But a big obstacle to research on marijuana as medicine is that it’s listed by the federal government on what’s called Schedule I. Assignment to Schedule I means that the Food and Drug Administration does not recognize a legitimate1 medical purpose to a substance.
目前有28个州可购买到医用大麻。但大麻作为医学研究的一大障碍是,它被联邦政府列入了一级管制药物名单,而这意味着食品和药物管理局不承认它拥有合法的医学用途。
\At a session on medical marijuana at the annual meeting of the American Association for the Advancement2 of Science on February 19th, I asked researcher Ryan Vandrey, of the Johns Hopkins University School of Medicine, about getting marijuana off of the list of Schedule I substances.
在2月19日召开的美国科学促进会年会上,我在一次关于医用大麻的会议上询问了约翰·霍普金斯大学医学院的研究员瑞安·沃瑞,关于把大麻从一级管制药物名单中移除的问题。
RV: “Well, it can’t come off of Schedule I to a different schedule until the traditional drug development work has been done, and I don’t think the traditional drug development work really can be done while it’s Schedule I. It just makes large Phase III trials in hospital-based programs near impossible.”
“嗯,在传统药物开发工作已经完成之前,大麻就不能从一级管制药物名单中去除然后移到另一个药物管制名单中。而我认为只要大麻还在一级管制药物名单中,传统的药物开发工作就不可能完成。它使得医院项目中大规模的三期临床实验几乎不可能完成。”
SM: “So it’s a catch-22.”
“所以这就像是‘第22条军规’。”
“It’s a catch-22. So I think the only way to really get around that is kind a two paths. One, you just unscheduled it completely. Alcohol is not scheduled, for example, so that’s the pathway that some of the states have gone, just making it available. Or treating is as like a botanical, herbal product. The other way would be to kind a wait until we get more targeted, specific products. So not whole plant cannabis, but maybe more specific formulations with specific cannabinoid profiles, would be the other way.”
“是的。我认为可行的办法只有两种。第一,把它完全移出名单。例如,酒精就不在名单中,有些州就采取了这种方法,就让医用大麻能够被购买到。或者,将大麻当作植物性药材和草药产品。另一种方法是一直等到我们研发出更有针对性、更具特效的药物。可以不用整株大麻,而是用含有特定大麻素成分的更具体的配方。这或许会是一种行得通的方法。”
SM: “Your life would be easier with it off?”
“如果将其移除,你会觉得更轻松吗?”
RV: “Oh, absolutely. [laughs] Without a doubt. And just to clarify, the limitations that we have in doing research is that we are limited to doing research with products that are available through the federal drug supply program. They have quite a bit, but they don’t have everything. And then the limitation is even using their product we have to go through extra levels of regulatory scrutiny3 and experience substantial delays in doing our research.”
“当然。毫无疑问。特别说明一下,我们做研究会有局限性,是因为我们只能通过联邦药品供应计划提供的药品来做研究。虽然他们有很多种药品,但并不是什么都有。另一个局限性就是,即使我们使用的是他们提供的药物,我们也仍必须接受额外的监管审查,这也使得我们的研究经常被拖延。”
1 legitimate | |
adj.合法的,合理的,合乎逻辑的;v.使合法 | |
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2 advancement | |
n.前进,促进,提升 | |
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3 scrutiny | |
n.详细检查,仔细观察 | |
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