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医用大麻面临药物名单困境

医用大麻面临药物名单困境(科学60S) 0:00/0:00
最新发布时间: 2017-07-31
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Doing large studies of marijuana’s potential as medicine means getting it removed from an official federal list of substances with no official medical use-which requires more proof of its potential as medicine.

如果对大麻的潜在药理研究能获得更多大麻药物潜能的证据,那么联邦非官方药用名单有望将其移除。

 

撰文/播音:史蒂夫·米尔斯基(Steve Mirsky)

翻译:郭鑫鹏

审校:杨枭

 

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. Assignment to Schedulemeans that the Food and Drug Administration does not recognize a legitimate medical purpose to a substance.

医用大麻目前在28个州被使用。但是大麻作为药物研究一个巨大的障碍是它被联邦政府列入了Ⅰ类药物名单。Ⅰ类药物表明食品和药物管理局并不承认某个物质的合法药用目的。

 

At a session on medical marijuana at the annual meeting of the American Association for the Advancement 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 Schedulesubstances.

2月19日美国科学促进会年度会议有关医用大麻的议程上,我询问了约翰·霍普金斯大学医学院研究员瑞安·班得瑞(Ryan Vandrey)关于将大麻从Ⅰ类药物中去除的事情。

 

RV: ”Well, it can’t come off of Scheduleto 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. It just makes large Phase trials in hospital-based programs near impossible.”

瑞安·班得瑞:“嗯,在传统药物发展工作没完成之前它不能从Ⅰ类药物归为其他类药物,但我也不认为它被归为Ⅰ类药物的现在,传统药物工作能够完成。现在这样的情况做大量Ⅲ期临床试验几乎不可能。”

 

SM: “So it’s a catch-22.”

科学美国人:“所以这是一个两难问题。“

 

RV: “It’s a catch-22. So I think the only way to really get around that is kinda 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 kinda 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.”

瑞安·班得瑞:“没错。所以我认为有两条途径能够解决这个问题。一是,你完全将它列入未分类。例如酒精就没被归类。某些州已经采取了这样的措施,让它能够使用。或者把它看作一个植物、草药作物。另一条路需要等我们得到更多特定的产品。所以,虽然不是整株大麻,但更具体的具有特定大麻成分的配方可能会是另一条解决途径。“

 

SM: “Your life would be easier with it off?”

科学美国人:“这样的话你的生活会更轻松吗?“

 

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 scrutiny and experience substantial delays in doing our research.”

瑞安·班得瑞:“噢,当然。【笑】毫无疑问。澄清一点,我们做研究的限制是我们仅被限制使用联邦药物供应项目中允许的产品做研究。他们有不少,但不是所有。甚至我们使用他们的产品还需要通过额外的监管审查,这会耽误研究的进度。“

 

-Steve Mirsky

 


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