(单词翻译:单击)
And physicians and researchers are stuck.
这可把医生和研究人员都给难住了 。
On the one side, we don't have adequate studies that establish the safety and efficacy of these drugs,
因为一方面我们没有足够的研究证明这些药物的安全性和有效性,
but we don't have studies that negate it, either.
但我们也没有研究能否定它不具有安全性和有效性 。
The National Academy of Science released a major report
国家科学院发布了一份重要的报告,
that found conclusive evidence that cannabis can treat chronic pain,
该报告发现,有确凿证据表明大麻可以治疗慢性疼痛,
multiple sclerosis, and improve nausea symptoms during chemotherapy.
多发性硬化症,还能改善化疗期间的恶心症状 。
There’s moderate and limited evidence for other diseases in the 10,000 abstracts they considered.
但在被纳入考察的一万篇摘要中,表明大麻还能够治疗其他疾病的研究比较有限 。
Still there's a lot scientists don't know about weed.
即便如此,科学家们对大麻的了解仍十分有限 。
But that's not stopping patients from taking matters into their own hands.
燃热,这也没能阻止病人们自作主张 。
Patients really didn't need our permission or our approval to go after these therapies.
病人决定做这些治疗的时候并不需要我们的许可或批准 。
And given the desperation that parents face when they have a child with infantile spasms or other similar disorders,
而且考虑到父母在孩子患有婴儿痉挛或其他类似疾病后绝望的心情,
it's understandable that they would be looking outside the box.
即便他们求助于那些偏方也是情有可原的 。
There were a few patients who responded to cannabidiol extracts and we didn't have a better explanation for why
有几个病人还真的对大麻二酚提取物有反应,对此我们也给不出一个合理的解释,
and that's what really got us curious.
所以我们也很好奇 。
Self-medicating with cannabis may be able to solve some medical issues,
用大麻进行自我治疗说不定还真能解决一些医学问题,
but unknowingly they could be causing others.
但也可能在无意之间引发别的问题 。
So doctors responded to their patients by launching their own investigations.
因此,医生们给病人的回应是先自己调查 。
The first step that we started upon was to systematically survey parents
首先,我们对那些父母进行了系统的调查,
and we asked people to bravely describe what they were doing even though it was illegal.
鼓励他们勇敢地说出他们现在采用的治疗方法,哪怕那些方法是违法的 。
And that's pretty low quality research when you ask clinical scientists out there.
但这种方法的效率是很低的,问问那些临床科学家你就知道了 。
We wanted to go after formal clinical trials, but that's where it got tricky.
我们想进行正规的临床试验,但麻烦就麻烦在这里 。
All three experts we spoke to are at different stages of their trials,
接受采访的三位专家目前处于不同的试验阶段,
but the hoops they have to jump through are mostly the same.
但他们要跨越的障碍基本是一样的 。
Well, the first step is to go to the FDA.
第一步是去FDA 。
Describe your study. Explain all the risks and benefits.
介绍你的研究 。解释研究的所有风险和好处 。
It's quite a process.
这个环节就已经比较耗时了 。
There really wasn't a lot of literature.
这方面的文献并不多 。
At the end of the day, we did have to make some reasonable guesses to design the study.
所以,我们最后不得不做出一些合理的猜测才能完成这项研究的设计 。
And once you get approval from the FDA.
拿到FDA的批准以后 。
The next step is going to the DEA.
下一步就是去缉毒局 。
So there is a federal DEA and then each state has its own narcotics control regulatory agency.
但缉毒局又分联邦缉毒局,然后每个州还有自己的麻醉品管制机构 。
In order to be granted a Schedule 1 license,
要拿到一类管制药品的许可,
the DEA wants to make sure that you are taking appropriate precautions to protect and safeguard drugs.
缉毒局就要确保你有采取适当的预防措施保护好药品 。
And it seems strange that we need to lock it in a vault,
这事儿貌似还挺奇怪的,因为我们需要把它锁在保险库里,
while the same patients that we are trying to recruit into our studies
而我们想要拉过来调查研究的那些病人
have the opportunity to get a nearly identical product in a dispensary one mile from our hospital.
在离我们医院不过一英里的药房就能买到几乎一模一样的东西 。
And this entire process could take years.
而整个上报的过程可能要好几年 。
And I'll be frank, I'm not sure if my funding is going to last before all these regulatory agencies approve the study
而且,说实话,我的资金是否能支撑到通过所有这些监管机构的批准我心里都没谱 。
so it's enormously frustrating.
这点让人特别郁闷 。
We tried to work our way through the red tape and pretty much gave up.
我们也试过努力去顺从那些繁文缛节,但最后基本上都半途而废了 。
It wasn't until there was a little bit more pharmaceutical development,
到后面药物研发变得普遍了一点,
and that folks with deeper pockets and more resources were willing to partner with me to run clinical trials.
那些财力雄厚、资源丰富的人也愿意与我合作开展临床试验之后情况才好一点 。
That seems to be the trend here.
这似乎也是整个行业的一个趋势 。
Because the red tape is so thick,
因为那些条条框框实在是太繁琐了,
pharmaceutical companies can jump in to partner with doctors on cannabis clinical trials.
制药公司便开始插进来与医生们合作,开展大麻临床试验了 。
They know how to work the system and have the resources to develop cannabis therapies in the UK and Canada.
因为他们知道怎么上下疏通,也有那个资源在英国和加拿大研究大麻的医疗用途 。