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。