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author: Dianne Feinstein
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og:image:alt: U.S. Sen. Dianne Feinstein (D-CA) (R) and U.S. Sen. Chuck Grassley (R-IA) talk during s Senate Caucus on International Narcotics Control hearing on Capitol Hill in Washington, DC, on May 14, 2014.
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![](https://static.time.com/v3/assets/bltea6093859af6183b/bltd77489e8e3ac7ef0/69885af90b72e330a76e4ec5/feinstein-grassley.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9)


# Senators Feinstein and Grassley: Break Down Barriers to Medical Marijuana Research

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<!-- video src="https://cdn.jwplayer.com/manifests/6Ic4KUCK.m3u8" -->
## Video: Inside the World of Medical Marijuana for Kids

[Watch (HLS stream): Inside the World of Medical Marijuana for Kids](https://cdn.jwplayer.com/manifests/6Ic4KUCK.m3u8) (16:16)

![Inside the World of Medical Marijuana for Kids](https://cdn.jwplayer.com/v2/media/6Ic4KUCK/poster.jpg?width=720)

_Published 2014-10-21. The story of a family's illegal cross-country drive to transport marijuana oil for their epileptic 3-year-old daughter. A look inside the quasi-legal, science free world of medical marijuana for children from TIME's Red Border Films_


by [Dianne Feinstein](https://time.com/author/dianne-feinstein/) and [Chuck Grassley](https://time.com/author/chuck-grassley/)

Jul 16, 2015 3:30 PM UTC

![U.S. Sen. Dianne Feinstein \(D-CA\) \(R\) and U.S. Sen. Chuck Grassley \(R-IA\) talk during s Senate Caucus on International Narcotics Control hearing on Capitol Hill in Washington, DC, on May 14, 2014.](https://static.time.com/v3/assets/bltea6093859af6183b/bltd77489e8e3ac7ef0/69885af90b72e330a76e4ec5/feinstein-grassley.jpg?branch=production&width=1200&quality=75&auto=webp&crop=3:2)

U.S. Sen. Dianne Feinstein (D-CA) (R) and U.S. Sen. Chuck Grassley (R-IA) talk during s Senate Caucus on International Narcotics Control hearing on Capitol Hill in Washington, DC, on May 14, 2014.

U.S. Sen. Dianne Feinstein (D-CA) (R) and U.S. Sen. Chuck Grassley (R-IA) talk during s Senate Caucus on International Narcotics Control hearing on Capitol Hill in Washington, DC, on May 14, 2014. Mark Wilson—Getty Images

by [Dianne Feinstein](https://time.com/author/dianne-feinstein/) and [Chuck Grassley](https://time.com/author/chuck-grassley/)

Jul 16, 2015 3:30 PM UTC

Soon after her first birthday, [Mallory Minahan](http://www.malloryshope.org/) began suffering from debilitating seizures. For a decade she suffered these attacks—a symptom of intractable epilepsy—as many as 30 or 40 times a month. Her parents, both medical professionals, were powerless to help.

After years of failed treatments, her parents decided to try cannabidiol oil in October 2013\. This product is derived from the marijuana plant, administered orally, and has a very low level of tetrahydrocannabinol, or THC, the component of marijuana that makes users high. According to Tom Minahan, Mallory’s father and an ER doctor in Colton, Calif., it took just 36 hours to see profound changes.

But the process hasn’t been easy. A one-month supply of cannabidiol oil, commonly referred to as CBD oil, can cost up to $2,500\. Because CBD oil is not approved by the Food and Drug Administration (FDA), there’s no guarantee that the formulation of each batch will be the same, or that each bottle actually contains CBD oil, rather than some other unknown substance.

In fact, the FDA recently sent [warning letters](http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm435591.htm) to six companies marketing unapproved products that they claim contain CBD, but don’t. This is why Mallory’s parents are forced to spend up to $100 per bottle of oil if they want to have it tested to verify the contents. And even how much of the oil to administer was a mystery. Dr. Minahan and his wife, Carrin, arrived at the proper dosage for Mallory through trial and error.

This isn’t how modern medicine should work.

For Mallory, who wasn’t responding to any other treatments or medications, the results were spectacular. Her seizures have decreased by 90%. Yet CBD oil hasn’t been effective for everyone. Many questions remain about its long-term effects and how it interacts with other medications.


Simply put, we need to know more about CBD, and the only way to gain that knowledge is to remove barriers to research. Research will shed light on critical safety issues as well as how effective CBD oil is and the proper formulations and dosages for patients.

After hearing from constituents, we asked the Justice Department (DOJ) and the Department of Health and Human Services (HHS) in October 2014 to clarify their positions on CBD research and what it would take to ensure research could move forward. After some back-and-forth with the two departments, we’re pleased to report that both have taken significant steps to ensure that CBD research can proceed. The DOJ [agreed](http://www.feinstein.senate.gov/public/index.cfm/press-releases?ID=db100e7a-5e4e-446f-8c7f-9c23b368934f) to initiate what is known as an “eight-factor analysis” to definitively determine whether CBD has scientific and medical benefits, and if so the proper schedule for it.

Another key step was HHS’s decision that privately-funded researchers are no longer required to submit research proposals for additional review. It is also allowing Epidiolex, a purified form of CBD currently in clinical trials, to be administered to 400 children under a compassionate use program that allows sick patients to access medicines before they are approved by the FDA.


While these are important developments, they’re not enough. That’s why we held a [hearing](http://www.drugcaucus.senate.gov/content/drug-caucus-hearing-barriers-cannabidiol-research) of the Senate Caucus on International Narcotics Control last month to hear from experts on the subject.

We learned that the research process is still overly burdensome. We need to cut red tape and streamline the licensing and regulatory processes so research can move ahead. In addition, we must also find ways to ensure that researchers have access to the quantity and quality of marijuana that they need. Finally, we need to look at expanding compassionate access programs where possible, to benefit as many children as possible.

Patients like Mallory have helped draw attention to this issue. Now, the federal government should step up, continue to reduce research barriers and help the many patients who could benefit from this treatment.


## Transcript

We don't wanna break the law. We don't wanna do this, we have to do this. Cannabis extract is illegal. And that's what my product is. I never stop thinking about the legal issues. As I cross into every state, that's breaking a lot of federal law. I don't believe that any of the law enforcement agencies want to lock out what is potentially a last treatment option for these patients. [ NOISE ] It's okay. It's okay. There still are many, many children and adults with epilepsy who can't be controlled with existing therapies. I cannot recommend using a medical marijuana product. It was worth it because it helps my daughter.

If it's helping kids, why isn't it. We thought, well, why can't you do it? [ MUSIC ] [ NOISE ] [ MUSIC ] This is about as big of a piece as we'd wanna cut at once. This is our first day of harvest. [ INAUDIBLE ] in here, that's the problem. Say we get this big girl [ NOISE ] Each plant is a whole- plant extract, so we have to cut the plant. And final, so we'll kinda put the next plant about right here. So as long as we all know. The size that we're cutting for has to dry, fully dry before we're able to process it in the lab. Now you're through that. Now you can start on the next one. Here is the next one.

I've got a, I've got a really nice one We stepped onto the field June 3rd. Is that your sandal? I'll fill this one up. Perfect. We planted 17 acres with an estimated 36, 000 plants. [ MUSIC ] We'll likely serve several thousand patients with this. These grow big. [ MUSIC ] Which is good. My name is Penn Madison and I am the head manager here at Stanley Brothers Social Enterprises. You need to change hands. [ LAUGH ] [ INAUDIBLE ] And we grow medical hemp. [ MUSIC ] We have a little girl, Nellie, who's two and a half. Yeah. Is that one hurting? Are you getting frustrated? Huh? She is intractable apolopsy.

That's a debilitating form of epilepsy. One in 26 people will have epilepsy in their lifetime. Three million Americans have epilepsy. 50 million people world wide have epilepsy. It is one of the most common neurologic disorders. Yeah. We had no idea wether or not medical help would work. What we did know is that, everything else we had tried had not. We'd seen specialist all over the country. We tried multiple anti- epileptic drugs. Hm- mm. Yeah? I would say in the last year too we have seen an increase in children that are here from out of state. That have been brought by families to try variants of medical marijuana.

[ MUSIC ] The laws in Tennessee didn't allow us to have this delivered to us there. It didn't allow this to be an option to give it to her there. [ MUSIC ] So the option of moving to Colorado to pursue medical marijuana was a viable option for us. And so we chose to do that. [ NOISE ] [ MUSIC ] We start with tissue culture plants. They'll be grown for their entire season. When they're ripe they'll be harvested. Dried. Once they're cured right they will come back to the lab for extraction. In which we will extract all of the valuable parts of the plant into a fine oil. Then that oil is used to create specific dilutions of a dietary supplement.

That they'll be called Charlotte's Web. [ MUSIC ] At nine months old she was sleeping 20 hours a day. Kids that age like to grab things. Swat at things. We would have things hanging over her she would have no interest. Finally at about her nine month appointment. After we were able to find a neurologist to see us relatively quickly. He was fairly confident that [ INAUDIBLE ] spasms. She was barely able to grow in function, because she was having upwards of 200 seizures a day. Seizures are incredibly debilitating but there's also a lot of other things that can happen with a cognitive problems. Depression, anxiety [ MUSIC ] Hello!

Hello! [ UNKNOWN ] Three times a day. [ UNKNOWN ] I see patients here two days a week on Tuesdays and Thursdays, and these are the consultation days, and also days where people come to pick up their medicine. In order to be ready for those two days, I spend. It's probably about another four days in lab making oil. Or with my brothers at the girl facilities. He was our first state licensee for the charlotte's web products. And it's fitting that he is a parents of a child with [ UNKNOWN ] syndrome. I am involved in this industry because of my daughter who is ten years old now and her name is Emily.

Who has intractable epilepsy. [ NOISE ] It's okay. It's okay. It's okay. At her worst times, she's had a hundred to a hundred and fifty seizures a day. We've been told by a couple of doctors that we have to go home and enjoy our daughter as much as we can cause there is really not much hope left or anything else that will help so I spent a lot of time in California trying to find this medicine and you know I didn't have a lot of luck .

>> We started doing our own research to see. What type of side effects? But why not try it. I just put my daughter on a medication that could've killed her. If it doesn't work, you put it to rest and we can move on with our lives. But if it does, nothing else has. Not everybody can come to Colorado, so there has to be something. Else we can do. My daughter was not doing good. She was having seizures, and I knew that there could be something that helps her, but I can't bring it to California, or I can't transport it. so it was very frustrating. It's okay. In the state where we live they do have a medical marijuana program.

However, even if you were able to get through all of the bureaucratic hoops they have set up, the appropriate product for our daughter is not available. [ MUSIC ] Here I am, desperate father. I have to help my daughter. I need to have this for my daughter. So what is it gonna take? One thing led to another. How're you guys doing? [ INAUDIBLE ] We're doing okay. I am now the director of the foundation's California chapter. And that was the only way to do this legally. [ MUSIC ] I wish. When Emily started having seizures, ten years ago, somebody in this position. Existed. Where somebody would sit down across from me and say, this is what failed for people.

This is what didn't. This is what others are doing. We were scared, one, to pick up and move and leave everything behind, but we weren't sure it was gonna work. Even in Colorado, the waiting list for Charlotte's Web oil is quite long, so it's not like you can just. Fly or drive to Colorado, pick it up and come home. Which apart from violating federal and state laws, It's just you can't do it. In California we found, an apartment, that we could do a short term rental. When we started giving her the marijuana in the first couple of doses even, we saw changes. She became more verbal. She became a lot more attentive.

She was a lot more awake than she had been. [ LAUGH ] After the summer we wanted to give a longer time for our trial. So we made a decision that we were going to. Bring a supply back with us. [ MUSIC ]. They were able to identify a supplier in California my understanding who had what appears to be a very good product of oil high in CBD and they didn't want to fly with it, so apparently drove cross country to get their child this medication. Well I never stopped thinking about the legal issues. As I cross into every state I tried to make sure to be very careful. Any time I was tired I took a break.

My daughter is doing great. She's now down to about 20 a day. She's far more interactive with the world around her. She has far more enjoyment. She's not playing beside the world, she's playing in the world where she lives now. And that, to me, is everything. Fortunately, that child is doing quite well. And they've gone through a huge pilgrimage to get that oil and, what appears to be, help their daughter. [ MUSIC ] I actually haven't heard anything about you know, negative potential side effects in the media. And I think it's a really important thing for parents to know is this is not risk free.

It's not something I told them to do but when they said they were determined to do it, I was supportive, as their physician, to say listen, I will be here to guide you on helping to adjust the therapy and monitor the other drugs and, and the girls' epilepsy. Overall, at least so far, our experience here at Children's Colorado has been that, that only about a third of families are really reporting that they see much of an improvement in their children. And of those children when we look at brain waves, none of those are we really seeing the kind of EEG change that we would expect from a really effective medication.

We also don't understand how marijuana products will interact with other medicines these children are on. Concerning things that we have seen in general, her seizures have gotten worse. Severe enough to require them to go into our intensive care unit. We absolutely don't have the scientific data and I think if I could make one point to the parents, it is that you need science. The other concern with the artisanal products is that we don't always know what's in them. They vary from batch to batch, they vary from grower to grower. [ MUSIC ] Unfortunately, we're giving it out to large numbers of very vulnerable people like children.

Without knowing what the correct dose it. Without knowing what kind of epilepsy it's going to work for. Most of my critics, especially in the medical field, are critics that are criticizing lack of research. I blame them. That's their job. You're a researcher. You're a scientist. You're a doctor. Why don't you research this? These procedures are gaining. Something stronger. The schedule one listing for marijuana has made it much more difficult to do research on marijuana, there is no question about that. Really all hemp products lie in a gray area. We are faced with a bit of a moral dilemma. We do have some legal area to operate here.

But at the same time, that's up for interpretation. [ MUSIC ] The supply is gonna run out, because we only brought back six months. There are options. Realm of Caring is talking about challenging the law and sending medication across state lines. Right, one more on the end and let's get it there. This product, this fall. Coming from hemp regulations, this will be our first time to actually be able to ship this to patients across the country. If it works, it would make a huge difference because then we could have it delivered right to our house. Cannabis [ UNKNOWN ] and that's what my product is.

The last. Drug enforcement agency position that I read stated that hemp products made for human consumption, which have any detectable THC in them, are technically a violation of federal law. Now, however, they go on to say that they realize that all of these products exist throughout grocery store shelves throughout America. At this point in time I don't feel like the legal landscape has us such that people are going to come in with guns and handcuffs and try and shut down something that is providing hope and options for people. We don't want to break the law. We don't want to do this, we have to do this.

How can kids not get what they need? I mean anyone you talk to about it, it's like, it's ridiculous. If it's helping kids, why isn't it. Reba like why can't you do it? [ MUSIC ] Everything has to start somewhere [ MUSIC ]

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