#what does Basen do? STUDY

[youngyoo-apologist]

I’m never letting go of the Lock and Basen friends HC I don’t care that they’ve never interacted in canon I think they would be best friends

[polpoka]

Birthdays

Shippings-Bapen/Pensen

Rating- K+

(Fluff)

Part 1

Basen wasn’t the type to celebrate his birthdays. It wasn’t that he regretted being born or anything, he just didn’t think it was any different from any day. 

‘It wasn’t that special,’ he personally thought.

However, his lover didn’t think so. 

“What! You- you don’t celebrate your birthdays!?” 

Basen looked at him, confused. 

“Yes? What about it?”

Pen looked shocked and got up from his partner’s lap.

“So many things!? What do you mean, ‘what about it’. A birthday is meant to be celebrated. How are you alright with just not doing anything special? What about gifts?”

“Gifts? I don’t need gifts. My family already does a lot for me.”

“Eh? B-but it’s your birthday!”

“So?”

“When is your birthday, anyway?”

“In a week. Why?”

Pen’s jaw dropped.

“ A week. And you tell me now.”

Basen just stared at him.

“You never asked.”

Basen was getting under Pen’s skin.

“...But you know mine.”

Basen however, had no clue as to what was happening.

“You told me yours.”

Pen huffed.

“You were supposed to tell me too, you know?”

“Was I?”

“You really-”

Pen sighed, sometimes Basen really got on his nerves, even though that was what Pen loved about him.

“I’ll be getting you a gift for your birthday. So, do you have anything you want currently?”

“Nothing in particular.”

Pen frowned at the lukewarm response.

“Fine. I’ll get you something I can guarantee you’ll like.”

“ Don’t get me a pen. Hyung already bought me one from Capital when he was visiting.”

“Tch.”

Pen grumbled.

That was the one thing Pen had guaranteed that Basen would love. He got up from the couch and looked the other man in the eye.

“I’ll see you in a week then.”

Basen looked a little confused.

“Why? You could still visit me. I rarely get to see you anyway.”

“I’ll be busy selecting a good gift and planning a party in a week.”

“A party is unnecessary.”

Pen ignored the last statement and walked out of the room, grabbing his coat in the process.

“That idiot,” he grumbled, before remembering his first meeting with his brother.

“Just like his brother.”

***

He walked through to the roads to take a closer look at the shops. Thankfully, he had the liberty to do so, since his secret bodyguards would be insuring his protection.

‘Being under disguise isn’t that bad.’

He then spotted something that caught his eye. A monocle.

 He could imagine the younger man wearing the monocle and having a permanent scowl on his face.

Pen chuckled. ‘He would look hilarious in that, but it suits him. Weird.’

He hummed as he walked down the street, eying various titbits, varying from magical equipment to clothes to flowers.

Nothing seemed to suit Basen, and though there were numerous times he was tempted to buy something and get it over with, he remembered his words and sighed, bringing him back to his goal.

“What would he like?” Pen mumbled.

“Excuse me, sir, would you like some help?”

He turned to see a very professional-looking attendant.

“Yes, I would like to see something for a seventeen-year old boy. His measurements are xxx.”

“Is it for the young lord?”

‘This woman really does have a keen eye.’

“Yes.”

The woman however, despite her stoic face, was trying not to show how nervous she was.

‘This man...He’s the prince of the Breck Kingdom, isn’t he? That face is something I’d recognize  anywhere, especially since we specialize in nobility. What is he doing here?’

“Please sit here and look at these.” She led him to a room which had the prototypes of the outfits, for the demographic, and handed him a list of the outfits.

Pen looked through the list of outfits and finally, after half a day, found something that would suit Basen.

It was a gorgeous coat which he was sure would look good on Basen. The shade of brown used, had a richer color,and a lovely germanium was used as the fabric underneath, the exact color as Pen’s hair. It had no embroidery and would definitely appeal to the younger man.

He smiled at the wonderful choice.

He walked out of the store, happy at the fact he had managed to finish one of the many tedious jobs to come.

***

He headed back to the residence that the Henituse estate had prepared for him to proceed with the plan, but Pen was a little too tired and, honestly just wanted to rest. He collapsed on his bed after his arrival at the designated room, and just as his eyes were about to close, he heard a knock.

He grumbled, and reluctantly parted from his comfortable bed to open the door and see who it was.

Pen frowned.

"Well, well, well, look who it is."

Basen looked down at his lover's feet, a little flustered and still confused at the response he got.

Pen noticed this. He really wanted to smirk at his victory at proving his point, but still kept a stoic face.

"Didn't I ask you to not visit me for the time I'm here?"

"B-but I didn't know that you'd be so stubborn on that point! It's just a birthday,"

Basen protested.

"Just a birthday? It was the day you were born. It should be celebrated."

Pen sighed. His rational side tried to reason with his emotional side. He knew that Basen was a different person, but he couldn't just let it go.

'Why does he not celebrate? It's his birthday. It's a day to be celebrated. Why doesn't he get it!?'

Basen was getting frustrated. He didn't understand what the problem was, yet he was being bombarded with these comments on his life, which he believed to be completely fine. Basen knew he wasn't an emotional person. He knew that he wasn't able to understand what his partner was feeling, and so did his partner know that he couldn’t.

 He just couldn't help raising his voice;

"Just tell me what's wrong already! I don't get it! I don't get these things if you don't tell me, you know that!"

Pen's eyebrows loosened and he became stiff. Though, it wasn't often Basen raised his voice, Pen never liked it when he did. He paused for a minute, took a deep breath and got his thoughts on order.

"Come in."

Basen frowned, but went through with it, taking a seat where he thought it would be appropriate to sit as a guest.

Pen walked to the tea brewer in the room,

"I'll get the tea."

"No need. I won’t be staying here for long anyway."

Pen halted and went over to take a seat right in front of Basen. They both let their eyes search the other  for a while to study what they were feeling, Pen felt sorry for driving his other half, as he called him so lovingly, to such a limit. His guilt started to overtake his anger.

"I'm sorry. It was my fault."

Unfortunately, Basen was irritated, which made his vision clouded. This wasn't something that he felt that often, but the situation was just so irksome.

He looked at him in disbelief and disgust.

Pen flinched at the gaze.

"It IS your fault. Prince, we established that. Moving on," he sighed,"I think I needed some time to myself, since you're going to act like that." He snapped, as he gestured towards the door.

Pen knew instinctively that Basen was losing his temper. The feeling was icky and seeped through his organs and through his bones, slowly creeping into his heart.

'No.' He started to wave his hands in panic and also partly because of the fear of the other man's rejection.

"Please-"

"See you later, Pen. Do not follow me.Well, you won’t. Since, you don’t want to meet me anyway."

He was cut off with those icy words, his name said with such disdain, he felt as if Basen was using his name as an insult in itself.

***

Basen got up from the couch and walked out of the room. He was hurt. Even though this was such a small thing, his mind couldn't register the way Pen had treated him. He had completely trampled over his emotions and way of doing things. He needed to be away from his lover for some time, to at least cool off.

It wasn't that these kinds of arguments weren't normal and a daily occurrence, they did bicker occasionally, but this time it had gone too far. Never had he expected Pen to follow his way of life, nor did he think Pen would want him to do so. Pen was a person who was not that accepting, Basen knew that, but still he believed that some things were different about them and those had to be accepted.

 He walked down the staircase to find a maid or a butler.Instead, he saw a familiar face, yet found it unusual to see at home.

"Hyung!"

He walked quickly to close in on the distance between them.

The older man looked down at him with a cold expression. 

"Basen," his cool voice responded.

"Will you be staying for long?" 

"No. I'll be leaving after dinner.”

“Alright. I'll just let you know that Mother would like to see you.” Basen wasn’t surprised, since he was used to this.

He walked past Cale, who noticed that his younger brother who he wasn’t that close with, was odd. since he did promise Og! Cale to take care of his younger brother, he asked him about what happened, but not that much not to encroach on his privacy.

“You look depressed. Did something happen?”

Basen stiffened, but nodded and walked out of the residence.

Cale felt a bit concerned, even though he didn’t show it on his face.

***

Basen went into his room, all his energy had been sapped and he brewed himself some tea and took a seat on his bed. He gradually sipped on it, emptying the cup, taking his time. He huffed the steam coming out of the cup. He needed to calm his nerves. The tea he was drinking, Earl Grey, was also introduced to him by Pen. He unconsciously found himself smiling and remembering the times Pen had got him the tea, not to forget, the first time he had got it for him.

‘He was so excited,’ he thought, he looked at his reflection in the tea and frowned remembering the events that had just taken place. He felt the tea in his mouth go bitter.

“I need rest.” 

He mumbled.

He quickly gulped down the entire cup and kept the cup on his side table, before falling over in his bed. He could feel a headache coming over him. He exhaled sharply.

“I’m tired. That’s all it is.” He mumbled, trying to ignore the thoughts running rampant in his mind.

His eyelids drooped, shutting his thoughts along with his eyes.

[fitnesshealthyoga-blog]

New Post has been published on https://fitnesshealthyoga.com/the-disturbing-links-between-too-much-weight-and-several-types-of-cancer/

The disturbing links between too much weight and several types of cancer

An image of a breast cancer tumor and its microenvironment. Tumor cells are in cyan, macrophages in red and collagen fibers in green.

An image of a breast cancer tumor and its microenvironment. Tumor cells are in cyan, macrophages in red and collagen fibers in green.

Photo: Joseph Szulczewski, David Inman, Kevin Eliceiri And Patricia Keely/Carbone Cancer Center At The University Of Wisconsin/National Cancer Institute/National Institutes Of Health

Photo: Joseph Szulczewski, David Inman, Kevin Eliceiri And Patricia Keely/Carbone Cancer Center At The University Of Wisconsin/National Cancer Institute/National Institutes Of Health

An image of a breast cancer tumor and its microenvironment. Tumor cells are in cyan, macrophages in red and collagen fibers in green.

An image of a breast cancer tumor and its microenvironment. Tumor cells are in cyan, macrophages in red and collagen fibers in green.

Photo: Joseph Szulczewski, David Inman, Kevin Eliceiri And Patricia Keely/Carbone Cancer Center At The University Of Wisconsin/National Cancer Institute/National Institutes Of Health

The disturbing links between too much weight and several types of cancer

Smoking has been the No. 1 preventable cause of cancer for decades and still kills more than 500,000 people a year in the United States. But obesity is poised to take the top spot, as Americans’ waistlines continue to expand while tobacco use plummets.

The switch could occur in five or 10 years, said Otis Brawley, a Johns Hopkins oncologist and former chief medical officer of the American Cancer Society. The rise in obesity rates could threaten the steady decline in cancer death rates since the early 1990s, he said.

Yet only about half of Americans are aware of the link between excess weight and cancer. And researchers are struggling to answer such fundamental questions as how surplus weight increases the risk of the disease and whether, conversely, losing weight helps prevent cancer or a recurrence.

Being obese and overweight – long implicated in heart disease and diabetes – has been associated in recent years with an increased risk of getting at least 13 types of cancer, including stomach, pancreatic, colorectal and liver malignancies, as well as postmenopausal breast cancer. Researchers at the American Cancer Society say that excess body weight is linked to about 8 percent of all cancers in the United States and about 7 percent of cancer deaths.

Compared with people of normal weight, obese patients are more likely to see their cancer come back and have a lower likelihood of survival. Perhaps most alarming, young people, who as a group are heavier than their parents, are developing weight-related malignancies, including colorectal cancer, at earlier ages than previous generations, experts say.

The precise link between cancer and excess weight isn’t known, but researchers are focusing on the “visceral” fat that surrounds internal organs. Rather than being a harmless glob, this fat is a “metabolically active organ” that produces hormones such as estrogen, which is associated with a higher risk of breast and some other cancers, according to the American Institute for Cancer Research, a nonprofit group that focuses on diet, nutrition and cancer.

The fat also secretes proteins that drive insulin levels higher, which may spur cell growth and increase the possibility of cancer. And it can cause chronic inflammation, another risk factor for the disease, according to the group.

“It’s a complex interplay of metabolism, inflammation and immunity,” said Jennifer Ligibel, a breast oncologist at the Dana-Farber Cancer Institute. “It creates an environment that is more permissive for cancer.”

About 7 in 10 Americans are overweight or obese, according to a 2015 article in JAMA Internal Medicine. People are considered overweight if they have a body mass index (BMI) of 25 to 29, and obese if they have a BMI of 30 or more.

The proportion of adults who are overweight has remained relatively stable in the past several decades, but the obesity rate has soared. In the early 1960s, almost 11 percent of men and nearly 16 percent of women were obese; in 2016, those percentages were 38 percent and 41 percent, respectively, according to the cancer society.

The risk of cancer rises along with excess weight. “It does appear that the risk is greater the more obese you are,” said Jonathan Wright, a urologist at Fred Hutchinson Cancer Research Center in Seattle. There is a link between being overweight and cancer, “but it is not as strong,” he said.

The type of cancer that is most strongly associated with obesity is endometrial, which develops in the lining of the uterus. Obese and overweight women are two to four times as likely to develop the disease as women of normal weight, and the risk rises with increased weight gain, according to the National Institutes of Health.

Meanwhile, people who are overweight or obese are about twice as likely to develop liver and kidney cancer, and about 1.5 times as likely to develop pancreatic cancer than normal-weight people, according to NIH.

In addition, having too much belly fat – a larger waistline – is linked to an increased risk of colorectal and some other cancers, regardless of body weight, the cancer society said.

Several researchers are running clinical trials to try to prove what many already believe – that losing weight reduces the odds of developing cancer or having a recurrence. There are some indications they may be right – severely obese people who have bariatric surgery, for example, lessen their odds of getting cancer – but much more data is needed.

Carol Massey, who is 59 and was treated for breast cancer two years ago, is enrolled in a nationwide trial designed to see if losing weight makes it less likely breast cancer will come back. She has reduced her calorie intake, stepped up her exercise and gotten regular advice from a health coach based at Boston’s Dana-Farber Cancer Institute, which is leading the Breast Cancer Weight Loss Study, or BWEL.

To be eligible for the trial, women must have a BMI of 27 or higher. The study, which will enroll about 3,100 women, will compare Massey’s group – which gets supervised weight loss and health-education materials – with a group that receives only the educational materials.

Massey, who lives in Paola, Kansas, said she quickly came to look forward to her coach’s calls, which initially were once a week. “We got to be friends, she would ask about my family,” she said. “One time, she even called me when she was on vacation in Cabo San Lucas” in Mexico.

Over time, the 5-foot-8 Massey lost 30 pounds. She is now 150 pounds.

Those are the kind of results Ligibel, the principal investigator, is hoping for. If the study shows that slimming down is associated with reduced recurrence, doctors could prescribe a weight-loss program as standard therapy for breast cancer patients – much as cardiac rehabilitation is urged for heart-attack patients. That could pave the way for insurance coverage.

Gail Folloder joined a 16-week program at University of Texas MD Anderson Cancer Center for heavier women at high risk of breast cancer because both of her parents had had cancer and she wanted to prevent it. The 67-year-old Houston resident underwent “hunger training,” which uses continuous glucose monitoring to show participants when they need fuel and urges them to limit their eating to those times.

“The idea is to help people learn to eat only when they are really hungry,” said Karen Basen-Engquist, a behavioral scientist at the cancer center. “We eat for all kinds of reasons – sometimes because we are with other people or because we are bored or stressed.”

It worked for Folloder. “I used to say that I was hungry all the time but I really wasn’t,” she said. “Now I’m more in tune with my body.”

Besides talking to a dietitian weekly, she stepped up her physical activity by using a hula hoop and an exercise bike. Folloder, who is 5-foot-9, went from 219 pounds to 191 pounds.

The women in Folloder’s group will be compared to a “control” group that takes part in a weight-loss program but does not do blood sugar monitoring. Results are expected this year.

Fred Hutchinson’s Wright is focusing on overweight and obese men with low-grade, slow-growing prostate cancer who have decided to take an “active surveillance” approach – which involves monitoring via blood tests, physical exams and biopsies – rather than treatment such as radiation or surgery. He is investigating whether keeping patients’ glucose levels under control through weight loss will prevent the cancer from getting worse and improve survival. The goal is for participants to lose 7 percent of their body weight.

The study is based on the Diabetes Prevention Program, which showed that people at high risk for Type 2 diabetes can prevent or delay the disease by losing a modest amount of weight through dietary changes and increased physical activity.

Steve Borden, 57, enrolled in the trial, called Prostate Cancer Active Lifestyle or PALS, last November and was assigned to a nutritionist and exercise physiologist to coach him on diet and exercise.

The 5-foot-10 Borden has lost 30 pounds and now weighs 198 pounds. His target is just 1,800 calories a day, and he regularly uses the treadmill and lifts weights. He said a recent test showed his PSA – for prostate-specific antigen, which when elevated can be an indication of cancer – has dropped slightly, although his doctors don’t know whether that is connected to his weight loss.

In general, how much do people need to lose to improve their cancer odds? Ligibel of Dana-Farber said it is not clear but that data suggests a 5 percent reduction in body weight has a beneficial impact on blood sugar and inflammation.

For anyone wanting to reduce their cancer risk, avoiding weight gain in the first place is important, experts say. Brawley of Johns Hopkins said that the goal should be maintaining “energy balance” – consuming no more calories than are burned off through exercise and other activity.

Nutritionists say the key is cutting down on portion sizes, avoiding sugar and aiming for meals that are rich in vegetables, fruits and whole grains and beans and light on animal protein.

Anthony Perre, chief of outpatient medicine at Cancer Treatment Centers of America, said the Mediterranean diet – which emphasizes plant-based food, whole grains and olive oil – has been linked to improved cancer outcomes.

“But the diet that is the right one is the one that you can sustain over the long term,” he said. “Whether it’s Atkins, low-carb or low-calorie, they all work if you stick with them.”

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[useyourheadnotliterally]

Op-Ed Research Articles

When searching around for Op-Ed articles, I was able to find nothing on the NFL besides the kneeling during the National Anthem, as well as the concussion and CTE battle in the NFL. Since my blog is about league rule controversies and changes, the article about taking a knee doesn’t apply to my blog. What this shows me about the rest of the rule controversies, is that there is so much more information and research done on the concussion topic, rather than something like the tuck rule or the catch rule. It’s going to be a lot easier for me to find information about concussions than anything else.

The articles that I found were from the New York Times and NBC. Both of these articles started out talking about the investigation into how playing in the NFL ties into brain injury, CTE, and tau (protein) buildup in the brain. Once the articles move along, they start to talk about different things. The article from the New York Times is talking about how the concussions crisis is going to change the rules and how these rule changes are going to shift the way that the game is played. The article from NBC shifts it’s focus onto how the league and the medical professionals involved can use science and technology to find a way to save players from traumatic brain injury and CTE.

The article from the New York Times is called N.F.L. Shifts on Concussions, and Game May Never Be the Same. It was written by Ken Belson and Alan Schwarz on March 15, 2016, and published by the New York Times. This article mainly focuses on how the NFL is reacting to concussion data, and how it is affecting the way that the game is played. In the article, it starts off my talking about how the NFL’s senior vice president of player health and safety, Jeff Miller, acknowledged a tie between football-related head injuries and CTE. Not only is it about how the league officials and higher-ups are reacting, but also the players from past, present, and future. Players from the past filed a lawsuit against the league for putting them at risk and not telling them about that risk. Present players are demanding more money and sitting out longer for injuries so they don’t risk making their conditions any more serious. “Future players” are quitting football due to these serious risks that playing football entails. I feel as though the authors are trying to reach out to each category of player, fan, and anyone who is involved in football that wants to know the risks and history of the concussion debate in professional football.

In my opinion, I think that there was a bit of bias in this article, as the authors only included half of the investigation process, talking about all of the research that went into finding out this information, and how the league and the people in charge didn’t want to hear any of what the scientists and doctors were saying about CTE. By doing this they painted a picture of the league not caring about the well-being of it’s players, and only caring about the money aspect and attracting younger players to keep playing so that there will be more source of income in many years to come.

The second article is called Can Science Solve Football's Concussion Crisis? It was written by Ryan Basen on October 27, 2017, and published by NBC. This article is based on the scientific study behind the concussion crisis. It starts off by saying that out of 111 former NFL brains studied, 110 showed serious signs of CTE. The article then talks about how there’s been a serious decline in high school involvement and that there needs to be a serious rule change if they want that percentage to increase. Due to the fact that it is a stat based article, there isn’t much room for bias, however it does seem as though they are trying to expose the real facts behind the crisis, thus taking sides against the NFL.

All in all, I definitely learned a lot that I didn’t know before, and these Op-Ed articles definitely offered some explanation and information towards my topic.

[blockheadbrands]

Study Finds CBD Drug Epidiolex Reduces Seizures by 42%

Ryan Basen of Leafly Reports:

The New England Journal of Medicine just published more evidence of the effectiveness of cannabidiol (CBD) in treating seizures.

The new study offers the strongest evidence yet of CBD's effectiveness in reducing seizures in severe forms of epilepsy.

Patients taking two different doses of a Epidiolex, an experimental CBD medication manufactured by GW Pharmaceuticals, experienced fewer epileptic seizures and fewer seizures overall, according to study published online by The New England Journal. The trial was funded by GW Pharmaceuticals, which has submitted this medication for FDA approval to treat epileptic seizures.

In addition to a recent FDA committee recommendation and other recent studies showing CBD reduced epileptic seizures, this new study—the first large-scale trial examining the effects of specific CBD medication doses—increases the likelihood of the first cannabis plant-derived medication arriving soon on the U.S. market.

“This new study adds rigorous evidence of cannabidiol’s effectiveness in reducing seizure burden in a severe form of epilepsy and, importantly, is the first study of its kind to offer more information on proper dosing,” co-lead author Orrin Devinsky said in a news release issued by NYU Langone Health, his employer. “These are real medications with real side effects.”

RELATED STORY Cannabis Pharmaceutical Epidiolex Aids Children With Epilepsy, Study Finds

Preventing ‘Drop’ Seizures

Devinsky’s team conducted a phase 3 multi-center, randomized, double-blind, placebo-controlled trial internationally, aiming to assess the efficacy and safety of two different CBD doses and compare them to a placebo. They added the CBD and placebo doses to regimens of traditional anti-epileptic medication prescribed to treat “drop” seizures in patients with the rare but severe Lennox–Gastaut syndrome form of epilepsy.

They measured the resulting drop-seizure frequency. Patients taking a daily high dose (20mg of CBD per kilogram of body weight; e.g., about 1,600mg daily for a 180-pound adult) of the CBD medication while continuing their conventional antiepileptic regimen experienced a median 41.9% percent reduction in seizures after 28 days. Participants taking a lower dose of CBD (10mg per kilogram of body weight) experienced a 37.2% decrease. Patients in a placebo group experienced a 17.2% drop in seizures. Results were statistically significant.

An earlier study published in The Lancet in March 2018 concluded: 'Add-on cannabidiol is effective for the treatment of patients with drop seizures associated with Lennox-Gastaut syndrome.'

Researchers also found significant differences when they examined who experienced at least a 50% drop-seizure reduction: 39% of the 20-mg cannabidiol group, 36% in the 10-mg group and 14% in the placebo group. One-quarter of the 20-mg patients experienced at least a 75% reduction, versus 11% of the 10-mg cannabidiol group and 3% in the placebo group.

The median percent reduction in occurrences of all types of seizures was 38.4% in the 20-mg group, 36.4% in the 10-mg group and 18.5% in the placebo group.

“This trial involving children and adults with the Lennox-Gastaut syndrome showed that a pharmaceutical formulation of purified cannabidiol, administered at a dose of either 10 mg or 20 mg per kilogram (of body weight) per day, resulted in a significantly greater reduction in the frequency of drop seizures than placebo,” the authors concluded.

“This landmark study provides data and evidence that Epidiolex can be an effective and safe treatment for seizures seen in patients with Lennox Gastaut Syndrome, a very difficult to control epilepsy syndrome,” said co-author Anup Patel, MD, chief of Neurology at Nationwide Children’s Hospital, according to the release.

RELATED STORY Cannabis-Based Drug Gets Positive Review From US Agency

FDA Approval Expected in June

Devinsky, an NYU School of Medicine professor who directs Langone’s Comprehensive Epilepsy Center, co-authored a study published in last May’s New England Journal showing a decrease in monthly seizure frequency in patients with Dravet syndrome, another rare form of epilepsy. Another study published in The Lancet in March concluded: “Add-on cannabidiol is (effective) for the treatment of patients with drop seizures associated with Lennox-Gastaut syndrome and is generally well tolerated.” Researchers are extending that trial to assess CBD’s long-term efficacy and safety.

The FDA reviewed some of these studies before an April meeting of its Peripheral and Central Nervous System Drugs Advisory Committee. The committee then heard testimony and recommended Epidiolex for FDA approval as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, via a 13-0 vote.

The FDA is expected to officially decide the medication’s fate by late June, according to Justin Gover, CEO of GW Pharmaceuticals. “We are reviewing this application on an expedited timeline,” an FDA representative said after the committee vote, “working to accelerate this process as much as we can.” The FDA is not obliged to follow the advisory committee’s recommendations, but it often does.

RELATED STORY How GW Pharma Could Use U.S. Patents to Shape the Future of Medical Cannabis

The Secret Formula: It’s CBD

If approved, Epidiolex would become the first medication derived from the cannabis plant allowed in the U.S. The FDA has previously approved synthetic cannabis medications, which more closely resemble tetrahydrocannabinol (THC), but nothing plant-derived nor anything featuring CBD. Sativex, a GW Pharma product that incorporates both THC and CBD, has been approved for medical use outside the U.S.

Epidiolex features a solution of 100 mg/ml of CBD dissolved in sesame oil, ethanol, sweetener, and a flavoring agent, according to the FDA review. The medication is harvested from cannabis plants specifically bred for medical purposes, with high CBD concentration, according to a GW Pharmaceuticals report.

RELATED STORY What is CBD (Cannabidiol), What Does It Do & What Are Its Brain Effects?

Specific Doses of CBD Used

GW Pharmaceuticals supplied the CBD and placebo used in the new trial, according to the study, and three co-authors have been employees of GW Pharmaceuticals. Devinsky received research funding from GW Pharmaceuticals, according to the NYU release, and a consulting fee for advising during the FDA committee meeting.

His team enrolled 225 patients with Lennox-Gastaut syndrome, randomly assigning them to receive CBD at a dose of either 20 mg per kilogram of body weight per day, the 10-mg dose or placebo. They siphoned 76 participants to the 20-mg group, 73 to the 10-mg cannabidiol group and 76 to the placebo group.

The CBD or placebo was administered orally twice daily, with patients or their caregivers trained to record the number and type of seizures that occurred each day. They also recorded CBD or placebo use, use of concomitant medications, and any adverse events.

RELATED STORY 6 Common Myths and Controversies About High-CBD Cannabis

Who Was Tested

Patients were eligible if they were between 2 and 55 years old; had an electro-encephalogram showing “a pattern of slow spike-and-wave complexes” (characteristic of the disorder); and had at least two types of generalized seizures—including drop seizures—for at least 6 months.

Patients were taking between 1 to 4 other antiepileptic drugs and had at least two drop seizures each week during the study’s baseline period. The had previously received a median of 6 antiepileptic drugs, which had failed to control the seizures, and were receiving a median of 3 antiepileptic drugs simultaneously when they started the trial.

A majority of the patients were white, from the U.S., and under 18.

Patients were excluded if they had unstable medical conditions during the four weeks before screening, a history of alcohol or substance abuse, or had used recreational or medicinal cannabis over the previous 3 months.

RELATED STORY Which Cannabis Strains Are High in CBD?

FDA Approval Still Not Assured

LGS and Dravet syndrome are rare, severe, refractory epilepsy syndromes that emerge early in childhood and are linked to higher mortality rates. Medications on the market often do not adequately treat these conditions.

The Epilepsy Foundation applauded the FDA’s April committee vote. “More than a third of people living with epilepsy do not have seizure control, and many more live with significant side effects that impact cognitive ability, mood, and memory,” the Foundation said in a statement issued shortly after the meeting. “Epidiolex represents hope for the many individuals living with intractable seizures and rare epilepsies.”

Still, FDA committee members in April cautioned that more research needs to be done on Epidiolex dosing. Devinsky issued a similar warning in the NYU statement about the new study.  “While the news gives hope for a new treatment option to the epilepsy community,” he said, “more research remains imperative to better determine the effects of CBD and other similar cannabis-derived compounds on other forms of the disease and in more dosing regimens.”

TO READ MORE OF THIS ARTICLE ON LEAFLY, CLICK HERE.

https://www.leafly.com/news/health/study-finds-cbd-drug-epidiolex-reduces-seizures-by-42