Charlotte's Web (cannabis)

Cannabis as illustrated in Köhler's book of medicinal plants from 1897

Charlotte's Web is a form of medical cannabis produced by the Realm of Caring Foundation (RoC) in Colorado.[1] It is processed into a marijuana extract[2] that is high in cannabidiol (CBD) content. It does not induce the psychoactive "high" typically associated with recreational marijuana strains that are high in tetrahydrocannabinol (THC). In September 2014, RoC announced that they would ensure that the product consistently contained less than 0.3% THC, and would thus qualify for classification as a "hemp-derived food product" with a minimum 30:1 CBD-to-THC ratio.[3]

Charlotte's Web is named after Charlotte Figi, born October 18, 2006, whose story has led to her being described as "the girl who is changing medical marijuana laws across America."[4] Her parents and physicians say she experienced a reduction of her epileptic seizures brought on by Dravet syndrome after her first dose of medical marijuana at five years of age. Her usage of Charlotte's Web was first featured in the 2013 CNN documentary "Weed". Media coverage increased demand for Charlotte's Web and similar products high in CBD, which has been used to treat epilepsy in toddlers and children. While high profile and anecdotal reports have sparked interest in treatment with cannabinoids,[5] there is insufficient medical evidence to draw conclusions about their safety or efficacy.[5][6]

Families who say they have run out of pharmaceutical options have moved to Colorado to access Charlotte's Web. The demand has spurred calls for more research to determine whether these products actually do what is claimed. While many U.S. states have legalized the use of medical marijuana products, including Charlotte's Web, within their borders, the nationwide legal status of Charlotte's Web is less clear. CBD-only legislation in several states is aimed at legalizing use of this particular form of medical marijuana, even though other uses of cannabis are still forbidden in those states. Federal legislation is under way which will affect the legal status in the whole country.

Background

Development, production, and growth

Cannabis oil

Charlotte's Web was developed in 2011 by the Stanley brothers (Joel, Jesse, Jon, Jordan, Jared and Josh[7]) by crossbreeding a strain of marijuana with industrial hemp.[8] This process created a variety with less tetrahydrocannabinol (THC) and more cannabidiol (CBD) than typical varieties of marijuana.[9] The variety shows potential for medical usage, especially for those who do not wish to experience the typical high of recreational marijuana use.[10] As it is so low in THC, the variety was originally called "Hippie's Disappointment",[11] and also has been labeled "boring".[12] It is a less profitable plant[13] with "close to no value to traditional marijuana consumers."[14] It is currently classified as an herbal supplement.[15]

The Stanley brothers grow the plants at their farm and greenhouses. A CBD rich oil is extracted from the harvested plants and concentrated through rotary evaporation.[16] To make it easier to perform clinical trials, they are planning to move the Charlotte's Web part of their operation to Uruguay. By doing so, they will also be able to import it into any U.S. state as hemp.[17][18]

The Realm of Caring Foundation (RoC),[1] a 501(c)(3) nonprofit organization,[19] was set up by the Stanley brothers to help patients "who can't afford the treatment."[11] They have also started "Stanley Brothers Social Enterprises, Inc.",[20][15][18] which has registered the trademark "Charlotte's Web Hemp Products".[21] Some products are marketed through CW Botanicals.[22]

Named after Charlotte Figi

Charlotte, born October 18, 2006 to Matt and Paige Figi, was diagnosed with Dravet syndrome (also known as severe myoclonic epilepsy of infancy or SMEI) when she was two years old. It is a condition where 80% of individuals have a mutation of the SCN1A gene. According to her parents, Charlotte was having 300 grand mal seizures a week,[9] seizures so violent that her parents put a do not resuscitate order in her medical records:[9][23] "They did give up on her. She was five years old, and she was do not resuscitate, wheelchair, end of life, hospice, feeding tube, oxygen, seizing every thirty minutes."[24]

Paige Figi was inspired by the experience of Jayden David, another child with Dravet Syndrome, who had been using medical marijuana since June 2011. Later Jayden's father stated that sufferers should be able to experiment with different THC and CBD ratios from the whole plant, and that the low THC Charlotte's Web oil preparation did not help Jayden.[25]

Before trying medical marijuana, the Figis had already tried "every other option before resorting to this type of prescription ..."[26] They got the cooperation of two physicians licensed in Colorado to prescribe medical marijuana, Margaret Gedde and Alan Shackelford.[27] First they tried a type called R4, which was low in THC and high in CBD, and saw immediate and dramatic improvement.[9] As their supply was running out, they sought the help of the Stanley brothers, "one of the state's largest marijuana growers and dispensary owners".[9] The Figis examined the options available and tried the variety which later would carry the name of their daughter. Her parents and physicians said her seizures were reduced to two to three per month,[9] and that she improved after being put on a regular regimen. The Stanley brothers then changed the name of the variety from "Hippie's Disappointment" to "Charlotte's Web".[11] Rather than smoking the product, Charlotte uses an olive oil solution containing the high CBD marijuana extract that she receives under her tongue[28] or in her food.[9] Her parents said in 2013 that she had about four seizures per month, and is able to engage in normal childhood activities.[9][23]

Charlotte's story has been featured on CNN documentaries[10][13] and The Doctors TV show,[29] among many other sources. An article in the National Journal detailing the role of several children as "uniquely powerful advocates for medicinal pot across the country" described Charlotte as the "first poster child for the issue...."[30] Her story has led to her being described as "the girl who is changing medical marijuana laws across America,"[4] as well as the "most famous example of medicinal hemp use..."[31]

Publicity and demand

When Charlotte was five years old, her story was featured in the August 11, 2013 CNN documentary "Weed", hosted by Sanjay Gupta.[10] On November 24, 2013, Paige Figi was a guest on The Doctors TV show, where Charlotte's story was told.[29] She was also featured in Gupta's March 11, 2014 CNN documentary "Weed 2: Cannabis Madness".[13] The extract received more publicity on October 6, 2014, when The Doctors TV show again featured a story about usage of Charlotte's Web. The physicians called for a change of the Federal classification.[32] Sanjay Gupta has also expressed his support for Charlotte's Web on The Doctors TV show.[33] On the October 17, 2014 episode of the ABC TV series The View, Paige Figi and Joel Stanley were interviewed by Whoopi Goldberg and Nicolle Wallace.[24]

The CNN documentaries received widespread publicity and popularized Charlotte's Web as a possible treatment for epilepsy and other conditions.[9] Colorado has legalized both the medicinal and recreational use of marijuana, and many parents have flocked there with their suffering children in search of Charlotte's Web and other forms of medical marijuana.[34] In November 2013, CBS Denver reported that "[t]here is now a growing community of 93 families with epileptic children using marijuana daily. Hundreds are on a waiting list and thousands are calling."[11] In October 2014, Time noted the Stanley brothers had a waiting list of "more than 12,000 families".[35] They have been termed "marijuana refugees",[11] "part of a migration of families uprooting their lives and moving to Colorado, where the medicinal use of marijuana is permitted ... forced to flee states where cannabis is off limits."[36][37] In November 2014, David Nutt mentioned Charlotte's Web in the Royal Pharmaceutical Society's Pharmaceutical Journal, where he appealed for "the UK government [to] acts on evidence, allowing the use of medicinal cannabis and reducing barriers to its research."[38]

Some have attempted to use the extract for treatment of cancer. The mother of a child with acute lymphocytic leukemia (ALL), a common form of childhood cancer, moved to Colorado to seek treatment with the marijuana extract. This form of cancer is highly curable with chemotherapy, and she was investigated when she refused chemotherapy for her three-year-old child.[39][40]

Need for research and caution

In the United States, the relationship between the Federal illegal status of cannabis and the lack of scientific research on cannabis is directly related.[41][42] The situation has been described as a "catch-22" paradox: "Marijuana is restricted in large part because there is little research to support medical uses; research is difficult to conduct because of tight restrictions."[43] Sanjay Gupta has described the complex interaction between restrictive laws and lack of scientific research:

"Gupta repeated throughout the evening that the 'policy has outpaced the science.' The states, he said, are moving forward without waiting for the science, and the issue is only compounded by the fact that the 'policies and the laws we have in [the US] make it challenging for the science to get done.'"[42]

Colorado law permits the use of medical cannabis for eight conditions: cancer, glaucoma, HIV/AIDS, muscle spasms, seizures, severe pain, severe nausea and cachexia or dramatic weight loss and muscle atrophy.[9] The publicity surrounding anecdotal reports of successful treatment of intractable epilepsy with cannabinoids is likely to lead to a surge in interest.[5] There is little supportive clinical evidence about the safety or efficacy of cannabinoids in the treatment of epilepsy;[5] a 2012 Cochrane review said there is not enough evidence to draw conclusions about their use.[6] There have been few studies of the anticonvulsive properties of CBD and epileptic disorders.

Even though the Florida "Compassionate Medical Cannabis Act of 2014" (SB 1030)[44] provides funding for research, the status of all cannabis products as illegal Schedule I drugs has limited the amount of research, with the University of Florida refusing to do such research for fear of losing federal funding.[45][46]

The interest created by the documentary highlighted a need for increased scientific research, as well as caution against "bad medicine" and raising false hopes: Ed Maa, a Colorado neurologist, specialist in epilepsy, and board member of the Colorado Epilepsy Foundation, stated: "This is not going away. ... I think it needs to be studied vigorously and very quickly." He hopes to "launch a clinical trial to study the pot and its potential".[11] Physicians have called for more research to better understand the potential benefits of controlled use of medical marijuana;[5] Sharon Levy, MD, MPH, and director of the Adolescent Substance Abuse Program at Children's Hospital Boston and an assistant professor of pediatrics at Harvard Medical School in Massachusetts said:

"The AAP strongly supports more cannabinoid research to better understand both how these substances can be used therapeutically as well as their potential side effects—which we may well be underestimating ... [But] the AAP does not support 'medical marijuana' laws as they circumvent regulations put in place to protect patients, and children are a particularly vulnerable population."[5]

Physicians have expressed both positive interest and worry about the sudden explosion of interest in the legalization of medical marijuana and its research, admitting legalization is both "a scientist's dream or a doctor's nightmare". They fear that some parents are too open to trying anything before proper research has been conducted, and that they may be disappointed. They are "alarmed by parallels to past miracle-cure manias later proved false ..." and "... wary of the heightened placebo effect in treatments involving children, when reports of progress depend on the view of parents".[47] There is also danger that "the [legalization] movement also opens the way for bad medicine ... through treatments at best giving hope to the hysterical and at worst delivering damaging side effects".[47] According to Alan Shackelford, Charlotte Figi's physician: "We really don't know how it works... The cannabidiol seems to act as a neuro-stabilizer, but how? The research is minuscule on this."[48]

The American Epilepsy Society said:[49][50]

"While there are some anecdotal reports of marijuana use in treating epilepsy, scientific evidence for the routine use of marijuana for this indication is lacking. The lack of information does not mean that marijuana is ineffective for epilepsy. It merely means that we do not know if marijuana is a safe and efficacious treatment for epilepsy....
"In addition, little is known about the long term effects of using marijuana in infants and children, and chronic exposure during adolescence has been shown to have lasting negative effects on cognition and mood. Such safety concerns coupled with a lack of evidence of efficacy in controlled studies result in a risk/benefit ratio that does not support use of marijuana for treatment of seizures at this time."

Orrin Devinsky, a neurologist at New York University's Comprehensive Epilepsy Center, where he will conduct clinical trials on Epidiolex,[51] a high-CBD drug from GW Pharmaceuticals, expressed his sympathy for those who "can't wait for results from research":[2]

"If I had a child who had failed 15 medications and drug treatments and there was nothing else to do, and they were having many seizures a day that were terribly disabling, I think it would be a very reasonable thing to do to try a high-CBD cannabis product."

He also expressed concern that the number of parents using the Charlotte's Web extract will make it harder to find children for the clinical trials, and that:

"There are many more unknowns than knowns ... the focus of the community—lay and scientific and governmental—should be on getting good information. That should be the real focus of what we need right now."[2]

The Epilepsy Foundation and Devinsky issued a joint statement calling for increased research and immediate access to medical marijuana, specifically naming Charlotte Figi's case. Devinsky said:

"We need to make a balanced decision about compassionate use. If I were Charlotte Figi's parents and lived in Colorado I would have done exactly what they did. And as a doctor, I would gladly prescribe marijuana products for many of my patients who failed existing therapies if it were legal in my state.... Until we have the scientific data, we should make medical marijuana available to physicians who care for people with treatment-resistant epilepsy and their patients."[52]

The American Cancer Society says:

"While it shows promise for controlling cancer pain among some patients, there is still concern that marijuana may cause toxic side effects in some people and that the benefits of THC must be carefully weighed against its potential risks. There is no available scientific evidence from controlled studies in humans that cannabinoids can cure or treat cancer."[40]

The National Cancer Institute says that delta-9-THC has been shown to damage or kill cancer cells for liver cancer in mice (hepatocellular carcinoma), also having possible benefits of reducing colon cancer and breast cancer, as well as helping chemotherapy cancer patients regain their appetite. However, they also agree that more studies need to be done.[53]

Due to reports that some Dravet Syndrome patients seem to benefit from treatment with Charlotte's Web, and others do not, an observational clinical trial was launched in September 2014 at the University of Colorado. The study, which is now accepting applicants and will run until February 2016, will focus on genetic differences between responding and non-responding patients, and attempt to determine if such genetic factors may be related to the success or failure of treatment.[54] This information "...may prove useful for identifying patients likely to be helped by this therapy, as well as shed light on the putative mechanisms by which marijuana may exert any antiepileptic effect."[55]

Legal status

While the use of medicinal marijuana products is allowed in many U.S. states, the nationwide legal status of Charlotte's Web is less clear. The publicity associated with Charlotte's Web has inspired a number of legislative bills, some of which are in the planning stages, and others which have been proposed or actually passed. Children, as "uniquely powerful advocates for medicinal pot across the country,"[30] have inspired "the movement to legalize medicinal marijuana," a movement which "has a face like Charlotte’s–and it’s a young one that’s hard to ignore. Lawmakers across the country are pushing legislation to legalize marijuana oil as a treatment for children with epilepsy."[56]

In 2013, the parents of a two-year-old with Dravet's syndrome confronted New Jersey governor Chris Christie, who signed a bill allowing access for sick children to medical marijuana[14] in a controversy dubbed "pot for tots".[14][39][57]

In 2014, legislative proposals in Utah,[58][59] Arizona,[60] New York,[61] Washington state,[14] Minnesota,[49] and Florida[44][62] are being considered, where "even some staunch opponents of medical marijuana now are willing to make an exception" to allow the marijuana extract for medical treatment.[2]

In Utah, Rep. Gage Froerer, R-Huntsville, said in October 2013: "Nothing in federal or state law prohibits the sale or use of hemp products."[16] He pledged to consult with the Utah Substance Abuse Authority, saying: "We need to take a strong look at this and make sure that we as a legislature and we as citizens understand really what this is and what it's not."[63] In November 2013, he said he would address "three components in sponsoring legislation: access, quality control and research. He said the Utah Department of Health would probably be involved in quality-control efforts ..."[64] Annette Maughan, President of the Epilepsy Association of Utah, said: "The current Utah law doesn't exclude its use but also doesn't allow for its use. We are in limbo until Utah lawmakers decide what to call it."[63] On March 21, 2014, Gary Herbert, the governor of Utah, signed a bill giving "families access to the marijuana extract for treating epilepsy."[60] The state bill, HB0105, allows import of Charlotte's Web extract across state lines from Colorado to Utah, and covers only use for intractable epilepsy with the consent of a neurologist.[58][59] Also on March 21, 2014, an Arizona court found "that Arizona's medical marijuana law allows consumption of the plant in extract form."[60]

On March 20, 2014, the Florida House of Representatives Budget Committee passed the "so-called Charlotte's Web measure (CS/HB 843)"[62] designed to limit prosecutors' ability to prosecute those in possession of low THC/high CBD marijuana ("0.5 percent or less of tetrahydrocannabinol and more than 15 percent of cannabidiol") used for treating seizures. The law took effect July 1, 2014.[65][66] Since then, Florida legislators have passed a bill with bipartisan support legalizing the use of Charlotte's Web,[67] and Governor Rick Scott signed the "Compassionate Medical Cannabis Act of 2014" (SB 1030)[44][68] into law on June 6, 2014. The law is also referred to as the "Charlotte's Web" law.[45][69] The law specifies the number of distribution centers, which types of nurseries can grow the plants, requires various other controls,[70] and provides funding for research.[44]

Federal legislation is under way which will affect the legal status in the whole country. Federal action began on July 28, 2014 with the introduction of bill H.R.5226,[71] "The Charlotte's Web Medical Hemp Act of 2014", which was sponsored by Rep. Scott Perry, R-Pennsylvania. "The three-page bill would amend the Controlled Substances Act -- the federal law that criminalizes marijuana -- to exempt plants with an extremely low percentage of THC, the chemical that makes users high."[43][72] If it is passed by subcommittees, it will be considered by the full House of Representatives.[73] As of September 28, 2014, it has 26 bipartisan cosponsors.[71] A related bill known as "H.R.525 - Industrial Hemp Farming Act of 2013", sponsored by Rep. Thomas Massie, R-Kentucky, is also before Congress. As of September 28, 2014, it has 50 bipartisan cosponsors.[74]

Reactions to CBD-only laws inspired by Charlotte's Web

The Marijuana Policy Project has expressed frustration over the fact that many legislative efforts inspired by Charlotte's Web are aimed at only legalizing low or no THC, high CBD medical marijuana products. They believe that such legislation is too restrictive and ignores claimed benefits of THC, leaving "behind around 98% of the individuals who can benefit from it."[75] Referring to the "Charlotte’s Web Medical Hemp Act of 2014", an editorial in Ladybud Magazine expressed concern that the law "leaves thousands of patients out in the cold without safe, legal access to medical cannabis. It also ignores science that seems to indicate that whole plant medicine is optimal."[76]

Distribution

In November 2013, Josh Stanley said that Charlotte's web was 0.5% THC and 17% CBD,[7] and that it "is as legal as other hemp products already sold in stores across Utah, including other oils, clothing and hand creams, but is illegal, federally, to take across state lines."[77] The legalities of selling the product to people who transport it across state lines is complicated, with difficulties for both the sellers and transporters. Regardless of state laws in Colorado and Utah which would allow the practice, it is still a Federal offense to transport hemp products across state lines.[78][79] In September 2014, the content was measured at 0.3% THC and it was classified "as a hemp-derived food product".[3]

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  71. ↑ 71.0 71.1 H.R.5226 - Charlotte's Web Medical Hemp Act of 2014, House of Representatives, July 28, 2014, retrieved August 11, 2014 "Official Title as Introduced: To amend the Controlled Substances Act to exclude therapeutic hemp and cannabidiol from the definition of marihuana, and for other purposes."
  72. ↑ Ferner, Matt (July 28, 2014), House Bill Would Legalize 'Charlotte's Web' Medical Marijuana, The Huffington Post, retrieved July 29, 2014
  73. ↑ Perry, Scott (July 28, 2014), Congressman Perry Introduces Bipartisan Legislation to Help Children / Individuals Suffering from Epilepsy and Other Seizure Disorders, United States House of Representatives, retrieved July 29, 2014
  74. ↑ H.R.525 - Industrial Hemp Farming Act of 2013, House of Representatives, February 6, 2013, retrieved September 28, 2014
  75. ↑ Low or No THC, High CBD Medical Marijuana Bills: Leaving Most Patients Behind, Marijuana Policy Project, 2014, retrieved April 6, 2014
  76. ↑ Admin, Ladybud (August 29, 2014), National CBD-Only Law Proposed: Is Charlotte’s Web Choking out Legalization?, Ladybud Magazine, retrieved August 29, 2014
  77. ↑ Leonard, Wendy (November 12, 2013), Utah parents look to Colorado for 'life-improving therapy' found in cannabis extract, Deseret News, retrieved January 1, 2014
  78. ↑ Stewart, Kirsten (March 25, 2014), How will marijuana grower decide who gets cannabis oil?, The Salt Lake Tribune, retrieved March 26, 2014
  79. ↑ Price, Michelle (March 25, 2014), Utah to welcome marijuana for limited medical use, Associated Press, retrieved March 26, 2014

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