Jennie Stormes sounded exhausted. She was sitting in a private room in the Epilepsy Monitoring Unit at Hackensack University Medical Center, where her 15-year-old son, Jackson—known to all as Jax—was trying to sleep. Interviewed by phone, she described her son’s lifetime of suffering. Jax’s moans of pain could be heard in the background.
Jax began having seizures when he was four months old. Eventually, he was diagnosed with Dravet syndrome, a severe, rare, genetic form of early-onset epilepsy.
A few days before this latest hospital trip, Stormes had made the difficult decision to move from the picturesque Warren County town of Hope to Colorado, where she can get readier access to the medical marijuana she says Jax needs to control his seizures.
Stormes is frustrated with New Jersey’s health care system, which she says makes life difficult for medical marijuana patients. According to Stormes, on at least one occasion when Jax was suffering a seizure, she and her son were forced to leave the Hackensack UMC emergency room when she tried to give him a few drops of cannabis oil or even mentioned that he was being treated with medical marijuana. “They kicked us out,” Stormes claims. “We were sent home unstable because I had to choose between the cannabis and traditional medications.” (A Hackensack UMC spokesperson denies that the Stormes family was forced to leave the hospital. However, she adds that cannabis is not permitted to be administered in the facility.)
As an infant, Jax began taking a prescribed cocktail of pharmaceuticals in an attempt to treat his debilitating seizures. The drugs included phenobarbital, Klonopin, ONFI, Depakote, Banzel and stiripentol, most of which are not FDA approved for long-term use in children. By age 13, Jax still had the mental capacity of a toddler and was experiencing hundreds of seizures a week. Stormes recalls the advice of one doctor: “There are no options, there’s nothing new coming on the market, so would you like to go home now and love your child?”
In the summer of 2012, Stormes attended a Dravet conference where she heard numerous success stories about cannabis treatment. She decided to give it a try. “I had nothing to lose,” she says. “My son has been on drugs that are not FDA-approved for use in children since he was four months old.” Jax was one of the first minors to register in the state’s Medical Marijuana Program (MMP), which was implemented in October 2010 following enactment of the state’s medical marijuana law 10 months earlier.
The results, Stormes says, have been astonishing. “He’s had 30-minute and hour-long seizures before, and now if he has a two-minute seizure, that’s a long one. He used to have 20 to 30 seizures in one night. Now, he can go 10 days without a seizure.”
Last May, when Hackensack UMC allegedly turned Jax away for the second time while he was having a seizure, the incident made the front page of the Record. “There was no apology, nothing,” Stormes says. Still, the family continued to seek treatment at the hospital’s Epilepsy Monitoring Unit, the closest such facility that accepted their health insurance. In the hospital, Stormes gave Jax furtive drops of cannabis oil on what she calls a “don’t ask, don’t tell” basis.
In early September, Stormes and her son flew to Colorado, where they met with Dr. Alan Shackleford, a leading expert on cannabis treatment, and came away convinced Colorado is where they need to be. “His life depends on it,” she says. “If he’s not on cannabis, he will die.”
Patient grievances about New Jersey’s 4-year-old MMP have been widely reported. Though the law calls for the establishment of a “sufficient” number of at least six dispensaries (known as Alternative Treatment Centers, or ATCs), so far only three have opened. The registration process for both physicians and patients—especially minors—is long and cumbersome, leading to only 2,994 patients so far, compared to the tens of thousands anticipated. And for those in the program, the medicinal-grade herb is costly—and not covered by insurance.
Epilepsy is one of the conditions—along with end-stage cancer, glaucoma, ALS, muscular dystrophy and others—eligible for treatment under New Jersey’s medical marijuana law. The drug’s potential for helping children with epilepsy was the subject of Weed, a 2013 CNN special report by chief medical correspondent Dr. Sanjay Gupta. He told the story of Charlotte Figi, a Colorado child with Dravet syndrome who began targeted cannabis treatment when she was five. According to the documentary, Figi went from 300 seizures a week and being unable to walk to having only one or two seizures a week under cannabis treatment. She is now learning how to ride a horse and has become the national poster child for the medical marijuana movement.
While some parents of epileptic children are eager to get their kids into the New Jersey program, the hurdles to enroll children are higher than for adults. Minors must have approval from two to three doctors: a pediatrician and a psychiatrist are required; if neither is registered with the MMP, an additional registered physician is also needed. Adults need only one approval. At press time, there were only five pediatricians registered in the state program.
Stormes is among those befuddled by the regulations. Her teenage son, she points out, is nonverbal and has been deemed untestable for neuropsych issues. “Now,” she says, “you want him to go see a psychiatrist?”
Oaklyn resident Ricardo Rivera is similarly frustrated. His 7-year-old daughter, Tatyana, has Lennox-Gastaut syndrome, another rare form of pediatric epilepsy. The child, known as Tuffy, has been treated with more than 50 combinations of medications and has had up to 300 seizures in a 24-hour period.
It took Rivera over a year to complete the MMP registration process for Tuffy. “Waiting lists are months long; it was hard to find a pediatrician,” says Rivera. “Why is it that my daughter has to wait a year and half [for treatment] when her life expectancy is nine years?” Tuffy started cannabis treatment in June and now has about one seizure a week.
The treatment, while effective, has financially stressed the Riveras. It costs $200 every two years to register for the New Jersey program; that’s one of the highest rates among the 23 states with medical marijuana programs. (New York charges a one-time fee of $50.) At the state’s three operating dispensaries, the medicinal-quality drug costs about $500 an ounce, twice the street value. Patients are allowed to buy 2 ounces per month.
The costs don’t end there. Cannabis is the only doctor-recommended medicine taxed by the state. All transactions are in cash or by debit card, since banks and credit card companies have been reluctant to process payments for marijuana. Insurance won’t cover even the required preliminary doctor visits. Most patients spend nearly $1,000 before they get into the program, and not all get in. Rivera says he spent nearly $5,000 in cash on doctors before Tuffy was accepted.
Another troubling flaw in New Jersey’s program is lack of access to the drug in edible form. That’s a particular concern for lung-cancer patients and children, for whom smoking dried medicinal cannabis is problematic. What’s more, medical marijuana advocates say that edible cannabis, typically a highly concentrated oil-like tincture, is preferable because it eliminates extraneous plant material and contains only the essential medicinal cannabinoids. The extracts are more potent and can be dispensed in exact doses. Julio Valentin, the CEO of Greenleaf Compassion Center in Montclair, one of the state’s three dispensaries, says making edibles available is the “number one” change the state should make to the program.
In January 2010, in the final hours of his governorship, Jon Corzine signed the Compassionate Use of Medical Marijuana Act into law. That left it to the new governor, Chris Christie, to implement the program, even though he is openly hostile to the concept. Like many opponents, he has described medical marijuana as a back door to recreational legalization.
Advocates fault Christie for the ineffectiveness of the program and for placing onerous restrictions on doctors, dispensaries and patients. In rolling out the program, Christie eliminated a provision that allowed edibles. The move sparked criticism, prompting the governor to back off and approve edibles—but only for minors—in September 2013.
More than a year later, edibles are still unavailable through the dispensaries. The state Department of Health is studying the safety and efficacy of various extraction methods as well as proper dosages and labeling. For now, patients, and parents like Stormes and Rivera, must make edibles in their kitchens from recipes found on web forums. Home extraction methods include using high-proof grain alcohol or coconut oil as binders to isolate the medicinal cannabinoids.
“I’m actually making oil for my daughter as we speak,” Rivera said in a phone interview. “I’m not qualified to do this. I’m not a pharmacist.”
Parents and patients are also in the dark about dosage. Some would like to test the potency of their homemade edibles in medical labs, but there’s no legal way to do so.
While parents are hopeful that edibles will be available soon, hope was not enough for Stormes, who worried about what would happen when her son turned 18 in New Jersey. At a town hall meeting in Sayreville in April, she asked Christie why he approved edibles only for minors. “No one has come through to us with evidence yet that there’s a large enough demand for edibles at the adult level,” Christie declared, concluding, “We believe that most people over the age of 18 can take it the normal way”—which in Christie’s world apparently means smoking.
Other states take a different view. New York and Minnesota have banned patients from smoking altogether. Their programs allow only tinctures, edibles or vaporizing (a smokeless method of inhaling, similar to using an e-cigarette).
Dave Knowlton, president and CEO of the New Jersey Health Care Quality Institute and board chairman of the Compassionate Care Foundation, a dispensary in Egg Harbor, also finds the minors-only revision inadequate. “A lot of my patients in Egg Harbor are older, like cancer patients and people in their 70s. Sitting down and smoking a joint isn’t going to work for them,” he says. “But putting something in their tea will work for them.”
The medical community has its own issues with the state’s program. Only 353 of the state’s more than 25,000 licensed physicians have completed the registration process required to “certify” marijuana (it cannot be “prescribed” under federal law). Some have avoided the program because the list of doctors who register is available publicly. That makes the doctors easy targets for people trying to abuse the system. “It’s almost like a list of shame,” says Stormes. “Until [inclusion on] the public register becomes voluntary, you’re going to have resistance from doctors.”
Further, to be approved for the program, physicians must complete a course on addiction medicine and pain management. Many doctors regard that as an unnecessary obstacle. They point out that a family physician can prescribe a powerful and addictive narcotic like OxyContin, a Schedule II drug, without completing a comparable course.
Dr. Mark Angelo, a registered medical marijuana physician at the Palliative Care Program at Cooper University Hospital’s cancer center in Camden, says if the state is going to require a course, it should cover the endocannabinoid system, which controls how the body breaks down and absorbs the plant’s 100 or so cannabinoids. Only one—tetrahydrocannabinol (THC)—causes the high sought by recreational users; THC also has medicinal uses. In a survey of 157 U.S. medical schools, only 13 percent mention the endocannabinoid system in the curriculum. “I’m surprised it was even that high,” says Angelo.
Other physicians, such as Dr. Kathleen Toomey, a hematologist and oncologist at Regional Cancer Care Associates in Somerville, question the validity of the medical marijuana movement. “I’m not anti-marijuana,” Toomey says. “I don’t see why something like alcohol, which is more toxic than marijuana, is legal.”
Toomey’s skepticism stems from the lack of large-scale clinical trials. “I believe in the scientific method,” she says. The FDA’s drug-review process involves three phases of clinical trials, with phases II and III requiring several hundred to 3,000 patients using placebo control groups. All drug trials require federal approval, but of the cannabis trials that have been approved, most have not gone beyond the small samples of Phase I.
Cannabis is a Schedule I drug under the federal Controlled Substances Act of 1970; the most restrictive of the five categories of narcotics, meaning it has no approved medical use under federal law. Getting FDA approval of a Schedule I drug is a catch-22. For the FDA to study the drug, it needs the cooperation of the National Institute on Drug Abuse and the Drug Enforcement Administration, two law-enforcement agencies that have a history of treating marijuana use as a crime. “Treat it in the medical model,” says Toomey, who feels the “demonization” of the war on drugs has caused suffering patients to be treated like addicts and criminals. “Get it out of the justice system.”
However, the FDA has approved two synthetic versions of THC, dronabinol and nabilone, both of which are used to increase appetite and treat nausea in chemotherapy patients. Toomey prescribes dronabinal for a few of her patients. “It’s easily titrated to the correct dose,” she says. “Every patient metabolizes things differently. It’s been well studied and is continuously monitored by the FDA. So why would I use something that’s less precise?”
Another cannabis synthetic, Sativex, now approved for use in most of Europe, is in Phase III U.S. clinical trials for treating cancer pain. Sativex has equal parts THC and another cannabinoid, CBD, short for cannabidiol. CBD is non-psychoactive—that is, it does not cause a high—but it appears to have a wide range of biological benefits, including relief from anxiety, convulsions, nausea, inflammation and spasms. In rare cases, it has been shown to eliminate malignant tumors.
In November 2013, the FDA approved clinical trials under Livingston neurologist Dr. Orrin Devinsky to treat epileptic children with Epidiolex, a liquid form of pure CBD developed by U.K.-based GW Pharmaceuticals. In a June 2014 statement, GW Pharmaceuticals said the initial trials “provided encouraging results.”
It is known that patients react to a variety of cannabinoids in the plant, not just THC and CBD. It is not known why certain cannabinoids, or a combination of several, work for some patients and not for others. For Jax Stormes, CBD by itself doesn’t work. He needs a mixture of THC, CBD and another cannabinoid, THCa.
“Everyone sees CBD as some type of miracle treatment,” says Dr. Lorraine Lazar, a pediatric neurologist at Morristown Medical Center’s Goryeb Children’s Hospital. She doesn’t agree. “I think CBD will be just like other therapies. It’s not going to be the end-all for everyone.”
The University of Colorado at Denver began recruiting epilepsy patients in September for a clinical trial that will examine the role of genes in the efficacy of CBD treatment. CBD’s success stories prompted U.S. Representative Scott Perry, a Pennsylvania Republican, to introduce a bill this past summer that would amend the federal Controlled Substances Act to permit CBD or cannabis strains so low in THC that they are technically hemp. The bill, called the Charlotte’s Web Medical Hemp Act of 2014, is named after the high-CBD strain of cannabis that helped Charlotte Figi in Colorado. Parents around the country are unsure how to react to the bill, which would help those who respond to CBD, but could become an obstacle to wider approval of other cannabinoids.
In New Jersey, an Assembly bill to modify the state’s MMP was introduced in July. The bill would allow edibles for adults, add to the number of medical conditions that qualify for treatment, and remove the requirement that minors must have a psychiatric evaluation. The sales tax on medical cannabis and the renewal fee for registration would be eliminated. If the bill is passed, Assemblywoman Linda Stender (D-Scotch Plains) one of its sponsors, expects Christie will not sign it. “I fully understood that I introduced it with a governor in office who is opposed,” says Stender. “But I remain committed to trying to help the sick people in my district and in the state.”
For Jennie Stormes, the bill won’t matter. She moved to Colorado in late October—the second New Jersey family in the last year to make headlines for such a move. She frequently wonders how Jax’s life would have been different if he had been allowed to use cannabis earlier in life. Would he have had fewer seizures? Would he have been spared the damaging effects of pharmaceuticals? Would he have developed proper brain function? “I think my son will forever be between 3 and 5 mentally,” Stormes says tearfully.
Ricardo Rivera says he hopes state policies will change soon, affording Tuffy a better quality of life. The Camden native doesn’t see leaving New Jersey as an option.
“I’m not moving to Colorado,” says Rivera, who served in the army from 1999 to 2003 and is now a surgical technologist at a New Jersey hospital. “I served my country. I help people every day. Why should I become a medical marijuana refugee from my home state?”