CHICAGO — Nicole Gross was so desperate to find relief for her son's near-constant, debilitating seizures that she moved him from Naperville, Ill., to Colorado so he could receive medical marijuana.
Weeks after Chase Gross, 8, started taking a marijuana oil extract through a dropper, his mother believed she saw a dramatic decrease in the number of daily seizures he suffered, allowing him to make developmental leaps, like dressing himself and learning several new sign language words, since his condition has left him unable to speak.
Nicole Gross became so convinced of pot's effectiveness in treating her son's severe epilepsy that she has joined a growing number of parents and advocates lobbying Illinois to change its rules - not only to add epilepsy to the list of qualifying conditions, but also to make medical marijuana available to children, as Colorado and several other states do.
The drug's positive effects on Chase, his mother said, was "shocking."
Public opinion has been shifting in favor of medical marijuana: Twenty states have legalized it, and the vast majority allow children to get it. But its use, particularly among juveniles, remains controversial.
Marijuana is still illegal under federal law, where it is classified as a dangerous substance with no medical value. While its proponents cite largely anecdotal evidence as they lobby to expand the use of medicinal pot for a growing number of conditions, many physicians warn there's not nearly enough research to demonstrate pot's effectiveness for treating sick adults - let alone children.
Dr. Kent Kelley, chief of pediatric neurology at NorthShore University HealthSystem's Evanston's hospital, treats several children who suffer from seizures and whose parents have asked him about marijuana as a last-resort option. He advises them to wait and try to seek out clinical trials for their children.
"It's a hard thing to ask parents. On the other hand, it may not be as good as we think, so we want data to know how effective it is and what the risks are," Kelley said. He added he would support the proposed change in the Illinois law but hopes more clinical research will take place first.
The American Academy of Pediatrics notes that while research on pot's potential therapeutic benefits is scarce, the drug's harmful effects on memory, motivation, judgment and motor control are well-known.
Dr. Sharon Levy, director of the Adolescent Substance Abuse Program at Boston Children's Hospital, said using state laws to sidestep federal medical regulations makes bad public policy. She noted that marijuana abuse remains common among her patients, and that use during adolescence is associated with drops in IQ, and increased rates of schizophrenia and other psychiatric disorders.
While there may be rare special cases that warrant exceptions to the rule, Levy said drugs that derive from the marijuana plant, called cannabinoids, should go through the same rigorous testing and approval process as every other drug to show they work safely. Otherwise, she said, children may be taking something that ends up doing more harm than good, particularly for other conditions that are much more common than extreme forms of epilepsy.
"Failing to develop cannabinoids as medication is a disservice to the kids who may benefit from them," she said. "The answer is better regulation, not less of it."
Marijuana advocates counter that federal regulation has stood in the way of the very research that is needed. The U.S. Drug Enforcement Administration classifies marijuana the same as it does heroin, as a Schedule I controlled substance with no accepted medical use and high potential for abuse.
Yet of the 38,000 people who died from drug overdoses in the U.S. in 2010, according to the Centers for Disease Control and Prevention, 60 percent were related to FDA-approved prescription drugs, while reported deaths from marijuana are extremely rare.
Advocates argue that children with debilitating, sometimes fatal diseases don't have time to wait for the years it typically takes the FDA to approve a new medication. Many parents say they've already spent years giving their children legal prescription drugs that don't work or have horrible side effects, and they deserve access to other treatment options.
Before their struggle to save their son, Nicole and Randy Gross said they were the last people to support marijuana use. Randy Gross attended the Air Force Academy in Colorado Springs, where he met his wife, who was a biologist who later worked in a forensics lab.
Their feelings began to shift when they heard that other children with severe epilepsy were finding relief through marijuana. Chase is thought to have myoclonic astatic epilepsy, also called Doose syndrome, and his parents say that, before he started ingesting marijuana, he would have hundreds of short seizures each day.
But the oily extract they administer to their son is low in THC - the psycho-active component of marijuana that causes smokers to get "stoned" - and high in CBD, or cannabidiol, which has shown promising results in animal studies.
That strain of marijuana is known as Charlotte's Web, named for a 5-year-old girl named Charlotte Figi, who gained national attention last year when CNN reported that the drug had drastically reduced her severe seizures.
Though Charlotte previously could not walk, talk or feed herself, she is now doing all those things and riding a bike, according to her physician, Dr. Alan Shackelford, who also helped approve Chase for medical marijuana use.
But even advocates like Shackelford, who estimates he's seen about 30 children who are being treated successfully with medical marijuana, agree that the drug needs clinical trials to establish proper and standardized content and dosing. However, he said, time is of the essence.
About 200 kids are registered in Colorado to receive medical marijuana, according to the Colorado Department of Public Health and Environment. Children need approval from two doctors, not just one as for adults.
Dr. Larry Wolk, the department's director and chief medical officer, said it appears that most of the children approved to use medical pot have epilepsy, and the majority have come from out of state. Yet children make up only a small fraction of medical marijuana patients, he said.
Wolk worries that the spotlight on children brings medical expectations that the research has yet to support.
"It's possible that your child may not respond," Wolk said. "And it's also possible that even if your child does respond, you might be trading treating the seizure for creating a different kind of problem."
Despite calls for broader legalization, FDA officials say, not so fast. Spokeswoman Sandy Walsh said in an email that manufacturers and researchers must show new drugs to be safe and effective before they're marketed in the U.S.
Any efforts to bypass that process "would not serve the interests of public health because they might expose patients to unsafe and ineffective drug products," she wrote.
The FDA has approved two synthetic drugs to treat nausea, Marinol and Cesamet, which contain active ingredients found in marijuana, but neither was studied for children.
The National Organization for the Reform of Marijuana Laws reports that few patients like Marinol because of its high price, delayed onset and heightened psychoactivity. In clinical trials, Cesamet was safe and effective, but also prompted adverse reactions, such as moderate drowsiness, vertigo or euphoria, according to the National Institutes of Health.
Last year, the FDA gave approval for five studies of 25 pediatric patients with severe epilepsy, each being treated with Epidiolex, a raspberry-lime syrup that has CBD but no THC. One of those clinical trials will be conducted at Ann and Robert H. Lurie Children's Hospital in Chicago.
Lurie officials issued a statement that "the findings will then guide us on the best treatments available for children with epilepsy."
The maker of Epidiolex, GW Pharmaceuticals in London, also makes Sativex, a THC/CBD mix that has been approved for legal use in 25 countries, generally for spasticity in multiple sclerosis patients. The company plans to seek FDA approval for both drugs.
Illinois, Delaware and Connecticut are the only three states whose medical marijuana laws do not cover children, said Karen O'Keefe, Marijuana Policy Project's director of state policies. She said it is becoming much less controversial to include children, and noted that the states that allow it often establish additional restrictions.
"I think any sentiment among a minority of otherwise supportive legislators that minors should be excluded has changed," O'Keefe said in an email. "There are hundreds of parents who are desperate to quell their children's seizures, which can result in sudden death and can prevent them from walking, talking, and using the toilet."
Other groups have also started weighing in to support the medical uses for marijuana.
Last week, the nonprofit Epilepsy Foundation called for changing state laws to allow children to receive the drug for seizures. It also called on the DEA to ease its classification of marijuana to promote its use in research, a move the DEA has resisted.
The foundation estimates that 1 million people with epilepsy do not respond to conventional treatment, and stated that "an end to seizures should not be determined by one's ZIP code."
In Illinois, state Sen. Iris Martinez is sponsoring a bill to add myoclonic-astatic epilepsy as a qualifying condition for medical marijuana, and to add children as potential recipients for that condition alone. She plans to have a committee hearing on the matter in March in hopes of passage this spring.
This would be the first change to the Illinois medical marijuana law, which just took effect this year but is not expected to be fully implemented until next year.
Until the FDA takes action, Martinez said, "If this is going to bring some form of relief, we really need to look at this."
Randy Gross, Chase's father, said that after already trying 10 different pharmaceutical medications with little relief and sometimes serious side effects, Chase deserves the opportunity to use a drug that his parents assert is helping him.
"Every day lost is one that we can't get back to teach him the most basic of life skills," Randy Gross said. "We're at the end of our rope medically."
Margaret Storey, whose 10-year-old daughter Josie has Aicardi syndrome, a rare and debilitating seizure disorder, is hoping the bill passes. The Evanston mother said she's aware of the potential risks, but said they've tried numerous medications and even implanted a nerve stimulation device to treat Josie's seizures. Nothing has worked, she said.
"From our point of view, (medical marijuana) just doesn't look that scary after what we've been through," Storey, whose daughter is a patient of Dr. Kelley at NorthShore Evanston Hospital.
Storey and her husband, Jonathan Heller, have contemplated moving to Colorado or California to get Josie treatment. They talked about all it would entail - leaving their home and jobs, Josie's school, doctors, therapists, their entire support system - and said they're going to wait before making that decision.
"What I would love is for Illinois to change the law," Storey said, "and we wouldn't have to go anywhere."