By Dana Ferguson
Nine-year-old Nicholas Volker asks his mother every day when he'll be able to get the medicine that could end the scores of seizures that shake his body every day.
His disheartened mother, Amylynne Santiago Volker, tells him, "Not yet."
Two months after Gov. Scott Walker signed into law a measure allowing the use of cannabidiol, a marijuana derivative used to treat epileptics without giving them a high, Wisconsinites have not yet been able to access the drug. That's in part because of obstacles written into the legislation at the last minute.
"It is frustrating," Volker said of the roadblocks between her son and the experimental treatment. "It's there in paper, but we can't access it."
On Friday, Walker told reporters he wasn't sure if his administration could do anything on its own to open up access to the substance. But if more could be done through state legislation to help families, Walker said he was committed to working with lawmakers to do so.
"Right now I don't know exactly how that would be done," Walker said.
State Rep. Robb Kahl (D-Monona),the lead sponsor of the legislation, said when first proposed, the measuredid not include a provision requiring FDA approval for physicians seeking to prescribe the drug. The bill had bipartisan support in the Assembly but stalled in the Senate, Kahl said.
"It wasn't going to be passed without the amendment" adding the FDA requirement, Kahl said.
The amendment has prevented some physicians from investigating and prescribing cannabidiol, or CBD, much to the dismay of Wisconsin families dealing with extreme seizure conditions.
Children's Hospital of Wisconsin in Wauwatosa and American Family Children's Hospital in Madison said they will not apply for the federal Food and Drug Administration drug trialpermits needed to use the drug in Wisconsin.
Toni Morrissey, a spokeswoman for University of Wisconsin Health, said none of the physicians was prescribing the drug because it hasn't yet been through the rigorous tests required to prove a drug's safety and effectiveness.
"It's really simple. It's not FDA approved, so we're not prescribing it," she said.
To use the experimental drug, a UW physician would need to seek approval to set up a larger clinical trial testing the drug with a number of patients.
"That would be the only way it could happen," she said.
Children's Hospital of Wisconsin issued a statement calling CBD an "exciting prospect" but noting that the American Academy of Neurology has not yet recommended the drug. The statement listed dangers such as potential impurities from the manufacturing process and unknown long-term effects from its use.
"We very much understand the interest in cannabidiol and are deeply sympathetic toward families who would like to see if this is a viable option for their children," the statement says. "That is why we take the necessary steps to ensure this and any other new treatments are safe before we administer them."
Jerry Halverson, a psychiatrist at Rogers Memorial Hospital in Oconomowoc and president-elect of the Wisconsin Medical Society, said the society initially was not in full support of the bill, even though there appeared to be a need for a treatment for children with extreme seizure disorders. He said without strong evidencefor the drug, he and many other physicians worried about the potential harm from prescribing CBD.
"Just because nothing else works doesn't mean we should try anything," Halverson said.
Still, Halverson said, physicians and patients who understand CBD's potential risks and benefits should have the opportunity to try it. They should also understand that greater scrutiny may be placed on the use of CBD because it's become a political dispute.
"I can certainly understand why physicians would be hesitant to use it," Halverson said. "If something goes wrong with this, you really are out there flapping in the wind, unfortunately."
Volker said she and her son, whom they call Nic for short, may not be able to wait much longer for the drug she pushed to legalize. In an interview, Volker said she is seriously considering moving with her son to a state that allows CBD and has doctors willing to prescribe the controversial medication.
"We're really at a standstill. There's really no movement right now as far as I know," Volker said. "In the midst of trying to figure out exactly what the next steps are, I think we're looking at the possibility of having to make a move."
Unlike the 22 states and the District of Columbia that legally allow medical marijuana, Wisconsin physicians cannot prescribe CBD, nor can dispensaries provide it, without FDA approval. The bill requires physicians interested in treating patients with CBD to apply for and carry out an FDA investigational drug trial.
The bill passed so quickly that few physicians realize CBD can now be potentially used, Kahl said.
"I wasn't out there banging the drums. I was just trying to quietly pass it," Kahl said. "People understand that it's not a flip you can switch. It's a process, and it's only been two months."
Kit Beyer, a spokeswoman for Assembly Speaker Robin Vos (R-Rochester), said there is little more that legislators can do. "The legislation was intended to give families more treatment options, but lawmakers can't force doctors to prescribe it," Beyer said.
Kahl said federal laws removing CBD from the list of controlled substances would also help make it more accessible. Currently, transporting the drug across some state lines isa federal crime, so physicians or families seeking to obtain the drug from out of state run the risk of criminal charges.
That danger is one that Volker has considered as she contemplated obtaining the drug from a physician in another state and driving with it back to Wisconsin.
Nic, 9, suffers up to 100 seizures a day and, because of his extensive health challenges, has endured 169 trips to the operating room. The Milwaukee Journal Sentinel wrote a Pulitzer Prize-winning series of articles about Nic in 2010 when doctors sequenced his DNA to fight a mysterious illness.
After working with Kahl to draft and pass the law allowing CBD this spring, Volker said she wants to see the tangible results.
Only a few states -- Virginia, Florida and Utah -- have also recently legalized cannabidiol for the treatment of seizures. The FDA has just begun allowing physicians to testnew drugs containing the drug and synthetic variations.
"It's going to take a first doctor who is willing to go out there and go through all the requirements of applying with the FDA," Kahl said. "I suspect that once one is out there, many more will go do it."
Volker said that may not come soon enough in Wisconsin to save her and Nic the hardship of moving and leaving the rest of their family behind.
"It could mean so many things to have CBD. It would mean a new hope for more of a normal life for Nic," Volker said. "He's already missed out on so much of his childhood."
Erin Richards of the Journal Sentinel staff contributed to this report from Waukesha.
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