Pubdate: Mon, 16 Jun 2014
Source: Milwaukee Journal Sentinel (WI)
Copyright: 2014 Journal Sentinel Inc.
Author: Dana Ferguson


Doctors in Wisconsin Worried About FDA Provision in New Cannabidiol

Madison - 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

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

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

State Rep. Robb Kahl (D-Monona), the lead sponsor of the legislation,
said when first proposed, the measure did 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 trial permits 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

"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 evidence for 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 is a 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 test new 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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