Baton Rouge (CNN Business)Ramsey Castleberry, 8, is what is known in autism circles as a “runner.”
“Every day you have to open up your cabinet and see something called ‘amphetamines’ and give them to your child,” says their mother, Katelyn Castleberry, looking at a shelf full of pill bottles. “The shock never wears off.”
Castleberry wants to do everything she can to help her boys have normal childhoods. But there’s one promising remedy she hasn’t been able to try: marijuana.
Unlike in most states, it’s technically legal for use as a therapy for autistic children in Louisiana. It’s just not available yet, and because of the thicket of rules the state legislature imposed to keep marijuana as medical as possible, Castleberry worries it never will be.
As state after state across America has moved to legalize marijuana for recreational as well as medical use — or medical use with such liberal rules that almost anyone qualifies — conservative Louisiana set out to make sure it’s used only for the conditions spelled out in its laws, and for research in a tightly controlled setting.
Currently, 33 states and the District of Columbia have some kind of medical marijuana access law, though not all of them have set up programs to implement them yet. If Louisiana succeeds, it could light the way for other conservative states that want marijuana’s therapeutic benefits — especially as a relatively non-addictive alternative to the opioids that have wreaked such havoc in communities across the country — but don’t want adults getting high just for fun.
In an effort to keep tight control over the marijuana industry, Louisiana has limited production to just two state universities, which makes the supply chain highly vulnerable to disruptions. Paul Armentano, deputy director of the National Organization for the Reform of Marijuana Laws, says that in itself sets the program up for failure.
“Louisiana seems to be an example of how to over regulate the product,” Armentano says. “The program is not in the best interests of many of the patients it’s designed to serve.”
Washington isn’t helping matters. The Department of Justice in January rescinded an Obama-era policy
that had eased the enforcement of federal marijuana laws in states where use had been deemed legal. Once again, federal prosecutors can decide how to go after people for the possession, sale or cultivation of marijuana. With cannabis still considered a Schedule 1 substance, the federal government also rarely funds research on it, the Food and Drug Administration won’t approve most drugs derived from it, and hospitals fear losing federal dollars if they even let it in the door.
Other potential pitfalls for the program include limitations on the forms and potency the medication can take to a lack of clarity on whether physicians who recommend the drug will be punished for doing so. Because of testing and inspection delays, the first vials of tetrahydrocannabinol solution, or THC, that are approved for medical use won’t be on shelves until late January, and even then will be limited to the highest-need patients until more supply is available.
Every once in a while, Castleberry thinks about moving to one of the seven states where parents can currently get medical marijuana for their autistic children. Instead, she’s been devoting her spare time to advocating for broadening access to the drug in Louisiana. But it’s a wrenching choice.
“Do I stay in the place I love with my family and make where I live a better place?” she asks. “Or do I go to a place that will allow my sons to live?”
A long slog toward making medicine
Technically, some Louisiana patients have been legally entitled to marijuana for decades.
The state first allowed cannabis back in 1978 for use by glaucoma and cancer patients. In 1991, they added spastic quadriplegia, a form of cerebral palsy. But the health department never set a system for production and distribution, mired in deep misgivings about a drug that meanwhile had sent thousands to prison.
That finally changed with the Alison Neustrom Act of 2015, named after a 42-year-old pancreatic cancer patient who made legalization her dying wish.
At the time, other states were designing their rules such that a diagnosis for back pain or trouble sleeping could get you virtually any type of cannabis in any amount from a shop down the street. Fred Mills, the Republican pharmacist who designed the new law, initially favored a more free-market system. But he soon learned that he’d have to go the other direction.
“I could tell that the law enforcement community was so against the bill that I had to make it a lot more conservative,” says Mills. “It was worth it to at least see the program develop.”
To do that, Louisiana came up with something unique: It granted a total monopoly over marijuana production to two public universities, Louisiana State University and Southern University, an historically black college in Baton Rouge. Both of them contracted with private companies to build and operate grow facilities, in partnership with academic researchers who would study the plants.
In theory, that puts Louisiana — and the two companies with exclusive licenses — in an excellent position to develop a repository of proprietary therapeutic compounds that could prove lucrative if the drug were ever legalized on a national level.
“Everyone from the United States is going to come to us to get these genetics,” says John Davis, president of the Louisiana division of GB Sciences, the Las Vegas-based company that won LSU’s contract.
LSU is already very good at working with plants. Its agriculture department has for decades done research on cash crops like rice and sweet potatoes, and reaped financial rewards from licensing patents they obtained for different strains.
That income is especially important after a decade of state budget cuts slashed funding for higher education in half. So when the prospect of doing the same thing for marijuana came up at the legislature, LSU jumped at the chance.
“That’s where we see the benefit to the university long-term,” says Ashley Mullens, LSU’s coordinator for the marijuana program. “That’s why we decided to take this chance.”
Agricultural research on rice, however, is a lot different from weed. For one thing, federal rules require all marijuana for research to come from a facility at the University of Mississippi
, which since 1968 has had a sole-source contract with federal drug regulators to produce it. But researchers have long complained that it’s low-quality and doesn’t represent the varieties now available commercially.
That’s why Louisiana’s program carries such promise — but also risk. They’re working around the prohibition, resting on assurances from federal prosecutors that state-sanctioned marijuana programs are not on their list of priorities. “We’re committed to operating under regulations established by state statutes,” says Hampton Grunewald, LSU AgCenter’s associate vice president for government relations.
Because of elaborate security requirements imposed by regulators, the grow facility in an industrial park in South Baton Rouge looks like a cross between a biopharmaceutical lab and a prison.
Along with the usual glass-walled rooms and whiteboards of a scientific research facility, there’s also a wall of televisions with feeds covering every inch of the building, a room in between the front door and the entrance that will catch any intruder, key card access to every room, and security guards on site 24/7.
The plants themselves are grown on long tables in individually climate-controlled rooms, in a special nutrient mixture, irrigated with water that’s been fed through a reverse osmosis system to remove any impurities. Any visitors will wear full-body Tyvek suits In order to keep them sterile and free of contaminants. The goal: Make them as uniform as possible, to create compounds that are exactly the same every time.
“Our approach has been to capture different varieties of cannabis and grow them in a way that any time you go to a pharmacy, it’s identical,” says Andrea Small-Howard, GB Sciences’ chief science officer. “It’s like you go to a pharmacy and pick up Advil or Tylenol or Aleve.”
But that costs money. Lots of money.
GB Sciences, which is a public companywith shares that are traded over the counter, made big promises: Investing $6.5 million in a grow facility, providing at least half a million dollars in research funding annually, and cutting the university in on 10% of its gross revenues, which with an estimated market of 60,000 to 100,000 eligible patients, could be substantial. Proceeds from any intellectual property that comes out of the partnership will be split 50-50.
GB Sciences’ own future depends on that bet paying off. Although the company has been producing cannabis products for the recreational market in Nevada to generate revenue, it posted a net loss of $23 million in fiscal year 2018
, and has been saying publicly
that a successful patent could make it into a multi-billion dollar business.
Winning the LSU contract was a big boost to GB Sciences’ credibility, and it gives them something few if any U.S.-based cannabis companies have at this point: The ability to do research in partnership with a university on marijuana grown in-house, rather than on the stuff that comes from Ole Miss.
But unless and until those patents are granted, the medicine GB Sciences produces in Louisiana will have to start paying for itself — and the prolonged rollout has created huge pressures on the company to keep it affordable, especially since insurance doesn’t cover marijuana products and patients will have to pay out of pocket. Davis declined to provide pricing information, saying that it is a “very sensitive issue in this biopharmaceutical industry,” and promised that the cost would be on par with other states.
But that’s only wholesale. The nine licensed pharmacy operators also have to recoup millions of dollars spent going through the arduous application process and building whole new buildings to house their marijuana operations. They have almost as much mandated security as the grow facilities, including a safe for cash that must be bolted to the ground.
“The pharmacy will have no choice but to double the price,” says Randy Mire, a pharmacist who won the license for the Baton Rouge area.
To make matters worse, the one institution that’s supposed to provide a check on GB Sciences’ pricing power — Southern University — has lagged far behind schedule.
The school awarded its contract to a brand-new company called Advanced Biomedics, funded by a local racehorse trainer named Carol Castille who promised to invest between $6 million and $10 million in the new facility. But a legal dispute between him and an investor delayed the start of the program by months, and the company never actually hired the experienced team of researchers they had originally advertised.
In November, another company bought out Advanced Biomedics, meaning that the program will essentially start from scratch.
All of this has patients and their advocates worried that the supply of marijuana could be interrupted if GB Sciences has manufacturing problems or goes bankrupt, and in any case might be prohibitively expensive for all but the very wealthy, while the poor are forced out on to the vibrant but unregulated black market.
“If there is only one producer, how much availability will we have for patients?” asks Kevin Caldwell, president of CommonsenseNOLA, a group that advocates for marijuana legalization. “And at what cost?”
Who will prescribe it?
Even if you get the marijuana supply flowing, someone has to prescribe it. And in Louisiana, that’s proving to be another bottleneck.
Other states have shielded physicians by allowing them to essentially write blank prescriptions saying that the patient has a qualifying condition under state law, leaving the dosage up to the pharmacist or the patient, and no physicians have yet been prosecuted for doing so. But Louisiana wanted to keep that control over dosing in the hands of the physicians, which leaves them potentially more vulnerable to legal scrutiny.
To make matters even more perilous for the half of the state’s doctors who work for hospitals, most of their employers have not taken a stand on whether it’s ok to prescribe marijuana, for use inside or outside the hospital. Ochsner Health System, for example, said only that the issue was “extremely complex.”
“In the interest of our patients and providers, Ochsner Health System is carefully considering all of the factors and continues to monitor discussions as more information becomes available,” it said in a statement.
Physicians have to do an online course to get certified to prescribe marijuana, and to date, only 68 physicians in the entire state have done so. The state’s medical community hasn’t exactly been encouraging: The Louisiana State Medical Society didn’t support the 2015 legislation, citing a “lack of science-based evidence that shows it’s an effective treatment option, or safe, for patients.”
There is substantial evidence on certain conditions like chronic pain, spasticity and multiple sclerosis, according to a comprehensive 2017 overview
by the National Academies. The pace of research has accelerated in recent years, a review published in the journal Population Health Management
found, with an increase in research on children and the elderly over the past five years.
John Vanchiere, a Shreveport physician who is the president of the state’s chapter of the American Association of Pediatrics, remains skeptical of the entire project. He advocated for a requirement that doctors writing marijuana recommendations for autistic children consult with a pediatric sub-specialist, creating an additional barrier to access that regulators are still working to fully define.
“Why would a physician wade into those waters with what the legislature believes will be helpful to children, based on compelling stories?” Vanchiere says. “I’d be surprised if many general pediatricians decide to take this on.”
To get around the hospital problem, some physicians are forming their own marijuana-specific practices. Kathryn Thomas had built a chain of opioid addiction treatment clinics, which she sold in 2017
. When the marijuana option opened up in Louisiana, she decided to open a new type of treatment clinic
for people seeking therapeutic marijuana.
Thomas then found five mostly young doctors employed at other hospitals who wanted to start the practice as a side job, and plans to contract with others. She already has a well-appointed office in Shreveport, with plans to expand to New Orleans as soon as product is available, and 3,000 people who have pre-registered on her website. Many of these people wouldn’t be comfortable asking their primary care physicians for marijuana, she says.
“At least when you’re coming here, we hope to decrease the stigma, and provide compassionate, respectful care,” Thomas says.
Another group that depends on physicians stepping up to write recommendations: The nine pharmacists who’ll be dispensing all of the state’s marijuana. They’re not allowed to advertise the product, even so much as creating a Facebook group or a website, so they’ll need doctor referrals.
Doug Boudreaux is a third-generation pharmacist in Shreveport who decided to pursue a license because of the hospice patients with pain and nausea that no medication has managed to fix. “Imagine throwing up so much that you throw up fecal matter,” he says.
After spending $200,000 on the application process, he poured another $800,000 into a new pharmacy right across the street from Shreveport’s major hospital cluster. He thinks he can break even within a few years, as long as the number of doctors licensed to recommend marijuana keeps rising.
“It’s a slow process for them,” Boudreaux says. “But it is going up.”
How much control is too much?
Every state that decides to legalize marijuana in any form is making things up as they go along. So in some ways, Louisiana isn’t unusual.
But currently, without the normal support system around other medicines — big pharmaceutical companies and federal funding to develop drugs, hospitals to administer them, and insurance companies to pay for them — the economics of going an exclusively medical route aren’t great.
That’s partly why so many states end up legalizing marijuana for recreational use as well. Once that happens, most of the money flows into products that might have some therapeutic effect, but aren’t up to the standards of treating specific diseases. In states like California and Colorado, for example, medical and recreational products aren’t that different.
“I think Louisiana has a chance to do something I would really appreciate,” says Jacob Irving, a pro-marijuana activist who suffers from spastic quadriplegia. “Which is to have a robust medical system that is so different from a recreational system that the two industries would be able to survive if the state ever does go down that route.”
All of this could change, of course, if Congress were to legalize medical marijuana on a national level — a possibility that became slightly less remote with the new Democratic majority in the House and the recent departure of Attorney General Jeff Sessions, who had taken a hardline stance toward the drug.
ran Colorado’s marijuana program until last year, and now consults with governments setting up their own systems. He thinks Louisiana’s approach could work, but it would help if the federal government opened up the market for investment in marijuana research, both public and private.
“I do think that they can be a leader of making medical marijuana medical,” he says. “The truth is, without massive resources behind it, we can’t get the medical research anyway.”
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