Katelyn Baker
Well-Known Member
At age 8, John Pesch was diagnosed with Crohn's disease, an incurable and often painful inflammatory condition of the gastrointestinal tract. He has to be careful about what he eats, and he's not growing as much as he should because he isn't absorbing enough nutrients from his food.
He says he "can't really go anywhere" because he needs constant access to a bathroom.
"I can't go to a normal school," says Pesch, now 12. "After you're home-schooled for a couple years, you get really lonely and isolated."
He has tried various drugs to manage his symptoms, with disappointing results and severe side effects. He hopes to follow the example of Coltyn Turner, a teenage advocate for treating Crohn's with cannabis oil derived from marijuana plants. Turner takes four pills a day and is said to be in remission - and able to lead a normal life.
John's father Alan Pesch has warned his son about the dangers of drugs and alcohol, and would never let him take anything that would get him "high." But Alan lobbied the Louisiana Legislature this year to give his son and others like him access to a medical version of marijuana. Alan says research he shared with lawmakers, who ultimately approved a medical marijuana initiative, shows cannabis oil fights the inflammation caused by Crohn's and lacks the toxicity of his son's FDA-approved medications.
"If it didn't pass, we were going to move to Colorado," says Alan, referring to the state where medical and recreational marijuana is legal. "This is life-changing for us."
Smoking pot still will be against the law here, regardless of your medical condition. But when and where medical marijuana will be available, what form it will take, and many other key details are up in the air.
RESEARCH AND DEVELOPMENT
In theory, medical marijuana has been legal in Louisiana for decades. But the state never set up a system to make it available.
The law passed during this year's regular session, which builds upon similar legislation approved last year, allows for cannabis treatments for patients suffering from several illnesses, including Crohn's. The Louisiana State Board of Medical Examiners can recommend more conditions at future legislative sessions. It's illegal to prescribe marijuana under federal law, so the state will let physicians "recommend" it, a semantic loophole that has protected doctors in other states.
The law bans distribution of raw marijuana or marijuana to be inhaled. It also says THC, which causes the buzz sought by recreational users, "shall be reduced to the lowest acceptable therapeutic levels available." Otherwise, the Louisiana Board of Pharmacy decides what form the final product will take and will choose the state's 10 distributors.
"The board is not inclined to try to dictate drug product formulations, but rather likely will rely on whatever creativity may exist at the producer level," says pharmacy board Executive Director Malcolm Broussard. The agricultural research centers of LSU and Southern University are the only state-approved producers.
Neither the Legislature nor the medical and pharmacy boards have experience developing and approving new drugs. This isn't how we normally do medicine in this country, to put it mildly, which worries medical marijuana skeptics like Dr. Dean Robinson, chief of mental health service at Southeast Louisiana Veterans Health Care System.
The large-scale clinical trials the U.S. Food and Drug Administration requires prior to drug approvals have not been conducted for most marijuana-based treatments, Robinson notes.
"Instead, [the state will] do an end run around the FDA," he says.
Robinson describes a patient with severe mood problems and symptoms of psychosis who has tried various medicines with mixed results. She has been following the news about medical marijuana, and unfortunately she's convinced it's the solution she has been looking for, he says.
"I think that little scenario is going to be repeated a lot of times with a lot of people," Robinson says.
Approved drugs such as Marinol already provide some of the clinically useful aspects of marijuana. Robinson fears the state initiative, unmoored from the FDA approval process, will create a product with higher concentrations of dangerous ingredients than the illegal street version.
"The plan is to get the lowest THC content," says Dr. Rani Whitfield, a Baton Rouge physician and Southern University Board of Supervisors board member who has been Southern's point man on the medical marijuana project. "You're going to reduce the most psychoactive components of the marijuana."
State Sen. Fred Mills Jr., R-St. Martinville, who authored the medical marijuana bill, notes that there are many over-the-counter products that carry risks and purported health benefits but aren't subject to FDA approval. And lots of drugs have been approved by the FDA only to be later recalled after having been found to be too dangerous for public consumption.
"The FDA is not the cure-all to anything," he says, adding that there is enough research to show patients with debilitating conditions can benefit. "I think we found the safe balance."
TAKING IT TO MARKET
Under current state law, medicine is not taxed. The medical marijuana initiative is meant to be revenue neutral for the state, Mills says. The Louisiana Department of Agriculture and Forestry's regulatory oversight is to be paid for through permit, application and licensing fees and a cut of the gross sales.
"The whole idea is to try to create this product at as low of a cost as possible," says LDAF Commissioner Mike Strain. "Insurance is not going to cover it, and these are people that are ill."
For the producers, cost estimates for getting the system off the ground have ranged from $4 million to $20 million. The boards of supervisors for LSU and Southern have approved their respective universities' participation, and both universities hope the project will be a moneymaker - or at least not a money-loser.
"It can't be revenue negative," says Bill Richardson, LSU's vice president for agriculture. "My budget's stretched so tight already, I can't take this on if I'm going to lose money doing it."
The AgCenter has been consulting with the LSU Health Sciences Center in New Orleans and the Pennington Biomedical Research Center, also part of the LSU System. Pennington has one of only three federally funded botanical research centers in the country, according to Dr. Will Cefalu, the center's executive director.
"We look at promising botanicals in extract form, and we test their benefits in the lab and in clinical trials," Cefalu says. If the opportunity presents itself, and the appropriate regulations are in place, Pennington could apply that same expertise to medical marijuana, he says.
Richardson expects LSU to issue a request for proposals from the private sector. He's already fielding calls from medical marijuana advocates who want to help as well as potential third-party investors.
"I'm trying to sort out the serious, legitimate people from the snake oil salesmen," Richardson says. "We'll get some people coming out of the woodwork."
Southern has been studying models in California, Colorado and Maryland, Whitfield says, and like Richardson, he says a private sector partnership could be a viable option. Collaborating with LSU also is possible, although "there is a need for more dialogue" before that could happen. Whitfield and Adell Brown, interim director of Southern's Agricultural Research and Extension Center, envision a Center for Natural Products Research that could expand the existing body of knowledge about medical marijuana.
Presumably, private sector investors will want to make money. A report by the Denver-based Marijuana Policy Group suggests the state's market eventually could exceed $300 million annually. But that study assumes eligible patients would use medical marijuana at similar rates as their counterparts in Oregon and Colorado, which is far from certain, given the different cultures and different products available in those states.
"We don't even know what the product that is going to be available in Louisiana is yet," says Matt Moreau, president of the Louisiana Cannabis Association, who supports the state's initiative. And while there's certainly demand for medical marijuana, he adds, it's not clear how much demand there will be among people who have the specific conditions listed in the state statute for whatever form the state will provide.
It could be a year or two before the state-sanctioned program is producing the new drug. While participants will be immune from prosecution for marijuana possession under state law, patients who obtain a prescription or product from out of state are not. Federal law bans transporting marijuana, medicinal or not, across state lines.
Pete Adams, executive director of the Louisiana District Attorneys Association, says DAs are unlikely to prosecute a seriously ill person for possessing medical marijuana. On the other hand, someone with a trunk full of weed or a bunch of THC-infused gummy bears shouldn't expect to get a pass.
Adams doubts the wisdom of circumventing the FDA, and says the state initiative will allow "big pot" to make money off "families of poor, sick kids that are out of options."
"Now [Louisiana is] going to do what the FDA couldn't do," he says. "It will be interesting to watch."
News Moderator: Katelyn Baker 420 MAGAZINE ®
Full Article: Expansion Of Medical Marijuana Access Could Lead To An Entire New Industry, But Many Questions Remain
Author: David Jacobs
Contact: (225) 928-1700
Photo Credit: Collin Richie
Website: Business Report
He says he "can't really go anywhere" because he needs constant access to a bathroom.
"I can't go to a normal school," says Pesch, now 12. "After you're home-schooled for a couple years, you get really lonely and isolated."
He has tried various drugs to manage his symptoms, with disappointing results and severe side effects. He hopes to follow the example of Coltyn Turner, a teenage advocate for treating Crohn's with cannabis oil derived from marijuana plants. Turner takes four pills a day and is said to be in remission - and able to lead a normal life.
John's father Alan Pesch has warned his son about the dangers of drugs and alcohol, and would never let him take anything that would get him "high." But Alan lobbied the Louisiana Legislature this year to give his son and others like him access to a medical version of marijuana. Alan says research he shared with lawmakers, who ultimately approved a medical marijuana initiative, shows cannabis oil fights the inflammation caused by Crohn's and lacks the toxicity of his son's FDA-approved medications.
"If it didn't pass, we were going to move to Colorado," says Alan, referring to the state where medical and recreational marijuana is legal. "This is life-changing for us."
Smoking pot still will be against the law here, regardless of your medical condition. But when and where medical marijuana will be available, what form it will take, and many other key details are up in the air.
RESEARCH AND DEVELOPMENT
In theory, medical marijuana has been legal in Louisiana for decades. But the state never set up a system to make it available.
The law passed during this year's regular session, which builds upon similar legislation approved last year, allows for cannabis treatments for patients suffering from several illnesses, including Crohn's. The Louisiana State Board of Medical Examiners can recommend more conditions at future legislative sessions. It's illegal to prescribe marijuana under federal law, so the state will let physicians "recommend" it, a semantic loophole that has protected doctors in other states.
The law bans distribution of raw marijuana or marijuana to be inhaled. It also says THC, which causes the buzz sought by recreational users, "shall be reduced to the lowest acceptable therapeutic levels available." Otherwise, the Louisiana Board of Pharmacy decides what form the final product will take and will choose the state's 10 distributors.
"The board is not inclined to try to dictate drug product formulations, but rather likely will rely on whatever creativity may exist at the producer level," says pharmacy board Executive Director Malcolm Broussard. The agricultural research centers of LSU and Southern University are the only state-approved producers.
Neither the Legislature nor the medical and pharmacy boards have experience developing and approving new drugs. This isn't how we normally do medicine in this country, to put it mildly, which worries medical marijuana skeptics like Dr. Dean Robinson, chief of mental health service at Southeast Louisiana Veterans Health Care System.
The large-scale clinical trials the U.S. Food and Drug Administration requires prior to drug approvals have not been conducted for most marijuana-based treatments, Robinson notes.
"Instead, [the state will] do an end run around the FDA," he says.
Robinson describes a patient with severe mood problems and symptoms of psychosis who has tried various medicines with mixed results. She has been following the news about medical marijuana, and unfortunately she's convinced it's the solution she has been looking for, he says.
"I think that little scenario is going to be repeated a lot of times with a lot of people," Robinson says.
Approved drugs such as Marinol already provide some of the clinically useful aspects of marijuana. Robinson fears the state initiative, unmoored from the FDA approval process, will create a product with higher concentrations of dangerous ingredients than the illegal street version.
"The plan is to get the lowest THC content," says Dr. Rani Whitfield, a Baton Rouge physician and Southern University Board of Supervisors board member who has been Southern's point man on the medical marijuana project. "You're going to reduce the most psychoactive components of the marijuana."
State Sen. Fred Mills Jr., R-St. Martinville, who authored the medical marijuana bill, notes that there are many over-the-counter products that carry risks and purported health benefits but aren't subject to FDA approval. And lots of drugs have been approved by the FDA only to be later recalled after having been found to be too dangerous for public consumption.
"The FDA is not the cure-all to anything," he says, adding that there is enough research to show patients with debilitating conditions can benefit. "I think we found the safe balance."
TAKING IT TO MARKET
Under current state law, medicine is not taxed. The medical marijuana initiative is meant to be revenue neutral for the state, Mills says. The Louisiana Department of Agriculture and Forestry's regulatory oversight is to be paid for through permit, application and licensing fees and a cut of the gross sales.
"The whole idea is to try to create this product at as low of a cost as possible," says LDAF Commissioner Mike Strain. "Insurance is not going to cover it, and these are people that are ill."
For the producers, cost estimates for getting the system off the ground have ranged from $4 million to $20 million. The boards of supervisors for LSU and Southern have approved their respective universities' participation, and both universities hope the project will be a moneymaker - or at least not a money-loser.
"It can't be revenue negative," says Bill Richardson, LSU's vice president for agriculture. "My budget's stretched so tight already, I can't take this on if I'm going to lose money doing it."
The AgCenter has been consulting with the LSU Health Sciences Center in New Orleans and the Pennington Biomedical Research Center, also part of the LSU System. Pennington has one of only three federally funded botanical research centers in the country, according to Dr. Will Cefalu, the center's executive director.
"We look at promising botanicals in extract form, and we test their benefits in the lab and in clinical trials," Cefalu says. If the opportunity presents itself, and the appropriate regulations are in place, Pennington could apply that same expertise to medical marijuana, he says.
Richardson expects LSU to issue a request for proposals from the private sector. He's already fielding calls from medical marijuana advocates who want to help as well as potential third-party investors.
"I'm trying to sort out the serious, legitimate people from the snake oil salesmen," Richardson says. "We'll get some people coming out of the woodwork."
Southern has been studying models in California, Colorado and Maryland, Whitfield says, and like Richardson, he says a private sector partnership could be a viable option. Collaborating with LSU also is possible, although "there is a need for more dialogue" before that could happen. Whitfield and Adell Brown, interim director of Southern's Agricultural Research and Extension Center, envision a Center for Natural Products Research that could expand the existing body of knowledge about medical marijuana.
Presumably, private sector investors will want to make money. A report by the Denver-based Marijuana Policy Group suggests the state's market eventually could exceed $300 million annually. But that study assumes eligible patients would use medical marijuana at similar rates as their counterparts in Oregon and Colorado, which is far from certain, given the different cultures and different products available in those states.
"We don't even know what the product that is going to be available in Louisiana is yet," says Matt Moreau, president of the Louisiana Cannabis Association, who supports the state's initiative. And while there's certainly demand for medical marijuana, he adds, it's not clear how much demand there will be among people who have the specific conditions listed in the state statute for whatever form the state will provide.
It could be a year or two before the state-sanctioned program is producing the new drug. While participants will be immune from prosecution for marijuana possession under state law, patients who obtain a prescription or product from out of state are not. Federal law bans transporting marijuana, medicinal or not, across state lines.
Pete Adams, executive director of the Louisiana District Attorneys Association, says DAs are unlikely to prosecute a seriously ill person for possessing medical marijuana. On the other hand, someone with a trunk full of weed or a bunch of THC-infused gummy bears shouldn't expect to get a pass.
Adams doubts the wisdom of circumventing the FDA, and says the state initiative will allow "big pot" to make money off "families of poor, sick kids that are out of options."
"Now [Louisiana is] going to do what the FDA couldn't do," he says. "It will be interesting to watch."
News Moderator: Katelyn Baker 420 MAGAZINE ®
Full Article: Expansion Of Medical Marijuana Access Could Lead To An Entire New Industry, But Many Questions Remain
Author: David Jacobs
Contact: (225) 928-1700
Photo Credit: Collin Richie
Website: Business Report