Katelyn Baker
Well-Known Member
More than half the states—28, to be exact—including Arkansas, Florida and North Dakota as of the Nov. 8 election, and the District of Columbia have legalized marijuana for certain medical conditions.
And yet, the Drug Enforcement Administration still classifies marijuana as a Schedule I drug, defined by the 1970 Controlled Substances Act as a drug that has a high potential for abuse and no accepted medical use (emphasis is mine) in the United States. Other Schedule I drugs include heroin, LSD and ecstasy.
Only the Food and Drug Administration can determine whether marijuana has an accepted medical use, according to the DEA, and so far, it hasn't. Because marijuana is a Schedule I drug, doctors can only "recommend" it to patients, not write prescriptions for it that they can fill at a drugstore.
But Congress has the authority to reclassify controlled substances, and the president can ask his attorney general, who oversees the DEA, or his Health and Human Services secretary, who oversees the FDA, to initiate rulemaking to reclassify them, Brookings Institution senior fellow John Hudak told me.
Don't expect Congress or the Donald Trump administration to take those steps, though.
The closest Congress has come recently were identical bills introduced in early 2015 in the House and the Senate, neither of which came up for a vote. The Compassionate Access, Research Expansion and Respect Status, or "CARERS," Act, which had bipartisan support, would have reclassified marijuana from Schedule I to Schedule II, which includes drugs such as morphine and oxycodone that have a high potential for abuse but also have an accepted medical use. The CARERS Act also would have amended the Controlled Substances Act to say that its provisions related to marijuana did not apply to people complying with state medical marijuana laws.
And while Democratic presidential nominee Hillary Clinton said she would reclassify marijuana as a Schedule II drug, Trump was vaguer during the campaign. At a rally a year ago, he said only that "I think medical should happen" when asked about marijuana.
"This isn't something that Trump really cares about," Hudak said of the question of whether marijuana should be reclassified.
When Eric Holder was President Barack Obama's attorney general, he "basically came out and instructed the state attorneys general not to make this an issue," Scott Novak, a senior scientist at RTI International in Research Triangle Park, N.C., told me. With a new administration, though, "you could very well see an attorney general with the mandate and support of the White House say, 'You know what, we are going to make this a federal issue,'" Novak said. "You never know what could happen."
Trump is said to be considering N.J. Gov. Chris Christie for attorney general and retired Johns Hopkins neurosurgeon Dr. Ben Carson for HHS secretary, both former rivals for the Republican presidential nomination. At a campaign stop in February, Christie called himself an "anti-marijuana guy," while Carson, at a 2015 campaign rally, said "I have no problem with medical marijuana" but added that he would never legalize it for recreational use.
"I think that a president's or president-elect's choice of an attorney general has to do with quite a bit more than marijuana scheduling," said Hudak, who coauthored a blog post earlier this year about how marijuana could be reclassified. Maintaining marijuana's status quo "will just be a policy consequence of that choice," he said.
For now, state laws have no bearing on marijuana's status under federal law. In August the DEA published its denial of two petitions—one submitted in 2011 by Democrats Lincoln D. Chafee, then governor of Rhode Island, and Christine O. Gregoire, then governor of Washington—to reschedule marijuana. The other petition had been submitted in 2009 by Bryan Krumm, a psychiatric nurse practitioner in Albuquerque, N.M. According to his website, Krumm, an Army veteran who helped draft New Mexico's medical marijuana legislation, uses marijuana to treat post-traumatic stress disorder.
DEA said it denied the petitions because the Food and Drug Administration had not yet approved a medical use for marijuana. "DEA and FDA believe that the drug approval process is the most appropriate way to assess whether a product derived from marijuana or its constituents is safe and effective and has an accepted medical use," according to a DEA press release issued when it announced that it had denied the petitions.
"The DEA cannot judge that a drug has some good effects," Pius Farinu told me. "That has to come from the FDA." Farinu is a postdoctoral research associate at the National Center for Natural Products Research at the University of Mississippi School of Pharmacy.
Back in 1988, though, the DEA Chief Administrative Law Judge Francis Young ruled that requiring FDA approval before reclassifying marijuana from Schedule I was an unnecessarily high bar for a plant that has been used for medicinal purposes for centuries.
"In this country today, 'new drugs' are developed by pharmaceutical companies possessing resources sufficient to bear the enormous expense of testing a new drug, obtaining FDA approval of its efficacy and safety, and marketing it successfully," Young wrote. "No company undertakes the investment required unless it has a patent on the drug."
Since marijuana was a plant, not a synthetic drug, Young said, it was "unreasonable" to hold it to FDA standards. His ruling came in response to a petition filed 16 years earlier by NORML—a nonprofit that advocates for legalization of marijuana—which had sought to reschedule marijuana. But Young's ruling was rejected by John Lawn, the DEA administrator at the time.
Critics such as Hudak have said that conducting research into marijuana's safety and effectiveness is challenging, in part because the DEA has licensed only one source—a farm at the University of Mississippi funded through a contract with the National Institute on Drug Abuse (NIDA)—for that purpose. However, in August, the DEA announced it would increase the number of authorized marijuana producers.
"This change illustrates DEA's commitment to working together with the FDA and NIDA to facilitate research concerning marijuana and its components," according to a DEA press release, which noted that 350 individuals have registered to conduct research on marijuana and its components. Last December, the agency eased some of the requirements imposed by the Controlled Substances Act for researchers conducting FDA-approved clinical trials of cannabidiol, or CBD, an extract of the marijuana plant that contains less than 1% tetrahydrocannabinol, or THC, the ingredient in marijuana that makes users high.
"When you remove all the talk of abuse, which is dependent on the THC, there is no need for scheduling," Farinu noted. "I think we are getting closer to that more than people realize."
So far, the closest the FDA has come to giving the green light to a medical use for marijuana has been its approval of Marinol and, in July, Syndros, both of which contain dronabinol, a synthetic version of THC. They're approved to treat nausea and vomiting related to cancer chemotherapy that hasn't responded to other medications, and lack of appetite associated with weight loss in AIDS patients. A third FDA-approved drug, called Cesamet, contains nabilone, a synthetic ingredient whose chemical structure is similar to THC. Like Marinol and Syndros, Cesamet is a last-resort treatment for nausea and vomiting related to cancer chemotherapy.
Farinu coauthored a report published in July about therapeutic CBD preparations in the research pipeline. The authors noted that 16 states have legalized or decriminalized possession of products high in CBD but low in THC, mostly for use in children whose epileptic seizures can't be controlled with conventional treatments. CBD, which has received regulatory approval in several European countries, appears to be effective in treating anxiety, psychosis and inflammation as well as epilepsy, Farinu and his colleagues wrote.
"Most of the research is trying to avoid the psychoactive part," he said, acknowledging "there are some people who prefer it the way it is."
Brian Thomas, a principal scientist at RTI International, told me that the FDA could approve the first CBD product in a couple of years. A frontrunner is Epidiolex, in development by the U.K.-based company G.W. Pharmaceuticals for severe, treatment-resistant epilepsy in children.
Epidiolex is not yet on the market in any country, but another G.W. product, Sativex, has been approved or recommended for approval in 18 European countries, according to the company. Sativex, a mouth spray whose active ingredient is a marijuana extract that contains both CBD and THC, is used to treat spasticity in people with multiple sclerosis. The company says it expects additional Sativex approvals in Latin America and the Mideast in the next year.
Because medical marijuana products aren't regulated, patients can't be sure what's in them, Thomas said. "That's the problem when you go into a dispensary, and you see a thousand different products. Right now they sell products that have been tailored to help you sleep, improve your mood, manage your pain. They're all being touted, but they don't have the FDA stamp of approval, and their claims aren't supported."
The FDA issued several warning letters in 2015 and 2016 about inappropriate and illegal medical claims for products whose labels said they contained CBD, Thomas and coauthor Gerald Pollard noted in an article published in August. In some cases, the products contained no CBD at all. One recent study found that more than half of the products it evaluated had significantly less marijuana content that their labels indicated, while others had significantly more THC than labeled, placing patients at risk of bad side effects, Thomas and Pollard wrote.
"The explosive increase in open sale and use of herbal cannabis and its products has occurred with widely variable and in many cases grossly inadequate quality control at all levels—growing, processing, storage, distribution and use," they concluded.
I wanted to talk to someone from the FDA about marijuana, but the agency's press office declined. The agency does have information about marijuana on its website, though, including a slide presentation by Dr. Douglas Throckmorton, deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research.
Throckmorton presented the slides in April at a meeting of the International Conference on the Science of Botanicals and the American Society of Pharmacognosy, which is a branch of pharmacology dealing with medicinal substances derived from plants. The meeting was held in Oxford, Miss., home of the University of Mississippi, home of the only DEA-authorized marijuana farm.
"FDA has [a] clear role in supporting scientific and rigorous assessment of marijuana, including product development and regulation of marketing," according to one of Throckmorton's slides. "The promise of safety, efficacy and reliability is not good enough. However, FDA needs to do all it can to support the needed scientific research with marijuana to characterize its therapeutic promise."
News Moderator: Katelyn Baker 420 MAGAZINE ®
Full Article: Many States Have Legalized Medical Marijuana, So Why Does DEA Sill Say It Has No Therapeutic Use?
Author: Rita Rublin
Contact: Forbes
Photo Credit: Drew Angerer
Website: Forbes
And yet, the Drug Enforcement Administration still classifies marijuana as a Schedule I drug, defined by the 1970 Controlled Substances Act as a drug that has a high potential for abuse and no accepted medical use (emphasis is mine) in the United States. Other Schedule I drugs include heroin, LSD and ecstasy.
Only the Food and Drug Administration can determine whether marijuana has an accepted medical use, according to the DEA, and so far, it hasn't. Because marijuana is a Schedule I drug, doctors can only "recommend" it to patients, not write prescriptions for it that they can fill at a drugstore.
But Congress has the authority to reclassify controlled substances, and the president can ask his attorney general, who oversees the DEA, or his Health and Human Services secretary, who oversees the FDA, to initiate rulemaking to reclassify them, Brookings Institution senior fellow John Hudak told me.
Don't expect Congress or the Donald Trump administration to take those steps, though.
The closest Congress has come recently were identical bills introduced in early 2015 in the House and the Senate, neither of which came up for a vote. The Compassionate Access, Research Expansion and Respect Status, or "CARERS," Act, which had bipartisan support, would have reclassified marijuana from Schedule I to Schedule II, which includes drugs such as morphine and oxycodone that have a high potential for abuse but also have an accepted medical use. The CARERS Act also would have amended the Controlled Substances Act to say that its provisions related to marijuana did not apply to people complying with state medical marijuana laws.
And while Democratic presidential nominee Hillary Clinton said she would reclassify marijuana as a Schedule II drug, Trump was vaguer during the campaign. At a rally a year ago, he said only that "I think medical should happen" when asked about marijuana.
"This isn't something that Trump really cares about," Hudak said of the question of whether marijuana should be reclassified.
When Eric Holder was President Barack Obama's attorney general, he "basically came out and instructed the state attorneys general not to make this an issue," Scott Novak, a senior scientist at RTI International in Research Triangle Park, N.C., told me. With a new administration, though, "you could very well see an attorney general with the mandate and support of the White House say, 'You know what, we are going to make this a federal issue,'" Novak said. "You never know what could happen."
Trump is said to be considering N.J. Gov. Chris Christie for attorney general and retired Johns Hopkins neurosurgeon Dr. Ben Carson for HHS secretary, both former rivals for the Republican presidential nomination. At a campaign stop in February, Christie called himself an "anti-marijuana guy," while Carson, at a 2015 campaign rally, said "I have no problem with medical marijuana" but added that he would never legalize it for recreational use.
"I think that a president's or president-elect's choice of an attorney general has to do with quite a bit more than marijuana scheduling," said Hudak, who coauthored a blog post earlier this year about how marijuana could be reclassified. Maintaining marijuana's status quo "will just be a policy consequence of that choice," he said.
For now, state laws have no bearing on marijuana's status under federal law. In August the DEA published its denial of two petitions—one submitted in 2011 by Democrats Lincoln D. Chafee, then governor of Rhode Island, and Christine O. Gregoire, then governor of Washington—to reschedule marijuana. The other petition had been submitted in 2009 by Bryan Krumm, a psychiatric nurse practitioner in Albuquerque, N.M. According to his website, Krumm, an Army veteran who helped draft New Mexico's medical marijuana legislation, uses marijuana to treat post-traumatic stress disorder.
DEA said it denied the petitions because the Food and Drug Administration had not yet approved a medical use for marijuana. "DEA and FDA believe that the drug approval process is the most appropriate way to assess whether a product derived from marijuana or its constituents is safe and effective and has an accepted medical use," according to a DEA press release issued when it announced that it had denied the petitions.
"The DEA cannot judge that a drug has some good effects," Pius Farinu told me. "That has to come from the FDA." Farinu is a postdoctoral research associate at the National Center for Natural Products Research at the University of Mississippi School of Pharmacy.
Back in 1988, though, the DEA Chief Administrative Law Judge Francis Young ruled that requiring FDA approval before reclassifying marijuana from Schedule I was an unnecessarily high bar for a plant that has been used for medicinal purposes for centuries.
"In this country today, 'new drugs' are developed by pharmaceutical companies possessing resources sufficient to bear the enormous expense of testing a new drug, obtaining FDA approval of its efficacy and safety, and marketing it successfully," Young wrote. "No company undertakes the investment required unless it has a patent on the drug."
Since marijuana was a plant, not a synthetic drug, Young said, it was "unreasonable" to hold it to FDA standards. His ruling came in response to a petition filed 16 years earlier by NORML—a nonprofit that advocates for legalization of marijuana—which had sought to reschedule marijuana. But Young's ruling was rejected by John Lawn, the DEA administrator at the time.
Critics such as Hudak have said that conducting research into marijuana's safety and effectiveness is challenging, in part because the DEA has licensed only one source—a farm at the University of Mississippi funded through a contract with the National Institute on Drug Abuse (NIDA)—for that purpose. However, in August, the DEA announced it would increase the number of authorized marijuana producers.
"This change illustrates DEA's commitment to working together with the FDA and NIDA to facilitate research concerning marijuana and its components," according to a DEA press release, which noted that 350 individuals have registered to conduct research on marijuana and its components. Last December, the agency eased some of the requirements imposed by the Controlled Substances Act for researchers conducting FDA-approved clinical trials of cannabidiol, or CBD, an extract of the marijuana plant that contains less than 1% tetrahydrocannabinol, or THC, the ingredient in marijuana that makes users high.
"When you remove all the talk of abuse, which is dependent on the THC, there is no need for scheduling," Farinu noted. "I think we are getting closer to that more than people realize."
So far, the closest the FDA has come to giving the green light to a medical use for marijuana has been its approval of Marinol and, in July, Syndros, both of which contain dronabinol, a synthetic version of THC. They're approved to treat nausea and vomiting related to cancer chemotherapy that hasn't responded to other medications, and lack of appetite associated with weight loss in AIDS patients. A third FDA-approved drug, called Cesamet, contains nabilone, a synthetic ingredient whose chemical structure is similar to THC. Like Marinol and Syndros, Cesamet is a last-resort treatment for nausea and vomiting related to cancer chemotherapy.
Farinu coauthored a report published in July about therapeutic CBD preparations in the research pipeline. The authors noted that 16 states have legalized or decriminalized possession of products high in CBD but low in THC, mostly for use in children whose epileptic seizures can't be controlled with conventional treatments. CBD, which has received regulatory approval in several European countries, appears to be effective in treating anxiety, psychosis and inflammation as well as epilepsy, Farinu and his colleagues wrote.
"Most of the research is trying to avoid the psychoactive part," he said, acknowledging "there are some people who prefer it the way it is."
Brian Thomas, a principal scientist at RTI International, told me that the FDA could approve the first CBD product in a couple of years. A frontrunner is Epidiolex, in development by the U.K.-based company G.W. Pharmaceuticals for severe, treatment-resistant epilepsy in children.
Epidiolex is not yet on the market in any country, but another G.W. product, Sativex, has been approved or recommended for approval in 18 European countries, according to the company. Sativex, a mouth spray whose active ingredient is a marijuana extract that contains both CBD and THC, is used to treat spasticity in people with multiple sclerosis. The company says it expects additional Sativex approvals in Latin America and the Mideast in the next year.
Because medical marijuana products aren't regulated, patients can't be sure what's in them, Thomas said. "That's the problem when you go into a dispensary, and you see a thousand different products. Right now they sell products that have been tailored to help you sleep, improve your mood, manage your pain. They're all being touted, but they don't have the FDA stamp of approval, and their claims aren't supported."
The FDA issued several warning letters in 2015 and 2016 about inappropriate and illegal medical claims for products whose labels said they contained CBD, Thomas and coauthor Gerald Pollard noted in an article published in August. In some cases, the products contained no CBD at all. One recent study found that more than half of the products it evaluated had significantly less marijuana content that their labels indicated, while others had significantly more THC than labeled, placing patients at risk of bad side effects, Thomas and Pollard wrote.
"The explosive increase in open sale and use of herbal cannabis and its products has occurred with widely variable and in many cases grossly inadequate quality control at all levels—growing, processing, storage, distribution and use," they concluded.
I wanted to talk to someone from the FDA about marijuana, but the agency's press office declined. The agency does have information about marijuana on its website, though, including a slide presentation by Dr. Douglas Throckmorton, deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research.
Throckmorton presented the slides in April at a meeting of the International Conference on the Science of Botanicals and the American Society of Pharmacognosy, which is a branch of pharmacology dealing with medicinal substances derived from plants. The meeting was held in Oxford, Miss., home of the University of Mississippi, home of the only DEA-authorized marijuana farm.
"FDA has [a] clear role in supporting scientific and rigorous assessment of marijuana, including product development and regulation of marketing," according to one of Throckmorton's slides. "The promise of safety, efficacy and reliability is not good enough. However, FDA needs to do all it can to support the needed scientific research with marijuana to characterize its therapeutic promise."
News Moderator: Katelyn Baker 420 MAGAZINE ®
Full Article: Many States Have Legalized Medical Marijuana, So Why Does DEA Sill Say It Has No Therapeutic Use?
Author: Rita Rublin
Contact: Forbes
Photo Credit: Drew Angerer
Website: Forbes