Published: Sat, 01 Oct 2016 00:00:00 -0400
Last Build Date: Sat, 01 Oct 2016 14:35:41 -0400
Mon, 26 Sep 2016 06:30:00 -0400Insys Therapeutics, the Arizona-based pharmaceutical company that recently became the biggest financial supporter of the campaign against marijuana legalization in that state, makes an oral spray that delivers the opioid painkiller fentanyl and plans to market another one that contains dronabinol, a synthetic version of THC. Insys says it gave $500,000 to the main group opposing Arizona's legalization initiative because the measure "fails to protect the safety of Arizona's citizens, and particularly its children." But one needn't be terribly cynical to surmise that Insys also worries about the impact that legalization might have on its bottom line, since marijuana could compete with its products. A new study suggests Insys has good reason to worry. In an article published last week by the American Journal of Public Health, Columbia University epidemiologist June Kim and her colleagues report that fatally injured drivers are less likely to test positive for opioids in states that allow medical use of marijuana. That finding, together with the results of earlier studies, indicates that making marijuana legally available to patients saves lives by reducing their consumption of more dangerous medications. Kim et al. collected data from the Fatality Analysis Reporting System (FARS) for 1999 through 2013, focusing on 18 states that drug-tested at least 80% of drivers who died in crashes. They found that drivers between the ages of 21 and 40 were half as likely to test positive for opioids in states that had implemented medical marijuana laws (MMLs) as in states that had not. "Among 21-to-40-year-old deceased drivers, crashing in states with an operational MML was associated with lower odds of testing positive for opioids than crashing in MML states before these laws were operational," the researchers write. "Although we found a significant association only among drivers aged 21 to 40 years, the age specificity of this finding coheres with what we know about MMLs: a minimum age requirement restricts access to medical marijuana for most patients younger than 21 years, and most surveyed medical marijuana patients are younger than 45 years." The fact that a driver tested positive for opioids does not necessarily mean the painkillers he took contributed to the crash, so it is not safe to draw any conclusions about medical marijuana's impact on traffic safety from this study. But the FARS data are an indirect way of measuring the extent of opioid consumption in a given state. Kim et al. note that "severe or chronic pain is among the most common indications cited by medical marijuana patients." It therefore makes sense that opioid use would decline (or rise less) in states that recognize cannabis as a medicine. The FARS numbers reinforce the results of another recent study, published last July in the journal Health Affairs, that looked at prescriptions covered by Medicare from 2010 through 2013. Ashley Bradford, a graduate student in public policy at the University of Georgia, and her father, W. David Bradford, an economist at the same school, found that "the use of prescription drugs for which marijuana could serve as a clinical alternative fell significantly once a medical marijuana law was implemented." The most dramatic decline was in painkiller prescriptions, which fell by 3,645 daily doses per physician after medical marijuana laws were implemented. There were also statistically significant drops in prescriptions for drugs used to treat seizures (down 1,370 daily doses per doctor), depression (1,280), psychosis (1,123), anxiety (1,106), nausea (1,028), and sleep disorders (615). Meanwhile, Bradford and Bradford "found no changes after implementation of a medical marijuana law in the number of daily doses filled in condition categories with no medical marijuana indication," which "provides strong evidence that the observed shifts in prescribing patterns were in fact due to the passage of the medical marijuana laws." Medicare prescription drug coverage is mainly available to people who are 65 or older, although people receiving [...]
Fri, 23 Sep 2016 06:30:00 -0400
(image) While sounding the alarm about an "opioid epidemic" that included a record number of painkiller-related deaths in 2014, the federal government insists marijuana has "no currently accepted medical use." As I explain in my latest Forbes column, that dogmatism may be deadly:
Insys Therapeutics, the Arizona-based pharmaceutical company that recently became the biggest financial supporter of the campaign against marijuana legalization in that state, makes an oral spray that delivers the opioid painkiller fentanyl and plans to market another one that contains dronabinol, a synthetic version of THC. Insys says it gave $500,000 to the main group opposing Arizona's legalization initiative because the measure "fails to protect the safety of Arizona's citizens, and particularly its children." But one needn't be terribly cynical to surmise that Insys also worries about the impact that legalization might have on its bottom line, since marijuana could compete with its products.
A new study suggests Insys has good reason to worry. In an article published last week by the American Journal of Public Health, Columbia University epidemiologist June Kim and her colleagues report that fatally injured drivers are less likely to test positive for opioids in states that allow medical use of marijuana. That finding, together with the results of earlier studies, indicates that making marijuana legally available to patients saves lives by reducing their consumption of more dangerous medications.
Mon, 19 Sep 2016 18:17:00 -0400
Seriously, could weed's reputation take a bigger hit, especially now that it's trying to go street legal all over the country?
Hat tip: A. Barton Hinkle's Twitter feed.
Fri, 16 Sep 2016 07:30:00 -0400Officials at the Drug Enforcement Administration (DEA) seem to have been surprised by the negative reaction to the agency's "temporary" ban on kratom, which it implausibly claimed was necessary "to avoid an imminent hazard to public safety." That ban, which will last at least two years, can be extended for another year, and during that time the DEA is supposed to go through the motions of justifying the decision it has already made. But according to DEA spokesman Melvin Patterson, the agency may decide not to keep kratom in Schedule I, the most restrictive category under the Controlled Substances Act (CSA). "I don't see it being Schedule II [or higher] because that would be a drug that's highly addictive," Patterson tells Washington Post drug policy blogger Christopher Ingraham. "Kratom's at a point where it needs to be recognized as medicine. I think that we are going to find out that probably it does [qualify as a medicine]." Patterson makes it sound as if the DEA had no idea Americans were using kratom for medical purposes, even though it discusses those uses in its explanation of the ban. The storm of protest from medical users of kratom, which included a demonstration near the White House on Tuesday, "was eye-opening for me personally," Patterson says. "I want the kratom community to know that the DEA does hear them. Our goal is to make sure this is available to all of them." And what better way to do that than banning all kratom products? Patterson's comments are surprising, not least because they contradict conclusions the DEA already has reached about kratom, a pain-relieving leaf from Southeast Asia that recently gained a following in the United States as a home remedy and recreational intoxicant. Explaining why it decided to ban kratom, the DEA says "available information indicates that [mitragynine and 7-hydroxymitragynine, kratom's main active ingredients] have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision." Those are the criteria for Schedule I, which Patterson now says is not appropriate for kratom. Although the DEA does not have to demonstrate that kratom meets the criteria for Schedule I to put it there temporarily, it goes to great lengths to show that kratom has "a high potential for abuse," mainly by classifying everything people do with it as abuse. Under the CSA, drugs in the top two schedules are all supposed to have a "high potential for abuse," while drugs in lower schedules (III through V) are supposed to have progressively less abuse potential. Patterson suggests a drug cannot have a high potential for abuse unless it is "highly addictive," which kratom is not. Yet neither are many other substances in Schedule I, including marijuana, qat, LSD, psilocybin, mescaline, MDMA, and dimethyltryptamine, assuming addictiveness is measured by the percentage of people who become heavy users after trying a drug. Evidently a drug need not be highly addictive to be placed in Schedule I. Nor does the DEA define abuse potential based on the hazards a drug poses. Chuck Rosenberg, the agency's acting administrator, notes that "Schedule I includes some substances that are exceptionally dangerous and some that are less dangerous (including marijuana, which is less dangerous than some substances in other schedules)." Emphasis mine, because people tend to assume that Schedule I is a list of what the DEA considers to be the world's most dangerous drugs. The DEA does not see it that way. "It is best not to think of drug scheduling as an escalating 'danger' scale," Rosenberg says. If "high potential for abuse" does not refer to addictiveness or to danger, what does it signify? Nothing more than the DEA's (or Congress's) arbitrary preferences. "High potential for abuse" is a political concept, not a medical or scientific assessment. If the DEA (or Congress) does not like a particular kind of drug use, that use is abuse by defin[...]
Tue, 13 Sep 2016 08:45:00 -0400
(image) Insys Therapeutics, the Arizona-based pharmaceutical company that recently became the biggest financial supporter of the campaign against marijuana legalization in that state, makes an oral fentanyl spray that might compete with cannabis as a painkiller. But as Lee Fang notes at The Intercept, Insys has another, more direct financial interest in defeating marijuana legalization: It is about to introduce an oral spray to deliver dronabinol, a synthetic version of THC, marijuana's main active ingredient, as a treatment for AIDS wasting syndrome and the nausea and vomiting caused by cancer chemotherapy.
In a 2007 disclosure statement that Insys filed with the Securities and Exchange Commission, the company noted the competitive threat posed by marijuana legalization:
Legalization of marijuana or non-synthetic cannabinoids in the United States could significantly limit the commercial success of any dronabinol product candidate.…If marijuana or non-synthetic cannabinoids were legalized in the United States, the market for dronabinol product sales would likely be significantly reduced and our ability to generate revenue and our business prospects would be materially adversely affected.
The Food and Drug Administration (FDA) approved Marinol, a dronabinol capsule, in 1985 for the same two indications cited by Insys. The company's oral spray, which the FDA approved in July, should take effect faster than Marinol and be easier for patients suffering from severe nausea to absorb. But smoked or vaporized marijuana has those same advantages and will no doubt be considerably less expensive than the product Insys plans to sell, especially in a full-scale legal market like the one voters could decide to authorize this fall in Arizona, where marijuana is already legal for medical use.
Insys says it gave $500,000 to Arizonans for Responsible Drug Policy, the main group opposing Arizona's legalization initiative, because the measure "fails to protect the safety of Arizona's citizens, and particularly its children."
Mon, 12 Sep 2016 11:17:00 -0400
(image) As Jacob Sullum notes, anybody trying to enter the United States from a foreign country who has used a controlled substance is inadmissible without a special waiver. This law often trips up Canadians driving into the country from the Great White North and Sullum writes about concertgoers being kept out, a medical doctors denied entry simply because he'd written a journal article detailing decades-ago use of psychedelics, and a former Canadian football player who had been convicted of possessing a joint 30 years prior to his attempted visit.
But if America is serious about keeping out potheads from Canada and really wants to send a message, we should insist on an all-points-bulletin for the current prime minister, Justin Trudeau. Young, hip, and hunky, Trudeau has never made a secret of his past pot use. And yet, there was earlier this year, toasting his spiritual "sibling" (and another admitted pot user) Barack Obama at the White House! In 2013, he told Huffington Post Canada:
Trudeau said he's smoked pot five or six times in his life. "It has never really done anything for me," he later told HuffPost in an email.
"When the joint went around the room, I usually passed it around to the next person," he said.
"(But) sometimes throughout my life, I've had a pull on it."
"Sometimes, I guess, I have gotten a buzz, but other times no. I'm not really crazy about it."
Drugs, Trudeau said, were never his thing. He also described himself as not much of a drinker. He has never smoked cigarettes and doesn't drink coffee.
Even worse, there's this statement of personal responsibility that would be ruinous to our own war on drugs:
Trudeau said that his decision to smoke pot was personal and that adults should be allowed to make their own decisions.
Trudeau is also outspoken in his desire to legalize marijuana and treat it akin to alcohol. He also notes that all sorts of international treaties make that tougher than it should be.
Somebody get Rep. Louie Gohmert (R-Texas) on the horn and make sure he knows about this. It may help the prohibitionist legislator in his pernicious quest to sink criminal-justice reform on the grounds that currently illegal drugs are inherently violent commodities. Certainly, President Barack Obama, no stranger to the bong himself, seems at least half-heartedly committed to keep marijuana illegal. Despite the apparent spectacle of one of his daughters lighting up, about 600,000 people will be arrested for pot-related crimes this year.
Aren't our elected leaders supposed to set examples for the rest of us, who are incapable of making our own life choices?
Hat Tip: rachel gurstein
Fri, 09 Sep 2016 13:15:00 -0400"I was sitting in the training room one day and I just watched player after player come in to take a Toradol shot just to practice," says former NFL player Ricky Williams. "I realized if we have to take all this medication, all these pharmaceuticals, just to practice it can't be good for our bodies in the long run. And that's when I started to look at my health seriously and look for alternatives." Williams, the Heisman-winning running back who set multiple rushing records for the Miami Dolphins, was suspended by the NFL and then retired under a cloud of shame in 2003 for testing positive for marijuana. Dolphins fans, the media, and the league all turned on Williams, labeling him an underachiever with a drug problem. Williams ultimately returned in 2005 and played several more seasons in the NFL, but the stigma never went away. But what if the league and the public were wrong to judge Ricky Williams? What if he was just ahead of his time? Some researchers are now finding evidence that cannabidiol (CBD) and tetrahydrocannabinol (THC) have two major benefits for athletes: 1) they act as a non-addictive pain reliever and 2) they can protect the brain from injury. These healing properties could be beneficial in a league where opioid addiction and concussions have become significant health concerns. Williams is now part of a group of former NFL players who are lobbying the league to reconsider its position on marijuana. The former NFL star was one of several athletes in attendance at the 420 Games in Santa Monica, CA this Spring representing the Gridiron Cannabis Coalition, a group dedicated to the advancement of medical marijuana. Cannabis is a banned substance under the NFL's player agreement and commissioner Roger Goodell has made clear that he will not change league policy to allow medicinal marijuana until research proves it is a legitimate drug. But marijuana is classified as an illegal substance at the federal level, which makes getting grants and approval for research a long and arduous process. So former players are putting up their own money to get around the government's tight regulations and fund their own studies. "Cannabis has been in the closet. It's been suppressed. It's coming out," says Constance Finley, founder of the cannabis extract firm Constance Therapeutics. Finley is working with the Gridiron Cannabis Coalition to produce the evidence players need to change NFL policy. "The owners have to see responsible, smart people who are completely mainstream to have their experiences reflected, have their minds opened," says Finley. "I think that we could move past the impasse with the level of research that we're talking about doing. It will be irrefutable." Players like Ricky Williams are hoping their participation in these studies can lead to change and help future athletes stay healthy long after their playing days are over. "Hopefully as public opinion starts to change the leagues will soften their stance," says Williams. "Especially the NFL. They could really be ahead of the charge as far as getting this medicine to people who really need it." "Wouldn't it be great if the NBA and the NFL and the other professional sports organizations accepted the validity of the science and the experience of their players and we came to a compromise of efficacy and performance and using cannabis oil to promote health instead of using opioids and other drugs [that] kill health?," says Finley. "There's this marvelous plant that with regular use could really truly minimize that damage. That's a beautiful story." Approximately 5 minutes. Produced by Alexis Garcia. Camera by Alex Manning and Zach Weissmueller. Graphics by Joshua Swain and Meredith Bragg. Music by Podington Bear, VYVCH, and Alex Fitch. Scroll down for downloadable versions. Subscribe to Reason TV's YouTube channel for daily content like this.[...]
Tue, 06 Sep 2016 14:50:00 -0400These aren't your filthy hippies and stoners looking for an excuse to toke (not that there's anything wrong with that!): The American Legion is calling for the federal government to reclassify marijuana to acknowledge its potential benefits as a medical treatment. As Jacob Sullum previously noted, The Drug Enforcement Agency (DEA) is stubbornly refusing to change the federal classification of marijuana as a drug that has no "accepted medical use" until science proves them wrong. Fortunately they're easing off on the Catch-22 situation that has resulted in this classification making it extremely difficult for researchers to perform the very scientific testing that could determine marijuana's medical value. One of the potential medical values of medical marijuana is as a treatment for Post-Traumatic Stress Disorder (PTSD). And in what must certainly at this point make it abundantly clear where the majority of Americans stand on marijuana use, the American Legion has just voted at its national convention to support a resolution calling on Congress to legislatively reclassify cannabis and place it in a category that recognizes its potential value. The resolution, readable here at marijuana.com, highlights a number of important statistics that have helped push the Legion to support it. Across two years, the Department of Veterans Affairs have diagnosed thousands of Afghanistan and Iraq War veterans as having PTSD or Traumatic Brain Injuries (TBI). More than 1,300 veterans in fiscal year 2009 were hospitalized for brain injuries. And the resolution notes that systems in the brain can respond to 60 different chemicals found in cannabis. Therefore, the American Legion wants the DEA to license privately-funded medical marijuana and research facilities and to reclassify marijuana away from being lumped in with drugs like cocaine and meth. Tom Angell over at marijuana.com notes that Sue Sisley, a psychiatrist and medical marijuana researcher, has been lobbying the Legion and their local posts to get their support. Sisley is notable for actually getting federal permission to research marijuana as a treatment for PTSD and then getting dumped by the University of Arizona (where she worked) in 2014. What does this mean for a legislative effort to give VA docs permission to actually talk about medical marijuana as a treatment for veterans? As I noted in May, there was an amendment to a military appropriations bill that would end a gag order that prohibits VA doctors from recommending or even discussing medical marijuana treatment with patients, even in states where it had been legalized. The amendment would end the gag order, but wouldn't permit the VA to prescribe or pay for marijuana. The amendment passed the House and Senate, but as Angell notes, after the two sides went through the reconciliation to hammer out any difference, the language completely disappeared. It is no longer part of the Veterans Administration package. Legislators return to session today to hammer out last-minute spending bills to keep the government running (and the Democrats and Republicans are currently in disagreement on how long to extend spending authorizations for the incoming administration). Technically the amendment's language could be restored.[...]
Mon, 05 Sep 2016 00:01:00 -0400At the end of this month, kratom will be illegal throughout the United States thanks to the Drug Enforcement Administration (DEA), which last week announced that a ban is necessary "to avoid an imminent hazard to public safety." The way the DEA reached that conclusion provides an illuminating window on the prohibitionist mindset, which dresses pharmacological phobias in the garb of science. Kratom is a pain-relieving leaf that acts as a stimulant or a sedative, depending on the dose. But the most important thing to know about kratom, if you want to understand the DEA's reasoning, is that it's not from here. Kratom comes from a tree, Mitragyna speciosa, that is native to Thailand, Malaysia, Indonesia, Myanmar, and Papua New Guinea. It has gained a following in the United States only recently, hawked by online merchants and head shops as an herbal medicine, "dietary supplement," or legal high. As far as the DEA is concerned, the fact that people in other countries have used kratom for centuries to ease pain, boost work performance, and wean themselves from opiate addiction counts for nothing. All the DEA needs to know is that our shores have been invaded by a foreign drug that is increasingly popular among Americans as a home remedy and recreational intoxicant. From the DEA's perspective, that is intolerable, regardless of the drug's hazards or benefits. If you think I'm exaggerating, consider how the DEA decided that kratom meets the criteria for "temporary" placement in Schedule I of the Controlled Substances Act, the law's most restrictive category. The DEA has at least two years to make that designation permanent, which it almost certainly will do after going through a somewhat more elaborate process of bureaucratic self-justification. For the time being, it need only consider three factors: "the substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health." That exercise is easy, because according to the DEA all use of kratom is abuse and the substance has no benefits. That means any hazards associated with kratom pose an unacceptable risk to public health, even if they compare favorably to those associated with legal intoxicants, over-the-counter remedies, and prescription drugs. "Kratom is abused for its ability to produce opioid-like effects," the DEA says. "Kratom is misused to self-treat chronic pain and opioid withdrawal symptoms, with users reporting its effects to be comparable to prescription opioids." So if you use kratom to relax, relieve pain, or get off heroin, that's abuse. "Kratom is an increasingly popular drug of abuse and readily available on the recreational drug market in the United States," the DEA says. So if you use kratom for fun, that's abuse. Any medicinal use of kratom has to be abuse, the DEA figures, because kratom has not been approved for any indication by the Food and Drug Administration. Nor has the government approved kratom as a recreational intoxicant or a utilitarian stimulant (possibly because no such regulatory categories exist for new drugs), so those uses are also beyond the pale. The DEA's blinkered thinking is especially glaring when it frowns on kratom as a substitute for heroin. "Kratom has a history of being used as an opium substitute in Southeast Asia," it says. "Especially concerning, reports note users have turned to kratom as a replacement for other opioids, such as heroin." So if a heroin addict switches to a less dangerous drug, that is "concerning," even if the switch enables him to taper off his drug use and ultimately stop completely. In other words, even using kratom to reduce drug abuse is drug abuse. With logic like that, it's a cinch for the DEA to conclude that mitragynine and 7-hydroxymitragynine, kratom's main active components, have "a high potential fo[...]
Fri, 02 Sep 2016 06:30:00 -0400
(image) If you are curious about kratom, the pain-relieving leaf from Southeast Asia that is both a stimulant and a sedative, now would be the time to try it. As I explain in my latest Forbes column, a national ban on kratom takes effect at the end of September, thanks to a DEA analysis that arrives at a predetermined conclusion by assuming the drug has no benefits:
At the end of this month, kratom will be illegal throughout the United States thanks to the Drug Enforcement Administration (DEA), which this week announced that a ban is necessary "to avoid an imminent hazard to public safety." The way the DEA reached that conclusion provides an illuminating window on the prohibitionist mindset, which dresses pharmacological phobias in the garb of science.
Kratom is a pain-relieving leaf that acts as a stimulant or a sedative, depending on the dose. But the most important thing to know about kratom, if you want to understand the DEA's reasoning, is that it's not from here. Kratom comes from a tree, Mitragyna speciosa, that is native to Thailand, Malaysia, Indonesia, Myanmar, and Papua New Guinea. It has gained a following in the United States only recently, hawked by online merchants and head shops as an herbal medicine, "dietary supplement," or legal high. As far as the DEA is concerned, the fact that people in other countries have used kratom for centuries to ease pain, boost work performance, and wean themselves from opiate addiction counts for nothing. All the DEA needs to know is that our shores have been invaded by a foreign drug that is increasingly popular among Americans as a home remedy and recreational intoxicant. From the DEA's perspective, that is intolerable, regardless of the drug's hazards or benefits.
Thu, 01 Sep 2016 06:00:00 -0400Yesterday a federal appeals court ruled that banning gun sales to people who hold medical marijuana cards, whether or not they actually use marijuana, does not violate their Second Amendment rights. In reaching that conclusion, the U.S. Court of Appeals for the 9th Circuit relied on antiquated, scientifically unsupportable assumptions about the violent tendencies of cannabis consumers. The case, Wilson v. Lynch, involves a Nevada woman, Rowan Wilson, who in 2011 tried to buy a firearm from a gun shop in Mound House, a tiny town in Lyon County, but was turned away because the owner, Frederick Hauser, knew she had recently obtained a medical marijuana registry card from the state Department of Health and Human Services. Hauser had just received a letter from the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) that said anyone who uses marijuana as a medicine, "regardless of whether his or her State has passed legislation authorizing marijuana use for medicinal purposes," qualifies as an "unlawful user of a controlled substance" and is therefore forbidden to buy or possess guns under 18 USC 922. The ATF added that "if you are aware that the potential transferee is in possession of a card authorizing the possession and use of marijuana under State law, then you have 'reasonable cause to believe' that the person is an unlawful user of a controlled substance," meaning "you may not transfer firearms or ammunition to the person." Since violating that edict is a felony punishable by up to 10 years in prison, Hauser was understandably reluctant to sell Wilson a gun. Two weeks later, Wilson filed a federal lawsuit arguing (among other things) that the ban on gun sales to illegal drug users in 18 USC 922(d)(3), as interpreted by the ATF, violates her constitutional right to keep and bear arms. In 2014 a federal judge rejected that claim, noting that the 9th Circuit had upheld the federal ban on gun ownership by illegal drug users in the 2011 case United States v. Dugan. In yesterday's ruling, the 9th Circuit said Dugan did not dispose of the matter, since Wilson "alleges that, although she obtained a registry card, she chose not to use medical marijuana for various reasons, such as the difficulties of acquiring medical marijuana in Nevada, as well as a desire to make a political statement." The question posed by Wilson's appeal, then, was whether it is constitutional to block gun sales to someone who is not an unlawful user of a controlled substance but is suspected of being one because she has a medical marijuana card. The appeals court decided that rule is constitutional, based on the same silly pharmacological prejudices reflected in Dugan. The 9th Circuit concedes that the ATF's reading of 18 USC 922(d)(3) "directly burden[s Wilson's] core Second Amendment right to possess a firearm" but says the burden "is not severe," since she could have bought a gun before registering as a medical marijuana patient and could regain her right to buy a gun by "surrendering her registry card." The court therefore applies "intermediate scrutiny," which requires "(1) the government's stated objective to be significant, substantial, or important; and (2) a reasonable fit between the challenged regulation and the asserted objective." Since Wilson concedes that the government's interest in preventing gun violence is substantial, the only question is whether a rule preventing people like her from buying guns is a reasonable way of accomplishing that goal. "The Government argues that empirical data and legislative determinations support a strong link between drug use and violence," the 9th Circuit notes. The government did not actually present any of that evidence, but that's OK, because "studies and surveys relied on in similar cases suggest a significant link between dr[...]
Wed, 24 Aug 2016 06:30:00 -0400
(image) Rick Doblin, who as head of the Multidisciplinary Association for Psychedelic Studies (MAPS) has been trying for years to jump through the hoops required to get marijuana approved as a medicine, says the Drug Enforcement Administration's new willingness to license more than one producer of cannabis for research will finally make it at least theoretically possible to complete that process.
The National Institute on Drug Abuse (NIDA) has long had exclusive control over the legal supply of marijuana, which is grown by a single contractor at the University of Mississippi. In a legal battle that lasted more than a decade, MAPS tried to break that monopoly, which was a crucial barrier to meeting the Food and Drug Administration's requirements for approving a new medicine. The problem was not just the quality and variety of marijuana available from NIDA, or the agency's lack of enthusiasm for studies aimed at demonstrating the drug's benefits rather than its hazards. It was also the fact that NIDA's marijuana is available only for research, not for sale to patients following FDA approval.
"The FDA requires the Phase III studies be conducted with the exact same drug that the sponsor of the research is trying to market," Doblin explained in a recent interview on the Pacifica drug policy show Century of Lies. "So as long as the NIDA monopoly was in existence, FDA would never accept its marijuana for use in Phase III, and we could never get data that was necessary to reschedule."
MAPS is about to start a Phase II study of marijuana as a treatment for post-traumatic stress disorder in veterans, for example, but it has to use marijuana from NIDA. Since federally approved researchers are not allowed to buy marijuana from state-licensed suppliers in Colorado or Washington, NIDA is the only legal source. One problem with that is MAPS could not get all the strains it wanted: It asked for one with 12 percent THC and 12 percent cannabidiol (CBD), which NIDA did not have. But even if NIDA had a bigger variety, its marijuana would not be suitable for Phase III studies should the Phase II results look promising.
Now that the DEA has agreed to authorize other growers, research sponsors like MAPS can apply for licenses or contract with new licensees, which will make it possible to ensure that the marijuana used in their studies is the same as the marijuana they plan to make available as a medicine. "What's been so frustrating [is] that, on the one hand, the federal government has said there's not enough evidence to reschedule marijuana," Doblin said, "but on the other hand, they've blocked the ability to get the evidence. And so now that DEA has said that they'll end the NIDA monopoly, that evidence can be gathered....It's going to take four to six years, it could be $15 to $25 million, to gather it. But at least it's possible now, whereas before it was not possible."
Mon, 22 Aug 2016 00:01:00 -0400On August 11, when the Drug Enforcement Administration (DEA) rejected two petitions asking it to reclassify marijuana, Fox News anchor Shepard Smith did not try to conceal his contempt. "LSD, MDMA, a plant that grows in the yard—all one thing," he said sarcastically. "The DEA announced today it will keep marijuana on the list of the most dangerous drugs in all the world, along with heroin, LSD, and MDMA….Thanks, DEA, you've really got a lot of credibility." Smith's dismay was echoed by activists, scientists, commentators, and members of Congress from both major parties, who said the DEA's decision was at odds with what we know about marijuana's hazards and benefits. There is a lot of truth to that critique, and the DEA can reasonably be faulted for stubbornly refusing to remove marijuana from Schedule I of the Controlled Substances Act (CSA), a category that is supposedly reserved for drugs with "a high potential for abuse," "no currently accepted medical use," and "a lack of accepted safety for use…under medical supervision." But bureaucratic intransigence is only part of the story. The other part is the CSA itself, a legal morass that leaves crucial phrases undefined, gives the DEA wide discretion to decide where drugs belong, and establishes arbitrary, inconsistent rules that make it impossible to properly classify many drugs. Since Schedule I is the CSA's most restrictive category, people tend to assume it's supposed to be a list of "the most dangerous drugs in all the world," as Shepard Smith put it. But Chuck Rosenberg, the DEA's acting administrator, says that's a misleading way of describing Schedule I. In fact, he says, the decision to keep marijuana in that category did not involve an assessment of its relative hazards. While the DEA's determination that marijuana belongs in Schedule I was widely interpreted to mean it thinks marijuana is about as dangerous as other drugs in that category and more dangerous than drugs in lower schedules, the head of the DEA insists that is not what the decision means. "Schedule I includes some substances that are exceptionally dangerous and some that are less dangerous (including marijuana, which is less dangerous than some substances in other schedules)," Rosenberg writes in an August 11 letter to Rhode Island Gov. Gina Raimondo and Washington Gov. Jay Inslee, whose predecessors filed one of the rescheduling petitions that the DEA rejected this month. "That strikes some people as odd, but the criteria [sic] for inclusion in Schedule I is not relative danger….It is best not to think of drug scheduling as an escalating 'danger' scale—rather, specific statutory criteria (based on medical and scientific evidence) determine into which schedule a substance is placed." Rosenberg's concession that marijuana "is less dangerous than some substances in other schedules" stands in stark contrast with his predecessor's refusal to say whether heroin is more dangerous than marijuana. A year ago, Rosenberg admitted that "heroin is clearly more dangerous than marijuana," and now he is taking the further step of saying some drugs in lower schedules are also more dangerous. But he argues that such observations do not mean marijuana should be reclassified. According to the DEA's official explanation of its decision, the only factor that mattered was whether marijuana has a "currently accepted medical use." The agency says meeting that criterion requires the sort of large, expensive clinical studies that the Food and Drug Administration (FDA) demands before approving a new medicine. While such studies have been conducted with marijuana's main active ingredient (which is how Marinol, a capsule containing synthetic THC, was approved by the FDA in 1985) and are under wa[...]
Fri, 19 Aug 2016 06:30:00 -0400
(image) Last week the Drug Enforcement Administration was widely criticized for refusing to move marijuana out of Schedule I, the most restrictive drug category under the Controlled Substances Act. But as I explain in my latest Forbes column, Congress shares the blame for marijuana's puzzling legal status because it created a classification scheme that defies logic:
Last week, when the Drug Enforcement Administration (DEA) rejected two petitions asking it to reclassify marijuana, Fox News anchor Shepard Smith did not try to conceal his contempt. "LSD, MDMA, a plant that grows in the yard—all one thing," he said sarcastically. "The DEA announced today it will keep marijuana on the list of the most dangerous drugs in all the world, along with heroin, LSD, and MDMA….Thanks, DEA, you've really got a lot of credibility."
Smith's dismay was echoed by activists, scientists, commentators, and members of Congress from both major parties, who said the DEA's decision was at odds with what we know about marijuana's hazards and benefits. There is a lot of truth to that critique, and the DEA can reasonably be faulted for stubbornly refusing to remove marijuana from Schedule I of the Controlled Substances Act (CSA), a category that is supposedly reserved for drugs with "a high potential for abuse," "no currently accepted medical use," and "a lack of accepted safety for use…under medical supervision."
But bureaucratic intransigence is only part of the story. The other part is the CSA itself, a legal morass that leaves crucial phrases undefined, gives the DEA wide discretion to decide where drugs belong, and establishes arbitrary, inconsistent rules that make it impossible to properly classify many drugs.
Wed, 17 Aug 2016 06:30:00 -0400Yesterday a federal appeals court ruled that a spending rider approved by Congress in 2014 and 2015 prohibits the Justice Department from prosecuting marijuana suppliers who "fully comply" with state laws allowing medical use of the plant. The DOJ had argued that the rider, which says the department may not use appropriated money to "prevent" states from "implementing" their medical marijuana laws, applies only to litigation against the states themselves, not to prosecution of individuals who provide cannabis to patients. A three-judge panel of the U.S. Court of Appeals for the 9th Circuit unanimously rejected that interpretation, saying federal marijuana defendants are entitled to evidentiary hearings at which they can try to show their actions were authorized by state law. The case, United States v. McIntosh, consolidates 10 appeals by medical marijuana growers and dispensary operators in California and Washington, including the proprietors of Hollywood Compassionate Care in Los Angeles. The defendants argued that prosecuting them violates Section 542 of the omnibus spending bill that Congress approved last December, which covers the fiscal year that ends on September 30, as well as a similar provision that applied to the previous fiscal year. The amendment, which was introduced by Reps. Dana Rohrabacher (R-Calif.) and Sam Farr (D-Calif.), says "none of the funds made available in this Act to the Department of Justice may be used" to "prevent [states] from implementing their own State laws that authorize the use, distribution, possession, or cultivation of medical marijuana." The 9th Circuit agreed with the defendants that the Rohrabacher/Farr amendment, although "not a model of clarity," covers criminal prosecution of people who engage in those activities as well as lawsuits aimed at overturning or neutralizing medical marijuana laws: DOJ argues that [Section 542] does not prevent the Medical Marijuana States from giving practical effect to their medical marijuana laws by prosecuting private individuals, rather than taking legal action against the state. We are not persuaded.... DOJ, without taking any legal action against the Medical Marijuana States, prevents them from implementing their laws that authorize the use, distribution, possession, or cultivation of medical marijuana by prosecuting individuals for use, distribution, possession, or cultivation of medical marijuana that is authorized by such laws. By officially permitting certain conduct, state law provides for non-prosecution of individuals who engage in such conduct. If the federal government prosecutes such individuals, it has prevented the state from giving practical effect to its law providing for non-prosecution of individuals who engage in the permitted conduct. We therefore conclude that, at a minimum, § 542 prohibits DOJ from spending funds from relevant appropriations acts for the prosecution of individuals who engaged in conduct permitted by the State Medical Marijuana Laws and who fully complied with such laws.... If DOJ wishes to continue these prosecutions, Appellants are entitled to evidentiary hearings to determine whether their conduct was completely authorized by state law, by which we mean that they strictly complied with all relevant conditions imposed by state law on the use, distribution, possession, and cultivation of medical marijuana. Passing that test may not be easy, since neither California nor Washington licensed or explicitly allowed commercial production and distribution of medical marijuana when these defendants were arrested. In both states dispensaries operated based on controversial interpretations of state law, as patient cooperatives or collec[...]