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Bill On Trump’s Desk Would Allow Marijuana (And Maybe MDMA) For Some Patients

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Seriously ill patients would finally be allowed to use marijuana — and potentially MDMA and psilocybin — without violating federal law under a congressionally approved bill now heading to President Trump’s desk.

The bill, know as the “Right to Try Act,” would give certain patients access to drugs that have not yet received U.S. Food and Drug Administration approval for broad use. The House voted 250 – 169 to pass the legislation on Tuesday, and it cleared the Senate by unanimous consent last August.

In order to qualify under the new program, a drug must have completed a phase 1 clinical trial, be under active development, and meet certain other criteria:

“(2) the term ‘eligible investigational drug’ means an investigational drug (as such term is used in section 561)—

“(A) for which a Phase 1 clinical trial has been completed;

“(B) that has not been approved or licensed for any use under section 505 of this Act or section 351 of the Public Health Service Act;

“(C) (i) for which an application has been filed under section 505(b) of this Act or section 351(a) of the Public Health Service Act; or

“(ii) that is under investigation in a clinical trial that—

“(I) is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 505 of this Act or section 351 of the Public Health Service Act; and

“(II) is the subject of an active investigational new drug application under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, as applicable; and

“(D) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 505(i); and

Marijuana meets all of those criteria, thanks to research on medical cannabis use by military veterans with post-traumatic stress disorder that is being funded by the Multidisciplinary Association for Psychedelic Studies (MAPS). That research is currently in Phase 2.

MDMA, commonly known as “ecstasy,” and psilocybin, the active ingredient in psychedelic mushrooms, have undergone Phase 1 and 2 clinical trials, with Phase 3 research on the way.

But while marijuana and potentially the other substances would be eligible for limited legal use under the new law once it is enacted, only patients who are seriously ill would be allowed to participate.

The legislation specifies that a qualifying patient must have been diagnosed with a life-threatening disease or condition, have exhausted approved treatment options and be unable to participate in the clinical trials themselves. A physician who is in good standing with a licensing board would then be able to certify the patient for access.

While the short title of the bill summarizes that it provides for the use of “unapproved medical products by patients diagnosed with a terminal illness in accordance with State law” (emphasis added), the legislative text itself provides no specific limitation concerning state laws. Thus, while patients who would otherwise qualify for medical cannabis access in their states would be clearly protected from federal harassment, it is somewhat of an open question as to whether the the use of psilocybin and MDMA, which are not legal for any use in any state, would be federally shielded.

That caveat aside, advocates are hopeful that the new law, when it is signed, could allow more patients to access substances that have until now only been available in limited clinical trials or through underground, unregulated therapy sessions.

“It seems passing Right to Try would grant people facing death across the country tremendous relief by allowing access to MDMA-therapy and psilocybin-therapy,” Natalie Lyla Ginsberg, MAPS’s policy and advocacy director, told Marijuana Moment in an email. “Both forms of psychedelic-therapy have been specifically researched as a treatment for anxiety associated with life-threatening illnesses, and have produced incredibly promising results, both for the patients and for their families and loved ones. We are hopeful Right to Try would inspire hospice centers to start integrating psychedelic therapy into their treatment.”

President Trump called on lawmakers to pass the legislation during his State of the Union address earlier this year.

“We also believe that patients with terminal conditions — terminal illness — should have access to experimental treatment immediately that could potentially save their lives,” he said. “People who are terminally ill should not have to go from country to country to seek a cure. I want to give them a chance right here at home. It is time for the Congress to give these wonderful, incredible Americans the right to try.”

The House previously passed a similar bill in March (after it failed during a prior attempt). Rather than seek to reconcile the differences between the two chambers’ proposals via a conference committee, a process that would require further Senate action that seems doubtful given broad Democratic opposition, House GOP leaders decided to simply pass the other chamber’s bill in order to get it to the president.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Tom Angell is the editor of Marijuana Moment. A 15-year veteran in the cannabis law reform movement, he covers the policy and politics of marijuana. Separately, he founded the nonprofit Marijuana Majority. Previously he reported for Marijuana.com and MassRoots, and handled media relations and campaigns for Law Enforcement Against Prohibition and Students for Sensible Drug Policy. (Organization citations are for identification only and do not constitute an endorsement or partnership.)

Politics

Colorado Governor Touts Marijuana Legalization’s Benefits

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After the 2012 election, which saw Colorado become the first state to legalize marijuana, Gov. John Hickenlooper (D) said he probably would have reversed the vote if he had a magic wand.

But with the perspective of a few years post-legalization, today he says he’d put that wand “back in the drawer.”

“I’m not quite there to say this is a great success, but the old system was awful,” Hickenlooper said at a forum hosted by the Economic Club of Chicago on Wednesday.

What’s more, “the things that we most feared—a spike in teenage consumption, a spike in overall consumption, people driving while high—we haven’t seen them,” he said.

“We had a little increase in teenage consumption, but then it went down. We do think that some of the teenage consumers are using it a little more frequently than they were five years ago before legalization. We have in many ways seen no demographic where there’s an increase in consumption, with one exception: senior citizens. I leave you to draw your own conclusions.”

Hickenlooper, who’s been floated as a potential 2020 presidential candidate, described the challenges his administration faced when Colorado voters approved an adult-use legalization measure. Elected officials and advisors were opposed to it, he said, and plus, “it’s no fun to be in conflict with federal law.”

But he pushed forward with implementation, recruiting the “smartest people” he could find to figure out the best approach to regulation and taxation. And Illinois, which recently elected pro-legalization J.B. Pritzker for governor, will likely be better off if they pursue reform because they can learn from the successes and failures of Colorado’s system, Hickenlooper said.

“Ultimately, I haven’t come to a final conclusion yet, but I think it’s looking like this is going to be—for all of the flaws and challenges we have—a better system than what we had. You guys are going to benefit, I think, having let us make a bunch of the mistakes and deal with it, I think you’re going to be able to have a much better system if indeed that is the direction that the state wants to go.”

Asked what advice he’d give to Pritzker if Illinois does elect to fully legalize cannabis, Hickenlooper offered three tips: 1) don’t overtax marijuana, or else the illicit marketplace will persist, 2) get data from law enforcement on the presence of cannabis metabolites in the blood after highway fatalities to establish “good baselines” for comparison and 3) set limits on THC concentrations in edibles.

“What they’re selling now, they tell me it’s 10-to-12 times more intense than what allegedly I smoked in high school,” Hickenlooper said, pausing before conceding, “I smoked pot in high school and I inhaled, but it was a fraction of the intensity of what these kids are getting now.”

Legal Marijuana Would Generate Hundreds Of Millions For Illinois, New Analysis Finds

Photo courtesy of YouTube/Economic Club of Chicago.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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The DEA Just Got Scolded Over Its Marijuana Eradication Program

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The Drug Enforcement Administration (DEA) got a slap on the wrist from a federal watchdog agency over its management of a multi-million dollar marijuana eradication program.

In a report released on Wednesday, the non-partisan Government Accountability Office (GAO) said the DEA had failed to adequately collect documentation from state and local law enforcement partners that received funds through the federal program. And that lapse could prevent the agency from being able to accurately assess “program performance.”

What’s more, the DEA “has not clearly documented all of its program goals or developed performance measures to assess progress toward those goals,” according to the report.

In other words, the agency expends about $17 million in funds to partners across the U.S. each year to help them get rid of illegal cannabis grows. That includes fully legal states like California, where enforcement efforts are generally limited to public lands—namely national forests. But due to inadequate record keeping, the DEA doesn’t really know if that money is serving its purpose.

To fix the problems, the GAO issued four recommendations:

1. The DEA Administrator should develop and implement a plan with specific actions and time frames to ensure that regional contractors are implementing DEA’s requirement for collecting documentation supporting participating agencies’ Domestic Cannabis Eradication And Suppression Program (DCE/SP) program expenditures in the intended manner.

2. The DEA Administrator should clarify DCE/SP guidance on the eradication and suppression activities that participating agencies are required to report, and communicate it to participating agencies and DEA officials responsible for implementing DCE/SP.

3. The DEA Administrator should clearly document all DCE/SP program goals.

4. The DEA Administrator should develop DCE/SP performance measures with baselines, targets, and linkage to program goals.

The DEA was able to review a draft of the GAO report ahead of its release and, in an October 17 letter, a Justice Department official said the agency concurred with all four of the recommendations and would take steps to address them.

You can listen to a podcast about the GAO report here:

Just because it’s the DEA’s program doesn’t mean it’s the only agency dropping the ball on marijuana eradication efforts. In April, a report from the inspector general for the U.S. Department of Agriculture found that agents weren’t adequately cleaning up public lands after cannabis busts, which can pose threats to humans, animals and the environment.

Feds Don’t Properly Clean Up After Marijuana Raids, Report Finds

Photo courtesy of Chris Wallis // Side Pocket Images.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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Here’s How Much Legal Marijuana Supporters And Opponents Spent Per Vote In Last Week’s Election

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Political committees concerned with marijuana law reform in four states have waged an information war over the past year, first to qualify cannabis initiatives for the ballot, and then to support or oppose those measures in the lead-up to last week’s midterm elections. In total, over $12.9 million in cash and in-kind services was spent attempting to convince voters about these marijuana ballot measures.

Now that voters have had their say, Marijuana Moment decided to calculate how much each “yes” and “no” vote cost the committees on either side of the debate. Our calculations are based on dollars raised and disclosed before the election, since final totals of actual expenditures won’t be available until December or January reports required in the states that voted on cannabis.

Michigan

In Michigan, where voters approved marijuana legalization, our calculations show that the two anti-legalization committees spent about $1.28 per “no” vote, as they raised $2.37 million for the 1.85 million votes against the measure. The proponents spent 19 percent more per vote, or $1.52 for each of 2.35 million “yes” votes.

Missouri

In Missouri, three separate medical cannabis initiatives competed in the run-up to Election Day, resulting in the highest funding levels of the four states we looked at. There, committees raised a total of $5.4 million dollars to influence voters. Across all the committees, the average cost per “yes” vote was $1.82.

Amendment 3, which was supported by Find the Cures PAC, spent $2.91 for each of its 747,977 votes. Proposition C, supported by Missourians for Patient Care, spent $1.44 for each of its 1.03 million votes. New Approach Missouri, which supported winning Amendment 2, which garnered the support of 1.57 million voters, spent the least, at $1.10 per vote. Only Amendment 2 received a majority and was approved.

Given that there were three competing measures on the ballot, vote costs cannot be parsed in the same binary “yes” or “no” on marijuana reform that is possible for initiatives in the other states. A “no” vote for one measure in Missouri was often paired with a “yes” vote for another.

North Dakota

In North Dakota, there were many fewer votes cast on the state’s marijuana legalization initiative as compared to cannabis measure elsewhere, a total of 324,550. The two committees that opposed Measure 3 heavily outspent the pro-reform committees, to the tune of $629,648 to $94,308. With 131,585 people voting for the initiative, the cost per “yes” vote was 72 cents. On the opposing side, winning came at a high price: Each “no” vote cost four and a half times as much, or $3.26, the most costly per-vote expense on a marijuana ballot measure in the nation this year.

Utah

In Utah, a relatively state where proponents of medical cannabis measure Proposition 2 were narrowly outspent by opponents, the cost per vote was higher. Votes are still being counted more than a week after Election Day, but preliminary vote totals show opponents spent $908,464, or $1.99 for each of the 455,879 votes against the initiative. The prevailing “yes” committees spent $831,471 for 493,060 votes, or $1.69 each. About 8 percent of precincts are yet to be counted, so both of these figures will decrease as more votes are added to both the support and opposition tallies.

Overall in the three states that had a straight up-or-down vote (Michigan, Utah and North Dakota), the average cost per “no” vote was slightly more than each “yes” vote, with prohibitionist committees spending an average of $1.56 for each “no” vote, versus $1.51 spent on average for each “yes” votes. It should be noted that those costs include millions of dollars in in-kind services. In Michigan, for example, The Coalition to Regulate Cannabis like Alcohol reported $706,900 in in-kind services, or 23 percent of their total fundraising.

Looked at another way, the average per state cost (rather than total votes average) for “yes” votes was $1.31 while “no” votes cost 67 percent more: $2.18. And with the total number of “yes” votes in those states outnumbering “no” votes by 19 percent, it would seem that in the state-by-state marijuana legalization battle, you don’t always get what you pay for.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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