Methadone & Other Opiate Maintenance

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FDA Appoves Drug to Treat Heroin, Morphine Addiction

The Food and Drug Administration has approved an injectable drug designed to treat people addicted to opiates who have undergone detoxification treatment. Vivitrol, made by Massachusetts drug maker Alkermes, is a so-called extended-release formulation of the drug naltrexone that is injected once a month into the muscle, according to an FDA statement. The drug works to block opioid receptors in the brain.
Publication/Source: 
All Headline News (FL)
URL: 
http://www.allheadlinenews.com/articles/7020200536?FDA%20Appoves%20Drug%20To%20Treat%20Heroin,%20Morphine%20Addiction

Revolutionary New Device Could Help Drug Addicts

Location: 
Researchers at the University of California Los Angeles say they’ve come up with an implanted device that administers the medication buprenorphine, which helps end dependence on heroin and opioids that are found in many prescription painkillers.
Publication/Source: 
WTMA (SC)
URL: 
http://www.wtma.com/rssItem.asp?feedid=116&itemid=29587707

UK: Liberal Democrats Told Drug Policy 'Wrong'

Location: 
United Kingdom
The Liberal Democrats were told that their drug policy is wrong and the party should support the legalization of cannabis and moves to provide pharmaceutical heroin to addicts instead of methadone. Ewan Hoyle, founder of Liberal Democrats for Drug Policy Reform, accused candidates and MPs of being "silent" on drugs since the issue was last discussed at conference in 2002.
Publication/Source: 
The Press Association (UK)
URL: 
http://www.google.com/hostednews/ukpress/article/ALeqM5jxlgY74TbfECJl5ClfDYmCD9zfkw

Cambodia Opens First Methadone Clinic

The Cambodian Ministry of Health has opened a clinic where people addicted to opiates, primarily heroin, can be administered methadone. The move is a significant departure in a country in which "drug treatment" has typically meant imprisonment, forced labor, and unproven herbal treatments.

Royal Palace, Cambodia (wikimedia.org)
The opening of the clinic is the culmination of years of quiet effort by harm reduction organizations, the BBC reported. Two of those groups, which run outreach programs for drug users, will identify candidates for treatment.

The program is strictly voluntary. Participants will be taken to the clinic for a needs assessment in line with international standards. The clinic is inside a public hospital and run by the Ministry of Health with support from the UN's World Health Organization.

While harm reductionists and public health workers are pleased with the government's new approach, they said more steps need to be taken to shut down the existing, punitive drug treatment centers. But the government says it has no plans to do so.

Read an expose of existing Cambodian drug treatment centers here.

Cambodia

Opioid Dependence Drug Gets Okay for New Delivery Mode

The FDA has approved a new sublingual film formulation of the opioid dependence treatment combination buprenorphrine/naloxone (Suboxone).
Publication/Source: 
MedPage Today (NJ)
URL: 
http://www.medpagetoday.com/ProductAlert/Prescriptions/21990

Swiss Pol Who Probed Secret CIA Prison System Says Legalize Drugs

In an interview Friday with the Austrian newspaper Kurier and reported in the Swiss newspaper Tagesanzeiger, prominent Swiss politician Dick Marty called drug prohibition a failure. Drugs should instead be legalized, taxed and regulated, he said.

Dick Marty
Marty was the state prosecutor in Ticino for 15 years and in 1987 won an award from the International Narcotic Enforcement Officers Association. He was elected to the Swiss Council of State in 1995 and the Parliamentary Assembly of the Council of Europe in 1998. He has hold both positions ever since. Marty gained international prominence when he was appointed by the Council to investigate the collaboration of various European governments in the CIA's secret prison program and issued a damning report in 2006.

Drug prohibition has been "a total bust," Marty said Friday. "It only leads to high prices and corresponding profits for the drug mafia, without diminishing the access to drugs."

Recalling his years as a prosecutor, Marty added that it was only the small-time dealers who got paraded through the courts, while the drug lords were "little bothered" and stayed in luxury hotels. And despite the endless low-level prosecutions, it has never been so easy to get drugs, he added.

Money wasted on enforcing drug prohibition could instead be spent on prevention, and after legalization, governments could control the drug sector through regulation and taxation, as is the case with alcohol and tobacco, Marty said.

Although he conceded that "drug prices will fall" and consumption would rise -- perhaps only temporarily -- if prohibition is ended, Marty said societies must confront the problem of consumption, much as the US did after the end of Alcohol Prohibition. He pointed to a Swiss example, as well: the use of heroin maintenance programs to reintegrate hard-core addicts into the social fabric. "These people are supported medically and they can work again," he said.

Ending prohibition must be a global affair, he said, pointing to the emerging discussion of the theme in Mexico as it is buffeted by prohibition-related violence that has left 28,000 dead in the past 3 ½ years. Still, Marty isn't holding his breath. "Worldwide drug legalization isn't going to happen" in my lifetime, he predicted.

Dick Marty is only 65. Let's see if we can't prove him wrong.

Switzerland

Feature: Drug War a Devastating Failure, Scientists and Researchers Say in Vienna Declaration

A decade ago, scientists, researchers, and AIDS activists confronted a sitting president in South Africa who denied that AIDS was caused by HIV. They responded by declaring at the 2000 Durbin AIDS conference that the evidence was in and the matter was settled. Now, with the Vienna AIDS conference coming up later this month, they are at it again -- only this time the target is the war on drugs.

https://stopthedrugwar.org/files/vienna2009demo1.jpg
HCLU-organized demonstration outside UN anti-drug agency, former SSDP executive director Kris Krane inside cage (drogriporter.hu/en/demonstration)
Their weapon is the Vienna Declaration, an official conference statement authored by experts from the International AIDS Society, the International Center for Science in Drug Policy, and the British Columbia Center for Excellence in HIV/AIDS. The document is a harsh indictment of the global drug war that calls for evidence-based policymaking. It demands that laws which criminalize drug users and help fuel the spread of AIDS be reformed.

The authors of the Vienna Declaration want you to sign on, too. You can do so at the web site linked to above.

"The criminalization of illicit drug users is fueling the HIV epidemic and has resulted in overwhelmingly negative health and social consequences. A full policy reorientation is needed," they said in the declaration.

Arguing there is "overwhelming evidence that drug law enforcement has failed to meet its stated objectives," the declaration lays out the consequences of the drug war:

  • HIV epidemics fueled by the criminalization of people who use illicit drugs and by prohibitions on the provision of sterile needles and opioid substitution treatment.
  • HIV outbreaks among incarcerated and institutionalized drug users as a result of punitive laws and policies and a lack of HIV prevention services in these settings.
  • The undermining of public health systems when law enforcement drives drug users away from prevention and care services and into environments where the risk of infectious disease transmission (e.g., HIV, hepatitis C & B, and tuberculosis) and other harms is increased.
  • A crisis in criminal justice systems as a result of record incarceration rates in a number of nations. This has negatively affected the social functioning of entire communities. While racial disparities in incarceration rates for drug offenses are evident in countries all over the world, the impact has been particularly severe in the US, where approximately one in nine African-American males in the age group 20 to 34 is incarcerated on any given day, primarily as a result of drug law enforcement.
  • Stigma towards people who use illicit drugs, which reinforces the political popularity of criminalizing drug users and undermines HIV prevention and other health promotion efforts.
  • Severe human rights violations, including torture, forced labor, inhuman and degrading treatment, and execution of drug offenders in a number of countries.
  • A massive illicit market worth an estimated annual value of US $320 billion. These profits remain entirely outside the control of government. They fuel crime, violence and corruption in countless urban communities and have destabilized entire countries, such as Colombia, Mexico and Afghanistan.
  • Billions of tax dollars wasted on a "War on Drugs" approach to drug control that does not achieve its stated objectives and, instead, directly or indirectly contributes to the above harms.

"Many of us in AIDS research and care confront the devastating impacts of misguided drug policies every day," said Julio Montaner, president of the International AIDS Society and director of the BC Center for Excellence in HIV/AIDS. "As scientists, we are committed to raising our collective voice to promote evidence-based approaches to illicit drug policy that start by recognizing that addiction is a medical condition, not a crime," added Montaner, who will serve as chairman of the Vienna conference.

"There is no positive spin you can put on the war on drugs," said Dr. Evan Wood, founder of the International Center for Science in Drug Policy. "You have a $320 billion illegal market, the enrichment of organized crime, violence, the spread of infectious disease. This declaration coming from the scientific community is long overdue. The community has not been meeting its ethical obligations in terms of speaking up about the harms of the war on drugs."

Stating that governments and international organizations have "ethical and legal obligations to respond to this crisis," the declaration calls on governments and international organizations, including the UN to:

  • Undertake a transparent review of the effectiveness of current drug policies.
  • Implement and evaluate a science-based public health approach to address the individual and community harms stemming from illicit drug use.
  • Decriminalize drug users, scale up evidence-based drug dependence treatment options and abolish ineffective compulsory drug treatment centers that violate the Universal Declaration of Human Rights.
  • Unequivocally endorse and scale up funding for the implementation of the comprehensive package of HIV interventions spelled out in the WHO, UNODC and UNAIDS Target Setting Guide.
  • Meaningfully involve members of the affected community in developing, monitoring and implementing services and policies that affect their lives.
  • We further call upon the UN Secretary-General, Ban Ki-moon, to urgently implement measures to ensure that the United Nations system -- including the International Narcotics Control Board -- speaks with one voice to support the decriminalization of drug users and the implementation of evidence-based approaches to drug control.

"This is a great initiative," enthused Ethan Nadelmann, executive director of the Drug Policy Alliance. "It is the most significant effort to date by the sponsors of the global AIDS conference to highlight the destructive impact of the global drug war. It is nicely coordinated with The Lancet to demonstrate legitimacy in the medical community. And it is relatively far reaching given that the declaration was drafted as a consensus statement."

"This is aimed at politicians, leaders of governments, the UN system, and it's aimed at housewives. We are trying to do basic education around the facts on this. There are still politicians who get elected vowing to crack down on drugs," said Wood. "While the declaration has a global aim and scope, at the end of the day, the person who is going to end the drug war is your average voter, who may or may not have been affected by it," he said.

"This was needed a long time ago," said Wood. "The war on drugs does not achieve its stated objectives of reducing the availability and use of drugs and is incredibly wasteful of resources in locking people up, which does little more than turn people into hardened criminals," he said.

The authors are hoping that an official declaration broadly endorsed will help begin to sway policy makers. "It will be interesting to see what kind of support it receives," said Wood. "Former Seattle Police Chief Norm Stamper has endorsed it, and we have a 2008 Nobel prize winner for medicine on the web site. There are high level endorsements, and more are coming. Whether we touch a nerve with the news media remains to be seen. I am hoping it will have a big impact since this is the official conference declaration of one of the largest public health conferences on the planet."

"We have reached a tipping point in the conversation about drugs, drug policy, drug law enforcement, and the drug war," said Stamper, now a member of Law Enforcement Against Prohibition. "More and more, science has found its way into the conversation, and this is one step to advance that in some more dramatic fashion. I've heard much from the other side that is emotional and irrational. This is one effort to create even more impetus for infusing this dialogue on drug policy with evidence-driven, research-based findings."

That the AIDS conference is being held in Vienna adds a special fillip to the declaration, Wood said. "Vienna is symbolically important because it is where the infrastructure for maintaining the global war on drugs is located," said Woods, "and also because of the problems in Eastern Europe. In Russia, it's estimated that one out of every 100 adults is infected with the AIDS virus because Russia has not embraced evidence-based approaches. Methadone maintenance therapy is illegal there, needle exchanges are severely limited, the treatment programs are not evidence-based, and there are all sorts of human rights abuses around the drug war."

With the AIDS conference set to open July 18, Wood and the other authors are hoping the momentum will keep building up to and beyond. "It is my hope that now that the Vienna Declaration is online, large numbers of people will come forward and lend their names to this effort," he said.

The Vienna Declaration is one more indication of just how badly drug war orthodoxy has wilted under the harsh gaze of science. It's hard to win an argument when the facts are against you, but as the declaration notes, there are "those with vested interests in maintaining the status quo." The declaration should make their jobs that much more difficult and bring progressive approaches to drug policy that much closer.

UNODC: The Russians Are Coming

[Update, 6:20pm EST: Peter Sarosi at HCLU just told me Ban Ki-moon has indeed picked Fedotov. Hence I have removed the question mark from the end of the title of this article. :( - DB]

Current head of the UN Office on Drugs and Crime (UNODC) Antonio Maria Costa is set to end his 10-year term at the end of this month, and according to at least one published report, a Russian diplomat has emerged as the frontrunner in the race to replace him. That is causing shivers in some sectors of the drug reform community because the Russians are viewed as quite retrograde in their drug policy positions.

The report names Russia's current ambassador to the United Kingdom, Yuri Fedotov, as the top candidate to oversee UNODC and its $250 million annual budget. Other short-listed candidates include Spanish lawyer Carlos Castresana, who headed a UN anti-crime commission in Guatemala, Colombian Ambassador to the European Union Carlos Holmes Trujillo, and Brazilian attorney Pedro Abramovay. The final decision is up to UN Secretary General Ban Ki-moon.

If Fedotov wins the position, Russia would be in a far more influential position to influence international drug policy, and that is raising concerns because of Russia's increasingly shrill demands that the US and NATO return to opium eradication in Afghanistan, its refusal to allow methadone maintenance and its refusal to fund needle exchange programs even as it confronts fast-growing heroin addiction and HIV infection rates.

The concerns have crystallized in a campaign to block his appointment, including a Facebook group called We Don't Want A Russian UN Drug Czar!, which is urging people to send an email message to that effect to Secretary General Ki-moon. Group organizers the Hungarian Civil Liberties Union have also produced a video on the subject:

Europe: Norwegian Committee Calls for Heroin Prescription Trials, Harm Reduction Measures

A blue-ribbon committee in Norway has called for heroin prescription trials and expanded harm reduction measures, such as expanding safe injection sites. The Stoltenberg Committee presented its findings in a 49-page report (sorry, Norwegian only) issued last month.

https://stopthedrugwar.org/files/norwegianfjord.jpg
Norwegian fjord (courtesy Erik A. Drabløs via wikimedia.org)
The committee was created last year by then Health Minister Bjarne Hakon Hanssen to review the situation of hard drug users in Norway. It was tasked in particular with evaluating whether the government should allow a trial heroin prescription program because the notion was so controversial in Norway. The committee did not address soft drug use.

Committee head Thorvald Stoltenberg is a well-known and well-respected political figure in Norway, having served in the past as foreign minister. He is the father of the current prime minister. He is also the father of an adult daughter who is a former heroin addict.

Current Health Minister Anna-Greta Strom-Erichsen agreed with the committee's call for more harm reduction and expanded treatment services, but wasn't ready to sign off on prescribed heroin just yet.

"I agree with the committee that services for the most vulnerable drug addicts must be better," she said in a press release. "The committee wants greater degree of coordination of services. This is a task that is central to the work of collaborative reform, which is especially important for people with drug problems," she added.

But heroin prescribing is "a difficult question" on which the government must move carefully, Strom-Erichsen said. "The government has not reached a conclusion on the question of heroin assisted treatment. Regardless of the conclusion to this question, there is a need for an intensified effort for people with drug problems, including medical treatment, "she said.

The committee report will now form the basis for a broad dialog on its recommendations among government officials, local officials, drug users, relatives, and other interested parties. After that, the Health Ministry will send a proposal to parliament.

While the committee report is quite moderate by international standards, it represents a major break from traditional Norwegian responses to hard drug use and an embrace of the harm reduction philosophy.

Feature: Pennsylvania Lawmakers' Aim at Reducing Methadone Deaths, But Shoot Wide

Late last month, Pennsylvania state Senate Republicans -- and one Senate Democrat -- held a press conference at the statehouse in Harrisburg to roll out their "Methadone Accountability Package." The package, they said, aims at increasing safety and fiscal accountability and reducing the illicit use of methadone and methadone overdose deaths. A related Senate resolution is also calling for a moratorium on new methadone treatment centers. But methadone treatment advocates and researchers are cautioning that the package may be unnecessary, and are calling for any legislation on methadone to be based on facts and scientific evidence -- rather than overheated rhetoric and anecdotes.

Drug overdoses have risen nationally in recent years, with the increase generally being attributed to increased use of prescription medications such as methadone and buprenorphine. Advocates have suggested overdose prevention approaches such as "Good Samaritan" policies protecting people who call for help -- Washington state's legislature enacted one this week -- or distribution of the overdose antidote naloxone, as ways of stemming the tide. But the PA package announced this week goes a different direction.

https://stopthedrugwar.org/files/pamethadonebills.jpg
the dark side: legislators seeking dramatic methadone restrictions
While the bundle of bills addresses keeping track of methadone-related deaths (SB 1293), diversion control (SB 1376), driving while using methadone (SB 1377, SB 1378), and micromanaging methadone maintenance treatment (SB 1382, SB 1383), the bill that strikes most directly at methadone maintenance treatment for opiate-dependent individuals, is SB 1294, the Methadone Addiction Prevention and Treatment Act, introduced by Sen. Mike Stack (D-District 5). Stack's bill would mandate that:

  • Potential patients be addicted to opiates for at least one year before methadone treatment is considered;
  • Potential patients must have twice failed other forms of treatment;
  • Patients have a written plan with goals and dates to be free from drug dependence, including methadone, within two to three years;
  • Patients must have a designated driver come with them to the clinic for the first two weeks of treatment; and
  • Driving under the influence of more than the prescribed dose of methadone be a violation of state driving under the influence laws.

"Pennsylvania needs better laws to prevent methadone abuse and provide patients with the proper protections and treatment plans they need to achieve a lifetime of sobriety," Sen. Stack said. "This package of bills is a solid step toward achieving those goals."

"Pennsylvania's law has not kept pace with the changes in the prescription of methadone -- and too frequently with deadly consequences," said Sen. John Eichelberger (R-District 30). "Methadone is a drug with its own unique properties. One pill or one dose can kill a non- or low-opiate-tolerant person. Even a day or two after the drug is taken, it has led to fatalities for those who mix alcohol or other drugs."

The senators cited reports from the National Drug Intelligence Center that unlawful diversion of methadone had more than doubled between 2003 and 2007 and from the National Center for Health Statistics that the number of methadone overdose deaths had increased nearly five-fold, with OD deaths among young people (15-24) increasing eleven-fold.

Not so fast, say experts. "Let's be careful about this; there are a lot of lives at stake here," said Eric Hulsey, director of performance, evaluation, and program development at the Institute for Research, Education, and Training in Addictions in Pittsburgh. "If the intention behind this stuff is better clinical care, that's a great thing, but we have to caution that it needs to be grounded on evidence-based practice."

Hulsey and National Association for Medication Assisted Recovery president Roxanne Baker also questioned some of the specifics in SB 1294. For Baker, the objections are a bill-killer.

"I would have to oppose this bill because it's too restrictive," she said. "There are already state and federal regulations on methadone treatment centers. Medicine is best left to doctors, not legislators."

Baker objected to the bill's provision for pushing methadone maintenance patients to get off the drug. "They really push the methadone abstinence schedule, don't they," she said. "Here in California, they just say it would be 'harmful to the patient' to taper off. I don't know why that needs to be in there; they don't make you taper off thyroid medication or insulin."

Hulsey didn't see a lot of evidence that methadone maintenance clinics are behind the problems being cited by the politicians. "Methadone prescribing has gone up seven-fold around the country, and we've seen all these methadone overdoses. Most of the federal reports and researchers have concluded that this is coming from the pain management clinics, yet everyone wants to crack down on the methadone treatment clinics."

Methadone treatment clinics are operated under different and stricter sets of regulations than pain clinics, Hulsey said. "It's unclear what the pain clinics are doing to prevent adverse incidents at their facilities, but it is clear that most diverted meds are coming from pain management, therefore, let's legislate against methadone maintenance clinics?"

Not that cracking down on pain clinics is the answer either, according to NAMA's Baker. Pointing out that methadone maintenance clinics are not the problem is fine, she said, but let's not be too quick to go after pain doctors. Citing the massive under-treatment of chronic pain in this country and her own decades-long experience with methadone in both the treatment and the pain clinic milieus, she said methadone patients already face enough barriers.

"I've been taking methadone since 1974," she said. "I stood in those methadone treatment lines, but now I get my medication from a pain specialist. A lot of people want to do that because they treat you better -- if you can find one who will treat you at all."

And that is a problem, Baker said. "A lot of doctors don't want to treat pain patients because they have the DEA breathing down their necks. We don't need more obstacles."

"This is misdirected legislation," said Mark Parrino, president of the American Association for the Treatment of Opioid Dependence. "Methadone treatment programs have been functioning for more than 40 years with a considerable degree of safety. There have been at least four federal studies showing that increasing methadone mortality is based on that fact that it is increasingly being used in pain management. If the legislation doesn't address the cause of the problem, it has no basis for existing."

"The science doesn't support a hard and fast rule to get off licit opiates," said Hulsey. "It can be very dangerous to put arbitrary deadlines on that. Treatment has to be individualized to promote recovery."

For Hulsey, the bill's requirement that potential patients first twice fail at treatment is just not good policy. "I am not aware of science that supports 'you fail first' policies," he said. "If you go to the expert consensus guidelines for management of methadone facilities, and more importantly, accepted patient placement criteria, you must demonstrate a year's dependency, as well as other thresholds, and that is what should determine appropriate placement. 'Fail first' doesn't capture the full range of factors that experts have agreed upon as the best approach for opiate-dependent individuals."

The consensus guidelines Hulsey cited were SAMSHA/CSAT's Treatment Improvement Protocol 43 and the American Society of Addiction Medicine's Patient Placement Criteria.

"Those are the gold standard for treatment," he said. "They provide a six-dimensional approach to dependence, and you would need to meet those criteria to be appropriately placed in methadone maintenance. It's not appropriate for everybody. Some people may require a detox approach rather than long-term maintenance."

For Hulsey, having the designated driver requirement for new patients was "good risk management," but creating methadone-impaired driving offenses seemed unnecessary. "There are already laws on the books regarding impairment," he said.

Nobody thought the moratorium on new methadone maintenance clinics was a smart move. "They shouldn't do that," said NAMA's Baker. "They don't put moratoriums on doctors who prescribe treatments for diabetics. But there is a lot of NIMBYism in Pennsylvania."

"Addiction is a chronic disease that is treatable when appropriate evidence-based treatment approaches are applied," said Hulsey. "We want to promote recovery and support people rather than limiting access. If we limit the treatment opportunities, we make these people criminals."

Parrino didn't think much of the moratorium idea, either. "You can have a moratorium, but that doesn't reduce the demand for treatment, so what's the rationale for restricting access to care? Do we think the number of people who need this has capped out? That state has to be careful saying that a moratorium seems smart, especially when the problem is not related to the treatment programs you're dealing with," he said.

But methadone maintenance clinics make convenient targets for a number of reasons, said Parrino. "There is NIMBYism, and there is a general stigma about treating addiction, which increases markedly when you talk about the use of medications to treat opiate addiction," he pointed out.

"And elected officials always feel like 'we must do something,'" he continued. "But unless the legislature is able to be more precise in identifying the problem and how to deal with it, I would suggest that they are not addressing the real source of the problem, but doing what seems manageable and convenient. It's easy to say let's put more restrictions on top of a system that is already highly regulated, but pain doctors aren't regulated at all."

So faced with mounting methadone mortality and increasing diversion not linked to methadone maintenance clinics, Pennsylvania legislators are aiming squarely at those clinics. The legislature and the people of Pennsylvania would be better served if this package of bills went back to the drawing board.

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