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'Overdose Prevention’ Bill Would Actually Increase Overdoses by Driving People Out of Treatment

Tue, 07/10/2018 - 10:42
Drug treatment and recovery groups are lining up against the measure, which strips drug patients of crucial privacy protections.

A bill ostensibly intending to reduce opioid overdoses passed the House last month, but rather than cheering it on, drug treatment and recovery advocates are lining up to block it in the Senate. That's because instead of being aimed at reducing overdoses, the bill is actually a means of removing patient privacy protections from some of the most vulnerable people with opioid problems, including people using methadone-assisted therapy to control their addictions.

And that, advocates say, is likely to increase—not decrease—opioid overdoses by pushing users away from drug treatment out of fear the information they reveal could be used against them. The fear is real: Unlike other medical conditions, drug addiction leaves patients open to criminal prosecution, as well as stigmatization and other negative social consequences if their status as drug treatment or maintenance patients is revealed.

This bill, H.R. 6082, the Overdose Prevention and Patient Safety Act, would remove drug treatment patients' ability to control the disclosure of information to health plans, health care providers, and other entities, leaving them with only the lesser privacy protections afforded to all patients under the Health Insurance Portability and Accountability Act (HIPAA) of 1996.

"The confidentiality law is often the only shield between an individual in recovery and the many forms of discrimination that could irreparably damage their lives and future," said Paul Samuels, president and director of the Legal Action Center. "Unfortunately, there is a very real danger of serious negative consequences for people whose history of substance use disorder is disclosed without their explicit consent."

The Legal Action Center is spearheading the effort to block this bill with the Campaign to Protect Patients' Privacy Rights, which counts more than a hundred organizations, including the American Association for the Treatment of Opioid Dependence, AIDS United, Community Catalyst, Faces and Voices of Recovery, Facing Addiction, Harm Reduction Coalition, National Advocates for Pregnant Women, National Alliance for Medication Assisted Recovery, and National Council on Alcoholism and Drug Dependence.

The current patient privacy protections, known as 42 C.F.R. Part 2 ("Part 2"), were established more than 40 years ago to ensure that people with a substance use disorder (SUD) are not made more vulnerable to discriminatory practices and legal consequences as a result of seeking treatment. The rules prevent treatment providers from disclosing information about a patient’s substance use treatment without patient consent in most circumstances. The bill’s plan to replace Part 2’s confidentiality requirements with HIPAA’s more relaxed standards would not sufficiently protect people seeking and receiving SUD treatment and could expose patients to great harm, the advocates charge.

"They should call this the Taking Away Protections Act," said Jocelyn Woods, head of the National Alliance for Medication-Assisted Recovery. "People will be afraid to go into treatment. I'm getting emails from people who want to leave treatment before this happens. If I were going into a program and they can't tell me my information will be safe, I would think about turning around and walking out," she told the Independent Media Institute.

"Many of us would not have gone to treatment or accepted services if we thought that our information would have been shared with other entities without our permission. We would not have put our careers, reputation or families at risk of stigma and discrimination if we were not assured that information about our substance use disorder was safe and would only be shared with our consent," added Patty McCarthy Metcalf, executive director of Faces and Voices of Recovery.

The push for the bill is being led by health information software companies and behavioral health providers, such as Hazelden and the Betty Ford Center, and it prioritizes convenience over patient privacy.

"This is because the behavioral health people see complying with the privacy requirements as a pain in the ass," said Woods. "They're going to have to fix their computer systems to block out any treatment program licensed by the federal government—not just methadone programs—and they don't want to do that. One of the software companies, Netsmart, complained that they don't want to mess with their programming," she said.

"We need Part 2," Woods continued. "It keeps police out of the program. Without it, police can walk right in. They already sit outside methadone clinics and bust people for DUI on the way out. If this passes, they will walk right in. If the police see anyone they think has a warrant or committed a crime, they're gone.”

While the bill has made its way through the House, advocates are hopeful it will stall in the Senate.  

"The House pushed this through because they wanted to look like they were doing something and because the behavioral health people were pushing for it," Woods said, "but my sense is that it's moving slowly in the Senate. We have this crazy president, and there's immigration, and the congressional break, and then campaign season. My hope is we can push this past the elections and a blue wave in November will give us a fighting chance."

But the campaign isn't taking any chances and is mobilized to fight on the Hill in the next few months to block the bill. As Mark Parrino, president of the American Association for the Treatment of Opioid Dependence, warned: "In the midst of the worst opioid epidemic in our nation’s history, we cannot afford to have patients fearful of seeking treatment because they do not have faith that their confidentiality will be protected."

This article was produced by Drug Reporter, a project of the Independent Media Institute.

 

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Mexico's President-Elect Plans to End the Nation's War on Drugs

Mon, 07/09/2018 - 23:11
The new course marks a dramatic shift from his predecessor.

On July 1, leftist politician Andres Manuel López Obrador—often referred to with the acronymic AMLO—won the Mexican presidency in a landslide. When he takes office in December, with his party in control of both houses of the Mexican Congress, Mexico's drug policies are likely to see some radical changes.

Just what AMLO does will have significant consequences on both sides of the border. His policies will impact how much heroin and cocaine make it to the streets of America, as well as how many Mexicans flee north to escape prohibition-related violence, and how much drug money flows back into Mexico, corrupting politicians, police, and the military.

That AMLO—and Mexico—wants change is no surprise. A vigorous campaign against the country's powerful and violent drug trafficking organizations—the so-called cartels—unleashed by rightist president Felipe Calderon in 2006 brought the Mexican military into the fight, but instead of defeating the cartels, the campaign, still ongoing under President Enrique Pena Nieto, has instead led to record levels of corruption and violence.

In 2012, when both the U.S. and Mexico had presidential elections and the drug war death toll was around 15,000, Mexico's drug prohibition-related violence was big news north of the border. But in the years since then, as U.S. attention to Mexico's drug wars wavered, it's only gotten worse. Last year, Mexico saw more than 30,000 murders, and the cumulative drug war toll in the past dozen years is more than 200,000 dead and tens of thousands of "disappeared."

But the toll runs deeper than just a count of the casualties. The relentless drug war violence and the endemic corruption of police forces, politicians, and even sectors of the military by cartels have had a deeply corrosive effect on the citizenry and its belief in the ability of the country's political institutions to address the problem.

López Obrador, the former mayor of Mexico City, campaigned heavily on the need for change, especially around drug policy, corruption, and public safety. "Abrazos, no balazos" ("hugs, not gunfights") was one of his favorite campaign slogans. AMLO campaigned cautiously, hammering away at crime, corruption, and violence and mentioning different drug policy-related changes, but not coming out with specific policy proposals. Still, from his own remarks and those of people who will be assuming key positions in his administration, we can begin to sketch an outline of what those policies may look like.

Marijuana Legalization

Mexico is one of the world's largest marijuana producers (although the local industry has been taking a hit in recent years from completion north of the border), it has decriminalized the possession of small amounts of the herb, and it has legalized medical marijuana.

AMLO's pick for interior minister, former Supreme Court official Olga Sánchez Cordero, has made no secret of her plans to seek full legalization and said last week that AMLO may seek a public referendum to gauge popular support for it. Why maintain pot prohibition when Canada and U.S. states are legalizing it, she said. “What are we thinking? Tell me. Killing ourselves. Really, keep on killing when... North America is decriminalizing?”

Drug Legalization

The possession of personal use amounts of all drugs has been decriminalized in Mexico since 2009, but that hasn't stopped the violence. AMLO and his advisers say he is open to considering taking the next step and legalizing all drugs.

"We’ll analyze everything and explore all the avenues that will let us achieve peace. I don’t rule out anything, not even legalization — nothing," AMLO told the New Yorker during the campaign.

"The war on drugs has failed," wrote Sánchez Cordero. "Nothing contributes to peace by legislating on the basis of more criminal punishment and permanent confrontation. Violence is not fought with violence, as López Obrador rightly points out."

Drug legalization would be a radical step, indeed. It probably isn't going to happen under AMLO, since that would pit Mexico not only against the U.S., but also against the international anti-drug treaties that serve as the legal backbone of global drug prohibition. But he is putting the idea squarely on the table.

Amnesty

As a candidate, AMLO floated the idea of amnesty for those involved in the drug trade, a notion that created huge controversy and forced his campaign to clarify that it did not mean cutting deals with bloody-handed cartel leaders or their henchmen. Instead, his campaign clarified, he was referring to peasants growing drug crops and other low-level, non-violent workers in the illicit business.

"Kidnappers? No," said Sánchez Cordero about possible amnesty recipients. "Who? The people working in rural areas, who are criminals because they work in the illegal drug business, but haven’t committed crimes such as murder or kidnapping."

Demilitarization and Policing Reforms

For the past 12 years, the Mexican military has been called on to fight the cartels and suppress the drug trade. But the level of violence has only increased, the military is implicated in massive human rights violations (as can only be expected when a government resorts to soldiers to do police work), and finds itself subject to the same corrupting influences that have turned state and local police forces into virtual arms of the competing cartels.

With regard to cartel violence, AMLO repeatedly said on the campaign trail that "you don't fight fire with fire" and that what was needed was not soldiers on the streets, but social and economic assistance for the country's poor and unemployed—to give them options other than going to work for drug gangs. Just this week, AMLO announced a $5 billion package of scholarships and job training support for the young.

Still, AMLO isn't going to send the soldiers back to the barracks immediately. Instead, says one of his security advisers, his goal is to do it over the next three years. He has also proposed replacing the military presence in the drug war with a 300,000-person National Guard, composed of both military and police, a notion that has been bruited by earlier administrations as a means of effectively replacing tainted state and local police participation.

Here, AMLO is not nearly as radical as with some of his other drug policy proposals. He as much as concedes that the bloody drug wars will continue.

"I’m not overwhelmed by any of it," Eric L. Olson, an expert on Mexico and security at the Wilson Center in Washington, told the Washington Post. "It falls well within the norm for what other politicians have been saying."

The U.S.-Mexico Relationship

Over the past couple of Mexican administrations, Mexican security agencies have cooperated closely with their U.S. counterparts in the DEA and FBI. It's not clear whether that level of cooperation will be sustained under AMLO. When he was running for president in 2012, he called for blocking U.S. intelligence work in Mexico, but during this campaign, he insisted he wanted a strong relationship with the U.S. on security and trade issues.

While Mexico may chafe under the continued threats and insults of President Trump, it benefits from security cooperation with the U.S. and would like to see the U.S. do more, especially about the flow of guns south across the border.

"We are going to ask for the cooperation of the United States" on gun trafficking, said Alfonso Durazo, one of AMLO's security advisers, repeating an ongoing refrain from Mexican politicians.

Mexico has also benefited from DEA intelligence that allowed it to kill or capture numerous cartel figures. But AMLO is a much pricklier personality than his predecessor, and between Trump's racist Mexico- and immigrant-bashing and his imposition of tariffs on Mexican exports, U.S.-Mexico relations could be in for a bumpy few years. AMLO's moves on changing drug policies at home are also likely to sustain fire from the White House, further inflaming tensions.

"The bottom line is he’s not going to fight the drug war in the way that it’s been fought in the last few decades," David Shirk, a professor at the University of San Diego who is an expert on security issues in Mexico, told the Post. "That is potentially a huge change."

This article was produced by Drug Reporter, a project of the Independent Media Institute.

 

 

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Can Magic Mushrooms Treat Cocaine Dependency?

Fri, 06/29/2018 - 14:19
A clinical trial underway right now hopes to find the answer—and more participants.

So far, no one has come up with a pharmacological agent to help people strung out on cocaine get off the marching powder, but researchers are looking at one promising prospect: psilocybin, the chemical that puts the magic in magic mushrooms.

Scientists at the University of Alabama–Birmingham's (UAB) School of Public Health are now conducting a clinical trial to see whether psilocybin can help break cocaine addiction. The trial currently has almost 20 people enrolled, but researchers are looking for more subjects—people who are currently using cocaine and have a strong desire to quit.

"Our goal is to create a tool or drug that provides significantly better outcomes for individuals addicted to cocaine than those that currently exist," said Sara Lappan, Ph.D., a postdoctoral scholar in the Department of Health Behavior.

In the trial, participants receive a dose of psilocybin and are monitored for six hours, about the duration of the experience. Then, the researchers track his or her cocaine use.

"Our idea is that six hours of being under the effects of psilocybin may be as productive as 10 years of traditional therapy," Lappan said.

The researchers theorize that psilocybin works on three levels: the biochemical, the psychological, and the spiritual. In terms of biochemistry, psilocybin disrupts brain receptors thought to reinforce addictive behaviors. Psychologically, the drug is believed to reduce cravings, increase motivation, and increase one's sense of self-efficacy. Spiritually—or transcendentally—psilocybin (along with other psychedelics) is thought to increase both a person's sense of purpose and his or her sense of universal connectedness or oneness.

"If our hypotheses are supported, this has the potential to revolutionize the fields of psychology and psychiatry in terms of how we treat addiction," Lappan said.

But don't run out and start gobbling down magic mushrooms to quit cocaine just yet, the researchers cautioned.

"We aren’t advocating for everyone to go out and do it," said Peter Hendricks, Ph.D., associate professor of health behavior in the School of Public Health at UAB. "What we are saying is that this drug, like every other drug, could have appropriate use in a medical setting. We want to see whether it helps treat cocaine use disorder."

They're not the only ones looking into the secrets of psilocybin. UAB is one of a half-dozen universities studying its potential medicinal benefits. The others are Johns Hopkins University, Imperial College London, New York University, University of California–San Francisco and Yale.

This article was produced by Drug Reporter, a project of the Independent Media Institute.

 

 

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Is Juul Making It Easy for Kids to Vape in School?

Fri, 06/29/2018 - 10:57
New research shows thousands of students sneak this nicotine delivery system onto school grounds.

The Juul vaporizer is the latest advancement in electronic cigarette technology, delivering nicotine to the user from a device about the size and shape of a thumb drive. Juul has taken the electronic cigarette market by storm experiencing a year-over-year growth of about 700 percent.

In recent months, stories about a possible Juul craze among teenagers have circulated in the media. In April, The Wall Street Journal reported that parents are fighting a Juul epidemic. In May, The New Yorker told a story about Juul’s presence at high schools in America’s more affluent ZIP codes.

I study ways to inform public health and policy by using data from social media. According to new research my colleagues and I conducted that was just published in Drug and Alcohol Dependence, thousands of students sneak this nicotine delivery system on to school grounds to use during school hours.

Using social media for science

Our study adds to this discussion by considering a novel source: posts to Twitter. Because posts on social media reflect the attitudes and behaviors of the public in their own words, researchers can treat this data source like a massive focus group.

For this reason, my colleagues and I will often turn to social media to track health behaviors, including the use of emerging tobacco products, to better understand the social and environmental setting in which they are used. For example, last year we discovered that “cloud chasing,” or the act of blowing the largest aerosol cloud possible in a competition, was one of the more appealing characteristics of electronic cigarettes among Instagram users.

In our most recent study, we wanted to document and describe the public’s initial experiences with Juul. We collected posts to Twitter containing the term “Juul” from April 1, 2017 to December 14, 2017. We analyzed over 80,000 posts representing tweets from 52,098 unique users during this period and used text classifiers (automated processes that find specified words and phrases) to identify topics in posts.

We found that 1 in 25 posts, or 4 percent, was indicative of use of Juul while at high school, middle school and even elementary school. These posts described young people talking about using Juul on school grounds, in classrooms, in bathrooms, in the library, at recess and during gym.

For example, if the words “school,” “principal,” “teacher,” “elementary” or “recess,” among dozens of others, co-occurred in posts with the word “Juul,” we identified that post as reflective of a young person using Juul or seeing someone use Juul while on school grounds.

In comparison, a recent national online survey showed that 7 percent of participants 15 to 17 years of age, who would most likely be high school students, reported ever using a Juul.

We only had access to posts from public accounts, so our findings do not reflect posts from private users suggesting our numbers may underreport the amount of youth talking about Juul on Twitter.

Juul’s discreetness may facilitate its use in places where vaping is prohibited, also known as “stealth vaping.”

How to handle vaping

Our findings suggest educators may be in need of training on how to identify Juul in the classroom. School administrators may consider installing vapor detectors in bathrooms and classrooms to deter use of Juul on school grounds.

Our study’s data source – posts to Twitter – may highlight a way parents can determine if their child is using Juul. While we analyzed anonymized data, parents could follow their child’s account to monitor such activities.

Twitter does not make its users’ demographic information (e.g., age) public in order to protect user privacy. As such, our study could not determine the exact age of Twitter users. However, posts contained combined words like “Juul” and “recess” suggesting posts were made by youth.

While Juul is marketed as a “smoking alternative” for adults trying to quit, we found relatively few posts containing phrases like “quit smoking.” One in 350 posts do.

Electronic cigarettes have stirred national debate where public health officials are trying to determine if these devices, like Juul, will help smokers quit combustible cigarettes or serve as a possible gateway product to combustible cigarette use among youth. While this debate will likely go on for some time, it is clear that nicotine use of any kind is known to be addictive and harmful to adolescent brain development. We believe that our findings underscore the need for policies to be implemented to keep such products out of the hands of youth.

Jon-Patrick Allem, Research Scientist, University of Southern California

This article was originally published on The Conversation. Read the original article.

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New Study Shows Amazonian Psychedelic May Ease Severe Depression

Fri, 06/29/2018 - 07:34
Scientists have conducted the first randomized, placebo-controlled clinical trial of ayahuasca.

“Leon” is a young Brazilian man who has long struggled with depression. He keeps an anonymous blog, in Portuguese, where he describes the challenge of living with a mental illness that affects some 300 million people worldwide, according to the World Health Organization.

Leon is among the roughly 30 percent of those patients with treatment-resistant depression. Available antidepressant drugs like selective serotonin reuptake inhibitors do not alleviate his depressed mood, fatigue, anxiety, low self-esteem and suicidal thoughts.

A new study may offer hope for Leon and others like him.

Our team of Brazilian scientists has conducted the first randomized, placebo-controlled clinical trial of ayahuasca – a psychedelic drink made of Amazonian plants. The results, recently published in the journal Psychological Medicine, suggest that ayahuasca can work for hard-to-treat depression.

The ‘vine of the spirits’

Ayahuasca, a word from the indigenous Quechua language, means “the vine of the spirits.” People in the Amazonian region of Brazil, Peru, Colombia and Ecuador have for centuries used ayahuasca for therapeutic and spiritual purposes.

The medicinal beverage’s properties come from two plants. Banisteriopsis caapi, a vine that twists its way up to the treetops and across river banks of the Amazon basin, is boiled together with Psychotria viridis, a shrub whose leaves contain the pyschoactive molecule DMT.

Starting in the 1930s, Brazilian religions were founded around the use of ayahuasca as a sacrament. By the 1980s, the ayahuasca ritual had spread to cities across Brazil and the world.

Ayahuasca first became legal for religious use in Brazil in 1987, after the country’s federal drug agency concluded that “religious group members” had seen “remarkable” benefits from taking it. Some people who drink ayahuasca describe feeling at peace with themselves, God and the universe.

For our study, which took place at Brazil’s Federal University of Rio Grande do Norte, researchers recruited 218 patients with depression. Twenty-nine of them were selected to participate because they had treatment-resistant depression and no history of psychotic disorders like schizophrenia, which ayahuasca use may aggravate.

These 29 people were randomly assigned to undergo a single treatment session, in which they were given either ayahuasca or a placebo substance to drink. The placebo was a brownish liquid, bitter and sour to the taste, made of water, yeast, citric acid and caramel colorant. Zinc sulphate mimicked two well-known side effects of ayahuasca, nausea and vomiting.

The sessions took place in a hospital, though we designed the space like a quiet and comfortable living room.

The acute effects of ayahuasca – which include dream-like visions, vomiting and intense introspection – last for about four hours. During this period, participants listened to two curated playlists, one featuring instrumental music and another with songs sung in Portuguese.

Patients were monitored by two team members, who provided assistance to those experiencing anxiety during this intense emotional and physical experience.

One day after the treatment session, we observed significant improvements in 50 percent of all patients, including reduced anxiety and improved mood.

A week later, 64 percent of the patients who had received ayahuasca still felt that their depression had eased. Just 27 percent of those in the placebo group showed such effects.

Building on past evidence

Our findings support a 2015 Brazilian clinical trial on the potential of ayahuasca as an antidepressant.

That study, led by Dr. Jaime Hallak of the University of São Paulo, likewise found that a single ayahuasca session had a fast-onset antidepressant effect. All 17 participants reported that depression symptoms diminished in the first hours after ayahuasca ingestion. The effect lasted 21 days.

This study received significant attention from scientists. Its promising conclusions were limited, however, because there was no control group of patients who received a placebo drug.

In clinical trials for depression, up to 45 percent of patients who take a placebo may report significant benefits. The placebo effect for depression is so strong that some scientists have questioned whether antidepressants really work.

Dr. Hallak and other researchers from the 2015 University of São Paulo study were part of our follow-up clinical trial.

Religion turned science

These two studies, while preliminary, contribute to a growing body of evidence that psychedelic drugs like ayahuasca, LSD and mushrooms can help people with difficult-to-treat depression.

But because these substances are illegal in many countries, including the United States, their therapeutic value has been difficult to test. Even in Brazil, using ayahuasca as an antidepressant remains a fringe, informal enterprise.

Leon, the Brazilian blogger, discovered the drug doing internet research. “Desperate” to find solutions for his intractable condition, Leon decided to take part in an ayahuasca ceremony at a Santo Daime church in Rio de Janeiro, one of several Brazilian religions that use ayahuasca as a sacrament.

The church does not track its membership, but the União do Vegetal, a similar faith, has approximately 19,000 members worldwide.

These religious organizations are among many groups across the Americas that harvest indigenous traditions around natural psychedelics. They believe psychoactive plants like ayahuasca, peyote or psilocybin open people’s minds to metaphysical realms and deeply meaningful experiences.

This spiritual knowledge is now being translated into the language of science, as researchers in Brazil, the United States, Canada and beyond begin rigorous medical evaluations of these substances.

The healing power of the psychedelic experience

Leon’s blog provides an excellent description of his ayahuasca experience.

At times, he conjured visions – dream-like scenarios that offered rare insight into the relationships in his life. At other times, Leon experienced “a feeling of ecstasy and a deep sensation of a manifesting inner spirituality.”

We believe that these effects are critical to why ayahuasca works.

Participants in our study responded to the Hallucinogen Rating Scale, which helps translate these ineffable experiences into numbers. Participants who took ayahuasca scored significantly higher on that questionnaire than those who drank a placebo.

Those who described the most abundant visual, auditory and physical effects during their ayahuasca trip had the most prominent depression reduction benefits seven days later.

Ayahuasca is not a panacea. Such experiences may prove too physically and emotionally challenging for some people to use it regularly as treatment. We have also observed regular ayahuasca users who still suffer from depression.

But, as our study demonstrates, this Amazonian sacred plant has the potential to be used safely and effectively to treat even the hardest to treat depression.

Luís Fernando Tófoli, Professor of Psychiatry, Universidade Estadual de Campinas; Dráulio Barros de Araújo, Professor, Brain Institute, Federal University of Rio Grande do Norte (Brazil), and Fernanda Palhano-Fontes, , Federal University of Rio Grande do Norte (Brazil)

This article was originally published on The Conversation. Read the original article.

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Activists in Hundreds of Cities Across the Globe Stage Actions Calling for Drug Policy Reform

Thu, 06/28/2018 - 11:34
It's a counter to the UN's Global Day Against Drug Abuse and Illicit Trafficking.

Tuesday, activists in NYC joined with thousands of people in over 200 cities around the world as part of the “Support. Don’t Punish” Global Day of Action to demand an end to drug policies that disregard the value of human life and reduce drug use to a one-dimensional law enforcement issue. The rally in NYC, held outside of the United Nations Headquarters, and the events around the world coincide with the United Nations’ International Day against Drug Abuse and Illicit Trafficking – a day when governments typically celebrate their record of drug arrests and seizures. In the past, some governments have even commemorated this day by holding public executions or beatings of drug offenders. Today’s “Support. Don’t Punish” events offer a platform for participants to reject the recent global drug policy trends that threaten international norms and human lives at home and abroad, as well as personal freedoms.

During the last year, the landscape of drug use and its related harms in the United States has only grown more severe. Fatal opioid-related overdoses have swelled, reaching unprecedented levels in 2016. Meanwhile, federal responses to this public health crisis have been lacking and ineffective, and the American public has paid for this with their lives. Treatment access for addiction is as elusive as ever, as it remains side-lined to the preferred response to drug use: court proceedings and incarceration.  By contrast, in New York City, community organizations and local government have worked to facilitate some harm reduction measures to combat drug misuse and harm. In addition to operationalizing sterile syringe access programs, the city also has issued a standing order to promote the use of the life-saving overdose reversal drug “naloxone”. But to meaningfully promote public safety and reduce harm, such reforms are insufficient. The United States must enact comprehensive drug policy reform that will center on the dignity of human beings and evidence-based research on drug use.

In addition to failing to implement any meaningful responses to drug use domestically, the United States has spent the year condoning the reprehensible drug policies that other nations have enacted. These countries have spent the last year trying to legitimize the practice of denying persons who use drugs access to treatment they may need, due process, dignity, and medicine. Although these policies have not eliminated the international problems of addiction, fatal overdose, drug trafficking or HIV infection prevalence, this has not immunized them from consideration by the US executive branch.

The President of the United States has proposed using the death penalty to respond to drug-related crimes, a statement legitimized by Attorney General Jeff Sessions’ subsequent memo encouraging federal prosecutors to use the death penalty to respond to certain drug crimes. But these crimes are better seen through the lens of public health, as it is illegal under international law to execute people for drug-related crimes. Similarly, “tough on drugs” approaches often result in policies that destroy families, as can be seen in the recent separation of families at the Southern US border. This family separation policy is significantly based on the need to prevent drugs from “spilling” into the United States. Such policies do nothing to curb drug trafficking.  Moreover, the ripple effects of policies like these destroy families at their core and fly in the face of everything that we know about the relevance of family connections that are crucial to the health and well-being of our society.

Advocates hope to sustain the momentum created by the “Support. Don’t Punish” campaign to increase pressure on United Nations member states to reform international drug policies at the 2019 Ministerial Segment during the 62nd Session of the Commission on Narcotic Drugs in Vienna.  The Ministerial Segment is important because in 2009, member states agreed to set 2019 as a target date for eliminating or significantly reducing the scale of the illicit drug market. Since there is no way that this goal will be met within the next six months, the Ministerial Segment will be a critical opportunity for member states to rethink their international drug control goals and create principles that will guide global drug control for the forthcoming decade.

The International Drug Policy Consortium (IDPC), a coalition of over 150 international organizations calling for drug policy reform, has developed concrete “asks” that aim to focus member states on creating principles that will be rooted in creating an effective and sustainable shift in international drug control policy. Specifically, IDPC has recommended that member states move away from the ‘drug free world’ targets; meaningfully reflect the impacts of drug policies on the UN goals of promoting health human rights, development, peace and security; reflect the realities of drug policies on the ground, both positive and negative; and end punitive approaches and put people and communities first. These key principles will offer member states an opportunity to consider a drug policy regime that is based on achievable and meaningful goals.

This year, events are being planned in cities in dozens of countries across six continents. The action in New York City will unite New Yorkers with those fighting for drug policy reform across the world, in a show of solidarity and to demonstrate the breadth and power of this movement. The “Support Don’t Punish” event in New York City is one of many opportunities for people in the United States to take action and demand better international drug policies. The event serves to memorialize a shifting public voice on how drug use should be dealt with.

As the UN Secretary-General António Guterres remarked to the 27th session of the Commission on Crime Prevention and Criminal Justice in May: “While each country must decide its own drug policy, I believe there is consensus around the need for a people-centered approach, based on results rather than dogma or prejudice.”

This article was produced by Drug Reporter, a project of the Independent Media Institute.

 

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One of the Reddest States in America Just Passed a Progressive Medical Marijuana Initiative

Wed, 06/27/2018 - 10:16
Voters defied conservative political and religious leaders by approving a law with no restrictive qualifying conditions.

One of the reddest of red states went green on Tuesday. Voters in Oklahoma approved a remarkably progressive medical marijuana initiative by a healthy margin of 56 percent to 43 percent.

The initiative, State Question 778, allows registered patients to possess up to three ounces of marijuana anywhere and up to eight ounces at home. Patients also have the right to grow up to six mature and six immature plants or have designated caregivers do it for them.

It also creates a system of licensed dispensaries, cultivation, and processing facilities and sets taxes at a relatively low 7 percent. The initiative also bars localities from using zoning laws to block dispensaries (although they wouldn’t be allowed within 1,000 feet of a school).

But what is most striking about Question 778 is that it does not restrict access to medical marijuana to a list of qualifying conditions. In fact, the initiative language explicitly states that "[T]here are no qualifying conditions" and that the only limitation on a doctor's recommending medical marijuana is that it must be done "according to the accepted standards a reasonable and prudent physician would follow when recommending or approving any medication."

That is the most wide-open language for a medical marijuana since California's groundbreaking Proposition 215 back in 1996. Prop 215 included a list of qualifying conditions, but also allowed recommendations for "any other chronic or persistent medical symptom…that may cause serious harm to the patient's health."

That Prop 215 language allowed medical marijuana to flourish in California and establish itself as something very near to actual legalization. Basically, anybody in the state who had the money to pay for a doctor's visit could get a medical marijuana card—and they did.

Oklahoma isn't likely to play out like California, but Oklahomans for Health, the folks behind the initiative ought to be feeling pretty good right about now. They have successfully passed a very enlightened medical marijuana law in the face of opposition from the state's Republican and religious establishment.

Conservative religious figures calling themselves Oklahoma for Faith teamed up with the likes of U.S. Sen. James Lankford in a last-ditch effort to derail the initiative.Lankford issued a press release early this month warning that the initiative would be “harmful to the social fabric of Oklahoma.”

But the voters of Oklahoma weren't buying what he was selling.

This article was produced by Drug Reporter, a project of the Independent Media Institute.

 

 

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Schumer Unveils Marijuana Decriminalization Bill That Would Establish Funding Stream for Women and Minority-Led Pot Businesses

Wed, 06/27/2018 - 07:45
Click here for reuse options! High there, millennial voters.

Senate Minority Leader Chuck Schumer (D-NY) on Wednesday unveiled a federal marijuana decriminalization bill that would respect states’ rights to regulate and sell cannabis and establish a dedicated funding stream for businesses run by women and minorities.

According to an outline of Schumer’s proposal, his bill “would maintain federal law enforcement’s authority to prevent marijuana trafficking” between states while also “[respecting] states’ rights” to legalize pot. 

The bill would also “establish dedicated funding streams to be administered by the Small Business Administration” for enterprising women and people of color, authorize $250 million to highway safety research and invest $500 million for the Secretary of Heath and Human Services to assess legalized marijuana’s impact on public health. 

In addition, Schumer’s bill would regulate marijuana advertising in a manner similar to tobacco and “grant programs to encourage state and local governments to administer, adopt, or enhance engagement of scaling programs for marijuana possession convictions.”

Read the full outline below:

.@SenSchumer’s federal marijuana legalization bill is out. Won’t hurt in driving young voters to the polls in Nov. pic.twitter.com/CoD520tMTz

— Todd Zwillich (@toddzwillich) June 27, 2018 Click here for reuse options!
Categories: News Feeds

Watch: Colbert Offers Hilarious Warning After Canada Votes to Legalize Marijuana

Tue, 06/26/2018 - 11:11
It's not too late to hesitate.

Canada officially legalizes weed on October 17, and that's just too darned much for Stephen Colbert.

With a clip that wouldn't have been out of place in his erstwhile incarnation as a deranged right-wing talk show host on the Colbert Report, the Late Show host takes aim at the marijuana menace looming on our northern border.

Replete with ominous Dragnet-style theme music, Colbert's "Reefer Madness Reaches Canada" hopes to scare some sense into innocent Americans enticed by those cosmopolitan Canadians and their wacky weed.

"It may seem tempting to go get high and far out with your moose mates," the narrator warns, but things can get out of hand: "Today, you're taking a toke; tomorrow, you're toting a tuque; the next thing you know, you're mainlining poutine."

And it only goes downhill from there.

Remember: Weed is legal in Canada as of October 17! Don't say we didn't warn you.

This article was produced by Drug Reporter, a project of the Independent Media Institute.

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FDA Repays Big Pharma By Rushing Risky Drugs to Market

Tue, 06/26/2018 - 05:18
As pharma companies underwrite three-fourths of the FDA’s budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health <p>Nuplazid, a drug for hallucinations and delusions associated with Parkinson&rsquo;s disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment.</p><p>Patients on Uloric, a gout drug, suffered more heart attacks, strokes and heart failure in two out of three trials than did their counterparts on standard or no medication.</p><p>Nevertheless, the U.S. Food and Drug Administration approved both of these drugs &mdash; with a deadly aftermath. Uloric&rsquo;s manufacturer reported last November that patients on the drug were 34 percent more likely to die from heart disease than people taking an alternative gout medication. And since the FDA fast-tracked approval of Nuplazid and it went on the market in 2016 at a price of $24,000 a year, there have been 6,800 reports of adverse events for patients on the drug, including 887 deaths as of this past March 31.</p><p>The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease. Once widely assailed for moving slowly, today the FDA reviews and approves drugs faster than any other regulatory agency in the world. Between 2011 and 2015, the FDA reviewed new drug applications more than 60 days <a href="https://www.nejm.org/doi/pdf/10.1056/NEJMc1700103">faster</a> on average than did the European Medicines Agency.</p><p>Europe has also rejected drugs for which the FDA accelerated approval, such as Folotyn, which treats a rare form of blood cancer. European authorities cited &ldquo;insufficient&rdquo; evidence of health gains from Folotyn, which shrinks some tumors but hasn&rsquo;t been shown to extend lives. It costs more than $92,000 for a seven-week course of treatment, according to research firm SSR Health.</p><p>As patients (or their insurers) shell out tens or hundreds of thousands of dollars for unproven drugs, manufacturers reap a windfall. For them, expedited approval can mean not only sped-up sales but also &mdash; if the drug is intended to treat a rare disease or serve a neglected population &mdash; FDA incentives worth hundreds of millions of dollars.</p><p>&ldquo;Instead of a regulator and a regulated industry, we now have a partnership,&rdquo; said Dr. Michael Carome, director of the health research group for the nonprofit advocacy organization Public Citizen, and a former U.S. Department of Health and Human Services official. &ldquo;That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.&rdquo;</p><p>While the FDA over the past three decades has implemented at least four major routes to faster approvals &mdash; the current commissioner, Dr. Scott Gottlieb, is easing even more drugs&rsquo; path to market. The FDA okayed 46 &ldquo;novel&rdquo; drugs &mdash; whose chemical structure hadn&rsquo;t been previously approved &mdash; in 2017, the most in at least 15 years. At the same time, it&rsquo;s rejecting fewer medications. In 2017, the FDA&rsquo;s Center for Drug Evaluation and Research denied 19.7 percent of all applications for new drugs, biologics, and efficacy supplements, down from a 2010 peak of 59.2 percent, according to agency data.</p><p>President Trump has encouraged Gottlieb to give patients faster access to drugs. &ldquo;You&rsquo;re bringing that down, right?&rdquo; Trump asked the commissioner at a May 30 event, referring to the time it takes to bring drugs to market. &ldquo;You have a lot of good things in the wings that, frankly, if you moved them up, a lot of people would have a great shot.&rdquo;</p><p>Faster reviews mean that the FDA often approves drugs despite limited information. It channels more and more experimental treatments, including Nuplazid, into expedited reviews that require only one clinical trial to show a benefit to patients, instead of the traditional two.</p><p>The FDA also increasingly allows drugmakers to claim success in trials based on proxy measurements &mdash; such as shrunken tumors &mdash; instead of clinical outcomes like survival rates or cures, which take more time to evaluate. In return for accelerated approval, drug companies commit to researching how well their drugs work after going on the market. But these post-marketing studies can take 10 years or longer to complete, leaving patients and doctors with lingering questions about safety and benefit.</p><p>&ldquo;Clearly, accelerated approval has greater uncertainty,&rdquo; Dr. Janet Woodcock, head of the FDA&rsquo;s Center for Drug Evaluation and Research, said in an interview. When only a single trial is used for approval, &ldquo;in some cases, there may be more uncertainty about safety findings or with the magnitude of effectiveness.&rdquo;</p><p>She attributed the increased use of expedited pathways to more drugmakers developing treatments for rare diseases, &ldquo;where there&rsquo;s unmet need, and where the patient population and providers are eager to accept more uncertainty.&rdquo;</p><p>The FDA&rsquo;s growing emphasis on speed has come at the urging of both patient advocacy groups and industry, which began in 1992 to contribute to the salaries of the agency&rsquo;s drug reviewers in exchange for time limits on reviews. In 2017, pharma paid 75 percent &mdash; or $905 million &mdash; of the agency&rsquo;s scientific review budgets for branded and generic drugs, compared to 27 percent in 1993.</p><p>&ldquo;The virginity was lost in &rsquo;92,&rdquo; said Dr. Jerry Avorn, a professor at Harvard Medical School. &ldquo;Once you have that paying relationship, it creates a dynamic that&rsquo;s not a healthy one.&rdquo;</p><p>Industry also sways the FDA through a less direct financial route. Many of the physicians, caregivers, and other witnesses before FDA advisory panels that evaluate drugs receive consulting fees, expense payments, or other remuneration from pharma companies.</p><p>&ldquo;You know who never shows up at the [advisory committee]? The people who died in the trial,&rdquo; lamented one former FDA staffer, who asked not to be named because he still works in the field. &ldquo;Nobody is talking for them.&rdquo;</p><p>The drug industry&rsquo;s lobbying group, Pharmaceutical Research and Manufacturers of America, continues to push for ever-faster approvals. In a policy memo on its website, PhRMA warns of &ldquo;needless delays in drug review and approval that lead to longer development times, missed opportunities, higher drug development costs and delays in treatments reaching patients.&rdquo;</p><p>The agency has internalized decades of criticism that painted it as an obstacle to innovation, said Daniel Carpenter, a professor of government at Harvard and author of a 2010 book on pharmaceutical regulation at the FDA. &ldquo;They now have a built-in fear of over-regulation that&rsquo;s set in over the last 20 years.&rdquo;</p><p>To be sure, nobody wants the FDA to drag out drug reviews unnecessarily, and even critics acknowledge that there&rsquo;s no easy way for the agency to strike the perfect balance between sufficient speed and ample information, particularly when patients have no other treatments available, or are terminally ill.</p><p>&ldquo;I think it&rsquo;s reasonable to move drugs faster particularly in the case where you&rsquo;re dealing with an extremely promising new product which treats a serious or life-threatening disease,&rdquo; said Dr. Aaron Kesselheim, an associate professor at Harvard Medical School. &ldquo;The key, though, when you do that is that you&rsquo;ve got to make sure you closely follow the drug in a thoughtful way and unfortunately, too often we don&rsquo;t do that in the U.S.&rdquo;</p><p>Gregg Gonsalves used to be a member of ACT UP, the HIV advocacy group that tried to take over the FDA&rsquo;s headquarters in Rockville, Maryland, in 1988, accusing the agency of holding back cures. While he didn&rsquo;t storm the FDA building, Gonsalves participated in other protests that led the FDA to accelerate approvals. Now an assistant professor of epidemiology at Yale School of Public Health, he said he fears HIV activists &ldquo;opened a Pandora&rsquo;s box&rdquo; that the industry and anti-regulation think tanks pounced on.</p><p>&ldquo;We were desperate. We naively had the idea that there were hundreds of drugs behind a velvet curtain at the FDA being held back from us,&rdquo; he said. &ldquo;Thirty years of our rash thinking has led us to a place where we know less and less about the drugs that we pay more and more for.&rdquo;</p><p>After thalidomide, taken by pregnant women to prevent nausea, caused thousands of babies in the early 1960s to be born with stunted limbs, Congress entrusted the FDA with ensuring that drugs going on the market were both safe and effective, based on &ldquo;substantial evidence&rdquo; from multiple trials.</p><p>Assembling this evidence has traditionally required three stages of clinical trials; the first in a small cohort of healthy volunteers to determine a safe dosage; the second to assess the drug&rsquo;s efficacy and side effects; and then, if results are positive, two larger trials to confirm the benefit and monitor for safety issues. An FDA team of in-house reviewers is then assigned to analyze the results and decide whether the agency should approve the drug. If reviewers want more input, the agency can convene an advisory committee of outside experts.</p><p>As the FDA&rsquo;s responsibilities expanded in the 1970s, review times began to lag, reaching more than 35 months on average in 1979. The AIDS crisis followed soon thereafter, prompting complaints from Gonsalves and other activists. Their protests spurred the Prescription Drug User Fee Act in 1992, which established industry fees to fund FDA staff salaries. In return, the FDA promised to review drugs within 12 months for normal applications, and 6 months for priority cases.</p><p>The more that the FDA relied on industry fees to pay for drug reviews, the more it showed an inclination towards approval, former employees say.</p><p>&ldquo;You don&rsquo;t survive as a senior official at the FDA unless you&rsquo;re pro-industry,&rdquo; said Dr. Thomas Marciniak. A former FDA medical team leader, and a longtime outspoken critic of how drug companies handle clinical trials, Marciniak retired in 2014. &ldquo;The FDA has to pay attention to what Congress tells them to do, and the industry will lobby to get somebody else in there if they don&rsquo;t like you.&rdquo;</p><p>Staffers know &ldquo;you don&rsquo;t get promoted unless you&rsquo;re pro-industry,&rdquo; he added.</p><p>This tilt is reflected in what senior officials choose to highlight. The agency&rsquo;s Center for Drug Evaluation and Research gives internal awards to review teams each year, according to Marciniak and the former FDA employee who requested anonymity. Both said they had never seen an award granted to a team that rejected a drug application. The FDA did not respond to ProPublica&rsquo;s request for a list of award winners.</p><p>Higher-ups would also send congratulatory emails to medical review teams when a drug was approved. &ldquo;Nobody gets congratulated for turning a drug down, but you get seriously questioned,&rdquo; said the former staffer, adding that the agency&rsquo;s attitude is, &ldquo;Keep Congress off your back and make your life easier.&rdquo;</p><p>Dr. Peter Lurie, a former associate commissioner who left the FDA in 2017, recalled that John Jenkins, director of the agency&rsquo;s Office of New Drugs from 2002 to 2017, gave an annual speech to employees, summing up the year&rsquo;s accomplishments. Jenkins would talk &ldquo;about how many approvals were done and how fast they were, but there was nothing in there saying, we kept five bad drugs off the market,&rdquo; said Lurie, now president of the nonprofit Center for Science in the Public Interest in Washington, D.C. Jenkins declined to comment.</p><p>&ldquo;I personally have no interest in pressuring people to approve things that shouldn&rsquo;t be approved &mdash; the actual person who would be accountable would be me,&rdquo; Woodcock said. She added that the FDA&rsquo;s &ldquo;accountability to the public far outweighs pressure we might feel otherwise.&rdquo;</p><p>Congress has authorized one initiative after another to expedite drug approvals. In 1988, it created &ldquo;fast track&rdquo; regulations. In 1992, the user fee law formalized &ldquo;accelerated approval&rdquo; and &ldquo;priority review.&rdquo; When the law was reauthorized in 1997, the goal for review times was lowered from a year to 10 months. In 2012, Congress added the designation, &ldquo;breakthrough therapy,&rdquo; enabling the FDA to waive normal procedures for drugs that showed substantial improvement over available treatments.</p><p>&ldquo;Those multiple pathways were initially designed to be the exception to the rule, and now the exceptions are swallowing the rule,&rdquo; Kesselheim said.</p><p>Sixty-eight percent of novel drugs approved by the FDA between 2014 and 2016 qualified for one or more of these accelerated pathways, Kesselheim and his colleagues have found. Once described by Rachel Sherman, now FDA principal deputy commissioner, as a program for &ldquo;knock your socks off, home run&rdquo; treatments, the &ldquo;breakthrough therapy&rdquo; label was doled out to 28 percent of drugs approved from 2014 to 2016.</p><p>Nuplazid was one of them. It was created in 2001 by a chemist at Acadia Pharmaceuticals, a small biotech firm in San Diego. Eight years later, in the first of two Phase 3 trials, it failed to prove its benefit over a placebo.</p><p>The company, which had no approved drugs and hence no revenue stream, halted the second trial, but wasn&rsquo;t ready to give up. Acadia executives told investors that the trials failed because the placebo patients had a larger-than-expected improvement. They asked the FDA for permission to revise the scale used to measure benefit, arguing that the original scale, which was traditionally used for schizophrenia assessments, wasn&rsquo;t appropriate for patients with Parkinson&rsquo;s-related psychosis. The agency agreed to this new scale, which had never been used in a study for drug approval.</p><p>Since there were no treatments approved for Parkinson&rsquo;s-related psychosis, the FDA also granted Acadia&rsquo;s request for the breakthrough therapy designation, and agreed that Nuplazid needed only one positive Phase 3 trial, instead of two, for approval.</p><p>In 2012, Acadia finally got the positive trial results it had hoped for. In a study of 199 patients, Nuplazid showed a small but statistically significant advantage over a placebo.</p><p>FDA medical reviewer Dr. Paul Andreason was skeptical. Analyzing all of Nuplazid&rsquo;s trial results, he found that you would need to treat 91 patients for seven to receive the full benefit. Five of the 91 would suffer &ldquo;serious adverse events,&rdquo; including one death. He recommended against approval, citing &ldquo;an unacceptably increased, drug-related, safety risk of mortality and serious morbidity.&rdquo;</p><p>The FDA convened an advisory committee to help it decide. Fifteen members of the public testified at its hearing. Three were physicians who were paid consultants for Acadia. Four worked with Parkinson&rsquo;s advocacy organizations funded by Acadia. The company paid for the travel of three other witnesses who were relatives of Parkinson&rsquo;s patients, and made videos shown to the committee of two other caregivers. Two speakers, the daughter and grand-daughter of a woman who suffered from Parkinson&rsquo;s, said they had no financial relationship with Acadia. However, the granddaughter is now a paid &ldquo;brand ambassador&rdquo; for Nuplazid. All begged the FDA to approve Nuplazid.</p><p>&ldquo;Acadia or its consultants interacted with some of the potential speakers to facilitate logistics and reimburse for travel, as is common practice,&rdquo; Acadia spokeswoman Elena Ridloff said in an email. &ldquo;&hellip;All speakers presented their own experience in their own words.&rdquo;</p><p>The only speaker who urged the FDA to reject the drug was a scientist at the National Center for Health Research who has never had any financial relationship with Acadia.</p><p>The witnesses&rsquo; pleas affected the panel members, who voted 12-2 to recommend accelerated approval. &ldquo;If there were a safe and effective alternative on the market, I would not have voted yes,&rdquo; said Almut Winterstein, a professor of pharmaceutical outcomes and policy at the University of Florida. &ldquo;But I think that, in particular, the public hearing today was very compelling. There clearly is a need.&rdquo;</p><p>Dr. Mitchell Mathis, director of the FDA&rsquo;s division of psychiatry products, sided with the advisory panel, overruling Andreason. &ldquo;Even this small mean improvement in a disabling condition without an approved treatment is meaningful,&rdquo; Mathis wrote, adding that its safety profile was no worse than other antipsychotics on the market. Like other antipsychotics, Nuplazid carries a warning on the label of increased deaths in elderly patients with dementia-related psychosis. Since Nuplazid&rsquo;s approval in 2016, Acadia has raised its price twice, and it now costs more than $33,000 a year.</p><p>As Nuplazid began to reach patients, reports of adverse events poured in. While it&rsquo;s impossible to ascertain whether the treatment was responsible for them, the sheer numbers, including the 887 deaths, are &ldquo;mind boggling,&rdquo; said Diana Zuckerman, president of the National Center for Health Research.</p><p>In more than 400 instances, Nuplazid was associated with worsening hallucinations &mdash; one of the very symptoms it was supposed to treat.</p><p>That&rsquo;s what happened to Terrence Miller, a former Hewlett Packard and Sun Microsystems employee who was diagnosed with Parkinson&rsquo;s in the early 1990s. About five years ago, Miller began to experience mild hallucinations, such as seeing cats and dogs in his home in Menlo Park, California. At the time, he realized that the animals weren&rsquo;t real, and the visions didn&rsquo;t bother him, so he didn&rsquo;t take any medication for them. But two years later, after surgery for a hip injury, the hallucinations worsened.</p><p>&ldquo;He was convinced that he hadn&rsquo;t had the surgery yet and people were going to harvest his organs,&rdquo; recalled his wife, Denise Sullivan. &ldquo;He&rsquo;d see spaceships outside the window and they had to call security to help restrain him.&rdquo;</p><p>In 2016, Dr. Salima Brillman prescribed Nuplazid. Miller tried Nuplazid twice, for a few months each time. His hallucinations became darker. &ldquo;I&rsquo;d say, &lsquo;Who are you talking to?&rsquo; and he said, &lsquo;They&rsquo;re telling me to do bad stuff,&rsquo;&rdquo; Sullivan said. Afraid &ldquo;he might hurt me because of what his evil &lsquo;friends&rsquo; were telling him,&rdquo; Sullivan, who was paying more than $1,000 a month for the drug out of her own pocket, then stopped the treatment.</p><p>What Sullivan and Miller didn&rsquo;t know is that Brillman earned $14,497 in consulting fees from Acadia in 2016, ranking as the company&rsquo;s seventh highest paid doctor, government records show. The top five prescribers of Nuplazid in Medicare, the government&rsquo;s health program for the elderly, all received payments from Acadia. Dr. David Kreitzman of Commack, New York, prescribed the most: $123,294 worth of Nuplazid for 18 patients in 2016, according to data company CareSet. He was paid $14,203 in consulting fees.</p><p>Brillman and Kreitzman didn&rsquo;t respond to multiple requests for comment.</p><p>Miller&rsquo;s new doctor switched him onto Seroquel, an old drug long used off-label for Parkinson&rsquo;s-related psychosis. With it, he&rsquo;s sleeping better and the hallucinations, while remaining, have become more benign again, Sullivan said. Patients like Miller, whose hallucinations worsen, may not have been on Nuplazid for long enough, said Ridloff, the Acadia spokeswoman.</p><p>The 887 reported deaths of Nuplazid patients may be an undercount. A nurse in Kansas, who specializes in dementia care, said a resident in one of the facilities she worked at had no history of cardiac issues, yet died from congestive heart failure within a month of starting on Nuplazid. The nurse requested anonymity because she continues to work in nursing care facilities.</p><p>&ldquo;We questioned the ordering physician whether this should be reported to the FDA in relation to Nuplazid and he said, &lsquo;Oh no, the drug rep said this couldn&rsquo;t have happened because of Nuplazid,&rsquo; and it was never reported,&rdquo; she said.</p><p>Acadia&rsquo;s Ridloff said such behavior by a sales representative would be &ldquo;absolutely not consistent with our protocols, policies and procedures.&rdquo;</p><p>She said that deaths are to be expected among patients who are elderly and in an advanced stage of Parkinson&rsquo;s, and that Nuplazid does not increase the risk of mortality.</p><p>&ldquo;Acadia&rsquo;s top priority has been, and continues to be, patient safety,&rdquo; she said. &ldquo;We carefully monitor and analyze safety reports from clinical studies and post-marketing reporting to ensure the ongoing safety of Nuplazid. Based on the totality of available information, Acadia is confident in Nuplazid&rsquo;s efficacy and safety profile.&rdquo;</p><p>After a <a href="https://www.cnn.com/2018/04/09/health/parkinsons-drug-nuplazid-invs/inde... report</a> in April about adverse events related to Nuplazid prompted lawmakers to question the FDA, Gottlieb said he would &ldquo;take another look at the drug.&rdquo; Agency spokeswoman Sandy Walsh confirmed that that an evaluation is ongoing, and the FDA &ldquo;may issue additional communications as appropriate.&rdquo;</p><p>Nuplazid isn&rsquo;t the only drug approved by an FDA senior official against the advice of lower-level staffers. In 2016, internal reviewers and an advisory committee called for rejecting a drug for a rare muscular disease called Duchenne muscular dystrophy. Only 12 patients participated in the single trial that compared the drug, Exondys 51, with a placebo. Trial results showed that Exondys 51 produced a small amount of dystrophin, a protein Duchenne patients lack. But the company didn&rsquo;t show that the protein increase translated into clinical benefits, like helping patients walk.</p><p>Woodcock approved the drug. Internal FDA documents later revealed that she was concerned about the solvency of the drugmaker, Sarepta Therapeutics in Cambridge, Massachusetts. A memo by the FDA&rsquo;s acting chief scientist recounted Woodcock saying that Sarepta &ldquo;needed to be capitalized&rdquo; and might go under if Exondys 51 were rejected. Exondys 51 went on the market with a price tag of $300,000 a year.</p><p>&ldquo;We don&rsquo;t look at a company and say they&rsquo;ll have a lower standard because they&rsquo;re poor, but we&rsquo;re trying to recognize that, small or large, companies will never work on developing a drug if they won&rsquo;t make a profit,&rdquo; said Woodcock. &ldquo;Our job is to work with the field, and with the firms to try and find a path forward,&rdquo; especially on rare diseases where a large trial is impractical, she said.</p><p>Last month, the European Medicines Agency&rsquo;s advisory committee recommended rejection of Exondys 51&rsquo;s application, saying &ldquo;further data were needed to show &hellip; lasting benefits relevant to the patient.&rdquo;</p><p>Sarepta is asking the committee to reconsider, the company said in a June press release.</p><p>The debate over Exondys 51 centered on the value of a so-called surrogate endpoint, a biological or chemical measure that serves as a proxy for whether the drug actually treats or cures the disease. Surrogate measures speed drug development because they&rsquo;re easier and quicker to measure than patient outcomes.</p><p>Some surrogate measures are well-established. Lowering cholesterol has been proven repeatedly to help reduce heart attacks and strokes. But others aren&rsquo;t, like how much dystrophin needs to be produced to help Duchenne patients, raising concerns that drugs may be approved despite uncertain benefits.</p><p>The jury is still out on two other drugs, Folotyn and Sirturo, which received expedited approval based on surrogate measurements. There&rsquo;s no proof that Folotyn helps patients with a rare cancer &mdash; peripheral T-cell lymphoma &mdash; live longer, while Sirturo, an antibiotic for multi-drug-resistant tuberculosis, has potentially fatal side-effects. Yet since both drugs were aimed at small or under-served populations, the FDA rewarded their manufacturers with valuable perquisites.</p><p>In a clinical trial, Folotyn reduced tumors in 29 of 107 patients, but the shrinkage lasted longer than 14 weeks in only 13 people. Since everyone in the study got Folotyn, it wasn&rsquo;t apparent whether the drug would help patients do better than a placebo or another drug. Meanwhile, 44 percent of participants in the trial suffered serious side effects, including sores in mucous membranes, including in the mouth, lips and digestive tract, and low levels of blood cells that help with clotting. One patient died after being hospitalized with sores and low white blood-cell counts.</p><p>While tumor shrinkage is a commonly used surrogate measurement in cancer trials, it often has a <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/232341... correlation</a> with longer life expectancy, according to a 2015 study. &ldquo;I would say to a patient, this drug may be more likely to shrink a tumor either partially or even completely, but that may in fact be a pyrrhic victory if it doesn&rsquo;t help you live better or longer,&rdquo; said Mikkael Sekeres, director of the leukemia program at the Cleveland Clinic Cancer Center, who voted against approving Folotyn at the FDA&rsquo;s advisory panel discussion in 2009. He was out-voted 10 to four. Three years later, the European Medicines Agency rejected the drug.</p><p>Because peripheral T-cell lymphoma only affects about 9,000 Americans each year, the FDA designated Folotyn as an &ldquo;orphan&rdquo; drug, giving its manufacturer, Allos Therapeutics, tax incentives and at least two extra years of patent exclusivity. Nevada-based Spectrum Pharmaceuticals acquired Allos in 2012. At more than $92,000 per course of treatment, Folotyn is Spectrum&rsquo;s top-selling product, earning $43 million in 2017.</p><p>Dr. Eric Jacobsen, clinical director of the adult lymphoma program at Dana-Farber Cancer Institute in Boston, has become disillusioned with Folotyn since he helped Allos run the original trial. &ldquo;Enthusiasm for the drug has waned,&rdquo; he said. &ldquo;It&rsquo;s been on the market for a long time, and there&rsquo;s no additional data suggesting benefit.&rdquo; He now prescribes other options first, particularly because of the mouth sores Folotyn can cause, which make it painful to eat or drink.</p><p>The FDA approved Sirturo in 2012 without requiring Johnson &amp; Johnson, the manufacturer, to demonstrate that patients on the drug were cured of tuberculosis. Instead, Johnson &amp; Johnson only had to show that the treatment, when added to a traditional drug regimen, killed bacteria in the sputum faster than did the regimen alone. Sirturo was successful by that measure, but 10 patients who took it died, five times as many as the two in the group on placebo.</p><p>Dean Follmann, a biostatistics expert at the National Institutes of Health, voted as an FDA advisory committee member to approve Sirturo but wrestled with how to read the sputum data in light of the higher death rate: &ldquo;The drug could be so toxic that it kills bacteria faster, but it also kills people faster.&rdquo;</p><p>The imbalance in deaths during the trial &ldquo;was a safety signal&rdquo; that led the FDA to require &ldquo;its most serious warning in product labeling,&rdquo; known as a boxed warning, said agency spokeswoman Walsh. The packaging, she added, specified that Sirturo &ldquo;should only be used for patients for whom an effective TB regimen cannot otherwise be provided. Thus, current labeling provides for a safe and effective use.&rdquo;</p><p>Under a 2007 provision in the user-fee law, aimed at spurring treatments for developing nations, Sirturo&rsquo;s approval qualified Johnson &amp; Johnson for a voucher given to manufacturers who successfully get a tropical disease drug to market. The voucher can be used in the future, for any drug, to claim priority review - within six months instead of the usual 10. Time is money in the drug industry, and beating your competitor to market can be worth hundreds of millions of dollars. Vouchers may also be sold to other drugmakers, and have garnered up to $350 million. Sarepta received a voucher under a similar program for pediatric rare diseases when the FDA approved Exondys 51.</p><p>In South Africa, where Sirturo is mainly used, the drug is seen as a helpful option for highly drug-resistant patients. A study at one South African hospital by Dr. Keertan Dheda found that 45 out of 68 patients who took Sirturo were cured, as against 27 out of 204 before the drug was available. That doesn&rsquo;t rule out the possibility that Sirturo may be killing a small subset of patients, said Dheda, but the risk is &ldquo;very minor compared to the disease itself.&rdquo;</p><p>Adrian Thomas, Johnson &amp; Johnson&rsquo;s vice president of global public health, said in an interview that observational results since the drug went on the market make him &ldquo;much more confident that there is no more unexplained imbalance in mortality&rdquo; and that the &ldquo;benefit/risk in drug-resistant tuberculosis is incredibly reasonable when you don&rsquo;t have other treatment choices.&rdquo;</p><p>Still, the World Health Organization said in a 2016 report that the &ldquo;quality of evidence remains very low&rdquo; regarding Sirturo. &ldquo;There is still some residual uncertainty for mortality,&rdquo; the group said, and &ldquo;specific harms&rdquo; to the respiratory system &ldquo;continue to be observed.&rdquo;</p><p>While the FDA expedites drug approvals, it&rsquo;s content to wait a decade or more for the post-marketing studies that manufacturers agree to do. Definitive answers about Sirturo are likely to be lacking until 2022, when Johnson &amp; Johnson is expected to finish its study, a full decade after the drug was approved. Studies of Nuplazid and Folotyn aren&rsquo;t expected until 2021. Spectrum has missed two FDA deadlines for post-marketing studies on Folotyn. Spectrum spokeswoman Ashley Winters declined comment.</p><p>Post-marketing studies often take far longer to complete than pre-approval trials, in part because it&rsquo;s harder to recruit patients to risk being given a placebo when the drug is readily available on the market. Plus, since the drug is already on the market, the manufacturer no longer has a financial incentive to study its impact&mdash; and stands to lose money if the results are negative. Of post-marketing studies agreed to by manufacturers in 2009 and 2010, 20 percent <a href="https://www.nejm.org/doi/full/10.1056/NEJMp1705800">had not started</a> five years later, and another 25 percent were still ongoing.</p><p>And, despite taking so long, most post-marketing studies of drugs approved on the basis of surrogate measures <a href="https://www.bmj.com/content/357/bmj.j1680">rely</a> on proxy criteria again rather than examining clinical effects on patients&rsquo; health or lifespans. In fact, Folotyn&rsquo;s post-marketing trials will measure what&rsquo;s known as &ldquo;progression-free survival,&rdquo; or the time it takes before tumors start growing again, but not whether patients live longer.</p><p>Proving that a drug extends survival is especially hard in cancer trials because patients don&rsquo;t want to stay in a trial if their disease gets worse, or may want to add another experimental treatment. &ldquo;In cancer, we&rsquo;re probably not going to get a clean answer,&rdquo; Woodcock said. Instead, the best evidence that cancer drugs are effective would be an increase in national survival rates over time, she said.</p><p>By law, the FDA has the authority to issue fines or even pull a drug off the market if a drugmaker doesn&rsquo;t meet its post-marketing requirements. Yet the agency has never fined a company for missing a deadline, according to Woodcock.</p><p>&ldquo;We would consider fines if we thought companies were simply dragging their feet, but we would have the burden to show they really weren&rsquo;t trying, and it&rsquo;d be an administrative thing that companies could contest,&rdquo; said Woodcock.</p><p>Even when post-marketing studies belatedly confirm that drugs are dangerous, the agency doesn&rsquo;t always pull them off the market. Consider Uloric, the gout treatment. Even though it consistently lowered uric acid blood levels, the FDA rejected it in 2005 and again in 2006, because trials linked it to cardiovascular problems. But a third study by the manufacturer, Takeda Pharmaceutical of Osaka, Japan, didn&rsquo;t raise the same alarms. So the agency decided in 2009 to let the drug on the market, while asking Takeda for a post-marketing study of 6,000 patients to clarify the drug&rsquo;s cardiovascular effects.</p><p>Takeda took more than eight years to complete the study. It found that patients on Uloric had a 22 percent higher risk of death from any cause and a 34 percent higher risk of heart-related deaths than patients taking allopurinol, a generic alternative. The FDA issued a public alert in November 2017, sharing the results of the trial, but left Uloric on the market.</p><p>Public Citizen has warned patients to stop taking Uloric. &ldquo;There is no justification for using it,&rdquo; said Carome. &ldquo;If the results of the most recent study had been available prior to FDA approval, the FDA likely would have rejected the drug.&rdquo;</p><p>FDA spokeswoman Walsh said it is &ldquo;conducting a comprehensive evaluation of this safety issue and will update the public when we have new information.&rdquo;</p><p>Takeda is working with the FDA to &ldquo;conduct a comprehensive review,&rdquo; spokeswoman Kara Hoeger said in an email. The company wants to ensure that &ldquo;physicians have comprehensive and accurate information to make educated treatment decisions.&rdquo; Thomas Moore, senior scientist of drug safety and policy at the Institute for Safe Medication Practices, warned that future post-marketing findings on Nuplazid could be similarly bleak. Uloric &ldquo;is the story of [Nuplazid] but a few years down the pike,&rdquo; he said.</p><p>Nevertheless, FDA Commissioner Gottlieb is forging ahead with more shortcuts. In May, he announced plans to approve gene therapies for hemophilia based on whether they increased the level of clotting proteins, without waiting for evidence of reduced bleeding.</p><p>Two years ago, a prescient Dr. Ellis Unger, FDA&rsquo;s Director of the Office of Drug Evaluation, had warned against precisely this initiative. After Woodcock approved Exondys 51 in 2016, Unger wrote, &ldquo;A gene therapy designed to produce a missing clotting factor could receive accelerated approval on the basis of a tiny yet inconsequential change in levels of the factor&hellip;The precedent set here could lead to the approval of drugs for rare diseases without substantial evidence of effectiveness.&rdquo;</p><p>Gottlieb seems less worried than Unger.</p><p>&ldquo;For some of these products, there&rsquo;s going to be some uncertainty, even at the time of approval,&rdquo; Gottlieb said when announcing the plan. &ldquo;These products are initially being aimed at devastating diseases, many of which are fatal and lack available therapy. In these settings, we&rsquo;ve traditionally been willing to accept more uncertainty to facilitate timely access to promising therapies.&rdquo;</p><p>His decision pleased investors. That day, while biotechnology stocks overall fell, shares of hemophilia gene therapy manufacturers rose.</p></div><p><em>ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for their <a href="http://www.propublica.org/forms/newsletter_daily_email">newsletter</a></... <link href="https://www.propublica.org/article/fda-repays-industry-by-rushing-risky-... rel="canonical" /> </p><p>&nbsp;</p><p> <meta content="https://www.propublica.org/article/fda-repays-industry-by-rushing-risky-... name="syndication-source" /> <script type="text/javascript" src="http://pixel.propublica.org/pixel.js" async></script></p>
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600-Pound Heroin Spoon Sculpture Placed Outside OxyContin Creator's Corporate Headquarters by Protesters

Sat, 06/23/2018 - 20:05
The sculpture remained in place for over two hours before city workers arrived to remove it.

Addiction profiteer and OxyContin creator Purdue Pharma just can’t get a break. The privately held pill-pusher palace faces myriad lawsuits for being a driving force in the addiction crisis currently gripping the nation, most recently coming from the state of Massachusetts on June 12. Then, the opiate factory announced massive layoffs this week, the second such move of 2018, along with a focus shift to drugs that actually help people rather than kill them.

Just days after the layoffs were announced, employees at the family-owned death factory arrived Friday to find a most challenging piece of street art outside of the Stamford, Connecticut, headquarters of the company who still totally sells addictive painkillers: a nearly 600-pound sculpture of a heroin spoon, bent and dirty with residue.

Massachusetts artist Domenic Esposito tells the Hartford Courier that his sculpture represents addiction as an epidemic, as well as paying tribute both to his brother’s 14-year struggle with addiction, and his mother who always finds the dirty spoons that signal his relapses. 

Esposito said his brother started with OxyContin and Percocet and moved to heroin.

“People say [OxyContin and Percocet] aren’t a big deal, but then you’re hooked and you run out of money and you turn to heroin.

“My mom would call me in a panic ... screaming she found another burnt spoon,” Esposito said. “This is a story thousands of families go through. He’s lucky to be alive.”

The Danbury News-Times reports that the sculpture was installed as part of the Fernando Luis Alvarez Gallery’s “Opioid: Express Yourself” multimedia exhibit. Strategically placed by Alvarez to block both a driveway and a sidewalk, the sculpture, called “Purdue,” remained in place for over two hours before city workers arrived to remove it.

Alvarez was arrested for both a misdemeanor—for putting the sculpture outside the painkiller palace and thus blocking traffic—and a felony, for (amicably) refusing to remove it under police orders. 

Purdue Pharma issued a predictably meaningless statement in response to the installation.

“We share the protesters’ concern about the opioid crisis, and respect their right to peacefully express themselves. Purdue is committed to working collaboratively with those affected by this public health crisis on meaningful solutions to help stem the tide of opioid-related overdose deaths.”

The “Purdue” spoon remains in police custody.

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Physical Therapy Can Lower Need for Opioids — But Many People Can't Afford It

Sat, 06/23/2018 - 19:34
Many people addicted to opioids are first exposed through a medical prescription for pain.

Physical therapists help people walk again after a stroke and recover after injury or surgery, but did you know they also prevent exposure to opioids? This is timely, given we are in a public health emergency related to an opioid crisis.

Many people addicted to opioids are first exposed through a medical prescription for pain. Opiate-based drugs provide relief for acute conditions, such as post-surgical pain.

Unfortunately, the effectiveness of opioids decreases after time, requiring higher doses of the drug for the same effects and, perhaps counter-intuitively, worsening pain in some people. Many people progress from this prescription to other opiate derivatives, including heroin and fentanyl. As a result, a growing emphasis has been placed on nonpharmacological alternatives to opioids.

I am a physical therapist and I have studied non-pharmacological methods of preventing the transition from acute to chronic pain. It’s an exciting time for the field, because practice and research are showing that physical therapy could diminish the need for opioids, and thus lower the risk of addiction.

Reducing initial exposures to opioids

Part of the proposed solution to the opioid crisis is to limit new opioid exposures. Physical therapists are an important part of this process. And it is not just physical therapists who are saying this.

A letter to the president from the Commission on Combating Drug Addiction and the Opioid Crisis stated, “individuals with acute or chronic pain must have access to non-opioid pain management options. Everything from physical therapy, to non-opioid medications, should be easily accessible as an alternative to opioids.” U.S. Surgeon General Jerome Adams echoed this call for alternative treatments, including physical therapists.

The Centers for Disease Control and Prevention also issued prescribing guidelines in 2016 that recommend physical therapists be considered a first-line treatment for people with chronic pain conditions.

Research supports these positions, including research papers studying opioid use for common musculoskeletal pain conditions like back, knee and neck pain.

These studies show quite convincingly that the probability of receiving a prescription for opioids is 89 percent lower for people seeing a physical therapist for pain. Seeing the physical therapist sooner, rather than later, makes this protective effect even greater.

Why don’t more people see a physical therapist?

People in pain can go directly to a physical therapist in every state. So why don’t more people to do this? The simple answer: time and money.

Steven George, the director of musculoskeletal research for the Duke Clinical Research Institute, recently wrote, “Our existing health care system is designed to treat pain through easily delivered products, like opioids, injections and surgery,” suggesting that alternatives are not as easily delivered.

Only about 10 percent of people who see a physician for back pain get referred to a physical therapist. Only 37 percent of those people actually go. The process to make an appointment can be lengthy and time-consuming, and insurance companies often slow down the process. Some HMO insurance plans require that physical therapy treatment be certified as medically necessary, or they will not pay. And, there’s another step: pre-authorization. This, too, delays the access to covered care even more. For a person in pain and in need of help, this is a deterrent. It’s much easier to ask for a pill.

Then there is the cost. Physical therapists are often classified as specialists, so co-payments may be as high as US$75 a visit. The average patient with back pain sees a physical therapist for seven visits. Even with insurance coverage, this episode of care still will cost the person over US$500 out of pocket compared to the cost of a single primary care visit and prescription. Several states, including Kentucky, have enacted laws limiting co-payment for many services. One of the recommendations from the President’s Commission was that alternatives to opioids, including physical therapy, should be adequately covered by payers. These recommendations have yet to be acted upon.

So what does all of this mean for people in pain? First, seeing a physical therapist is effective for many pain conditions. Second, getting to a physical therapist sooner rather than later decreases the use of opioid medication. The current health care system must change in order for people in pain to access this safe and effective non-opioid alternative for pain management.

Mark Bishop, Associate Professor of Physical Therapy, University of Florida

This article was originally published on The Conversation. Read the original article.

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Trump Country Has the Highest Opioid Prescription Rates in the Nation

Fri, 06/22/2018 - 23:49
Those counties with both high opioid use and high Trump support were largely in the South, Midwest, and southern Appalachia.

The two fevers gripping the land—opioid addiction and support for Donald Trump—are related. A new study from University of Texas researchers finds that counties with the highest opioid prescription rates were also more likely to favor Trump in the 2016 election.

The study was published Friday in JAMA Network Open. The cross-sectional analysis examined data from the Census Bureau, Medicare Part D, and uselectionatlas.org to try to understand what has been deemed the "Oxy electorate."

Focusing on legally available prescription pain relievers, like oxycodone and hydrocodone, codeine and morphine, but not illegal substances like heroin, the study examined Medicare Part D records for some 3.7 million people in 3,128 of the 3,142 counties in the U.S. Researchers designated people who had received at least one 90-day supply of prescription opioids as "high opioid users."

Some 693 counties, typically with populations smaller than one million, had rates of opioid prescribing that were significantly higher than the national mean. Another 638 counties were identified as having significantly lower than average opioid use.

In those high opioid use counties, Trump won 59.96% of the vote. In the low opioid use counties, he won only 38.7% of the vote. (Trump won 45.92% of the overall vote.)

Those counties with both high opioid use and high Trump support were largely in the South, Midwest, and southern Appalachia.

The researchers found that the link between opioid use rates and Trump support was as strong as the link between other commonly cited socioeconomic factors—such as unemployment, household income, and education levels—and support for Trump. In the high opioid use counties, those other indicators also suggested high levels of social distress. Those counties had higher unemployment rates, fewer adults with a high school diploma, and lower household median incomes than the country as a whole.

Does that mean Trump got the opioid addict vote? No.

"With an ecological analysis, you can't say that. And not only can't you say it, but it's probably not true," said lead author Dr. James Goodwin, chair of geriatric medicine at the UT Medical Branch in Galveston.  "If you're stoned out on opioids, you're probably not voting," he told Dallas News.

Instead, he and others suggested, high levels of opioid use tend to correlate with those other indicators of social distress, exacerbating feelings of being left behind or disenfranchised and making voters more likely to support candidates promising to shake things up.

"Trump tapped into something in that segment of voters," said Katharine Neill Harris, a drug policy fellow at the Baker Institute, a nonpartisan think tank of Rice University in Houston.  "It’s about more than just prescriptions. "This is a very complex relationship, and representative of a deeper problem... of problems we are not addressing as a society," she told Dallas News.

This article was produced by Drug Reporter, a project of the Independent Media Institute.

 

 

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The Canadian Parliament Has Spoken — Country Will Become Second in the World to Legalize Marijuana

Wed, 06/20/2018 - 23:49
It’s the first G7 country to legalize cannabis.

With final approval by the Senate Tuesday night, the Canadian parliament has legalized marijuana. That makes Canada the second country to legalize marijuana (after Uruguay), with what will be the world's second-largest legal marijuana market (after California).

Canada also becomes the first G7 country to free the weed. While nine U.S. states and the District of Columbia have also legalized marijuana, it remains illegal under federal law here.

The move, fulfilling a campaign promise by Prime Minister Justin Trudeau and the ruling Liberal Party, puts an end to nearly a century of marijuana prohibition in the Great White North. It didn’t come without a struggle, with Conservative senators seeking to delay the measure and succeeding in pushing back the actual rollout date from a once-promised July to what Trudeau announced Wednesday would be October 17.

Under the Cannabis Act, people 18 and over (19 in some provinces) will be able to legally possess up to 30 grams of pot in public, and each household can grow up to four plants. The House of Commons and the government turned back a Senate amendment that would have allowed provinces to ban home cultivation.

The law retains criminal penalties for possession of more than 30 grams or growing more than four plants, and includes an especially harsh provision mandating up to 14 years in prison for sales to minors.

Each province will have its own scheme for handling sales, with some considerable variation. In Ontario and New Brunswick, for instance, sales will be handled by the province, while in most other provinces, sales will be handled by the private sector or private-public collaborations. Marijuana will also be available for sale online.

But Canadians will have to wait for edibles. Marijuana-infused foods will not be available for purchase for some months until the government develops regulations for them.

Marijuana is already big business in Canada, generating an estimated $4.5 billion in sales in 2015, and Canadian marijuana producers are already geared up to produce a huge legal marijuana crop—in fact, maybe too huge. The two largest producers, Aurora Cannabis and Canopy Growth, are set to produce a million pounds each, while second-tier producers will be adding to a possible glut.

But those are worries for down the road. Tuesday evening for was for celebrating.

“It’s been too easy for our kids to get marijuana - and for criminals to reap the profits. Today, we change that,” a triumphant Trudeau tweeted just after the final vote.

“We’ve just witnessed a very historic vote that ends 90 years of prohibition,” Liberal Senator Tony Dean told reporters. “It ends 90 years of needless criminalization, it ends a prohibition model that inhibited and discouraged public health and community health in favor of just-say-no approaches that simply failed young people miserably.”

Not everyone was pleased. Senator Leo Housakos, a Quebec conservative, tweeted forebodingly that passage of the law would be “catastrophic for Canadian generations to come.”

But while Canadian conservatives foresaw disaster, American activists saw a model to emulate.

"Canada should be applauded for taking bold and decisive steps towards ending the failed prohibition of marijuana," said Hannah Hetzer, Senior International Policy Manager for the Drug Policy Alliance. "Canada's progress will galvanize support for drug policy reforms in the US and all around the world."

Hetzer also lauded Canada's federalist approach to the issue and called for redressing the damage done to individuals by pot prohibition.

"Canada's decentralized system will give provinces the freedom to tailor marijuana legalization to their local needs and contexts, allowing us to study and learn from the many different models that will emerge," she said. "Canada should ensure that the harms of marijuana prohibition are rectified, especially by expunging people's marijuana arrest records and by investing in communities most harmed by prohibition."

“This is a historic step forward for the movement to end marijuana prohibition,” said Marijuana Policy Project spokesman Mason Tvert. “We commend the members of Parliament and the prime minister for their extraordinary demonstration of leadership on this issue. Canada will set a great example for countries that are considering similar reforms, and it will inspire much-needed debate in those that are not.”

While the U.S. states have taken the lead, it’s an end to federal prohibition that is required, said Tvert. “It is time for the U.S. to take similar action and adopt a more rational federal marijuana policy. There has been a lot of positive movement in Congress lately, so hopefully, members will be inspired to finally address this issue head-on, as Canada has.”

This article was produced by Drug Reporter, a project of the Independent Media Institute.

 

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Many Psychedelics Share This Common Trait — And It Will Literally Change The Way You Think

Wed, 06/20/2018 - 10:24
This helps explain why they are increasingly seen as a valuable treatment for psychiatric disorders such as depression, anxiety, and addiction.

New research suggests that different classes of psychedelic drugs all share the tendency to promote the growth of new brain cells, especially the kind that reach out and forge connections with other brain cells. This finding could help explain both the mind-expanding properties of the drugs and the mechanisms by which they appear to act as valuable treatments for a broad range of psychiatric disorders.

Earlier research had identified the dissociative anesthetic ketamine as promoting growth in key brain cells (as well as being a fast-acting and effective treatment for depression), but this new research finds similar effects in amphetamine-based psychedelics such as DOI (2,5-dimethoxy-4-iodoamphetamine), ergoline psychedelics (such as LSD), and tryptamines (such as DMT).

Using experiments in cell culture and with animals, researchers led by Dr. David Olson of the University of California at Davis found that various classes of hallucinogenic drugs acted on the structure and function of cortical neurons using the same mechanisms as ketamine. The findings could point to new treatment approaches for depression, anxiety, PTSD, and addiction, the researchers wrote last Tuesday in the peer-reviewed journal Cell Reports.

“The state-of-the-art, prototypical, fast-acting antidepressant is ketamine—a compound that promotes neural plasticity and repairs circuits involved in mood and anxiety disorders,” Olson told MedPage Today. “Our work demonstrates that psychedelics produce comparable effects on neuronal structure and function, providing a potential explanation for why MDMA, psilocybin, and ayahuasca seem to have antidepressant and anxiolytic effects in the clinic.”

Using test tubes, as well as rats and fruit fly larvae, the researchers found that all of these classes of psychedelics increased “neural plasticity,” the ability to create new connections among brain cells. The drugs all excited the growth of dendritic spines and axons, the cerebral hangers-on that brain cells use to reach out and create connections, or synapses, with other brain cells.

That’s the opposite of what happens with depression, anxiety, PTSD, and addiction. The current theory is that these disorders may occur when neurites retract, not allowing brain cells to connect at synapses.

“One of the hallmarks of depression is that the neurites in the prefrontal cortex—a key brain region that regulates emotion, mood, and anxiety—those neurites tend to shrivel up,” Olson said in a statement.

Olson’s research found that the neural plasticity effect found with ketamine was also “remarkably potent” with even very small doses of LSD, which could help explain the popularity of “microdosing” among people seeking happier and more creative lives. Chemical compounds that mimicked psilocybin and MDMA also increased neural plasticity on the same level as ketamine, and that could mean new opportunities for researchers working with psychiatric disorders.

The studies also showed that the effect outlasted the action of the drugs. In rats, for example, psilocybin produced results that lasted for hours after the drug had left the body. Similarly, rats given a single dose of DMT not only saw an increase in dendritic spines similar to ketamine but saw that effect last for 24 hours when the drug itself had been eliminated within one hour.

This is potentially very good news for researchers working on treatments for anxiety, depression, and addiction, which all seem to act on the same brain circuits.

“Prior to this study, there was only one player in town and that was ketamine. This opens up some new doors,” Olson said. “As the diversity of chemical structures capable of producing ketamine-like plasticity effects continues to grow, so does my hope that we will find a safe and effective fast-acting treatment for depression,” he said.

This article was produced by Drug Reporter, a project of the Independent Media Institute.

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The Power and Promise of Psychedelics: Michael Pollan Show Us How to Change Our Minds

Mon, 06/18/2018 - 23:05
The acclaimed foodie author serves up a heaping platter of mind-bending science and history.

Can psychedelic drugs improve our lives? Michael Pollan thinks so, and he makes a pretty persuasive case in his latest book, How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence.

This is good stuff. Pollan elegantly blends science, medicine, memoir, travel writing and history in a dazzlingly authoritative dive into his subject matter. If you want to read only one book on psychedelics, make it this one.

The subject is something of a departure for Pollan, who has risen to prominence as the consummate foodie, authoring such well-known tomes as The Omnivore’s Dilemma, Food Rules, and In Defense of Food. But it’s not entirely surprising: In his 2001 The Botany of Desire, Pollan delved into the world psychoactive substance to examine the mutually beneficial relationship between humans and marijuana. (He also described our relationship with apples, tulips, and potatoes.)

In his current effort, Pollan dives into the science of psychedelics, going deep into brain chemistry and the actual mechanisms by which these drugs alter consciousness. Basically, the science suggests, psychedelics damp down the brain’s default mode network, the cerebral mechanism that allows us to maintain normal consciousness. When the default mode network is weakened, new neural pathways open up, brain parts that don’t usually communicate with each other start talking, and the going gets weird.

And that opens the door not only for trippy imagery, but also for spiritual epiphanies or, less grandly, coming to terms with oneself and one’s issues. As Pollan reviews the current research taking place in this psychedelic revival, he encounters terminal cancer patients whose closely guided trips help them grapple with their own mortality, spiritual seekers finding enlightenment, and drug users who find themselves able to break noxious addictions.

He also tries psychedelics himself—something he hadn’t done before—taking LSD, magic mushrooms, and toad venom containing DMT. His description of his experiences is vivid and compelling, and he tries his best to express those ineffable “truths” the psychedelic experience offers. Describing the subjective reality of an acid trip is a difficult feat, and Pollan does better than most.

And speaking of magic mushrooms, who knew that the term was coined by a Time/Life publicist in the 1950s? I didn’t. But that was indeed the case as Life editors were putting together the groundbreaking tale of Gordon Wasson’s experience eating psilocybe cubensis with Mexican shaman Maria Sabina.

Pollan’s book is full of such delicious little tidbits of psychedelic lore and history, including an account of the Stoned Ape hypothesis, favored by some mycophiles, which argues that hominids ingesting magic mushrooms led to the development of human consciousness.

But it also tells the tale of psychedelics as never before, revealing a “secret history” of lost research on psychedelics in the 1950s and 1960s, where thousands of subjects ingested them in more than a thousand scientific experiments. Some of the results were impressive—LSD appeared to help curb alcoholism, as well as helping people come to terms with mental disorders or terminal illnesses—but that body of research was largely forgotten as the federal government and scientific establishment led a severe crackdown once Tim Leary and the hippies got ahold of acid.

Naturally, Leary remains the central figure of the 1960s psychedelic scene—and a highly contentious one—but one of Pollan’s biggest contributions is showing how psychedelics were busily leaking out of the lab and into the culture at large in ways that had nothing to do with Leary. Hollywood actors and other elites were taking LSD in therapeutic sessions, spreading the word and participating in group sessions that in some cases seemed more like acid parties than therapeutic encounters.

Still, once Leary shed his researcher’s objectivity to become a messianic acid missionary with his slogan of “tune in, turn on, and drop out,” and undertook a mission to cure not sick people but the culture itself, it was game over for the first wave of psychedelic research:

“The fact that by their very nature or the way that first generation of researchers happened to construct the experience, psychedelics introduced something deeply subversive to the West that the various establishments had little choice but to repulse. LSD truly was an acid, dissolving almost everything with which in came into contact, beginning with the hierarchies of the mind (the superego, ego, and unconscious) and going from there to society’s various structures of authority and then to lines of every imaginable kind, between patient and therapist, research and recreation, sickness and health, self and other, subject and object, the spiritual and the material. If all such lines are manifestations of the Apollonian strain in Western civilization, the impulse that erects distinctions, dualities, and hierarchies, and defends them, the psychedelics represented the ungovernable Dionysian force that blithely washes all those lines away.”

For the past half-century, psychedelics have been making a slow, but now rapidly accelerating recovery from the repression sparked by Leary’s proselytizing and the specter of a psychedelicized America. Again, Pollan shines with his explication of the mind-blowing research taking place and the possibilities being opened up. If there was any question that psychedelics are enjoying a scientific and medical renaissance, Pollan puts that to bed.

Yet, in awe of the power of psychedelics, Pollan stops short of calling for their legalization. Instead, he seems to want every trip to be guided, every journey to have a destination. Has he been captured by the very scientists and researchers whose stories he tells? He writes about the spiritual and the psychological, religion and science, and “shamans in white lab coats,” but he doesn’t want to talk about recreational use of the drugs.

But the psychedelics are here, and they are being used just for fun. The molecule is in our midst and the fungus is among us. Neither is going away nor are they staying in the lab.

How to Change Your Mind is a major addition to the literature on psychedelics. Reading it will blow your mind. Do it now.

This article was produced by the Drug Reporter, a project of the Independent Media Institute.

 

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The DEA's Move to Restrict Opioid Prescriptions Had an Unforeseen Consequence—It Pushed Users to the Dark Web

Sat, 06/16/2018 - 11:55
Meet the "iron law of prohibition."

By the end of 2013, the country's quiet opioid addiction crisis was no longer so quiet. Opioid overdose deaths that year topped 16,000, more than four times the same statistic for 1999. That prompted a number of measures at the state and federal level to rein in opioid prescriptions, including a move by the DEA in October 2014 to tighten its policies around some of the most commonly prescribed opioids.

The new DEA policy—aimed at popular opioids such as Vicodin and Lortab—imposed restrictions on doctors' prescribing and made it more difficult for patients to get refills. In one sense, the policy was a success: Prescriptions for those drugs decreased almost immediately. But new research adds to an increasing body of evidence that restricting opioid prescribing has not solved the opioid crisis but instead worsened it.

Since the DEA policy shift, opioid overdose deaths continued to grow with more than 40,000 fatal opioid overdoses in 2016. And while prescription opioid overdose deaths have slightly decreased—there were about 14,000 that year—overdose deaths from heroin and non-prescription synthetic opioids such as fentanyl went through the roof. Heroin and illicit synthetics accounted for nearly two-thirds of all opioid overdose deaths in 2016.

In the new study, published this week in the British Medical Journal, researchers examining the impact of the DEA policy shift found evidence that while the change indeed lowered prescribing rates for the opioids in question, it was also linked to an increase in illicit online sales of those drugs in Dark Web drug markets.

The researchers used software called DATACRYPTO to crawl encrypted Dark Web marketplaces where people can anonymously buy damned near anything, from drugs to guns to credit card numbers. DATACRYPTO harvested data on which drugs were for sale, their country of origin, and the number of customer comments on each seller's comments page. Researchers used that last figure as a proxy for how much of a drug that seller sold. They examined sales of prescription opioids, sedatives, stimulants, and steroids, as well as heroin. It was only with prescription opioids that they found a significant Dark Web sales bump.

Here's what they found: "The sale of prescription opioids through US cryptomarkets increased after the schedule change, with no statistically significant changes in sales of prescription sedatives, prescription steroids, prescription stimulants, or illicit opioids."

According to their data, prescription opioids doubled their market share of U.S. Dark Web drug sales thanks to the DEA policy change. By July 2016, opioids represented 13.7% of all drug sales in U.S. cryptomarkets, compared with a modeled estimate of 6.7% of all sales.

While the researchers were careful to not make claims of causation—only correlation—their conclusion speaks for itself: "The scheduling change in hydrocodone combination products coincided with a statistically significant, sustained increase in illicit trading of opioids through online US cryptomarkets. These changes were not observed for other drug groups or in other countries. A subsequent move was observed towards the purchase of more potent forms of prescription opioids, particularly oxycodone and fentanyl."

Not only is the DEA policy change linked to increased Dark Web opioid sales, it is also linked to a move toward more powerful, and thus more dangerous, opioids. The researchers noted that while fentanyl was the least purchased Dark Web opioid in the summer of 2014, it was the second most frequently purchased by the summer of 2016. Fentanyl killed as many people as prescription opioids that year.

This study—one of the few that examines supply reduction (as opposed to demand reduction) as a means reducing drug use—strongly suggests that supply-side interventions carry unintended consequences, especially the resort to more dangerous and more powerful substitutes.  The study's authors refer to this effect as "the iron law of prohibition, whereby interventions to reduce supply, such as increased enforcement and changes to drug scheduling, lead to illicit markets dominated by higher potency products."

Perhaps better than restricting opioid prescriptions, which has deleterious impacts on the tens of millions of Americans suffering chronic pain, or other supply-side interventions, would be increased access to addiction treatment, as well as greatly expanded harm reduction measures to try to get people off opioids and keep them alive in the meantime.

This article was produced by the Drug Reporter, a project of the Independent Media Institute.

 

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Meet the Man Sentenced to 13 Years for Two Marijuana Joints

Fri, 06/15/2018 - 08:18
Bernard Noble shares his heartbreaking story—one that is all too common thanks to the war on drugs.

This podcast was originally published on Drugs and Stuff, a podcast from the Drug Policy Alliance.

We were lucky to talk with Bernard Noble, who recently came home after serving more than 7 years in a Louisiana prison. Bernard was finally granted parole after being sentenced to 13 years for allegedly possessing two joints of marijuana. You’ll hear all about this grave injustice directly from the man whose case drew national attention as an example of extremely harsh drug sentences in the United States, and how an entire family is tragically affected when a parent is sent to prison.

We were also joined by DPA's Anthony Papa, who became the first person in New York State history to receive both clemency (from Gov. George Pataki 1997) and a pardon (from Gov. Andrew Cuomo 2016) after he was unfairly sentenced to 15-to-life for a first-time, nonviolent drug offense under New York’s draconian Rockefeller Drug Laws. This discussion between two men who served a number of years behind bars because of the war on drugs is powerful and, at times, heart-breaking.

If you want to support Bernard, you can give here: https://www.youcaring.com/bernardnoble-1182699

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Expanding Medicare to Everyone Is the Only Way We Can Fully Protect It

Wed, 06/13/2018 - 07:37
Our health care system is incredibly inefficient.

Medicare is under attack. The only way to fully protect it is to expand it to everyone.

Today’s Republican politicians have made no secret of their desire to end Medicare as we know it. For years, they have supported raising Medicare’s age of eligibility from age 65 to age 67 and transforming it from a guaranteed benefit program into one in which the government gives you an inadequate “voucher” for private health insurance. The well-respected Center on Budget and Policy Priorities has explained that the Republican proposals “would shift substantial costs to Medicare beneficiaries and… leave many 65- and 66-year olds without any health coverage at all.”

This anti-Medicare battle is one that conservatives have been waging since its enactment. Like Social Security, which they argued at the time of its passage was “socialism,” opponents in 1965 accused Medicare of being “socialized” medicine and claimed it would put the government between you and your doctor.

Social Security and Medicare have now stood the test of time. That means it’s harder for opponents to scare you about “socialism” and government “interference.” Instead, they claim that the issue is affordability, and that they are simply trying to “save” Social Security and Medicare. But these programs don’t need saving. They are both solutions, not problems. The fight is about ideology and values, as well as whether to protect the profits of powerful political donors.

Those who oppose Medicare are against government-sponsored insurance. They want to keep for-profit corporate middle men involved in delivering our health care. But that is what is truly unaffordable, as well as morally bankrupt.

Our health care system is incredibly inefficient. Just look at the drug prices we pay. They are the highest in the world.

The following graph, prepared by the non-partisan Congressional Budget Office, projects the nation’s health care costs over 75 years, assuming that future costs rise at their historical rate.

If we keep going as we have been, our health care costs will eventually consume 99 percent of GDP. Obviously, that is impossible. We cannot spend all of our collective wealth on health care and leave nothing for food, housing, and other necessities! Rising health care costs overall are what is unsustainable, not Medicare.

While Medicare and Medicaid are much more efficient than private sector insurance, they cannot keep their costs in check when overall health care costs are rising so rapidly. This is particularly true when Donald Trump and the other Republicans hamstring Medicare by prohibiting it from negotiating for lower drug prices and implementing other cost-saving measures. It is overall costs, private as well as public, that must be addressed.

By ending Medicare and substituting vouchers so that seniors and people with disabilities must fend for themselves against private insurance companies, what Republicans aim to do is to shift costs away from the government and onto the shoulders of seniors, people with disabilities, and low-income families. That will make the government balance sheet look better, but it will cause all of our health care costs to go up.

If Republicans are successful in raising Medicare’s initial age of eligibility from 65 to 67, for example, that action alone would reduce the federal government’s balance sheet by $5.7 billion—but it would cost individuals, employers, and states $11.4 billion! And that’s only in the first year.

Ending Medicare—or simply continuing to constrain it, so that it can’t even negotiate for lower drug prices—will enrich corporations but bury the rest of us. It will allow Republicans to cut taxes even more for their billionaire donors and spend more on military contractors, while more and more of us will have to choose between health care and food.

That is no solution. Market-based provision of health care using for-profit corporations is vastly inferior to universal, government-sponsored health insurance, which is the most effective and efficient way to cover everyone. Insurance is most cost-efficient and reliable when the risks can be spread across as broad a population as possible and when no one can purchase the insurance only when personal risk factors increase—a practice known as adverse selection.

Only the national government has the power and ability to establish a nationwide, universal risk pool, which makes adverse selection impossible. And when the federal government administers the insurance, overhead is minimized. Instead of high-paid CEOs, hardworking civil servants are in charge. And other costs, like advertising and marketing, are unnecessary. Moreover, the government is not seeking a profit for shareholders. Consequently, the government can provide health care less expensively and more efficiently for everyone.

For these reasons, every other industrialized country provides universal health care coverage, spends far less as a percentage of GDP, and produces better outcomes. But we don’t have to look to other countries to see the advantages.

Given the greater efficiency of government-sponsored wage and health insurance, it is not surprising that Social Security and Medicare are so cost effective. More than 99 cents of every dollar Social Security spends is paid in benefits. Less than a penny goes to administration. These are much lower administrative costs than can be found under Social Security’s private sector counterparts.

Similarly, Medicare covers seniors and people with disabilities, people who, on average, have the worst health and the most expensive medical conditions, requiring the largest numbers of doctor and hospital visits. Accordingly, they have the largest number of health care claims. Yet, Medicare is significantly more efficient than private health insurance.

According to the most recent Trustees Report, Medicare spends just 1.1 penny of every dollar on administrative costs. The rest is paid in benefits. In contrast the administrative costs of private health insurance average around 11 to 17 percent. In some cases, they can run as high as 30 percent.

Medicare’s per capita administrative costs are substantially lower than those in the private sector. And that is without universal coverage, which would allow even greater efficiencies and even lower prices.

It is noteworthy that if the United States had the same per capita health care cost as any other industrialized country, our nation would project long-term federal budget surpluses for the foreseeable future. (The Center for Economic and Policy Research has an online calculator that allows you to pick any of those other countries and see the effect on the U.S. budget.)

Unless we extend Medicare to everyone, costs will rise, giving Republicans the excuse that they want to cut or, worse, privatize Medicare. By replacing for-profit insurance corporations with Medicare for All, we will lower Medicare’s per capita costs and dramatically reduce how much our nation spends on health care. This will free up resources to provide better benefits and still have money left over for other pressing federal needs.

Medicare for All is extremely wise policy. Its efficiency will make adding dental, hearing, vision, and other important treatments much more affordable. Unlike cutting Medicare, which would shift costs to seniors and people with disabilities, expanding Medicare would reduce the costs all of us pay.

So why isn’t Medicare for All the law of the land yet? Big Pharma and other powerful donors know that it would reduce their profits. Therefore, they have resisted this sensible solution for a century. They fight against Medicare for All so that their profits can grow even larger at the expense of the rest of us.

Including everyone in Medicare will protect the program politically. Instead of politicians and their corporate donors playing the young against the old, they will instead have to bow to the will of all of us. Expanding Medicare will finally force politicians to improve Medicare, eliminating lifetime caps and making other reforms that should have been enacted long ago. If they refuse, we can vote them out of office in favor of elected officials who listen to the people.

Medicare for All will be better for seniors, better for people with disabilities and better for all of us. It will make guaranteed, high quality health care a right, not a privilege. But to win against the powerful special interests and their political lackeys, we must all stand together and make sure our voices are heard and our votes counted.

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Mind Molding Psychedelic Drugs Could Treat Depression and Other Mental Illnesses

Wed, 06/13/2018 - 07:02
Psychedelic drugs have inspired great songs and works of art. But they may also have potential for treating disease like depression and PTSD by helping to regrow damaged regions of the brain.

It seems that psychedelics do more than simply alter perception. According to the latest research from my colleagues and me, they change the structures of neurons themselves.

My research group has been studying the effects of psychedelics on neuronal structure and function, and we found that these compounds cause neurons to grow. A lot. Many of these compounds are well-known and include lysergic acid diethylamide (LSD), psilocin (from magic mushrooms), N,N-dimethyltryptamine (DMT, from ayahuasca) and 3,4-methylenedioxymethamphetamine (MDMA, aka ecstasy).

These are among the most powerful drugs known to affect brain function, and our research shows that they can alter the structure of the brain as well. Changes in neuronal structure are important because they can impact how the brain is wired, and consequently, how we feel, think and behave.

Prior to our study, there were relatively few compounds known to have such drastic and rapid effects on neuronal structure. One of those compounds was ketamine – a dissociative anesthetic and quite possibly the best fast-acting antidepressant that we have available to us at the moment.

If you think of a neuron like a tree, then its dendrites would be the large branches, and its dendritic spines – which receive signals from other neurons – would be the small branches. Some of these small branches might have leaves, or synapses in the case of a neuron. In fact, neuroscientists often use terms like “arbor” and “pruning” much like a horticulturist would. When we grew neurons in a dish – which is not unlike growing a plant in a pot – and fed them psychedelic compounds, the neurons sprouted more dendritic branches, grew more dendritic spines, and formed more connections with neighboring neurons.

Rethinking depression

Thanks to studies on ketamine, slow-acting antidepressants and chronic stress models of depression, scientists now know that depression is not simply the result of a “chemical imbalance,” as pharmaceutical companies like to suggest. It is far more complicated and involves structural changes in key neural circuits that regulate emotion, anxiety, memory and reward.

One of the hallmarks of depression is the atrophy of neurons in the prefrontal cortex – a region of the brain that controls anxiety and regulates mood among other things. Basically, these branches and spines shrivel up, disconnecting from other neurons in the brain. One hypothesis for why ketamine is so effective is because it can rapidly regrow the arbors and spines of these critical neurons.

Like ketamine, psychedelics have shown promise in the clinic for treating neuropsychiatric diseases. The DMT-containing herbal tea known as ayahuasca produces fast-acting antidepressant effects within a day, psilocybin eases the anxiety of terminally ill cancer patients and MDMA can reduce fear in those suffering from post-traumatic stress disorder (PTSD). Our recent papers suggest the intriguing possibility that psychedelic compounds and ketamine might share a common therapeutic mechanism.

Psychedelics vs. psychoplastogens

Strictly speaking, a psychedelic is a “mind-manifesting” drug – a definition that’s open to interpretation. They tend to produce perceptual distortions or hallucinations by activating 5-HT2A receptors. Our research group has found that compounds typically regarded as psychedelics, like LSD and DMT, as well as those that are sometimes called psychedelics, like MDMA, and those that are not usually called psychedelics, like ketamine, are all capable of profoundly impacting neuronal structure.

Our group has coined the term “psychoplastogen” to refer to such compounds, and we believe that these molecules may hold the key to treating a wide variety of brain diseases.

Our studies on neurons grown in dishes, as well as experiments performed using fruit flies and rodents, have demonstrated that several psychoplastogens, including psychedelics and ketamine, encourage neurons to grow more branches and spines. It seems that all of these compounds work by activating mTOR – a key protein involved in cell growth.

The biochemical machinery that regulates mTOR activity is intricate. As we tease apart how psychedelics and other psychoplastogens turn on mTOR signaling, we might be able to engineer compounds that only produce the therapeutic effects on neuronal growth while bypassing pathways that lead to undesired hallucinations.

This figure shows the effects of three psychedelics and one control (VEH) on cortical neurons. These neurons were treated for 24 hours before being visualized using super-resolution microscopy. The colors represent proteins found in specific locations of the neuron. Orange protrusions from the purple dendrite indicate dendritic spines. Ly et al., CC BY-ND

The field has known for some time now that psychedelics can produce lasting positive effects on brain function, and it’s possible that these long-lasting changes result from the psychoplastogenic effects of these drugs. If true, this would suggest that psychoplastogens might be used to repair circuits that are damaged in mood and anxiety disorders.

Panacea or poison?

Many diseases, such as depression and anxiety disorders, are characterized by atrophy of dendritic branches and spines. Therefore, compounds capable of rapidly promoting dendritic growth, like psychedelics, have broad therapeutic potential. The number of papers demonstrating that psychedelics can produce therapeutic effects continues to grow every year.

However, we should temper our enthusiasm because we do not yet know all of the risks associated with using these drugs. For example, it’s possible that promoting neuronal growth during development could have negative consequences by interfering with the normal processes by which neural circuits are refined. We just don’t know, yet.

Similarly, it is unclear what effects psychoplastogens will have on the aging brain. It’s important to keep in mind that excessive mTOR activation is also associated with a number of diseases including autism spectrum disorder (ASD) and Alzheimer’s disease.

To me, it’s obvious that we need to understand how these powerful compounds affect the brain, in both positive and negative ways, if we hope to fully comprehend the fundamental laws governing how the nervous system works and how to fix it when it doesn’t.

David E. Olson, Assistant Professor, Department of Chemistry; Department of Biochemistry & Molecular Medicine; Center for Neuroscience, University of California, Davis

This article was originally published on The Conversation. Read the original article.

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