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Archive for the ‘Drug laws’ Category

Contaminants Found in 90% of Herbal Supplements Tested

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The FDA does not jurisdiction over herbal supplements as it does over drugs, so it cannot act to ensure purity or validity of claims of efficacy. Thus the decision by Congress is to use the honor system, with corporations on their honor to ensure that their products are pure, safe, and efficacious. That works pretty much as one would expect. Dr. Michael Greger blogs:

The majority of dietary supplement facilities tested were found noncompliant with good manufacturing practices guidelines.

“The U.S. public is not well protected” by current dietary supplement recommendations, an issue I explore in my video Dangers of Dietary Supplement Deregulation. Sometimes, there is too little of whatever’s supposed to be in the bottle, and other times, there’s too much, as I discussed in my video Black Raspberry Supplements Put to the Test. In one case, as you can see at 0:20 in my video, hundreds of people suffered from acute selenium toxicity, thanks to an “employee error at one of the ingredient suppliers.” Months later, many continued to suffer. Had the company been following good manufacturing practices, such as testing their ingredients, this may not have happened. In 2007, the FDA urged companies to adhere to such guidelines, but seven years later, the majority of dietary supplement facilities remained noncompliant with current good manufacturing practices guidelines.

What are the consequences of this ineffective regulation of dietary supplements? Fifty-thousand Americans are harmed every year. Of course, prescription drugs don’t just harm; they actually kill 100,000 Americans every year—and that’s just in hospitals. Drugs prescribed by doctors outside of hospital settings may kill another 200,000 people every year, but that doesn’t make it any less tragic for the thousands sickened by supplements.

Sometimes the supplements may contain drugs. Not only does a substantial proportion of dietary supplements have quality problems, the “FDA has identified hundreds of dietary supplements…that have been adulterated with prescription medications” or, even worse, designer drugs that haven’t been tested—like tweaked Viagra compounds. About half of the most serious drug recalls in the U.S. aren’t for drugs but for supplements, yet two-thirds or recalled supplements were still found on store shelves six months later.

There is also inadvertent contamination with potentially hazardous contaminants, such as heavy metals and pesticides in 90 percent of herbal supplements tested, as you can see at 2:09 in my video. Mycotoxins, potentially carcinogenic fungal toxins like aflatoxin, were found in 96 percent of herbal supplements. Milk thistle supplements were the worst, with most having more than a dozen different mycotoxins. It’s thought that since the plant is harvested specifically when it’s wet, it can get moldy easily. Many people take milk thistle to support their livers yet may end up getting exposed to immunotoxic, genotoxic, and hepatotoxic—meaning liver toxic—contaminants. How is this even legal? In fact, it wasn’t legal until 1994 with the passage of the Dietary Supplement Health and Education Act. Prior to that, supplements were regulated like food additives so you had to show they were safe before they were brought to market—but not anymore. Most people are unaware that supplements no longer have to be approved by the government or that supplement ads don’t have to be vetted. “This misunderstanding may provide some patients with a false sense of security regarding the safety and efficacy of these products.”

This deregulation led to an explosion in dietary supplements from around 4,000 when the law went into effect to more than 90,000 different supplements now on the market, each of which is all presumed innocent until proven guilty, presumed safe until a supplement hurts enough people. “In other words, consumers must suffer harm…before the FDA begins the slow process toward restricting [a] product from the market.” Take ephedra, for example. Hundreds of poison control center complaints started back in 1999, increasing to thousands and including reports of strokes, seizures, and deaths. Yet the FDA didn’t pull it off store shelves for seven years, thanks to millions of dollars from the industry spent on lobbying.

What did the companies have to say for themselves?  . . .

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Written by LeisureGuy

4 June 2020 at 1:20 pm

Kansas sheriff finally pays up for stupid and botched raid

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I remember this from when it happened and now — seven years later — the sheriff’s department is finally giving up. Kansas.

Jacob Sullum reports at Reason:

The Leawood, Kansas, couple whose home was raided in 2012 after sheriff’s deputies claimed that loose tea found in their trash was marijuana will receive $150,000 for their trouble under a settlement agreement with the Johnson County Sheriff’s Office. The settlement—which caps seven years of litigation, including two trips to the U.S. Court of Appeals for the 10th Circuit—falls far short of the $7 million that Adlynn and Robert Harte originally sought. But it represents an implicit acknowledgment that the Hartes and their children suffered an outrageous invasion of their privacy and dignity in the service of a comically inept publicity stunt.

Here are some of the absurd facts that emerged as the couple’s case was making its way through the courts:

  • The family was targeted because Robert Harte bought supplies at a hydroponic gardening store in Kansas City. Harte was planning to grow vegetables with his son as a science project. But to Sgt. James Wingo of the Missouri State Highway Patrol, who was staking out the store, he looked like a cannabis kingpin.
  • Wingo passed his hot tip to the Johnson County Sheriff’s Office, which sat on the information for eight months. Deputies did not start investigating the Hartes until early April 2012, a couple of weeks before they planned to conduct a bunch of pot raids on April 20, the unofficial stoner holiday.
  • The deputies never conducted a background investigation, which would have revealed not only that the Hartes had clean criminal records but that they were both former CIA employees with the highest level of security clearance.
  • Desperate to justify a raid that had already been planned, deputies rummaged through the Hartes’ garbage on three occasions. The first time around, Deputies Edward Blake and Mark Burns found “a small amount of wet, green vegetation,” which they deemed innocuous.
  • During his second inspection of the Hartes’ trash, Burns found the same leaves, which he suddenly decided looked like “wet marijuana plant material.” A drug field test supposedly confirmed the presence of THC.
  • When Burns dove into the family’s refuse a third time, just three days before the big 4/20 event, he found more leaves, which again supposedly tested positive for THC.
  • The “wet marijuana plant material” was actually loose tea that Adlynn Harte favored. Burns later confessed that he had never seen loose tea before but thought, based on his training and experience, that it looked like marijuana leaves.
  • A lab technician consulted after the raid disagreed, saying the leaves found in the Hartes’ trash didn’t “appear to be marijuana” to the unaided eye and didn’t “look anything like marijuana leaves or stems” under a microscope.
  • Field tests for drugs are notoriously unreliable. As 10th Circuit Judge Carlos Lucero noted after considering this case in 2017, one study “found a 70% false positive rate using this field test, with positive results obtained from substances including vanilla, peppermint, ginger, eucalyptus, cinnamon leaf, basil, thyme, lemon grass, lavender, organic oregano, organic spearmint, organic clove, patchouli, ginseng, a strip of newspaper, and even air.”
  • The label on the test kit used by Burns warns that its results “are only presumptive in nature” and should be confirmed by laboratory analysis. Yet then-Sheriff Frank Denning, who authorized the search of the Hartes’ home without laboratory confirmation of the field test results, claimed he had never heard such tests could generate false positives, despite four decades in law enforcement and despite the warning on the label.
  • The visit to the hydroponic store and the tea in the trash were the sole basis for the search warrant.
  • On the day of the raid, 10th Circuit Judge Joel Carson noted in a 2019 opinion, “Bob opened the front door” shortly before 7:30 a.m., “and the deputies flooded in the foyer. Bob ended up on the ground with an assault rifle pointed at or near him. The deputies ordered Addie and the couple’s two young children to sit cross-legged against a wall. A deputy eventually allowed the family to move to the living room couch where an armed deputy kept watch over them.”
  • It soon became clear that Johnson County’s Keystone Cops had screwed up. “After searching the home for about fifteen to twenty minutes,” Carson wrote, “the deputies found the hydroponic tomato garden that was readily visible from the exterior of the home through a front-facing basement window. And after ninety minutes of extensive searching, a couple of the deputies claimed to smell the ‘faint odor of marijuana’ at various places in the residence. A drug-detection dog showed up, but did not alert the officers to any other areas of the house requiring further searches. The dog’s handler also did not smell marijuana.”
  • The deputies found no marijuana or any other evidence of illegal activity, even after searching the house “from stem to stern.” But the same deputies who did not know the difference between tea and marijuana also did not realize there could be a legal explanation for the purchase of hydroponic gardening equipment. Blake “testified that up to that point in time, he had never seen a layout of a hydroponic-grow operation similar to Plaintiffs’ that was not being used to grow marijuana.”

Lucero summed up the situation well three years ago. “The  . . .

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Written by LeisureGuy

12 May 2020 at 8:28 am

Walmart Was Almost Charged Criminally Over Opioids. Trump Appointees Killed the Indictment.

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Jesse Eisinger and James Bandler report in ProPublica:

On a Tuesday just before Halloween in 2018, a group of federal prosecutors and agents from Texas arrived in Washington. For almost two years, they’d been investigating the opioid dispensing practices of Walmart, the largest company in the world. They had amassed what they viewed as highly damning evidence only to face a major obstacle: top Trump appointees at the Department of Justice.

The prosecution team had come to Washington to try to save its case. Joe Brown, the U.S. attorney for the Eastern District of Texas, led the group, which included Heather Rattan, an over-20-year veteran of the office who had spent much of her career prosecuting members of drug cartels.

They first went to the Drug Enforcement Administration’s headquarters to meet the acting administrator, Uttam Dhillon. There Rattan laid out the evidence. Opioids dispensed by Walmart pharmacies in Texas had killed customers who had overdosed. The pharmacists who dispensed those opioids had told the company they didn’t want to fill the prescriptions because they were coming from doctors who were running pill mills. They pleaded for help and guidance from Walmart’s corporate office.

Investigators had obtained records of similar cries for help from Walmart pharmacists all over the country: from Maine, North Carolina, Kansas and Washington, and other states. They reported hundreds of thousands of suspicious or inappropriate opioid prescriptions. One Walmart employee warned about a Florida doctor who had a “list of patients from Kentucky that have been visiting pharmacies in all of central Wisconsin recently.” That doctor had sent patients to Walmarts in more than 30 other states.

In response to these alarms, Walmart compliance officials did not take corporate-wide action to halt the flow of opioids. Instead, they repeatedly admonished pharmacists that they could not cut off any doctor entirely. They could only evaluate each prescription on an individual basis. And they went further. An opioid compliance manager told an executive in an email, gathered during the inquiry and viewed by ProPublica, that Walmart’s focus should be on “driving sales.”

After they finished their presentation, Dhillon sat back in his chair and exclaimed, “Jesus Christ,” according to five people familiar with the investigation. “Why aren’t we talking about this as a criminal case?”

That’s precisely what had occurred seven months earlier: Rattan had informed Walmart that she was preparing to indict the corporation for violating the Controlled Substances Act. Indictments of Fortune 500 companies are unheard of, let alone of one with $500 billion in annual revenue and over 2 million employees. But Rattan, with support from her boss Brown, believed the evidence justified such an unprecedented step.

Before the Texas prosecutors could file their case, however, Walmart escalated concerns to high-ranking officials at the DOJ, who then intervened. Brown was ordered to stand down. On Aug. 31, 2018, Trump officials officially informed Walmart that the DOJ would decline to prosecute the company, according to a letter from Walmart’s lawyer that lays out the chronology of the case.

But the Texas prosecutors hadn’t given up. Now, two months later, they still thought they had a chance to bring the then-deputy attorney general, Rod Rosenstein, and other top officials around. After the first presentation at the DEA offices that day, the Texas group — now accompanied by the DEA’s Dhillon — caravanned over to the DOJ.

They filed into a big, bright conference room, where they were received by Rosenstein and a collection of political appointees and career staff. Rattan and her team were given a half-hour to make their presentation. She explained that dispensing opioids without a legitimate medical purpose is legally akin to dealing heroin. Criminal law says if a person or entity is willfully blind or deliberately ignorant, they are as liable as if they had acted intentionally. Once Walmart’s headquarters knew its pharmacists were raising alarms about suspicious prescriptions, but the compliance department continued to allow — even push — them to fill them, well, that made the company guilty, the Texas prosecutors contended.

This was not a question of a few rogue employees, Rattan explained. Walmart had a national problem. Worse, the prosecutors contended, the company was a repeat offender. Walmart had agreed to a settlement with the DEA seven years earlier in which it had promised to improve its controls over the abuse of opioid prescriptions. Still the problems persisted. That’s why the prosecutors believed they needed to pursue the extraordinary path of a criminal prosecution. As they concluded, Brown was emphatic, telling Rosenstein: “We have to act.”

A fine would not be a sufficient deterrent, the DEA’s Dhillon added, since Walmart “has more money than it knows what to do with.”

“Not that there’s anything wrong with that,” Rosenstein responded, according to five people familiar with the investigation. “We are all capitalists here.”

Rosenstein’s quip brought the prosecutorial team up short. They weren’t pursuing Walmart because it was profitable but because, in their view, the company had put its customers at deadly risk. . .

Continue reading. There’s much more — and it’s disgusting.

Written by LeisureGuy

25 March 2020 at 3:27 pm

A Communist LSD Trip: The Story of Czechoslovak Acid

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From Prezkroj, an article by Aleksander Kaczorowski:

The history of Czechoslovak LSD is one of the greatest phenomena of the second half of the 20th century. How come for almost a quarter of a century, in a communist state, thousands of people, including many popular artists such as Karel Gott, were able to use psychedelic drugs entirely legally?

Why was 1960s Czechoslovakia the leading manufacturer and exporter of LSD? And why could psychiatrists there, under the guardianship of the secret police and military intelligence, experiment freely with this substance long after it had been banned all over the world?

The most unbelievable thing about this story is that it originated long before the era of Flower Power, the counterculture movement and the 1968 Prague Spring, in a past as distant and gloomy as possible: during the first years of communist rule in Eastern Europe.

In the autumn of 1952 – at the exact moment when the paranoically suspicious USSR leader Joseph Stalin unleashed a purge among the Kremlin doctors, accusing them of conspiring to assassinate him and other leaders – several young psychiatrists in Prague ingested for the first time a mysterious substance that had been sent from a laboratory in Basel. This is how the Czechoslovak adventure with LSD began.

The substance arrived in Prague in an entirely legal way. A standard shipment from the pharmaceutical company Sandoz was sent to Dr Jiří Roubíček, an associate professor at the Faculty of Psychiatry at the Medical University of Prague. It contained ampoules with an oily, transparent substance described as ‘lysergic acid diethylamide’, a substance first synthesized in 1938 by the Swiss scientist Albert Hofmann. Initially considered useless, LSD attracted the attention of the company owners after Hoffman accidentally tested its effects on himself on 19th April 1943. Four years later, the first study summarizing the results of LSD tests involving healthy volunteers and patients in psychiatric hospitals was released. The article was attached to the parcel that landed on Roubíček’s desk.

Doctors in their patients’ shoes

Roubíček was a well-regarded researcher of phenomena related to brainwave activity, and the author of pioneering research on the application of encephalography methods in psychiatry. He regularly received various parcels from the Swiss company, but this one was particularly interesting. The description stated that the mysterious substance evoked hallucinations characteristic of mental illnesses. After a series of tests on animals, Roubíček decided to administer the substance to a group of healthy volunteers and explore how LSD would affect the human brain.

The initial experiments were carried out at a psychiatric hospital in Prague’s Bohnice district. The participants were given minimal doses – doctors already knew that just one gram of the substance would be sufficient to induce hallucinations in 10,000 people. Each volunteer drank a glass of water mixed with the hallucinogen and was locked in a padded room equipped with a one-way mirror.

The doctors then began testing the substance on themselves. “I was one of the first people in Czechoslovakia who took LSD,” the eminent psychiatrist Professor Jan Srnec recalled 60 years later. “It was something unbelievable. First of all, it was extraordinary that such a small dose could cause a complete disintegration of the psyche. Second, LSD had an entirely different effect on different people. In my case, it was a state of pure euphoria, elation.”

Thanks to LSD, psychiatrists were able to put themselves in their patients’ shoes. They could experience, in a controlled environment, the conditions faced by people with incurable mental illnesses. Many orthopaedists have shared the experience of a patient with a broken arm or leg. But how can someone relate to the condition of a person with severe schizophrenic delusions if they themselves do not experience any mental health issues? How can a psychiatrist help such a patient? LSD was the door through which Czechoslovak doctors entered the world of delusions and psychoses, and they left it wide open for those willing to explore.

The first to take advantage of this opportunity were artists, especially painters and graphic designers. Roubíček had acquaintances in the circles of artistic bohemia. So, he came up with the idea to invite some of them to take part in the experiment. In return, they were to express through visual means what other volunteers could only talk about.

The effect surpassed all expectations. The artistic depictions of hallucinations and visions were extremely suggestive, and news of the extraordinary substance quickly spread among non-conformist Czechoslovak artists.

One of them was Vladimír Boudník, the creator of an innovative graphic technique known as ‘explosionism’. Since the mid-1950s, the legendary Gentle Barbarian – the eponymous character of Bohumil Hrabal’s 1973 novel – had been creating prints using filings randomly scattered on industrial sheet metal and imprinted in the graphic press. In this way, he obtained extraordinary visual effects reminiscent of drug-induced visions. Besides LSD administered under the supervision of psychiatrists from Bohnice, Boudník did not take any other drugs or hallucinogenic substances.

As a result, there were so many people keen to participate in the experiments that Roubíček and his colleagues decided to train a group of assistants. . .

Continue reading. There’s much more.

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Written by LeisureGuy

29 January 2020 at 2:21 pm

Cannabinoids remove plaque-forming Alzheimer’s proteins from brain cells

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The Salk Institute for Biological Studies reports:

Salk Institute scientists have found preliminary evidence that tetrahydrocannabinol (THC) and other compounds found in marijuana can promote the cellular removal of amyloid beta, a toxic protein associated with Alzheimer’s disease.

While these exploratory studies were conducted in neurons grown in the laboratory, they may offer insight into the role of inflammation in Alzheimer’s disease and could provide clues to developing novel therapeutics for the disorder.

“Although other studies have offered evidence that cannabinoids might be neuroprotective against the symptoms of Alzheimer’s, we believe our study is the first to demonstrate that cannabinoids affect both inflammation and amyloid beta accumulation in nerve cells,” says Salk Professor David Schubert, the senior author of the paper.

Alzheimer’s disease is a progressive brain disorder that leads to memory loss and can seriously impair a person’s ability to carry out daily tasks. It affects more than five million Americans according to the National Institutes of Health, and is a leading cause of death. It is also the most common cause of dementia and its incidence is expected to triple during the next 50 years.

It has long been known that amyloid beta accumulates within the nerve cells of the aging brain well before the appearance of Alzheimer’s disease symptoms and plaques. Amyloid beta is a major component of the plaque deposits that are a hallmark of the disease. But the precise role of amyloid beta and the plaques it forms in the disease process remains unclear.

In a manuscript published in June 2016’s Aging and Mechanisms of Disease, the Salk team studied nerve cells altered to produce high levels of amyloid beta to mimic aspects of Alzheimer’s disease.

The researchers found that high levels of amyloid beta were associated with cellular inflammation and higher rates of neuron death. They demonstrated that exposing the cells to THC reduced amyloid beta protein levels and eliminated the inflammatory response from the nerve cells caused by the protein, thereby allowing the nerve cells to survive.

“Inflammation within the brain is a major component of the damage associated with Alzheimer’s disease, but it has always been assumed that this response was coming from immune-like cells in the brain, not the nerve cells themselves,” says Antonio Currais, a postdoctoral researcher in Schubert’s laboratory and first author of the paper. “When we were able to identify the molecular basis of the inflammatory response to amyloid beta, it became clear that THC-like compounds that the nerve cells make themselves may be involved in protecting the cells from dying.”

Brain cells have switches known as receptors that can be activated by endocannabinoids, a class of lipid molecules made by the body that are used for intercellular signaling in the brain. The psychoactive effects of marijuana are caused by THC, a molecule similar in activity to endocannabinoids that can activate the same receptors. Physical activity results in the production of endocannabinoids and some studies have shown that exercise may slow the progression of Alzheimer’s disease.

Schubert emphasized that his team’s findings were conducted in exploratory laboratory models, and that the use of THC-like compounds as a therapy would need to be tested in clinical trials. . .

Continue reading.

Written by LeisureGuy

25 January 2020 at 6:52 pm

Inside Purdue Pharma’s Media Playbook: How It Planted the Opioid “Anti-Story”

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David Armstrong reports in ProPublica about how wealthy drug dealers get away with it.

In 2004, Purdue Pharma was facing a threat to sales of its blockbuster opioid painkiller OxyContin, which were approaching $2 billion a year. With abuse of the drug on the rise, prosecutors were bringing criminal charges against some doctors for prescribing massive amounts of OxyContin.

That October, an essay ran across the top of The New York Times’ health section under the headline “Doctors Behind Bars: Treating Pain is Now Risky Business.” Its author, Sally Satel, a psychiatrist, argued that law enforcement was overzealous, and that some patients needed large doses of opioids to relieve pain. She described an unnamed colleague who had run a pain service at a university medical center and had a patient who could only get out of bed by taking “staggering” levels of oxycodone, the active ingredient in OxyContin. She also cited a study published in a medical journal showing that OxyContin is rarely the only drug found in autopsies of oxycodone-related deaths.

“When you scratch the surface of someone who is addicted to painkillers, you usually find a seasoned drug abuser with a previous habit involving pills, alcohol, heroin or cocaine,” Satel wrote. “Contrary to media portrayals, the typical OxyContin addict does not start out as a pain patient who fell unwittingly into a drug habit.”

The Times identified Satel as “a resident scholar at the American Enterprise Institute and an unpaid advisory board member for the Substance Abuse and Mental Health Services Administration.” But readers weren’t told about her involvement, and the American Enterprise Institute’s, with Purdue.

Among the connections revealed by emails and documents obtained by ProPublica: Purdue donated $50,000 annually to the institute, which is commonly known as AEI, from 2003 through this year, plus contributions for special events, for a total of more than $800,000. The unnamed doctor in Satel’s article was an employee of Purdue, according to an unpublished draft of the story. The study Satel cited was funded by Purdue and written by Purdue employees and consultants. And, a month before the piece was published, Satel sent a draft to Burt Rosen, Purdue’s Washington lobbyist and vice president of federal policy and legislative affairs, asking him if it “seems imbalanced.”

On the day of publication, Jason Bertsch, AEI’s vice president of development, alerted Rosen to “Sally’s very good piece.”

“Great piece,” Rosen responded.


Purdue’s hidden relationships with Satel and AEI illustrate how the company and its public relations consultants aggressively countered criticism that its prized painkiller helped cause the opioid epidemic. Since 1999, more than 200,000 people have died from overdoses related to prescription opioids. For almost two decades, and continuing as recently as a piece published last year in Slate, Satel has pushed back against restrictions on opioid prescribing in more than a dozen articles and radio and television appearances, without disclosing any connections to Purdue, according to a ProPublica review. Over the same period, Purdue was represented by Dezenhall Resources, a PR firm known for its pugnacious defense of beleaguered corporations. Purdue was paying Dezenhall this summer, and still owes it money, according to bankruptcy filings.

Purdue funded think tanks tapped by the media for expert commentary, facilitated publication of sympathetic articles in leading outlets where its role wasn’t disclosed, and deterred or challenged negative coverage, according to the documents and emails. Its efforts to influence public perception of the opioid crisis provide an inside look at how corporations blunt criticism of alleged wrongdoing. Purdue’s tactics are reminiscent of the oil and gas industry, which has been accused of promoting misleading science that downplays its impact on climate change, and of big tobacco, which sought to undermine evidence that nicotine is addictive and secondhand smoke is dangerous.

Media spinning was just one prong of Purdue’s strategy to fend off limits on opioid prescribing. It contested hundreds of lawsuits, winning dismissals or settling the cases with a provision that documents remain secret. The company paid leading doctors in the pain field to assure patients that OxyContin was safe. It also funded groups, like the American Pain Foundation, that described themselves as advocates for pain patients. Several of those groups minimized the risk of addiction and fought against efforts to curb opioid use for chronic pain patients.

Purdue’s campaign may have helped thwart more vigorous regulation of opioid prescribing, especially in the decade after the first widespread reports of OxyContin abuse and addiction began appearing in 2001. It may also have succeeded in delaying the eventual reckoning for Purdue and the billionaire Sackler family that owns the company. Although Purdue pleaded guilty in 2007 to a federal charge of understating the risk of addiction, and agreed to pay $600 million in fines and penalties, the Sacklers’ role in the opioid epidemic didn’t receive widespread coverage for another decade. As backlash against the family swelled, the company filed for Chapter 11 bankruptcy in September.

“Efforts to reverse the epidemic have had to counter widespread narratives that opioids are generally safe and that it is people who abuse them that are the problem,” said Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School of Public Health, who has served as a paid expert witness in litigation alleging that Purdue’s marketing of OxyContin misled doctors and the public. “These are very important narratives, and they have become the lens through which people view and understand the epidemic. They have proven to be potent means of hampering interventions to reduce the continued oversupply of opioids.”

Satel, in an email to ProPublica, said that she reached her conclusions independently. “I do not accept payment from industry for my work (articles, presentations, etc),” she wrote. “And I am open to meeting with anyone if they have a potentially interesting topic to tell me about. If I decide I am intrigued, I do my own research.”

As for Purdue’s funding of AEI, Satel said in an interview that she “had no idea” that the company was paying her employer and that she walls herself off from information regarding institute funders. “I never want to know,” she said. She didn’t disclose that the study she referred to was also funded by Purdue, she said, because “I cite peer-reviewed papers by title as they appear in the journal of publication.”

The sharing of drafts before publication with subjects of stories or other interested parties is prohibited or discouraged by many media outlets. Satel said she didn’t remember sharing the draft with Rosen and it was not her usual practice. “That’s very atypical,” she said. However, Satel shared a draft of another story with Purdue officials in 2016, according to emails she sent. In that case, Satel said, she was checking facts.

Satel said she didn’t remember why the doctor with a patient on high doses of painkillers wasn’t named in the Times story. The draft she sent to Purdue identified him as Sidney Schnoll, then the company’s executive medical director, who defended OxyContin at public meetings and in media stories. In an interview, Schnoll described Satel as an old friend and said her description of his patient was accurate. He left Purdue in 2005 and now works for a consulting company that has Purdue as a client, he said.

Purdue, in a statement, said it has . .

Continue reading.

Written by LeisureGuy

19 November 2019 at 4:45 pm

Jeff Bezos Mocks France

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Matt Stoller writes in Big:

Those of you who have read BIG for awhile know that I pay a lot of attention to foreign enforcers. I wrote up how the Russians are actually effective at protecting competition in search, whereas the EU is not. I’m also intrigued by Rod Sims in Australia, who is likely to take significant action.

My favorite enforcer in Europe is the German head of their cartel office, Andreas Mundt. Mundt has been the most aggressive antitrust enforcer in the world when it comes to Facebook. In February, his office attacked the core of its targeted advertising program, ruling “that the company stop automatically sharing data among the services it owns, like Instagram and WhatsApp, or websites that use its “like” and “share” buttons.”

This ruling wasn’t just about privacy. Data is a key input in advertising, so preventing Facebook from using data to undermine its competitors who sell advertising would have a big impact on the market. Mundt is also a fighter. A German court just ruledagainst Mundt using the rationale that Facebook’s collection of data isn’t a competition problem. And Mundt is appealing.

Mundt, however, is on the leading edge of enforcement. Many European officials are, like center-left Americans in the antitrust bar, still libertarian-leaning, though sort of embarrassed about it. The most recent example of European unwilling to confront power happened last month when the French decided to impose a tax on big techinstead of restructuring market power directly. The tax applies to companies with revenue of higher than 750 million euros and 25 million euros in France.

So what did Jeff Bezos do? His response is almost comical.

Virginie Lemaire recently opened her email to an unsettling message from Amazon: fees for sellers like her in France will be increasing by 3%.

Lemaire, a single mother of two, started her jewelry company Perle d’un jour in 2011. Trained as an artisan jeweler, she makes handmade custom pieces like necklaces, bracelets and rings.

The French small business owner started selling her products on Amazon two years ago and now generates one-fifth of her sales from the e-commerce giant’s marketplace.

So it was an unwelcome surprise when she found out Amazon would be raising seller fees for her and thousands of other small and medium-sized French businesses starting in October. The reason the company cited was simple: a 3% digital tax passed by the French government in July.

Yup, Amazon just passed the tax along to French businesses. That’s monopoly power, baby. Bezos can simply impose private taxes, pretty much at willThe idea of taxing monopolies, instead of breaking them up, is coming from those who like centralized power but are uncomfortable with American control of it.

Another example of this philosophy is the just leaked documents of plans to create a $100 billion European sovereign wealth fund to build European competitors to American and Chinese big tech.

The officials identify Google, Apple, Facebook, Amazon, Microsoft, Baidu, Alibaba and Tencent among the companies Europe needs to rival. “Europe has no such companies,” their document notes.

Europeans are embarrassed they don’t have large tech companies, instead of recognizing the leverage this gives them. Financing competitors to monopolists isn’t likely to work, and it will also violate trade commitments. And conceptually it’s problematic because it mis-frames the problem as Europeans not being innovative enough to compete. But Europeans are just as innovative as anyone else. The problem is that European markets, like markets dominated everyone by big tech, are monopolized by centralized institutions.

This philosophy also misframes leverage. Europe is not some weak set of feckless states who must bow before Google or Amazon. These are countries with sovereign power, and Amazon and Google need European markets a hell of a lot more than these countries need Amazon and Google. Europe should just break these guys up, as Mundt is effectively doing with Facebook.

The reason these officials do not want to break up big tech monopolies is that they don’t fear concentrated power, they just believe that only European leaders should be able to concentrate it. Similarly, some on the left in the U.S. just do not care that Google and Facebook have monopolized advertising, thinking as they do that advertising is a dirty business. They prefer publicly financed media, a sort of ‘we like centralized power but the people in charge have to be nice people.’ This preference for centralized power goes all the way back to Teddy Roosevelt and the New Nationalists, so the debate isn’t new.

Jeff Bezos’s almost casual ability to ward off France’s digital tax shows, however, that the philosophy of ‘concentrate power but in nice peoples’ hands’ is conceptually flawed. The only way to deal with big tech is by going at their monopoly power directly. Doing so will requires more enforcers within the European regulatory apparatus adopting Mundit’s creativity and aggressiveness, and more importantly, his philosophy that concentrations of private power are intrinsically a threat to liberty.

One of the key officials who has to change her mind is Margareth Vestager, the head of the European Competition Authority (though for how much longer it’s not clear). Vestager is somewhat assertive and gets big fines from Google, but on a conceptual level she basically accepts the thinking of big tech lobbyists. This attitude came out when she was asked about Elizabeth Warren’s plan to break up big tech. She said she opposes it, and explained why. . .

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Written by LeisureGuy

27 August 2019 at 10:11 am

Seattle Has Figured Out How to End the War on Drugs

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The War on Drugs, let us remember, is thanks to Richard Nixon, infamous crooked president, who rejected the findings of his own expert commission on the problem figuring that, since he was president, he knew a lot more than a group of people who had seriously studied the issues for years. (Sound familiar?) Nicholas Kristof writes in the NY Times:

On gritty streets where heroin, fentanyl and meth stride like Death Eaters, where for decades both drugs and the war on drugs have wrecked lives, the city of Seattle is pioneering a bold approach to narcotics that should be a model for America.

Anyone caught here with a small amount of drugs — even heroin — isn’t typically prosecuted. Instead, that person is steered toward social services to get help.

This model is becoming the consensus preference among public health experts in the U.S. and abroad. Still, it shocks many Americans to see no criminal penalty for using drugs illegally, so it takes courage and vision to adopt this approach: a partial retreat in the war on drugs coupled with a stepped-up campaign against addiction.

The war on drugs has been one of America’s most grievous mistakes, resulting in as many citizens with arrest records as with college diplomas. At last count, an American was arrested for drug possession every 25 seconds, yet the mass incarceration this leads to has not turned the tide on narcotics.

The number of opioid users has surged, and more Americans now die each year from overdoses than perished in the Vietnam, Afghan and Iraq wars combined. And that doesn’t account for the way drug addiction has ripped apart families and stunted children’s futures. More than two million children in America live with a parent suffering from an illicit-drug dependency.

So Seattle is undertaking what feels like the beginning of a historic course correction, with other cities discussing how to follow. This could be far more consequential than the legalization of pot: By some estimates, nearly half of Americans have a family member or close friend enmeshed in addiction, and if the experiment in Seattle succeeds, we’ll have a chance to rescue America from our own failed policies.

In effect, Seattle is decriminalizing the use of hard drugs. It is relying less on the criminal justice toolbox to deal with hard drugs and more on the public health toolbox.

Decriminalization is unfolding here in part because of Dan Satterberg, the prosecuting attorney for King County, which includes Seattle. It’s also arguably underway because of what happened to his little sister, Shelley Kay Satterberg.

At the age of 14, Shelley ran away from home because her parents wouldn’t let her go to a concert on a school night. It was a rebellion that proved devastating. She was away for several months, was gang-raped by two men, was introduced to hard drugs and began to self-medicate with those drugs to deal with the trauma of rape.

As Dan Satterberg rose through the ranks of prosecutors, Shelley Satterberg wrestled with addiction. She was never arrested or jailed (middle-class drug users often avoid police attention, which focuses on marginalized people who use or sell in public).

Dan told me that he was angry at Shelley — angry that she had made terrible choices, angry that she had hurt their parents. But over time he also concluded that his own approach of prosecuting drug users accomplished little, except that it isolated them from the family and friends who offered the best support system to escape addiction.

In 2015, Dan took Shelley to Navos, a nonprofit that provides mental health and addiction services, and she was able to stop using street drugs and gradually put her life back in order. Dan saw that treatment made a huge difference in Shelley’s life and became a believer.

Yet it wasn’t enough. Shelley died of a urinary tract infection last year at age 51, a consequence of previous drug and alcohol abuse.

“It gave me some insight about what works better than jail,” Dan Satterberg told me. “What Shelley needed was not a jail cell and not a judge wagging a finger at her, but she needed some support.”

Seattle’s first crucial step came in 2011 when Satterberg and others started a program called LEAD, short for Law Enforcement Assisted Diversion. The idea is that instead of simply arresting drug users for narcotics or prostitution, police officers watch for those who are nonviolent and want help, and divert them to social service programs and intensive case management.

Almost immediately, this was a huge success. A 2017 peer-reviewed study found that drug users assigned to LEAD were 58 percentless likely to be rearrested, compared with a control group. Participants were also almost twice as likely to have housing as they had been before entering LEAD, and 46 percent more likely to be employed or getting job training.

LEAD isn’t cheap — it costs about $350 per month per participant to provide case managers. But it is cheaper than jail, courts and costs associated with homelessness. As a result, this approach has spread rapidly around the country, with 59 localities now offering LEAD initiatives or rolling them out.

Chian Jennings, 45, who had struggled with drugs for years, living in the streets and financing her habit by selling sex and by stealing, was smoking crack when a policeman stopped her.

“It was probably the best thing that happened to me,” Jennings told me. “It saved my life.” Instead of locking her up, the police officer handed her over to social workers at LEAD.

Through LEAD, Jennings got medical care, clothing and housing. She also gained confidence in herself, people who cared for her and the idea that life could get better. “They’re some of the most caring people I’ve ever met,” she said of the counselors. “Whether you come in high or not, they always treat you with respect.” Now, she said, “I work to make them proud of me.”

Jennings remains a work in progress. She says she still sometimes uses cocaine, but less over time, and she adds that she’s no longer stealing. If she had been held in jail, she said, “it would have pissed me off, and I would have gotten high when I got out. I’d still be homeless, stealing for food and drug money.”

Prison, she says, just makes people more miserable and more dependent on drugs when they are released. “This bit about ‘I learned my lesson’ — no, it doesn’t work that way,” she said. “People are hurting inside. That’s why they’re using in the first place.”

The war on drugs began in 1971 out of a legitimate alarm about narcotics both in the United States and among U.S. troops in Vietnam. But the “war” approach locked up enormous numbers of people and devastated the family structure. Drug laws discriminated against African-Americans (possession of crack cocaine, disproportionately used by blacks, drew far harsher sentences than possession of the same quantity of powdered cocaine, more likely to be used by whites).

Yet locking up endless waves of users has had little deterrent effect, and overdose deaths have surged. The White House has estimated that the economic cost of the opioid crisis in the United States exceeds $500 billion a year, equivalent to about $4,000 per household. And that doesn’t even include cocaine, meth and other drug use.

While the U.S. doubled down on the criminal justice approach to drugs, Portugal took the opposite avenue, decriminalizing possession of all drugs in 2001. It was a gamble, but it succeeded. As I’ve reported, Portugal’s overdose deaths plunged. The upshot is that drug mortality rates in the United States are now about 50 times higher than in Portugal. . .

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Written by LeisureGuy

26 August 2019 at 3:05 pm

The Opioid Crisis Is About More Than Corporate Greed

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Zachary Siegel reports in the New Republic:

“Just like Doritos keep eating. We’ll make more.”

“It’s like people are addicted to these things or something. Oh, wait, people are…”

These lines are from emails sent between opioid manufacturers and distributors, recently pried loose by attorneys general suing Big Pharma for its role in fueling a massive wave of overdose deaths. Similar to the damning internal memos revealing that Big Tobacco knew that cigarettes indeed caused cancer, these emails appear to show that Big Pharma knew that a significant share of their product was landing in the street, feeding addiction. And yet they kept shipping out obscene quantities to rural towns across America, creating even more demand.

Nearly every step of the pharmaceutical supply chain is implicated in the soaring death rate. According to the Centers for Disease Control and Prevention, prescription opioids killed 218,000 people from 1999 to 2017. Many of the companies—from Johnson & Johnson to obscure distributors like Cardinal Health—are listed as defendants in hundreds of lawsuits filed by nearly every state in the country. The government thinks these corporations should pay up and treat the addiction their products caused. But the companies claim to have been acting legally and in compliance with federal regulators like the Drug Enforcement Administration (DEA). Was it all, technically, legal?

What the opioid crisis illustrates is not that there are a few bad apples in the pharmaceutical industry, but that the country’s entire health care system is driven by profit at the expense of public health and safety. Drug manufacturers, pharmacy chains, drug distributors, and insurance companies got rich while people, especially people lower down the income ladder, suffered—and the DEA, through neglect or incompetence or a mix of both, watched it all happen.


While there are significant similarities between Big Pharma and Big Tobacco, there is also a key difference that makes today’s story of corporate malfeasance even worse: namely, that the supply chain for tobacco is much simpler than opioids, which are, theoretically, tightly controlled substances that pass through a dizzying array of actors and regulators.

First, a doctor must write a prescription, which must be filled at a pharmacy, and is likely paid for by an insurance company. Depending on the needs of their customers, pharmacies place orders for these drugs (customers, it turns out, need a lot of them). Shipping companies then go between the pharmacy and the drug manufacturers. Overseeing this entire system is the DEA, which sets the quota for how many opioids a company is allowed to manufacture, and tracks where those pills go.

While politicians are making hay out of Big Pharma’s wanton greed and recklessness, far less attention has been paid to the DEA. Attorneys general suing Big Pharma recently unearthed a database that both the corporations and the government—each for their own self-interested reasons—fought to keep sealed, called the Automation of Reports and Consolidated Orders System (ARCOS). Mammoth in size and granular in detail, ARCOS tracks the shipments of every single controlled substance, from the company that manufactured it, to the company that shipped it, to the pharmacy that received it. It is the world atlas for how the opioid crisis began.

All told, from 2006 to 2012, roughly 76 billion oxycodone and hydrocodone pills criss-crossed America, according to a Washington Post analysis. While many of these pills went to legitimate patients, millions more were showered on troubled communities with a voracious thirst for pain relief. While drug manufacturers produced more and more opioids (approved by the DEA), and distributors shipped those pills to pharmacies all over the country (tracked by the DEA), drug companies saw record profits—and America’s overdose death rate soared off the charts.

“I think this [database] brings home what we all knew,” says Corey Davis, an attorney and public health expert at the Network for Public Health Law. “This wasn’t just incompetence on the part of the DEA and the Department of Justice, it was knowing and intentional failure to do what most people think is their jobs.”

What is the DEA’s job, exactly? Its first task, and the one most associated with the agency, is the Sicario-esque disruption of illicit flows of drugs coming into the U.S. from abroad, like intercepting speedboats filled with cocaine. Its other major responsibility is controlling licit pharmaceuticals. “The whole goal of the prescription system is to make sure that patients are getting their medications, and that medications are not going to those who aren’t patients,” which is called “diversion,” says Bryce Pardo, a drug policy researcher at the RAND Corporation. “That’s the whole point of the system, which was invented a hundred years ago. Clearly, the system broke. The system failed.”

Pardo points out, in the DEA’s defense, the story of a so-called DEA whistle-blower blaming a pharma-backed piece of legislation passed by Congress in 2016, which prevented agents from stopping suspicious shipments of opioids, and stunted investigations into the very corporations that are now being villainized and sued. Just as DEA agents were working their way up the pharmaceutical supply chain, much as they would in a case against any transnational crime organization, Congress hamstrung their enforcement efforts.

Or so the story goes—but that’s not the whole of it. “These companies, often times acting legally, were asking for preclearance from the DEA to go about their business,” says Leo Beletsky, a professor of law and health sciences at Northeastern University (where I’m currently a journalism fellow). “Now, the DEA is saying their hands were tied when, in fact, their hands were not tied. They were completely asleep at the wheel. And by the time the DEA began constricting the [prescription] supply and targeting certain doctors and distributors, it was too late.”


In drug policy scholarship, there is a concept called the “balloon hypothesis.” When one end of a balloon gets squeezed, the air inside, rather than disappearing, rushes to fill the other end of the balloon. The balloon hypothesis is used to describe, often critically, America’s drug enforcement strategy. If cocaine production in Colombia is stamped out, production will shift to, say, Peru. If the Dark Web’s Silk Road gets shut down, a new Dark Web market pops up. The air has to go somewhere.

The balloon hypothesis also applies to the ever-shifting demand for drugs. “Over a period of 20 years, the DEA provided the green light to a 39-fold increase in the oxycodone quota and a 12-fold increase in the hydrocodone quota, even as our opioid epidemic unfolded,” Senator Dick Durbin wrote in a letter to the editor to The Washington Post. 

In other words, the prescription balloon expanded, under the DEA’s watch, big time. But starting in 2011, the prescription market finally began to shrink after Purdue Pharma reformulated its blockbuster drug OxyContin with so-called abuse deterrent technology, and pill mills serving the black market were shut down. The supply was squeezed. The air still had to go somewhere, and it rushed to deadlier opioids like heroin spiked with illicit fentanyl. With enforcement focused on prescription opioids, the overdose crisis got worse.

Dan Ciccarone, a physician-researcher at the University of California, San Francisco who studies heroin use, says the crisis unfolded in three waves:  . . .

Continue reading. There’s much more, including some pertinent observations on reducing demand (which ultimately is the only solution).

The Four Ordinary People Who Took On Big Pharma

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Beth Macy writes in the NY Times:

In the beginning, there were just four: the Godfather from Philly, the Army sergeant from Georgia, the professor from California and the feisty mom from Florida.

It was the early 2000s, and they usually talked over old-school computer message boards. Occasionally they gathered in person, carrying posters of their children and middle-aged spouses — all dead from OxyContin overdoses.

Today we know just how dangerous this drug is. Purdue Pharma, the company that made OxyContin, the first extended-release opioid to be widely prescribed, may finally be held to account. Some 200,000 people have died from overdosing on prescription opioids, and around 2,000 lawsuits attempting to make opioid makers and distributors pay for the damage unleashed by careless overprescribing are wending their way through the courts. But experts predict it will take more than $100 billion to turn the crisis around, and it’s hard to feel optimistic when you know the story of how long and hard these four labored in obscurity before anyone listened to them.

The four called themselves RAPP, short for Relatives Against Purdue Pharma, and they testified at hearings, lent support at whistle-blower trials and marched outside pharmaceutical-funded physician meetings at fancy resorts. They were outgunned at every pass — by a pharma-funded phalanx of lawyers and by doctors who had become paid spokesmen for the company. One resort even turned a sprinkler on them. But they picked up new members by the week.

Their leader was Ed Bisch, an I.T. worker from Philadelphia who’d lost his 18-year-old son, Eddie, in 2001. They called him the Godfather because he’d brought them together in the first place, via his website, OxyKills, shortly after Eddie’s death.

Mr. Bisch had wanted to believe Purdue’s excuses at first. He was persuaded, even, to change the name of his message board to OxyAbuseKills, after the company approached him about softening his tone, then gave him a $10,000 grant to put toward his education efforts. “They kept blaming it on the ‘abusers,’ but finally I said, ‘Look, at least 50 percent of my emails are from relatives of peoplewho are patients who are either dead or addicted,’” Mr. Bisch recalled. “It took me a while to realize how evil this company was.”

Barbara Van Rooyan, a professor of counseling at Folsom Lake College in California until she retired in 2012, told Mr. Bisch recently that finding his website “saved my life and gave me hope that the grief could be used for some good.” Her 24-year-old son, Patrick, died after taking OxyContin at a Fourth of July party in 2004. “It’s kind of like a muscle relaxant, and it’s F.D.A.-approved, so it’s safe,” the friend told Patrick.

The following year, with support from RAPP, Ms. Van Rooyan petitioned the Food and Drug Administration to recall OxyContin until it could be reformulated to make it harder for abusers to crush or dissolve the pills for a more intense high; she also wanted the drug restricted to end-of-life care and to treatment of cancer and other severe pain. It took eight years before the F.D.A. responded by noting that Purdue had voluntarily reformulated the drug in 2010 (so that point was moot), and her restriction petition was denied.

By 2007, RAPP numbered in the hundreds. That August scores of them converged in the rain outside a tiny federal courthouse in Abingdon, Va., because they wanted “to look evil in the face,” as the Florida mother, Lee Nuss, put it. Three of Purdue’s top executives had flown in to be sentenced on misdemeanor misbranding charges. Purdue’s parent company pleaded guilty to a felony misbranding charge, admitting that for six years it had fraudulently marketed OxyContin as being less prone to abuse and having fewer narcotic side effects than competing drugs.

All four of the original members of RAPP spoke at the hearing. They knew one another so well by then that they car-pooled to Abingdon and doubled up in hotel rooms to save money. One of them, Ed Vanicky, had fed evidence to the Virginia prosecutors — including a now-infamous cassette tape of a public-relations conference in which a Purdue spokesman brushed off the problems of OxyContin in Appalachia by saying, “The fact is, these rural areas have had problems with prescription drug abuse since the Civil War.” (In other words, the hillbillies, not Purdue’s drug, were defective.)

Mr. Vanicky was an Army sergeant in 2000 when he found his 44-year-old wife, Mary Jo, in bed dead after taking OxyContin for a herniated disc. He had just returned home from a yearlong posting in Korea and had never even heard the word OxyContin until the coroner who performed his wife’s autopsy inquired about it.

As she stepped down from the Abingdon witness stand, the Florida mother, Ms. Nuss, brandished a small brass urn containing some of the ashes of her son, Randall, who was 18 when he overdosed on OxyContin. There was a metal detector in the courthouse, and her friends still can’t figure out how she managed to sneak in that urn.

In the end, the company was forced to pay some $634 million in fines. A pittance, compared to the billions it had earned on the drug.

That fine is still the largest paid by Purdue to date, and it would do nothing to slow the epidemic. Not a single executive went to jail, and none of the settlement money went to treatment. OxyContin sales surged in its aftermath, topping $2 billion in 2008.

When Purdue finally reformulated OxyContin to make it abuse-resistant, the pill-addicted switched to heroin and, later, fentanyl to keep their dopesickness at bay. Within another decade, nearly 400,000 people would be deadMore than 2.6 million Americans are now addicted.

Today, the group’s prescience is clear. But they are sad, and they are tired. They still believe the company’s owners, the Sackler family, and executives should go to jail. But more than anything, they want the judges overseeing the lawsuits to make sure Purdue and the family use their riches to guarantee Americans access to treatment.

Recent news of the company’s misdeeds — like the allegation from New York’s attorney general, Letitia James, that Sackler family members moved hundreds of millions of dollars into private or offshore accounts, paying themselves when they knew the company was already insolvent or close to it — only confirms what the four have long believed.

In March, Oklahoma settled its case against Purdue and the Sacklers for $270 million — in part because the company was contemplating filing bankruptcy, and the state feared bankruptcy claims would insulate it from paying restitution. That meant all the documents in the case would remain sealed — a fate RAPP laments because it allows the company to hide its tactics from public scrutiny, occluding the dangers of the drug. “I have been saying for years that sealing the lawsuits let them get away with murder,” Mr. Bisch said.

This summer Vanity Fair published a rare interview with David Sackler, grandson of one of the three brothers who founded Purdue Pharma, who said his family had suffered “endless castigation,” including the taunting of his 4-year-old at nursery school. With a tone-deafness reserved for people who can afford to surround themselves with sycophants, he told the writer Bethany McLean, “Look at all the good Purdue has done.”

Mr. Vanicky read the article and told me, “I bet it sucks to be a Sackler these days.” He has personally called the offices of many attorneys general to thank them for filing suit against the Sacklers and Purdue.

Now 72,  . . .

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Written by LeisureGuy

21 July 2019 at 3:27 pm

It’s bad when the government lies to the public: Most Heroin Addicts Didn’t Start By Being Prescribed Pain Pills, Despite Drug Czar’s Claims

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Philip Smith reports in Drug War Chronicles:

As part of its campaign to stem opioid addiction and overdoses, the White House Office of National Drug Control Policy (ONDCP — the drug czar’s office) has launched an education campaign called The Truth About Opioids, but some of the material it is presenting has more than a whiff of spin to it — and could imperil the ability of pain patients to get the relief they need.

The web site declares in big, bold letters that “80% of heroin users started with a prescription painkiller,” and highlights the words “80%,” “heroin,” “started,” and “prescription” in lurid purple. The graphic suggests that heroin users were prescribed opioids, developed a habit, and then went on to junk, with the further implication that a way to reduce heroin addiction is to tighten and reduce the prescribing of opioids.

The web site then asks readers if they are “shocked,” “ah-ha,” “outraged,” or “fired up” by the information. It is only if readers scroll down the page that they are informed that the basis for the statistic is a 2013 study of “Heroin use and heroin use risk behaviors among nonmedical users of prescription opioid pain relievers.” (Emphasis added.)

That’s right, even though the graphic shouts out that people prescribed opioids then went on to become heroin addicts, the science it uses to back its claim is about recreational pain pill users. That’s deceptive.

Misleading claims about prescribing opioids and the potential for opioid addiction are, of course, nothing new. Twenty years ago, PurduePharma infamously claimed that the risk of addiction from OxyContin was so low as to be negligible, a marketing tactic that helped kick into overdrive the pain pill phase of the current wave of opioid use.

But the drug czar’s office, with its misleading suggestion that being prescribed opioids leads to heroin addiction, tips the pendulum too far in the other direction. There are real world consequences to using such faulty information. The Drug Enforcement Administration cited that 80% figure last year when it ordered steep decreases in the supply of prescription opioids, and it claimed in the Federal Register that patients got addicted “after first obtaining these drugs from their health care providers.”

“The 80% statistic is misleading and encourages faulty assumptions about the overdose crisis and medical care,” Pain News Network columnist Roger Chriss argued in a column last year.

And now, a new study from researchers at Penn State University published in the Journal of Addictive Studies bolsters that claim. Concentrating on southwestern Pennsylvania, an area with high levels of addiction, the researchers conducted surveys and in-depth interviews with drug users to determine their drug using histories. The sample size was small, with 125 people surveyed and 30 interviewed, but the results were illuminating.

The researchers found that two out of three of those interviewed got their first prescription opioids not from a doctor’s prescription, but either bought or stole it from a family member or friend. Another 7 percent bought their drugs from a stranger or a dealer. And only one out of four (26 percent) began with opioid medications prescribed by a doctor.

“What emerged from our study — and really emerged because we decided to do these qualitative interviews in addition to a survey component — was a pretty different narrative than the national one. There’s a lot about that narrative that I think is an overly simplistic way of thinking about this,” said lead author Ashton Verdery, PhD, an assistant professor of sociology, demography and social data analytics at Penn State.

“We found that most people initiated through a pattern of recreational use because of people around them. They got them from either siblings, friends or romantic partners,” he continued. “Participants repeatedly reported having a peer or caregiver in their childhood who had a substance use problem. Stories from childhood of witnessing one of these people selling, preparing, or using drugs were very common. Being exposed to others’ substance use at an early age was often cited as a turning point for OMI (opioid misuse) and of drug use in general.”

Among study participants, recreational drug use — or polysubstance abuse, in public health speak — was common, Verdery noted, and usually began not with prescription opioids but with drugs such as alcohol, marijuana, cocaine, methamphetamine, and prescription sedatives and stimulants.

“It is important to note that interviewees universally reported initiating OMI only after previously starting their substance use career with another drug (e.g., alcohol, marijuana, cocaine). Opioids were never the first drug used, suggesting that OMI is likely associated with being further along in one’s drug using career,” he added.

Researchers studying opioid addiction need to be aware of the role other substances play in the process, Verdery said. Understanding how opioid addiction is intertwined with other drug use is necessary to figure out the correct steps to take to prevent addiction before it takes hold. . .

Continue reading.

Written by LeisureGuy

21 June 2019 at 10:23 am

The War on Cocaine Only Strengthens Drug Cartels, Study Finds

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Philip Smith reports in Drug War Chronicles:

If you’ve spent nearly a half-century and $250 billion trying to stop the flow of cocaine into the US and the white powder is now cheaper and more plentiful than ever, maybe it’s time to rethink. That’s the implicit lesson lurking behind a new study on the impact of drug interdiction efforts on drug trafficking organizations.

Interdiction is the supply side approach to reducing drug use. Rather than reducing demand through education, prevention, and treatment, interdiction seeks to reduce the supply of drugs available domestically by blocking them en route to the US or at the border.

Published in the Proceedings of the National Academy of Sciences and conducted by scientists from a half-dozen American universities, the study relied on a computer model called NarcoLogic that shows how drug traffickers respond to interdiction strategies and tactics. More sophisticated than previous attempts to simulate the drug trade, NarcoLogic models local- and network-level trafficking dynamics at the same time.

“Our team consists of researchers who worked in different parts of Central America during the 2000s and witnessed a massive surge of drugs into the region that coincided with a reinvigoration of the war on drugs,” David Wrathall of Oregon State University’s College of Earth, Ocean and Atmospheric Sciences said in a press release announcing the research results. “We asked ourselves: did drug interdiction push drug traffickers into these places?”

The short answer is yes, and that has implications that go far beyond drug policy. The Central American migrants who are at the center of the current “border crisis” are fleeing not only poverty but also high levels of violence generated by the movement of Mexican drug trafficking groups into the region a decade ago as they faced increasing interdiction efforts at home and from US authorities.

In fact, although it is not addressed in this new research, it was earlier interdiction efforts aimed at Colombian cocaine trafficking groups in the 1980s that led directly to the transformation of formerly small-scale Mexican cross-border smuggling organizations into the Frankenstein’s monster of drug prohibition that the cartels are today. With the Colombians under intense pressure, Mexican traffickers rose to the occasion and have been making billions of dollars a year ever since.

This despite five decades of US interdiction efforts with an average annual expenditure of $5 billion. Instead of curbing the flow of cocaine into the United States, all that has been accomplished is making the drug trafficking operations more widespread and harder to eradicate. Putting pressure on one route or location simply leads traffickers to scatter and regroup. This is the “balloon effect,” where suppressing traffic or production in one area prompts it to pop up elsewhere, and the “cockroach effect,” where traffickers simply decentralize their operations.

“Between 1996 and 2017, the Western Hemisphere transit zone grew from 2 million to 7 million square miles, making it more difficult and costly for law enforcement to track and disrupt trafficking networks,” Wrathall said. “But as trafficking spread, it triggered a host of smuggling-related collateral damages: violence, corruption, proliferation of weapons, and extensive and rapid environmental destruction.”

And for all that effort, the impact on cocaine price and availability has been negligible — or even perverse.

“Wholesale cocaine prices in the United States have actually dropped significantly since 1980, deaths from cocaine overdose are rising, and counterdrug forces intercept cocaine shipments at a low rate. More cocaine entered the United States in 2015 than in any other year,” Wrathall said. “And one thing people who support interdiction and those who don’t can agree on is that change is needed. This model can help determine what that change should look like.”

The main takeaway from the study is not that drug trafficking became more widespread and resilient because of ineffective interdiction efforts, but because of interdiction itself. The policy aimed at suppressing the drug trade has only made it stronger and wealthier. . .

Continue reading.

Written by LeisureGuy

11 April 2019 at 9:27 am

Portugal’s Path to Breaking Drug Addiction

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Rob Waters has a very interesting article in Craftsmanship magazine. It begins:

For the past 50 years, Italy, Portugal and the United States have taken radically different approaches to drug enforcement and to the epidemics of drug use and addiction that have afflicted each country. One, the U.S., has emphasized punishment. It leads the world in incarcerating people—and at burying them after drug overdoses. Another, Portugal, has decriminalized drugs and created a model for effective drug treatment. Italy, meanwhile, has veered wildly between these two poles, never settling on a clear approach.

This is the story of how Portugal has dealt with its drug problems and largely succeeded, while the U.S. and Italy, despite pockets of success—like the San Patrignano rehabilitation community in northern Italy described in another article in this issue—have mostly failed.

For all three countries, the modern epidemic of hardcore drugs began with a dramatic rise in the use of heroin. In the U.S., heroin use surged during the Vietnam War, as American soldiers experimented with Southeast Asian heroin and many became addicted. When they came home, drug syndicates saw a market and filled it, putting large quantities of heroin onto the streets of U.S. cities.

Heroin came to Italy in the mid-1970s and its use grew rapidly, striking all social classes. By the late 1980s, Milan alone had an estimated 100,000 heroin users, according to a 1989 article in the New York Times, which noted that in 1988,  809 Italians died of overdoses.

At its peak in the late 1990s, Portugal had one of the highest rates of heroin addiction and fatal overdoses in the world. About one percent of Portugese people were using heroin and one person a day was dying of an overdose—in a country of just 10 million. Then Portugal changed course and took a radical step, eliminating criminal penalties for drug use and possession and making a commitment to provide treatment to all who want it. Today, Portugal has arguably the world’s most enlightened set of drug policies.

As in the U.S., Portugal’s heroin experience began with war. Throughout the 1960s and early 1970s, Portugal deployed hundreds of thousands of soldiers to suppress uprisings in the country’s African colonies. Like the Americans’ experience in Vietnam, these soldiers were exposed to marijuana and other drugs. Then, in 1974, a military coup struck Portugal, followed by a peaceful popular uprising (the “Carnation Revolution”). Almost overnight, decades of rule by a right-wing dictatorship were brought to an end.

A young doctor named João Goulão was then working in the Algarve area of southern Portugal. He had a front-row seat to what happened next.

“Suddenly almost a million soldiers and settlers came back to the mainland, bringing literally tons of cannabis, and there was an explosion of experimentation,” Goulão, who now runs the country’s drug agency, told me in a recent interview. Portugal at the time was going through an extraordinary upheaval, creating a new government and new laws. Young people and returning soldiers savored their new freedom by experimenting with drugs as marijuana, heroin, cocaine and LSD flooded in. “We were completely naïve about drugs,” says Goulão, “and completely unprepared to deal with it.”

FROM BAD TO WORSE

In a flash, Portugal went from having one of the lowest rates of drug use among European countries to having perhaps the highest. The biggest problem was heroin.

“Heroin spread very fast and among all social groups,” says Goulão. “It was not something that happened only among marginalized people and minorities, or in ghettoes. Suddenly everybody knew someone who had problems with drugs.”

As heroin use grew, so did overdoses. Doctors and public health professionals throughout the country began setting up treatment programs. After his daughter died of an overdose, the Minister of Justice set up treatment centers in three large cities. Private programs popped up as well, but Goulão says most were of poor quality and many ripped off the patients and families who came to them for help.

These efforts amounted to Band-Aids, not a concerted national policy. The number of providers and treatment programs kept growing but heroin use grew even faster. The sharing of needles also spread AIDS, adding to the death toll. With drug possession and sales seen as crimes, the prison population soared. And since drugs circulated widely within prisons, it had little effect on the underlying problem.

“People could spend two or three years in jail and come back worse than when they went there,” says Goulão. “The situation was getting worse every day.”

STEP ONE: DECRIMINALIZATION

In 1998, Portugal Prime Minister António Guterres, (now secretary-general of the United Nations) convened a group of nine experts—judges, psychologists and health professionals including Goulão—to develop a national strategy for addressing the crisis. The group visited other European countries, interviewed professionals and researched different approaches. In the end, they concluded they could do relatively little to address the supply of drugs—but could do a lot to address the demand.

The committee developed a set of concrete proposals focused largely on “prevention, treatment, harm reduction, and the reintegration of people,” Goulão says. “All of it was based in the idea that we were dealing with a health and social condition rather than a criminal one.”

The committee’s most radical proposal was to eliminate criminal penalties for the use and possession of drugs. Government leaders accepted the proposal but it also required the approval of Parliament. So Goulão and his colleagues took their case to the public and spent the next year presenting their plan in dozens of forums and discussions.

Their proposal was opposed by right-wing parties and Goulão remembers their arguments: “Portugal will become a paradise for drug addicts and drug users from all over the world. We will have planes coming to Lisbon every day with people to use drugs. Our children will start using drugs at early ages.”

But support from the public and, surprisingly, from the Catholic Church carried the day—in 2001, Parliament passed the sweeping changes. “Using drugs in Portugal was no longer a crime,” Goulão says.

STEP TWO: MULTIPLE OPTIONS FOR TREATMENT

Today, some 40 programs in Portugal provide detoxification and long-term treatment, with 1600 beds in residential treatment programs known as “therapeutic communities,” Goulão says. Most are run by nonprofit agencies, under contract with the government. They employ a variety of treatment approaches, but all must provide  . . .

Continue reading.

Written by LeisureGuy

29 March 2019 at 4:58 pm

A belief in meritocracy is not only false: it’s bad for you

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Clifton Mark, who writes about political theory, psychology, and other lifestyle-related topics and lives in Toronto, Ontario, writes in Aeon:

‘We are true to our creed when a little girl born into the bleakest poverty knows that she has the same chance to succeed as anybody else …’ Barack Obama, inaugural address, 2013

‘We must create a level playing field for American companies and workers.’ Donald Trump, inaugural address, 2017

Meritocracy has become a leading social ideal. Politicians across the ideological spectrum continually return to the theme that the rewards of life – money, power, jobs, university admission – should be distributed according to skill and effort. The most common metaphor is the ‘even playing field’ upon which players can rise to the position that fits their merit. Conceptually and morally, meritocracy is presented as the opposite of systems such as hereditary aristocracy, in which one’s social position is determined by the lottery of birth. Under meritocracy, wealth and advantage are merit’s rightful compensation, not the fortuitous windfall of external events.

Most people don’t just think the world should be run meritocratically, they think it is meritocratic. In the UK, 84 per cent of respondents to the 2009 British Social Attitudes survey stated that hard work is either ‘essential’ or ‘very important’ when it comes to getting ahead, and in 2016 the Brookings Institute found that 69 per cent of Americans believe that people are rewarded for intelligence and skill. Respondents in both countries believe that external factors, such as luck and coming from a wealthy family, are much less important. While these ideas are most pronounced in these two countries, they are popular across the globe.

Although widely held, the belief that merit rather than luck determines success or failure in the world is demonstrably false. This is not least because merit itself is, in large part, the result of luck. Talent and the capacity for determined effort, sometimes called ‘grit’, depend a great deal on one’s genetic endowments and upbringing.

This is to say nothing of the fortuitous circumstances that figure into every success story. In his book Success and Luck (2016), the US economist Robert Frank recounts the long-shots and coincidences that led to Bill Gates’s stellar rise as Microsoft’s founder, as well as to Frank’s own success as an academic. Luck intervenes by granting people merit, and again by furnishing circumstances in which merit can translate into success. This is not to deny the industry and talent of successful people. However, it does demonstrate that the link between merit and outcome is tenuous and indirect at best.

According to Frank, this is especially true where the success in question is great, and where the context in which it is achieved is competitive. There are certainly programmers nearly as skilful as Gates who nonetheless failed to become the richest person on Earth. In competitive contexts, many have merit, but few succeed. What separates the two is luck.

In addition to being false, a growing body of research in psychology and neuroscience suggests that believing in meritocracy makes people more selfish, less self-critical and even more prone to acting in discriminatory ways. Meritocracy is not only wrong; it’s bad.

The ‘ultimatum game’ is an experiment, common in psychological labs, in which one player (the proposer) is given a sum of money and told to propose a division between him and another player (the responder), who may accept the offer or reject it. If the responder rejects the offer, neither player gets anything. The experiment has been replicated thousands of times, and usually the proposer offers a relatively even split. If the amount to be shared is $100, most offers fall between $40-$50.

One variation on this game shows that believing one is more skilled leads to more selfish behaviour. In research at Beijing Normal University, participants played a fake game of skill before making offers in the ultimatum game. Players who were (falsely) led to believe they had ‘won’ claimed more for themselves than those who did not play the skill game. Other studies confirm this finding. The economists Aldo Rustichini at the University of Minnesota and Alexander Vostroknutov at Maastricht University in the Netherlands found that subjects who first engaged in a game of skill were much less likely to support the redistribution of prizes than those who engaged in games of chance. Just having the idea of skill in mind makes people more tolerant of unequal outcomes. While this was found to be true of all participants, the effect was much more pronounced among the ‘winners’.

By contrast, research on gratitude indicates that remembering the role of luck increases generosity. Frank cites a study in which simply asking subjects to recall the external factors (luck, help from others) that had contributed to their successes in life made them much more likely to give to charity than those who were asked to remember the internal factors (effort, skill).

Perhaps more disturbing, simply holding meritocracy as a value seems to promote discriminatory behaviour. The management scholar Emilio Castilla at the Massachusetts Institute of Technology and the sociologist Stephen Benard at Indiana University studied attempts to implement meritocratic practices, such as performance-based compensation in private companies. They found that, in companies that explicitly held meritocracy as a core value, managers assigned greater rewards to male employees over female employees with identical performance evaluations. This preference disappeared where meritocracy was not explicitly adopted as a value.

This is surprising because impartiality is the core of meritocracy’s moral appeal. The ‘even playing field’ is intended to avoid unfair inequalities based on gender, race and the like. Yet Castilla and Benard found that, ironically, attempts to implement meritocracy leads to just the kinds of inequalities that it aims to eliminate. They suggest that this ‘paradox of meritocracy’ occurs because explicitly adopting meritocracy as a value convinces subjects of their own moral bona fides. Satisfied that they are just, they become less inclined to examine their own behaviour for signs of prejudice.

Meritocracy is a false and not very salutary belief. As with any ideology, part of its draw is that it justifies the status quo, explaining why people belong where they happen to be in the social order. It is a well-established psychological principle that people prefer to believe that the world is just.

However, in addition to legitimation, meritocracy also offers flattery.  . .

Continue reading.

Written by LeisureGuy

14 March 2019 at 7:09 pm

How rehab recruiters are luring recovering opioid addicts into a deadly cycle.

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Julia Lurie writes in Mother Jones:

The offer was too good to resist: Go to rehab for a week, get $1,000 in cash. It was early 2017, and Brianne, a 20-year-old from a woody Atlanta suburb, had come to South Florida to leave her heroin addiction behind. At a residential facility called Recovery Villas of the Treasure Coast, she was approached by a charismatic guy I’ll call Daniel, a Pennsylvania native six years her elder. He could relate to her troubles—he’d struggled with addiction himself—and he could get her into another rehab after Recovery Villas. He would even pay her: $1,000 for the first week of her stay and $500 each week thereafter. That money could buy Brianne a whole lot of heroin.

Brianne, whose full name has been withheld to protect her privacy, could be a poster child for the opioid crisis: a blond, green-eyed former softball star who experimented with pills from the medicine cabinet with her high school boyfriend and within a few years was plunging needles into her veins. In 2016, she broke down and admitted to her mom, a software executive named Jen, that she needed help. They made a plan: Brianne would go to treatment for a few months, sober up, and then return home to study at Chattahoochee Technical College.

That never happened. Brianne took Daniel up on his offer and, over the next 18 months, did more than a dozen stints at Florida rehab centers from Palm Beach to Miami. She mainly flitted between Recovery Villas—which in addition to group therapy and 12-step meetings offered apartment housing and a pool—and Compass Detox, which felt like somewhere between a hospital and a hotel.

Sometimes, between stays, Daniel rented a room for Brianne and a few other “clients” at a Super 8 or Comfort Inn and supplied them with heroin and the overdose reversal medication Narcan, just in case. When the drugs ran out, Brianne would head into a detox program with dirty urine, an admission requirement for some facilities. Other times, she coordinated directly with rehab staffers who called her “honey” and “sweetie” and arranged free transportation—Ubers, flights if need be—to their centers. Daniel encouraged Brianne to try her hand at recruiting: For every patient she steered his way, he would pay her $400. After she started dating a recovering user who lacked health insurance, Daniel found rehabs that would take her boyfriend for free as long as Brianne attended with her Aetna insurance card, a practice known as “piggybacking.”

The addiction community has a name for what happened to Brianne. It’s called the “Florida shuffle,” a cycle wherein recovering users are wooed aggressively by rehabs and freelance “patient brokers” in an effort to fill beds and collect insurance money. The brokers, often current or former drug users, troll for customers on social media, at Narcotics Anonymous meetings, and on the streets of treatment hubs such as the Florida coast and Southern California’s “Rehab Riviera.” The rehabs themselves exist in a quasi-medical realm where evidence-based care is rare, licensed medical staffers are optional, conflicts of interest are rampant, and regulation is stunningly lax.

While experts say the practices described in this story are widespread, it is important to note that there are plenty of responsible treatment providers, and not all the facilities named engage in all the practices described. Recovery Villas, which was raided by Florida authorities last summer on suspicion of insurance fraud and is now under investigation by the state, did not respond to my questions. A Compass Detox spokesman said that paying clients for treatment and giving them drugs between rehab stints “is illegal and we don’t do that.” Compass obeys all relevant laws and regulations, he emphasized.

Drug addiction rates have skyrocketed over the past decade: If every American addicted to opioids lived in one city, it would be nearly the size of Houston(pop. 2.3 million). The demand for treatment, the increasingly white face of addiction, and recent laws requiring insurers to cover substance use services have all resulted in a surge in rehab spending and private investment. But as the Braff Group, which tracks health care trends, warned investors in a 2014 brief, “It’s not all kittens and rainbows. As we have seen countless times in other frenzied health care sectors, when the money flows in, so do the ne’er-do-wells, which can bring the sector the kind of attention it doesn’t want.”

It’s a given in the world of addiction treatment that relapses are likelyobstacles on the road to recovery. But for rehab owners and brokers who make money each time a patient is admitted, relapses can be a profit center. Dozens of drug users and parents I spoke with had tales like Brianne’s, and “there are probably thousands” of others, according to Karen Hardy, a Maine addiction counselor whose own son shuffled among dozens of rehabs. “Some end in death. Some don’t,” she says. “It’s Russian roulette.”

For Jen, Brianne’s recovery saga has been a nightmarish roller-coaster ride. At work one morning in June 2017, she received a text from an unrecognized number that made her blood run cold: “I OVERDOSED CALL ME NOW.” Over the phone, Brianne frantically explained she was at a hospital near Palm Beach after overdosing for the first time—in a motel room, with heroin provided by Daniel. There were more panicked calls that summer: Brianne at a gas station, without shoes, money, or transportation. Brianne bawling after yet another friend overdosed. (She lost 15 friends in a single year, Jen says.) The sounds of sickening shrieks and thumps as her boyfriend flew into a violent rage. Brianne overdosing again. Back home, her 13-year-old sister filled an Ugg shoebox with prayers jotted on slips of paper, begging God not to let Brianne die.

The amounts billed to Jen’s insurance company seemed outlandish: $3,000 for a routine drug test and, in one case, $22,000 in rehab charges in a single day. (Residential rehabs often charge private insurers $50,000 to $100,000 per month of treatment.) . . .

Continue reading. There’s much more.

The US seems increasingly dysfunctional.

Written by LeisureGuy

1 March 2019 at 9:29 am

Here’s How One Small Town Beat The Opioid Epidemic

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Dan Vegano reports in Buzzfeed News:

The stomp of boots echoed above her head. Her father had found the empty cashbox. Monica Rudolph, a 25-year-old living in her parents’ basement after her second eviction, had robbed the box to pay for heroin.

She was working two jobs in this small town, waitressing by day and bartending at night, to pay for drugs, but still never had enough. Like a mouse nibbling cheese, she’d steal $30 at a time from her dad’s stash to buy bags of brown powder, until all of the money — $2,000 — was gone.

Now it was a Saturday morning, her father had discovered the theft, and she was shaking from heroin withdrawal. She knew days of knee-buckling vomiting, diarrhea, and stomach pain lay ahead.

“I had nothing. My life was broken down into four- to five-hour increments to get high, to put off feeling sick,” Monica told BuzzFeed News. After realizing the money was gone, her father railed against her boyfriend. Her mother, Louise Rudolph, asked her if she was on drugs. And after years of pretending otherwise on that day in 2017, Monica said yes.

“I just didn’t want my daughter to die,” Louise told BuzzFeed News. “Oh my God, I was so scared she would die. I just wanted to get her help.”

She opened the Yellow Pages and started calling treatment centers in cities all over Minnesota. Again and again, Monica and Louise heard recorded out-for-the-weekend messages saying to call back on Monday.

Monica was scared too. She knew from past attempts to get clean that it would be at least two weeks before a treatment center could take her, because they needed a diagnosis and referral from a doctor first. And she knew she’d never last. “Mom, I cannot be sick that long,” she told her.

“Why not call the local hospital?” her mother finally asked, the last place Monica would have thought of. Somebody picked up the phone at St. Gabriel’s Hospital in Little Falls. Monica was immediately transferred to a substance abuse counselor, who did her referral over the phone and then asked if she could come the next morning to start treatment.

“My hometown of 8,000 people was the one place in the state that picked up the phone,” Monica said. “Think of all the people like me who don’t have that hometown.”

This small town has managed, in just five years, to curb its drug epidemic — a rare feat in a country where overdose deaths continue to rise, with more than 70,000 last year alone. Nationwide, fewer than one-third of people addicted to opioids can find the treatment that Monica found.

Little Falls didn’t do anything revolutionary. They just spent real money — at least $1.4 million in state grants since 2014 — on basic public health measures: limiting prescription refills, increasing access to addiction medications, and putting drug users in treatment programs instead of jail.

In other words, they began treating addiction as a disease instead of a crime.

And it worked: Emergency room visits to obtain painkillers fell from the top occurrence to out of the top 20 within six months after the hospital started monitoring prescriptions. There are now 100 patients on addiction medication at St. Gabriel’s, and 626 people have been tapered off opioids.

“One thing led to another,” Kurt DeVine, the first doctor Monica saw at St. Gabriel’s, told BuzzFeed News. “We realized we had to do a lot of things we weren’t doing, and that we had to do them together, or it wasn’t going to work.”

DeVine and his colleague Heather Bell became certified to prescribe buprenorphine, the milder opioid they favor to taper patients with opioid use disorders, in 2016. Now they teach people in other Minnesota cities, and as far away as Alaska, how things work in Little Falls through regular online seminars. Another 24 doctors have become certified through their efforts in the state, up from 100 three years ago. They talk to many towns, he said, who aren’t thinking big enough.

“They get Narcan” — an opioid-reversal drug — “or they get one little project and they think that is going to fix it,” he said. “There is no easy answer. It is a lot of work. If we were doing only one thing, just Narcan, our problem would be as bad as anywhere else. You have to do it all.”

Like a lot of places across the US, the overdose crisis snuck up on Little Falls, largely because of a surge in opioid painkiller prescriptions. Those excess pills ended up on the black market, often stolen by teenagers from their parents or grandparents and sold to their friends.

On Thanksgiving Day 2012, a shocking double murder got everyone talking about the opioid crisis. A retired homeowner, Byron David Smith, shot and then executed two teenage cousins, Nicholas Brady and Haile Kifer, who had broken into his house. The cops found prescription painkillers, stolen from another retiree the previous week, in their car.

“That made it clear to everyone that something bad was going on,” investigator Jason McDonald of the Morrison County Sheriff’s Office told BuzzFeed News.

A year later, “we had our first local heroin overdose, of a young woman,” he added. “We knew we had a problem.”

The opioid crisis arrived in Morrison County a bit later than the rest of the country, but its spread there followed a similar pattern — with prescription opioids coming first, then a legal crackdown on pills that left some users desperate enough to try street heroin. That’s what happened to Monica too. She was prescribed Percocet painkillers after a high school car wreck, then started buying stolen pills and finally heroin.

By 2014, the community could no longer ignore the problem: As many as three people were dying of opioid overdoses every year, a shock to the small county of 33,000 people that hadn’t seen them before.

That year, St. Gabriel’s Hospital realized local pharmacies were prescribing far too many painkillers, with more than 100,000 opioid pills prescribed every month. Aided by a $368,000 state grant, the hospital began reading charts of patients to see who was getting so many refills and alerting pharmacies about overprescribing. Within a year, people seeking painkillers went from the top emergency room complaint to less than a top 20 concern. Around 660,000 fewer doses of painkillers have since been prescribed in the county. As of August, the prescription-monitoring program has helped 626 people, more than one-third of the people on high-dose prescriptions in the county, taper off opioids, while crimes related to drugs — the kind of thefts that led to the deaths of Brady and Kifer — have dropped.

But the team there soon realized that lowering prescriptions wasn’t enough, DeVine said. They also had to help the people already addicted to the drugs.

In a clinic, they formed a “care team” — a social worker, a nurse, two doctors, and a pharmacist — who devote themselves to helping people like Monica Rudolph. Usually they prescribe them Suboxone, a medication that combines a mild opioid, buprenorphine, with naloxone, a drug that reverses overdoses. This “medication-assisted treatment” lessens the addictive properties of opioids without triggering withdrawal sickness and is the most effective treatment for people with an opioid use disorder.

In the decade before the opioid crisis, Morrison County had a similar problem with methamphetamines and had created a public task force of health officials, cops, schools, and doctors to deal with it. That task force has since been repurposed for opioids, so that authorities can connect what is going on in schools with changes at pharmacies, traffic stops, and the county jail. There are endless programs, “coffee with a cop” meetings, school talks, naloxone trainings, and even yoga classes at the jail.

When a patient comes into the St. Gabriel’s emergency room with a 10-year-old prescription for painkillers, they aren’t just cut off cold turkey; a plan is created to taper them down to a safe dose. When the police find someone with stolen pills, they are referred for treatment, not arrest. When people prescribed opioids don’t test positive for opioids in routine medical checkups, questions are asked.

“If you find a person’s urine has a bunch of meth and not their pain meds, you make the assumption they are selling their pain meds to get meth,” family physician Heather Bell, DeVine’s colleague, told BuzzFeed News. “But we don’t kick them out of our clinic. We say, ‘OK, what is going on? Do you need help?’ Then we get them into treatment.”

When Monica came to their clinic, she was treated like any other patient, not as a drug addict or a criminal. “Honestly, if they had shuddered, I would have run out the door,” she said. “I told them all these horrible dark things things I had done, and Dr. DeVine was like, ‘OK, that stuff happened. Now let’s get you better.’”

The team found her an in-patient program at a clinic where she could work on recovering from her five-year addiction to heroin. “I knew I couldn’t do it at home,” she said.

What’s truly unusual about Morrison County is . . .

Continue reading. There’s much more.

Written by LeisureGuy

25 February 2019 at 6:56 pm

Did the FDA ignite the opioid epidemic?

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Bill Whittaker writes for 60 Minutes:

We have reported on the causes and effects of the opioid epidemic for several years — interviewing government whistleblowers, doctors, and Americans who’ve grown dependent on the powerful pain pills. We have not had a high-ranking executive from the pharmaceutical industry sit before our cameras, until now. Tonight, Ed Thompson, a drug manufacturer who spent decades managing and producing opioids for Big Pharma, breaks ranks to denounce his industry and its federal regulator, the Food and Drug Administration, which he says opened the floodgates on the crisis with a few little changes to a label.

Ed Thompson: The root cause of this epidemic is the FDA’s illegal approval of opioids for the treatment of chronic pain.

Bill Whitaker: The FDA ignited this opioid crisis?

Ed Thompson: Without question, they start the fire.

Ed Thompson told us when the top selling opioid, Oxycontin, was first approved in 1995, it was based on science that only showed it safe and effective when used “short-term.” But in 2001, pressured by Big Pharma and pain sufferers, the FDA made a fateful decision and, with no new science to back it up, expanded the use of Oxycontin to just about anyone with chronic ailments like arthritis and back pain.  

Ed Thompson: So this is what a package insert looks like.

Bill Whitaker: Wow

The FDA did it by simply changing a few words on the label, that lengthy insert no one ever reads. Today the label says the powerful pain pills are effective for “daily, around-the-clock, long-term… treatment.” And that small label change made a big change in the way drug companies would market all opioids, allowing them to sell more and more pills at higher and higher doses.

Ed Thompson: A drug’s label is the single most important document for that product. It determines whether somebody can make $10 million or a billion dollars.

Bill Whitaker: How so?

Ed Thompson: Because it allows you to then promote the drug based on the labeling.

Ed Thompson owns PMRS, a successful Pennsylvania pharmaceutical company that manufactures drugs for Big Pharma. It’s made him a rich man. But now he’s putting his livelihood at risk. He’s doing what no other drug maker has ever done, he’s suing the FDA in federal court to force it to follow the science and limit the opioid label to short term use.

“There are no studies on the safety or efficacy of opioids for long-term use.”

Thompson is challenging the FDA to start with his newest opioid. It’s Thompson’s creative way to sabotage the system. He may lose money rolling out his new drug, but if he is successful, it would set a precedent. Other manufacturers would be forced to change their labels and limit their marketing.

Bill Whitaker: A decision going in your direction could pull down a multi-billion-dollar industry.

Ed Thompson: Correct. Probably somewhere between $7 and $10 billion a year would come off the market. We made a decision to stop selling snake oil to U.S. citizens in 1962.

Bill Whitaker: Snake oil?

Ed Thompson: Yes, sir. You’re using high-dose, long-duration opioids when they’ve never been designed to do that. There’s no evidence that they’re effective. There’s extreme evidence of harms and deaths when you use them.

Brandeis professor Dr. Andrew Kolodny is one of the country’s most-recognized addiction specialists and has been an expert witness in litigation against Big Pharma, including Purdue, the maker of Oxycontin. He has been trying to get the FDA label changed since 2011 to make clear opioids are not for everyone.

Dr. Andrew Kolodny: These are essential medicines for easing suffering at the end of life and when used for a couple of days after major surgery or a serious accident. If you’re taking them around the clock every day, quickly, you become tolerant to the pain-relieving effect. In order to continue getting pain relief, you’ll need higher and higher doses. As the doses get higher, the treatment becomes more dangerous and the risk of death goes up.

Bill Whitaker: That sounds exactly like heroin addiction.

Dr. Andrew Kolodny: It’s essentially the same drug.

To understand how this began we traveled to this small courthouse in Welch, West Virginia, where we uncovered the minutes of secret meetings in 2001 between Purdue Pharma and the FDA. The files were part of the state’s lawsuit against Purdue for deceitful marketing.

60 Minutes got a court order to obtain these documents. They reveal it was at those secret meetings the FDA bowed to Purdue Pharma’s demands to ignore the lack of scientific data, and changed the label to, “around the clock…for an extended period of time.”

Ed Thompson: I can’t think of anything more harmful taking place that took place then. It opened the floodgates. It was the decision of no return for the FDA.

Purdue told us Oxycontin always was approved for long-term use. But an internal document shows the company was jubilant about the labeling change.  Quote: “The action by the FDA…has created enormous opportunities” to expand the market. The drug company’s ads soon extolled the virtues of Oxycontin’s effectiveness and sales tripled.

Dr. David Kessler: It was a marketing tsunami.  And the agency didn’t catch it.

60 Minutes has called on former FDA commissioner David Kessler many times for his expertise on drug safety issues. He ran the FDA in the 1990s when Oxycontin was first approved, but he left before the labeling change. Today, he’s been retained by cities and counties suing Big Pharma for the opioid crisis. After reviewing the documents we obtained, and checking on his own, he says changing the label to long-term use was a mistake.

Dr. David Kessler: There are no studies on the safety or efficacy of opioids for long-term use.

Bill Whitaker: But there’s a law that says that a drug cannot be promoted as safe and effective unless it’s proven to be safe and effective. But yet, with FDA sanction, these opioids are being used in that way that you say have not been proven.

Dr. David Kessler: That’s correct. The rigorous kind of scientific evidence that the agency should be relying on is not there.

The label change was a blank check – one the drug industry cashed in for billions and billions of dollars. Now, Big Pharma had a green light to push opioids to tens of millions of new pain patients nationwide.

Bill Whitaker: Let me remind you of some of the words that you have used to describe the pharmaceutical industry, your industry.

Ed Thompson: Yeah?

Bill Whitaker: Corrupt.

Ed Thompson: Yeah.

Bill Whitaker: Immoral?

Ed Thompson: Yes.

Bill Whitaker: Depraved?

Ed Thompson: Yes. They’re appropriate for the behavior that’s taken place.

Bill Whitaker: You are a drug executive. You manufacture drugs.

Ed Thompson: Many drugs.

Bill Whitaker: Are you at fault in this epidemic in any way?

Ed Thompson: I wish I was smart enough to have seen this epidemic before– before I got three or four years into it. Absolutely. But once you find out that it’s not correct, you have to do the right thing. Is there anything more important?

Emily Walden: My son wanted to fight for his country. His country failed him. . .

Continue reading.

There’s much more, and it is damning. The US government should start doing things to protect its citizens and stop protecting the corporations that destroy their lives. It’s not right.

Written by LeisureGuy

25 February 2019 at 12:19 pm

Oklahoma could provide first test of who will pay for the opioid crisis — and how much

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Lenny Bernstein and Katie Zezima report in the Washington Post:

Big pharma is facing a major test in a small courthouse 20 miles south of here: the first trial at which a jury could decide whether drug companies bear responsibility for the nation’s opioid crisis.

Thousands of cities, counties, Native American tribes and others have filed lawsuits up and down the opioid supply chain, advancing various allegations of culpability for the crisis that began with widespread abuse of powerful painkillers. Most of the cases have been consolidated in a major federal action in Cleveland. But as that case lags, smaller state cases like the one in Oklahoma are moving quickly to hear the allegations, creating an early test of how costly the opioid crisis might be for the pharmaceutical companies that made billions of dollars off the drugs.

Oklahoma’s case is scheduled to begin May 28 at a state courthouse in Norman. Judge Thad Balkman has repeatedly refused to delay the trial and has agreed to have it televised live every day, raising the prospect of nationwide coverage of grieving families and embarrassing internal company emails. Nearly 800 Oklahomans died of drug overdoses in 2017, about half of them from opioids.

“What happens there is going to set the standard for what happens after it,” said Abbe R. Gluck, a Yale Law School professor, who predicted that the outcome in Oklahoma could provide leverage to the victor in the larger federal case to follow.

Thirty-six states have filed cases in state courts, believing they will fare better in front of local juries that know the toll of addiction firsthand. The state cases have received far less attention than the mammoth case in Cleveland, where there are nearly 1,600 plaintiffs in an action known as multidistrict litigation, or MDL. If the trial holds to schedule, Oklahoma will be the first state to try a case in court.

The next few months will be critical to both cases.

Some believe the drug company defendants in Oklahoma — Purdue Pharma, Johnson & Johnson, Teva Pharmaceuticals, Actavis and others — will never risk a trial in that kind of venue, before a jury of Sooners who have seen the opioid epidemic’s impact on their communities.

“We feel confident in our case,” said Oklahoma Attorney General Mike Hunter, who filed the lawsuit in 2017. “We’d like a jury of Oklahomans to hear our evidence and determine the extent to which these companies should be held accountable for what’s happened in Oklahoma.”

The state contends that the drug manufacturers’ deceptive marketing of their products set off the epidemic and created a “public nuisance” that injured or endangered the health of Oklahoma citizens. The state could seek more than $1 billion from the companies, either in a settlement or at trial, according to people familiar with the case.

Oklahoma’s biggest target might be Janssen Pharmaceuticals, part of Johnson & Johnson. Janssen sells the Duragesic fentanyl patch and sold the opioid Nucynta until 2015.

Janssen said in a statement that “our actions in the marketing and promotion of these medicines were appropriate and responsible. The labels for our prescription opioid pain medicines provide information about their risks and benefits, and the allegations made against our company are baseless and unsubstantiated.”

Purdue said in a statement that it “continues to have active discussions with attorneys general, and is fully engaged with the multidistrict litigation process outlined by Judge Polster to help communities address the opioid crisis.” U.S. District Judge Dan Aaron Polster of the Northern District of Ohio is hearing the MDL case.

In Oklahoma, Purdue will argue that it controls a small share of the market for opioid drugs — about 2 percent to 3 percent. It claims its sales representatives and marketing initiatives are not responsible for deaths from illicit heroin and fentanyl, a powerful synthetic opioid manufactured overseas that is blamed for many opioid deaths in recent years.

Polster has aggressively pushed the parties in his courtroom toward a settlement of what some call the most complex litigation in U.S. history. The judge has said his goal is not just recompense for the costs of addressing addiction and death; he wants to abate the epidemic by providing money for treatment and other needs. More than 47,000 people died of opioid overdoses in 2017.

Settlement talks are continuing, but the attorneys missed Polster’s goal of reaching a unified agreement last year.

At the same time, Polster has set an October trial date for three bellwether cases — from the city of Cleveland and two Ohio counties — designed to determine how plaintiffs and defendants might fare before juries. Defendants include not just pharmaceutical manufacturers but opioid distributors, drugstore chains and pharmacy benefit managers.

State lawsuits like the one in Oklahoma could expose granular detail about the inner workings of the companies and their attitudes toward profits and the drug crisis. The cases already have revealed private Purdue emails that attorneys general say make the Sackler family — which owns the company — seem insatiably greedy and callous to the suffering opioid abuse has caused.

Perdue also has been fighting a lawsuit in a Massachusetts state court, proceedings that led to the release of previously secret documents in support of allegations that Purdue deceived patients and doctors to persuade them to take higher doses of its painkiller OxyContin more often and longer.

That strategy came even after the company and three executives pleaded guilty to similar deception in 2007 and paid more than $600 million in fines.

“Millions of dollars were not enough. They wanted billions,” the lawsuit alleges. “They cared more about money than about patients, or their employees, or the truth.”

Purdue has said . . .

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Written by LeisureGuy

22 February 2019 at 10:59 am

When our guardians fail: FDA, drug companies, doctors mishandled use of powerful fentanyl painkiller

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Lenny Bernstein reports in the Washington Post:

The Food and Drug Administration, drug companies and doctors mishandled distribution of a powerful fentanyl painkiller, allowing widespread prescribing to ineligible patients despite special measures designed to safeguard its use, according to a report released Tuesday.

The unusual paper in the medical journal JAMA relies on nearly 5,000 pages of documents that researchers obtained from the government via the Freedom of Information Act, rather than a more typical controlled scientific study.

After reviewing the data, the researchers concluded that prescribers, pharmacists, drug companies and the FDA — all of whom had agreed to special rules and monitoring for use of the powerful opioid — had allowed it to fall into the hands of thousands of inappropriate patients. Over time, the FDA and drug companies became aware this was happening but took no action, the researchers found.

Using five years of insurance claims data, the researchers found that between 34.6 percent and 55.4 percent of patients shouldn’t have received the drugs.

“The whole purpose of this distribution system was to prevent exactly what we found,” said Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at the Johns Hopkins University Bloomberg School of Public Health, and one of the leaders of the study. “It should never happen. It’s a never event. And yet we found it was happening in 50 percent” of the cases.

The researchers looked at the distribution of pharmaceutical fentanyl for cancer patients experiencing “breakthrough pain” despite receiving opioids round the clock. The fentanyl, administered via lollipops, lozenges or nasal spray, marketed under several names by different companies, is about 100 times as powerful as morphine. According to the FDA, about 5,000 people in the United States receive such prescriptions at any one time.

In a statement, a spokesperson for the FDA said the agency “shares the concerns” about how the drug is being prescribed and whether its safeguards are working.

“These products are medically important for a small group of patients who are opioid-tolerant but also pose serious risks. That’s why the agency has sought to ensure that the. . . program is achieving its public health goal of assuring safe use and mitigating the risks of misuse, abuse, addiction, overdose and complications due to medication errors.”

The JAMA paper comes during the trial in Boston of Insys Therapeutics founder John Kapoor, who is accused of racketeering. Prosecutors say that the company paid doctors kickbacks to increase the use of its product Subsys, a form of fentanyl that is sprayed under the tongue for pain relief, and encouraged them to offer higher doses.

The strength of pharmaceutical fentanyl products and their quick absorption through the mucosal linings of the mouth and nose pose a serious risk of overdose, abuse and addiction for anyone who hasn’t already built up a tolerance to opioids. To guard against prescribing to such patients, the FDA created a “risk evaluation and mitigation strategy” for the products.

Under the plan, drug companies, doctors, pharmacists and patients themselves received special instruction on the use of the drugs and signed up to be part of the small, closed group allowed to prescribe, dispense and take them. Drug companies and the FDA monitored prescribing.

But the report contends that those safeguards didn’t work. In an assessment of claims data after four years, the drug industry told the FDA that 12,916 of 25,322 patients who took the drugs, or about 51 percent, had not built up tolerance to opioids, according to FDA standards.

A report after 60 months determined that 34.6 percent to 55.4 percent of patients were ineligible, depending on the product, the Hopkins researchers reported. The FDA concluded that its primary goal of keeping the drug out of the hands of ineligible patients was not being met.

The FDA responded to a few complaints that the rules tied the hands of clinical decision-makers by making the definition of opioid tolerance more specific, the report shows. Doctors have authority to prescribe medications “off-label” — for problems other than those spelled out on the drug packaging. But in this case, the drugs were specifically prohibited for patients who weren’t already tolerant of other opioids.

Drug companies were supposed to boot doctors and others who wrongly prescribed the drugs. But after two years, and in subsequent analyses, the researchers found “no reports” of the medications “being prescribed to an opioid non-tolerant individual.” No prescriber was cut from the program despite the results available in the claims data, they said. . .

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Outsourcing regulation to companies whose profits increase if they ignore regulatory responsibilities is the acme of stupidity. It’s equivalent to paying manufacturing quality control inspectors based on how many items pass inspection: stupid, stupid, stupid.

Written by LeisureGuy

20 February 2019 at 9:56 am

Teens who use cannabis at a higher risk of developing depression, suicidal behaviour: study

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I would back a law that restricts cannabis sales to persons who are 21 or older. Wency Leung reports in the Globe & Mail:

Teens who use cannabis are at a higher risk of developing depression and suicidal behaviour in young adulthood, compared with those who do not use the drug, according to a new study led by researchers in Montreal.

The findings, published Wednesday in the journal JAMA Psychiatry, suggest a greater need for education about the mental-health risks associated with cannabis, says lead author Gabriella Gobbi, a researcher at the Research Institute of the McGill University Health Centre.

“A lot of young students and parents are not informed about the risks … of cannabis. They think it’s a light herb because it’s natural,” she says.

While previous research has linked cannabis to psychosis and schizophrenia, this new meta-analysis investigates the impact of the drug on young people’s risk of mood disorders and suicide. The findings provide further evidence to suggest cannabis may be particularly harmful to developing teenage brains.

The researchers conducted a systematic review and meta-analysis of 11 studies, involving a total of 23,317 participants. While they discovered the risk for anxiety was not statistically significant, they found daily-to-weekly cannabis use was related to a high risk for suicidal attempts, and a low to medium risk for developing depression.

For individuals, this risk of depression may be small, Dr. Gobbi says. But given the prevalence of cannabis use among young Canadians (33 per cent of cannabis users are in the 15 to 24 age group, according to National Cannabis Survey data), this risk becomes “very important” at a population level, she says. It means earlier cannabis use may be linked to an estimated 7 per cent of young adults with depression, she says.

The study found only an association, and not a causal relationship, between cannabis use and later depression and suicidal behaviour. But Dr. Gobbi notes that only studies in which young participants were healthy prior to using cannabis were included in the analysis. So in these studies, participants did not start using cannabis because they were depressed, she explains. Rather, they developed depression after they started using the drug.

Among the limitations of the meta-analysis, the researchers noted not all of the studies they analyzed accounted for other drugs or psychosocial factors that may be linked to depression and early cannabis consumption, and they used different methods for detecting major depressive disorder. The researchers were also unable to evaluate the quantity or potency of cannabis that participants consumed.

Catherine Orr of Australia’s Swinburne University of Technology, who was not involved in the study, says there is a lot of research that suggests adolescents are more vulnerable to the potential brain effects of cannabis than adults.

“We cannot say for certain why this is, but a likely explanation is that adolescence is a period of rapid brain development in which grey matter volume is pruned,” says Dr. Orr, who recently published a different study showing structural brain changes in teens who had used cannabis. This “pruning” refers to the natural elimination of unnecessary brain connections. Dr. Orr explains it is possible that cannabis consumption may disrupt this process. . .

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Written by LeisureGuy

14 February 2019 at 2:16 pm

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