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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 . . .

Continue reading.

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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