The prescription opioid epidemic in a nutshell

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He pointed to epidural steroid injections for the back, which, he said, have not been demonstrated as effective for long-term relief. “We need more generalists who are fluent in the treatment of chronic pain,” he said."
No one, that I am aware of, has ever made the claim that epidural steroid injections, in isolation, are intended to provide long term relief, so this is a straw man argument.

More generalists? Oregon and Connecticut must have FPs who are trained very differently than they are down here. My typical FP referral has been ramped up to insanely high doses. The doc gets scared, or gets in trouble, and then, far too late, asks for help.

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As I've said before, opioids PROP/PROMPT, and CS are all proxy wars for what really
angers you. I am not a believer in the IPM-physician being the shepherd of the CNP
flock we have failed with pills and procedures. Get used to hearing it.

That said, I realize that not all IPM can be painted with the same brush. Like a lot of things
in life professional ethics exists upon a continuum:)

http://www.rep-am.com/lifestyle/2016/09/11/training-in-pain-management-is-not-a-top-priority/

"Still, Becker, who researches pain management at Yale, does not believe more pain specialists will solve the problem. “Yes, there are not nearly enough ‘pain specialists,'” he said. “But really pain specialists are not suited to managing chronic pain. Historically, they have been more interested in highly reimbursed procedures that aren’t really what improve outcomes in patients with chronic pains.” He pointed to epidural steroid injections for the back, which, he said, have not been demonstrated as effective for long-term relief. “We need more generalists who are fluent in the treatment of chronic pain,” he said."

Classic example of "punching down" on PCP's. I'd like to see PCP's manage all sort of things better: DM, HTN, onychomycosis, etc. Currently, ACGME-approved fellowships are to open graduates from all primary care specialties. All they have to do is sign up. The problem is that most primary care specialists have little or no desire/skills/ability to manage chronic pain. It's actually a training barrier for them: http://www.ncbi.nlm.nih.gov/pubmed/17564536

It's a stupid argument: Physicians are woefully under-trained in managing pain. Therefore, don't train any more pain specialists. Instead, make people do things they don't want to do...practice outside their scope or interest.
 
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http://www.timesnews.net/Local/2016...id-limits-amid-crisis.html?ci=stream&lp=1&p=1

Drugmakers fought state opioid limits amid crisis
GEOFF MULVIHILL, Associated Press and Center for Public Integrity; LIZ ESSLEY WHYTE, Associated Press and Center for Public Integrity; BEN WIEDER, Associated Press and Center for Public Integrity • Today at 11:00 AM
The makers of prescription painkillers have adopted a 50-state strategy that includes hundreds of lobbyists and millions in campaign contributions to help kill or weaken measures aimed at stemming the tide of prescription opioids, the drugs at the heart of a crisis that has cost 165,000 Americans their lives and pushed countless more to crippling addiction.





The drugmakers vow they're combatting the addiction epidemic, but The Associated Press and the Center for Public Integrity found that they often employ a statehouse playbook of delay and defend that includes funding advocacy groups that use the veneer of independence to fight limits on the drugs, such as OxyContin, Vicodin and fentanyl, the narcotic linked to Prince's death.

The mother of Cameron Weiss was no match for the industry's high-powered lobbyists when she plunged into the corridors of New Mexico's Legislature, crusading for a measure she fervently believed would have saved her son's life.

It was a heroin overdose that eventually killed Cameron, not long before he would have turned 19. But his slippery descent to death started a few years earlier, when a hospital sent him home with a bottle of Percocet after he broke his collarbone in wrestling practice.

Jennifer Weiss-Burke pushed for a bill limiting initial prescriptions of opioid painkillers for acute pain to seven days. The bill exempted people with chronic pain, but opponents still fought back, with lobbyists for the pharmaceutical industry quietly mobilizing in increased numbers to quash the measure.

From our partners: NARCAN Nasal Spray Inventor on U.S. Drug Epidemic
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They didn't speak up in legislative hearings. "They were going individually talking to senators and representatives one-on-one," Weiss-Burke said.

Unknowingly, she had taken on a political powerhouse that spent more than $880 million nationwide on lobbying and campaign contributions from 2006 through 2015 — more than 200 times what those advocating for stricter policies spent and more than eight times what the formidable gun lobby recorded for similar activities during that same period.

The pharmaceutical companies and allied groups have a number of legislative interests in addition to opioids that account for a portion of their political activity, but their steady presence in state capitals means they're poised to jump in quickly on any debate that affects them.

Collectively, the AP and the Center for Public Integrity found, the drugmakers and allied advocacy groups employed an annual average of 1,350 lobbyists in legislative hubs from 2006 through 2015, when opioids' addictive nature came under increasing scrutiny.

"The opioid lobby has been doing everything it can to preserve the status quo of aggressive prescribing," said Dr. Andrew Kolodny, founder of Physicians for Responsible Opioid Prescribing and an outspoken advocate for opioid reform. "They are reaping enormous profits from aggressive prescribing."

The drug companies say they are committed to solving the problems linked to their painkillers. Major opioid-makers have launched initiatives to, among other things, encourage more cautious prescribing, allow states to share databases of prescriptions and help stop drug dealers from obtaining pills.

And the industry and its allies have not been alone in fighting restrictions on opioids. Powerful doctors' groups are part of the fight in several states, arguing that lawmakers should not tell them how to practice medicine.

While drug regulation is usually handled at the federal level — where the makers of painkillers also have pushed back against attempts to impose restrictions — ordinary citizens struggling with the opioid crisis in their neighborhoods have looked to their state capitals for solutions.

Hundreds of opioid-related bills have been introduced at the state level just in the last several years. The few groups pleading for tighter prescription restrictions are mostly fledgling mom-and-pop organizations formed by families of young people killed by opioids. Together, they spent about $4 million nationwide at the state and federal level on political contributions and lobbying from 2006 through 2015 and employed an average of eight state lobbyists each year.

Prescription opioids are the synthetic cousins of heroin and morphine, prescribed to relieve pain. Sales of the drugs have boomed —quadrupling from 1999 to 2010 — and overdose deaths rose just as fast, totaling 165,000 this millennium. Last year, 227 million opioid prescriptions were doled out in the U.S., enough to hand a bottle of pills to nine out of every 10 American adults.

The drugmakers' revenues are robust, too: Purdue Pharma, the maker of OxyContin and one of the largest opioid producers by sales, pulled in an estimated $2.4 billion from opioids last year alone, according to estimates from health care information company IMS Health.

That's even after executives pleaded guilty to misleading the public about OxyContin's risk of addiction in 2007 and the company agreed to pay more than $600 million in fines.

Opioids can be dangerous even for people who follow doctors' orders, though they also help millions of people manage pain associated with cancer, injuries, surgeries and end-of-life care.

The industry group Pharmaceutical Research and Manufacturers of America issued a statement saying, "We and our members stand with patients, providers, law enforcement, policymakers and others in calling for and supporting national policies and action to address opioid abuse."

And Purdue said: "Purdue does not oppose — either directly or indirectly — policies that improve the way opioids are prescribed, including when those policies may result in decreased opioid use."

One of the chief solutions the drugmakers actively promote now are new formulations that make their products harder to crush or dissolve, thwarting abusers who want to snort or inject painkillers. But the new versions also extend the life of their profits with fresh patents, and some experts question their overall effectiveness.

___

A FOCUS ON PAIN TREATMENT

An analysis of state records collected by the National Institute on Money in State Politics provides a snapshot of the drugmakers' battles to limit opioids. For instance, they show that pharmaceutical companies and their allies ramped up their lobbying and campaign contributions in New Mexico in 2012 as lawmakers considered — and ultimately killed — the bill backed by Cameron Weiss' mother.

But one of the drug companies' most powerful engines of political might isn't part of the public record — a largely unknown network of opioid-friendly nonprofits they help fund and meet with monthly known as the Pain Care Forum, formed more than a decade ago.

Combined, its participants contributed more than $24 million to 7,100 candidates for state-level offices from 2006 through 2015, with the largest amounts going to governors and the lawmakers who control legislative agendas, such as house speakers, senate presidents and health committee chairs.

They've gotten involved in nitty-gritty fights even beyond legislatures. After Washington state leaders drafted the nation's first set of medical guidelines urging doctors not to prescribe high doses of opioids in 2007, the Pain Care Forum hired a public relations firm to convince the state medical board that the guidelines would hurt patients with chronic pain.

A sizable slice of the drugmakers' battles are carried out by pharma-funded advocates spreading opioid-friendly narratives — with their links to drug companies going unmentioned — or by persuading pharma-friendly lawmakers to introduce legislation drafted by the industry.

Two years ago, it was a major patient organization receiving grants from the opioid industry, the American Cancer Society's Cancer Action Network, that led the fight against a measure in Tennessee aimed at reducing the number of babies born addicted to narcotics.

And in Maine last year, drugmakers persuaded a state representative to successfully push a bill — drafted by the industry — requiring insurers to cover so-called abuse-deterrent painkillers, the new forms of opioids that are harder to abuse.

Legislatures have begun considering limits on the length of first-time opioid prescriptions. But the new laws and proposals in states including Connecticut and Massachusetts carve out a common exception: They do not apply to chronic pain patients. Drugmaker-funded pain groups, which can mobilize patients to appear at legislative hearings, advocate for the exceptions.

Many patients vouch that opioids have given them a better quality of life.

"There's such a hysteria going on" about those who have died from overdoses, said Barby Ingle, president of the International Pain Foundation, which receives pharmaceutical company funding. "There are millions who are living a better life who are on the medications long term."

That's contrary to what researchers are increasingly saying, however. Studies have shown weak or no evidence that opioids are effective ways to treat routine chronic pain. And one 2015 study from a hospital system in Pennsylvania found about 40 percent of chronic non-cancer pain patients receiving opioids had some signs of addiction and 4 percent had serious problems.

"You can create an awful lot of harm with seven days of opioid therapy," said Dr. David Juurlink, a toxicology expert at the University of Toronto. "You can send people down the pathway to addiction . when they never would have been sent there otherwise."

___

A SURPRISING OPPONENT

Letting advocacy groups do the talking can be an especially effective tactic in state legislatures, where many lawmakers serve only part time and juggle complicated issues.

Lawmakers in Massachusetts, for example, said they didn't hear directly from pharmaceutical lobbyists when they took up opioid prescribing issues this year. But they did hear from a patient advocate with ongoing back pain who works with and volunteers for groups that receive some of their funding from pharmaceutical companies. She also brought in patients to meet with them.

"A lot of times those legislators, they don't have the ability to really thoroughly look into who these organizations are and who's funding them," said Edward Walker of the University of California Los Angeles, who studies grassroots groups.

Nonprofit advocacy groups led the countercharge in Tennessee in 2014 when Republican state Rep. Ryan Williams began work to stanch the flow of prescription painkillers, alarmed by a rapidly rising number of drug-addicted babies, who suffer from withdrawal in their first weeks of life and complications long after they leave the hospital.

More than 900 babies had been born addicted in Tennessee the year before, many of them hooked on the prescription opioids their mothers had taken. That number had climbed steadily since 2001, when there were fewer than 100.

Whitney Moore and her husband adopted two girls born addicted to prescription opioids and other drugs in eastern Tennessee, and she still remembers her older daughter's cries in the hospital, "the most high-pitched scream you've ever heard in your life"__ a common symptom in babies in the throes of withdrawal.

Doctors gave Moore's infant daughter morphine to ease her seizures, vomiting and diarrhea, and she stayed in a neonatal intensive care unit more than a month. Now 3 years old, she still suffers from gastrointestinal problems and remains sensitive to loud noises.

When Williams was mulling potential legislation, doctors told him that part of Tennessee's problem was a 2001 law — similar to measures on the books in more than a dozen states — that made it difficult to discipline doctors for dispensing opioids and allowed clinicians to refuse to prescribe powerful narcotics only if they steered patients to an opioid-friendly doctor.

The result, according to the experts Williams worked with, was a rash of prescribing, even for pregnant women. In 2014, Tennessee ranked third in the country for per-capita opioid prescriptions, with roughly 1.3 prescriptions doled out for every person in the state, according to an analysis of prescription data from IMS Health.

Williams' mission to repeal the law failed that year, and he was shocked by the group that came out in opposition __ the American Cancer Society Cancer Action Network, the advocacy arm of one of the country's biggest and best-known charities.

Two Cancer Society lobbyists worked against the bill, even though prescribing painkillers for cancer patients is a widely accepted medical practice that would have remained legal.

"We injected ourselves into the debate because we did not want cancer patients to not be able to have access to their medication," said Theodore Morrison, a lobbyist working for the network that year.

The society's annual ranks of about 200 lobbyists around the country have taken similar positions elsewhere, defending rules that some argue encourage extensive prescriptions and opposing opioid measures even if the proposed legislation specifically exempted cancer patients.

The Cancer Action Network listed four major opioid makers that provided funding of at least $100,000 in 2015, in addition to five that contributed at least $25,000. Companies that donate such sums get one-on-one meetings with the group's leaders and other chances to discuss policy.

The network said only 6 percent of its funding last year came from drugmakers and that its ties to drug companies do not influence the positions it takes. "ACS CAN's only constituents are cancer patients, survivors, and their loved ones nationwide," spokesman Dave Woodmansee said.

The network said it advocates for certain measures despite exemptions for cancer because some patients continue to experience pain even after their cancer is gone.

ACS CAN teamed up with another group to defend the Tennessee painkiller law — the Academy of Integrative Pain Management, an association of doctors, chiropractors, acupuncturists and others who treat pain, until recently known as the American Academy of Pain Management. The group promotes access to pain drugs as well as non-pharmaceutical treatments such as acupuncture.

Seven of the academy's nine corporate council members listed online are opioid makers. The other two are Astrazeneca, which has invested heavily in a drug to treat opioid-induced constipation, and Medtronic, which makes implantable devices that deliver pain medicine.

The academy's executive director, Bob Twillman, said his organization receives 15 percent of its funding from pharmaceutical companies, not including revenue from advertisements in its publications. Its state advocacy project is 100 percent funded by drugmakers and their allies, but he said that does not mean it is beholden to pharmaceutical interests.

"We don't always do the things they want us to do," he said. "Most of the time we're saying, 'Gosh, yes, there should be some limits on opioid prescribing, reasonable limits,' but I don't think they would be in favor of that."

Both the academy and the cancer group have been active across the country, making the case that lawmakers should balance efforts to address the opioid crisis with the needs of chronic pain patients. Between them, they have contacted legislators and other officials about opioid-related measures in at least 18 states.

In Massachusetts this year, they helped persuade lawmakers to soften strict proposals that would have limited first-time opioid prescriptions to three days' worth. They also have weighed in on how often doctors should be required to check prescription-monitoring databases, which can help crack down on prescription-shopping with multiple doctors.

The academy reported on its website that, since 2013, its state advocacy network had provided "extensive comments" on clinician guidelines in New Mexico, Pennsylvania, Indiana and elsewhere; issued action alerts resulting in more than 300 emails and phone calls to more than 80 legislators in 2014 alone; and held teleconferences with more than 100 advocates.

Purdue, which gives to both the academy and the cancer network, said it contributes to a range of advocacy groups, including some with differing views on opioid policy. "It is imperative that we have legitimate policy debates without trying to silence those with whom we disagree. That's the American political system at work," the company said in a statement.

As for Williams, he tried again last year to repeal Tennessee's intractable pain law — and won unanimous approval in both houses. The extra year had given Williams and his co-sponsor time to help educate their fellow lawmakers, he said, even though the Cancer Society still opposed the repeal.
 
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And more to come...

"
About the investigation

This two-part investigation took seven months. Reporters collected and analyzed campaign finance and lobbying data covering 2006 through 2015 from the National Institute on Money in State Politics, Center for Responsive Politics, Federal Election Commission, the U.S. House of Representatives Office of the Clerk and the IRS. They reviewed hundreds of documents and interviewed more than 150 officials, experts, advocates and others to gain insights into how the political process influenced the response to the opioid epidemic.

Coming soon: Part 2"
 
http://journals.lww.com/painrpts/Fu...k_side_of_opioids_in_pain_management__.3.aspx

The dark side of opioids in pain management: basic science explains clinical observation

Rivat, Cyril; Ballantyne, Jane

Abstract

Introduction: In the past 2 decades, opioids have been used increasingly for the treatment of persistent pain, and doses have tended to creep up. As basic science elucidates mechanisms of pain and analgesia, the cross talk between central pain and opioid actions becomes clearer.

Objectives: We aimed to examine the published literature on basic science explaining pronociceptive opioid actions, and apply this knowledge to clinical observation.

Methods: We reviewed the existing literature on the pronociceptive actions of opioids, both preclinical and clinical studies.

Results: Basic science provides a rationale for the clinical observation that opioids sometimes increase rather than decrease pain. Central sensitization (hyperalgesia) underlies pain chronification, but can also be produced by high dose and high potency opioids. Many of the same mechanisms account for both central pain and opioid hyperalgesia.

Conclusion: Newly revealed basic mechanisms suggest possible avenues for drug development and new drug therapies that could alter pain sensitization through endogenous and exogenous opioid mechanisms. Recent changes in practice such as the introduction of titration-to-effect for opioids have resulted in higher doses used in the clinic setting than ever seen previously. New basic science knowledge hints that these newer dosing practices may need to be reexamined. When pain worsens in a patient taking opioids, can we be assured that this is not because of the opioids, and can we alter this negative effect of opioids through different dosing strategies or new drug intervention?




 
Who’s Calling the Shots in State Politics?
Pro-painkiller echo chamber shaped policy amid drug epidemic
A coalition of drugmakers, industry-backed nonprofits blanketed Washington with messages about the importance of painkillers
By Matthew PerroneemailBen Wiederemail

15 hours, 3 minutes ago Updated: 14 hours, 37 minutes ago


Demonstrators march along Main Street in Abingdon, Va., on July 20, 2007, to raise awareness about the abuse of OxyContin. Since 2000, prescription opioid abuse has claimed the lives of 165,000 Americans, according to federal estimates.

Editor's note: This is the second installment of a two-day series. The first day covers the state political efforts surrounding opioids.

For more than a decade, members of a little-known group called the Pain Care Forum have blanketed Washington with messages touting prescription painkillers’ vital role in the lives of millions of Americans, creating an echo chamber that has quietly derailed efforts to curb U.S. consumption of the drugs, which accounts for two-thirds of the world’s usage.

In 2012, drugmakers and their affiliates in the forum sent a letter to U.S. senators promoting a hearing about an influential report on a “crisis of epidemic proportions”: pain in America. Few knew the report stemmed from legislation drafted and pushed by forum members and that their experts had helped author it. The report estimated more than 100 million Americans — roughly 40 percent of adults — suffered from chronic pain, an eye-popping statistic that some researchers call deeply problematic.

The letter made no reference to another health issue that had been declared an epidemic by federal authorities: drug overdoses tied to prescription painkillers. Deaths linked to addictive drugs like OxyContin, Vicodin and Percocet had increased more than fourfold since 1999, accounting for more fatal overdoses in 2012 than heroin and cocaine combined.

An investigation by the Center for Public Integrity and The Associated Pressreveals that similar feedback loops of information and influence play out regularly in the nation’s capital, fueled by money and talking points from the Pain Care Forum, a loose coalition of drugmakers, trade groups and dozens of nonprofits supported by industry funding that has flown under the radar until now.

Hundreds of internal documents shed new light on how drugmakers and their allies shaped the national response to the ongoing wave of prescription opioid abuse, which has claimed the lives of roughly 165,000 Americans since 2000, according to federal estimates.

Painkillers are among the most widely prescribed medications in the U.S., but pharmaceutical companies and allied groups have a multitude of legislative interests beyond those drugs. From 2006 through 2015, participants in the Pain Care Forum spent over $740 million lobbying in the nation’s capital and in all 50 statehouses on an array of issues, including opioid-related measures, according to an analysis of lobbying filings by the Center for Public Integrity and AP.

The same organizations reinforced their influence with more than $140 million doled out to political campaigns, including more than $75 million alone to federal candidates, political action committees and parties.

That combined spending on lobbying and campaigns amounts to more than 200 times the $4 million spent during the same period by the handful of groups that work for restrictions on painkillers. Meanwhile, opioid sales reached $9.6 billion last year, according to IMS Health, a health information company.

“You can go a long, long way in getting what you want when you have a lot of money,” said Professor Keith Humphreys of Stanford University, a former adviser on drug policy under President Barack Obama. “And it’s only when things get so disastrous that finally there’s enough popular will aroused to push back.”

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Politics of Pain[/paste:font]About this project[/paste:font]
Obama gave his first speech on the opioid epidemic last fall. In July, Congress passed its first legislation targeting the crisis, an election-year package intended to expand access to addiction treatment. But the law includes little new funding and no restrictions on painkillers, such as mandatory training for prescribers, a step favored by federal advisory panels.

Obama administration officials say they have tried to strike a balance between controlling the harms of opioids and keeping them available for patients.

“We did not want to deny people access to appropriate pain care,” said Michael Botticelli, Obama’s drug czar. “We were all trying to figure out what the balance was, and that’s still the case going forward.”

Painkillers are modern versions of ancient medicines derived from the opium poppy, also the source of heroin. Prescription opioids were long reserved for the most severe forms of pain associated with surgery, injury or terminal diseases like cancer.

That changed in the 1990s with a surge in prescribing for more common ailments like back pain, arthritis and headaches. A combination of factors fueled the trend, including new medical guidelines, insurance policies and pharmaceutical marketing for long-acting drugs like OxyContin.

The drug’s manufacturer, Purdue Pharma, pleaded guilty and agreed to pay more than $600 million in fines in 2007 for misleading the public about the risks of OxyContin. But the drug continued to rack up blockbuster sales, generating more than $22 billion over the last decade.

Despite having no physical address or online presence, the Pain Care Forum hosts high-ranking officials from the White House, Food and Drug Administration and other agencies at its monthly gatherings.

Purdue’s Washington lobbyist, Burt Rosen, co-founded the forum more than a decade ago and coordinates the group’s meetings, which include dozens of lobbyists and executives.

Purdue declined to make Rosen available for interviews and did not answer specific questions about its lobbying activities or financial support for forum participants. Purdue said it supports a range of advocacy groups, including some with differing views on opioids.

“In practice and governance, the Pain Care Forum is like any of the hundreds of policy coalitions in Washington and throughout the nation,” the company said in a statement, adding: “Purdue complies with all applicable lobbying disclosure laws and requirements.”

While Purdue, Endo Pharmaceuticals and other members have maintained the forum does not take policy positions, the AP and Center for Public Integrity's reporting shows the group’s participants have worked together to push and draft federal legislation, blunt regulations and influence decisions around opioids.

Opioid drugmakers say they are striving to improve the safety of their products and how they are used. They point to new harder-to-crush pills and initiatives that, among other things, allow states to share databases designed to spot “doctor shopping” by patients.

Elsewhere, experts are reevaluating the effectiveness of opioids for most forms of chronic pain, noting little long-term research.

“The biggest myth out there is that there’s a conflict between reducing our dependence on opioids and improving care for patients in pain,” said Dr.Caleb Alexander, co-director of Johns Hopkins University’s Center for Drug Safety and Effectiveness. “It’s an artificial conflict, but there are lots of vested interests behind it.”

FDA Commissioner Dr. Margaret Hamburg, shown here speaking at the White House in February 2014, has used the statistic that 100 million Americans suffered from chronic pain to illustrate the importance of keeping painkillers accessible, despite the escalating toll of opioid addiction and abuse in American communities.

‘The epidemic of pain’

By spring 2014, the figure that 100 million Americans suffered from chronic pain was getting new attention: as a talking point for the nation’s top drug regulator.

The head of the FDA used the statistic to illustrate the importance of keeping painkillers accessible, despite the escalating toll of opioid addiction and abuse in American communities.

In an online essay, then-Commissioner Dr. Margaret Hamburg said reducing the toll was a “highest priority,” but that her agency had to “balance it with another major public health priority: managing the pain that affects an estimated 100 million Americans.”

That line populated her speeches and interviews for months.

But Michael Von Korff of the Group Health Research Institute, whose research contributed to the statistic, said the number has no connection to opioids. Instead, he said, it mostly represents “people with run-of-the-mill pain problems who are already managing them pretty well.”

Von Korff’s work is funded by federal, foundation and health insurance sources. He also is an officer with Physicians for Responsible Opioid Prescribing, a group pushing for restrictions on the drugs.

Pain Care Forum participants spent nearly $19 million on lobbying efforts that included the legislation requiring federal research on pain and the Institute of Medicine report that first highlighted the figure.

Concerns about the use of the statistic in connection with opioids and ties between some of the report authors and the pharmaceutical industry were covered by the Milwaukee Journal Sentinel in 2014.

Nearly half the experts assembled by the Institute of Medicine to write the 364-page report had served as leaders in Pain Care Forum-affiliated groups, such as the American Pain Foundation, the American Pain Society and the American Academy of Pain Medicine — all supported by industry funding.

Hamburg said in an email that the report was “another piece of scientific literature that helped inform the broader field,” which her agency had no role in producing.

The Pain Care Forum discussed the legislation that led to the report at its first meeting in February 2005, according to notes by one of the group’s principal members, The American Pain Foundation. Memos from the now-defunct foundation are among hundreds of documents obtained through public information requests by the AP and the Center for Public Integrity from the city of Chicago, which accused six drugmakers of misleading the public about opioid risks in an ongoing lawsuit.



Politics of pain: Drugmakers fought state opioid limits amid crisis
By Liz Essley Whyte, Geoff Mulvihill and Ben Wieder

September 18, 2016


Orrin Hatch, R-Utah, and former Sen. Chris Dodd, D-Conn., who together introduced the Senate version of the bill, received more than $360,000 and $190,000 respectively from forum participants.

Staffers for Hatch did not respond to repeated requests for comment. Dodd, who left office in 2011, said in a statement: “Sen. Hatch and I worked together to increase awareness and understanding of this serious medical condition in the hopes of providing relief to the millions of Americans who suffer from chronic pain.”

Phil Saigh, the executive director of the American Academy of Pain Medicine, said he informed the Pain Care Forum years ago that his group did not consider itself a member of the coalition. Yet the academy has continuously appeared in directories of forum participants since 2006, including as late as 2013, the most recent documents available.

The academy and the American Pain Society say some of the funding they receive from drugmakers is in the form of grants used for expenses tied to educational meetings and events. Both organizations also operate separate “corporate councils,” in which companies are granted meetings with physicians in exchange for annual payments up to the $20,000 range.

Jennifer Walsh, a spokeswoman for the National Academies of Sciences, Engineering and Medicine, said, “We stand by our report, the committee, and the process that produced it.”

Experts who could personally profit from reports are prohibited from serving on its committees, she added. But the academies, which advise the federal government on scientific and medical topics, declined to release financial disclosure forms completed by panelists.

Those on opposite sides of the opioids debate agree that the report raised important points about pain treatment, including warnings about the addictiveness of painkillers.

After the report’s release in June 2011, the American Pain Foundation received $150,000 from Purdue to promote its findings through the Pain Care Forum. The foundation planned “congressional briefings and hearings” and “meetings with the leadership of various federal agencies,” according to a November 2011 letter.

The foundation closed the next year. Senate investigators had asked about the nonprofit receiving nearly 90 percent of its funding from industry.

Meanwhile, a handful of lawmakers tried to draw attention to rising rates of painkiller abuse.

In 2010, then-Rep. Mary Bono, R-Calif., co-founded the Congressional Caucus on Prescription Drug Abuse, which focused on educating lawmakers about drug abuse. She clipped newspaper stories from her colleagues’ home states, but recalled, “They’d just say ‘Yeah, yeah, yeah,’ and move on to more pressing matters.”

Bono, whose family had dealt with opioid addiction, drafted legislation in 2010 designed to curb opioid prescribing by requiring the FDA to limit the labeling for OxyContin and related drugs to “severe pain.” OxyContin had long been marketed for a broader indication listed on the label as “moderate-to-severe pain.”

According to Bono, a Purdue lobbyist visited her and threatened to pull back on its state-level funding for drug abuse initiatives.

“They were just letting it be known that if I didn’t play nicer with them, they could cause some things to happen that I wouldn’t like,” she said.

Purdue said in a statement that it met with Bono to support “her efforts to stop prescription drug abuse.” The company says it does not oppose measures that “improve the way opioids are prescribed,” even when they could reduce sales. Former Rep. Bill Brewster, D-Oklahoma, a contract lobbyist for Purdue at the time, said in an email that he recalled the conversation as “cordial and constructive.”

Purdue spent nearly $800,000 on lobbying efforts that included Bono’s bill and subsequent versions of it. Pain Care Forum participants gave her campaigns more than $60,000 from 2006 through 2012.

Bono’s bill, the Stop Oxy Abuse Act, never received a congressional vote or hearing, even after Republicans regained control of the House in the November 2010 elections. She lost her congressional seat in 2012.

‘What’s a regulator to do?’

In June 2012, a senior FDA official gave a presentation to the Pain Care Forum titled: “FDA and Opioids: What’s a regulator to do?”

For several years, the FDA had been developing risk-management plans to reduce misuse of long-acting opioids like OxyContin. With oversight of drugmakers and their marketing efforts, the agency seemed perfectly positioned to tackle the problem.

But the plans that the FDA laid out lacked the major reforms suggested by the agency itself in 2009, when it announced the initiative. Instead of mandatory certification training for doctors and electronic registries to track opioid prescriptions to patients, the FDA official outlined much milder steps: Drugmakers would fund optional classes for prescribers and supply pharmacy brochures to patients about opioid risks.

Over several years, the FDA seemed to have backed away from any significant restrictions.

“It was my observation that the staff at FDA had really bought into the idea that pain was greatly undertreated in the United States,” said Dr. Elinore McCance-Katz, former chief medical officer with the Substance Abuse and Mental Health Service Administration, a federal health agency.

As early as December 2008, the Pain Care Forum was developing a strategy to “inform the process” at the FDA, according to meeting minutes from the American Pain Foundation.

When the FDA sought public comment on how to proceed, the forum helped generate more than 2,000 comments opposing new barriers to opioids, according to a 2010 foundation memo. Additionally, the forum produced a 4,000-signature petition opposing electronic registries for opioid prescriptions, which advocacy groups said would stigmatize patients.

In 2010, Dr. Nathaniel Katz, a former adviser to the Food and Drug Administration and currently CEO of Analgesic Solutions, traveled to Washington, D.C., to implore an FDA panel to support tougher requirements to manage opioid risks.


AP Photo/Steven Senne

Finally, in July 2010, the FDA assembled a panel of outside advisers — primarily physicians — to review its plans to manage opioid risks, including voluntary doctor training.

During a comment period, several members of the public warned it was a mistake. Dr. Nathaniel Katz, a former FDA adviser turned pharmaceutical consultant, traveled from Boston to implore the panel to support tougher requirements.

“The days of prescribers not being trained how to safely prescribe the number one medication in the United States have to be brought to an end by you today,” said Katz, who had previously chaired the FDA panel, according to a meeting transcript.

Ultimately, the panel voted 25-10 against the measures developed by the FDA, saying they would have little effect on opioid abuse. But the FDA put them in place anyway, one month after the agency briefed the Pain Care Forum on the plans. The FDA is not required to follow the recommendations of its advisory panels.

Agency officials said they decided that requiring certification for opioid prescribers would have been overly burdensome and disrupted care for patients.

“You can’t imagine the bitter screeds we hear from the prescribing community about the paperwork involved,” said Dr. Janet Woodcock, head of the FDA’s drug center. She added that the opioid crisis fundamentally stems from individual prescribing decisions, saying, “We don’t regulate medical practice.”

In the last two years, the FDA has placed several limitations on opioids, including adding new bolded warnings to immediate-release opioids such as Vicodin and Percocet. But prescriber training remains optional, even after a second FDA advisory panel again recommended the step earlier this year. Woodcock says the agency is still weighing that recommendation.

Currently, states such as Massachusetts are imposing their own physician-training requirements, a development that Katz attributes to a lack of federal action.

“The FDA failed to make a decision that could have averted many of the thousands of deaths we’re seeing per year,” Katz said. “So when people continue to die and communities continue to be devastated, then others will arise to do the policing.”

Charting a ‘safer course’

It was a federal agency hundreds of miles from Washington that finally sidestepped the influence of the pain care lobbyists.

The Centers for Disease Control and Prevention, located in Atlanta, overcame threats of congressional investigation and legal action to publish the first federal guidelines intended to reduce opioid prescribing earlier this year.



Drugmakers fought domino effect of Washington opioid limits
By Geoff Mulvihill and Liz Essley Whyte
September 18, 2016



Essentially, the agency said the risks of painkillers greatly outweigh the benefits for the vast majority of patients with routine chronic pain. Instead, the guidelines said, doctors should consider alternatives like non-opioid pain relievers and physical therapy.

For more than 15 years, CDC officials have tracked the precipitous rise in painkiller overdoses, which has been followed by a similar surge in heroin deaths. The CDC called the painkiller trend an epidemic in 2011, pushing Washington officials to do the same. The agency’s director, Dr. Tom Frieden, labeled opioids “dangerous medications” that “should be reserved for situations like severe cancer pain.”

When the CDC drafted its opioid guidelines, it moved quickly and quietly, initially giving outside groups just 48 hours to comment on draft guidelines distributed last September.

Opioid proponents said the guidelines were not based on solid evidence and criticized the CDC for not disclosing outside experts who had advised the effort, alleging that they included physicians who were biased against painkillers.

One pharma-aligned group, the Washington Legal Foundation, said the lack of disclosure constituted a “clear violation” of federal law. And a longtime Pain Care Forum participant — now known as the Academy of Integrative Pain Management — asked congressional leaders to investigate how the CDC had developed the guidelines. A House committee asked the CDC to turn over documents about its advisers, but staffers said the probe did not uncover any violations.

Pharma lobbying held deep influence over opioid policies

Some of the most vigorous pushback came from Pain Care Forum affiliates embedded in the federal system. Under the 2010 pain legislation backed by the forum, the NIH had created a 19-member panel to coordinate pain research made up of federal officials, civilian physicians and pain advocates.

At the group’s December meeting, panelists with connections to the Pain Care Forum called the CDC’s approach “horrible” and “shocking.”

Dr. Richard Payne, a former board member of the American Pain Foundation, questioned whether the experts advising the CDC had “conflicts of interests in terms of biases, intellectual conflicts that needed to be disclosed.”

Payne himself had received more than $16,240 in speaking fees, meals, travel and other payments from drugmakers, including Purdue, between 2013 and 2015, according to federal records.

Myra Christopher, a long-time Pain Care Forum participant, said the panel should inform the CDC that it could not support the opioid guidelines and that their release should be delayed.

Christopher holds a chair at the nonprofit Center for Practical Bioethics, which receives funding from opioid drugmakers, and her position was established through a $1.5 million gift from Purdue. Both she and Payne also served on the Institute of Medicine panel on pain in America.

Christopher and Payne said they were thoroughly vetted before serving on the panel and disclosed their past work and activities. Federal officials who oversee the panel responded that all members met federal requirements to serve, including completing financial disclosure forms, though the NIH said those cannot be publicly released.

One week after the NIH panel’s critique, the CDC said it would delay finalizing its guidelines to allow more public comment and released a list of advisers. One of 17 “core experts” advising the agency reported serving as a paid consultant to Cohen Milstein Sellers & Toll, the law firm suing multiple opioid drugmakers on behalf of the city of Chicago.

In March, the final guidelines appeared.

The first recommendation for U.S. doctors: “Opioids are not first-line therapy” for chronic pain. It was a statement considered common practice by many doctors as recently as the early-1990s, a decade before the Pain Care Forum formed in Washington.

"We're trying to chart a safer and more effective course for dealing with chronic pain," Frieden said. "We don’t expect any magic. We don’t expect things to be better in 15 months when it’s taken 15 years to get this much worse.”

Center for Public Integrity reporter Liz Essley Whyte and Associated Press reporter Geoff Mulvihill contributed to this article.
 
Who’s Calling the Shots in State Politics?
Pro-painkiller echo chamber shaped policy amid drug epidemic
A coalition of drugmakers, industry-backed nonprofits blanketed Washington with messages about the importance of painkillers
By Matthew PerroneemailBen Wiederemail

15 hours, 3 minutes ago Updated: 14 hours, 37 minutes ago


Demonstrators march along Main Street in Abingdon, Va., on July 20, 2007, to raise awareness about the abuse of OxyContin. Since 2000, prescription opioid abuse has claimed the lives of 165,000 Americans, according to federal estimates.

Editor's note: This is the second installment of a two-day series. The first day covers the state political efforts surrounding opioids.

For more than a decade, members of a little-known group called the Pain Care Forum have blanketed Washington with messages touting prescription painkillers’ vital role in the lives of millions of Americans, creating an echo chamber that has quietly derailed efforts to curb U.S. consumption of the drugs, which accounts for two-thirds of the world’s usage.

In 2012, drugmakers and their affiliates in the forum sent a letter to U.S. senators promoting a hearing about an influential report on a “crisis of epidemic proportions”: pain in America. Few knew the report stemmed from legislation drafted and pushed by forum members and that their experts had helped author it. The report estimated more than 100 million Americans — roughly 40 percent of adults — suffered from chronic pain, an eye-popping statistic that some researchers call deeply problematic.

The letter made no reference to another health issue that had been declared an epidemic by federal authorities: drug overdoses tied to prescription painkillers. Deaths linked to addictive drugs like OxyContin, Vicodin and Percocet had increased more than fourfold since 1999, accounting for more fatal overdoses in 2012 than heroin and cocaine combined.

An investigation by the Center for Public Integrity and The Associated Pressreveals that similar feedback loops of information and influence play out regularly in the nation’s capital, fueled by money and talking points from the Pain Care Forum, a loose coalition of drugmakers, trade groups and dozens of nonprofits supported by industry funding that has flown under the radar until now.

Hundreds of internal documents shed new light on how drugmakers and their allies shaped the national response to the ongoing wave of prescription opioid abuse, which has claimed the lives of roughly 165,000 Americans since 2000, according to federal estimates.

Painkillers are among the most widely prescribed medications in the U.S., but pharmaceutical companies and allied groups have a multitude of legislative interests beyond those drugs. From 2006 through 2015, participants in the Pain Care Forum spent over $740 million lobbying in the nation’s capital and in all 50 statehouses on an array of issues, including opioid-related measures, according to an analysis of lobbying filings by the Center for Public Integrity and AP.

The same organizations reinforced their influence with more than $140 million doled out to political campaigns, including more than $75 million alone to federal candidates, political action committees and parties.

That combined spending on lobbying and campaigns amounts to more than 200 times the $4 million spent during the same period by the handful of groups that work for restrictions on painkillers. Meanwhile, opioid sales reached $9.6 billion last year, according to IMS Health, a health information company.

“You can go a long, long way in getting what you want when you have a lot of money,” said Professor Keith Humphreys of Stanford University, a former adviser on drug policy under President Barack Obama. “And it’s only when things get so disastrous that finally there’s enough popular will aroused to push back.”

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Politics of Pain[/paste:font]About this project[/paste:font]
Obama gave his first speech on the opioid epidemic last fall. In July, Congress passed its first legislation targeting the crisis, an election-year package intended to expand access to addiction treatment. But the law includes little new funding and no restrictions on painkillers, such as mandatory training for prescribers, a step favored by federal advisory panels.

Obama administration officials say they have tried to strike a balance between controlling the harms of opioids and keeping them available for patients.

“We did not want to deny people access to appropriate pain care,” said Michael Botticelli, Obama’s drug czar. “We were all trying to figure out what the balance was, and that’s still the case going forward.”

Painkillers are modern versions of ancient medicines derived from the opium poppy, also the source of heroin. Prescription opioids were long reserved for the most severe forms of pain associated with surgery, injury or terminal diseases like cancer.

That changed in the 1990s with a surge in prescribing for more common ailments like back pain, arthritis and headaches. A combination of factors fueled the trend, including new medical guidelines, insurance policies and pharmaceutical marketing for long-acting drugs like OxyContin.

The drug’s manufacturer, Purdue Pharma, pleaded guilty and agreed to pay more than $600 million in fines in 2007 for misleading the public about the risks of OxyContin. But the drug continued to rack up blockbuster sales, generating more than $22 billion over the last decade.

Despite having no physical address or online presence, the Pain Care Forum hosts high-ranking officials from the White House, Food and Drug Administration and other agencies at its monthly gatherings.

Purdue’s Washington lobbyist, Burt Rosen, co-founded the forum more than a decade ago and coordinates the group’s meetings, which include dozens of lobbyists and executives.

Purdue declined to make Rosen available for interviews and did not answer specific questions about its lobbying activities or financial support for forum participants. Purdue said it supports a range of advocacy groups, including some with differing views on opioids.

“In practice and governance, the Pain Care Forum is like any of the hundreds of policy coalitions in Washington and throughout the nation,” the company said in a statement, adding: “Purdue complies with all applicable lobbying disclosure laws and requirements.”

While Purdue, Endo Pharmaceuticals and other members have maintained the forum does not take policy positions, the AP and Center for Public Integrity's reporting shows the group’s participants have worked together to push and draft federal legislation, blunt regulations and influence decisions around opioids.

Opioid drugmakers say they are striving to improve the safety of their products and how they are used. They point to new harder-to-crush pills and initiatives that, among other things, allow states to share databases designed to spot “doctor shopping” by patients.

Elsewhere, experts are reevaluating the effectiveness of opioids for most forms of chronic pain, noting little long-term research.

“The biggest myth out there is that there’s a conflict between reducing our dependence on opioids and improving care for patients in pain,” said Dr.Caleb Alexander, co-director of Johns Hopkins University’s Center for Drug Safety and Effectiveness. “It’s an artificial conflict, but there are lots of vested interests behind it.”

FDA Commissioner Dr. Margaret Hamburg, shown here speaking at the White House in February 2014, has used the statistic that 100 million Americans suffered from chronic pain to illustrate the importance of keeping painkillers accessible, despite the escalating toll of opioid addiction and abuse in American communities.

‘The epidemic of pain’

By spring 2014, the figure that 100 million Americans suffered from chronic pain was getting new attention: as a talking point for the nation’s top drug regulator.

The head of the FDA used the statistic to illustrate the importance of keeping painkillers accessible, despite the escalating toll of opioid addiction and abuse in American communities.

In an online essay, then-Commissioner Dr. Margaret Hamburg said reducing the toll was a “highest priority,” but that her agency had to “balance it with another major public health priority: managing the pain that affects an estimated 100 million Americans.”

That line populated her speeches and interviews for months.

But Michael Von Korff of the Group Health Research Institute, whose research contributed to the statistic, said the number has no connection to opioids. Instead, he said, it mostly represents “people with run-of-the-mill pain problems who are already managing them pretty well.”

Von Korff’s work is funded by federal, foundation and health insurance sources. He also is an officer with Physicians for Responsible Opioid Prescribing, a group pushing for restrictions on the drugs.

Pain Care Forum participants spent nearly $19 million on lobbying efforts that included the legislation requiring federal research on pain and the Institute of Medicine report that first highlighted the figure.

Concerns about the use of the statistic in connection with opioids and ties between some of the report authors and the pharmaceutical industry were covered by the Milwaukee Journal Sentinel in 2014.

Nearly half the experts assembled by the Institute of Medicine to write the 364-page report had served as leaders in Pain Care Forum-affiliated groups, such as the American Pain Foundation, the American Pain Society and the American Academy of Pain Medicine — all supported by industry funding.

Hamburg said in an email that the report was “another piece of scientific literature that helped inform the broader field,” which her agency had no role in producing.

The Pain Care Forum discussed the legislation that led to the report at its first meeting in February 2005, according to notes by one of the group’s principal members, The American Pain Foundation. Memos from the now-defunct foundation are among hundreds of documents obtained through public information requests by the AP and the Center for Public Integrity from the city of Chicago, which accused six drugmakers of misleading the public about opioid risks in an ongoing lawsuit.



Politics of pain: Drugmakers fought state opioid limits amid crisis
By Liz Essley Whyte, Geoff Mulvihill and Ben Wieder

September 18, 2016


Orrin Hatch, R-Utah, and former Sen. Chris Dodd, D-Conn., who together introduced the Senate version of the bill, received more than $360,000 and $190,000 respectively from forum participants.

Staffers for Hatch did not respond to repeated requests for comment. Dodd, who left office in 2011, said in a statement: “Sen. Hatch and I worked together to increase awareness and understanding of this serious medical condition in the hopes of providing relief to the millions of Americans who suffer from chronic pain.”

Phil Saigh, the executive director of the American Academy of Pain Medicine, said he informed the Pain Care Forum years ago that his group did not consider itself a member of the coalition. Yet the academy has continuously appeared in directories of forum participants since 2006, including as late as 2013, the most recent documents available.

The academy and the American Pain Society say some of the funding they receive from drugmakers is in the form of grants used for expenses tied to educational meetings and events. Both organizations also operate separate “corporate councils,” in which companies are granted meetings with physicians in exchange for annual payments up to the $20,000 range.

Jennifer Walsh, a spokeswoman for the National Academies of Sciences, Engineering and Medicine, said, “We stand by our report, the committee, and the process that produced it.”

Experts who could personally profit from reports are prohibited from serving on its committees, she added. But the academies, which advise the federal government on scientific and medical topics, declined to release financial disclosure forms completed by panelists.

Those on opposite sides of the opioids debate agree that the report raised important points about pain treatment, including warnings about the addictiveness of painkillers.

After the report’s release in June 2011, the American Pain Foundation received $150,000 from Purdue to promote its findings through the Pain Care Forum. The foundation planned “congressional briefings and hearings” and “meetings with the leadership of various federal agencies,” according to a November 2011 letter.

The foundation closed the next year. Senate investigators had asked about the nonprofit receiving nearly 90 percent of its funding from industry.

Meanwhile, a handful of lawmakers tried to draw attention to rising rates of painkiller abuse.

In 2010, then-Rep. Mary Bono, R-Calif., co-founded the Congressional Caucus on Prescription Drug Abuse, which focused on educating lawmakers about drug abuse. She clipped newspaper stories from her colleagues’ home states, but recalled, “They’d just say ‘Yeah, yeah, yeah,’ and move on to more pressing matters.”

Bono, whose family had dealt with opioid addiction, drafted legislation in 2010 designed to curb opioid prescribing by requiring the FDA to limit the labeling for OxyContin and related drugs to “severe pain.” OxyContin had long been marketed for a broader indication listed on the label as “moderate-to-severe pain.”

According to Bono, a Purdue lobbyist visited her and threatened to pull back on its state-level funding for drug abuse initiatives.

“They were just letting it be known that if I didn’t play nicer with them, they could cause some things to happen that I wouldn’t like,” she said.

Purdue said in a statement that it met with Bono to support “her efforts to stop prescription drug abuse.” The company says it does not oppose measures that “improve the way opioids are prescribed,” even when they could reduce sales. Former Rep. Bill Brewster, D-Oklahoma, a contract lobbyist for Purdue at the time, said in an email that he recalled the conversation as “cordial and constructive.”

Purdue spent nearly $800,000 on lobbying efforts that included Bono’s bill and subsequent versions of it. Pain Care Forum participants gave her campaigns more than $60,000 from 2006 through 2012.

Bono’s bill, the Stop Oxy Abuse Act, never received a congressional vote or hearing, even after Republicans regained control of the House in the November 2010 elections. She lost her congressional seat in 2012.

‘What’s a regulator to do?’

In June 2012, a senior FDA official gave a presentation to the Pain Care Forum titled: “FDA and Opioids: What’s a regulator to do?”

For several years, the FDA had been developing risk-management plans to reduce misuse of long-acting opioids like OxyContin. With oversight of drugmakers and their marketing efforts, the agency seemed perfectly positioned to tackle the problem.

But the plans that the FDA laid out lacked the major reforms suggested by the agency itself in 2009, when it announced the initiative. Instead of mandatory certification training for doctors and electronic registries to track opioid prescriptions to patients, the FDA official outlined much milder steps: Drugmakers would fund optional classes for prescribers and supply pharmacy brochures to patients about opioid risks.

Over several years, the FDA seemed to have backed away from any significant restrictions.

“It was my observation that the staff at FDA had really bought into the idea that pain was greatly undertreated in the United States,” said Dr. Elinore McCance-Katz, former chief medical officer with the Substance Abuse and Mental Health Service Administration, a federal health agency.

As early as December 2008, the Pain Care Forum was developing a strategy to “inform the process” at the FDA, according to meeting minutes from the American Pain Foundation.

When the FDA sought public comment on how to proceed, the forum helped generate more than 2,000 comments opposing new barriers to opioids, according to a 2010 foundation memo. Additionally, the forum produced a 4,000-signature petition opposing electronic registries for opioid prescriptions, which advocacy groups said would stigmatize patients.

In 2010, Dr. Nathaniel Katz, a former adviser to the Food and Drug Administration and currently CEO of Analgesic Solutions, traveled to Washington, D.C., to implore an FDA panel to support tougher requirements to manage opioid risks.


AP Photo/Steven Senne

Finally, in July 2010, the FDA assembled a panel of outside advisers — primarily physicians — to review its plans to manage opioid risks, including voluntary doctor training.

During a comment period, several members of the public warned it was a mistake. Dr. Nathaniel Katz, a former FDA adviser turned pharmaceutical consultant, traveled from Boston to implore the panel to support tougher requirements.

“The days of prescribers not being trained how to safely prescribe the number one medication in the United States have to be brought to an end by you today,” said Katz, who had previously chaired the FDA panel, according to a meeting transcript.

Ultimately, the panel voted 25-10 against the measures developed by the FDA, saying they would have little effect on opioid abuse. But the FDA put them in place anyway, one month after the agency briefed the Pain Care Forum on the plans. The FDA is not required to follow the recommendations of its advisory panels.

Agency officials said they decided that requiring certification for opioid prescribers would have been overly burdensome and disrupted care for patients.

“You can’t imagine the bitter screeds we hear from the prescribing community about the paperwork involved,” said Dr. Janet Woodcock, head of the FDA’s drug center. She added that the opioid crisis fundamentally stems from individual prescribing decisions, saying, “We don’t regulate medical practice.”

In the last two years, the FDA has placed several limitations on opioids, including adding new bolded warnings to immediate-release opioids such as Vicodin and Percocet. But prescriber training remains optional, even after a second FDA advisory panel again recommended the step earlier this year. Woodcock says the agency is still weighing that recommendation.

Currently, states such as Massachusetts are imposing their own physician-training requirements, a development that Katz attributes to a lack of federal action.

“The FDA failed to make a decision that could have averted many of the thousands of deaths we’re seeing per year,” Katz said. “So when people continue to die and communities continue to be devastated, then others will arise to do the policing.”

Charting a ‘safer course’

It was a federal agency hundreds of miles from Washington that finally sidestepped the influence of the pain care lobbyists.

The Centers for Disease Control and Prevention, located in Atlanta, overcame threats of congressional investigation and legal action to publish the first federal guidelines intended to reduce opioid prescribing earlier this year.



Drugmakers fought domino effect of Washington opioid limits
By Geoff Mulvihill and Liz Essley Whyte
September 18, 2016



Essentially, the agency said the risks of painkillers greatly outweigh the benefits for the vast majority of patients with routine chronic pain. Instead, the guidelines said, doctors should consider alternatives like non-opioid pain relievers and physical therapy.

For more than 15 years, CDC officials have tracked the precipitous rise in painkiller overdoses, which has been followed by a similar surge in heroin deaths. The CDC called the painkiller trend an epidemic in 2011, pushing Washington officials to do the same. The agency’s director, Dr. Tom Frieden, labeled opioids “dangerous medications” that “should be reserved for situations like severe cancer pain.”

When the CDC drafted its opioid guidelines, it moved quickly and quietly, initially giving outside groups just 48 hours to comment on draft guidelines distributed last September.

Opioid proponents said the guidelines were not based on solid evidence and criticized the CDC for not disclosing outside experts who had advised the effort, alleging that they included physicians who were biased against painkillers.

One pharma-aligned group, the Washington Legal Foundation, said the lack of disclosure constituted a “clear violation” of federal law. And a longtime Pain Care Forum participant — now known as the Academy of Integrative Pain Management — asked congressional leaders to investigate how the CDC had developed the guidelines. A House committee asked the CDC to turn over documents about its advisers, but staffers said the probe did not uncover any violations.

Pharma lobbying held deep influence over opioid policies

Some of the most vigorous pushback came from Pain Care Forum affiliates embedded in the federal system. Under the 2010 pain legislation backed by the forum, the NIH had created a 19-member panel to coordinate pain research made up of federal officials, civilian physicians and pain advocates.

At the group’s December meeting, panelists with connections to the Pain Care Forum called the CDC’s approach “horrible” and “shocking.”

Dr. Richard Payne, a former board member of the American Pain Foundation, questioned whether the experts advising the CDC had “conflicts of interests in terms of biases, intellectual conflicts that needed to be disclosed.”

Payne himself had received more than $16,240 in speaking fees, meals, travel and other payments from drugmakers, including Purdue, between 2013 and 2015, according to federal records.

Myra Christopher, a long-time Pain Care Forum participant, said the panel should inform the CDC that it could not support the opioid guidelines and that their release should be delayed.

Christopher holds a chair at the nonprofit Center for Practical Bioethics, which receives funding from opioid drugmakers, and her position was established through a $1.5 million gift from Purdue. Both she and Payne also served on the Institute of Medicine panel on pain in America.

Christopher and Payne said they were thoroughly vetted before serving on the panel and disclosed their past work and activities. Federal officials who oversee the panel responded that all members met federal requirements to serve, including completing financial disclosure forms, though the NIH said those cannot be publicly released.

One week after the NIH panel’s critique, the CDC said it would delay finalizing its guidelines to allow more public comment and released a list of advisers. One of 17 “core experts” advising the agency reported serving as a paid consultant to Cohen Milstein Sellers & Toll, the law firm suing multiple opioid drugmakers on behalf of the city of Chicago.

In March, the final guidelines appeared.

The first recommendation for U.S. doctors: “Opioids are not first-line therapy” for chronic pain. It was a statement considered common practice by many doctors as recently as the early-1990s, a decade before the Pain Care Forum formed in Washington.

"We're trying to chart a safer and more effective course for dealing with chronic pain," Frieden said. "We don’t expect any magic. We don’t expect things to be better in 15 months when it’s taken 15 years to get this much worse.”

Center for Public Integrity reporter Liz Essley Whyte and Associated Press reporter Geoff Mulvihill contributed to this article.


This is no different than big pharma lobbies that support payment for cancer drugs that don't work, lyrica that barely works, lack of Medicare negotiation of drug prices due to lobbying, etc.

If you eliminated Pfizer's whole patented formulary, you probably wouldn't effect health at all.

There is a lack of level 1 evidence for any of their current patented products besides very small benefit with lyrica but far more side effects.

In fact, the biggest racket are all the psychiatric drugs they have patented that have shown to INCREASE suicidal ideation, obesity, etc with no long term efficacy studies.

Kindve like the whole field of psychiatry using medications to manage depression or psychosis with absolutely no evidence.

Or how about benzodiazepines?
 
Attached is a bar graph of opioid overdose deaths from 1980 to 2014. These are combined prescription opioids and heroin compiled by the CDC. The legend for the graph is provided below.

1. 1980: Porter and Jick write a letter to the New England Journal of medicine describing 4 cases of addiction among 12000 hospitalized patients receiving opioids. This was a one paragraph letter which wasn’t peer-reviewed, but it punched above it’s weight.

2. 1986: Portenoy and Foley - Portenoy is a neurologist and cancer pain/palliative care physician - publish and article on the use of opioids among 38 chronic non-cancer pain with no reported misuse/addiction.

3. 1989: Weissman & Haddox publish and article that coins the term “pseudo-addiction” based upon their experience with one 17y/o patient with leukemia and chest wall pain who acted like an addict because he wasn’t being given enough pain medication. (You can envision how an unscrupulous opioid manufacturer - like Purdue - might use the term in non-cancer pain to encourage over prescribing, this is precisely what they did.)

Those three articles loosed the reins on opioid prescribing for chronic non-cancer pain. Heretofore opioids had been reserved for end of life pain, cancer pain, and trauma. When those ‘palliative care’ principles were imported into the treatment of non-cancer pain along with them came these additional two:

a.“Pain is what ever the patient says it is and occurs whenever the patient says it does.” Attributed to McCaffrey an oncology nurse in 1968.
b. “There is no ceiling effect for opioids.” As cancer or end of life patients become tolerant to their opioid pain medication you simply increase the dose until you overcome the tolerance.

4. 1990: Fibromyalgia is introduced into the medical lexicon. This is a condition for which there is pain, but no demonstrable tissue injury. This is a key event because it legitimized treating the subjective experience of pain in the absence of any physical sign of disease. Fibromyalgia really highlights the dilemma doctors face when treating non-cancer pain as though it were cancer pain, i.e., “Pain is whatever the patient says it is.” In creating this diagnosis the American College of Rheumatology unwittingly endorsed treating non-cancer pain as though it were cancer pain. And shortly thereafter the diagnosis of many other subjective pain complaints - irritable bowel syndrome, chronic fatigue, headache, chronic pelvic pain, back ache, TMJ, etc - began to explode, as did the use of opioids. In 2008 Fred Wolfe - the rheumatologist who coined the term 'Fibromyalgia' - himself recants his belief in the condition in the NYT: http://www.nytimes.com/2008/01/14/health/14pain.html

5. 1992: Haddox - see #3 above - goes to work for Purdue pharma and he and Purdue apply for a patent on a long acting form of oxycodone: Oxycontin is born.

6. 1996: Oxycontin is approved by the FDA and The American Pain Society pushes the “Pain as a 5th Vital Sign” initiative endorsing an aggressive - narcotic - treatment for the subjective experience of non-cancer pain.

7. 1998: Purdue and Endo - both opioid manufacturers - fund the Federated State Medical Board’s liberal opioid prescribing guidelines, further loosening the reins on prescribing opioids for chronic non-cancer pain.

8. 2001: The Joint Commission mandates the use of the pain scale in the hospital as a “Patient’s right”. The effort and literature used to support it was funded by Purdue.

9. 2004: William Hurwitz, MD is pursued by the Feds for drug distribution and overdose deaths. Hurtwitz was the index case when the DEA - to their credit - realized that something was wrong with opioid prescribing for non-cancer pain in America. In spite of a defense team laden with “pain thought leaders" Hurwitz was convicted to 25yrs in prison.

That same year (2004) the DEA assembles a panel of experts to develop a FAQ on opioids but, after the release of the FAQs, they are immediately retracted due to the enormous PHARMA COI’s of their expert panel.

10. 2006: Purdue settles for $634M for off label marketing of Oxycontin.

11. 2008: Cephalon pays $425M for off label marketing of Actiq.

12. 2011: The IOM proclaims that 100M Americans experience chronic pain.

13. 2012: Russel Portenoy recants in the WSJ, apologizing for his role in the opioid epidemic: http://www.wsj.com/articles/SB10001424127887324478304578173342657044604

14. 2015: State of KY settles lawsuit with Purdue Pharma for $24M but files another one for $1B. State of OR wins a settlement against Insys for off-label marketing of an oral fentanyl product in Oregon. Millennium Laboratory - national urine drug screening company - pays $256M for false billing and kickbacks to physicians. Sam Quinones publish Dream Land, documenting the parallel rise in prescription opioid deaths/addiction and the resurgence of heroin.

15. 2016: CDC issues Opioid Prescribing Guidelines for chronic non-cancer pain. Suffolk County sues the big opioid manufacturers - and for the first time - names as co-defendants Drs. Portenoy, Webster, Fine, and Fishman, all well known pain “though leaders” with extensive ties to Pharma. Miss AG plans mega-suite against opioid manufacturers.

Opioid induced constipation is such an iatrogenic crisis in the US that it gets it's own Superbowl Ad.

And now Fentanyl is displacing heroin as the preferred opioid of abuse.
 

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how about we stop focusing on the prescription opioid epidemic and start focusing on the chronic pain epidemic and the regulatory problems preventing it from being addressed adequately
 
how about we stop focusing on the prescription opioid epidemic and start focusing on the chronic pain epidemic and the regulatory problems preventing it from being addressed adequately


Your kidding right?
 
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State mandated PDMP use reduces opioid dosage by 8% and ODD's by 12%.

http://content.healthaffairs.org/content/35/10/1876.abstract

Mandatory Provider Review And Pain Clinic Laws Reduce The Amounts Of Opioids Prescribed And Overdose Death Rates
  1. Deborah Dowell1,*,
  2. Kun Zhang2,
  3. Rita K. Noonan3 and
  4. Jason M. Hockenberry4
+Author Affiliations

  1. [email protected]) is a senior medical advisor at the National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC), in Atlanta, Georgia.
  2. *Corresponding author
Abstract
To address the opioid overdose epidemic in the United States, states have implemented policies to reduce inappropriate opioid prescribing. These policies could affect the coincident heroin overdose epidemic by either driving the substitution of heroin for opioids or reducing simultaneous use of both substances. We used IMS Health’s National Prescription Audit and government mortality data to examine the effect of these policies on opioid prescribing and on prescription opioid and heroin overdose death rates in the United States during 2006–13. The analysis revealed that combined implementation of mandated provider review of state-run prescription drug monitoring program data and pain clinic laws reduced opioid amounts prescribed by 8 percent and prescription opioid overdose death rates by 12 percent. We also observed relatively large but statistically insignificant reductions in heroin overdose death rates after implementation of these policies. This combination of policies was effective, but broader approaches to address these coincident epidemics are needed.
 
Drug Dealer, MD: How Doctors Were Duped, Patients Got Hooked, and Why It’s So Hard to Stop 1st Edition
by Anna Lembke (Author)
Three out of four people addicted to heroin probably started on a prescription opioid, according to the director of the Centers for Disease Control and Prevention. In the United States alone, 16,000 people die each year as a result of prescription opioid overdose. But perhaps the most frightening aspect of the prescription drug epidemic is that it’s built on well-meaning doctors treating patients with real problems.

In Drug Dealer, MD, Dr. Anna Lembke uncovers the unseen forces driving opioid addiction nationwide. Combining case studies from her own practice with vital statistics drawn from public policy, cultural anthropology, and neuroscience, she explores the complex relationship between doctors and patients, the science of addiction, and the barriers to successfully addressing drug dependence and addiction. Even when addiction is recognized by doctors and their patients, she argues, many doctors don’t know how to treat it, connections to treatment are lacking, and insurance companies won’t pay for rehab.

Full of extensive interviews―with health care providers, pharmacists, social workers, hospital administrators, insurance company executives, journalists, economists, advocates, and patients and their families― Drug Dealer, MD, is for anyone whose life has been touched in some way by addiction to prescription drugs. Dr. Lembke gives voice to the millions of Americans struggling with prescription drugs while singling out the real culprits behind the rise in opioid addiction: cultural narratives that promote pills as quick fixes, pharmaceutical corporations in cahoots with organized medicine, and a new medical bureaucracy focused on the bottom line that favors pills, procedures, and patient satisfaction over wellness. Dr. Lembke concludes that the prescription drug epidemic is a symptom of a faltering health care system, the solution for which lies in rethinking how health care is delivered.
 

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Drug Dealer, MD: How Doctors Were Duped, Patients Got Hooked, and Why It’s So Hard to Stop 1st Edition
by Anna Lembke (Author)
Three out of four people addicted to heroin probably started on a prescription opioid, according to the director of the Centers for Disease Control and Prevention. In the United States alone, 16,000 people die each year as a result of prescription opioid overdose. But perhaps the most frightening aspect of the prescription drug epidemic is that it’s built on well-meaning doctors treating patients with real problems.

In Drug Dealer, MD, Dr. Anna Lembke uncovers the unseen forces driving opioid addiction nationwide. Combining case studies from her own practice with vital statistics drawn from public policy, cultural anthropology, and neuroscience, she explores the complex relationship between doctors and patients, the science of addiction, and the barriers to successfully addressing drug dependence and addiction. Even when addiction is recognized by doctors and their patients, she argues, many doctors don’t know how to treat it, connections to treatment are lacking, and insurance companies won’t pay for rehab.

Full of extensive interviews―with health care providers, pharmacists, social workers, hospital administrators, insurance company executives, journalists, economists, advocates, and patients and their families― Drug Dealer, MD, is for anyone whose life has been touched in some way by addiction to prescription drugs. Dr. Lembke gives voice to the millions of Americans struggling with prescription drugs while singling out the real culprits behind the rise in opioid addiction: cultural narratives that promote pills as quick fixes, pharmaceutical corporations in cahoots with organized medicine, and a new medical bureaucracy focused on the bottom line that favors pills, procedures, and patient satisfaction over wellness. Dr. Lembke concludes that the prescription drug epidemic is a symptom of a faltering health care system, the solution for which lies in rethinking how health care is delivered.


Its hard to treat "addiction" because most of the "addicted" don't want to do addiction therapy. Not too complicated.
 
Three out of four people addicted to heroin probably started on a prescription opioid, according to the director of the Centers for Disease Control and Prevention.


Misleading quote. Need to qualify what percent of these people were prescribed the medication to themselves for a legitimate medical purpose vs stole from grandma or bought drug off street.
 
Misleading quote. Need to qualify what percent of these people were prescribed the medication to themselves for a legitimate medical purpose vs stole from grandma or bought drug off street.

Correct, most are people who bought it off the street or stole from "friends and family".

Actually, a big Ortho article recently done out of MGH showed that VAST VAST majority (>99%) of OPIOD NAIVE older patients who got some Norco/T3 after an ortho surgery were OFF narcotic meds within one year.

The problem is with people who were ALREADY ADDICTION problems already. These people will be on the streets regardless of prescription drugs getting heroin/fentanyl/cocaine/meth/etc. These people need depression/addiction management plus BETTER Job conditions since our economy has few high paying jobs.
 
I'm reading a book by Tyler Cowen called "Average is Over". In it, he presents in really convincing detail data showing that unemployment, especially for poorly educated men, is way up, and that incomes are stagnant for those can get a job. Increasingly, people aren't bothering to get poorly paid and demanding jobs and just living on the fringes of the economy or going on disability. These folks don't work and don't raise families and I suspect they make up a big portion of the people on chronic high dose opioids.
This is growing problem ever since the 80's and it seems to be effecting every developed country, so I don't think it's realistic for pain doctors, or doctors in general, to promise to fix it. Nobody knows how to fix it, and if you read Tyler Cowen's book, it probably can't be fixed; we're going through a painful transition from one economic model to another. All pain doctors can do is try to limit the harm we do.
 
I'm reading a book by Tyler Cowen called "Average is Over". In it, he presents in really convincing detail data showing that unemployment, especially for poorly educated men, is way up, and that incomes are stagnant for those can get a job. Increasingly, people aren't bothering to get poorly paid and demanding jobs and just living on the fringes of the economy or going on disability. These folks don't work and don't raise families and I suspect they make up a big portion of the people on chronic high dose opioids.
This is growing problem ever since the 80's and it seems to be effecting every developed country, so I don't think it's realistic for pain doctors, or doctors in general, to promise to fix it. Nobody knows how to fix it, and if you read Tyler Cowen's book, it probably can't be fixed; we're going through a painful transition from one economic model to another. All pain doctors can do is try to limit the harm we do.

This is a correct analysis of the problem. Its a FAR larger issue than the symptom of the "prescription drug epidemic" where the cause/effect is being reversed.

The real CAUSE is the hopelessness/depression of this large segment of the population. Physicians should be able to identify this group relatively easily due to many RED FLAGS that present to the astute observer.

However, the problem won't be "solved" because these patients will just go out on the street to abuse the drugs illegally when it becomes necessary, leaving NO CHANGE in overdose death rates as noted in Florida.

Until the underlying problem causing this issue is FIXED, no amount of "recovery programs" or "addiction programs" will solve the problem either since these people are literally medicating away their depression from lack of job opportunities/future. Talking with a therapist won't solve their inherent problems overall.
 
I'm reading a book by Tyler Cowen called "Average is Over". In it, he presents in really convincing detail data showing that unemployment, especially for poorly educated men, is way up, and that incomes are stagnant for those can get a job. Increasingly, people aren't bothering to get poorly paid and demanding jobs and just living on the fringes of the economy or going on disability. These folks don't work and don't raise families and I suspect they make up a big portion of the people on chronic high dose opioids.
This is growing problem ever since the 80's and it seems to be effecting every developed country, so I don't think it's realistic for pain doctors, or doctors in general, to promise to fix it. Nobody knows how to fix it, and if you read Tyler Cowen's book, it probably can't be fixed; we're going through a painful transition from one economic model to another. All pain doctors can do is try to limit the harm we do.

I think the only fix is prevention. We need to be willing to spend liberally on early childhood development in order to head off the
development of the pain-prone, unemployment-prone, disablement-prone, and addiction-prone personality types. IMO these
maladies are best viewed through the sociological lens of early behavioral modeling and personality development rather than through
the disease lens. I wouldn't deny that the neurotic, disagreeable, unconscientious personality types certainly come to enormous suffering
in life and they end up in our waiting rooms, but we don't have the tools to help them. They are looking for a do over. Unfortunately,
personality types tend to develop early and persist in life. I don't really think that CBT, ACT, MBSR, psychoanalysis etc can budge them,
by the time most of them get to us. In the words of Adam Perkins it's trying to add eggs to a baked cake.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4201784/
 
I think the only fix is prevention. We need to be willing to spend liberally on early childhood development in order to head off the
development of the pain-prone, unemployment-prone, disablement-prone, and addiction-prone personality types. IMO these
maladies are best viewed through the sociological lens of early behavioral modeling and personality development rather than through
the disease lens. I wouldn't deny that the neurotic, disagreeable, unconscientious personality types certainly come to enormous suffering
in life and they end up in our waiting rooms, but we don't have the tools to help them. They are looking for a do over. Unfortunately,
personality types tend to develop early and persist in life. I don't really think that CBT, ACT, MBSR, psychoanalysis etc can budge them,
by the time most of them get to us. In the words of Adam Perkins it's trying to add eggs to a baked cake.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4201784/

Simple. Promote Christian Science the national religion and mandatory to receive any government benefits

https://www.advocatehealth.com/documents/faith/Christian_Science_final2.pdf

According to Christian Science, drugs do not have real power; they are effective only insofar as they are supported by general human faith in material cause and effect. “Certain results, supposed to proceed from drugs, are really caused by the faith in them which the false human consciousness is educated to feel.” Because this faith is fundamentally misguided, the effect can only be temporary. Eddy explained, “A hypodermic injection of morphine is administered to a patient, and in twenty minutes the sufferer is quietly asleep. To him there is no longer any pain. Yet any physician— allopathic, homoeopathic, botanic, eclectic—will tell you that the troublesome material cause is unremoved, and that when the soporific influence of the opium is exhausted, the patient will find himself in the same pain, unless the belief which occasions the pain has meanwhile been changed.”
 
I grew up Catholic but around Adventist communities (Angwin). Adventists built health into their religious crede. I've admired them ever since.
 
While we have been tooling away with the 'pain/addiction epidemic' our sociologist colleagues have been quietly
explaining it's origins. Research on the development of personality traits probably explains the IOM's 100M # better
than than any biological explanation. The sociologists use the Big 5 personality questionnaire for research and they are
explaining many of the things we see in clinic much more accurately than than our traditional medical model. The big
5 personality traits are known by the acronym OCEAN: Openness, Contentiousness, Extroversion, Agreeableness, and
Neuroticism. Personality traits tend to have a stronger environmental influence than genetic. With catastrophizing it's
believed to be 60% environment and 40% genetic. This explains the strong familial clustering of FMS. It's an environ-
mental contagion, or maladaptive coping style, that is passed on to the kids. Traits tend to emerge early in life and persist.
Sociology research on welfare recipients suggests that early life events are a key determinant of eventual long-term employment
outcome. This fits nicely with Felitti's ACES findings on childhood trauma and ultimate long-term health outcomes. The
window of prevention is early and short. This is where we need to spend if we want to prevent adverse health and employment
outcomes, not on more pain research or new drugs. Early nurture goes a long way. As we clinicians know, by the time they see us -
pain management - the horse is out of the barn.

Neuroticism, a concept abandoned by us, wasn't abandoned in the academic sociology realm and it predicts both
chronic pain and addiction. Catastrophizing, the single strongest predictor of pain outcome, is neuroticism's little
brother. The confounder now are all the vested interests in 'medicalizing' the distress resulting from childhood
neglect and personality mal-development. Pfizer's advertising for Lyrica is something like $300M/yr. Do you think
they will let FMS die without a fight? Similarly the AAPM, APS, AIPM, ASSIP, Academic pain dept's, the disability
industry, us, etc. There are deep pockets propping up the medicalization of chronic non-cancer pain - i.e. distress/
suffering - in the US.
 
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While we have been tooling away with the 'pain/addiction epidemic' our sociologist colleagues have been quietly
explaining it's origins.

I don't disagree with the model. Just bringing up the question. What are "we"(pain mgmt. doctors, or doctors in general) supposed to do about this? Release position statements that the social aspect of bio-psycho-social should be where the focus is?
 
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Agreement on addiction Tx crosses political boundaries, so does childhood development. This, if anything is a common ground in a divided country.
 
I can see us saying something about Addition Treatment. Seems like childhood development should be a cause taken up by the FP/Pediatrics societies. Maybe Peds PMR.
 
While we have been tooling away with the 'pain/addiction epidemic' our sociologist colleagues have been quietly
explaining it's origins. Research on the development of personality traits probably explains the IOM's 100M # better
than than any biological explanation. The sociologists use the Big 5 personality questionnaire for research and they are
explaining many of the things we see in clinic much more accurately than than our traditional medical model. The big
5 personality traits are known by the acronym OCEAN: Openness, Contentiousness, Extroversion, Agreeableness, and
Neuroticism. Personality traits tend to have a stronger environmental influence than genetic. With catastrophizing it's
believed to be 60% environment and 40% genetic. This explains the strong familial clustering of FMS. It's an environ-
mental contagion, or maladaptive coping style, that is passed on to the kids. Traits tend to emerge early in life and persist.
Sociology research on welfare recipients suggests that early life events are a key determinant of eventual long-term employment
outcome. This fits nicely with Felitti's ACES findings on childhood trauma and ultimate long-term health outcomes. The
window of prevention is early and short. This is where we need to spend if we want to prevent adverse health and employment
outcomes, not on more pain research or new drugs. Early nurture goes a long way. As we clinicians know, by the time they see us -
pain management - the horse is out of the barn.

Neuroticism, a concept abandoned by us, wasn't abandoned in the academic sociology realm and it predicts both
chronic pain and addiction. Catastrophizing, the single strongest predictor of pain outcome, is neuroticism's little
brother. The confounder now are all the vested interests in 'medicalizing' the distress resulting from childhood
neglect and personality mal-development. Pfizer's advertising for Lyrica is something like $300M/yr. Do you think
they will let FMS die without a fight? Similarly the AAPM, APS, AIPM, ASSIP, Academic pain dept's, the disability
industry, us, etc. There are deep pockets propping up the medicalization of chronic non-cancer pain - i.e. distress/
suffering - in the US.


Cool story bro

You can't even get the govt of Oregon to stop paying for surgeries where we cut a male's genitalia off if he feels like he is female and consider this "normal". Anyone being against this procedure is deemed a "hater who is a transphobe" if he doesn't believe taxpayer money shouldn't be used to pay for this type of surgery. You really think the govt/school system/etc can solve this problem?
 
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I would hazard that if we were able to effect societal change at an early age, that this might reduce the incidence of those individuals requesting sex change not based on some esoteric genetic or anatomic reason. this goes beyond what the government or school system would do, and would involve changing the mores and social customs of the entire nation.
 
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I would hazard that if we were able to effect societal change at an early age, that this might reduce the incidence of those individuals requesting sex change not based on some esoteric genetic or anatomic reason. this goes beyond what the government or school system would do, and would involve changing the mores and social customs of the entire nation.


All I know is Oregon Medicaid seems to have money to literally cut off the genitals of men who believe they are "women" with some kind of "evidence" proving this is effective treatment.

Guys like Chou have written meta analyses to prove that cutting a man's penis off when he decides he's a woman is a good usage of taxpayer dollars.

Ergo, there are now millions of dollars in Oregon being spent by the MEDICAID system to ensure this outcome.

Please tell me about that "EBM" again?
 
I would hazard that if we were able to effect societal change at an early age, that this might reduce the incidence of those individuals requesting sex change not based on some esoteric genetic or anatomic reason. this goes beyond what the government or school system would do, and would involve changing the mores and social customs of the entire nation.

I have also written another post comparing how the Statin Guidelines with ZERO EBM have been made LARGER despite the fact there is ZERO evidence to do so by the "US Task Force on Disease Prevention".

Let's be honest, "EBM" is anything the academic wants it to be when they do the analysis depending on whose paying them off.
 
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I would hazard that if we were able to effect societal change at an early age, that this might reduce the incidence of those individuals requesting sex change not based on some esoteric genetic or anatomic reason. this goes beyond what the government or school system would do, and would involve changing the mores and social customs of the entire nation.

I don't see much of a role for physicians in this, unless one's purpose is to advocate for a system that de-medicalizes chronic pain, and thus, shifts resources away from treating it?
 
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I don't see much of a role for physicians in this, unless one's purpose is to advocate for a system that de-medicalizes chronic pain, and thus, shifts resources away from treating it?

Shift resources toward preventing it.
 
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our kids role models nowadays are more visibly flawed and don't always have that "true grit"...

they would not be mistaken for John Wayne or Humphrey Bogart, Alvin York or George Patton...
 
Not to turn this into a transgender thread but thought these were some good facts:

You won't hear it from those championing transgender equality, but controlled and follow-up studies reveal fundamental problems with this movement. When children who reported transgender feelings were tracked without medical or surgical treatment at both Vanderbilt University and London's Portman Clinic, 70%-80% of them spontaneously lost those feelings. Some 25% did have persisting feelings; what differentiates those individuals remains to be discerned.

We at Johns Hopkins University—which in the 1960s was the first American medical center to venture into "sex-reassignment surgery"—launched a study in the 1970s comparing the outcomes of transgendered people who had the surgery with the outcomes of those who did not. Most of the surgically treated patients described themselves as "satisfied" by the results, but their subsequent psycho-social adjustments were no better than those who didn't have the surgery. And so at Hopkins we stopped doing sex-reassignment surgery, since producing a "satisfied" but still troubled patient seemed an inadequate reason for surgically amputating normal organs.

It now appears that our long-ago decision was a wise one. A 2011 study at the Karolinska Institute in Sweden produced the most illuminating results yet regarding the transgendered, evidence that should give advocates pause. The long-term study—up to 30 years—followed 324 people who had sex-reassignment surgery. The study revealed that beginning about 10 years after having the surgery, the transgendered began to experience increasing mental difficulties. Most shockingly, their suicide mortality rose almost 20-fold above the comparable nontransgender population. This disturbing result has as yet no explanation but probably reflects the growing sense of isolation reported by the aging transgendered after surgery. The high suicide rate certainly challenges the surgery prescription.
 
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Clubdeac, do you have a link? This is very interesting. If gender dysphoria is real but surgery is not a great treatment for it, then the medical profession is going about things all wrong.
 
Not to turn this into a transgender thread but thought these were some good facts:

You won't hear it from those championing transgender equality, but controlled and follow-up studies reveal fundamental problems with this movement. When children who reported transgender feelings were tracked without medical or surgical treatment at both Vanderbilt University and London's Portman Clinic, 70%-80% of them spontaneously lost those feelings. Some 25% did have persisting feelings; what differentiates those individuals remains to be discerned.

We at Johns Hopkins University—which in the 1960s was the first American medical center to venture into "sex-reassignment surgery"—launched a study in the 1970s comparing the outcomes of transgendered people who had the surgery with the outcomes of those who did not. Most of the surgically treated patients described themselves as "satisfied" by the results, but their subsequent psycho-social adjustments were no better than those who didn't have the surgery. And so at Hopkins we stopped doing sex-reassignment surgery, since producing a "satisfied" but still troubled patient seemed an inadequate reason for surgically amputating normal organs.

It now appears that our long-ago decision was a wise one. A 2011 study at the Karolinska Institute in Sweden produced the most illuminating results yet regarding the transgendered, evidence that should give advocates pause. The long-term study—up to 30 years—followed 324 people who had sex-reassignment surgery. The study revealed that beginning about 10 years after having the surgery, the transgendered began to experience increasing mental difficulties. Most shockingly, their suicide mortality rose almost 20-fold above the comparable nontransgender population. This disturbing result has as yet no explanation but probably reflects the growing sense of isolation reported by the aging transgendered after surgery. The high suicide rate certainly challenges the surgery prescription.

I think you need to put facts in quotations if this is what you're using...

http://www.huffingtonpost.com/brynn-tannehill/myths-about-transition-regrets_b_6160626.html

As for Johns Hopkins - the only person saying that is the former chair. No one else from Hopkins is agreeing with what he's saying
 
Clubdeac, do you have a link? This is very interesting. If gender dysphoria is real but surgery is not a great treatment for it, then the medical profession is going about things all wrong.
It isn't going about things wrong because that "quote" is nonsense.
 
I think you need to put facts in quotations if this is what you're using...

http://www.huffingtonpost.com/brynn-tannehill/myths-about-transition-regrets_b_6160626.html

As for Johns Hopkins - the only person saying that is the former chair. No one else from Hopkins is agreeing with what he's saying
I'm not sure I would base my opinions regarding transgender surgery on what one outspoken, gay, transgender advocate says. Anything but unbiased

Brynn Tannehill
is originally from Phoenix, Ariz. She is a writer and transgender advocate who has written for OutServe magazine, The New Civil Rights Movement, and The Bilerico Project as a blogger and featured columnist.
 
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Clubdeac, do you have a link? This is very interesting. If gender dysphoria is real but surgery is not a great treatment for it, then the medical profession is going about things all wrong.

They are going about things all wrong, primarily b/c of extreme pressure from the far left leaning media and LGTB community. It don't work and it's never worked. They knew this 30+ years ago and swept the truth under the rug

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0016885
https://www.theguardian.com/society/2004/jul/30/health.mentalhealth
https://www.ncbi.nlm.nih.gov/pubmed/19105079
https://www.ncbi.nlm.nih.gov/pubmed/23398495
http://lvtgw.jadephoenix.org/Info_htm/Herbal_G/ginko_b2.htm
www.ncbcenter.org/index.php/download_file/force/195/159
 
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You know, I've come to expect better statistical analysis in this forum that what you've shown me here.

First link: you didn't even read the conclusion did you? Persons with transsexualism, after sex reassignment, have considerably higher risks for mortality, suicidal behaviour, and psychiatric morbidity than the general population. Our findings suggest that sex reassignment, although alleviating gender dysphoria, may not suffice as treatment for transsexualism, and should inspire improved psychiatric and somatic care after sex reassignment for this patient group.

Well holy ****, even after surgery these patients have problems beyond the general population. I don't know a single person who claims that surgery is a cure-all. The study shows that surgery helps but is not enough by itself. Also, this study doesn't compare transgendered patients who had surgery with ones who did not - that would be the way to see if surgery actually helps.

Second link: first, this is a newspaper article. Second, there is one piece of it that I really like: A 1998 review by the Research and Development Directorate of the NHS Executive found attempted suicide rates of up to 18% noted in some medical studies of gender reassignment. This is interesting because traditionally around 40% of transgendered patients as a whole attempt suicide. So if only 18% of post-operative patients attempt it, I'd say that's pretty good (nb: I know that's not scientific but neither is a Guardian article). Beyond all of that, the article's main point is that we need more research because what we have isn't all that good. No shock there.

Third link: are you kidding me with this? 10 patients in a study about political implications? The authors even admit to violating ethical guidelines in doing all of this.

Fourth link: seriously, I'm like 90% sure you didn't actually read any of these studies. Let's look at the conclusion:
Results suggest the need for practitioners to focus on interventions that reduce avoidant coping strategies, while simultaneously increasing social support, in order to improve mental health for transgender individuals. Individuals who are in the beginning stages of their transition will use different coping strategies than those who are in later stages; interventions should be adjusted on the basis of the transition status of transgender clients. There is nothing in this article that says surgery is bad. All it says is that we should increase focus on healthy coping strategies and social support. Oh, and lots of transgender patients have anxiety/depression. No duh.

Fifth link: This is from 1979. You'll forgive me if I ignore psychiatric research from back in those days on this topic.

Sixth link: An article from the National Catholic Bioethics Center. Of course they are going to be against this as they are many accepted medical practices. Heck, if it was up to them I wouldn't have kids (we did IVF). So, if you'll pardon my French: **** the Catholics (as far as medical ethics go anyway, outside that they're fine in my book).
 
You know, I've come to expect better statistical analysis in this forum that what you've shown me here.

First link: you didn't even read the conclusion did you? Persons with transsexualism, after sex reassignment, have considerably higher risks for mortality, suicidal behaviour, and psychiatric morbidity than the general population. Our findings suggest that sex reassignment, although alleviating gender dysphoria, may not suffice as treatment for transsexualism, and should inspire improved psychiatric and somatic care after sex reassignment for this patient group.

Well holy ****, even after surgery these patients have problems beyond the general population. I don't know a single person who claims that surgery is a cure-all. The study shows that surgery helps but is not enough by itself. Also, this study doesn't compare transgendered patients who had surgery with ones who did not - that would be the way to see if surgery actually helps.

Second link: first, this is a newspaper article. Second, there is one piece of it that I really like: A 1998 review by the Research and Development Directorate of the NHS Executive found attempted suicide rates of up to 18% noted in some medical studies of gender reassignment. This is interesting because traditionally around 40% of transgendered patients as a whole attempt suicide. So if only 18% of post-operative patients attempt it, I'd say that's pretty good (nb: I know that's not scientific but neither is a Guardian article). Beyond all of that, the article's main point is that we need more research because what we have isn't all that good. No shock there.

Third link: are you kidding me with this? 10 patients in a study about political implications? The authors even admit to violating ethical guidelines in doing all of this.

Fourth link: seriously, I'm like 90% sure you didn't actually read any of these studies. Let's look at the conclusion:
Results suggest the need for practitioners to focus on interventions that reduce avoidant coping strategies, while simultaneously increasing social support, in order to improve mental health for transgender individuals. Individuals who are in the beginning stages of their transition will use different coping strategies than those who are in later stages; interventions should be adjusted on the basis of the transition status of transgender clients. There is nothing in this article that says surgery is bad. All it says is that we should increase focus on healthy coping strategies and social support. Oh, and lots of transgender patients have anxiety/depression. No duh.

Fifth link: This is from 1979. You'll forgive me if I ignore psychiatric research from back in those days on this topic.

Sixth link: An article from the National Catholic Bioethics Center. Of course they are going to be against this as they are many accepted medical practices. Heck, if it was up to them I wouldn't have kids (we did IVF). So, if you'll pardon my French: **** the Catholics (as far as medical ethics go anyway, outside that they're fine in my book).
I'll concede, the literature is sparse however I think this is the most compelling evidence against gender reassignment surgery. They followed 300+ patients for 30 yrs!!

"A 2011 study at the Karolinska Institute in Sweden produced the most illuminating results yet regarding the transgendered [sic], evidence that should give advocates pause. The long-term study—up to 30 years—followed 324 people who had sex-reassignment surgery. The study revealed that beginning about 10 years after having the surgery, the transgendered [sic] began to experience increasing mental difficulties. Most shockingly, their suicide mortality rose almost 20-fold above the comparable nontransgender population. This disturbing result has as yet no explanation but probably reflects the growing sense of isolation reported by the aging transgendered [sic] after surgery. The high suicide rate certainly challenges the surgery prescription"

If you have good data supporting your position that meets strict EBM standards please do post. Basically I will disagree with you to the grave so no need to post a rant arguing otherwise.... unless of course you have some good EBM studies, which you don't....
 
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I'll concede, the literature is sparse however I think this is the most compelling evidence against gender reassignment surgery. They followed 300+ patients for 30 yrs!!

"A 2011 study at the Karolinska Institute in Sweden produced the most illuminating results yet regarding the transgendered [sic], evidence that should give advocates pause. The long-term study—up to 30 years—followed 324 people who had sex-reassignment surgery. The study revealed that beginning about 10 years after having the surgery, the transgendered [sic] began to experience increasing mental difficulties. Most shockingly, their suicide mortality rose almost 20-fold above the comparable nontransgender population. This disturbing result has as yet no explanation but probably reflects the growing sense of isolation reported by the aging transgendered [sic] after surgery. The high suicide rate certainly challenges the surgery prescription"

If you have good data supporting your position that meets strict EBM standards please do post. Basically I will disagree with you to the grave so no need to post a rant arguing otherwise.... unless of course you have some good EBM studies, which you don't....
That's part of the problem - there isn't good EBM one way or another regarding this issue. There isn't great data saying surgery helps, but neither is there good data saying it makes things worse. Neither pro- or anti-surgery groups have good level 1 evidence.

Interestingly, if you take the results of the Swedish study and break them down even further, you find this: Furthermore, the mortality rate was only statistically significant for people who had surgery before 1989; for those who had their surgery between 1989 and 2003, the increased mortality for transgender people was not statistically significant.

Even more interesting from the Swedish study: One telling finding, however, is that suicide attempt rates were higher than the general population for transgender women (people who had been assigned “male” at birth), but not for transgender men (people who had been assigned “female” at birth), whose attempt rate remained consistent with the rates for cisgender females in the general population.

So it all boils down to this, really: why do you oppose the surgery? If you think it shouldn't be paid for by insurance/Medicare - well heck, I can get behind that idea. If you think we need more study on this - again, we agree. Of course we have to do the surgery to study outcomes, but that's easy enough. If you think its harmful and not a good treatment - well the data doesn't say that (nor does it say its a great treatment either, if we're being honest), so we're back to needing more data.
 
That's part of the problem - there isn't good EBM one way or another regarding this issue. There isn't great data saying surgery helps, but neither is there good data saying it makes things worse. Neither pro- or anti-surgery groups have good level 1 evidence.

Interestingly, if you take the results of the Swedish study and break them down even further, you find this: Furthermore, the mortality rate was only statistically significant for people who had surgery before 1989; for those who had their surgery between 1989 and 2003, the increased mortality for transgender people was not statistically significant.

Even more interesting from the Swedish study: One telling finding, however, is that suicide attempt rates were higher than the general population for transgender women (people who had been assigned “male” at birth), but not for transgender men (people who had been assigned “female” at birth), whose attempt rate remained consistent with the rates for cisgender females in the general population.

So it all boils down to this, really: why do you oppose the surgery? If you think it shouldn't be paid for by insurance/Medicare - well heck, I can get behind that idea. If you think we need more study on this - again, we agree. Of course we have to do the surgery to study outcomes, but that's easy enough. If you think its harmful and not a good treatment - well the data doesn't say that (nor does it say its a great treatment either, if we're being honest), so we're back to needing more data.
Ok I personally don't think surgery's the right answer but I'll limit my argument to opposing insurance/gov't payment for it. That I think is completely wrong. If they're going to pay for that then then should start paying for all plastic surgery. If it's your right to have your genitalia cut off on my tax dollar then it's my right to have a hair transplant, breast augmentation, tummy tuck, brow lift, or whatever etc. on your tax dollar.
 
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In psychology, the most popular and rigorously tested account of personality is the so-called Big 5 model of personality traits. Four of them sound pretty nice to have: conscientiousness, which makes you on time for things; agreeableness, which makes you nice; extraversion, which makes you social; and openness to experience, which makes you adventurous in thought and deed. Then there’s neuroticism, which not only disposes you to anxiety and other negative emotions, but to spending lots of time ruminating about all those feelings.

Digging into the studies, you find that neuroticism sounds less like a personality trait and more like a curse. People who score highly on it tend to be lousy spouses, deal worse with uncertainty, are more distracted at work, prefer inaction to action, and have a higher likelihood of panic attacks and anxiety or depression disorders. They’re also more likely to get addicted to cigarettes, booze, or heroin; they also die sooner. But in talking with researchers, it’s clear that the trait itself isn’t necessarily a bad thing; it’s a matter of how you respond to it.

Neuroticism, like all personality traits, starts to show up in early childhood. Temperament researchers, who study such things, consider the neuroticism to be an expression of “negative emotionality,” or being disposed to more negative emotions than other people. (Neurotic babies will shrink from novel situations or people, exhibiting early forms of withdrawal, or cry when faced with things that frustrate them, an early sign of volatility.)

Rebecca Shiner, a Colgate University psychologist and co-author of the Handbook of Temperament, tells Science of Us that behaviors like these are expressions of a biological system attuned to perceiving threats. Everybody “has” negative emotionality, but to varying degrees: Some people will get freaked out by even the smallest inconvenience, while others couldn’t care less about a would-be crisis. The leading research indicates that these feelings lead neurotic people to either internalize, withdrawing into their insecurities and ruminations, or externalize, getting angry, irritable, or impulsive. But this disposition itself isn’t a problem to be solved; the issues come when people don’t have the skills to handle their unwieldy interior energies.

More specifically, people who get into trouble with their negative emotionality typically don’t like to have difficult emotions, like anger or anxiety; thus, they do everything they can to suppress them, said David Barlow, the founder and director emeritus of the Center for Anxiety and Related Disorders at Boston University and author of Anxiety and Its Disorders. But that doesn’t work, especially since, he says, they are super sensitive to the physical sensations that are a part of their problems. “People with panic disorder are so sensitive to expressions of fear, like breathing quickly and perspiration, that those sensations come to trigger a panic attack,” he says.

Attempt to numb, avoid, or suppress those emotional responses, and you risk developing disordered behaviors, which, essentially, “are people’s ill-fated attempts to feel better,” Shiner says. “OCD is an attempt to cope with an obsessive thought. Substance abuse involves trying to deal with the discomfort of feeling bad. You can think of a lot of disorders as a lot of ways of coping with feeling bad.” The right way to handle your own sensitivity to threats, then, would be to change the way you relate to them.

Reframe “negative” to “difficult.”

To that end, it might be helpful to revise the language from “negative emotions,” which makes them sound like something you need to get rid of, like a negative balance in a checking account. Ethan Nichtern, senior teacher in Shambhala Buddhism and author of The Road Home, says that he likes the way that the Dalai Lama conceptualizes it: Rather than calling sadness or anger a negative emotion, call it what it rightly is — a difficult emotion. “It points to there being an emotion there, but doesn’t create a bias toward or away from the experience,” he says.

Seek adventure.

Psychotherapist Louis Cozolino, author of Why Therapy Works, says that one of the biggest dangers about being neurotic is that if you’re unwilling to experience difficult emotions, then you’re going to preclude yourself from great swathes of life, whether that’s relationships or fitness or career. (For example, Atlanta Hawks center Dwight Howard has said that he doesn’t take jump shots because he wants “to be perfect,” and missing — something that even LeBron James does half the time — would be proof of being otherwise.) “Probably the best thing to do is develop a discipline of risk-taking, forcing yourself to do things you wouldn’t do and make that a regular part of your life,” Cozolino says, observing that the point isn’t to cure neuroticism but to counterbalance it. “The opposite of anxiety is exploration.”

Get more granular.

Internally, having a fine-grained understanding of your emotional states can be liberating. Since the 1990s, Northeastern University psychologist Lisa Feldman Barrett has developed the concept of “emotional granularity.”Her and others’ experiments indicate that when people can describe their emotional states with complexity — not just “feeling bad” about what’s going on with the water in Flint, Michigan, but experiencing “righteous indignation” — they experience all sorts benefits, like less alcoholism or aggression and more “emotion regulation,” or being able to keep your psychological footing when things get bumpy. Greater granularity allows you to live more “precisely,” she wrote in the New York Times earlier this year, since being able to clearly behold an emotion suggests an action in kind. If you’re righteously indignant about Flint, she argues, you’ll respond by looking up ways to protect your family from lead poisoning or get the ear of your congressperson.

Put it into words.

The actual act of putting those states into words grants relief. In a line of research developed by University of Texas psychologist James Pennebaker, expressively writing for 20 minutes a day for three days has shown to help people become less depressed, less anxious, and take fewer visits to the doctor. The effects are almost magical: In one compelling experiment, Pennebaker did the writing exercises with a group of software engineers who had just been laid off, and he found that they were three times more likely to find new gigs than their peers who hadn’t expressed themselves in such a way.

Hold your thoughts with a looser grip.

Shiner likes the cognitive-behavioral-therapy technique that encourages people to think of their thoughts more objectively, like, Is the feeling I have about this thing actually true? If my colleague doesn’t hold the elevator for me, does that really mean that he’s an dingus? Put another way: Don’t believe everything you think.

Dispositional mindfulness — or the quality of generally being aware of what you’re thinking and feeling — has been shown to lessen the depressive effects of neuroticism in British and American populations; mindfulness meditation practice can help people, too. Like Mark Epstein observes in The Trauma of Everyday Life, one of the things that meditation trains you to do is to regard your interior states like an alert, present mother cares for an infant: You nonjudgmentally attend to your own emotions, even if they don’t make you comfortable.

Befriend yourself.

Put into proper Buddhist terminology, you’d call this self-compassion. Nichtern, the Buddhist teacher, says that it’s kind of like bringing a friend with you’re getting a root canal: You might have anxiety about the operation, so you bring a bud. “The friend is offering you the warmth and allows you to not avoid the situation,” he says. “The combination of attention with warmth normalizes the experience.” With self-compassion, then, you’re holding your own hand, befriending the emotion, make empathy intrapersonal. “It’s pointing friendship inward,” he says. In a formal, say 20-minute, practice, it would go like this: Spend five or seven minutes in body-based mindfulness, which sets the table and gets you out of your head, then summon an emotion that you’re having difficulty with — heartache, anxiety about work, regret about the thing you did last weekend — and wish yourself well. In traditional Tibetan Buddhism, the four slogans used for this kind of contemplation are May I be happy, May I be safe, May I be at ease, May I be healthy. “You can bring to mind the difficult emotion, then say ‘May I live at ease — may I incorporate this emotion into my experience and have ease,’” Nichtern says.

*This post has been corrected to show that Lou Cozolino is not a psychoanalyst; he is a psychotherapist.

All of this self-focus may sound a little like narcissism or self-absorption; it’s not. What’s crucial to realize, Nichtern says, is that this is the farthest thing away from narcissism; rather than self-obsession, it’s self-awareness. As evidenced by the fact that the most self-aware people are the ones that move into the center of the car when the subway doors open, being self-aware is super relational. This is because, Nichtern says, once you start examining yourself, you realize how interdependent you are — how much your family, friends, and colleagues shape your life. The contemplation can also be done on the spot, he says, like if you’re feeling an unwieldy emotion or awaiting election results. Just breathe three times, then wish yourself one of the phrases: May I be safe. May I be healthy. May I be happy. May I be at ease.
 
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