Mother Who Lost Son to OxyContin Vindicated by Purdue Settlement

By Mark Kreidler, Kaiser Health News

In the 15 years since she lost her son to a single OxyContin pill, Barbara Van Rooyan has had but one up-close look at the people representing the company that made it.

It was in a small courthouse in Abingdon, Va., where Van Rooyan and other relatives of OxyContin victims gathered for a sentencing hearing in 2007. Three executives of Purdue Pharma had pleaded guilty to federal charges related to their misbranding and marketing of the powerful opioid. The company had pleaded guilty as well.

Van Rooyan and the others in her group spoke during the sentencing, giving voice to their grief and their pain. They wanted the executives sent to jail for knowingly expanding an opioid crisis fast engulfing the country.

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Instead, Purdue paid fines totaling $634 million. The executives served no time. The company was allowed to continue aggressively marketing its product, and the following year, sales of OxyContin reached $2 billion.

From 1999 to 2017, more than 700,000 people in the U.S. died of drug overdoses, according to the Centers for Disease Control and Prevention. In 2017, nearly 68% of the more than 70,000 recorded overdose deaths involved opioids, mostly illicit opioids such as fentanyl and heroin.

“I never really thought a whole lot about evil before this all happened,” Van Rooyan said recently, seated on a couch in the living room of her Irvine, Calif., home. “But to see this kind of malevolence or disregard for human life — I don’t know what else to call it but evil.”

The outcome in that Virginia courthouse was a far cry from last week’s news of a tentative mass settlement of many of the 2,000-plus lawsuits against the company, which could total upward of $12 billion and result in Purdue’s dissolution.

The potential settlement amount would include $3 billion from the Sackler family, owners of Purdue, whose fortune is estimated at $13 billion. The family has amassed that money over the past two decades, largely by selling OxyContin, an opioid painkiller.

‘The Lid Is Off’

Van Rooyan’s Purdue experience is a story of deception, sadness and frustration — yet when she tells it now, she emits a surprising spark of energy. That’s because Van Rooyan, part of the unlikely group of citizens who repeatedly took flailing swings at Purdue Pharma, is watching the giant fall.

Van Rooyan, who has studied the cases against Purdue closely, sees the paradox in the proffered settlement: Much of the payout would be financed by profits from the continued sale of OxyContin, under a new company that would be formed following a Chapter 11 bankruptcy.

But in some regard, she said, Purdue Pharma’s complicity in the opioid crisis has finally emerged into the general public’s view. “The world really knows now. They get it,” she said. “The lid is off, and all this stuff is bubbling out.”

That wasn’t the case on the night of July 4, 2004, when Van Rooyan and her husband, Kirk, got the call that changed their world. Barbara, then a professor of counseling at Folsom Lake College near Sacramento, was told that her son, Patrick Stewart, lay in a San Diego hospital, in a medically induced coma from which he was unlikely to emerge.

Patrick, a graduate of Oak Ridge High School in El Dorado Hills, Calif., and San Diego State University, died at age 24.

His friends told Barbara they had attended an Independence Day party at which someone offered her son an OxyContin pill, telling him it “was kind of like a muscle relaxant and it was FDA approved, so it was safe,” she said. Patrick, who had also consumed a couple of beers, was opioid intolerant and suffered respiratory failure in his sleep.

Barbara Van Rooyan holds picture of her son, Kirk

Barbara Van Rooyan holds picture of her son, Kirk

“At the time,” Van Rooyan said, “all I knew about Oxy was that Rush Limbaugh had been addicted to it.”

She was about to learn a lot more.

OxyContin Abuse

Van Rooyan channeled her grief through intense research into Oxy’s vast potential for damage despite the company’s sales pitches to the contrary. A slow-release pain treatment with a heavy dose of the narcotic oxycodone, it could be easily crushed or dissolved for a more intense and addictive high. Rampant abuse already had begun to be reported, particularly in the Appalachian area, author Beth Macy wrote in her national bestseller “Dopesick.”

Later in 2004, Van Rooyan found Ed Bisch, a Philadelphia man who had begun a website to expose Oxy abuse in the wake of his teenage son’s death. The following year, Van Rooyan and her husband, a plastic surgeon, petitioned the Food and Drug Administration to require that OxyContin be made more abuse-resistant, and that its use be strictly limited to severe pain.

“This was an exhausting process, which she and Kirk did as a labor of love to try to save others,” Bisch recalled.

Van Rooyan became the California arm of a grassroots movement known as RAPP — Relatives Against Purdue Pharma. The group, originally just four in number, protested at physician meetings funded by pharmaceutical companies and testified before Congress. Van Rooyan enlisted the help of U.S. Sen. Dianne Feinstein (D-Calif.), who wrote the FDA on her behalf and later sent Van Rooyan a letter of commendation.

But most members of Congress did not reply to Van Rooyan’s letters, she said. The FDA said its review needed more time — which turned out to be eight years. By then, Purdue already had reformulated OxyContin to make it more abuse resistant and to renew its patent, but the FDA declined to restrict its use to managing severe pain.

Van Rooyan pressed on, but for a long while, the opioid crisis felt to her like a topic hiding in plain sight. And fighting Purdue while still grieving the loss of son Patrick was taking a toll.

“Her determination was tireless,” Bisch said, “but eventually the frustration burned us out.”

And then came the turn.

A rash of high-profile opioid overdoses and deaths, from actor Heath Ledger to Tom Petty to Prince, put the topic squarely in the public eye — and 15 years after the death of Van Rooyan’s son, Purdue Pharma and other drugmakers were suddenly on the run.

(Editor’s note: Ledger, Petty and Prince all died from a lethal mix of opioids and other drugs that were apparently obtained on the street.)

Wants Purdue Settlement Spent on Treatment

Van Rooyan tracks every development related to Purdue, including a lawsuit in New York that alleges members of the Sackler family have been offloading their fortunes into private or offshore accounts to shield them from a settlement.

But she’s not out for vengeance. Her goals have changed.

“Do I want the records to be public? Do I want these people to have their business shut down? Yes, I do,” she said. “But more than vindictiveness, I want that money of theirs to go to treatment and rehab. If that happens, something good can come out of it.”

If she has a regret, it is that the case in Virginia ended in 2007 with no more than a fine. “If that result had been different — if people had gone to jail — it could have changed the trajectory of this,” she said.

Ana Venegas for KHN

Ana Venegas for KHN

But momentum finally appears to be gathering, and Van Rooyan finds herself identified as one of the trailblazers of the anti-OxyContin movement. She spends little time dwelling on that. Instead, she quotes her younger son, Andrew, who told her, “We didn’t want any of this — this is just the hand we were dealt. We need to play the cards the best we can.”

“She’s just a really strong person,” said Kirk Van Rooyan, who has been with Barbara throughout the ordeal, though he is not Patrick’s biological father. “There have been times when I’d think to myself, ‘How would I be doing if I were in her shoes?’ And the answer usually is, ‘Not as well as she’s doing.’”

Van Rooyan, a longtime artist, now spends much of her time volunteering with veterans in Orange County, Calif., helping them get back into the workforce and using art therapy to help them express themselves.

The art is special to Van Rooyan, she said, because it is part of what saved her in the aftermath of her son’s death.

“Patrick was the one who suggested I take my first class,” she said. After a few delays, she finally enrolled. It was about a month before that Fourth of July in 2004.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

How West Virginia Became the Epicenter of the Opioid Crisis

By Douglas Hughes, Guest Columnist 

Aggressive promotion by the distributors of OxyContin, the best pain medication ever formulated (when properly used), led to excessive prescribing by West Virginia doctors. 

This caused a methamphetamine drug problem in the state to morph into a prescription opioid epidemic, mostly due to unused opioids squirreled away in medicine cabinets.  Adolescents ignored by their guardians had complementary party favors of these excess opioids. This is why so many families were affected. 

After a few years of this, once the addiction problems were exposed, the excess prescribing stopped. Those desiring to misuse OxyContin went to pain clinics and lied to receive more.  Since we don’t have tachometers on our foreheads to gauge real subjective pain, lying to doctors was effective for many to get drugs to abuse.  

Not wanting to assist pain specialists and willing to deny legitimate intractable pain treatment, the West Virginia legislature passed the “Chronic Pain Clinic Licensing Act.”

When implemented on January 1, 2015, the goal to deny licenses to a dozen new and existing pain clinics was achieved. This left only pills being hoarded in medicine cabinets, which were quickly depleted.  

OxyContin distribution was suspended to pharmacies in most of West Virginia in 2015. 

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These two efforts stopped most OxyContin prescribing and decimated legitimate disabled intractable pain sufferers in West Virginia, the state with the highest incidence of industrial and worker compensation injury cases. 

For the sake of argument, let’s estimate pain clinic patients were 50% legitimate pain sufferers and 50% abusers lying in order to get opioids.  Each of those twelve pain clinic closures turned a thousand or more patients onto the streets.  Some wanted to abuse, while others desperately sought to replace critical pain treatment denied to them by state law.  Some turned to street drugs as their answer. 

In 2015, West Virginia police departments reported that pain pills seized from drug arrests fell a remarkable 89 percent. The opioid crisis was shifting rapidly to heroin, as the drug sub-culture always does when a drug source changes. The prescription opioid epidemic in West Virginia essentially ended in 2015.  There was no memo from the CDC.

Those thousands of good and bad patients from pain clinics were both naive to the strength and use of heroin.  Dosing, once regulated by prescription, now was more lethal. Learning how to prepare and inject heroin without becoming infected, overdosing and dying was problematic. There were record overdose deaths in 2015, even though there were fewer pain pills. 

Counterfeit medication and heroin laced with illicit fentanyl appeared and record overdose deaths continued in 2016 and 2017 because there were so many inexperienced street drug users.  

Since 2015, West Virginia has wasted millions of dollars annually chasing imaginary diversion and investigating and prosecuting good physicians. This satisfied everyone except legitimate pain patients, who were left suffering and dying in their beds.  A suicide epidemic ensued.

West Virginia lacks a prevention component to their drug crisis response, which insured the re-occurrence of another epidemic. Apparently, we are satisfied with this catastrophe. May we have another?   

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Douglas Hughes is a disabled coal miner and retired environmental permit writer in West Virginia.

Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

60 Minutes Fails to Consider Pain Patients

By Laura Mills, Kate M. Nicholson, and Lindsay Baran

In a Feb. 24 segment, CBS’s 60 Minutes accused the Food and Drug Administration (FDA) of igniting the overdose epidemic in the United States with its “illegal approval of opioids for the treatment of chronic pain.” While the program highlighted the adverse consequences of misleading pharmaceutical marketing and lax government oversight, this segment failed to consider the perspective of patients who legitimately use opioids for pain, stigmatized them as drug-seekers, and propagated misconceptions about the overdose crisis, such as the idea that opioid treatment for chronic pain is indisputably illegitimate and is driving overdose deaths in the U.S.

When OxyContin went to market in 1996, its FDA label said that addiction was “very rare” when the medication was used to manage chronic pain. Although that warning was enhanced in 2001, the market for OxyContin was already booming: advertising spending for the drug increased from $700,000 in 1996 to $4.6 million in 2001. Lawsuits allege that Purdue Pharma, the maker of the drug, targeted high-prescribing physicians and continued to aggressively market OxyContin even after it learned its product had become a go-to drug for illicit use. The lack of government oversight and Purdue’s practices certainly deserve media scrutiny that could help shed light on actions that may underlie the overdose crisis.

However, the guests featured in the 60 Minutes segment gave the impression that the use of opioids for chronic pain is illegitimate or illegal, that prescription opioids are still driving overdose deaths in the United States, and that the use of prescribed opioids to manage chronic pain is equivalent to “heroin addiction.”

These are false narratives that do real harm to pain patients, who have been regularly stigmatized in the media and elsewhere as drug-seekers. In presenting this report, 60 Minutes failed to tell the other side of the story: that of pain patients who rely on these medications to function, and that of the medical community which largely agrees that opioids may help patients whose pain isn’t resolved by other means.

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Chronic pain is a large category that includes pain associated with incurable illnesses, severe neurological conditions, and catastrophic trauma as well as more common ailments like arthritis. There is growing agreement that using opioids across this broad category was inappropriate and did harm, and that it is important to balance the potential benefits of opioids with misuse and diversion risks. But the medical community still largely agrees that, for some patients, opioids provide benefits. Indeed, the Centers for Disease Control, the Federation of State Medical Boards, a 2011 report by the Institute of Medicine, and all applicable medical and government guidelines on prescribing opioids have reaffirmed that opioids may be appropriate for patients whose chronic pain isn’t resolved by other means. 

Re-evaluating the use of opioids in long-term pain makes sense given recent history, but rushing to judgment before we do so can do real harm and risks violating a fundamental component of the right to health, including the right to adequate treatment for pain.  In over 80 interviews with patients, physicians, and experts, a recent Human Rights Watch report found a disconcerting trend: chronic pain patients are being forced off opioid medications simply because doctors fear regulatory oversight and reprisal. In many cases, physicians acted against their better medical judgment. Even when they believed their patients’ health was improved by long-term opioid treatment, they felt they had no option but to reduce patients’ doses dramatically or cut them off completely. They felt a wide range of pressures, from fear of Drug Enforcement Agency or state medical board scrutiny to the heavy bureaucratic burden created by insurance companies through their efforts to discourage opioid prescribing.

When deprived of their medication, the consequences for patients can be devastating: their health declines to the point where they can no longer work, do simple chores, or take care of their personal hygiene.  Several patients said they had turned to alcohol or illicit drugs to manage their pain when they were deprived of care.

Take Maria Higginbotham, whose story is included in the report. She has undergone 12 operations to prevent the collapse of her spine. Unfortunately these operations, which failed to relieve her pain, also left her with adhesive arachnoiditis, an incredibly painful condition that causes the nerves of the spinal cord to “stick together.”

Re-evaluating the use of opioids in long-term pain makes sense given recent history, but rushing to judgment before we do so can do real harm and risks violating a fundamental component of the right to health.
— Human Rights Watch

Maria is now being forced to a lower dose of medication by a provider who believes she needs opioids, but is afraid of attracting law enforcement scrutiny of his practice. Previously, Maria could function independently; she now requires assistance to go to the toilet.  To suggest that Maria has no legitimate right to these medications—and that her need for them is misguided, inappropriate or the result of drug misuse — is stigmatizing to all patients like her.

Hundreds of leading physicians and experts from with varying views on the efficacy of opioids have called attention to the dangers of involuntarily discontinuing opioids for the estimated 18 million Americans who currently use them for long-term pain, a practice the CDC and other medical bodies do not encourage. These dangers include medical destabilization, the lost ability to work and function, and suicide. The National Council on Independent Living (NCIL), a national disability rights organization, shares these concerns, which have a disproportionate impact on people with disabilities living with chronic pain who already face major barriers to accessing healthcare.  The American Medical Association has similarly criticized the indiscriminate discontinuation of opioids, and has underscored that the stigma surrounding opioids now affects cancer and palliative care patients who, despite explicit exemptions, face increased barriers to access as well

While liberal prescribing undoubtedly caused harm, further perpetuating inflammatory and stigmatizing ideas about people who rely on opioids helps legitimize the growing reluctance of physicians to prescribe these medications to those who they believe need them. At a time when the prescribing of opioids has dropped precipitously and drug overdose deaths are largely attributed to illicit substances, such harm ought to figure into the conversation.

It’s true that there is a lack of high quality data studying the efficacy of opioids beyond 12 weeks, but it is also the case that most medications approved for the treatment of pain reflect studies of similar duration.  This is in part because doing long-term, placebo-controlled trials with real human beings who are suffering presents practical and ethical challenges. 

FDA Commissioner Scott Gottlieb recently responded to the concerns raised by 60 Minutes, by announcing that the agency will conduct new studies into the efficacy of opioid analgesics for chronic pain, a move that he signaled could have an impact on how these drugs are marketed in the future. We agree that more research is critical and have backed initiatives such as the National Pain Strategy that call for much needed additional research into chronic pain. In the meantime, the dangers of reinforcing an incomplete or incorrect narrative and of stigmatizing patients are real—60 Minutes should ensure it doesn’t do either in its coverage, and should show all sides of the story.

This article was originally published on the Human Rights Watch website and is republished with permission.   

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Laura Mills is a health researcher at Human Rights Watch and author of the HRW report, “Chronic Pain, the Overdose Crisis, and Unintended Harms in the U.S.”

Kate M. Nicholson is a civil rights and health policy attorney. She served for 20 years in the Department of Justice’s civil rights division, where she drafted current regulations under the Americans With Disabilities Act. She gave a TEDx talk about chronic pain, “What We Lose When We Undertreat Pain.

Lindsay Baran is the policy analyst at the National Council on Independent Living (NCIL), the longest-running national cross-disability grassroots organization run by and for people with disabilities.

How Sackler Family Built an OxyContin Fortune

By Christine Willmsen and Martha Bebinger, WBUR

The first nine months of 2013 started off as a banner year for the Sackler family, owners of the pharmaceutical company that produces OxyContin, the addictive opioid pain medication. Purdue Pharma paid the family $400 million from its profits during that time, claims a lawsuit filed by the Massachusetts attorney general.

However, when profits dropped in the fourth quarter, the family allegedly supported the company’s intense push to increase sales representatives’ visits to doctors and other prescribers.

Purdue had hired a consulting firm to help reps target “high-prescribing” doctors, including several in Massachusetts. One physician in a town south of Boston wrote an additional 167 prescriptions for OxyContin after sales representatives increased their visits, according to the latest version of the lawsuit filed in Suffolk County Superior Court in Boston.

The lawsuit claims Purdue paid members of the Sackler family more than $4 billion between 2008 and 2016. Eight members of the family who served on the board or as executives as well as several directors and officers with Purdue are named in the lawsuit.

This is the first lawsuit among hundreds of others that were previously filed across the country to charge the Sacklers with personally profiting from the harm and death of people taking the company’s opioids.

WBUR along with several other media sued Purdue Pharma to force the release of previously redacted information that was filed in the Massachusetts Superior Court case. When a judge ordered the records to be released with few, if any, redactions, Purdue filed two appeals and lost.

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The complaint filed by Massachusetts Attorney General Maura Healey says that former Purdue Pharma CEO Richard Sackler allegedly suggested the family sell the company or, if they weren’t able to find a buyer, to milk the drugmaker’s profits and “distribute more free cash flow” to themselves.

That was in 2008, one year after Purdue pleaded guilty to a felony and agreed to stop misrepresenting the addictive potential of its highly profitable painkiller, OxyContin.

At a board meeting in June 2008, the complaint says, the Sacklers voted to pay themselves $250 million. Another payment in September totaled $199 million.

The company continued to receive complaints about OxyContin similar to those that led to the 2007 guilty plea, according to unredacted documents filed in the case.

While the company settled lawsuits in 2009 totaling $2.7 million brought by family members of those who had been harmed by OxyContin throughout the country, the company amped up its marketing of the drug to physicians by spending $121.6 million on sales reps for the coming year. The Sacklers paid themselves $335 million that year.

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The lawsuit claims Sackler family members directed efforts to boost sales. An attorney for the family and other board directors is challenging the authority to make that claim in Massachusetts. A motion on jurisdiction in the case hasn’t been heard. That attorney hasn’t responded to a request for comment on the most recent allegations.

Purdue Pharma, in a statement, said the complaint filed by Healey is “part of a continuing effort to single out Purdue, blame it for the entire opioid crisis, and try the case in the court of public opinion rather than the justice system.”

Purdue went on to charge Healey with attempting to “vilify” Purdue in a complaint “riddled with demonstrably inaccurate allegations.” Purdue said it has more than 65 initiatives aimed at reducing the misuse of prescription opioids. The company says Healey fails to acknowledge that most opioid overdose deaths are currently the result of fentanyl.

Purdue fought the release of many sections of the 274-page complaint. Attorneys for the company said at a hearing on Jan. 25 that they had agreed to release much more information in Massachusetts than has been cleared by a judge overseeing hundreds of cases consolidated in Ohio. Purdue filed both state and federal appeals this week to block release of the compensation figures and other information about Purdue’s plan to expand into drugs to treat opioid addiction.

The attorney general’s complaint says that in a ploy to distance themselves from the emerging statistics and studies that showed OxyContin’s addictive characteristics, the Sacklers approved public marketing plans that labeled people hurt by opioids as “junkies” and “criminals.”

Richard Sackler allegedly wrote that Purdue should “hammer” them in every way possible.

Addiction Treatment ‘Attractive Market’

While Purdue Pharma publicly denied its opioids were addictive, internally company officials were acknowledging it and devising a plan to profit off them even more, the complaint states.

Kathe Sackler, a board member, pitched “Project Tango,” a secret plan to grow Purdue beyond providing painkillers by also providing a drug, Suboxone, to treat those addicted.

“Addictive opioids and opioid addiction are ‘naturally linked,'” she allegedly wrote in September 2014.

According to the lawsuit, Purdue staff wrote: “It is an attractive market. Large unmet need for vulnerable, underserved and stigmatized patient population suffering from substance abuse, dependence and addiction.”

They predicted that 40-60 percent of the patients buying Suboxone for the first time would relapse and have to take it again, which meant more revenue.

Purdue never went through with it, but Attorney General Healey contends this and other internal documents show the family’s greed and disregard for the welfare of patients.

This story is part of a reporting partnership between WBUR, NPR and Kaiser Health News

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Lessons from 'American Overdose' on the Opioid Crisis

By Roger Chriss, PNN Columnist

The book “American Overdose: The Opioid Tragedy in Three Acts” by Chris McGreal takes a hard look at the opioid crisis. The book focuses on the legal and political side of the crisis, along with a history of Purdue Pharma and OxyContin, and a detailed description of pill mills and rogue pharmacies in Appalachia.

“It is a tragedy forged by the capture of medical policy by corporations and the failure of institutions in their duty to protect Americans,” is how McGreal describes the genesis and evolution of the crisis.

The book highlights the massive collusion and corruption in communities in West Virginia and Kentucky, leading to the Williamson Wellness Center and other pill mills that were protected by law enforcement, ignored by state and federal regulators, and encouraged or exploited by drug manufacturers and distributors.

McGreal also traces the history of Purdue and the Sackler family, and how their efforts to improve pain management led to the creation of the blockbuster drug OxyContin. He explains how Purdue’s marketing claims “proved to be demonstrably false, including an assertion that addiction is rare when opioids are taken under a doctor’s care.”

However, McGreal does not depict Purdue as a lone bad actor. Instead, federal and state dysfunction and disinterest contributed to the crisis. “The FDA wasn’t the only one to drop the ball. A clutch of federal agencies with long names have responsibility for combating drug addiction and overdose,” he wrote. And they all failed.

The failure was both systemic and systematic. As the crisis unfolded, local law enforcement had to contend with “indifference and what they regarded as the political cowardice of the system.” Perhaps more important than the cowardice and corruption was greed, not just corporate greed but also local greed for the money brought in by pill mills: “The businesses did good. You had pharmacies that were doing really good.”

The problem soon extended far beyond Appalachia. Among the earliest and biggest pill mills was American Pain, set up in 2007 near Fort Lauderdale, Florida by twin brothers Chris and Jeff George – neither of whom had medical training.

Opioid addiction also rose across the nation because of cultural factors, writes McGreal. In Utah, “the dominance of the conservative Church of Latter-day Saints appeared to be a cause of addiction, not a deterrent” because of the church’s “toxic perfectionism.”

Government agencies and officials were encouraged to ignore it all. Florida Sen. Marco Rubio’s office wasn’t interested in pursuing pill mills and the “political leadership within Florida wasn’t much better.”

Rudy Giuliani, Eric Holder, and James Comey all helped Purdue, according to McGreal, by delaying investigations of the company as addiction and overdose rates rose rapidly in the 2000’s.

The CDC’s involvement is described as delayed and dysfunctional. "Until 1998 the United States used a classification system lumping heroin, morphine, and prescription opiate deaths together," McGreal points out. Even when CDC researcher Len Paulozzi documented rising trends in overdose deaths, no one paid serious attention until Thomas Frieden, MD, became director. Even then, serious flaws remain in how the CDC reports on overdose deaths.  

Anti-opioid activists Andrew Kolodny, MD, founder of Physicians for Responsible Opioid Prescribing (PROP), and PROP President Jane Ballantyne, MD, sounded warnings about opioids, but offered little in the way of solutions outside of cutting off prescriptions. Many of their warnings proved to be unfounded, in particular with the opioid analgesic Zohydro. The drug was approved by the FDA amid dire warnings of a major spike in addiction and overdoses, but “there was no great surge of overdoses because of Zohydro.”

“FDA officials don’t like Kolodny. They characterize him as unreasonable and difficult. One described him as a ‘complex character’,” McGreal writes.

Similarly, the 2016 CDC opioid prescribing guideline is described as too late to be useful. McGreal looks closely at the debate about the CDC guideline and recommendations from the 2017 opioid commission set up by President Trump. But despite these much-touted steps, “little changed on the ground for states desperate for treatment facilities and help with the social costs of the tragedy.”

The book concludes on a pessimistic note, captured in a comment from Nathaniel Katz, MD, about opioid addiction and overdose: "I don’t really see any prospect for intelligent policy in this area in the United States.”

McGreal summarizes his ideas with an indictment of American culture.

"In large parts of the United States, opioids were popular because they were a fix. A fix for emotional pain. A fix for failing bodies. A fix for struggling to make it in a society that promises so much, and judges by what is achieved, but turns it back on so many of those who fail to live up to that promise," he writes.

If “American Overdose” offers lessons, it is that the opioid crisis is a result not only corporate greed but also American culture; in particular politicians, regulators and a broader medical industry with agendas contrary to the public good. The book is an origin tale of the opioid crisis that offers little hope for the future.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network. 

Tennessee’s ‘Absolutely Crazy’ Opioid Law

By Pat Anson, PNN Editor, and Blake Farmer, Nashville Public Radio

Since the CDC released its opioid guideline in 2016, over 30 states have passed legislation that limit opioid prescriptions in some way. Most limit the supply to a few days for initial opioid prescriptions and some set limits on the doses that doctors can prescribe.

Which state has the toughest opioid regulations?

“Tennessee is just absolutely crazy,” says Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

Twillman is referring to a strict and complicated state law that took effect in July that restricts how long Tennessee doctors can prescribe opioids to patients.

“Depending on what you document and depending on your judgement of what’s going on with the patient, you’re either limited to a 3-day supply, a 10-day supply, a 21-day supply or a 30-day supply of an opioid,” Twillman told PNN.

“You wonder how in the world they’re ever going to police this. If it’s a particularly severe case you could do a 21-day supply, but if it’s a rare case then you can do a 30-day supply. What is the difference?”

Tennessee also limits the dose that doctors prescribe, under a complicated formula that lowers the allowable dose the longer a prescription lasts. In other words, you may get more pills but the dose will be smaller.

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Any “significant deviation” from Tennessee’s opioid law could result in disciplinary action for a doctor not showing “sound medical judgment.” First offenders could be banned from prescribing opioids for five years.

“They’ve left us saying make your own best judgement and document the reason for it and cross your fingers and hope you’re going to be okay,” says Twillman.

Some doctors have decided not to take that risk. Many primary care providers in Tennessee have stopped prescribing opioids and are referring patients to the state’s dwindling supply of pain clinics, where waiting lists are long and there’s no guarantee a new patient will even be able to get treatment.

Insurers Drop OxyContin

But it’s not just legislation that limits how pain patients are being treated in Tennessee. Insurance companies are refusing to pay for some opioids.

The largest insurer in Tennessee recently announced it will no longer cover prescriptions for OxyContin, what was once a blockbuster pain reliever. It’s the latest insurance company to turn against OxyContin, whose maker, Purdue Pharma, faces dozens of lawsuits related to its high-pressure sales tactics around the country and contribution to the opioid crisis. Last fall, Cigna and Florida Blue both dropped coverage of the drug.

Top officials at BlueCross BlueShield of Tennessee (BCBST) say newer abuse-deterrent opioids work better than OxyContin, and starting in January, the insurer covering 3.5 million Tennesseans will only pay for opioids made by other pharmaceutical companies.

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“We felt it was time to move to those products and remove Oxycontin from the formulary, which does still continue to have a higher street value,” said Natalie Tate, the insurer’s vice president of pharmacy.

OxyContin was reformulated in 2010 to make the drug harder to misuse — but it’s still possible to crush or liquefy in order to snort or inject it.

The latest long-acting opioids that BlueCross BlueShield of Tennessee is going to start covering — Xtampza and Morphabond — are still more difficult to misuse, according to the company and some pharmaceutical experts.

Practicing pain physicians in Tennessee — who regularly battle with insurance companies —  approve of the change, though they said OxyContin was already falling out of favor. And they argue trading one opioid for slightly safer ones doesn’t address a larger gripe that physicians have with insurers over paying for other, non-addictive types of treatment.

“We will have denials and prior authorizations on a muscle relaxer, and we will have no issue getting an opioid through the insurance company,” said Dr. Stephanie Vanterpool, an anesthesiologist at the University of Tennessee and the president-elect of the Tennessee Pain Society.

“The physicians or the doctor’s offices jump through hoops to get the better medication for the patients,” said Vanterpool. “And when I say better medication, I mean the medication that’s treating the cause of the pain, not just the medication that’s covering up the pain.”

Not to say OxyContin won’t be sorely missed by some patients.

“There are plenty of people who benefit from that drug,” said Terri Lewis, a patient advocate and rehabilitation specialist from Cookeville, Tenn.

Lewis is suspicious of BCBST’s motives since the insurer may be blamed for its role in the opioid crisis. Embattled Purdue Pharma could also be a convenient scapegoat.

“Maybe this is a good decision,” Lewis said. “But it smells like a political decision.”

This would be just the latest decision inserting politics into a nuanced medical problem that affects millions of pain patients.

John Venable of Kingsport, Tenn., was shown the door by his pain clinic in July after more than a decade on oxycodone — a generic, short-acting version of OxyContin.

“I just felt like I was in a hopeless state, like, ‘there is no help for John,'” he recalled.

At their worst, he said his headaches get so debilitating “that death would be a relief.” Despite his dread, he’s noticed something surprising over the last few months without opioids — his crippling headaches haven’t gotten that much worse, if at all.

“It very well might be a blessing in disguise,” Venable said.

The retired builder and one-time pastor said he prays that those losing OxyContin also will get to use the moment as an opportunity, though he knows many can’t cut ties with opioids. And he worries some will turn to more dangerous drugs off the street or even contemplate ending their own lives.

Experts point out that the number of opioid prescriptions has already been falling around the country. And in Tennessee, BCBS has experienced a 26 percent drop in opioid prescription claims over three years.

But restricting legal access to opioids hasn’t turned back the rise in overdose deaths, which hit a record in Tennessee and nationwide last year.

This story is part of a partnership that includes Nashville Public Radio, NPR and Kaiser Health News.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

OxyContin, Heroin and the Opioid Crisis

By Roger Chriss, PNN Columnist

The roles of heroin and OxyContin in the opioid crisis are frequently mischaracterized and misunderstood. Such is the case with a recent op/ed in The Washington Post.

“In the 1990s, when the industry began aggressively marketing prescription opioids such as OxyContin, heroin was a minimal presence in American life," wrote Keith Humphreys, PhD, a professor of psychiatry at Stanford University

This is an unfortunate and common error about the role of heroin in the opioid crisis. Humphreys is repeating what many politicians and policymakers have also claimed. It’s important to correct this error because otherwise we will misunderstand how to treat heroin addiction, what our options are for pain management, and how to create sound policies to address the opioid crisis.

In fact, the U.S. has long had a major problem with heroin. Mexican black tar heroin arrived decades before OxyContin, and opioid addiction is usually a result of recreational use starting during adolescence, with addiction due to medical care being uncommon.

According to the book “Dark Paradise” by historian David Courtwright, researchers estimated the number of heroin addicts in the U.S. during the 1990s at a half million or more, about the same level as in the mid-1970s. This is also close to the 626,000 heroin addicts that the National Institute of Drug Abuse estimates for 2016.

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Fatal overdoses involving Mexican black tar heroin were increasing even before OxyContin was introduced by Purdue Pharma in 1996. Sam Quinones notes in “Dreamland” that Oregon’s Multnomah County had only 10 heroin overdose deaths in 1991, about the time Mexican drug dealers arrived in Portland, but by 1999 there were 111 heroin overdoses.

So the idea that “heroin was a minimal presence in American life” isn’t supported by data. Neither is the claim that heroin traffickers “set up shop in the areas of the United States with the highest prevalence of prescription opioid addiction.”

According to Quinones, the Mexican drug gang the “Xalisco Boys” went into communities that were not a part of the established drug trade and were not subject to turf wars or other forms of gang violence. They wanted to fly below the radar, to avoid detection by law enforcement, and deliberately avoided carrying guns, driving fancy cars, or living large.
So the Xalisco Boys went to smaller cities like Portland and rural communities like Appalachia that were specifically chosen because they were low risk. And they were there well before 1996 and the advent of OxyContin.

Humphreys makes an additional error with his claim that about 80 percent of Americans who became heroin addicts started out with prescription opioids, according to an assessment from the National Institutes of Health. The 80% statistic varies significantly with time and place. As I wrote in a previous column,  non-medical use of opioid medication was found in 50% of young adult heroin users in Ohio, in 86% of heroin users in New York and Los Angeles, and in 40%, 39%, and 70% of heroin users in San Diego, Seattle, and New York respectively.

It's also important to note that “prescription opioids” does not necessarily mean prescribed opioids. Many addicts don't have a prescription and steal, buy or borrow pain medication. The National Institute on Drug Abuse estimates that about 10 percent of patients legally prescribed opioids develop an opioid use disorder. And only about 5 percent of those who misuse their medication transition to heroin.

There is also a disturbing new trend in heroin use. A study in JAMA Psychiatry last year found that about one-third of heroin users had no prior experience with any opioid, prescription or otherwise. Heroin users often have extensive prior drug use with a variety of different substances, along with a history of severe childhood trauma or mental illness.

Humphreys’ claim that the “heroin-addicted were transfers from prescription opioids” ignores another route on the path to opioid addiction. In “Drug Dealer, MD,” Stanford psychiatrist Anna Lembke says some drug addicts switched from heroin to prescription opioids in the late 1990s and early 2000s because of the increased availability of the latter.

None of this is meant to exonerate OxyContin or Purdue Pharma. Barry Meier’s recent book “Pain Killer” does a good job of explaining the history of the company and why it is the focus of so many lawsuits. Purdue was fined over $600 million for the illegal marketing of OxyContin and important questions about the company’s actions remain to be answered.

Heroin addiction has been a major presence in American life for generations. The current opioid crisis may have been jump-started with prescription drugs, but heroin came long before OxyContin. It is better to view OxyContin as gasoline tossed on a smoldering fire, rather than blame OxyContin for heroin. The crisis is more complicated and pervasive than that.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.