Full Court Press on Opioid Pain Medication

By Pat Anson, Editor

A full court press is a defensive basketball tactic in which a team applies relentless pressure on an opponent the entire length of the court.

This past week felt like a full court press against prescription opioids, with government regulators, politicians, and even economists weighing in on the opioid crisis – almost all of them pointing a finger of blame at pain medication.

Where to begin?

On Tuesday, sixteen U.S. senators wrote a letter to the head of the Drug Enforcement Administration asking the agency to make further cuts in the production of hydrocodone, oxycodone and other opioid pain medications in 2018. The DEA has already reduced the supply of Schedule II opioids by 25 percent or more in 2017.

The letter, which was signed by 15 Democrats and one independent -- many from states where deaths from heroin and illicit fentanyl have eclipsed those from painkillers -- doesn’t even mention the role of illegal drugs in the overdose crisis, pinning the blame solely on pain medication.

“In order to effectively combat this raging crisis, stakeholders -- especially our federal oversight agencies -- must use every tool available to prevent the flood of addictive narcotic painkillers onto the market that can result in misuse, abuse, and diversion,” said the letter.

On Thursday, the Food and Drug Administration signaled that it was prepared to use some of those tools. An FDA funded report by the National Academies of Sciences, Engineering, and Medicine called for a national campaign to combat the opioid crisis, including more aggressive regulation of opioid medications and a “cultural change” in the way they are prescribed.

At the same time, the report warned that the illicit and prescription drug markets are "intertwined" and that "regulatory efforts designed to reduce harms associated with the use of prescription opioids may be contributing to
increased heroin use."

FDA commissioner Scott Gottlieb, MD, welcomed the report with a lengthy statement that completely ignored the role of heroin and illicit fentanyl in the opioid crisis.

“I’ve asked my FDA colleagues to take a fresh look at some key features of the agency’s regulation of opioids, including provider education, benefit-risk assessment in the pre- and post-market setting, and steps we can take to reduce overall exposure to these drugs,” Gottlieb said.

‘Extreme Amount’ of Opioids Prescribed

Also on Thursday, the Department of Health and Human Services’ Office of Inspector General (OIG) published a widely cited and inflammatory report claiming that over half a million Medicare beneficiaries were receiving high doses of prescription opioids.  The estimate is based on the premise that a daily morphine equivalent dose (MME) greater than 120 mg is a “high amount” and a dose of 240 mg or more is an “extreme amount.”

Those would be high doses for most pain patients, but not for Rick Martin, a retired Nevada pharmacist disabled by severe chronic back pain. Martin says he needs up to 300 mg (MME) of opioids daily just to be able to stand and walk for any length of time.

“I am really really incensed about the OIG using the word ‘extreme’ in defining people who take greater than 240 MME/day.  This is shouting fire in the movie theater,” Martin wrote in an email to PNN. “Patients who have long term persistent pain are where they are due to the medical community failing to correctly diagnose and treat what is causing the pain in the first place.  

“So in the OIG's eyes, not only am I a chronic pain patient on long term monitored opioid prescription medications, I am now considered EXTREME ! What a degrading moniker that is. In 6 months, I'll be called an EXTREME OPIOID ABUSER.  That's the next level to come down the pike.”

Like the senators’ letter to the DEA and the FDA study, the OIG report virtually ignores the illegal drug trade, instead blaming patients and providers for the opioid crisis. The report estimates that 400 doctors have “questionable” prescribing practices and 22,000 Medicare beneficiaries are doctor shopping.

“The extreme use of opioids and apparent doctor shopping described in this study put beneficiaries at risk and may indicate that opioids are being prescribed for medically unnecessary purposes and then diverted for resale or recreational use. It may also indicate that beneficiaries are receiving poorly coordinated care,” the report says.

On Thursday, the Justice Department also announced a nationwide crackdown on health insurance fraud and the illegal distribution of prescription opioids. Over 400 people were arrested nationwide, including many doctors, nurses and healthcare providers.

"While today is a historic day, the Department's work is not finished. In fact, it is just beginning. We will continue to find, arrest, prosecute, convict, and incarcerate fraudsters and drug dealers wherever they are,” warned Attorney General Jeff Sessions.

Opioid Crisis Affecting Job Market

Surprisingly, it was left to economists to take a more nuanced view of the opioid crisis – noting there are many other factors involved besides pain medication

Federal Reserve chair Janet Yellen told the Senate Banking Committee that economic despair was one reason that the labor force participation rate remains stubbornly low, despite declines in the unemployment rate.

“Unfortunately this is likely tied to the opioid crisis, the problems that many communities have. We’ve seen an increase in death rates due to despair, suicide, drugs in these communities,” Yellen said, adding that the United States is "the only advanced nation that I know of where in these communities we're actually, especially among less-educated men, seeing an increase in death rates partly reflecting opioid use."

Yellen was reacting in part to a Goldman Sachs report  which blamed opioids of all kinds – both legal and illegal – for keeping millions of Americans unemployed during their prime working years.

“Use of both legal prescription pain relievers and illegal drugs is part of the story of declining prime-age participation, especially for men,” economist David Mericle wrote in a research note that attributed a spike in overdoses to “heroin and illicit fentanyl users, most of whom previously used prescription opioids but switched to these cheaper, more accessible drugs.”

Trump Opioid Commission Delays Report

Curiously silent during a week full of opioid news was the White House Office of National Drug Control Policy, which quietly postponed the second meeting of President Trump’s Opioid Commission.  A notice published in the Federal Register Friday said the commission’s second meeting has been postponed until July 31, the second time the meeting has been rescheduled.  No explanation for the delay was given.

Also delayed was the commission’s interim report on how the federal government should address the opioid crisis, which is now over a month overdue.

At the commission’s first meeting in June, testimony was taken only from government officials and addiction treatment advocates. Pain management experts and patient advocates were not asked to appear, nor are they represented on the commission itself.

FDA Study Calls for More Aggressive Opioid Regulation

By Pat Anson, Editor

A new report commissioned by the U.S. Food and Drug Administration is calling for a sustained and coordinated national campaign to combat the opioid crisis, including more aggressive regulation of opioids by the FDA and a “cultural change” in the prescribing of opioid medication,

The report by a special committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) focuses primarily on restricting the supply of prescription opioids, not illicit opioids such as heroin and fentanyl, which are now driving the so-called opioid epidemic.

"The broad reach of the epidemic has blurred the formerly distinct social boundary between prescribed opioids and illegally manufactured ones, such as heroin," said committee chair Richard Bonnie, a Professor of Medicine and Law at the University of Virginia.

“This report provides an action plan directed particularly at the health professions and government agencies responsible for regulating them. This plan aims to help the millions of people who suffer from chronic pain while reducing unnecessary opioid prescribing. We also wanted to convey a clear message about the magnitude of the challenge. This epidemic took nearly two decades to develop, and it will take years to unravel."

The report estimates that at least 2 million people in the U.S. have an “opioid use disorder” involving prescription opioids -- meaning they are addicted to prescription painkillers -- and almost 600,000 have an opioid use disorder involving heroin.

Although opioid prescribing has been declining and the number of overdose deaths from prescription opioids has remained relatively stable in recent years, deaths from illicit opioids such as heroin have tripled in the past decade.

NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINES

The report claimed that many people who normally would use prescription opioids have transitioned to heroin because of the declining price of heroin and the introduction of abuse-deterrent formulations that make opioid medication harder to snort or inject. The Centers for Disease Control and Prevention (CDC) has said there is no evidence to support the theory that legitimate patients are transitioning to heroin.

"Evidence does not support the hypothesis that initiatives intended to reduce opioid prescribing increase illicit opioid-related overdose at a population level," Deborah Dowell, MD, of the CDC recently wrote in the Annals of Internal Medicine.

The NASEM committee recommended that further efforts be made to restrict the supply of opioid medication, even though there is “limited evidence” that steps taken so far are working and may, in fact, be harming patients.

“Although more research is needed, limited evidence suggests that state and local interventions aimed at reducing the supply of prescription opioids in the community may help curtail access. Importantly, however, none of these studies investigates the impact of reduced access on the well-being of individuals suffering from pain whose access to opioids was curtailed,” the report states.

The NASEM report also recommends broader insurance coverage of non-opioid treatments.and better education of physicians in pain management.

“The committee’s recommended changes to provider education and payer policy should be accompanied by a change in patient expectations with respect to the treatment and management of chronic pain. Attention is not being paid to educating the general public on the risks and benefits of opioid therapy, or the comparative effectiveness of opioids with nonopioid or nonpharmacologic therapies,” the committee said.

The committee also recommended that the FDA conduct a full review of currently approved opioids and that it consider “public health considerations” in all of its regulatory decisions. Such a policy would require the agency to not only consider the safety and efficacy of opioids for legitimate pain needs, but also their impact on addicts and the illicit drug market.

“I was encouraged to see that many of NASEM’s recommendations for the FDA are in areas where we’ve already made new commitments,” FDA commissioner Scott Gottlieb, MD, said in a statement.  “Among these important new actions is our work to ensure drug approval and removal decisions are made within a benefit-risk framework that evaluates not only the outcomes of opioids when used as prescribed, but also the public health effects of the inappropriate use of these drugs.”

Last month the FDA asked that the opioid painkiller Opana ER be removed from the market, not because it was harming legitimate pain patients, but because addicts were abusing it and spreading infectious diseases through infected needles. It was the first time the agency has taken steps to remove an opioid from the market.

“These are just some of the important efforts we have underway. But to make a meaningful impact, this epidemic must be addressed as a public health emergency, and requires an all-of-the-above approach. As underscored in the NASEM report, the scope of this epidemic is so large, it’s going to require a coordinated effort that includes federal, state, and local partners,” Gottlieb said.

The NASEM study was funded by the FDA.

16 Senators Urge DEA to Lower Opioid Supply Again

By Pat Anson, Editor

Sixteen U.S. senators have sent a letter to the head of the Drug Enforcement Administration asking the agency to consider further cuts in the supply of hydrocodone, oxycodone and other opioid pain medication in 2018.

The DEA, which regulates that amount of controlled substances that can be manufactured each year, reduced the quota for Schedule II opioids by 25 percent or more in 2017 after receiving a similar letter last summer.  The supply of hydrocodone, one of the most widely used painkillers, was cut by 34 percent.

“We commend DEA on taking initial steps last year to lower production quotas for the first time in a generation,” the senators wrote to DEA acting administrator Chuck Rosenberg.

“However, the 2017 production quota levels for numerous schedule II opioids remain dramatically higher than they were a decade ago.  Further reductions, through DEA’s existing quota-setting authority, are necessary to rein in this epidemic.”

The letter, which was drafted by Illinois Democrat Dick Durbin, was signed by 15 other Democrats and one Independent: Senators Sherrod Brown (D-Ohio), Amy Klobuchar (D-Minn.), Edward J. Markey (D-Mass.), Joe Manchin (D-W.Va.), Dianne Feinstein (D-Calif.), Claire McCaskill (D-Mo.), Patrick Leahy (D-Vt.), Tammy Baldwin (D-Wisc.), Jeanne Shaheen (D-N.H.), Kirsten Gillibrand (D-N.Y.), Catherine Cortez Masto (D-Nev.), Maggie Hassan (D-N.H.), Richard Blumenthal (D-Conn.), Al Franken (D-Minn.) and Angus King (I-Maine).

Between 1993 and 2015, the senators say the DEA allowed production quotas for oxycodone to increase 39-fold, hydrocodone to increase 12-fold, hydromorphone to increase 23-fold, and fentanyl to increase 25-fold.

Production quotas may have been rising, but opioid prescriptions have actually been falling for several years.  Last week the CDC released a report acknowledging that opioid prescribing in the U.S. has fallen by 18 percent since 2010.  

Many PNN readers have complained that since the 2017 quotas were adopted they now have trouble getting legitimate prescriptions filled because pharmacies do not keep enough pain medication in stock.

“My pharmacy has been trying to fill my pain medication for 6 days now,” wrote Karen. “So I call my pain management office and (they) don't know there is a shortage! Help us get our medication!”

“I am horrified by the absolute stupidity of these lawmakers who have no business making any decisions about my pain management!” wrote Tracey, who has been taking pain medication for 5 years. “All of the lawmakers said this would not affect those with already established chronic pain! Well guess what they lied!”

“I am writing to each one of these senators and letting them know how I feel on this issue. We need to vote these people OUT of office come election time, send them a powerful message. Although at this point the damage is already done. People like myself shouldn't have to consider suicide to end their constant pain,” wrote Jenny.

While many patients complain of shortages, the senators who signed the letter talk about states being “flooded” with opioids.

“Pharmaceutical companies have irresponsibly flooded states with millions and millions of opioids pills – enough, in fact, for every adult in America to have their own bottle,” Sen. King said in a statement. “And the consequences are both clear and dire: As the number of pills has grown, so has the drug epidemic. By scaling back the overabundance of these opioids, the DEA can help directly stem the tide of addiction while still also ensuring that those who suffer from chronic pain have the medication they need.”

Drug Maker Pays $35 Million Fine for Opioid Sales

By Pat Anson, Editor

A British drug maker has agreed to pay a $35 million fine to settle allegations that it failed to report suspiciously large orders in the U.S. for the opioid painkiller oxycodone.

In the settlement, Mallinckrodt refused to admit any wrongdoing and said it was paying the fine “to eliminate the uncertainty, distraction and expense of litigation.”

Federal prosecutors say the company failed to detect and notify the Drug Enforcement Administration of unusually large orders for oxycodone from U.S. pharmacies and pain clinics from 2008 to 2011.  

The government also alleged that Mallinckrodt failed to keep accurate records at a manufacturing facility in upstate New York, which resulted in discrepancies between the actual number of oxycodone tablets produced and the number of tablets reported by the company.

“Mallinckrodt’s actions and omissions formed a link in the chain of supply that resulted in millions of oxycodone pills being sold on the street,” Attorney General Jeff Sessions said in a statement.

Prosecutors say the settlement includes a “groundbreaking parallel agreement” with the DEA, under which the company will analyze data it collects from customers down the supply chain to identify suspicious sales. The DEA maintains that drug makers need to go beyond a “know your customer” policy and should use all available data to “know your customer’s customer” to prevent opioid painkillers and other controlled substances from getting into the wrong hands.

“Mallinckrodt has agreed to do everything they can to help us identify suspicious orders in the future. And as a result of today's settlement, we are sending a clear message to drug companies: this Department of Justice will hold you accountable for your legal obligations and we will enforce our laws,” Sessions said.

"While Mallinckrodt disagreed with the U.S. government's allegations, we chose to resolve the legacy matter in order to eliminate the uncertainty, distraction and expense of litigation and to allow the company to focus on meeting the important needs of its patients and customers,” said Michael-Bryant Hicks, General Counsel, Mallinckrodt.

"We are proud of the fact that Mallinckrodt has long been an industry leader in actively combatting the serious issue of prescription drug abuse with a demonstrated record of meeting and exceeding the requirements of federal and state laws governing the manufacturing, sale and distribution of controlled substances.”

CVS to Pay $5 Million Fine

In a related story, CVS Health Corp agreed to pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of the opioid painkiller hydrocodone.

“The Company agreed to settle this matter to avoid the delay, uncertainty, inconvenience and expense of protracted litigation,” CVS said in a statement. 

The allegations resolved by the settlement were uncovered by a DEA investigation that began in 2012 after CVS self-reported thefts and losses of hydrocodone at five of its Sacramento-area pharmacies. Under the Controlled Substances Act, pharmacies are required to report any thefts or significant losses of controlled substances to the DEA.

“National retailers that distribute massive amounts of controlled substances have a responsibility to comply with recordkeeping regulations because these regulations are specifically designed to prevent dangerous drugs from being diverted into the community and abused,” said U.S. Attorney Phillip Talbert.

In addition to paying the $5 million fine, CVS also agreed to a compliance plan for 168 its pharmacies in California, under which pharmacy staff would be provided with better training and monitoring.

“CVS Health is committed to the highest standards of ethics and business practices, including complying with all federal and state laws governing the dispensing of controlled substance prescriptions and is dedicated to helping reduce prescription drug abuse and diversion,” the company said. 

This is certainly not the first time CVS has been accused by the federal government of failing to comply with the Controlled Substances Act.

Last year CVS agreed to pay a $3.5 million fine to resolve allegations that 50 of its pharmacies in Massachusetts and New Hampshire filled forged prescriptions for opioid painkillers. One forger signed a dentist’s name on 131 prescriptions for hydrocodone and had them filled at eight CVS stores. Another forger obtained over 200 prescriptions for hydrocodone and methadone by forging the name of an emergency room physician.

In 2015, CVS paid a $22 million fine after two of its pharmacies in Florida were found to be routinely filling bogus prescriptions for painkillers, including some for customers as far away as Kentucky.

And in 2010, the DEA fined CVS $75 million for the improper selling of cold medicines in California and Nevada. The cold medicines contained pseudoephedrine, an ingredient that can be used to make methamphetamine.

From Bad to Worse: The Future of the Opioid Crisis

By Roger Chriss, Columnist

The opioid crisis is getting worse. STAT News is predicting that “opioids could kill nearly half a million people across America over the next decade as the crisis of addiction and overdose accelerates.” The Guardian calls it “this generation’s AIDS crisis.”

There are three developments now at work that are likely to determine the future direction of the opioid crisis: Illicit drugs coming from China and Mexico; healthcare reform and funding for addiction treatment; and the White House Commission on Combating Drug Addiction and the Opioid Crisis, chaired by New Jersey governor Chris Christie.  

With opioid prescriptions dropping since 2010, heroin and illicit fentanyl are now the main drivers of the opioid crisis. The U.S. is trying to get China to shut down illicit labs and stop the shipment of fentanyl and other synthetic opioids to Mexican drug cartels. But The Globe and Mail warns that “hoping Chinese police and border officials can solve the problem is unlikely to be an effective strategy.”

The New York Times reports illicit drugs can also be obtained online over the “dark web” and attempts to block overseas shipments of such drugs have met with little success so far.

In the U.S. Senate, the GOP healthcare bill would allocate $2 billion to addiction treatment, but CNN reports that “those on the front lines say the bill won't help the opioid crisis -- and very well could make matters worse.” The reason, says Politico, is that “throwing a pile of cash at addiction won’t make it go away.”

Presidential advisor Kellyanne Conway echoes that belief, warning that “money alone hasn’t solved the problem. Obamacare spent billions of dollars and where are we?”

“It takes money and it also takes a four letter word called will,” she told ABC News, a comment that infuriated addiction treatment supporters.

Two Republican senators want to boost funding for addiction treatment to $45 billion, but experts say even that amount of money would be inadequate because it doesn’t provide for the treatment of other healthcare problems – like HIV and hepatitis C – that many addicts have.

Addiction treatment was the focus of the first meeting of the White House Opioid Commission, which was appointed by President Trump to come up with solutions to the opioid crisis.  During last month’s meeting, Mitchell Rosenthal, MD, founder of the addiction treatment chain Phoenix House, warned that “nothing we are doing today has been able to halt the spread of opioid addiction. Controlling prescription opioid medication has not done so.”

The commission has until October 1 to present its recommendations to President Trump, but the panel has already missed one deadline for an interim report and postponed its second meeting until next week.

As you can see, there are no easy solutions. The opioid crisis is a perfect storm of increasingly available illicit drugs, very limited and costly treatment resources, and virtually no early detection or prevention. We can’t simply legislate, regulate or incarcerate our way out.

Nothing less than a comprehensive and coordinated national response will end the crisis. We need early intervention and preventative education, long-term treatment of opioid addiction using medication-assisted therapy, and careful and humane oversight of prescription opioids that doesn’t take them away from patients who need them. What we will get remains to be seen.

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.

PROP Urges Members to Oppose FDA Opioid Strategy

By Pat Anson, Editor

An anti-opioid activist group has sent an “Urgent Action Request” to it members, asking them to oppose plans by the Food and Drug Administration to give new guidance to health care providers about prescribing opioid pain medication.

The initial draft of the guideline for Prescriber Education for Extended-Release and Long-Acting Opioids Risk Evaluation and Mitigation Strategies – more simply known as REMS -- warns prescribers at length about the risk of overdose, addiction and the “epidemic of prescription opioid drug abuse.” But Physicians for Responsible Opioid Prescribing (PROP) doesn’t think the draft goes far enough.

“The current draft is seriously flawed,” wrote PROP founder and Executive Director Andrew Kolodny, MD, in an email to supporters urging them to leave a comment in the Federal Register before the public comment period on the REMS guideline ends on Monday, July 10.

“Please post a comment about the draft on the FDA federal docket. FDA is required to review the comments and tally them. If FDA receives enough critical comments, there is a good chance they'll improve the document.” 

Kolodny’s email provides a “sample comment” for PROP members to use, urging the FDA to adopt an upper dose limit on opioids, mention the “lack of evidence supporting long-term opioid use” and provide a list of pain conditions for which opioids are “inappropriate” – such as fibromyalgia and chronic headache.

Until now, the REMS draft guideline – an update to a similar guideline released in 2012 – has drawn little public attention. Less than 300 comments have been made in the Federal Register, most of them focused on whether acupuncture and chiropractic care should be included as alternative treatments to opioids. 

The 10-page guideline warns doctors repeatedly about using caution when prescribing opioids, but it stops short of setting an artificial ceiling on doses, such as those recommended last year by the Centers for Disease Control and Prevention and an even tougher guideline recently adopted by the Departments of Veterans Affairs and Defense (VA/DOD).

“We believe the REMS curriculum should be based on the CDC guideline and the VA/DOD guideline,” wrote Kolodny and other PROP board members in a letter to FDA commissioner Scott Gottlieb, MD. “The CDC and VA/DOD guideline warn against prescribing high doses of opioids and specifically recommend against doses greater than 90mg morphine equivalents. The Blueprint omits this critical topic.”

“I don't agree that the new blueprint is inconsistent with recommendations from other government agencies. For one thing, there is a specific statement in the blueprint that HCPs (health care providers) should know about the CDC guideline and other guidelines regarding safe opioid prescribing,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, an organization of pain management providers.

“Let me also point out that PROP's call for inclusion of ‘an upper dose limit consistent with recommendations from other federal agencies’ perpetuates the myth that the CDC guideline contains such an upper dose limit. CDC was very clear when it issued the guideline that it should be considered to contain recommendations, not limits.”

The REMS guideline not only does not endorse a specific limit on opioids, it recommends that “a comprehensive treatment plan should be developed and customized to the needs of the individual patient.”  The focus on individualized patient care is something else that PROP takes issue with.

“Since the purpose of the Blueprint is to teach more cautious prescribing the focus should be first and foremost on when to use opioids for acute and chronic pain, and secondly, on how to use opioids as safely as possible. The Blueprint does not need to teach how to make a pain diagnosis, or what alternatives there are to opioids, both of which should be considered beyond the scope of REMS,” wrote Kolodny his his letter. “Until opioids are prescribed more cautiously it will not be possible to bring the opioid addiction epidemic under control.”

But opioids are being prescribed more cautiously and have been since 2010, as we learned from a new CDC study. Yet the nation’s opioid crisis continues to worsen, fueled by heroin, illicit fentanyl, counterfeit painkillers, and failed strategies to control the crisis by denying many pain patients their only form of treatment.   

To see the FDA’s draft REMS guideline, click here. To leave your own comment on the Federal Register, click here.

Drug Maker to Stop Sales of Opana ER

By Pat Anson, Editor

Endo International has agreed to voluntarily remove Opana ER from the market, one month after the Food and Drug Administration said safety risks posed by the pain medication outweigh its benefits. Opana ER is the brand name for Endo’s extended release opioid painkiller oxymorphone.

“Endo International continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER when used as intended, and notes that the Company has taken significant steps over the years to combat misuse and abuse,” the company said in a statement.

“Endo reiterates that neither the FDA's withdrawal request nor Endo's decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed.”

If Endo had not agreed to stop Opana sales, the FDA would have taken steps to require its removal by withdrawing approval for the drug. The company said it would work with the FDA to remove Opana “in a manner that looks to minimize treatment disruption for patients” and to give patients time to consult with doctors about other alternative painkillers.

The FDA action is the first time the agency has taken steps to stop an opioid painkiller from being sold. Opana was reformulated by Endo in 2012 to make it harder to abuse, but addicts quickly discovered they could still inject it. The FDA said Opana was linked to serious outbreaks of HIV, hepatitis C and a blood clotting disorder spread by infected needles.

Next week the FDA will meet with “external thought leaders” to review the effectiveness of other painkillers made with abuse deterrent formulas, which make medications harder for addicts to crush or liquefy for snorting and injecting.

FDA commissioner Scott Gottlieb, MD, has hinted the agency could take other painkillers off the market.

“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” Gottlieb said last month.

“I’m hopeful that this signals a change at FDA—and that Opana might be just the first opioid that they’ll consider taking off the market. It’s too soon to tell,” Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing (PROP) told Mother Jones.

Endo said it will incur a pre-tax impairment charge of $20 million in the second quarter of 2017 to write-off the remaining book value of Opana.  Sales of Opana reached nearly $159 million in 2016.

CDC: Opioid Prescribing Peaked in 2010

By Pat Anson, Editor

The Centers for Disease Control and Prevention admitted something today that most doctors and pain patients could have told the agency several years ago: prescriptions for opioid painkillers are declining.

In its newest Vital Signs report, the CDC analyzed prescription drug data compiled by QuintilesIMS from 2006 to 2015, and found that opioid prescribing in the U.S. peaked in 2010.  More recent data indicates the downward trend continued in 2016.

The CDC's new report undermines one of the main reasons behind the agency’s 2016 opioid prescribing guidelines, which falsely claimed that “opioid prescriptions per capita increased from 2007 to 2012,” when, in fact, they actually declined (see chart below).  

“Overall, opioid prescribing in the United States is down 18 percent since 2010,” said CDC Acting Director Anne Schuchat, MD.  

But even with that downward trend in prescribing, the CDC maintains opioid doses are still too high and contributing to the nation’s overdose crisis.

“Despite these overall declines, the bottom line remains we still have too many people getting opioid prescriptions for too many days at too high a dose,” said Schuchat. “In addition, the dramatic increase we’ve been seeing in heroin overdose is another tragic consequence of exposing too many people to prescription opioids, since most people who use heroin started off with misusing prescription opioids.”

Schuchat did not explain how her theory could account for the fact that heroin overdoses were increasing at a time when opioid prescriptions were declining. The association between heroin use and prescription painkillers is a common misconception at best, and a misleading half-truth at worst.

While many heroin users start out with painkillers (as well as tobacco, marijuana, alcohol and other drugs), most obtain their opioids illegally through friends, relatives and the black market. Heroin use by patients who are legally prescribed painkillers is actually quite rare, although the CDC's acting director makes it sound like one of the leading causes of overdoses.

"We're now experiencing the highest overdose drug death rates ever recorded in the United States, driven by prescription opioids and illicit opioids like heroin and illicitly manufactured fentanyl," Schuchat said.

Contrary to its own prescribing guideline, the CDC found that the average per capita daily morphine equivalent dose (MME) has been in decline for nearly a decade, from 59.7 MME per capita in 2006 to 48.1 MME in 2015.

The latter dose is well below the highest recommended limit of 90 MME in the CDC guidelines.

AVERAGE DAILY PER CAPITA MORPHINE EQUIVELANT DOSE (MME)

Source: CDC/QuintilesIMS

The CDC also found a wide variation in prescribing practices around the country, with six times more opioids per resident dispensed in the highest-prescribing counties than in the lowest-prescribing ones.

Many of the high-prescribing counties are in rural, economically depressed areas such as Appalachia, where there are high rates of disability, suicide and unemployment; suggesting that the so-called "opioid epidemic" is actually more of an epidemic of despair. Other factors associated with high rates of opioid prescribing are a high percentage of white residents, high rates of uninsured or Medicaid recipients, and high rates of patients with diabetes and arthritis.

Gabapentin Boosts High For Opioid Abusers

By Carmen Heredia Rodriguez, Kaiser Health News

ATHENS, Ohio — On April 5, Ciera Smith sat in a car parked on the gravel driveway of the Rural Women’s Recovery Program here with a choice to make: go to jail or enter treatment for her addiction.

Smith, 22, started abusing drugs when she was 18, enticed by the “good time” she and her friends found in smoking marijuana.

She later turned to addictive painkillers, then anti-anxiety medications such as Xanax and eventually Suboxone, a narcotic often used to replace opioids when treating addiction.

Before stepping out of the car, she decided she needed one more high before treatment. She reached into her purse and then swallowed a handful of gabapentin pills.

CIERA SMITH (KAISER HEALTH NEWS)

Last December, Ohio’s Board of Pharmacy began reporting sales of gabapentin prescriptions in its regular monitoring of controlled substances. The drug, which is not an opioid nor designated a controlled substance by federal authorities, is used to treat nerve pain. But the board found that it was the most prescribed medication on its list that month, surpassing oxycodone by more than 9 million doses. In February, the Ohio Substance Abuse Monitoring Network issued an alert regarding increasing misuse across the state.

And it’s not just in Ohio. Gabapentin’s ability to tackle multiple ailments has helped make it one of the most popular medications in the U.S. In May, it was the fifth-most prescribed drug in the nation, according to GoodRx.

Gabapentin is approved by the Food and Drug Administration to treat epilepsy and pain related to nerve damage, called neuropathy. Also known by its brand name, Neurontin, the drug acts as a sedative. It is widely considered non-addictive and touted by the federal Centers for Disease Control and Prevention as an alternative intervention to opiates for chronic pain. Generally, doctors prescribe no more than 1,800 to 2,400 milligrams of gabapentin per day, according to information on the Mayo Clinic’s website.

Gabapentin does not carry the same risk of lethal overdoses as opioids, but drug experts say the effects of using gabapentin for long periods of time or in very high quantities, particularly among sensitive populations like pregnant women, are not well-known.

As providers dole out the drug in mass quantities for conditions such as restless legs syndrome and alcoholism, it is being subverted to a drug of abuse. Gabapentin can enhance the euphoria caused by an opioid and stave off drug withdrawals. In addition, it can bypass the blocking effects of medications used for addiction treatment, enabling patients to get high while in recovery.

Athens, home to Ohio University, lies in the southeastern corner of the state, which has been ravaged by the opioid epidemic. Despite experience in combating illicit drug use, law enforcement officials and drug counselors say the addition of gabapentin adds a new obstacle.

“I don’t know if we have a clear picture of the risk,” said Joe Gay, executive director of Health Recovery Services, a network of substance abuse recovery centers headquartered in Athens.

‘Available To Be Abused’

A literature review published in 2016 in the journal Addiction found about a fifth of those who abuse opiates misuse gabapentin. A separate 2015 study of adults in Appalachian Kentucky who abused opiates found 15 percent of participants also misused gabapentin in the past six months “to get high.”

In the same year, the drug was involved in 109 overdose deaths in West Virginia, the Charleston Gazette-Mail reported.

Rachel Quivey, an Athens pharmacist, said she noticed signs of gabapentin misuse half a decade ago when patients began picking up the drug several days before their prescription ran out.

“Gabapentin is so readily available,” she said. “That, in my opinion, is where a lot of that danger is. It’s available to be abused.”

In May, Quivey’s pharmacy filled roughly 33 prescriptions of gabapentin per week, dispensing 90 to 120 pills for each client.

For customers who arrive with scripts demanding a high dosage of the drug, Quivey sometimes calls the doctor to discuss her concerns. But many of them aren’t aware of gabapentin misuse, she said.

Even as gabapentin gets restocked regularly on Quivey’s shelves, the drug’s presence is increasing on the streets of Athens. A 300-milligram pill sells for as little as 75 cents.

(kAISER HEALTH NEWS)

Yet, according to Chuck Haegele, field supervisor for the Major Crimes Unit at the Athens City Police Department, law enforcement can do little to stop its spread. That’s because gabapentin is not categorized as a controlled substance. That designation places restrictions on who can possess and dispense the drug.

“There’s really not much we can do at this point,” he said. “If it’s not controlled … it’s not illegal for somebody that’s not prescribed it to possess it.”

Haegele said he heard about the drug less than three months ago when an officer accidentally received a text message from someone offering to sell it. The police force, he said, is still trying to assess the threat of gabapentin.

Little Testing

Nearly anyone arrested and found to struggle with addiction in Athens is given the option to go through a drug court program to get treatment. But officials said that some exploit the absence of routine exams for gabapentin to get high while testing clean.

Brice Johnson, a probation officer at Athens County Municipal Court, said participants in the municipal court’s Substance Abuse Mentally Ill Program undergo gabapentin testing only when abuse is suspected. Screenings are not regularly done on every client because abuse has not been a concern and the testing adds expense, he said.

The rehab program run through the county prosecutor’s office, called Fresh Start, does test for gabapentin. Its latest round of screenings detected the drug in five of its roughly 238 active participants, prosecutor Keller Blackburn said.

Linda Holley, a clinical supervisor at an Athens outpatient program run by the Health Recovery Services, said she suspects at least half of her clients on Suboxone treatment abuse gabapentin. But the center can’t afford to regularly test every participant.

Holley said she sees clients who are prescribed gabapentin but, due to health privacy laws, she can’t share their status as a person in recovery to an outside provider without written consent. The restrictions give clients in recovery an opportunity to get high using drugs they legally obtained and still pass a drug test.

“With the gabapentin, I wish there were more we could do, but our hands are tied,” she said. “We can’t do anything but educate the client and discourage” them from using such medications.

A stone painted with the phrase “Perfect Imperfection” is among the inspirational messages along the sidewalk leading to the main entrance of the Rural Women’s Recovery Program. (Carmen Heredia Rodriguez/KHN)

Smith visited two separate doctors to secure a prescription. As she rotated through drug court, Narcotics Anonymous meetings, jail for relapsing on cocaine and house arrest enforced with an ankle bracelet, she said her gabapentin abuse wasn’t detected until she arrived at the residential recovery center.

Today, Smith sticks to the recovery process. Expecting a baby in early July, her successful completion of the program not only means sobriety but the opportunity to restore custody of her eldest daughter and raise her children.

She intends to relocate her family away from friends and routines that helped lead her to addiction and said she will help guide her daughter away from making similar mistakes.

“All I can do is be there and give her the knowledge that I can about addiction,” Smith said, “and hope that she chooses to go on the right path.”

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

‘Catastrophizing’ Doesn’t Mean Pain Is All in Your Head

(Editor’s Note: Last month we published a story about pain “catastrophizing,” and how a new study showed that women who have negative or emotional responses to pain are more likely than men to be prescribed opioid medication. Several readers were offended by the study, as well as our story, feeling they belittled women and their ability to handle pain.

The two co-authors of the study, which was published in the journal Anesthesiology, kindly agreed to address some of these concerns and further explain their research.)

By Yasamin Sharifzadeh and Beth Darnall, PhD, Guest Columnists

Thank you for taking the time to share your thoughts and ideas about our recently published paper on opioid prescription and pain catastrophizing. We would like to address a few concerns brought up and to clarify some of the statements made in our publication.

First and foremost, our study analyzed pain catastrophizing, which has a different and more nuanced definition than terms such as complaining or worrying, that are commonly used to describe it.

Pain catastrophizing is measured via a 13 question survey, with specific subsets used to assess varying aspects of the way we emotionally approach pain. This term is not meant to downplay or discredit pain or its associated emotions. In fact, we use it to better understand the many manifestations of pain.

But for some people, the term “catastrophizing” is offensive. We hear those negative responses, but in clinic, when the term is described, many patients will say:  “I do that!  That is totally me.”  So while not everyone is offended by the term, some people are. It’s important to know that catastrophizing does not mean that pain is all in your head, or your fault, or that you did anything wrong.

Our nervous systems are hardwired to respond to pain with alarm. It is actually an acquired skill to learn to disengage one’s attention to pain and develop strategies that counteract this agitation in the nervous system. Otherwise, it can set us up to have greater distress and pain. This is true for everyone, but for some people the alarm in the nervous system rings louder. 

We sometimes use “negative mindset” as a way to describe difficulties in disengaging from attention to pain or focusing on worsening pain or worst-case scenarios. The science is clear on how our thoughts, attention, and emotions impact pain and pain treatment response.

Whatever the term used to describe this specific form of pain-related distress, it is highly predictive of response to various pain treatments. For this reason, it is important that we identify it and treat it. Not addressing these issues would be neglectful, given the degree to which one’s mindset can undermine treatment response and contribute to suffering.

Men and Women Catastrophize

We also wish to clarify some of the findings of the study. We found that men and women, in a general sample of chronic pain patients, had similar levels of pain catastrophizing. In other words, men and women do not significantly differ in their pain-related emotions. Also, consistent with previous peer-reviewed work, we found that women reported higher than average pain levels.

We took our robust analysis a few steps further to show that in women, pain-related emotions played a bigger role in the likelihood of having an opioid prescription than it did in men. Again, this is not saying that pain catastrophizing played no role in opioid prescribing for men -- just that it had a higher effect in women despite equal levels of pain catastrophizing between the sexes.

Overall, we view our study as a stepping-stone towards an improved understanding of both the physical and emotional manifestations of pain.

Pain catastrophizing is a unique term that describes just one of many ways that we can look at pain-related emotional distress, and it is not meant to discount pain in any way. Rather, it validates the importance of treating pain comprehensively in order to attain better results.

We hope that this study helps people with pain look at pain from many angles and work with their physician to find the solution that works best for them.

Yasamin Sharifzadeh is lead author of the study. She is a second year medical student at Virginia Commonwealth University.

Beth Darnall, PhD, is senior author of the study.  She is a clinical associate professor at Stanford University School of Medicine and author of 3 books:    "Less Pain, Fewer Pills," "The Opioid-Free Pain Relief Kit," and a forthcoming book entitled “Psychological Treatment for Chronic Pain.”

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.

What It’s Like to Get a Lidocaine Infusion

By Crystal Lindell, Columnist

So I’m kind of annoyed at the wellness people out there for making the word “infusion” sound like something vitamin-related that rich people get at the spa right before a couple’s massage and a facial.

That is not what an infusion is. At least, that’s not what a lidocaine infusion is. It’s also not a shot. That seems to come up at lot. Everyone thinks I went into the hospital, got a quick shot in the arm, and then went to Chipotle. Again, that is incorrect.

I recently got my first lidocaine infusion at the recommendation of my pain specialist and my primary care doctor. They were hoping it would help me with the daily pain I have on my right side from what they think is intercostal neuralgia —  basically I always feel like I have a broken rib.

I was really apprehensive about trying it though, and the only reason I agreed to do it was because my primary care doctor strongly encouraged me to try it and I trust him. We’ve been through some stuff together and he has always seemed to have my best interest at heart.

He said of the like five people he knew who tried it, all had found success with it. I’m pretty sure he also is hoping to get me off opioids because it’s a huge hassle for him to write a hydrocodone script these days — all sorts of government regulatory boards are involved and he has to check a drug database every time to make sure I’m not coming up with a red flags. But I get that — I don’t actually love being high all the time either.

The way the lidocaine infusion was explained to me was not super encouraging though. Basically, they give you an IV at the hospital infusion center, and you have to sit there for an hour while they slowly pump the medication into your system. Then, at least for the first visit, you have to sit there for another hour after that and get a saline solution to keep the line open. Then they do a blood test and send you home. Also, you have to bring someone with you the first time, in case you can’t drive home afterward.

If it works, you have to go in every month and do it again.

The doctors told me that they don’t even really know why lidocaine infusions work because the effects seem to last longer than the drug should even be in your system. But they think it somehow blocks pain signals in your body.

On a personal note, I was apprehensive because I spend most days dreaming of living in Paris, and I didn’t want to be dependent on something that I’d have to do monthly and that might not even be available in France. In fact, Paris is why I want to get off the hydrocodone in the first place. It’s harder to get opioids over there.

But, like I said, my PCP was all about this infusion, so I decided to do it. They told me I could expect things like numbness and tingling in my fingers, toes and my mouth, a metallic taste, lightheaded, and a feeling of cotton in my mouth.

And, depending on how it went, I also might get nauseous and dizzy. But, they made it sound like all the side effects would go away as soon as they stopped the infusion, and that I should be fine as soon as it was over.

They did not tell me I would feel like I had been drugged.

I mean, I guess, looking back, feeling lightheaded is kind of along those lines, but the feeling is way more intense than that. At least it was for me.

I brought my mom and sister with me, and thank God I did, because the whole thing ended up being a lot more traumatic than I was expecting.

When they started the infusion I was actually FaceTiming my best friend, who said she could literally see the effects of the lidocaine on me in the span of one sentence. My speech got slower, my head got heavy and I could not think clearly.

“I... don’t... think... I.... can..... talk....... anymore,” I told her. 

“Yeah, I know,” she said before wishing me luck and hanging up the phone. 

I don’t know why I was not expecting such an intense reaction, but I wasn’t. About 10 minutes in, I literally started crying for no reason. And the reason I know I had no reason to cry is that I remember telling everyone around me that I didn’t know why I was crying. 

When I started getting really nauseous, they did stop the infusion and give me some graham crackers, which helped. But as soon as they started again the drugged feeling came back. 

The nurse at the infusion center said a lot patients describe it as having too many cocktails. So it’s past that fun one-or-two-glasses-of-wine stage, but just shy of the blackout-drunk stage. Add in that it all feels like it’s happening against your will, and it’s not exactly a fun two hours.

Also, my legs turned to jelly, and I couldn’t think clearly at all. I was literally so naïve going in that I honestly thought I might be able to get some work done while they were doing the infusion. I was not. All I could manage was lying on my back, asking everyone around me if my lips were swollen, and closing my eyes. 

Overall, it was a lot more like going into the hospital for a small procedure than I was expecting it to be — traumatic, time consuming and hard on my body.

When they finished everything, they just let me get up and walk out of the hospital, but I should have had a wheelchair. My legs did not seem to work at all and my brain was in a fog. I felt like how people in action movies look when they’ve been drugged and kidnapped against their will. 

I was hoping to go home and sleep it off, but I woke up the next day still feeling pretty drunk. All told, it took about 15 hours after the infusion before I felt like I had my brain back. 

Did It Work?

Of course, none of this really matters. What really matters is whether or not this thing worked. And I have to tell you it did — for about six days. 

Then, on day seven I woke up at 1 a.m. feeling like someone was stabbing my ribs and I remembered how much chronic pain sucks. I spent the whole day on hydrocodone trying to get my pain under control. 

Those first six days were glorious though.  I would literally wake up pain free. Healthy even. And I got so much done around the house. I did the dishes, I vacuumed. I went for walks without any pain at all. My body felt like it did before I ever had intercostal neuralgia. It was incredible.

Today is day eight, and I haven’t taken any hydrocodone yet, but it’s early and who knows how I will feel later. 

Maybe day seven was just a fluke. Maybe it was the weather related, or maybe it was because I ate too much sugar and it spiked my inflammation. I don’t know. I’m seeing my pain specialist again in a couple weeks, and we’ll decide at that time if another infusion makes sense for me. I hoping she will tell me that the more infusions you get the longer they last, but I have no idea if that’s the case. 

Whether or not it makes sense for you is another matter altogether. It depends on what type of pain you have, what types of drugs you are already on, and what your feelings are on being drugged.

I will leave you with this though. The nurse at the infusion center said they are getting way more patients for lidocaine infusions for chronic pain and she thought it was directly related to the push to get people off opioids.  The nurse also admitted that the lidocaine doesn't work for everyone, and she was seeing lots of patients who had been managing their pain with things like hydrocodone for decades suddenly being forced to get off them. She said it was hard to watch patients suddenly lose access to drugs that had been helping them. 

But, she also said that for some patients the lidocaine infusions were life changing and a miracle. 

Pain is complicated and how we treat it has to be complicated as well if it’s going to be effective. Maybe lidocaine can help some people, but maybe opioids are the only thing that help others. And maybe, as most of us already know, everyone is different. 

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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

Patient Shoots Two at Las Vegas Pain Clinic

By Pat Anson, Editor

A gunman who shot and wounded two people at a Las Vegas pain clinic before taking his own life has been identified as 50-year old Chad Broderick of Las Vegas.

Police say Broderick walked into the Center for Wellness and Pain Care of Las Vegas Thursday afternoon and asked for an unscheduled appointment to see a doctor. When it was refused, he pulled out a gun and started shooting in the lobby. About a dozen people were inside the clinic at the time.

“When I heard the first gunshot, I thought it was a bottle or something on the floor, like something just popped,” a patient told the Las Vegas Review-Journal.

“When I started hearing that ‘pop, pop, pop,’ I was so scared.”

“One of the most frightening experiences ever!” Neville Campbell, MD, the pain clinic’s medical director, wrote on his Facebook page soon after the shooting.

NEVILLE CAMPBELL/FACEBOOK

Campbell said there were “piercing screams” as people ran to escape the gunfire.

“As we barricaded ourself (with 5 others ) with a wooden desk behind the door in small office , the question of life, meaning and purpose overwhelmed my mind,” said Campbell. “But God is Good. He will never desert his own. Thank you for protecting my staff members.”

The two people who were hit by gunfire are expected to survive. Two others suffered minor injuries while trying to escape. Broderick died at the scene after shooting himself.

CHAD BRODERICK/FACEBOOK

Broderick’s neighbors told the Review Journal that he was a husband and father of two, who mostly kept to himself but had a friendly wave. One neighbor called Broderick a “really nice gentleman” who complained of back pain.

“He used to talk about taking pain pills,” said Welborn Williams. “He couldn’t get any sleep at night.”

Broderick’s Facebook page reveals a man who loved fishing and was a gun enthusiast. Ironically, in 2012 Broderick recommended without comment on his page a story about an employee at a Las Vegas medical clinic who was shot during an armed robbery.

The Review Journal reported that Broderick had a concealed weapons permit and five firearms. Williams said Broderick had offered to teach him about firearms.

“I hate to see anyone in pain like that,” Williams said. “But there should have been another way for him.”

In a statement on its Facebook page, the clinic thanked “all our patients and friends for your kind words and well wishes. We are grateful that everyone is ok.”

The clinic's website says its mission is to "foster an environment of healing" through interventional pain treatments such as epidural steroid injections, as well as massage, acupuncture, aromatherapy and prayer.

The Facebook statement said the clinic would probably remain closed until July 10. Its patients are being referred to another clinic in Henderson, a Las Vegas suburb.

Insurer Reports Soaring Rates of Opioid Addiction

By Pat Anson, Editor

The number of Blue Cross and Blue Shield (BCBS) customers diagnosed with opioid addiction has soared by nearly 500 percent in recent years, according to a new report that found only about a third of the addicted patients were getting medication assisted treatment.

The Health of America Report analyzed prescription data for over 30 million BCBS customers from 2010 to 2016. The report focused mainly on patients who use legally prescribed painkillers, while virtually ignoring addicts who use heroin, illicit fentanyl and other illegal opioids, who are now the driving force behind the nation’s opioid crisis.

"Opioid use disorder is a complex issue, and there is no single approach to solving it," said Trent Haywood, MD, senior vice president and chief medical officer for the Blue Cross Blue Shield Association, which represents 36 independent insurers that provide health coverage to over 100 million Americans.

“Opioid use disorder” is a broad and somewhat misleading term that includes illegal drug addicts, as well as chronic pain patients who take opioids responsibly, and develop a tolerance or dependence on them.

The BCBS report found that patients who filled prescriptions for high doses of opioids had much higher rates of opioid use disorder than those on lower doses. Women aged 45 and older had higher rates of the disorder than men. Women of all ages were also more likely to fill an opioid prescription.

The BCBS report found that patients who filled prescriptions for high doses of opioids had much higher rates of opioid use disorder. Women aged 45 and older had higher rates of the disorder than men. Women of all ages were also more likely to fill an opioid prescription.

Less than one percent of BCBC customers (0.83%) were diagnosed with opioid use disorder in 2016, a rate much higher than in 2010 (0.14%). The rise was attributed to “an increased awareness of the disorder,” suggesting that doctors were simply more likely to diagnose opioid addiction then they were in 2010.    

While the diagnosis of opioid use disorder rose by 493 percent during the study period, there was only a 65 percent increase in the number of BCBS customers who were prescribed addiction treatment drugs such as Suboxone (buprenorphine).

BCBS customers in the South were more likely to be diagnosed with opioid use disorder. Alabama led the nation with a diagnosis rate of over 1.6 percent, twice the national average.

The report noted that New England leads the nation in the use of medication-assisted treatments, even though the region has lower levels of opioid use disorder than other parts of the country. In Massachusetts, 84% of BCBS customers diagnosed with addiction were getting treatment with medication.

That prompted Blue Cross Blue Shield Association of Massachusetts to issue a press release claiming the state was “ahead of the nation when it comes to combating the opioid epidemic.” The insurer was one of the first in the country to take steps to significantly reduce access to opioids by its customers. As a result, only 2% of Blue Cross Blue Shield members in Massachusetts are receiving high doses of opioids, far less than the national average of 8.3 percent.

However, restricting access to pain medication has failed to stop a surge in opioid overdoses in Massachusetts, most of which are now caused by illicit fentanyl.  Over 2,000 people died of opioid overdoses in Massachusetts last year, almost three times the number of deaths in 2012, when Blue Cross Blue Shield began restricting access to painkillers.

MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

Prescription opioids were involved in only 9% of the overdose deaths in Massachusetts at the end of 2016. In addition, the most recent report from the state's prescription drug monitoring program identified only 264 of the 288,519 people receiving Schedule II opioids as having “activity of concern” that could indicate they were misusing the drugs. That minuscule rate of 0.0915% hardly suggests that legitimate pain patients are the source of Massachusetts’s drug problem.

This week the largest health insurer in the Philadelphia area, Independence Blue Cross, announced plans to limit the prescribing of opioids in its network to just five days for acute pain -- making it one of the first insurers in the country to adopt such a strict limit.

The Wrong Opioid War

By Roger Chriss, Columnist

The opioid crisis continues to worsen, with rising rates of addiction and overdose deaths. The 2016 CDC opioid prescribing guidelines and earlier state guidelines in Washington and Oregon have not helped. Government interventions, from increased physician surveillance to reduced opioid manufacturing quotas by the DEA, are not working.

And the reason is simple: they are fighting the wrong opioid war.

The American Society of Addiction Medicine (ASAM) reports that opioid addiction rates have doubled in the past decade to the current estimate of 2 million opioid addicts and another 500,000 heroin addicts.

It’s a myth that prescription painkillers are the leading cause of addiction. According to the National Institute of Drug Abuse (NIDA), “use of most drugs other than marijuana has stabilized over the past decade or has declined."

As can be seen in the chart below, overall prescription drug abuse was virtually flat between 2002 and 2013, the most recent year data is available. Significant increases were seen for marijuana, starting in 2007 with state-level legalization, and for illicit drugs like heroin.

NATIONAL INSTITUTE OF DRUG ABUSE

“Although heroin use in the general population is rather low, the numbers of people starting to use heroin have been steadily rising since 2007. This may be due in part to a shift from abuse of prescription pain relievers to heroin as a readily available, cheaper alternative,” says NIDA Director Nora Volkow, MD.

If opioid addiction were starting with medical opioids prescribed to adults for acute pain or persistent pain disorders, we’d be seeing a rise in prescription drug abuse and addiction, with a high percentage of addicts found among people on opioid therapy. But in fact this is not happening.

So the question becomes: When does opioid addiction start?

At a very young age, usually. There were over 2.8 million new users of illicit drugs in 2013, according to NIDA, or about 7,800 new users per day. Over half (54%) of these new users were under 18 years of age.

The National Center on Addiction and Substance Abuse reports that 90% of all drug addiction starts in the teens. Other studies tell us that opioid medications are rarely the first drug young people misuse, and that early signs of addiction start with alcohol, marijuana and tobacco use.

Further, Pain Medicine News reports that research at Boston Children’s Hospital found that “if a patient reaches the age of 25 years without misuse, the odds of that patient ever becoming an opioid misuser are much lower.” Thus, opioid abuse almost always starts during adolescence, a time when medical treatment with opioids is rare.

According to NIDA, 6.5 million Americans aged 12 or older used prescription drugs non-medically in 2013. The source of these drugs is usually not a doctor or a drug seeking patient.  Doctor shopping is rare, occurring in about 1 out of 143 patients. And according to ASAM, “most adolescents who misuse prescription pain relievers are given them for free by a friend or relative.”

The medical use of opioid drugs for persistent pain disorders is conspicuous by its absence. That is because pain patients are a statistically insignificant part of the opioid crisis. As Maia Szalavitz reported in Scientific American, “regulatory efforts will fail unless we acknowledge that the problem is actually driven by illicit—not medical—drug use.”

Federal agencies and state governments by and large have not recognized this. And we are witnessing the consequences. The CDC reports that overdose deaths for heroin and illicit fentanyl have been rising rapidly since 2010, while overdose deaths involving commonly prescribed opioids have been almost flat.

Moreover, a significant percentage of the overdose deaths are suicides. The CDC classified 10% of the overdose deaths in 2015 as suicides. Florida’s Medical Examiners Commission came up with even more startling numbers, classifying 20% of the state’s oxycodone deaths and 31% of its hydrocodone deaths as suicides.  

"Hidden behind the terrible epidemic of opioid overdose deaths looms the fact that many of these deaths are far from accidental. They are suicides," says Dr. Maria Oquendo, President of the American Psychiatric Association.  

The opioid crisis is about illicit drug use. Policies that fail to recognize that fact will end up fighting the wrong war, with consequences that are becoming all too common.

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.

Health Insurer to Adopt 5 Day Limit on Opioids

By Pat Anson, Editor

The largest health insurer in the Philadelphia area, Independence Blue Cross, has announced plans to limit the prescribing of opioids in its network to just five days for acute pain.

New Jersey and several others states have implemented or are considering laws to limit the number of days opioids can be prescribed for acute, short-term pain. But Independence is one of the first insurance companies to adopt such a measure as policy. The insurer provides health coverage to more than 2.5 million people in southeast Pennsylvania, and through its affiliates to another 8.5 million people in 25 states and Washington, DC.

Independence already limits the quantity of opioids that physicians can prescribe. The company claims that policy has reduced "inappropriate" opioid use by its members by nearly 30 percent since 2014.

"Beginning in July 2017, we will further restrict prescriptions to no more than five days for initial low dose opioids. We will continue to cover longer lengths of opioid prescription use for members suffering from cancer related pain and hospice patients," the company said in a statement.

"This safeguard prevents multiple opioid prescriptions from being filled at different pharmacies and reduces the risk for addiction while addressing legitimate pain treatment. It also reduces the risk of unused medication being diverted into the hands of unintended users."

The company said it regularly promotes the Centers for Disease Control and Prevention's opioid prescribing guidelines, however those guidelines are voluntary and only intended for primary care physicians who are treating chronic pain. They do not recommend limiting opioids for acute pain.

"Most people may not require more than 5 days of an opioid for minor operations like skin biopsies or dental procedures.  However, there are many people who will require more than 7 days due to the type of operation and the person's response to pain," said Lynn Webster, MD, past president of the American Academy of Pain Medicine. "This shows how uninformed the (insurance) payers are with limiting days of treatment.

"A 5-day limit of opioids will increase the insurance company’s profits by paying for fewer pills, but there will be people who will needlessly suffer." 

Independence's parent company reported record revenue of $16.7 billion in 2016, an increase of 21 percent from the previous year. The company ended 2016 with a surplus of $2.4 billion.

Last year, 907 people died of drug overdoses in Philadelphia. Heroin and illicit fentanyl were involved in about half of the opioid overdoses. The city is currently on track to reach 1,200 fatal overdoses in 2017.

Deaths from prescription opioids like oxycodone and hydrocodone have been declining in Philadelphia since 2013, according to the city's Department of Public Health, a year before Independence started limiting access to painkillers.