What Are the Odds of Failing a Drug Test?

By Roger Chriss, Columnist

What are the odds that a person who tests positive for an illicit drug is actually using that drug?

That is a vital question in pain management and the opioid crisis, because millions of pain patients undergo drug tests regularly and some are falsely accused of failing them. The answer is not just a matter of looking at the accuracy of the test.

In a simple situation, like a toss of a coin or a roll of a die, computing the probability of an outcome is elementary. Most people realize that a toss of a coin has an equal chance of coming up heads or tails.

But drug testing is not as simple. It is an example of conditional probability. A drug test that is 95% accurate will not find drug users 95% of the time. That is because the test is applied to both drug users and non-users. We have to use a calculation known as Bayes’ Theorem to determine the real probabilities.

Bayes’ Theorem calculates the probability of one event happening given that another event has already happened. In terms of drug testing, this means the probability that a randomly selected person who has a positive test did in fact use that drug.

To perform the calculations, we need to know two things:

1. The accuracy of the drug test
2. The “base rate” at which drug use occurs in the population at large.

The accuracy of drug tests varies widely. A 2010 study estimated that drug tests generally produce false-positive results in 5% to 10% of cases and false negatives in 10% to 15% of cases.

Data on the base rate of drug use also varies. The CDC claims as many as 25% of chronic pain patients develop signs of opioid use disorder. However, a Cochrane review found addiction in less than 2% of long-term opioid users.

This gives us four general scenarios to consider when estimating the probability that a chronic pain patient with a positive test result is actually misusing opioids:

Scenario I (25% base rate; 95% accurate drug test):  90%
Scenario II (25% base rate; 90% accurate drug test): 83%
Scenario III (2% base rate; 95% accurate drug test):  29%
Scenario IV (2% base rate; 90% accurate drug test):  17%

With a high base rate of opioid misuse and a more accurate test, the probability is high at 90 percent. On the other hand, as the base rate falls and test accuracy decreases, the probability drops significantly, down to 17 percent. This means that the probability of a person getting a false positive result increases.

The Base Rate Fallacy

Bayes’ Theorem clearly shows that the base rate of drug use has a large effect on the probability that a person will get a false test result. Because clinical decisions and healthcare policy are often based on the results of such tests, knowing the probabilities is vitally important.

The base rate fallacy occurs when a decision is made without taking the real base rate into consideration. As shown above, the upper value of 25% is more than 10 times the lower value of 2 percent, indicating a high degree of uncertainty in the base rate.

Moreover, the base rate is not the same in all locations or across all populations. Drug abuse is known to be higher in some places and among some age groups. The accuracy of drug tests also represents an average, but factors such as biochemical individuality and testing conditions may influence actual performance.

Further, drug testing is not an entirely random process. For instance, prior to prescribing opioid medication, a doctor may perform a risk assessment using an Opioid Risk Tool. A doctor may also have hints that a patient is abusing opioids to motivate testing. In either case, randomness is lost and the base rate shifts.

Conditional probability produces counter-intuitive results, with a high degree of dependence on the base rate -- itself a number that requires constant attention.

The bottom line is that drug testing alone is not foolproof. Clinical judgment by experienced physicians, combined with information such as pharmacy data, pill counts and medical records, will always get better odds than drug testing alone.

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.

Cigna Won’t Pay for OxyContin in 2018

By John Burke, Guest Columnist

A major health insurance company -- Cigna -- announced this week that they it is removing OxyContin from its list of approved medications and replacing it with another extended release oxycodone product.

“Our focus is on helping customers get the most value from their medications — this means obtaining effective pain relief while also guarding against opioid misuse," said Jon Maesner, Cigna's chief pharmacy officer.

OxyContin is the only opioid-based prescription painkiller that Cigna is removing in 2018 as "a preferred option" from its formulary, a list of medications that its health plans will pay for.

On the surface, this declaration might appear to be a great stride toward reducing prescription drug abuse. Cigna is replacing OxyContin with Collegium’s product, Xtampza ER, which is also an abuse deterrent extended release oxycodone product. 

My problem with this announcement is that OxyContin, along with the other abuse deterrent formulations (ADFs), have very little abuse issues. OxyContin certainly did up until its reformulation in August 2010, but that was over 7 years ago! Since then, there is much documentation from a variety of sources that show the diversion of OxyContin has fallen extensively.

Xtampa ER and the other abuse deterrent formulations also have little to no abuse issues since they have been on the market. 

If Cigna wants to change drugs, that’s likely a financial decision and one they should make, but please don’t tout your move as striking a blow for reducing drug diversion.

It will do nothing to reduce drug diversion, since the clear majority of diversion falls into the immediate release opioids, primarily oxycodone and hydrocodone. 

What is even more concerning to me is the vilifying of any drug that hundreds of thousands of legitimate pain patients take to live a semblance of a normal life, especially when that drug does not have a recent history of abuse and diversion. It also tends to make suspect any and all abuse deterrent products, which is deceptive at best. 

One thing the abuse deterrent formulations have done is to help narrow their focus to legitimate pain patients. Those seeking to get “high” moved to immediate release opioids or black market heroin/fentanyl combinations, not the ADF products. That’s why the FDA is now considering requiring companies that produce generic opioids to develop ADF properties for their drugs. 

No matter what Cigna declares, the bottom line is that ADF’s have been successful. They are not an end all to diversion and abuse, but they do help pain patients get easier access to pain medication. I am hoping that is everybody’s ultimate goal. 

John Burke recently retired after nearly 50 years in drug and law enforcement in southwestern Ohio.

John is a former president of the National Association of Drug Diversion Investigators and current president of the International Health Facility Diversion Association.

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.

Heroin Overdoses in ER's Surpass Rx Opioid Overdoses

By Pat Anson, Editor

The number of patients admitted and discharged from U.S. hospitals for abuse of opioid pain medication has declined significantly this decade, while the abuse of heroin and illicit fentanyl has surged, according to a new study that documents the shifting nature of the nation’s overdose crisis.

Researchers at Stanford University analyzed national trends in hospital inpatient and emergency department (ED) discharges for opioid abuse, dependence and poisoning from 1997 to 2014, the last year data was available.

They found that hospital admissions for overdoses from pain medication started falling in 2010, the same year that opioid prescriptions began declining.

At the same time, hospital discharge rates for heroin poisoning increased at an annual rate of over 31 percent. By 2014, heroin overdoses exceeded those from prescription opioids in emergency rooms by almost a 2 to 1 margin.

“After 2008, ED discharge rates for heroin poisoning increased more sharply than the rates for any opioid poisoning -- signaling that the scope of heroin harm is worse than previously suggested -- while discharges for prescription opioid poisoning recently began to decline in both the ED and inpatient settings,” researchers reported in the journal Health Affairs.

“While these changes could be the result of national and local policies aimed at reducing the prescribing of opioids, the expanded availability of heroin and new lethal illicit drugs, such as nonpharmaceutical fentanyl, could mean that they are being used instead of prescription opioids.”

The findings add evidence to recent public health concerns that people misusing or addicted to prescription opioids are switching to heroin and synthetic opioids such as fentanyl because they are cheaper and easier to get.

"This suggests that the expanded availability of lethal illicit drugs are being used to replace prescription opioids in some cases," said Tina Hernandez-Boussard, PhD, associate professor of medicine, of biomedical data sciences and of surgery at Stanford University School of Medicine.

source: health affairs

The Centers for Disease Control and Prevention has been reluctant to admit that efforts to reduce opioid prescribing could be backfiring, although their own statistics indicate otherwise.  Deaths involving heroin and synthetic opioids overtook overdoses linked to prescription opioids in 2016, the same year the CDC released its opioid prescribing guidelines.

As PNN has reported,  the CDC last week launched a public awareness campaign to combat the abuse of prescription opioids, a marketing effort driven by surveys and focus groups that completely ignores the scourge of heroin and illicit fentanyl.

“The campaign does not include messages about heroin. Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging. Heroin is a related topic that also needs formative research and message testing,” the CDC explained.

The Stanford study found that discharge rates for prescription opioid poisonings declined annually by about 5 percent from 2010 to 2014, while discharge rates for heroin poisoning increased at an annual rate of 31.4 percent from 2008 to 2014. The trend has likely worsened since 2014, as heroin and illicit fentanyl are even more widely available on the black market.

"I'm cautiously optimistic that prescribing clinicians are positively reacting to the opioid crisis and therefore prescription opioids are contributing less to the overall drug epidemic," Hernandez-Boussard said. "That's the good news. The bad news is that although prescription opioid use decreased, heroin and methadone greatly increased.”

Anna Lembke, MD, an associate professor of psychiatry at Stanford and a board member of Physicians for Responsible Opioid Prescribing (PROP), says she has no doubt many people addicted to prescription opioids have switched to using heroin or illicit fentanyl.

"My patients have told me that's exactly what they did," said Lembke. "Heroin was cheaper and easier to get."

Fake Fentanyl Pills Found in 40 States

By Pat Anson, Editor

Counterfeit painkillers and fake medications made with illicit fentanyl have killed Americans in at least 16 states, according to a new report that found the highly dangerous pills have spread from coast to coast.

“We have documented the spread of counterfeit pills made with illegal fentanyl throughout 40 states. There is documentation that counterfeits made with fentanyl have killed Americans in at least 16 of those states. The other 24 states probably have deaths attributable to counterfeits made with fentanyl, but because of limited awareness of the problem, those deaths may not have been investigated for counterfeit drugs,” said the report by the Partnership for Safe Medicines (PSM) a coalition of pharmacy groups and other healthcare organizations.

The report is based on a review of court records, statements by law enforcement and public health agencies, and news reports.

Fentanyl is 50 to 100 times more potent than morphine. It is legally available in lozenges, patches and other medications to treat severe pain, but in recent years illicit fentanyl has become widely available on the black market, where it is often mixed with heroin or used in the production of counterfeit drugs.

Many addicts looking for a high or pain sufferers looking for relief have no idea what they’re buying. Experts say a single dose of fentanyl as small as two or three milligrams can be fatal.

“Up until now, it’s been difficult to grasp the scope and pervasiveness of the counterfeit drug problem,” said Dr. Marvin Shepherd, chairman of the PSM Board and former director of the Center for Pharmacoeconomic Studies at the University of Texas at Austin’s College of Pharmacy. “We’ve had a number of examples of counterfeit pill seizures and tragic fentanyl-related deaths, but this report paints a picture of a nation under siege from fake and lethal drugs coming across our borders.”

Massachusetts, Pennsylvania, New Jersey, Ohio and several states now report they have more people dying from overdoses of illicit fentanyl than from prescription opioids. 

Most of the illicit fentanyl is manufactured in China and smuggled into the U.S. by drug cartels. In August, the Mexican military found over 140 pounds of powdered fentanyl hidden inside a tractor trailer rig at a checkpoint near Yuma, Arizona. The shipment, which had an estimated street value of $1.2 billion, also included nearly 30,000 counterfeit tablets made with fentanyl.

The fake pills are often designed to look like oxycodone or the anti-anxiety drug Xanax, and are hard to distinguish from the real thing.

“They’re relatively cheap (to make) and the profit margin is phenomenal,” said Lisa McElhaney, President of the National Association of Drug Diversion Investigators, during a recent seminar for pain management providers. “You’re talking about such a miniscule amount (of fentanyl). But it has such a heavy potency and purity level that it is fatal.”

McElhaney said the black market in prescription drugs used to be dominated by legally-made medications that were stolen or diverted from medicine cabinets, pharmacies or drug manufacturers. She now believes most of the pills sold on the street are counterfeit.

counterfeit oxycodone pills

“I would say 99% of what we are seeing on the street, bought and sold, is product from China, India, Mexico, or from second or third-hand distributors. It is not pharmaceutical grade, FDA approved fentanyl,” she said.

While the DEA and other law enforcement agencies have been warning of the fentanyl problem for years, federal health officials have been slow to recognize or even address it – focusing instead on limiting the use of opioid pain medication.

For example, the Centers for Disease Control and Prevention recently launched a new marketing campaign, using videos, online advertising, billboards, newspapers and radio ads to raise awareness about the risks of prescription opioids. The campaign completely ignores the role of fentanyl and heroin in the overdose crisis, because the CDC didn't want to risk “diluting” its primary message.

“Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging,” the CDC explained.

Politicians are also focused on prescription opioids. Several states have adopted or are considering laws that limit opioid prescriptions for acute pain to only a few days’ supply – a move that President Trump’s opioid commission appears to be considering as a recommendation in its final report.

“This is a prevention measure… to limit the number of drugs that are out there for improper diversion and to make sure that we don’t inadvertently turn people into addicts by giving 30, 60, 90 pills the first time,” said commission chairman Gov. Chris Christie of New Jersey, whose state has adopted a five day limit on new opioid prescriptions.

This week the Pharmaceutical Research and Manufacturers of America -- an organization that represents virtually every major drug maker – told the commission that it would support a 7-day limit on opioid prescriptions for acute pain.  

Drug Makers Support 7-Day Limit on Rx Opioids

By Pat Anson, Editor

A leading organization of pharmaceutical companies announced today its support for a 7-day limit on opioid prescriptions for acute pain.  

The announcement -- made during a meeting of President Trump’s opioid commission – marks a significant shift for the industry and is likely to speed up efforts to have limits imposed nationwide on opioid medication for short-term pain.

“PhRMA is announcing for the first time our support to limit the supply of opioids to 7 days for acute pain management. Too often, individuals receive a 30-day supply of opioid medicines for minor treatments for short-term pain,” said Stephen Ubl, President and CEO of PhRMA, the Pharmaceutical Research and Manufacturers of America.  

“Overprescribing and dispensing can lead to patients taking opioids longer than necessary and excess pills falling into the wrong hands.”

PhRMA is a trade organization that represents over 3 dozen pharmaceutical companies, including AstraZeneca, Bayer, Allergan, Bristol-Myer Squibb, Eli Lilly, Johnson & Johnson, Merck, Pfizer, Teva, Novartis, GlaxoSmithKline, and Purdue Pharma.

“Our announcement is candidly an unprecedented step for the industry. We’ve always supported physician autonomy and the preservation of the physician-patient relationship, but as you know, given the scope of this (opioid) crisis,we believe this is the right thing to do,” Ubl said.

“I want to thank you and the industry for stepping forward," said commission chairman Gov. Chris Christie of New Jersey. “This is a prevention measure… to limit the number of drugs that are out there for improper diversion and to make sure that we don’t inadvertently turn people into addicts by giving 30, 60, 90 pills the first time. And so the fact that the pharmaceutical industry is willing to step up and acknowledge that there is something that needs to be done is an important first step.”

New Jersey, Ohio, New York and several other states have already implemented or are considering laws to limit the number of days opioids can be prescribed and dispensed for acute, short-term pain. This week Florida Gov. Rick Scott announced that he would support legislation for a 3-day limit on opioids for acute pain in his state. Strict conditions would have to be met to get a 7-day supply.   

A bill introduced in the U.S. Senate earlier this year would require doctors nationwide to limit the initial supply of opioids for acute pain to seven days, a prescription that could not be renewed.  The bill by Sen. John McCain and Sen. Kirsten Gillibrand was referred to the Senate Judiciary Committee in April, but has gone no further.

CVS Health announced last week that it would limit opioid medication for acute pain to 7 days in all of its pharmacies nationwide, starting February 1.

CVS will also limit opioid doses for both acute and chronic pain to 90mg morphine equivalent units, and patients would be required to try immediate release formulations before using extended release opioids.

‘Moonshot’ Needed for New Pain Treatments

Today’s meeting of President Trump’s opioid commission focused largely on expanding access to addiction treatment and developing new ways of treating chronic pain without the use of opioid medication. During the two-hour meeting, there was hardly any mention of illegal opioids or the scourge of heroin and illicit fentanyl now sweeping the country.

"Our nation needs a moonshot commitment to the development of non-opioid pain treatments. We need new therapies and we need them fast," said Jim Campbell, MD, President of Centrexion Therapeutics. "The abuse of opioids costs lives, but the other equally important issue is the problem of untreated pain. Untreated pain leads to lost work, depression, lack of sleep, social withdrawal and may even lead to suicide."

Commission member Patrick Kennedy, a former congressman in recovery from addiction, said the problems of pain, addiction, depression and suicide are all intertwined, and need better advocacy.

“Clearly, depression is rampant. The opioid crisis was driven by a depression crisis. And while we’re talking about the opioid crisis and overdose deaths, suicide is getting right up there, to the height of the AIDS epidemic itself,” said Kennedy. “Because these illnesses are so stigmatized, the advocacy is really anemic. There’s no one out there shaking the trees as if this were HIV and AIDS, like we saw in those crises.”

To watch a replay of the commission meeting, click here.

Trump Opioid Commission Delays Final Report

By Pat Anson, Editor

The chairman of President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis has asked for – and apparently been granted – a one month delay in releasing the panel’s final report.

In a letter posted on the White House website, New Jersey Gov. Chris Christie said the commission’s “research and policy development are still in progress,” and that he was extending the deadline from October 1 to November 1.

Christie said the opioid commission would hold its third public hearing September 27 at the White House. A notice published in the Federal Register indicates the meeting will focus on pain management and the diversion of opioid pain medication.

“The meeting will consist of statements to the Commission from invited government, nonprofit, and business organizations regarding Innovative Pain Management and Prevention Measures for Diversion followed by discussion of the issues raised,” the statement says. No list of attendees is included.

Christie’s letter also says the opioid commission will visit an Ohio medical center to learn about “innovative pain management strategies” and will meet in New Jersey with representatives of the pharmaceutical industry “to talk about partnership opportunities with the National Institutes of Health and the Food and Drug Administration.”

Until now the focus of the opioid commission has been on treating opioid addiction. An interim report released in July recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioid medication, and increased efforts to detect and stop the flow of illicit fentanyl into the country. There are no specific recommendations aimed at reducing access to prescription opioids or providing different forms of pain management.

Bondi Joins Commission

Another possible sign of a shift in the commission’s direction is the recent appointment of Florida Attorney General Pam Bondi to the panel. Bondi is now listed as member of the commission on the White House website,  although there has been no official announcement by the Trump administration. She is the fifth politician appointed to the six member panel.

Bondi played a prominent in shutting down on Florida’s pill mills several years ago, but critics say she has been slow to acknowledge that the opioid crisis has shifted away from prescription painkillers to street drugs like heroin and illicit fentanyl. Many pain patients in Florida still have trouble finding pharmacies willing to fill their opioid prescriptions.

Bondi recently joined other state attorneys general in asking pharmaceutical companies for information about their marketing, production and distribution of opioids.

“Florida citizens continue to become addicted to opioids and die daily -- meanwhile, prescription drug manufacturers, distributors and the medical profession all point fingers at each other as the cause of this national crisis,” Bondi said in a statement. “This far-reaching multistate investigation is designed to get the answers we need as quickly as possible. The industry must do the right thing. If they do not, we are prepared to litigate.”

Bondi also recently joined the National Association of Attorneys General in asking the insurance industry to do more to reduce opioid prescriptions and combat opioid abuse.

“Insurance companies can play an important role in reducing opioid prescriptions and making it easier for patients to access other forms of pain management treatment. Indeed, simply asking providers to consider providing alternative treatments is impractical in the absence of a supporting incentive structure,” the attorneys general said in a letter to an insurance industry trade group.

“Insurance companies thus are in a position to make a very positive impact in the way that providers treat patients with chronic pain.”

In addition to Bondi and Christie, opioid commission members include Gov. Charlie Baker of Massachusetts, Gov. Roy Cooper of North Carolina, Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School, and Patrick Kennedy, a former Rhode Island congressman.

The Trump administration has still not officially declared that the opioid crisis is a national emergency – something the President said he would do in August.  

Pam Bondi to Join Trump Opioid Commission

By Pat Anson, Editor

Less than three weeks before its final report is due, President Trump’s opioid commission is getting a new member --   Florida Attorney General Pam Bondi.

Bondi is a longtime supporter of the president, served as a member of his transition team, and was once rumored to be the next head of the White House Office of National Drug Control Policy. There was speculation back in March that Bondi would be named to the opioid commission, but it was not until last week that the White House confirmed it was President Trump's "intent to appoint" Bondi to the panel, which currently has five members.

Curiously, Bondi’s office blamed New Jersey Gov. Chris Christie, the chair of the opioid commission, for the six month delay in getting her on board. Both Bondi and Christie are lame ducks serving out their final months in elected office.

“The President always intended for the Attorney General to be on the Commission – however, Governor Christie choose (sic) to begin the Commission with only himself and four others,” Whitney Ray, Bondi’s spokesman, said in an email.

“The announcement (of Bondi's appointment) is protocol before the Executive Order is signed next week. The Attorney General will continue to work with President Trump, General Kelly, Kellyanne Conway and other leaders to combat the national opioid epidemic.“

Bondi's spokesman also reportedly said that the October 1 deadline for the commission to release its final report would be extended. No such announcement has been made and the White House website still doesn’t list Bondi as a commission member.

FLORIDA ATTORNEY GENERAL PAM BONDI

The Trump administration has also yet to issue an official declaration that the opioid crisis is a national emergency – something the President said he would do over a month ago.  

"The opioid crisis is an emergency, and I am saying, officially right now, it is an emergency. It's a national emergency. We're going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis,” Trump said on August 10.

Bondi played a prominent in shutting down Florida’s pill mills several years ago, but critics say she has been slow to acknowledge that the opioid crisis has shifted away from prescription painkillers to heroin and illicit fentanyl.

“The problem is Bondi isn't doing enough about the heroin epidemic,” the Miami Sun Sentinel said in an editorial.  “Considering that Bondi was once touted as a potential Trump drug czar — and infamously failed to investigate Trump University after receiving a major donation from Trump — it's no surprise that she was named to the commission. But she's still living off her reputation from the pill mill crack down.

“In fact, if you Google Bondi and heroin, by far the most you'll read about is when she slammed a drug dealer for stamping Trump's name on a batch of heroin. You won't find any solutions to our crisis.”

In a recent interview with WMBB-TV, Bondi warned that drug dealers were putting heroin and illicit fentanyl into counterfeit medications.

"It's a national epidemic and it truly affects everyone, and parents need to really warn their kids, their teens, adults need to know, never take a pill from someone you don't know, even if they say it is a Tylenol, an Advil or an aspirin. Don't take anything from someone who you don't know," said Bondi.

The initial focus of Trump's opioid commission has been on educating, preventing and treating opioid addiction. An interim report released by the commission in July recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioids, and increased efforts to detect and stop the flow of illicit fentanyl into the country.

There are no specific recommendations aimed at reducing access to prescription opioids, although they could be added to the commission’s final report.

In addition to Gov. Christie, commission members include Gov. Charlie Baker of Massachusetts, Gov. Roy Cooper of North Carolina, Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School, and Patrick Kennedy, a former Rhode Island congressman. No pain patients, pain management experts or practicing physicians were appointed to the panel.

Is This the Opioid of the Future?

By Pat Anson, Editor

What do you call a pain reliever that doesn't have a name yet, is not FDA approved and may not be available for years?

Nektar Therapeutics calls it the "opioid of the future."

Nektar is a research-based pharmaceutical company that has developed a new type of opioid medication that shows promise in relieving moderate to severe pain, but without the risk of abuse and addiction of traditional opioids like oxycodone or hydrocodone.

The experimental pill -- which for the time being is called NKTR-181 --  has recieved “fast track” designation  from the Food and Drug Administration, but is at least a couple of years away from full FDA approval and a commercial launch.

That hasn't stopped Nektar from promoting NKTR-181. This week it hosted a lunch symposium on the drug at PainWeek -- an industry trade show underway in Las Vegas -- a sign of just how confident the company is that NKTR-181 will receive final approval from the FDA.

"We think we could see approval as early as the end of next year," says Steve Doberstein, PhD, Chief Scientific Officer of Nektar. "So we could see a launch of this product in the first part of 2019. That would be my aspiration. If we have to do more clinical trial work, it would be delayed."

The FDA usually requires at least two "Phase 3" clinical studies to prove a new drug's effectiveness. Nektar has only completed one -- a Phase 3 study of over 600 patients with chronic back pain who reported that their pain scores dropped by an average of 65% when taking NKTR-181 twice daily.

Nektar has also completed smaller safety studies that found recreational drug users had significantly less “drug liking” of NKTR-181 -- even at high doses -- when compared oxycodone. Participants also had less daytime sleepiness and fewer withdrawal symptoms.

"NKTR-181 is quite boring as far as abuse metrics go. Boring is good. That was our goal. It doesn't appear to cause euphoria," says Doberstein.

NKTR-181 is "boring" because of its slow rate of entry into the brain's central nervous system – which significantly reduces the “high” or euphoric effect that recreational users seek. Many pain sufferers don't feel that high when taking opioid medication, they just get pain relief. But in the current regulatory and political climate, the only way a new opioid will be approved by the FDA is if it has a low or non-existent abuse potential.

"We're very focused on the fact that one of the building blocks of solving this problem is going to be a safe pain medication for chronic pain patients to take," Doberstein told PNN. "The things that work best are opioids. But the existing conventional old-fashioned opioids -- oxycodone is 100 years old -- come with an unacceptable side effect profile for many patients. And we think we've made something that is legitimately better. It's the first time in a very long time that a new opioid molecule has been developed."  

Doberstein thinks NKTR-181 has such low potential for abuse that it will not need to come in an abuse deterrent formula that would make it harder to crush or liquefy. The FDA could still require one, however, which would delay the drug's commercialization even longer. The agency is currently reviewing the effectiveness of all drugs with abuse deterrent formulas.

The FDA also has a new opioid policy steering committee that is examining whether the agency sufficiently considers the risk of abuse during its evaluation of new opioids.  That could result in rule changes that Nektar would have to address. Anti-opioid activists and politicians could also pressure the FDA to require more clinical studies on the safety and potential abuse of NKTR-181.

Another potential obstacle is that Nektar still needs to partner with a larger pharmaceutical company to help produce and commercialize NKTR-181 -- which is when the no-name "opioid of the future" will likely get a makeover with a branded name to make it more marketable.

"This is the kind of medicine that we think could be quite significant. It could really change medical practice. That means we need a lot of education, and a lot of outreach to physicians, hospitals, payers, patient advocates and law enforcement. We have a lot to do. And its probably beyond us to do it ourselves. So we'll have a commercialization partner of some kind," said Doberstein, who told PNN he expects Nektar to announce its new partnership by the end of the year.

How Fish Got Hooked on Hydrocodone

By Pat Anson, Editor

We hear it all the time from PNN readers. They don’t trust academic research about opioids and addiction, and feel much of it is biased or just plain fishy.

You can certainly say the latter about a new study by researchers at the University of Utah.

They devised a system that allows zebrafish, a small tropical fish popular in home aquariums, to self-administer doses of the painkiller hydrocodone. In less than a week, researchers say the fish were hooked on hydrocodone and showed signs of drug-seeking behavior and withdrawal.

"We didn't know if zebrafish would be a relevant model for opioid addiction, much less self-administer the drug," said Randall Peterson, PhD, a professor of Pharmacology and Toxicology, and senior author of the study published in the journal Behavioral Brain Research.

"What is exciting about this work is that we see many of the hallmarks of addiction in zebrafish. This could be a useful and powerful model."

How is this useful and how does it relate to people?

Zebrafish have more in common with people than you might think. They have 70 percent of the genes that humans have, including similar biological pathways that can lead to addiction. Like people, zebrafish have a μ-opioid receptor and two neurotransmitters, dopamine and glutamate, that trigger the natural reward system in the brain.

"Drugs of abuse target the pathways of the pleasure centers very effectively," said first author Gabriel Bossé, PhD. "These pathways are conserved in zebrafish, and the fish can experience some of the same signs of addiction and withdrawal as people."

Bossé and Peterson tested their system in a tank with a food dispenser equipped with a motion detector that the fish could trigger by swimming nearby. It didn’t take long for the zebrafish to learn how to get food.

Then the researchers removed the food dispenser and replaced it with one that injected small doses of hydrocodone into the water when a fish swam nearby. A continuous flow of water flushed the tank, which forced the fish to trigger the dispenser to receive another dose of hydrocodone.

Over the course of five days, the fish learned how to self-administer the drug. You can watch a demonstration below:

"The fish needed to perform an action to get the drug rather than receiving it passively," said Bossé. "Drug-seeking has been modeled before in rodents and primates, but having a model to study this in zebrafish could move the [study of addiction] forward."

The drug-seeking behavior increased when the zebrafish were forced to receive the opioid in progressively shallower water, a stressful environment that unconditioned fish would normally avoid.

"This was important, because we forced the fish to do more work to receive the drug, and they were more than willing to do more work," said Peterson.

The researchers took their experiment a step further by exposing the conditioned fish to naloxone, a drug used to treat overdoses that blocks opioid receptors. Sure enough, naloxone appeared to reduce the fish’s drug-seeking behavior.

The researchers believe their zebrafish model can lead to new drug therapies, because it can be used to rapidly test thousands of different chemical compounds. They also believe the genetic make-up of zebrafish can be altered to explore the specific biological pathways associated with addiction.

Zebrafish do have other qualities humans can learn from. Researchers at Duke University are studying proteins that enable a zebrafish to completely heal its spine -- even after it was severed. They hope this knowledge will someday lead to new therapies to repair damaged spinal cords in humans.

Trump Declares Opioid Crisis National Emergency

By Pat Anson, Editor

President Donald Trump said he would declare the opioid crisis a national emergency, just two days after his administration said a declaration wasn’t necessary.

"The opioid crisis is an emergency, and I am saying, officially right now, it is an emergency. It's a national emergency. We're going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis,” Trump said outside the clubhouse of his golf course in Bedminster, New Jersey.  “We’re going to draw it up and we’re going to make it a national emergency. It is a serious problem the likes of which we have never had.”

In a brief statement after the President’s remarks, the White House said Trump had instructed the administration “to use all appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic.”

An estimated 142 Americans are dying every day from drug overdoses of all kinds, not just opioids. Prescription painkillers are often blamed as the cause of the problem, although deaths linked to opioid medication have leveled off in recent years. Heroin and illicit fentanyl are currently driving the overdose crisis and in some states are involved in over half of the overdose deaths.  

A White House commission last week urged the president to declare a national emergency, but administration officials indicated as recently as Tuesday that such a declaration wasn’t necessary because the administration was already treating the opioid crisis as an emergency.

“We believe at this point that the resources that we need or the focus that we need to bring to bear to the opioid crisis at this point can be addressed without the declaration of an emergency, although all things are on the table for the president,” said Health and Human Services Secretary Tom Price.

New Jersey Gov. Chris Christie, who chairs the opioid commission, applauded the apparent change of heart.

“It is a national emergency and the President has confirmed that through his words and actions today, and he deserves great credit for doing so. As I have said before, I am completely confident that the President will address this problem aggressively and do all he can to alleviate the suffering and loss of scores of families in every corner of our country,” Christie said in a statement.

“This declaration is only one of many steps we must take on the federal level to reduce the death toll and help people achieve long-term recovery – but it’s a start. I’m committed to working with the President and my fellow commissioners to end the opioid overdose epidemic,” said commission member and former congressman Patrick Kennedy.

It was not immediately clear what steps the administration will take now that an emergency has been declared. A 10-page interim report released by the opioid commission recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioids, and increased efforts to detect and stop the flow of illicit fentanyl into the country.

There are no specific recommendations aimed at reducing access to prescription opioids, although they could be added to the commission’s final report, which is due in October. Prescriptions for opioid medication – long a target of addiction treatment and anti-opioid activists – have been in decline for several years. The DEA has plans to reduce the supply of many painkillers even more in 2018.

Other measures recommended by the commission:

• Grant waivers to states to eliminate barriers to mental health and addiction treatment
• Increase availability of naloxone as an emergency treatment for opioid overdoses
• Amend the Controlled Substance Act to require additional training in pain management for all prescribers
• Prioritize funding to Homeland Security, FBI and DEA to quickly develop fentanyl detection sensors
• Stop the flow of synthetic opioids through the U.S. Postal Service
• Enhance the sharing of data between prescription drug monitoring programs (PDMPs)

No estimate was provided on the cost of any of these measures.

In a statement on Tuesday, President Trump suggested that law enforcement and abstinence should be used to address the opioid crisis. 

“The best way to prevent drug addiction and overdose is to prevent people from abusing drugs in the first place. If they don’t start, they won't have a problem.  If they do start, it's awfully tough to get off," Trump said, according to a White House transcript.

Why Heroin Overdoses Are Worse Than We Thought

By Pat Anson, Editor

The number of Americans who died from opioid overdoses – particularly from heroin – is significantly higher than previously reported, according to a new study published in the American Journal of Preventive Medicine.

Researchers at the University of Virginia refined the overdose data from 2014 death certificates and estimated that overdose death rates nationally were 24 percent higher for opioids and 22 percent higher for heroin. Deaths involving heroin were substantially underreported in Pennsylvania, Indiana, New Jersey, Louisiana, and Alabama.

A major weakness of the study is that it does not differentiate between opioid pain medication that was prescribed legally, and prescription opioids or illegal opioids that were obtained illicitly. All “opioids” are lumped together in one category.

Virtually every study about drug overdoses is flawed in some way, because each state has different rules and procedures for death certificates. The expertise of county coroners and medical examiners can also vary widely.

There were over 47,000 fatal overdoses nationwide among U.S. residents in 2014. However, about one-quarter of the death certificates failed to note the specific drug involved in an overdose.

“A crucial step to developing policy to combat the fatal drug epidemic is to have a clear understanding of geographic differences in heroin and opioid-related mortality rates. The information obtained directly from death certificates understates these rates because the drugs involved in the deaths are often not specified," said lead author Christopher Ruhm, PhD, Frank Batten School of Leadership and Public Policy, University of Virginia, Charlottesville.

Ruhm and his colleagues developed a more refined database that supplemented the death certificate data with additional geographic information from states and counties. The supplemental data had a substantial influence on state mortality rankings.   

For example, the opioid and heroin death rates in Pennsylvania, based solely on death certificates, were 8.5 and 3.9 deaths per 100,000 people, respectively. The corrected data doubled the death rates in Pennsylvania to 17.8 for opioids and 8.1 and for heroin.

“Geographic disparities in drug poisoning deaths are substantial and a correct assessment of them is almost certainly a prerequisite for designing policies to address the fatal drug epidemic,” said Ruhm.

The Centers for Disease Control and Prevention has also tried to refine the data from death certificates to make it more reliable.  A CDC study released last December used new software to scan the actual text of death certificates, including notes left by coroners. That study found that heroin, cocaine, fentanyl and anti-anxiety medication (benzodiazepines) were responsible for more overdose deaths in the United States than opioid pain medication.

A more reliable way to determine the cause of an overdose is through toxicology reports, which some states are now utilizing to better assess their drug problems. Pennsylvania recently found that fentanyl was involved in over half of its overdoses, followed by heroin, cocaine and anti-anxiety medications such as Xanax and Valium.  Opioid pain medication was ranked as the fifth most deadly drug. Toxicology reports have also determined that fentanyl is involved in over half the drug overdoses in Massachusetts.

Lessons About the Opioid Crisis from ‘Unbroken Brain’

By Roger Chriss, Columnist

The book “Unbroken Brain: A Revolutionary New Way of Understanding Addiction” by Maia Szalavitz offers invaluable insights about addiction. Her key point is that addiction should be seen as a learning disorder -- not a moral failing or brain disease.

Szalavitz says addiction treatment and drug policy should meet addicts where they are and deal with their reality, instead of using the moralistic or legalistic framework commonly seen in the opioid crisis.

Throughout the book, Szalavitz shares her own experiences with drug use in a way that does not mythologize addiction or recovery. Instead, her personal history highlights that there is no such thing as a typical addict and that addiction is not simply a moral failing or choice.

Szalavitz explains that addiction results from a complex combination of a person’s genetic makeup, early life experiences, and socio-cultural situation. Specifically, she states that: "There are three critical elements to it; the behavior has a psychological purpose; the specific learning pathways involved make it become nearly automatic and compulsive; and it doesn’t stop when it is no longer adaptive.”

She likens addiction to dysfunctional self-medication, an effort to self-soothe and regulate internal states that have gone horribly wrong. This means that addiction is not about a substance, but about a person.

“Drugs alone do not ‘hijack the brain.’ Instead, what matters is what people learn -- both before and after trying them,” Szalavitz writes. “Addiction is, first and foremost, a relationship between a person and a substance, not an inevitable pharmacological reaction.”

Further, she states that “by itself, nothing is addictive; drugs can only be addictive in the context of set, setting, dose, dosing pattern, and numerous other personal, biological, and cultural variables.”

And there are several major risk factors for addiction, including severe early childhood trauma or abuse, existing mental illness, and serious life challenges. Particular emphasis is given to a history of abuse.

“In fact, one third to one half of heroin injectors have experienced sexual abuse, with the usual abuse rates for women who inject roughly double those for men. And in 50% of these sexual abuse cases, the offense was not just a single incident but an ongoing series of attacks, typically conducted by a relative or family friend who should have been a source of support, not stress,” wrote Szalavitz.

She also states that addiction is not just about euphoria: “Research now suggests that there are at least two distinct varieties of pleasure, which are chemically and psychologically quite different in terms of those effects on motivation. These types were originally characterized by psychiatrist Donald Klein as the ‘pleasure of the hunt’ and the ‘pleasure of the feast’.”

This means that addiction is about far more than just dopamine levels: “If dopamine is what creates the sense of pleasure, animals shouldn’t be able to enjoy food without it. Yet they do.”

Lower Risk of Addiction to Opioid Medication

On the subject of opioid medication, Szalavitz notes that about one in seven people do not tolerate opioids well enough to take them repeatedly and therefore have essentially no risk of opioid use disorder. Because of this and the importance of “set and setting” to addiction, she explains, “medical use of drugs carries a far lower risk of addiction than recreational use does.”

Because addiction involves a person in a particular sociocultural situation, she writes that “People with decent jobs, strong relationships, and good mental health rarely give that all up for intoxicating drugs; instead, drugs are powerful primarily when the rest of your life is broken.”

Approaches to addiction treatment that don't recognize the above are unlikely to succeed. Detox regimens, short-term medication therapy, and abstinence-only programs like Alcoholics Anonymous are generally inadequate. For instance, Szalavitz found a 2006 Cochrane Review that summarized the data plainly: “No experimental studies unequivocally demonstrated the effectiveness of AA.”

Instead, Szalavitz emphasizes the value of harm reduction, a process whose aim is to "meet the addicts where they are" and support them unconditionally, even if this means clean needle exchanges and safe injection sites.

“Don’t focus on whether getting high is morally or socially acceptable; recognize that people always have and probably always will take drugs and this doesn’t make them irrational or subhuman,” she wrote.

But American policy toward illegal drugs and attitudes toward medications with psychotropic effects are grounded in a moralistic view. “More generally, in the West, unearned pleasure has been labeled as sinful—the opposite of valued,” Szalavitz writes, explaining why any medication that helps a person feel good, or just not feel as bad, is viewed negatively. This has led to all manner of misguided policy in the War on Drugs.

“One of the sad ironies of our current drug policy is that the same treatment providers who have been cheerleaders for the war on drugs and who advocate the ongoing criminalization of drug use also claim to want to destigmatize ‘the disease of addiction’,” she wrote.

“This approach is doomed to failure because “punishment cannot solve a problem defined by its resistance to punishment.” Moreover, it is cruelly counterproductive because “the uniquely moral nature of the way we treat addicts as both sick and criminal also reinforces stigma.” By contrast, understanding addiction as a learning disorder leads to harm reduction as the core of a more effective approach to treatment.

“Unbroken Brain” is not pedantic or moralistic. Indeed, Szalavitz says that part of the reason U.S. policy toward drug addiction has failed is that it is pedantic and moralistic. But she also says that people who now say that addiction is a "brain disease" are missing the point too. "Drug exposure alone doesn't cause addiction," she says in the conclusion of the book.

A person's situation and circumstances matter a lot in drug use and addiction. And treatment requires recognizing that even the most addicted person can still learn and make positive changes in their life when given the chance.

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.

Trump Opioid Commission Calls for National Emergency

By Pat Anson, Editor

A White House commission on combating drug addiction and the opioid crisis has recommended that President Trump declare a national emergency to speed up federal efforts to combat the overdose epidemic, which killed over 47,000 Americans in 2015.

“If this scourge has not found you or your family yet, without bold action by everyone, it soon will. You, Mr. President, are the only person who can bring this type of intensity to the emergency and we believe you have the will to do so and to do so immediately,” the commission wrote in an interim report to the president.

The 10-page report was delayed by over a month, which New Jersey Gov. Chris Christie attributed to over 8,000 public comments the commission received after its first meeting in June. Christie, who chairs the commission, said the panel wanted to carefully review each comment.

In addition to declaring a national emergency, the commission recommended a variety of ways to increase access to addiction treatment, mandate prescriber education about the risks and benefits of opioids, and prioritize ways to detect and stop the flow of illicit fentanyl into the country.

There were no specific recommendations aimed at reducing access to prescription opioids, although they could be added to the commission’s final report, which is due in October.

“We urge the NIH (National Institutes of Health) to begin to work immediately with the pharmaceutical industry in two areas: development of additional MAT (medication assisted treatment)... and the development of new, non-opioid pain relievers, based on research to clarify the biology of pain,” Christie said. “The nation needs more options that are not addictive.  And we need more treatment for those who are addicted.”

“I think we also have to be cognizant that the advent of new psychoactive substances such as fentanyl analogs and heroin is certainly replacing the death rate due to prescription opioids. That is going to continue until we have a handle on the supply side of the issue,” said commission member Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School.

“If we do not stop the pipeline into substance use, into addiction, into problematic use, into the entire scenario of poly-substance use, we are really not going to get a good handle on this.”     

Other measures recommended by the commission:

• Grant waivers to states to eliminate barriers to mental health and addiction treatment
• Increase availability of naloxone as an emergency treatment for opioid overdoses
• Amend the Controlled Substance Act to require additional training in pain management for all prescribers
• Prioritize funding to Homeland Security, FBI and DEA to quickly develop fentanyl detection sensors
• Stop the flow of synthetic opioids through U.S. Postal Service
• Enhance the sharing of data between prescription drug monitoring programs (PDMPs)

No estimate was provided on the cost of any of these measures.

Gov. Christie also spoke about eliminating pain levels as a “satisfaction criteria” for healthcare providers being evaluated and reimbursed for federal programs like Medicare.

“We believe that this very well may have proven to be a driver for the incredible amount of prescribing of opioids in this country. In 2015, we prescribed enough opioids to keep every adult in America fully medicated for three weeks. It’s an outrage. And we want to see if this need for pain satisfaction levels, which is part of the criteria for reimbursement, is part of the driver for this problem,” Christie said.  

Last year, the Centers for Medicare and Medicaid Services (CMS) caved into pressure from politicians and anti-opioid activists by dropping all questions related to pain in patient satisfaction surveys in hospitals.  CMS agreed to make the change even though there was no evidence that the surveys contributed to excess opioid prescribing

Do You Use Alcohol to Relieve Chronic Pain?

By Rochelle Odell, Columnist

I’m in a Complex Regional Pain Syndrome (CRPS/RSD) support group and one of our members recently asked if any members were turning to alcohol because their pain medication had been reduced or stopped.

It piqued my interest, so I began researching the topic. There aren’t many current studies or reports, but it’s a valid question since alcohol is much easier to obtain than pain medication.

Alcohol was among the earliest substances used to relieve physical pain and, of course, many people use it to cope with emotional pain.

According to the National Institute on Alcohol Abuse and Alcoholism, as many as 28% of people with chronic pain turn to alcohol to alleviate their suffering.

Another study from 2009 found that about 25% of patients self-medicated with alcohol for tooth pain, jaw pain or arthritis pain.

There is no documented increase in alcohol use by chronic pain patients at this time, although I would hope there are studies in process that further clarify the question and problems arising from it -- especially with opioid pain medication being reined in and so many patients left with nothing to relieve their pain.

There are many reasons why a person may self-medicate with alcohol.

“People have been using alcohol to help cope with chronic pain for many years. Many people also may use alcohol as a way to manage stress, and chronic pain often can be a significant stressor,” Jonas Bromberg, PsyD, wrote in PainAction.

“One theory about why alcohol may be used to manage chronic pain is because it affects the central nervous system in a way that may result in a mild amount of pain reduction. However, medical experts are quick to point out that alcohol has no direct pain-relieving value, even if the short-term affects provide some amount of temporary relief. In fact, using alcohol as a way to relieve pain can cause significant problems, especially in cases of excessive use, or when it is used with pain medication.”

Constant, unrelenting pain is definitely a stressor -- that's putting it mildly -- but I’ve never added alcohol to my pain medication regimen. I was always afraid of the possible deadly side effects, coupled with the fact my mother was an alcoholic who mixed her medication with it. That's a path I have chosen not to go down.

Bromberg also tells us that men may be more likely to use alcohol for pain relief than women, and people with higher income also tend to use alcohol more to treat their chronic pain.

Interestingly, the use of alcohol is usually not related to how intense a person’s pain is or how long they’ve had it. It was the regularity of pain symptoms – chronic pain -- that seemed most related to alcohol use, according to Bromberg.

Those who self-medicate with alcohol for physical or emotional pain often use it with a variety of substances, both legal and illegal.

Researchers at Boston University School of Medicine and Boston Medical Center reported last year in the Journal of General Internal Medicine that in a study of nearly 600 patients who screened positive for illicit drugs, nearly 90 percent had chronic pain. Over half of them used marijuana, cocaine or heroin, and about half reported heavy drinking.

“It was common for patients to attribute their substance use to treating symptoms of pain,” the researchers reported. “Among those with any recent heavy alcohol use, over one-third drank to treat their pain, compared to over three-quarters of those who met the criteria for current high-risk alcohol use.”

“Substance use” (not abuse) was defined as use of illegal drugs, misuse of prescription drugs, or high risk alcohol use. I had not heard of this term before, it’s usually called substance abuse.  Perhaps these researchers were onto something really important that needs further study, particularly with opioid medication under fire.

“While the association between chronic pain and drug addiction has been observed in prior studies, this study goes one step further to quantify how many of these patient are using these substances specifically to treat chronic pain," they added.

What this information shows is that if one is on pain medication, using alcohol or an illegal substance does not make one unique. It is certainly not safe, but it does occur. We are all struggling to find ways to cope with chronic pain, and if someone is denied one substance they are at high risk of turning to another.

Rochelle Odell lives in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

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.

The Myth of the Opioid Addicted Chronic Pain Patient

By Roger Chriss, Columnist

Prescription opioid use for chronic pain does not usually lead to addiction or to the use of illicit opioids such as heroin. But media reports often say otherwise.

“Opioids can be so addictive that many people develop a desperate need for them even after the pain has subsided, or disappeared. So when they’re turned away by doctors and pharmacies, they look for a fix on the streets,” Fox News recently reported.

Public officials also confuse the issue.

“Most of our constituents with substance-use disorders began their path to addiction after forming dependencies to opioids prescribed as a result of an injury or other medical issue,’ Anne Arundel County Executive Steve Schuh wrote in a letter to Maryland doctors. ‘Their opioid dependence may have led to obtaining illegal street opioids like heroin, sometimes laced with fentanyl, after valid prescriptions ran out.’”

But this is not what usually happens.

“What the media has sometimes missed is that of those people who started with prescription opioids and then went on to use heroin, 75% never had a legal prescription for opioids. They were already stealing or buying the drugs illegally,” Judith Paice, PhD, RN, director of the Cancer Pain Program at Northwestern University told Medscape.

In other words, the reality of opioid therapy for chronic painful conditions is quite different from what media coverage and public officials claim.

In fact, the majority of chronic pain patients never even receive opioid medications. Recent estimates state that between 8 and 11 million chronic pain patients receive an opioid prescription at some point in a given year, with only some of them taking opioids for pain control on a daily basis.

Although that is a large number, it is dwarfed by the National Institutes of Health’s estimate that 25.3 million Americans live with daily chronic pain and nearly 40 million have severe pain. That  includes people in hospice and other end-of-life care, as well as people enduring cancer pain.

Moreover, many of the chronic pain patients who receive daily opioid therapy get there only after having failed many other treatment options, including non-opioid drugs and physical therapy. Opioids are rarely the first choice for treating persistent pain conditions, especially in the wake of opioid prescribing guidelines from the CDC, Department of Veterans Affairs, and some states.

Chronic pain patients are carefully screened, scrutinized, and monitored. They are subjected to risk assessment using the Opioid Risk Tool, required to take urine and saliva drug tests, told to show their prescription bottles and have their pills counted, and given pain contracts to sign. Their prescriptions are verified at pharmacies and tracked through prescription drug monitoring programs. Opioid misuse in any form is readily detected and is far from common.

Therefore, it is a myth that opioid addiction or other forms of opioid use disorder starts with a prescription. Instead, it almost always begins at a young age with the misuse of other drugs, such as tobacco, alcohol and marijuana. About 90% of drug addiction starts during adolescence.

And although most people who are addicted to heroin have previously used prescription opioids, the opposite is not true. Most people on opioid therapy do not become addicted to prescription opioids, and most of the people who do become addicted do not transition to heroin.

But the myth confuses and conflates chronic pain and opioid addiction. And this is having real-world consequences, both for people on opioid therapy for chronic pain and for people with opioid use disorder.

For people on opioid therapy, the problems include forced medication tapers or even termination of therapy. Pain management is an essential part of a variety of diseases and disorders, from the neuropathy of arachnoiditis and multiple sclerosis, to the visceral pain of interstitial cystitis and porphyria, to the musculoskeletal pain of Ehlers-Danlos syndrome. The choice and dose of medication should be a clinical decision made between patient and physician, not a blanket determination made by a guideline, regulation or committee.

Further, chronic pain is fast becoming undertreated or even untreated, which can have major health consequences. Forcing people to live without good pain management only creates more medical problems. 

For people suffering from opioid use disorder, the addiction myth embodies the idea that it is just accidental chemistry. But as Maia Szalavitz explains in her book Unbroken Brain, addiction has three key components: “The behavior has a psychological purpose; the specific learning pathways involved make it become nearly automatic and compulsive; and it doesn’t stop when it is no longer adaptive.”

The perpetuation of this myth has resulted in people not getting effective care, because the focus is on the substance instead of the sufferer.

“If we don’t invest in people and we focus on drugs, we end up creating another polarizing conversation about substances and people will continue to fall through the cracks,” Dr. Joseph Lee of the Hazelden-Betty Ford Foundation told the Minnesota Post.

The myth of the opioid-addicted chronic pain patient needs to be banished before it causes more people to fall through the cracks.

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.