The inappropriate treatment approach to back pain is a driving force behind the opioid epidemic, Dave Chase, co-founder of Health Rosetta, reports,1 citing the 2018 JAMA Network Open paper,2 “Opioid Prescribing for Low Back Pain: What Is the Role of Payers?”
One of the reasons for this is the sheer prevalence of back pain. Statistics3 suggest 8 in 10 American adults will be affected by it at some point in their life.
“It’s also a microcosm of all the things that are wrong with the U.S. health care system, including its contribution to the opioid crisis,” Chase writes.4 “Lower back pain puts people in desperate and vulnerable positions, and it puts doctors under pressure to Do Something Now.
From such a confluence arise many poor and potentially devastating treatments and choices. Among the worst is doctors’ decisions to write opioid prescriptions as a treatment for lower back pain and their patients taking these drugs.
Lower back pain is one of the most common reasons for an opioid prescription,5 but here’s the kicker: There’s no evidence that opioids are effective at treating this problem.”
Opioids Are Inappropriate for Back Pain
Indeed, according to the JAMA paper:6
“Recent data from the first randomized clinical trial with long-term outcomes demonstrated that opioid treatment did not confer benefit with respect to pain-related function and that adverse medication-related events were more common among patients receiving opioid therapy. In contrast, pain intensity was improved among patients randomized to nonopioid treatment.”
Other research7 published in 2018 also shows opioids (including morphine, Vicodin, oxycodone and fentanyl) fail to control moderate to severe pain any better than over-the-counter (OTC) drugs such as acetaminophen, ibuprofen and naproxen.
In fact, those taking nonopioid pain relievers actually fared “significantly better” in terms of pain intensity. Lead author Dr. Erin Krebs with the Minneapolis VA Center for Care Delivery and Outcomes Research (formerly Chronic Disease Outcomes Research), told WebMD:8
“We found that opioids had no advantages over nonopioid medications for pain, function or quality of life in patients with low back pain … This is important information for physicians to share with patients who are considering opioids.”
How Insurance Companies Contribute to the Opioid Crisis
Despite the medical consensus that back pain is best treated with nonpharmacological means, most insurance companies still favor opioids when it comes to reimbursement.
As noted in the American College of Physicians’ guideline9 “Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain,” heat, massage, acupuncture or chiropractic adjustments should be used as first-line treatments. When drugs are desired, nonsteroidal anti-inflammatory drugs (NSAIDs) or muscle relaxants should be used.
Other key treatments include exercise, multidisciplinary rehabilitation, mindfulness-based stress reduction, tai chi, yoga, relaxation, biofeedback, low-level laser therapy and cognitive behavioral therapy.
In a recent episode of Full Measure,10 Sharyl Attkisson interviewed Eileen Kopsaftis, a physical therapist who uses a combination of diet, connective tissue work, proper body dynamics and body balance to address back pain.
As for opioids, they “should only be considered if other treatments are unsuccessful and when the potential benefits outweigh the risks for an individual patient,” according to the American College of Physicians’ guideline.11
Alas, while clinical practice guidelines call for nonpharmacological intervention for back pain, most insurance plans don’t pay for such treatments. They do pay for opioids, though. In his article, Chase explains:12
“That doesn’t make sense until you look at the reason: For the carriers that administer health insurance plans, there is far more profit in pills than physical therapy. (This also explains why the three largest pharmacy benefits managers have recently merged with insurance carriers.)
Our entire health care system is built on a vast web of incentives that push patients down the wrong paths. And in most cases it’s the entities that manage the money — insurance carriers — that benefit from doing so.
They negotiate prices with health systems and pharmaceutical companies, all of which share the objective of increasing revenues, to craft and sell health plans that offer trumped up ‘discounts.’ As long as carriers negotiate a high price with a provider or a rebate scheme with a drug maker, they can still make a sizable profit even after a 50 percent discount.
This dynamic was accelerated by the Affordable Care Act’s Medical Loss Ratio,13 which requires that 80 percent of insurance premium dollars pay for medical expenses and that carriers pocket only 20 percent. It doesn’t take much to see that the higher the premium, the more they make from that 20 percent …
An estimated 700,000 people are likely to die from opioid overdoses between 2015 and 2025,14 making it absolutely essential to understand the connections between insurance carriers, health plans, employers, the public, and the opioid crisis. We will never get out of this mess unless we stop addiction before it starts … the opioid crisis isn’t an anomaly. It’s a side effect of our health care system.”
Doctors and Dentists Also Shoulder Blame
Other situations in which opioids are inappropriately prescribed, and massively so, are for tonsillectomies and wisdom teeth extractions.
Insurance claims data from 2016 and 2017 reveal 60% of children between the ages of 1 and 18 with private insurance filled one or more opioid prescriptions after surgical tonsil removal,15,16 and dentists wrote a staggering 18.1 million prescriptions for opioids in 2017.17
As noted by Ronnie Cohen in a March 2019 article18 in The Washington Post, “until recently, dentists seemed to have had no idea they may have been helping to feed an epidemic that resulted in a record 70,237 U.S. drug overdose deaths in 2017.”19
Andrew Kolodny, co-director of opioid treatment research at Brandeis University, told Cohen:20 “It’s almost a rite of passage in the United States having your wisdom teeth out. The aggressive prescribing of opioids to adolescents may be why we’re in an epidemic.”
While American family doctors prescribe an estimated 15% of all immediate-release opioids — the type most likely to be abused — dentists are not far behind, being responsible for 12% of prescriptions, according to a 2011 paper21 in the Journal of the American Dental Association.
According to a JAMA report22 published August 2018, opioids are “routinely” prescribed for wisdom tooth extractions. The Washington Post cites a 2004 survey, which found 85% of oral surgeons prescribe opioids after the removal of wisdom teeth.23
This practice is highly questionable, considering there’s no medical reference showing opioid pain relievers are more effective for this kind of post-surgical pain than NSAIDs.24
On the contrary, an April 2018 medical review25 found a combination of ibuprofen and acetaminophen offered the greatest pain relief, while opioids and opioid combinations had the highest number of adverse events in both children and adults.
Mind you, even though the ibuprofen/acetaminophen combination is less addictive, it can still cause serious potential complications if taken long term, so you also need to be careful when using these drugs and make sure to address the foundational cause of your pain.
Common sense would tell you this practice is putting youth at significant risk for addiction. Research26,27 confirms such suspicions, showing 6.9% of those receiving an opioid prescription from their dentist in 2015 were still using opioids between three and 12 months later. Among those who did not get an initial opioid prescription, only 0.1% sought an opioid prescription in the 12-months that followed.
The American Dental Association now urges dentists and oral surgeons to limit opioid prescriptions for acute pain to a maximum of seven days.28 In a 2018 article29 in The Philadelphia Inquirer, Dr. Rima Himelstein, an adolescent medicine specialist, urges parents whose children are undergoing oral surgery to:
“Be the gatekeeper for medications, including those prescribed after wisdom teeth extraction. Don’t just hand your teen the bottle of pills after surgery. And be sure to properly dispose of leftover prescription drugs …”
Johnson & Johnson’s Role in the Opioid Crisis
While Purdue Pharma and the Sackler family appear to have played a central role in the creation of the opioid crisis, few opioid makers and distributors are free of blame. An August 27, 2019, article in The New York Times30 highlights the influence of Johnson & Johnson, a leading supplier of opioid ingredients.
August 26, 2019, Johnson & Johnson was ordered to pay Oklahoma $572 million for violating state public nuisance law, thereby causing decades of opioid addiction and opioid-related deaths in the state.31,32 As reported by The New York Times:33
“The judge cited the company’s overly aggressive marketing tactics: Sales representatives were coached to avoid the ‘addiction ditch’ — the negatives associated with drug use and dependence — when encouraging doctors to prescribe opioids for patients with moderate to severe pain …
Its marketing tactics followed a similar playbook to one Purdue and other opioid manufacturers were employing, and also included so-called unbranded promotion, which was not tied to specific products and encouraged doctors to continue to prescribe more opioids.
Like its competitors, Johnson & Johnson sought to persuade doctors that pain was under-treated, training sales representatives to use ‘emotional selling’ to get across the idea that patients were being harmed by undertreatment.
Another concept was ‘pseudoaddiction,’ or the idea that if patients were asking a doctor for higher doses, they were not necessarily addicted but needed more of the drug to treat their pain.”
According to The New York Times, 326 million opioid pills were dispensed in Oklahoma in 2015 alone, “enough for every adult in the state to receive 110 pills.”34 Oklahoma prosecutors also stressed that were it not for Johnson & Johnson, OxyContin would not have become a blockbuster drug.
In 1994, when Purdue Pharma sought Food and Drug Administration approval for OxyContin, Johnson & Johnson’s supplier subsidiary Tasmanian Alkaloids developed a novel type of opium poppy, the Norman Poppy, which produces higher amounts of thebaine, the active painkilling ingredient in OxyContin.
An Important Break in the Kentucky Case Against Purdue
Purdue is still in the news, though, and chances are we’ll hear a lot more about it in coming weeks and months. The reason for this is because the Kentucky Supreme Court has finally ruled that sealed court records detailing the company’s marketing of OxyContin are to be unsealed and made public.
The cache is also said to include internal reports on the results of clinical trials, communications relating to previous legal cases, and a 2015 deposition of Dr. Richard Sackler. All of these documents were obtained during legal discovery in a lawsuit where Kentucky sued Purdue over the illegal marketing of OxyContin.
The case was settled in 2015, with Purdue being ordered to pay the state $24 million. Part of the settlement agreement called for the destruction of 17 million pages of litigation records held by the state attorney general’s office. Copies of some of the files, however, ended up being placed under seal in a Pike County courthouse. On August 26, 2019, STAT news reported:35
“The decision is a major victory for STAT, which first filed a motion36 to unseal the records in March 2016. Purdue has fought to keep the documents out of view, but the Supreme Court’s refusal is final and can’t be appealed.
Now, the public stands to get a glimpse of new information about how Purdue promoted OxyContin and what executives knew about the risk of addiction that came with the drug.
‘The case against Purdue was one of our first decisions when we launched STAT, and we’re thrilled that the trove of documents will finally be made public,’ said John W. Henry, the owner and publisher of STAT.
‘As the opioid crisis continues to devastate communities across the country, it is vital that we all have more answers to so many outstanding questions about the genesis of the epidemic and Purdue’s aggressive marketing of OxyContin.’”
FDA Advisory Panel Riddled With Conflicts of Interest
In related news, The BMJ recently published an editorial37 highlighting a recent BMJ investigation38 that revealed the National Academies of Sciences, Engineering and Medicine (NASEM), which advises FDA on opioid policies, has a number of hidden conflicts of interests, and this too may have played a role in the opioid crisis.
Among these undisclosed conflicts of interests was the fact that Victor Dzau, one of NASEM’s presidents, “had financial ties to Medtronic, a company that sells an implantable device to deliver pain medicine, until last year.”
What’s more, 7 of 15 academics serving on the NASEM panel that advised the FDA on opioid prescribing guidelines had ties to industry. On top of that, NASEM itself accepted $14 million from the Sackler family. The BMJ reports:39
“NASEM responded40 to The BMJ's investigation to say that it was reviewing its conflict of interest policies and its funding from the Sacklers. It said that it considers only ‘current’ financial ties; but past ties, particularly if recent, substantial, or longstanding, are also conflicts of interest, which is why journals like The BMJ ask authors for disclosures going back three years.
NASEM said that Dzau had complied with its policies; but requiring the public disclosure of all competing interests is essential if policy makers, practitioners, and patients are to be fully informed of how NASEM drafts its guidance.
NASEM said that the $1m of shares Dzau held for previous Medtronic board membership while president of the National Academy of Medicine were managed by his bank without his involvement; but still they constituted a substantial and undeclared conflict of interest because Dzau stood to gain if their worth rose.”
Will Justice Be Done?
In an August 29, 2019 article41 in The Atlantic, Dr. James Hamblin addresses the lack of justice currently on the table:
“The role of marketing in the pharmaceutical industry — the apparatus that profits more from maximizing use than optimizing outcomes — is at an inflection point. A reckoning could lead to serious reform.
But a settlement deal currently on the table — in which Purdue Pharma … would pay about $11 billion42 — stands to repeat the mistakes of the past …
Several billion would come in the form of medications to help treat opioid addiction and overdoses. The Sackler family … would give up ownership of the company, which would file for bankruptcy and become a ‘public beneficiary trust’ …
But no new ground would be broken if the justice comes in the form of fines for what amounts to serious crimes. In 2018, President Donald Trump proposed the extreme measure of using the death penalty for certain drug traffickers and dealers …
Trump did not suggest that these dealers simply pay back a portion of their profits. The importance of sending a message is rarely invoked when it comes to white-collar crime. When drug dealing is done by corporations, the punishment is to impose fines, and to debate what sort of punishment would be fair and productive.
In this case, the proposal on the table would require Purdue to pay a fraction of the $35 billion in profits it claims to have made from Oxycontin — and far less than even the conservative estimates of the damage it caused … estimated in a 2017 White House report to be $504 billion.”
A Moral Reckoning Is Needed
I couldn’t agree more with Hamblin’s assertion that a settlement — and especially one that falls so short of the actual cost to society — will do nothing to change the drug industry’s ways.
“It is not a criminal prosecution. It is not a moral reckoning,” Hamblin writes, and indeed, without criminal prosecution of corporate executives who played an active part in the decisions that were made, the current trend of reckless malfeasance is bound to continue.
In 2007, Purdue pleaded guilty to charges that it misled doctors and patients about OxyContin’s addictive potential and paid $634 million in fines. They knew they were killing people, and the fine did nothing to realign the company’s moral compass. Purdue kept up the same shady practices — putting profits above public health — for another 12 years, bringing us to where we are today. As Hamblin so aptly states:43
“The job of the courts and regulatory apparatus is to help prevent future disaster. This will not happen when penalties are meted out such that loss of life is treated as a cost of doing business.
The Justice Department could impose a criminal framework on concealing information that led to thousands of deaths. There could be consequences … that make it clear to current and future sellers of dangerous products that this can never happen again.”