Heroin and Fentanyl Fueling Veteran Overdoses, Not Rx Opioids

By Pat Anson, PNN Editor

The U.S. Department of Veterans Affairs has taken a number of steps in recent years to reduce opioid prescribing for military veterans and their families. In 2015, the VA adopted the CDC opioid guideline before it was even finalized. Two years later, the agency adopted a clinical practice guideline for VA doctors that strongly recommends against prescribing opioids to patients for more than 90 days.

Both measures were intended to address “mounting concerns about prescription drug abuse and an overdose epidemic among veterans.”

But a new study has found that the “epidemic” of opioid overdoses among veterans is not fueled by prescriptions opioids – but by heroin, illicit fentanyl and other synthetic opioids obtained on the black market.

Researchers at the University of Michigan and VA Ann Arbor Healthcare System reported in the American Journal of Preventive Medicine that overdose deaths from all opioids increased by 65 percent for veterans from 2010 to 2016. But when then looked closer at prescription data on nearly 6,500 veterans who died, they found an unexpected trend.

"The percentage of veterans who had received an opioid pain prescription in the year before their opioid overdose death dropped substantially over this time period," says lead author Allison Lin, MD, an addiction psychiatrist at the VA Ann Arbor.

In 2010, half of the veterans who died of any opioid overdose had filled an opioid prescription in the three months before they died, and two-thirds had filled a prescription in the last year.

But by 2016, only a quarter of those who overdosed had filled an opioid prescription in the last three months, and 41 percent had done so in the past year.

At the same time, the death rate from heroin or from taking multiple opioids nearly quintupled, and the death rate from synthetic opioids such as fentanyl rose more than five-fold.

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“Interventions on opioid overdose prevention have often focused on those receiving opioid prescriptions; if we're only screening for risk in that population, this shows we will miss a lot," said Lin. "We really have to think about opioid overdose prevention and substance use disorder treatment more broadly, to determine where the greatest unmet need is, increase treatment access and accessibility, and improve outcomes."

The VA provides health services to 6 million veterans and their families. Over half the veterans being treated at VA facilities suffer from chronic pain, as well as other conditions that contribute to it, such as depression and post-traumatic stress disorder.

A 2016 study of veterans found a strong link between heroin use and the non-medical use of prescription opioids. Having a long-term prescription for opioids to treat chronic pain was not found to be a significant risk factor for heroin use.

Message to CDC: Tear Down Your Walls of Silence!

By Richard Lawhern, PhD, Guest Columnist

In March 2016, the Centers for Disease Control and Prevention published its guideline for primary care physicians on prescribing opioid medication for chronic non-cancer pain.

Three months before its publication, Congress and President Obama made the guideline mandatory for the Veterans Health Administration, leading to revised practice standards at the VA that sharply restrict opioid medication for all veterans, regardless of risk or benefit. These unjustified restrictions were again written into federal law by the Veterans Administration Mission Act and recently signed into law by President Trump.

In civilian practice -- and despite being phrased as voluntary and only for general practitioners -- the CDC guideline was immediately and widely interpreted as a mandatory standard of practice for all doctors. 

Many insurers and healthcare providers adopted the CDC’s 90mg morphine equivalent dose (MME) as the maximum safe level of treatment, and some states have limited opioids to 7 days' supply or less for initial prescriptions, even after major surgery. 

More recently, Oregon’s Medicaid program has proposed rule changes that would forcibly taper many chronic pain patients currently on opioid therapy to zero. 

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Major changes are also coming next year for Medicare patients nationwide that will sharply restrict high-dose opioid therapy for hundreds of thousands of older and disabled patients, by allowing insurers to require prior authorization for prescriptions in excess of 200 MMEs.

Almost immediately -- and despite wording in the CDC guideline discouraging such action -- doctors began coercing patients to eliminate or reduce opioids that were effective in managing their pain for years. State and federal law enforcement agencies like the Drug Enforcement Administration also ramped up the investigation and prosecution of doctors who prescribe high doses. 

Fearing loss of their livelihoods, many doctors refused to prescribe opioids or discharged patients who asked for them.  Some physicians left pain practice altogether.  As a result, tens of thousands of patients can no longer find effective pain treatment. There are widespread stories in social media, acknowledged in professional medical literature, of patients deserted by doctors who spiral down into agony, disability, and in some cases suicide. 

Where is CDC’s Guideline Evaluation?

One would think that federal agencies that caused such a public health disaster would be concerned with correcting course.  But that is not the case. 

Practice standards published by medical associations usually include a follow-up program to measure their safety and effectiveness. However, CDC has failed to conduct a full assessment of the opioid guideline in the nearly two and a half years since its release – even though the agency pledged in the guideline to conduct one:

“CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.”

It is obvious why the CDC has maintained a wall of silence in the face of widespread criticism of the guideline by both patients and doctors. The agency is desperately wrong on three central assumptions about the opioid crisis:

  1. The crisis was caused by “over-prescribing” medical opioids to patients in pain. Doctors were careless, greedy or deceived by evil pharmaceutical companies into ignoring risks of drug addiction.
  2. There is no evidence that opioid analgesics are effective for pain when used over long periods.
  3. Alternative pain therapies and non-opioid medications are safer and more effective than opioids and should be preferred over them.

All three of these assumptions are wrong.  Patient experience and published data from healthcare researchers demonstrate they are wrong. Let’s look at these three false assumptions.

Do Opioid Prescriptions Cause Overdose Deaths? 

Very rarely.  If prescribing increases the risk of opioid overdose deaths, then we would expect to see more overdoses in states and patient demographic groups where prescribing rates are highest.  But we do not. 

The following graphic compares overdose mortality rates from legal and illegal opioids to rates of opioid prescribing in all 50 states and Washington, DC in 2016.

SOURCE: CDC DATABASE

SOURCE: CDC DATABASE

It might be difficult for a layman to make much sense of this graphic.  And that is precisely the point.  If there was a clear cause and effect relationship between prescribing and overdose deaths, then we would see higher death rates on the right side of the chart, with most data clumped closely around a rising central trend line.  But we don’t see that. 

The contribution of medically prescribed opioids to overdose deaths is so small that it gets lost in the noise of illegal street drugs.  Contrary to the screaming headlines in the media, prescription drugs aren’t killing people in large numbers. Illegal street drugs are.

This is not to say prescription drugs played no role in worsening the opioid crisis.  But in recent years, their role in opioid mortality has become small.  Even when they are found in the bloodstream of an overdose victim, opioid prescriptions are almost never found alone.  In Massachusetts, illicit fentanyl was found last year in 85% of blood toxicology screens of overdose victims, while heroin and/or cocaine were detected in about 45% of them.  Prescription opioids were found in only 15% of overdose victims.

Those numbers obviously don’t add up to 100 percent.  That is because the great majority of overdose victims had taken more than one illegal drug plus alcohol and/or benzodiazepine drugs.  We don’t really know which drug or combination of drugs caused the overdose.   

Overdose data also suggest that death is not a predictable outcome of opioid prescribing, nor is it common in groups that use the most opioid prescriptions. 

Basic trends in the chart below stand out.  First, rates of overdose deaths among people over age 50 have been stable for the last 17 years, while death rates among young people have risen sharply. In 2016, they were six times higher than in seniors.

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We know that rates of opioid prescribing for seniors are at least 250% higher than for kids under 21. Thus, the group that benefited the most from liberalized prescribing policies of a decade ago – older adults -- has shown no higher risk of overdose deaths, even as kids who receive fewer opioid prescriptions are now dying in record numbers.

The asserted demographics of “over-prescribing” are plainly wrong. They don’t work and never have.  Exposure to medically managed opioids does not cause increased opioid mortality, at least not directly. 

Brief exposure to prescription opioids contributes very little to addiction or long term use. In two recent large-scale studies, opioid abuse and prolonged prescribing of opioids were evaluated for over 650,000 patients given opioids for the first time to control pain after surgery.  Fewer than 0.6% of these patients were diagnosed with opioid abuse 2.5 years later. 

This means that opioid treatment for acute pain is safe, effective and usually free of bad outcomes for over 99% of opioid-naive post-surgical patients.

Do Opioid Medications Relieve Chronic Pain?

Of course they do!

We hear a lot of noise that there is no evidence or proof that opioids work for long periods.  But “no proof” is not the same as “proof of no effect”. 

There are very few double blind clinical trials for opioids longer than 90 days -- and this reality is entirely understandable.  When people with severe pain are given placebos, they lapse into agony and drop out of trials.  Long term studies of any pain treatment can easily rise to the level of being inhumane – which is why so few have been conducted.

It isn’t rocket science, and the writers of the CDC guideline knew it.  Instead of comparing shorter trials of opioid analgesics against behavioral therapies and non-opioid medications, the guideline writers stacked the deck against opioids.  And they got caught at it by their medical peers. 

If trials of all three therapies had been limited to studies of at least a year -- as opioids were but alternative therapies were not -- none of the three could have provided “evidence” of useful effect.

We must also acknowledge that not all patients do well on opioids.  Some develop persistent nausea, sedation, constipation, suppression of sexual libido and depression. Some patients also become drug tolerant, requiring ever-increasing doses of opioids to achieve the same pain-relieving effects.  It has been theorized that a condition called “opioid induced hyperalgesia” may alter the action of opioid receptors in the brain.  But there is no medical consensus on how to measure such an effect in human beings, or even whether hyperalgesia exists. 

Many of the perceived failures of opioid therapy might be laid at the feet of ill-trained physicians.  Some doctors titrate their patients from zero to a therapeutic dose too fast.  Others fail to recognize factors in liver metabolism which make some patients poor metabolizers or hyper-metabolizers of opioids. Variation in metabolism means that there can be no one-size-fits-all pain treatment. Opioid therapy can be safe and effective for a small minority of patients at doses well above 1,000 MME.

Are Safe Substitutes for Opioids Widely Available?

For millions of patients, not yet.

We hear a lot of noise about tapering pain patients out of opioid therapy and into “alternative” or “integrative medicine.”  Indeed, it seems appropriate to first try less powerful medications such as NSAIDs or anticonvulsants before proceeding to opioids.  Exercise and massage therapy are also useful as palliative therapies.  But for millions of people, less powerful medications don’t work well enough -- or at all.  Tylenol or ibuprofen at high doses might also put you in a hospital with liver toxicity or major gastrointestinal problems.

What about “non-pharmacological” and “non-invasive” therapies?  Do they work well enough to be substituted for opioids?  Unfortunately, the answer is no. The state of science for alternatives like cognitive behavioral therapy, acupuncture, chiropractic, or various talk therapies is simply abysmal. 

At most, these alternative treatments are experimental.  They might be useful as supportive therapies in coordination with a well managed program of pain relieving medications.  But pending a more rigorous evaluation, we simply cannot offer such experimental techniques as substitutes for opioids. 

What Are Federal Agencies Doing to Correct Course?

In two words, “nothing apparent.”

The CDC, Food and Drug Administration, Health and Human Services (HHS), and the National Institutes of Health seem to be collectively dragging their feet in a campaign of deliberate inaction, refusing to respond to criticism or examine their own medical evidence of error.

This author and others have been trying for years to get healthcare agencies to reevaluate the relationship between opioid prescribing and overdose mortality. These efforts have included recent testimony to the FDA Opioid Policy Steering Committee and to the HHS Inter Agency Task Force on Best Practice in Pain Management.

In addition, copies of our analysis have been sent to the following authorities.  Most have been silent and none have responded in substance.

  • Dr. Scott Gottlieb, FDA Commissioner and senior analytics staff
  • Dr. Sharon Hertz, Director, Division of Anesthesia, Analgesia, and Addiction Products, FDA
  • Dr. Mary Kremzner, Director, Division of Drug Information, FDA. (Dr. Kremzner responded with a courteous letter referring to a press release from Scott Gottlieb). 
  • Alicia Richmond Scott, Designated Federal Officer, and Dr. Vanilla Singh, Chair of the HHS Inter Agency Task Force on Best Practices in Pain Management  
  • Dr. Nora Volkow, Director of the National Institute on Drug Abuse
  • The Whistleblower gateway of the House Subcommittee on Government Oversight

An inquiry was also filed online with the CDC. A dismissive response was received from the CDC Center for Injury Prevention – which oversaw development of the opioid guideline -- claiming to have read my analysis and asserting their previous positions.  This response was clearly a brush-off adapted from previous form letters.

A request is now in preparation to the HHS Office of the Inspector General, asking for investigation of CDC for malfeasance and possible fraud.

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Richard Lawhern, PhD, has for 21 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids.  He is co-founder and corresponding secretary of the Alliance for the Treatment of Intractable Pain.

Graphics in this article originally published by The Crime Report on January 21, 2018, in "The Phony War Against Opioids - Some Inconvenient Truths."

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.

Is JAMA Opioid Study Based on Junk Science?

By Pat Anson, Editor

You may have read about a research study published this week in the Journal of the American Medical Association (JAMA), which compared the effectiveness of opioid and non-opioid medications in treating chronic pain. 

The yearlong study of 240 patients found that opioids were not superior to pain relievers like acetaminophen and ibuprofen in treating chronic back pain or hip and knee pain caused by osteoarthritis.  Pain improved for 41% of the patients who took opioids, compared to 54% in the non-opioid group.  

It’s an interesting study – one of the few to look at the effectiveness of any pain relievers long term – but some critics are questioning the study’s methodology and the alleged anti-opioid bias of its lead author, Erin Krebs, MD, a researcher for the Department of Veterans Affairs.

First let’s look at some of the news coverage the study is getting.

“Opioids Don’t Treat Chronic Pain Any Better Than Ibuprofen” reads the headline in Newsweek, an article that never mentions the JAMA study was limited to patients with back pain or osteoarthritis.

“Opioids Don’t Beat Other Medications for Chronic Pain” was the headline in NPR.com, while the Chicago Tribune went with “Opioids no better than common painkillers for treating chronic pain.”

The Tribune article included a quote from one of the co-authors of the CDC opioid guidelines. "The fact that opioids did worse is really pretty astounding," said Roger Chou, MD. "It calls into question our beliefs about the benefits of opioids."

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Notice the news coverage strongly suggests that opioids are ineffective for all types of chronic pain – not just back pain and osteoarthritis.  Patients living with chronic pain from arachnoiditis, trigeminal neuralgia or some other intractable pain condition would probably disagree about that. And they'd find the idea of taking ibuprofen laughable, if not infuriating. But no one asked for their opinion.

Also unmentioned is that opioids are usually not prescribed for osteoarthritis or simple back pain, which are often treated with NSAIDs and over-the-counter pain relievers.

So, what JAMA has published is a government funded study designed to look at a treatment (opioids) that most people with back pain and arthritis never actually get.

“You've been had by anti-opioid advocates disguising their advocacy as science.  Krebs is well known in professional circles for this kind of distorted advocacy junk science,” wrote patient advocate Red Lawhern, PhD, in a comment submitted to the Philadelphia Inquirer after it published a misleading headline of its own, “Prescription opioids fail rigorous new test for chronic pain.”

“I suggest that you retract your article.  In its present form, it is propaganda not fact,” said Lawhern, a co-founder of the Alliance for the Treatment of Intractable Pain (ATIP). “Opioids have never been the first-line medical treatment of choice in lower back pain or arthritis. That role is served by anti-inflammatory meds, some of them in the prescription cortico-steroid family.  NSAIDs have a role to play, recognizing that they are actively dangerous in many patients if taken at high doses for long periods.  Hundreds of people die every year of cardiac arrest or liver toxicity due to high-dose acetaminophen or ibuprofen.” 

Who is Erin Krebs?  

Dr. Krebs is an associate professor at the University of Minnesota Medical School and a prolific researcher at the VA Medical Center in Minneapolis.

She was also an original member of the “Core Expert Group” – an advisory panel that secretly drafted the CDC’s controversial opioid guidelines while getting a good deal of input from the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP). The guidelines recommend that opioids not be prescribed for chronic pain.

Krebs also appeared in a lecture series on opioid prescribing that was funded by the Steve Rummler Hope Foundation, which coincidentally is the fiscal sponsor of PROP. 

Some of her previous opioid research has been controversial. In a study published last year in the Annals of Internal Medicine, Krebs reviewed 67 studies on the safety and effectiveness of opioid tapering. Most of the studies were of poor quality, but nevertheless Krebs came to the conclusion that pain levels and the quality of life of patients “may improve during and after opioid dose reduction.”

ERIN KREBS, MD

ERIN KREBS, MD

“This review found insufficient evidence on adverse events related to opioid tapering, such as accidental overdose if patients resume use of high-dose opioids or switch to illicit opioid sources or onset of suicidality or other mental health symptoms,” wrote Krebs.

PROP founder Andrew Kolodny, MD, read the review and liked it, tweeting that “dangerously high doses should be reduced even if patient refuses.”

But forced opioid tapering is never a good idea, according to a top CDC official.

“Neither (Kreb’s) review nor CDC's guideline provides support for involuntary or precipitous tapering. Such practice could be associated with withdrawal symptoms, damage to the clinician–patient relationship, and patients obtaining opioids from other sources,” wrote Deborah Dowell, MD, a CDC Senior Medical Advisor, in an editorial also published in the Annals of Internal Medicine. 

As for Krebs’ contention that there is “insufficient evidence” of adverse events associated with opioid tapering, that notion may be put to rest next month when the VA releases a new study showing that tapering has led to a growing number of suicides by veterans.

In a summary of the findings, which will be presented at the Rx Drug Abuse & Heroin Summit, VA researchers report that “opioid discontinuation was not associated with overdose mortality, but was associated with increased suicide mortality.”  

Who and what should we believe in the neverending debate about opioids? PNN columnist Roger Chriss wrote about Krebs’ opioids vs. non-opioids study last year, when the initial reports of its findings came out. Roger said prescribing decisions are best left to physicians who know their patients’ medical conditions – not researchers, regulators or the news media.

“In reality, there is no ‘versus’ here. Opioids and NSAIDs are both valuable tools for chronic pain management. To pretend that one is inherently better than the other is to miss the essential point: Both work and should be available for use as medically appropriate,” Roger wrote. 

VA Studies Find Little Evidence for Medical Cannabis

By Pat Anson, Editor

There is not enough evidence to support the effectiveness and safety of cannabis and cannabinoid products in treating chronic pain or post-traumatic stress disorder (PTSD), according to a pair of new studies published in the Annals of Internal Medicine.

Researchers at the U.S. Department of Veterans Affairs reviewed 27 clinical studies on the benefits and harms of cannabis in treating chronic pain, and found most of the studies were small, many had methodological flaws, and the long-term effects of cannabis were unclear because there was little follow-up in most of the studies.

None of the studies directly compared cannabis with opioid pain medication and there was no good-quality data on how cannabis affects opioid use, according to researchers.

“Although cannabis is increasingly available for medical and recreational use, little methodologically rigorous evidence examines its effects in patients with chronic pain. Limited evidence suggests that it may alleviate neuropathic pain, but evidence in other pain populations is insufficient,” wrote lead author Shannon Nugent, PhD, VA Portland Health Care System.

“Even though we did not find strong, consistent evidence of benefit, clinicians will still need to engage in evidence-based discussions with patients managing chronic pain who are using or requesting to use cannabis.”

Medical marijuana is legal in 28 states and the District of Columbia, and many patients are using it for pain relief. Up to 80 percent of people who seek medical cannabis do so for pain management and nearly 40 percent of those on long-term opioid therapy for pain also use cannabis. Veterans Affairs policy currently doesn’t allow for cannabis use in the huge VA healthcare system, even in states where it is legal.

According to a 2014 Inspector General’s study, more than half of the veterans being treated at the VA have chronic pain, as well as other conditions that contribute to it, such as PTSD.

‘Very Scant Evidence’ on Cannabis for PTSD

More than a third of the patients who use cannabis in states where it is legal list PTSD as their primary reason. But, as with chronic pain, VA researchers found “very scant evidence” to support the use of cannabis to treat PTSD.

“Despite the limited research on benefits and harms, many states allow medicinal use of cannabis for PTSD. The popular press has reported many stories about individuals who had improvement in their PTSD symptoms with cannabis use, and cross-sectional studies have been done in which patients with more severe PTSD reported cannabis use as a coping strategy,” wrote lead author Maya O’Neil, PhD, VA Portland Health Care System.

“However, it is impossible to determine from these reports whether cannabis use is a marker for more severe symptoms or is effective at reducing symptoms, or whether the perceived beneficial effects are the result of the cannabis, placebo effects, or the natural course of symptoms.” 

Clinical evidence may be lacking, but supporters of medical marijuana say they’ve seen plenty of anecdotal evidence that cannabis works for both pain and PTSD.

“They claim no benefits are shown but with the number of people we have met with PTSD that have been able to function and improve with the use of cannabis, I would say the ‘proof is in the pudding.’ Seeing their lives improve tremendously says a lot about success,” said Ellen Lenox Smith, a PNN columnist who is co-director of cannabis advocacy for the U.S. Pain Foundation and a caregiver under Rhode Island’s medical marijuana program. 

“We have not met a person yet that has not been enjoying the improved quality of their life using cannabis for PTSD. We fought a long hard battle to have it included as a qualifying condition and it was worth the battle. Patients are finding peace and calm they were not experiencing before using cannabis. Sleep has improved and without a good night rest, anyone's next day is a terrible struggle.”

Like it or not, the “horse is out of the barn” when it comes to cannabis use, according to an editorial also published in the Annals of Internal Medicine.

“Even if future studies reveal a clear lack of substantial benefit of cannabis for pain or PTSD, legislation is unlikely to remove these conditions from the lists of indications for medical cannabis,” wrote Sachin Patel, MD, Vanderbilt Psychiatric Hospital.

“It will be up to front-line practicing physicians to learn about the harms and benefits of cannabis, educate their patients on these topics, and make evidence-based recommendations about using cannabis and related products for various health conditions. In parallel, the research community must pursue high-quality studies and disseminate the results to clinicians and the public.”

VA Study Could Lead to More Cuts in Opioid Prescribing

By Pat Anson, Editor

A new study by a prominent think tank could give further ammunition to the Department of Veterans Affairs to reduce access to opioid pain medication in its healthcare system.

Researchers at the RAND Corporation studied data from nearly 32,500 patients who were treated at VA facilities in 2007 and were identified as having an opioid use disorder. The goal was to identify “quality measures” that could help reduce the death rate of addicted patients.

The researchers found that deaths were much lower among patients who were not prescribed opioids or anxiety medications, those who received counseling, and patients who had regular visits with a VA physician. They estimate the number of deaths could be reduced by a third if all three quality measures were adopted. 

"This is a very large drop in mortality and we need to conduct more research to see if these findings hold up in other patient care settings," said Dr. Katherine Watkins, a physician scientist at RAND and lead author of the study published in the journal Drug and Alcohol Dependence.

"But our initial findings suggest that these quality measures could go a long way toward improving patient outcomes among those who suffer from opioid addiction."

The findings suggest that a key to reducing mortality is to minimize the prescribing of opioid medication and benzodiazepines to veterans with opioid addiction. Benzodiazepines are a class of psychiatric medication used to treat anxiety disorders.

Because lower death rates were also associated with counseling and quarterly visits with a VA physician, researchers concluded that addicted patients benefit from making a connection with a caregiver, who can identify changes in their behavior and potential for relapse.

Surprisingly, patients in the study who were prescribed addiction treatment drugs such as Suboxone (buprenorphine) did not have lower death rates.

"We know from other research that medication-assisted therapy can help people stay off drugs, get jobs and lead more-productive lives," Watkins said. "But in this study, the treatment strategy was not associated with lower mortality."

The VA has already taken a number of measures to reduce opioid prescribing, including a new guideline that strongly recommends against prescribing opioids for chronic pain. VA physicians are also being urged not to prescribe opioids long-term to anyone under the age of 30. The guideline recommends exercise and psychological therapies such as cognitive behavioral therapy as treatments for chronic pain, along with non-opioid drugs such as gabapentin.

“We’ve been working on this now for seven years and we’ve seen a 33 percent reduction in use of opioids among veterans, but we have a lot more to do. We have a lot we can learn,” Secretary of Veterans Affairs David Shulkin told a White House opioid commission earlier this month. "At the VA, my top priority is to reduce veteran suicides. And when we look at the overlap with substance abuse and opioid abuse, it’s really clear.”

According to a recent VA study, an average of 20 veterans die each day from suicide, a rate that is 21 percent higher than the civilian population.  Veterans also suffer from high rates of chronic pain, depression and post-traumatic stress disorder.

McCain Calls for New Study of Veteran Suicides

By Pat Anson, Editor

Arizona Senator John McCain has reintroduced legislation that calls for a comprehensive review of veteran suicides by the Department of Veterans Affairs (VA), including the role of opioids and other prescription drugs in their deaths.

Veterans suffer from high rates of chronic pain, depression and post-traumatic stress disorder (PTSD). According to a recent VA study, an average of 20 veterans die each day from suicide, a rate that is 21 percent higher than the civilian population.

“The tragedy of 20 veterans a day dying from suicide is a national scandal,” said McCain. “Combatting this epidemic will require the best research and understanding about the key causes of veteran suicide, including whether overmedication of drugs, such as opioid painkillers, is a contributing factor in suicide-related deaths.”

If passed, the Veterans Overmedication Prevention Act would authorize an independent study by the National Academies of Sciences of veterans who died of suicide, violent death or accidental death over the last five years – including what drugs they were taking at the time of their death.

The bill specifically calls for a listing of “any medications that carried a black box warning, were prescribed for off-label use, were psychotropic, or carried warnings that include suicidal ideation.”

SEN. JOHN MCCAIN

SEN. JOHN MCCAIN

Dozens of medications prescribed to treat chronic pain, depression or PTSD are psychotropic – meaning they affect a patient’s mental state. They include tranquilizers, sedatives, antidepressants and anticonvulsants such as Lyrica (pregabalin), Cymbalta (duloxetine), Neurontin (gabapentin), Xanax (alprazolam), and Valium (diazepam). Many of the drugs also have warning labels that they “may cause suicidal thoughts or actions.”

McCain’s bill may bring new attention to something that is rarely discussed in the national debate over opioids and the overdose epidemic: many of the drugs prescribed "off label” as alternatives to opioids raise the risk of suicide and have other side effects.

“I almost committed suicide myself after being prescribed Lyrica and Cymbalta. I went from 190 pounds to 300 pounds, and had suicidal thoughts almost from the outset,” Alessio Ventura wrote in a recent guest column for PNN. “After the Lyrica and Cymbalta were stopped, I stayed on OxyContin and had bi-weekly testosterone shots. I lost all of the weight and the suicidal thoughts went away. It was a miracle.”

Vietnam veteran Ron Pence was pressured by VA doctors to take Cymbalta for his chronic arthritis.

“The VA is really pushing these drugs that I would not give to a dog. They are a lobotomy in a pill. I WILL DIE BEFORE TAKING THEM. They take away your ability to think, speak and make decisions; and come with side effects such as permanent blindness, kidney stones and suicide, even in non-depressed people with no mental problems,” Pence wrote in a guest column.

“Even trying to get off this drug under a doctor's care can end in death for some people. Besides that, it’s nothing more than a sugar pill for the pain.”

As PNN has reported, the VA recently adopted new clinical guidelines that strongly recommend against the prescribing of opioids for chronic pain. The guidelines recommend exercise and psychological therapies such as cognitive behavioral therapy, along with non-opioid drugs such as Neurontin. No mention is made that Neurontin and other non-opioid drugs raise the risk of suicide, only that they “carry risk of harm.”

McCain’s bill would require the National Academies of Science to study the medications or illegal substances in the system of each veteran who died; whether multiple medications were prescribed by VA physicians or non-VA physicians; and the percentage of veterans who are receiving psychological therapy and its effectiveness versus other treatments.

Should CDC’s Opioid Guidelines Be Revised?

By Pat Anson, Editor

Suicidal patients. Illegal drug use. Hoarding of pain pills. Pharmacists refusing to fill prescriptions. Doctors worried about going to jail. Chronic pain going untreated.

Those are some of the many problems uncovered in a PNN survey of nearly 3,400 pain patients, doctors and healthcare providers, one year after the release of opioid prescribing guidelines by the Centers for Disease Control and Prevention (see "Survey Finds CDC Opioid Guidelines Harming Patients"). The guidelines were meant to be voluntary and are only intended for primary care doctors, but they're being widely implemented throughout the U.S. healthcare system – often with negative consequences for the patients they were intended to help.

Over 70 percent of patients say doctors have either reduced or stopped their opioid medication. Eight out of ten say their pain and quality of life are worse. Nearly half are having suicidal thoughts and some are hoarding opioids or turning to the black market for pain relief.

And hardly anyone believes the guideline has been successful in reducing opioid abuse and overdoses.

“This is astounding, but not surprising,” says Lynn Webster, MD, a leading expert in pain management and a longtime critic of the CDC guideline. “It may be time for the CDC to consider inviting the pain community to help revise the guideline to more align with a public health policy that finds a better balance of avoiding opioid related problems, while also allowing opioids to be used in a responsible way.  

“The CDC should not have issued the guideline without a plan to measure its possible benefits and unintended consequences.”

Does the CDC even have such a plan? PNN asked the agency if one exists and also for a comment on the survey findings. We have yet to get a response. 

The founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid group that helped draft the guidelines, also declined to comment on the survey findings.

“I’m not going to want to comment either way,” said Andrew Kolodny, MD, before launching into a defense of the guideline.

“Since the CDC guideline came out, the bad news on opioids for chronic pain continues to increase. The evidence keeps getting stronger and stronger that opioids are lousy drugs for most people with chronic pain,” said Kolodny, who is Co-Director of the Opioid Policy Research Collaborative at Brandeis University.

“Opioids for chronic pain should be a rare treatment. And unfortunately the practice is widespread. Millions of people like your readers are victims of this aggressive prescribing,” he told PNN.

CDC Pledged to Revise Guideline if Needed

The closing words of the CDC guideline say the agency is “committed” to revising it if evidence is found that it's not helping patients or doctors.

“CDC will revisit this guideline as new evidence becomes available,” the agency pledged last year. “CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.”

Some critics are skeptical that CDC has any intention to revise the guideline.

“I am not aware of any actions which would demonstrate that the CDC is actually open to revising their guideline, especially when they knew of the problems in advance of its release,” said Stephen Ziegler, PhD, a Professor Emeritus of Public Policy at Indiana University-Purdue University.

Instead of revising, did they instead opt to hire a PR firm? The negative outcomes, while unintended, were nevertheless foreseeable.”

Ziegler is referring to a contract the CDC signed last year with PRR – a Seattle-based public relations firm – to provide research and analysis for the agency. The research wasn’t focused on the “intended and unintended” impact of the guidelines, but on why they were received so poorly in the pain community.   

“They’ve heard a lot of outrage about this,” a source at PRR told us. “And so they hired our firm to gauge those perceptions and talk to people and come back to them with an analysis of what those perceptions are.”

Lynn Webster thinks the CDC needs to do more than hire a public relations consultant.

“I think it is time for Congress to ask the CDC to provide them a detailed report on the impact the opioid prescribing guideline has had on access to appropriate pain management, quality of care for people in pain, access to insurance coverage of alternative and complementary therapies recommended by the guideline, impact on the number of opioid related overdoses, rate of change reported in treatment for opioid use disorder, and change in possible suicide rate with people in pain due to inadequately treated pain,” said Webster, a former President of the American Academy of Pain Medicine.

Voluntary Recommendations Become Mandatory

Some believe the problem isn’t so much the wording of the guideline as the way it is being implemented by physicians, states, insurers and other federal agencies like the Department of Veterans Affairs (VA) and the Centers for Medicare and Medicaid Services (CMS). They’ve turned the CDC’s voluntary recommendations for primary care doctors into mandatory rules that all prescribers have to follow. 

“I've said about both the CDC guideline and the Washington state guidelines from years ago, that what they actually say isn't so bad. I can live with most of it. The problem is that people take what is there and turn it into something it shouldn't be,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“With respect to the CDC guideline, the problem is that everyone is trying to turn it into laws, rules, and criteria for prior authorization for payment, and those things absolutely shouldn't be done. If everyone treated it as what it is -- a series of expert-drafted suggestions -- we'd be doing OK. It might even have helped a lot of people.”

Millions of veterans and Medicare beneficiaries are about to learn what Twillman means about the guideline being turned “into something it shouldn’t be.”  

CMS is planning to adopt new rules to “better align” its policies with the CDC’s.  Medicare’s “Opioid Misuse Strategy” not only makes the guidelines mandatory, it allows insurance companies to take punitive action against doctors, pharmacists and patients who don’t follow them.

The VA and Pentagon have also released new guidelines that take the CDC’s recommendations a big step further. They strongly recommend against prescribing opioids long-term to anyone under the age of 30, and urge VA and military doctors to taper or discontinue opioids for any patients currently receiving high doses.

“You should take a look at the VA guideline that just came out, if you don’t like the CDC guideline,” says Andrew Kolodny. “The VA guideline is even stronger. It says don’t give opioids. Opioids are not preferred. Don’t do it.”

Lost in the shuffle of all these new rules and regulations is the voice of pain patients. Many who responded to our survey are fearful of becoming disabled or bedridden if opioids are taken away from them. And some believe the government has an ulterior motive.

“This is a silent genocide aimed squarely at Baby Boomers. An expedited way to avoid paying Social Security benefits to those who are approaching retirement or are receiving benefits. I am ashamed of our country,” wrote one patient.

“Completely wrong approach which will, I believe, result in more addiction as patients experiencing intolerable suffering are forced to look outside the medical system for relief,” said another.

“This is going to backfire on the CDC, Medicare, Medicaid, etc. The CDC is punishing every single person on pain medications,” wrote another patient. “People will die because of this, but they don't seem to care about any of the consequences of these guidelines. Being in pain is a terrible thing, I know from experience. I wouldn't even be able to work if it weren't for my pain medication. This is all very stressing, and I only see bad results coming out of this.”

The online survey of 3,108 pain patients, 43 doctors and 235 other healthcare providers was conducted between February 15 and March 11 by Pain News Network and the International Pain Foundation (iPain).

To see the complete survey results, click here.