Opioid Addiction Linked to Range of Health Problems

By Pat Anson, Editor

An extensive new analysis of insurance claims has found that patients being treated for opioid addiction are much more likely to suffer from a wide range of other health problems, including hepatitis C, HIV, bronchitis, fibromyalgia and chronic pain.

The large study by Amino – a healthcare information company – looked at 205 million private health insurance claims involving patients with “opioid use disorder,” a loosely defined diagnosis that includes both mild and severe forms of “problematic” opioid use. The diagnosis does not distinguish between prescription opioids used therapeutically and illegal opioids such as heroin that are used recreationally.

In just four years, Amino found a 6-fold increase in the number of Americans diagnosed with opioid use disorder, from 241,000 in 2012 to 1.4 million 2016.  

Amino also found that patients with opioid use disorder were significantly more likely to be diagnosed with diseases linked to substance abuse and intravenous drug use, including hepatitis C, HIV, alcoholism and mental health issues.

“Behavioral health issues like alcoholism and binge drinking were 8.4x and 5x more frequently diagnosed among patients who were also diagnosed with opioid use disorder, while mental health issues like suicidal ideation and post traumatic stress disorder were 6.9x and 4.2x more frequently diagnosed,” wrote Amino researcher Sohan Murthy.

Murthy and his colleagues also found many diagnoses related to pain, including chronic regional pain syndrome (CRPS), herniated disc, failed back syndrome, stenosis and fibromyalgia.

Stanford psychiatrist Anna Lembke, MD, a board member of Physicians for Responsible Opioid Prescribing (PROP), told Amino there is a high risk for addiction even when opioids are prescribed for a “bonafide” medical use.

“What I thought was really interesting was the correlation with failed back syndrome. Perhaps failed back syndrome is a risk factor for developing an opioid use disorder—and that could be part of the reason why this community experiences such chronicity and lack of improvement. This is a subgroup that’s especially vulnerable to opioid misuse,” Lembke said.

"Failed back syndrome" is a diagnosis used to describe patients who do not respond or whose pain grows worse after spinal surgery, injections or other "interventional" procedures. Ironically, these same procedures are often promoted as "non-opioid" treatments for chronic back pain.

Amino notes in the study that the data does not make a "causal" link between different diagnoses, meaning the study doesn't conclude that opioid use disorder causes hepatitis C or HIV. However, the FDA recently asked that Opana ER be removed from the market  because the painkiller was associated with outbreaks of hepatitis C, HIV and other diseases spread by intravenous drug use; indicating that health problems other than abuse and addiction are now being used by the agency as a rationale to limit the sale of opioids.

Amino found that geography is often a major factor in the diagnosis of opioid use disorder. The study found a disproportionate number of patients with opioid use disorder in Appalachia and Florida, suggesting that doctors in regions with a history of opioid abuse may simply be more likely to make the diagnosis.  Kentucky alone had 9 of the top 10 counties for doctors treating a high volume of patients with opioid use disorder.

Addiction Treatment Initial Focus of Opioid Commission

By Pat Anson, Editor

President Trump’s commission on drug addiction and the opioid crisis held its first public meeting today, a two-hour session focused largely on expanding access to addiction treatment.

Chaired by New Jersey Governor Chris Christie, the commission is expected to make interim recommendations to the president in the next few weeks on how to combat drug abuse, addiction and the overdose epidemic, which is blamed for the deaths of nearly 60,000 Americans last year. A final report from the commission is due by October 1.

It is not clear yet how much of a role opioid prescribing and pain medication will play in the commission’s work. Most of its five members have publicly blamed overprescribing for causing the opioid epidemic.

“No offense, but that is where this came from,” said Massachusetts Gov. Charlie Baker, a commission member.

“The opioid crisis is ruining lots of people’s lives and lots of families across America," David Shulkin, Secretary of Veterans Affairs told the commission. "At the VA, my top priority is to reduce veteran suicides. And when we look at the overlap between substance abuse and opioid abuse, it’s really clear.

“We’ve been working on this 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.”

Shulkin did not mention that veteran suicides have soared during that period, and are now estimated at 20 veterans each day.

“We also need to look at pharmaceutical companies making generic drugs more tamper resistant and looking at making drugs that do not cause addiction,” said North Carolina Gov. Roy Cooper, a commission member.

Commission member Patrick Kennedy, a former congressman who has battled substance abuse himself, said there has been a “historic discrimination” against mental health and addiction treatment.

“I’m excited by the chance to kind of push for ways that we can hold insurance companies more accountable, so that the public sector doesn’t have to pick up the tab. Because its taxpayers that are picking up the tab when insurance companies continue to push folks with these illnesses off into the public system,” Kennedy said. “This is a cost shift that is a windfall for insurance companies if they can get rid of people who have mental health or addiction issues.”

Limits on Opioid Medication Not Working

“Let me be blunt. Today there is not nearly enough drug treatment capacity in America to help most of the victims of the epidemic,” said Mitchell Rosenthal, MD, who founded Phoenix House, a nationwide chain of addiction treatment centers.

“Most terrifying is the reality that nothing we are doing today has been able to halt the spread of opioid addiction. Controlling prescription opioid medication has not done so. Prescription monitoring programs, strict limits on the number of pills physicians can prescribe, and the CDC pain management guidelines seem to have capped usage of prescribed opioid medications. But overdose deaths from heroin and highly potent synthetics like fentanyl have gone through the roof.”

One activist called for wider adoption of the CDC opioid guidelines and rigid enforcement if doctors don’t follow them. Gary Mendell, the CEO and founder of Shatterproof, a non-profit focused on preventing addiction, said each state should be held accountable and federal funding reduced to states if their prescribing exceeds a certain level.

“If every primary care doctor in this country followed the CDC guideline, you would cut by more than half, instantly, the number of new people becoming addicted,” said Mendell, whose son committed suicide after years of struggle with addiction. “We need a goal for the country. Divide it up by 50 states, a proper goal developed by the CDC, and then we need to publicize it and hold people accountable. Just like you would do in any business.”

Patrick Kennedy is a member of Shatterproof's board of advisors, and Andrew Kolodny, MD, founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP) is a member of its "opioid overdose advisory board."

No pain patients or pain management experts testified before the commission or were appointed to the panel.

Watch below for a replay of today's meeting:

FDA to Review All Abuse Deterrent Opioids

By Pat Anson, Editor

A week after asking that Opana ER be taken off the market, the head of the Food and Drug Administration has ordered a review of all opioid painkillers with abuse deterrent formulas to see if they actually help prevent opioid abuse and addiction.

The move is likely to add to speculation that the FDA may seek to prevent the sale of other opioid painkillers.

“We are announcing a public meeting that seeks a discussion on a central question related to opioid medications with abuse-deterrent properties: do we have the right information to determine whether these products are having their intended impact on limiting abuse and helping to curb the epidemic?” FDA commissioner Scott Gottlieb, MD, said in a statement.

Gottlieb said the FDA would meet with “external thought leaders” on July 10th and 11th to assess abuse deterrent formulas, which usually make medications harder for addicts to crush or liquefy for snorting and injecting. He did not identify who the thought leaders were.

“Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof. These drugs can still be abused, particularly orally, and their use can still lead to new addiction,” Gottlieb said. “Nonetheless, these new formulations may hold promise as one part of a broad effort to reduce the rates of misuse and abuse. One thing is clear: we need better scientific information to understand how to optimize our assessment of abuse deterrent formulations.”

In a surprise move last week, the FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing concerns that the oxymorphone tablets are being liquefied and injected. It’s the first time the agency has taken steps to stop an opioid painkiller from being sold.

“I am pleased, but not because I think that this one move by itself will have much impact,” Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing (PROP) told Mother Jones. “I’m hopeful that this signals a change at FDA—and that Opana might be just the first opioid that they’ll consider taking off the market. It’s too soon to tell.”

Opana was reformulated by Endo in 2012 to make it harder to abuse, but addicts quickly discovered they could still inject it. The FDA said Opana was linked to serious outbreaks of HIV, Hepatitis C and a blood clotting disorder spread by infected needles.

Endo has yet to respond to the FDA request. If the company refuses to stop selling Opana, the agency said it would take steps to require its removal from the market by withdrawing approval.

“The request to voluntarily remove the product is one thing, but it comes with a lot of other questions that are unanswered,” Endo CEO Paul Campanelli reportedly said at an industry conference covered by Bloomberg. “We are attempting to communicate with the FDA to find out what they would like us to do.”

Patient advocates say it would be unfair to remove an effective pain medication from the market just because it is being abused by addicts.

“The FDA is following a political agenda, rather than its mandate to protect the public health,” said Janice Reynolds, a retired oncology nurse who suffers from persistent pain. “Depriving those who benefit from the use of Opana ER to stop people from using it illegally is ethically and morally wrong.”

Sales of Opana reached nearly $160 million last year. The painkiller is prescribed about 50,000 times a month.

"This is something that could potentially apply to other drugs in the future, as it may signal a movement by the FDA to start taking products off the market that don't have strong abuse-deterrent properties," industry analyst Scott Lassman told CorporateCounsel.com.

The FDA put drug makers on notice four years ago that they should speed up the development of abuse deterrent formulas (ADF).  Acting on the FDA's guidance, pharmaceutical companies spent hundreds of millions of dollars developing several new opioid painkillers that are harder to chew, crush, snort or inject.

Were they worth the investment? Not according to a recent study funded by insurers, pharmacy benefit managers and some drug makers.

The Institute for Clinical and Economic Review (ICER), a non-profit that recommends which medications should be covered by insurance and at what price, released a report last month that gave ADF opioids a lukewarm grade when it comes to preventing abuse.

“Without stronger real-world evidence that ADFs reduce the risk of abuse and addiction among newly prescribed patients, our judgment is that the evidence can only demonstrate a ‘comparable or better’ net health benefit (C+),” the ICER report states.

The insurance industry has been reluctant to pay for ADF opioids, not because of any lack of effectiveness in preventing abuse, but because of their cost. A branded ADF opioid like OxyContin can cost nearly twice as much as a generic opioid without an abuse deterrent formula.  According to one study, OxyContin was covered by only a third of Medicare Part D plans in 2015. Many insurers also require prior authorization before an OxyContin prescription is filled.  

Trump Opioid Commission to Hold First Meeting

By Pat Anson, Editor

The pain community will get its first glimpse this month at how the Trump administration may address the nation’s opioid crisis, when the president’s new Drug Addiction and Opioid Commission holds its first two meetings.

The commisison's first meeting will be held Friday June 16, followed by a teleconference on Monday June 26. Both meetings are open to the public.

Details on how to watch or listen to the meetings can be found in the Federal Register, here and here.

Chaired by New Jersey Governor Chris Christie, the commission will make recommendations to the president later this year on how to combat drug abuse, addiction and the overdose crisis, which is blamed for over 50,000 deaths in 2015.

The White House says the commission will “work closely” with President Trump’s son-in-law and senior advisor, Jared Kushner.

“I made a promise to the American people to take action to keep drugs from pouring into our country and to help those who have been so badly affected by them. Governor Christie will be instrumental in researching how best to combat this serious epidemic and how to treat those it has affected,” Trump said in a statement.  

The public can submit written comments to the commission by emailing the Office of National Drug Control Policy at commission@ondcp.eop.gov.

“I'd really like to see the commission recognize that addressing opioid use disorders through increasing access to treatment and through attempting to reduce the supply of opioids (both legal and illegal) will only go so far, and that, to be truly successful, they also must address inadequacies in the way we treat pain,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, which represents pain management physicians.

“Unless and until we reach a point where we can truly implement the kind of integrative pain care called for by every guideline and highlighted in the National Pain Strategy, we are going to be unable to succeed in addressing both of the public health crises we are encountering.”

Twillman helped draft and submit a letter to the commission signed by 73 different medical and patient advocacy groups calling for more federal funding of pain research and treatments.

“This longstanding underinvestment in pain research has resulted in a limited number of safe and effective chronic pain treatments, and according to the FDA, a field that is 'strikingly deficient' in high-quality evidence to assess risks and benefits of current treatments,” the letter states. “As a result, even highly knowledgeable health care providers are left without clear guidance, and may spend months to years with their patients experimenting with treatments in the hope of finding relief.”

Richard Martin, a retired Nevada pharmacist disabled by chronic back pain, says the first item on the commission’s agenda should be to withdraw and re-write the CDC’s opioid guideline, which discourages physicians from prescribing opioids for chronic pain.

“Since the Guideline was released, there are now tens of thousands of non-cancer pain patients on long term opioid prescription therapy who are being INVOLUNTARILY tapered down or off of their pain medications.  This has resulted in patients being under treated, left to suffer with debilitating pain.  Some of these patients have had their opioid medications abruptly discontinued throwing them into withdrawal,” Martin wrote in an email to the commission.

“There now abounds significant anecdotal evidence and significant documented media reports, that these patients who have been involuntarily tapered down or off their opioid medications, are committing suicide due to the intense pain that has resulted.” 

Background of Commission Members

In addition to Gov. Christie and Jared Kushner, the president has appointed to the commission 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.

Gov. Christie, who lost a close friend to painkiller addiction, has seen his home state of New Jersey ravaged by the opioid crisis, with 1,600 overdose deaths in 2015.  Christie championed a new state law that limits opioid prescriptions for acute pain to just five days.  

Gov. Cooper supports similar legislation now under consideration in North Carolina.  Over 1,100 North Carolinians died from opioid overdoses in 2015, with prescription opioids involved in about half of them.

Gov. Baker’s home state of Massachusetts lost over 2,000 people to opioid overdoses in 2016, most of them caused by heroin and illicit fentanyl. Baker apparently got an inside track on the commission when he discussed the opioid crisis with Ivanka Trump while sitting next to her during a National Governors Association dinner.

Bertha Madras recently authored an editorial in JAMA Psychiatry in which she claimed that prescription opioids “remain a primary driver of opioid-related fatalities” and called on the medical community to limit the supply of opioid medication.

Patrick Kennedy has battled substance abuse issues since he was teenager, including addiction to the painkiller OxyContin. He now works for Advocates for Opioid Recovery, a non-profit funded in part by Braeburn Pharmaceuticals, which makes an implant that dispenses the addiction treatment drug buprenorphine.

New Drug Testing Guideline Warns Against Fraud

By Pat Anson, Editor

A new guideline on the use of drug testing by the American Society of Addiction Medicine (ASAM) warns against expensive and unnecessary tests that have led to “unethical and/or fraudulent activities.”

The ASAM is a professional society that represents over 4,300 physicians and specialists in addiction treatment. Its new guideline – the first attempt to set national standards for clinical drug testing – could also influence primary care providers and pain management specialists who are increasingly testing their patients for opioid misuse.  

"Drug testing is a valuable tool for supporting patients in addiction treatment, and this comprehensive set of recommendations should prove useful to providers in a variety of addiction treatment settings," said Margaret Jarvis, MD, Chair of ASAM's Quality Improvement Council.

The new guideline, developed by an 11-member expert panel, is published in the Journal of Addiction Medicine.

“ASAM is acutely aware that this document will be released in a context where a lack of clarity about the appropriate use of drug testing has led not only to inconsistent clinical practice, but also unethical and/or fraudulent activities,” the guideline says.

“One of the purposes of this document is to clarify appropriate clinical use of drug testing and, in so doing, shine a light on drug-testing practices that are clearly outside of these boundaries. The delineation of appropriate treatment practices will confer multiple benefits; most importantly, it will improve patient care. At the same time, it will reduce waste and fraud.”

Drug testing has grown into a multi-billion dollar industry – what some call “liquid gold” – largely because so many doctors who treat addicts and chronic pain patients require them to submit to urine drug screens. Many experts consider the “point-of-care” immunoassay tests widely used in doctors’ offices unreliable because they often give false negative or false positive results.

Several drug testing laboratories have also paid heavy fines to settle fraud and kickback charges after they bilked Medicare, Medicaid, private insurers, and patients for unnecessary and expensive lab tests. The practice was so egregious that the Department of Health and Human Services issued a Special Fraud Alert in 2014 to warn physicians not to accept any payments, referrals, rent or reimbursements from drug testing companies.

The new ASAM guidelines say drug tests "should be widely used in addiction treatment settings," but warn that negative or positive findings about a patient’s use of drugs do not necessarily mean they have a substance use disorder. A patient who consumes poppy seeds, for example, could have a positive finding for morphine.

“The list of potential sources of false positives is too extensive to list here, but a few noted examples include; cough suppressants resulting in positive opioid results, ephedrine in cold medicine resulting in positive result for amphetamines, and antidepressants resulting in positive opioid results,” the guideline says.

“There are known limitations to urine immunoassays for opiate use and providers should be cautious when interpreting their results. Providers should carefully review the testing report produced by the laboratory to ensure they understand which opiates and opioids a test is capable of detecting.”

The ASAM’s expert panel said there was no “magic formula” to determine how often a patient should be drug tested. Testing should be done at least weekly at the beginning of addiction treatment, according to the guideline, and at least monthly in patients in stable recovery. Testing should be performed on a random schedule, when possible.

The guideline also cautions physicians not to be confrontational with patients if a test has an unexpected finding.

“Drug testing should function as a therapeutic tool, so a provider's response to test results should not be confrontational. This approach can perpetuate an ‘us versus them’ mentality that reduces the effectiveness of drug testing to support recovery,” the guideline says.

The ASAM guideline also advises physicians on other issues such as urine tampering, patient confidentiality, practitioner education, and how to select reliable tests and laboratories.

Chronic Pain Patients Did Not Cause Opioid Epidemic

By Roger Chriss, Columnist

Contrary to common belief, chronic pain patients are not all opioid addicts and did not cause the opioid crisis. The vast majority of patients who are prescribed opioids rarely misuse or abuse them.

Opioid addiction is real and should not be ignored or downplayed, but we need to identify its true causes. Despite the growing number of restrictions on prescription opioids, overdoses and related deaths continue to rise, which strongly indicates that pain patients have very little to do with the so-called epidemic.

Some recent articles bear this out:

Science Daily reports that while the national death toll from opioid overdoses is soaring, only “a small minority of pain patients are represented in the mortality data.”

The journal Pain Medicine published research showing that most pain patients on low doses of short-acting opioids “have a low risk for developing a substance use disorder.”

Similarly, chronic pain patients generally do not experience dose escalation, but often remain stable at the same dose for months or even years. And according to the National Institute of Drug Abuse, doctor shopping by pain patients is rare.

For most chronic pain patients, opioid medications are part of a larger daily routine of pain management, and opioids are not craved any more than an athlete craves a vitamin supplement. Thus, the risks of opioid addiction among chronic pain patients is quite low overall, and there are well-established protocols such as the Opioid Risk Tool to screen patients and monitor those whose risk may be higher.

But all this evidence does not seem to convince regulators, politicians, the news media, and anti-opioid activists like Physicians for Responsible Opioid Prescribing (PROP). Fortunately, it can be clearly shown they are wrong and that chronic pain patients are unfortunate bystanders in the opioid epidemic.

First, there simply are not enough chronic pain patients on opioid therapy to account for the number of opioid and heroin addicts. The American Society of Addiction Medicine estimates that in 2016 there were over 2.5 million people addicted to prescription pain relievers or heroin.

There are at most 11.5 million chronic pain patients on opioid therapy. Even if 5 percent of them develop a substance abuse disorder, that would give us 575,000 opioid addicts. Where did the other 2 million addicts come from?

Second, people who suffer from chronic pain disorders are no longer prescribed opioids lightly or quickly. Instead, they start with NSAIDs like ibuprofen or naproxen, then onto anti-seizure medications like gabapentin or anti-depressants like amitriptyline or duloxetine, all the while also trying physical therapy, injections or other modalities. They are carefully screened, monitored and assessed along the way, with opioids considered only if everything else fails. This makes addiction a rare outcome.

Third, media coverage of the opioid epidemic and case literature on opioid use disorder routinely describe people becoming addicted to opioids after recreational use, trauma or surgery. It may be that “opioid addiction often starts with a prescription,” but it is usually a prescription for acute pain. And for many, the addiction starts with someone else’s prescription, perhaps taken from a family member or obtained from a friend.

Therefore, the treatment of chronic pain conditions can at most have only minimally contributed to the opioid epidemic. Chronic pain patients are not opioid addicts any more than a diabetic is an insulin addict, and in fact insulin is abused.

Unfortunately, chronic pain patients are often treated like addicts and the doctors who prescribe to them are even called “drug dealers.” This is harming chronic pain patients, doctors and people suffering from opioid addiction.

Opioid therapy helps people with chronic pain disorders remain employed, care for themselves and their families, and contribute to and participate in their communities. They are achieving what modern medicine and society wants: people who can work, pay taxes, avoid becoming a burden, and enjoy some quality of life.

Restricting opioids is not slowing the opioid epidemic. The increased availability of naloxone and improved care by first responders and emergency departments is helping to reduce fatalities, but opioid addiction still needs treatment and at present there is not enough of it.

To be clear, chronic pain patients and opioid addicts are two distinct groups, both of which deserve care and support. Treating pain patients as addicts can lead to denial of care, which may actually increase the number of opioid addicts. And conflating chronic pain with opioid addiction may be delaying care for people struggling to find addiction treatment.

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.

Poorly Treated Pain Linked to Opioid Misuse

By Pat Anson, Editor

A provocative new study has found that untreated or poorly treated pain is causing many young adults to self-medicate and turn to the black market for pain relief. The research adds to a growing body of evidence that efforts to limit opioid prescribing are leading to more opioid misuse and addiction, not less.

The study, published in the Journal of Addiction Medicine, involved nearly 200 young adults in Rhode Island who used opioid pain medication “non-medically” – meaning they didn’t have a prescription for opioids or used them in a way other than prescribed. About 85 percent had experienced some type of injury or health condition that caused severe pain.

Three out of four said they started misusing opioids to treat their physical pain. Most went to see a doctor to treat their pain, but about a third -- 36 percent of the women and 27 percent of the men -- said their doctor refused to prescribe a pain medication.

“In addition to being denied medication to treat severe pain by a physician, a significant percentage (20%) of young NMPO (non-medical prescription opioid) users who reported experiencing a high level of pain did not try to obtain treatment from a doctor for reasons including the belief that they would be denied prescription painkillers and/or having no health insurance,” said lead author Brandon D.L. Marshall, PhD, of Brown University School of Public Health.

“Pervasive negative perceptions of healthcare providers (and/or the medical system in general), and also issues related to accessing healthcare resources, may also underlie the high prevalence of professionally unmitigated physical pain in this population of young adults who use NMPOs in Rhode Island.”

Participants were between the ages of 18 and 29, used opioids at least once non-medically in the past 30 days, and were enrolled in the Rhode Island Young Adult Prescription Drug Study (RAPiDS). Most also used heroin, marijuana, cocaine, LSD or another illegal drug more than once a week.

“Although this is a small study and we can't draw conclusions from it, I do think it sheds light on what can be unintended consequences if we are not willing to treat pain in people with increased risk factors and co-morbid mental health disorders,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “These results may reflect the increased number of physicians who are unwilling to prescribe an opioid if there are risk factors or maybe just unwilling to prescribe an opioid.  It also shows that a consequence of not treating severe pain in people who also have significant risk of abuse may lead to illicit drug use and more harm."

Participants in the study who did not see a doctor for their pain had a variety of reasons:

• 48% Thought they could handle the pain or manage it with over-the-counter drugs
• 25% Thought they would be denied a prescription painkiller
• 40% Don’t like seeing a doctor
• 25% Had no health insurance

This was not the first study to find a correlation between poorly treated pain and drug abuse. A 2012 study of young adults who misused opioids in New York City and Los Angeles found that over half self-medicated with an opioid to treat severe pain. One in four had been denied a prescription opioid to manage severe pain.

A recent study of 462 adults who injected drugs in British Columbia found that nearly two-thirds had been denied prescription opioids. Nearly half had also been accused of drug seeking.

A recent survey of over 3,100 pain patients by PNN and iPain found that 11% had obtained opioids illegally for pain relief and 22% were hoarding opioids because they weren’t sure if they’d be able to get them in the future. Large majorities believe the CDC opioid guidelines were failing to prevent opioid abuse and overdoses (85%), and were harmful to pain patients (94%).

Are Abuse Deterrent Opioids Working?

By Pat Anson, Editor

In 2013, the U.S. Food and Drug Administration put drug makers on notice that they should speed up the development of abuse deterrent formulas for opioid pain medication.

“(The) abuse and misuse of these products have resulted in too many injuries and deaths across the United States,” Douglas Throckmorton, MD, a top FDA official said at the time. “An important step towards the goal of creating safer opioids is the development of products that are specifically formulated to deter abuse.”

Acting on the FDA's guidance, pharmaceutical companies have spent hundreds of millions of dollars developing abuse deterrent formulas (ADFs) that make opioid medications harder for addicts to chew, crush, snort or inject. Several new opioids with ADF formulas have been approved by the FDA and more are still in the pipeline.

Was it worth the investment? Not according to a new study funded by insurers, pharmacy benefit managers and some drug makers.

The Institute for Clinical and Economic Review (ICER), a non-profit that recommends which medications should be covered by insurance and at what price, released a Draft Evidence Report  earlier this month that questions the effectiveness of ADF opioids, giving them a middling grade of C+ when it comes to preventing abuse.

“Without stronger real-world evidence that ADFs reduce the risk of abuse and addiction among newly prescribed patients, our judgment is that the evidence can only demonstrate a ‘comparable or better’ net health benefit (C+),” the ICER report states.

ICER also gave a lukewarm review to OxyContin, the painkiller that was reformulated by Purdue Pharma in 2010 after widespread reports that it was being abused and causing addiction.   

“Evidence on the impact of reformulated OxyContin on opioid abuse is mixed. The majority of time series studies found that after the abuse-deterrent formulation of OxyContin was introduced, there was a decline in the rate of OxyContin abuse,” the ICER report states. “However, the rate of abuse of other prescription opioids (ER oxymorphone, ER morphine, IR oxycodone) and heroin abuse may have increased during the same period.

“Furthermore, findings from direct interviews with recreational users showed that reformulated OxyContin may have limited impact on changing overall abuse patterns.”

Purdue objects to ICER’s analysis – citing another study that found reformulated OxyContin prevented 7,200 cases of abuse and $200 million in additional medical costs.

“ICER missed the opportunity to fairly evaluate the impact of these innovative technologies, recognized by the FDA, DEA, NIDA (National Institute of Drug Abuse) and other policy makers as an important component of addressing the opioid crisis,” the company said in a statement.

Purdue and other ADF makers are troubled by the ICER report because it gives cover to insurers who are already reluctant to pay for branded ADF opioids like OxyContin when generic opioids without abuse deterrent formulas are much cheaper.  According to one study, OxyContin was covered by only 33% of Medicare Part D plans in 2015. Many insurers create more hoops for patients and doctors to jump through by requiring that prior authorization be given before an OxyContin prescription is filled.  

ICER estimates the average annual cost of an ADF opioid (90mg MED) prescription at $4,234, nearly twice that of a non-ADF opioid ($2,124).  If all opioid medication was made with ADFs, ICER says the additional cost to patients and insurers would be $645 million over five years.

Are ADFs worth it, given their mixed record in preventing abuse and addiction?

According to startling cost-benefit analysis devised by ICER, preventing a single case of opioid abuse with ADFs costs $165,868. The same analysis found that preventing just one overdose death with ADFs would cost $977,119,566 – almost a billion dollars.

Survey Shows Addicts Abusing ADF Opioids

A new report from RADARS, a national drug abuse tracking system, would seem to support ICER’s analysis that ADFs are not making a significant impact on abuse. A survey of 1,775 addicts about to enter treatment in early 2017 found that ADF opioids were still being chewed, snorted, injected and smoked, but at rates "slightly lower" than those of non-ADF opioids.

SOURCE: RESEARCHED ABUSE, DIVERSION AND ADDICTION-RELATED SURVEILLANCE SYSTEM (RADARS) 

“The majority of individuals who abused an ER (extended release) opioid abused an ADF opioid (58.6%), but the proportion of respondents who reported abuse via tampering was slightly lower for ADF opioids than ER opioids as a whole. Among individuals entering treatment, abuse of prescription opioids by chewing, snorting, or injecting is prevalent with oral solid dosage formulations of both IR (immediate release) and ER opioids,” the RADARS report said.

Lost in the debate over the cost and effectiveness of ADF’s is the decreasing role played by prescriptions opioids in the nation’s overdose epidemic. As PNN has reported, prescriptions for hydrocodone and other painkillers have been declining for years, yet drug overdoses continue to continue climb; fueled by heroin, illicit fentanyl and other illegal drugs, for which there are no abuse deterrent formulas other than abstinence and sobriety.

The Difference Between Addiction and Dependence

By Michael Thompson, Guest Columnist

When a person consumes alcohol or takes a mood altering medication, several things start to happen. First, they begin to develop a tolerance for it, so that over time it takes more of the drug to get the same effect. That can lead to abuse and addiction.

A person may also develop a dependence on a drug.  That means they have a clinical need for a medication.  

Many pain sufferers have found they need more opioid medication to provide relief from their pain, but that doesn’t mean they abuse or misuse it. It also doesn’t make them addicts.

I am dependent on my blood pressure medication to keep my blood pressure in check, but I’m not addicted it. Diabetics are dependent on their medication, but they are not addicted. 

Last year the CDC came out with opioid prescribing guidelines for general practitioners. But restricting the legal prescribing of these drugs will have no effect on the fact that most addicts don’t get their medication from Walgreens or Wal-Mart.  They get their drugs from Bobby the Rat behind Walgreens, or behind the pool hall from Billy the Snitch or Joe the Jerk.  What Bobby, Billy and Joe are selling is heroin, counterfeit painkillers and other illegal drugs.

What effect do these restrictive guidelines have on the illegal use of opioids?  None whatsoever.  The prescribing of opioid painkillers has been on the decline for years.  Most people who overdose are killing themselves with illegal drugs, not drugs obtained from their family doctor. 

Sure, everyone has heard of doctor shopping junkies who will go to an unscrupulous physician, who for $20 in cash will write an opioid prescription without even an examination. But the number of addicts pales in comparison to the number of legitimate chronic pain suffers who have been on these quality-of-life saving drugs for years without ever abusing their medications. Most have no idea where to find Bobby, Billy or Joe, or how to go about buying illegal drugs on the street.

Millions of older adults suffer from osteoarthritis and other neurologically painful conditions for which there is no cure, but there is treatment.  Many are on high doses of pain medication and have been taking these drugs for years, without ending up in the gutter shooting heroin or with a tag on the toe, lying on a tray in in the county medical examiner’s office.  They are not the ones causing headlines. 

Many doctors wrongly believe the CDC guidelines are rules that apply to all who prescribe opioid medication.  They fear that the DEA will come barging in if they go over a minimal amount, prosecute them and take away their license.  Their fear has left many chronic pain patients hanging out to dry, including some who will die because their pain is not being appropriately treated. 

If you have ever suffered from chronic, intense pain you are aware that it is all consuming.  It literally takes over your life.  Many, like me, who once led active lives on high doses of opioids, are now housebound, unable to shop, cook, clean or in many cases even just walk from the bedroom to the kitchen. 

It is a horrible existence, sitting in a chair all day, just trying to make it from morning to evening, and then unable to sleep because the pain is so intense.  Many of these once functional chronic pain sufferers have had their medication cut in half or more. 

As a personal example, I have two torn rotator cuffs that won’t heal.  I have had two surgeries that failed to correct the problem.  My surgeon says he won’t do any more surgeries because the rotator cuffs just continue to tear.  But that’s not all.  I have no cartilage left in my knees, a detached bicep tendon in my left elbow, and peripheral neuropathy in my feet and hands that causes them to burn and ache.  It’s been years since I was able to wear shoes. 

Before the CDC guidelines came out, I was on 6 pills of opioid medication a day.  I had been on this dose for five years and never once abused my medication or took more than was prescribed.  I was able to play golf and worked out three times a week, which helped me to keep my weight off.  When my pain specialist cut my dose in half, I literally crashed and burned.  Since then I have been practically home bound.  My story is similar to that of many other chronic pain sufferers.

So what do we do?  Practically every chronic pain patient has been running from one doctor to another, trying to find someone who will maintain them on the medication that helped them to live a somewhat normal life.  Imagine going to a new specialist, only to find the waiting room filled with dozens of other “new patients” trying to find someone, anyone, who wasn’t terrified of the DEA.

Is the CDC aware that their guidelines for primary care doctors have turned into rules for everyone?  Surely someone has told them about this.  Surely they know.

What’s to become of us?  Will we see a spike in the suicide rate of older adults who can no longer stand the daily struggle?  Will anyone care?

There are a lot of organizations that have tried to explain that the guidelines are not hard and fast rules and that they apply only to general practitioners. But fear is a stronger motivator than common sense. 

It cannot be that drug addicts are more important than patients. Don’t suffer in silence. Call, write a letter, or email your senators and congressman.

Don’t know who represents you in Congress? You can look them up by clicking here.

Michael Thompson is a retired clinical social worker and a licensed chemical dependency counselor. He lives in Texas.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

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

Get the Facts Right About Opioids

By Barby Ingle, Columnist 

This past week Tucker Carlson aired a series of reports on Fox News about opioids and addiction. After night two of watching the “Drugged” special segments, I wondered if Fox would be willing to tell the patient side of the story and wrote to some Fox News producers I know to see if they wanted to interview me.

I didn’t know the specific producer for Carlson, but the next morning I received an email from her. I immediately responded and said yes, I would come on the show. We set it up for Thursday or Friday. Well, on Thursday we bombed Afghanistan with the “Mother of All Bombs” and they were unable to get me in.

The producer did say that they would be doing additional segments on the topic and that they are interested in bringing me on sometime in the next few weeks.

I watched the rest of the series, and on Wednesday Carlson said that 60 percent of veterans have chronic pain. That didn’t sound right to me and I wondered where Carlson got his facts from. He never said in his broadcast.

When I looked it up, I found a 2014 study in JAMA Internal Medicine that said 44% of military personnel develop chronic pain after a combat deployment. Also, not all of them are taking opioids as Carlson reported. Only 15% are taking opioids – compared to 4% in the general population.

When I get my chance to speak to Carlson or any other news outlet, I always suggest that we not take opioids off the table as a form of treatment for those with chronic pain. It is not the right thing to do in my educated opinion as a chronic pain patient. There are hundreds of treatment options, but many patients can’t afford them and insurance often won’t pay for them. You can’t leave patients without options.

Many people I know, including one of my best friends, committed suicide because of lack of proper and timely care. She wasn’t looking for opioids, she was looking for relief. She jumped from a 10-story building in New York.

Another friend spent months fighting for her medication after her insurance would no longer pay for her infusion therapy. Once her doctor finally gave her a prescription for fentanyl patches, she went home, put on all 60 patches and tried to commit suicide. She was found in time by her husband and was in a coma at a hospital for about a week.

When she awoke, she was pissed that they didn’t let her die. She wanted to die because she didn’t know how she was going to get any pain relief going forward. My friend is in an even worse situation now because the attempted suicide is on her medical record. She wants infusion therapy, but is denied it -- even though it gave her life back when she did have access to it.

I have been living with chronic pain for 20 years. This year I have been unable to find a provider who will even charge my insurance company for the infusion therapy that keeps me out of my wheelchair. I choose not to use opioids daily because they don’t work for me. But I don’t want to take them away from someone who they do help. That decision needs to be on an individual basis, between a provider and their patient.

We need to encourage pharmaceutical companies to address the addiction and tolerance in pain medications, and one way is the use of abuse deterrent formulas. Another is to get insurance companies, Medicare and workers compensation to cover alternative treatments so that we have more options. And for those who tried and failed with other treatments, we need to keep opioid medication available.

Patients also need to be responsible for their own actions and choices. Recently my doctor gave me a new script. Before filling it, I went home, Googled it, and saw the medication has potential negative side effects. I will be talking with my provider again in a week and will let him know that the medication is not right for me.

Patients need to be proactive about reading medication labels and inserts, and looking up information on our treatment options. We must educate ourselves and we must ask our providers questions. Being a responsible patient will lower the risk of abuse, and increase our access to proper and timely care.

Addicts are going to abuse no matter what is available. We chronic pain patients are simply asking for a seat at the table. Instead we are portrayed as wrong doers, who just want to get high on pain pills.

Carlson ended his week long series by saying he will continue to bring different voices and information to his viewers. His producer personally echoed that sentiment to me. I hope to be given the chance soon to come on his program and tell the patient side of the story, and the many challenges we face getting proper and timely pain care.  

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

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.

Studies Identify Riskiest Patients for Opioids

By Pat Anson, Editor

Two studies released this week suggest that pre-existing medical conditions and substance abuse play a strong role in determining whether a patient becomes a long-term opioid user or is hospitalized by an overdose.

The findings could help doctors identify pain patients more likely to develop opioid addiction, instead of flatly assuming that opioids are risky for everyone.

The first study, published in JAMA Surgery, looked at over 36,000 adults who were given a limited supply of opioids to control their pain after surgery. None of the patients had an opioid prescription in the year preceding their operation.

Only about 6 percent of the patients were refilling opioid prescriptions three to six months after their surgery.

The rate didn’t differ significantly between those who had a minor operation and those who had major surgery.

When researchers dug deeper, they found that many of the long term opioid users had similar medical issues. People with arthritis were about 60 percent more likely to keep filling prescriptions, while smokers were about 25 percent more likely. Those who suffered from depression and anxiety were about 20 percent likely to keep taking opioids.

"This points to an under-recognized problem among surgical patients," said lead author Chad Brummett, MD, director of the Pain Research division in the University of Michigan Medical School Department of Anesthesiology. "This is not about the surgery itself, but about the individual who is having the procedure, and some predisposition they may have."

More than 50 million surgical procedures are performed in the U.S. every year. If the study's findings hold true for all patients, researchers say over 2 million people who were "opioid naïve" before surgery could wind up receiving the drugs for months afterward.

Medical Conditions Linked to Overdoses

The second, much larger study looked at a database of over 18 million patients who had an opioid prescription between 2009 and 2013. Over 7,200 opioid overdoses that required hospitalization were identified.  

Researchers found that a previous diagnosis of substance abuse was the single factor most strongly associated with an overdose.  Bipolar disorder, schizophrenia, stroke, renal disease, heart failure and non-malignant pancreatic disease were also strongly associated with overdose risk. 

The risks linked to many of these pre-existing health conditions were so strong they outweighed the risk associated with taking high daily doses of opioids over 100 mg morphine equivalent dose (MED).

“The authors have been able to demonstrate in a very large population there are many risk factors far more important than opioid dose that predict overdose,” said Lynn Webster, MD, a leading expert in pain management and past president of the American Academy of Pain Medicine. 

“I have been lecturing and writing for a decade that dose is less of a contributing factor for overdoses than mental health and history of substance abuse disorders. This study supports what I have been saying.”

The study also identified the prescription opioids most strongly associated with overdose were fentanyl, morphine and methadone. Interestingly, the use of benzodiazepines and antidepressants was riskier than taking hydrocodone, oxycodone and tramadol.   

The study, published in the journal Pain Medicine, was conducted by Venebio, a Virginia-based research group.

"Pain and its management are complex and multidimensional, and the risk of an opioid overdose is likewise dependent on many factors," said Barbara Zedler, MD, lead author and chief medical officer of Venebio. "Primary care professionals express concern about prescription opioid misuse and find managing patients with chronic pain to be stressful. Many feel inadequately trained in prescribing opioids and treating or managing opioid use disorder or addiction." 

Venebio has developed an opioid risk screening tool – called the Venebio Opioid Advisor (VOA) – to help doctors identify patients at risk of having an opioid overdose. According to company officials, VOA predicts the likelihood of an overdose with nearly 90 percent accuracy.

“The apparent accuracy is extraordinary and if broadly implemented should save lives,” said Webster. “I hope the CDC, CMS (Centers for Medicare and Medicaid Services) and policymakers study this paper before they suggest further changes that could cause more suffering and harm for people in pain.”

According to the CDC, over 15,000 overdose deaths in U.S. in 2015 were linked to prescription opioids, although there’s no way of knowing whether the drugs were taken medically or recreationally. Another 18,000 overdoses involved heroin or illicit fentanyl, which have replaced painkillers as the driving force behind the nation’s opioid epidemic.

Why Pain Patients Should Worry About Chris Christie

(Editor’s Note: Last month President Donald Trump named New Jersey Gov. Chris Christie as chair of a new commission that will study and draft a national strategy to combat opioid addiction..

Gov. Christie has been a prominent supporter of addiction treatment and anti-abuse efforts.

He also recently signed legislation to limit initial opioid prescriptions in New Jersey to five days, a law that takes effect next month.)

white house photo

By Alessio Ventura, Guest Columnist

Unfortunately, Chris Christie's crackdown on opioids will have extremely negative consequences for people with acute and chronic pain in New Jersey. It is equivalent to gun control, where because of crime and mass shootings, innocent gun owners are punished.

The fact is that only a small percentage of opioid deaths are from legitimate prescriptions. Most overdose deaths are from illegal drugs or the non-medical use of opioids.

The government crackdown on opioids has created a literal hell on earth for people with severe pain, who often can no longer find the medication they need. This has become a major issue, even though there are other drugs that are just as dangerous when misused:

• Every year 88,000 people die from alcohol poisoning. There is no government war on alcohol.
• Every year over 40,000 people die from antidepressants. There is no government war on antidepressants.
• Every year 15,000 people die from non-steroidal anti-inflammatory drugs (NSAIDs) and 100,000 are hospitalized. There is no government war on NSAIDs.

Deaths from alcohol, antidepressants and NSAIDs far exceed deaths from opioids, yet it is opioid medication that gets all of the attention.

So when we see Chris Christie leading a new opioid commission, we chronic pain patients know full well that this just means more restrictions for us. Addicts and criminals will continue to support their habit through the illegal market, and pain patients will continue to live a life of hell that will only get worse. Most of us don’t go to the black market to buy pain medication. We drive around in excruciating pain looking for a pharmacy that can fill our prescriptions.

We also cringe in fear every time we see the "opioid epidemic" headlines and the new initiatives to combat overdoses, because we know that we will pay the price, not the addict or criminal.  It’s like when a nut case opens fire and kills people. Gun owners know that new restrictions will impact them, not the criminals.

New Jersey’s 5-Day Limit on Opioids

Gov. Christie recently pushed for and convinced the New Jersey legislature to pass very restrictive pain medicine laws. Physicians in New Jersey were very much opposed to Christie's model, but it was forced upon them anyway. Since I am originally from New Jersey and most of my family still lives there, I know firsthand the devastating consequences these restrictions could have on family members.

I have had 18 invasive surgeries since 2008 and recently suffered from a sepsis infection after shoulder replacement surgery. The infection required 3 additional surgeries, two of which were emergency surgeries as the infection spread. I was fed broad spectrum antibiotics intravenously 3 times per day.

I also suffer from chronic pain from arthritis. I have tried every other pain treatment modality, and opioid-based pain medicine is the only one that works for me.

There is no way I would have been able to get up after a 5 days to visit my doctor just to refill pain medicine. But if New Jersey’s law were instituted in Florida, where I now live, it would require me to do just that. After the surgery, I was dealing with horrible pain in my shoulder, along with severe fatigue and other complications. Thank God that Florida law still allows for prescriptions of pain medicine beyond 5 days.

Chris Christie is now leading a study for President Trump, and my fear is that a new executive order will be forthcoming which will force the New Jersey model of restricting pain medicine across every state, including Florida.

Let me relay to you a recent experience of my 85 year old mother, who had invasive back surgery in New Jersey. They sent her home after 2 days in the hospital with a prescription for a 5 day supply of Percocet, and strict orders to "NOT MOVE FROM BED.”

There is already a shortage of pain medicine in New Jersey pharmacies. My sister took the script, started at a pharmacy in Bridgewater, and worked her way on Route 22 toward Newark. She visited 30 pharmacies along the way and was unable to find the medicine. She called me in tears because my mother was in terrible pain.

My sister even took my mother to the ER, but they would not give her any medicine for pain.

Thankfully, after asking several friends for help, my sister received a call from her best friend, who found a pharmacy that had Percocet. My mother received significant relief from the pain medicine, but 5 days was not nearly enough. My sister lives with my mother and was able to take her on the 4th day to see the doctor about a refill, but she never should have gotten out of bed. She was under strict orders to stay in bed, use a bed pan and not to get up until two weeks after the surgery.

Yet now on the 4th day she had no choice because of her pain. The patient has to be present to receive a new script for opioids in New Jersey, so my sister could not visit the doctor's office to pick up a script for her without my mother's presence.

This is an unbelievable intrusion into the doctor-patient relationship. Why is it that politicians are so hell bent on government intrusion when it comes to legitimate use of medicines? This is insanity.

It is time for a full court press in Washington DC. If you have acute, chronic or intractable pain, then you better wake up and do something to preserve your rights. Chronic pain is a disease, and for people who have tried all modalities and found that opioids are the only solution, you are about to lose access to the medicine that gives you some semblance of a normal life. I anticipate that an executive order mirroring the misguided New Jersey restrictions will be issued by President Trump, in essence trampling on your ability to obtain pain relief.

I am imploring you to make our voices heard. We should not be further punished because of people with addiction illness. Of course they need to be helped, but restricting access for law abiding, non-addicted patients is an outrage. It is already difficult enough to get pain medicine in Florida, often requiring visits to 20 or more pharmacies before one finds a pharmacist willing to fill a script.

I have often thought about suicide because of my pain. Many others have as well. If additional restrictions are forthcoming from Washington, then many of us will face life or death decisions. Please do not allow Chris Christie to tip the balance.

Alessio Ventura lives with chronic arthritis and post-surgical pain. He shared his experiences as a pain patient in a previous guest column. Alessio was born in Italy, came to the U.S. at age 17, and finished high school in New Jersey. He worked for Bell Laboratories for 35 years as a network and software engineer. 

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

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

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

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.

West Virginia Admits Pain Patients Suffering

By Pat Anson, Editor

As Ohio, New Jersey and other states move to put further limits on opioid prescribing, West Virginia is acknowledging that its own efforts may have gone too far.

This week the West Virginia House of Delegates unanimously passed a bill that would create a commission to review state regulations on opioid pain medication and report back to the legislature on ways to make them “less cumbersome.”

Senate Bill 339 calls the abuse of pain medication in West Virginia “a nearly insurmountable plague,” but recognizes that efforts aimed at curbing abuse and overprescribing have “resulted in unforeseen outcomes often causing patients seeking pain treatment to suffer from a lack of treatment options.”

“Effective early care is paramount in managing chronic pain. To that end, prescribers should have the flexibility to effectively treat patients who present with chronic pain. However, there must be a balance between proper treatment for chronic pain and the abuse of the opioids found most effective in its treatment,” the bill states.

The legislation calls for the Dean of the School of Public Health at West Virginia University to serve as chair of the commission, which is to be known as the Coalition for Responsible Chronic Pain Management. Other members of the panel will include a board certified pain specialist, three physicians, a pharmacist, a chiropractor and a pain patient. 

The coalition will meet quarterly to review regulations on physicians and pain clinics, and will advise the legislature on ways to “further enhance the provider patient relationship in the effective treatment and management of chronic pain.”

Because the bill was amended in the House, it now returns to the West Virginia Senate for approval.

In many ways, West Virginia was ground zero for the nation’s overdose epidemic, and was one of the first states to crackdown on pill mills and the overprescribing of pain medication. Fewer opioids are now being prescribed, but West Virginia still leads the nation with the highest overdose death rate in the country.

At least 844 people died of drug overdoses in the state in 2016, a record number, compared to 731 in 2015. As in other parts of the country, addicts in West Virginia have increasingly turned to heroin and illicit fentanyl, which are more potent, dangerous and easier to obtain than prescription painkillers. Over a third of the overdose deaths in West Virginia last year were linked to fentanyl. Most of the deaths involved multiple drugs.   

Ohio Tightens Opioid Regulations

In neighboring Ohio, Gov. John Kasich last week announced new plans to limit opioid prescriptions to just seven days of supply for adults and five days for minors. Doses are also being limited to no more than 30 mg of a morphine equivalent dose (MED) per day.

The new regulations, which are expected to take effect this summer, are more than just guidelines – they are a legal requirement for prescribers. Although only intended for acute pain patients, many chronic pain patients are worried they will lose access to opioid medication.

"Doctors are already feeling this pressure not to prescribe pain medications," Amy Monahan-Curtis told NBC News. "What I am hearing is people are already being turned away. They are not getting medications. They are not even being seen. "

Ohio has been down this path before. In 2012, it began a series of actions to restrict access to pain medication. By 2016, the number of opioid prescriptions in Ohio had fallen 20 percent, or 162 million doses.

As in West Virginia, however, the number of drug overdoses continues to soar. Ohio led the nation with over 3,000 drug overdoses in 2015, with many of those deaths linked to illicit fentanyl and heroin. The situation is so bad that some county coroners are storing bodies in temporary cold storage facilities because they’ve run out of room at the morgue.

Next month new regulations will go into effect in New Jersey that will limit initial opioid prescriptions to just five days of supply. Only after four days have passed can a patient get an additional 25 day supply.

That law is primarily intended for acute pain patients, but many chronic pain patients are worried they’ll be forced to make weekly trips to the doctor and pharmacy for their prescriptions, or not be able to get them at all.

“You can imagine my alarm and fear when I was told yesterday that I will likely have to have the dosage of my medications reduced soon,” said Robert Clayton, a New Jersey man who suffers from chronic back and neck pain.

“This is LUNACY. As a nurse who treats individuals with chronic pain and addiction issues, I can tell you these new laws are going to have catastrophic results. Most of the people abusing opiates and dying are the addicts who abuse heroin and other prescription drugs like benzodiazepines, not the chronic pain patients like myself and the other unfortunate souls who have a genuine need for these drugs through no fault of our own.”

According to a recent survey of over 3,100 pain patients by PNN and the International Pain Foundation, one in five pain patients are hoarding opioid medications because they fear losing access to them.

Little Evidence That Pain Contracts Work

By Roger Chriss, Columnist

Pain contracts are common. The Centers for Disease Control and Prevention recommends their use and many states all but require them. The contracts can be long, detailed and sometimes oddly demanding, as Crystal Lindell described in her recent column, "Signing a Pain Contract in the Age of Opioid Phobia."

In 2001, pain contracts and opioid use agreements were being promoted as “A Tool for Safely Treating Chronic Pain” by the American Academy of Family Physicians.

By 2011, Kaiser Health News was reporting that doctors were increasingly using contracts to protect themselves and to spell out the rules patients had to follow to reduce the risk of abuse and addiction.  

Some patients may end up signing multiple contracts with various providers, sometimes even watching video presentations about the content and intent of the contract.

So it seems reasonable to assume that pain contracts work, that research supports their use and establishes their benefits. Unfortunately, that is not the case.

The American Medical Association’s Journal of Ethics reported in 2013 that a review of opiate treatment agreements found “only weak evidence of a reduction in opiate misuse” in studies that were described as “methodologically poor.” The article also warned that “perhaps the greatest potential harm in the use of narcotics contracts is the inherent message to the patient that he or she can’t be trusted.”

Similarly, in 2010 the Annals of Internal Medicine published a review of a handful of observational studies rated as poor or fair quality, which found that opioid misuse was only modestly reduced in patients who signed contracts. In some of the studies, no benefit could be demonstrated.

In 2011, MD Magazine reported that “there is little evidence that these documents help reduce opioid misuse.” Steven King, MD, agreed with that assessment in the Psychiatric Times, writing that “there does not appear to be any firm evidence that these tools reduce the likelihood that opioids will be used in unintended ways.”

And as far back as 2002, the Clinical Journal of Pain published a study that stated “efficacy is not well established” for opioid contracts.

Thus, pain contracts have been researched for well over a decade with consistent results: they do little to reduce opioid misuse or abuse in any form.

Moreover, there is research and expert opinion suggesting that contracts can be harmful. For instance, in 2011 the Partnership for Drug-Free Kids reported that opioid contracts may damage patient trust and should not be used as a way to “fire” patients who violate the terms of the agreement.

In 2016, STAT reported on the unintended consequences of federal legislation promoting the use of such contracts, in particular how they could stigmatize and endanger patients who are struggling with substance abuse and addiction.

So why are pain contracts becoming more common and more complicated? And why is there a perception that they work?

Perhaps because chronic pain patients are in general compliant about pain medication, rarely share or sell their pills, and tend not to develop problems with abuse or addiction. In other words, pain contracts work because there is nothing for them to do.

The Johns Hopkins Arthritis Center tells us that patients who develop an opioid problem almost always have a prior history of substance abuse, and that stealing or forging prescriptions rarely occurs among patients. Another study found an opioid addiction rate of only about 3% in chronic pain patients.

Much like airport security scanners, pain contracts seem like a form of theater, a solution in search of a problem. But they are not just a benign if pointless exercise in paperwork.

Pain contracts unnecessarily lump together chronic pain patients and people suffering from drug addiction, and thus risk stigmatizing and misunderstanding two distinct groups. Chronic pain patients are not potential addicts or abusers-in-training, and substance abuse is a separate medical condition that requires a distinct approach from pain.

Perhaps there is a way to create pain contracts that actually help patients and clinicians. But until the evidence to support them is found, resources could be better used to improve treatments for chronic pain, as well as substance abuse.

Roger Chriss suffers from 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.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

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