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.

Patient Suicide Blamed on Montana Pain Clinic

By Pat Anson, Editor

A 54-year old Montana man who apparently committed suicide earlier this month was a patient at a Great Falls pain clinic accused of mistreating patients and poorly managing their chronic pain. Bryan Spece was found dead in his Lewistown home on May 3.

“From what we know, about two weeks before his death, they had cut his pain pills back significantly. We’re not sure the exact amount. We’re trying to get ahold of his medical records,” said a family member. “When they called and told us that he’d been found with a gunshot wound, we thought someone had attacked him. Suicide was not even on our charts anywhere.”

BRYAN SPECE

"He was the last person anyone would have thought to take his own life. He was just not that guy," another family member said. "I know he was in a lot of pain and in a very dark spot."

Until recently, Spece was one of several hundred patients being treated at the Benefis Pain Management Center by Rodney Lutes, a physician assistant. The 68-year old Lutes was discharged by Benefis in March for unexplained reasons and the care of his patients was transferred to other providers at the clinic.

Many of Lutes' former patients – including some who were on relatively high doses of opioid pain medication – say they are now being “bullied” and treated like drug addicts by Benefis doctors and clinic staff. Their prescriptions for pain medication have been drastically reduced or stopped entirely. 

The Centers for Disease Control and Prevention recommends a "go slow" approach when patients are weaned or tapered to minimize symptoms of opioid withdrawal. The CDC says a "reasonable starting point" would be 10% of the original dose per week. Patients who have been on opioids for a long time should have even slower tapers of 10% a month, according to the CDC.

The Department of Veterans Affairs recommends a taper of 5% to 20% every four weeks, although in some extreme cases the VA says an initial rapid taper of 20% to 50% a day is needed

Bryan Spece's dose may have been reduced by 70 percent.

"I talked to him a few days before he died and he said they had cut him from 100 milligrams of oxycodone a day to 30. He was not doing well," a relative told PNN.

“He was one of my patients that I saw routinely. He was doing very well on the regimen I had him on,” said Lutes, who treated Spece for about three years and never saw signs of depression.

“My suspicion is that, like the rest of my patients, he got totally slammed at this pain clinic at Benefis and they probably took all his medicines away,” Lutes said. “Right now I am so angry about this happening. This was a good guy.”

According to his obituary, Spece was a gun collector, Marine Corps veteran, Oakland Raiders fan and belonged to a motorcycle club. Friends and family called him “Bonz.”

“He was a very loud fun loving kind of guy you always knew when Bonz walked into a room,” reads the obituary published in the Helena Independent Record.

But recently some noticed that Spece was depressed about his inability to work regularly because of chronic pain from carpal tunnel syndrome and an old back injury.

“He was having money issues with not being able to work as often because of the pain and with having his pain pills cut back. He was just very stressed, constantly, about it,” said a family member, who believes Benefis is "100%" responsible for Spece's death.

“The police found several text messages on his phone. He was talking to his friends there in Lewistown, stating ‘Come get my guns. I’m in so much pain, I might do something stupid.’ And then he’d laugh it off. So nobody thought he was really thinking about ending his life.”

"We extend our condolences to the family during this difficult time," Benefis spokesman Ben Buckridge said in a statement. Buckridge said Benefis could not comment any further because of patient and employee privacy rights.

“I lay awake wondering how many Bryans are also laying awake at the same time and I pray to God to please let them know that we are here for them,” says Re Ann Rothwell, a former patient of Lutes who claims Benefis dropped her “like a dirty diaper.”

Rothwell has organized a support group for Lutes’ patients and has reached about 100 of them so far. The group has formed an active online community and is trying to locate hundreds of other former Lutes' patients to offer them support. Rothwell worries there could be more suicides.

“I truly feel that we failed in the case of Bryan Spece and perhaps several others who have taken their lives because of Benefis' actions. They felt so alone and in despair that suicide was the only answer. We just do not know about them yet.  It truly breaks my heart,” she said in an email. “We just need to figure out how to reach those folks. Perhaps Bryan's death will help us find a few more folks on the brink, who we can pull back with love, support and hugs.”

In April, a disgruntled pain patient burned down a doctor's home near Great Falls, held the doctor's wife at gunpoint and killed himself during a standoff with police. David Herron was not a patient at the pain clinic, but suffered from chronic back pain and apparently had a long-standing grievance with the doctor, an orthopedic surgeon for Benefis.

The pain clinic is part of Benefis Health System, a non-profit community-based health organization that operates a hospital and provides a wide variety of medical services in Great Falls, a city of over 58,000 people in north central Montana. With over 3,000 physicians and other employees, Benefis is the largest employer in the area outside of government.

In a statement emailed to PNN last week, a Benefis pain management specialist outlined the clinic’s policy about opioid medication.

“Our clinic does not suddenly discontinue opioid prescriptions for patients unless we feel it is unsafe to continue prescribing them,” said Katrina Lewis, MD. “We know so much more now about how these drugs work than we did 20 years ago. The practice of medicine, procedures, and guidelines change over time, and we’re certainly seeing an evolution in how we care for people with chronic pain.

“We are following evidenced-based practice and recommendations of reputable pain societies in approaching the care we provide. We recognize that opioids absolutely have a place in the management of chronic pain for some patients. Our focus is to treat each patient individually with use of risk stratification and evaluation of patient pathology and co-morbidities.”

‘Dear Valued Patient’

But the form letters sent by Benefis to hundreds of Rodney Lutes’ patients in March could hardly be described as treating “each patient individually.” Patients were notified that Lutes was no longer practicing at the pain clinic, that they were being reassigned to new providers, and that their prescriptions would probably be changed. They were also told not to complain.

“Your new provider will do a thorough evaluation of all your medications and will likely make changes that he or she feels are in your best interests,” a form letter with the salutation “Dear Valued Patient” states. “Please be aware that arguing or complaining about changes in your prescriptions will not alter your clinician’s care plan.” 

“The prescriptions you will be given may not be what you are used to. It will be what is appropriate for your care,” another form letter says. “Verbal or written complaints to staff and management will not result in a change to your prescription.”

As PNN has reported, some patients also received letters stating that “all care providers” in the Great Falls area had been made aware of the changes at Benefis and “with what is going on with PA Lutes’ patients.” Many of those patients are now having trouble finding new doctors and feel they’ve been branded as addicts and drug seekers.

“We do our best to care for our patients and regret that this transition has been difficult for some. We realize we have opportunities to improve our communication with patients and will be working on that as a team moving forward. We are always looking at new ways to improve the patient experience, and we value patient feedback,” Nikki Phillips, Office Manager at the Benefis Pain Clinic, said in last week’s emailed statement.

What’s happening at Benefis is a microcosm of what’s happening all over the country. Patients are being abruptly weaned off opioids or being abandoned by doctors and pain clinics that are fearful of running afoul of the CDC’s “voluntary” prescribing guidelines, the DEA, or their own medical liability insurers.  Some providers are steering patients toward surgeries or costly “interventional” procedures that they don’t want.

At PNN, we hear regularly from chronic pain patients who were able to lead stable and productive lives for years on relatively high doses of opioids – a medical treatment that many are now denied and are told doesn't work. Many pain sufferers are in despair, increasingly disabled and having suicidal thoughts.

Until the needs of those patients are taken into consideration and appropriately balanced with society's need to prevent addiction, there will be more Bryan Speces and more grieving families.

“This man was the most happy-go-lucky man. He adored his grandchildren. He was a good time, all of the time. If he hadn’t been in so much pain, I don’t think he would have had a negative thought,” a family member told us.

“He lost a sister 12 years ago to suicide and he was always so broken up about that. He’s always said he would never do that.”

Spece’s death is still classified as a homicide because his autopsy report is incomplete. The Fergus County coroner is still awaiting results from toxicology tests.

Law Firm Wants Transparency in Medicare Opioid Policy

By Pat Anson, Editor

A Washington-based legal firm is calling for more openness and transparency by the Centers for Medicare and Medicaid Services (CMS) as it establishes new rules that are likely to limit access to opioid pain medication for millions of Medicare patients.

“While opioid abuse undoubtedly presents a serious public health issue, CMS should take steps to foster transparency and avoid harming patients and providers alike by offering them a meaningful opportunity to participate in the development of policies that could limit pain management,” wrote Michelle Stilwell, a staff attorney for the Washington Legal Foundation (WLF), a non-profit law firm that generally supports business groups and companies in litigation against government agencies.

At issue are mandatory rules being developed by CMS for 2018 that would bring Medicare opioid policies into alignment with the “voluntary” prescribing guidelines released last year by the Centers for Disease Control and Prevention.

CMS wants to set a daily ceiling on opioid pain medication at 90mg morphine equivalent dose (MED). If a dose exceeds that level, Medicare insurers would be expected to impose a "soft edit" that would automatically block the prescription from being filled until the edit is overridden by a pharmacist.

Stilwell wrote on the WLF's blog that patients and providers were given little opportunity to see and comment on a Call Letter announcing the rule changes, while the insurance industry was.

“CMS’s changes will inevitably lead to even tighter restrictions on opioid prescriptions—which directly affects the patient community.  Many patients, doctors, and healthcare providers already complain that rules designed to prevent the improper prescribing of opioids are complicating patients’ legitimate access to appropriate medication,” said Stilwell. 

“But instead of directing this Call Letter at the affected patient community and granting that community an adequate opportunity to comment on the new opioid overutilization criteria, CMS directed it only to insurance companies.  In reality, opioid consumers and providers are given little to no notice or opportunity to comment."

As PNN has reported, the insurance industry appears to have played a major role in drafting the CMS rules, which contains some of the same strategies suggested in a “white paper” prepared by the Healthcare Fraud Prevention Partnership (HFPP), a coalition of insurers, law enforcement agencies and government regulators formed to combat insurance fraud. The HFFP met to discuss the white paper in a “special session” last October that was not open to the public.

Stilwell said the HFFP “operates largely in the dark” and may be in violation of the Federal Advisory Committee Act (FACA), which requires open meetings for all federal advisory panels. This week the WLF filed a Freedom of Information Act Request seeking more information about HFPP membership and meetings.

Major insurers such as Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation participate in the HFPP.

“It is time for CMS to bring HFPP into compliance with FACA requirements.  Doing so will reduce the risk that a court may invalidate any CMS policies found to have been adopted at least in part in reliance on HFPP recommendations.  It would also enable any patients affected by changes in opioid reimbursement policies to play a role in the development of HFPP’s opioid-related recommendations,” Stilwell wrote.

CMS contracts with dozens of insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policies often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.

In addition to limits on opioid prescribing, CMS plans to implement an opioid Overutilization Monitoring System (OMS) to identify physicians who regularly prescribe high doses of opioids. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged. Insurers would be required to identify pharmacies, doctors and patients who do not follow CMS policies, and could potentially drop them from Medicare coverage and their insurance networks.

FDA to 'Take Whatever Steps We Can’ to Stop Opioid Abuse

Meanwhile, the new commissioner of the Food and Drug Administration is calling on the agency to “take whatever steps we can” to ensure that opioids are only prescribed under “appropriate clinical circumstances.”

In a blog post on the FDA website, Scott Gottlieb, MD, announced the formation of an Opioid Policy Steering Committee to develop additional tools and strategies the FDA can use to prevent opioid abuse.

“Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use, which increases the risk of opioid addiction,” he wrote.

Gottlieb wants the committee to focus on three areas:

scott gottlieb, MD

• Consider mandatory education for health care professionals about opioid prescribing recommendations and how to identify patients at risk of abuse.
• Establish limits on the dose and quantity of opioid medication that are more closely tailored to the medical condition a patient is being treated for.
• Review the process the FDA uses to evaluate and approve new opioid medications.

Gottlieb cited some questionable statistics to dramatize the extent of the opioid prescription problem.

“In 2015, opioids were involved in the deaths of 33,091 people in the United States. Most of these deaths – more than 22,000 (about 62 people per day) – involved prescription opioids,” he wrote.

The new FDA commissioner may want to check his facts. As PNN has reported, a news release last December from the White House Office of National Drug Control Policy stated that 17,536 Americans died in 2015 from overdoses involving prescription opioids.

A CDC news release a few days later provided an an even lower estimate; that over 12,700 Americans died from pain medications in 2015.

When asked to explain the discrepancy, PNN was given a third estimate by the CDC, which put the number of deaths involving prescription opioids at 15,281 in 2015.

Gootlieb's post links to a CDC website that provides a fourth estimate, which is based on a "standard analysis approach" that combines all overdoses caused by natural, semi-synthetic, and synthetic opioids. Such an approach is misleading, because it counts overdoses caused by illicit fentanyl as prescription drug deaths. 

"Unfortunately, information reported about overdose deaths does not distinguish pharmaceutical fentanyl from illegally-made fentanyl," the CDC said, which Gottlieb neglected to mention in his blog post.

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%).

Montana Urine Tests Sent to Bankrupt Drug Lab

By Pat Anson, Editor

Imagine getting an unexpected medical bill for over $1,500 that your insurance won’t cover. You can’t afford to pay it, have already missed several weeks of work due to chronic back pain, and you’re worried about losing your job.

That’s the dilemma faced by a Montana woman, one of the patients at a Great Falls pain clinic who are getting unusually large bills for urine drug testing at a laboratory over 2,000 miles away in Georgia. 

“I spoke to my insurance about it and they told me that there are labs in Montana that could have done the same thing and would have been covered by my insurance. She asked me, why they would go to a Georgia lab?” said the patient, who asked that we not reveal her identity.

The lab in question is Confirmatrix Laboratory, a financially troubled company near Atlanta that specializes in urine drug testing.

For the last two years, Confirmatrix has conducted drug screens for the Benefis Pain Management Center, which is part of Benefis Health System, a non-profit community-based health organization that operates a hospital and provides other medical services in Great Falls.

As PNN has reported, some current and former patients at the Benefis pain clinic believe they are being unfairly labeled and treated as addicts. Many are having their opioid doses reduced or stopped completely. All are required to take regular drug tests to prove they’re not abusing their pain medication.

“For the safety of our patients, regular urine drug screens are conducted to ensure the appropriate levels of prescribed medications, and only those medications, are present,” says Katrina Lewis, MD, a pain management specialist at Benefis.  “Presence of too high of a level of opioids or other substances in the urine can make it inappropriate and unsafe to continue prescribing opioids.  Presence of none of the prescribed opioids in the urine indicates the care plan is not being followed and further prescribing is medically unnecessary.”

Urine drug testing is not uncommon at pain clinics, but the selection of Confirmatrix is. The company was founded by Khalid Satary, a convicted felon and Palestinian national that the federal government has been trying to deport for years.

Satary was arrested in 2001 and served more than three years in federal prison after pleading guilty to running a counterfeit CD operation in the Atlanta area valued at $50 million. At the time, it was the largest counterfeit music case in U.S. history, according to the Atlanta Journal Constitution.

Khalid and jordan satary (instagram photo)

Shortly after his release from prison, Satary founded Confirmatrix, Nue Medical Consulting and GNOS Medical, a medical billing firm, and then transferred his interests in the companies over to his son Jordan, a recent high school graduate.

The Journal Constitution reported in 2014 that Satary was subject to a federal deportation order, but immigration officials were unable to find a country willing to accept him. He still apparently lives in the U.S.

On November 2nd of last year, the FBI and the Georgia Department of Health and Human Services served search warrants at Confirmatrix and GNOS Medical, and agents removed documents from both facilities.

The agencies have not said what prompted the raids and no charges have been filed against either company.

Just two days after the search warrants were served, Confirmatrix filed for Chapter 11 federal bankruptcy protection, with Satary’s son Jordan the largest shareholder to sign the petition in the Northern District Court of Georgia. GNOS Medical is listed as one of the creditors that Confirmatrix owes money to.

“Although historically very profitable,” Confirmatrix CEO Ann Durham told the court the company “began experiencing financial troubles when recent changes to Medicare’s reimbursement rates resulted in a decrease (in) revenue from its toxicology business.”

Drug testing has indeed been a very profitable business for Confirmatrix and other drug labs. A 2013 study by the Centers for Medicare and Medicaid Services (CMS) listed Confirmatrix as the most expensive drug lab in the country, collecting an average of $2,406 from Medicare for each patient tested, compared to the national average of $751. The bills from Confirmatrix were high because the company ran an average of nearly 120 different drug screens on each patient, far more than any other drug lab.

These and other abusive billing practices, not only by Confirmatrix but other drug labs such as Millennium Health, finally caused Medicare to lower its reimbursement rates for drug testing.

Millennium filed for Chapter 11 bankruptcy in 2015, soon after paying a $256 million dollar fine to settle fraud and kickback charges, and to reimburse the government for unnecessary urine and genetic tests.

Under its Chapter 11 filing, Confirmatrix is still able to conduct business and perform lab tests, but it is exploring options for a possible sale of the company or a restructuring “to focus its operations on the blood testing business.” 

The company said it has 152 employees in 15 different states, including one employee in Montana who apparently works at the Benefis pain clinic in Great Falls.

“They had a gal who was there every day, I assume working there full time, and she was responsible for collecting the samples, processing them, and shipping them off to the lab,” said Rodney Lutes, a physician assistant who was discharged by Benefis in March. 

Benefis did not respond to inquiries from PNN about whether a Confirmatrix employee works at the pain clinic or if Benefis receives a commission or compensation from Confirmatrix for doing business with the company. According to clinic policy, patients on high doses of opioids "should have a minimum of one urine drug test every two months."

In a statement, a Benefis official said Confirmatrix performs a valuable service and “waives many costs.”

“The company we have partnered with has an extensive patient assistance program, which is part of the reason they were selected. That company was selected two years ago because it was one of the few labs nationwide that offered quantitative and qualitative testing AND patient assistant programs. This company does not send its patients to collections for an inability to pay a bill,” said Kathy Hill, Chief Operating Officer at Benefis Medical Group.

But some Benefis patients are getting letters from collection agencies demanding payment for Confirmatrix drug screens that cost well over $1,000, the same tests that Medicare is charged about $150 for under its new reimbursement rates. A call to Confirmatrix for comment was not returned.

Other patients say they are getting bills for drug tests they’ve already paid for, and that Benefis has lost some of their billing and medical records. Still other patients are surprised to learn they may be legally responsible for drug tests that their insurance company refused to pay for.  

“Confirmatrix is out of network, hence I am stuck with the bill unless Benefis writes it off,” said one woman, a chronic pain sufferer for over 30 years, whose opioid dose was recently reduced substantially. “In the last 6 weeks I have been dropped to one third of the dosage I was on with intentions that I will be dropped even more. I have no desire to live, because this is not living.”

In April, a suicidal patient at Benefis Health System burned down his doctor's home and killed himself during a standoff with police. David Herron was not a patient at the Benefis pain clinic, but suffered from chronic back pain and apparently had a long-standing grievance with his doctor, an orthopedic surgeon.

The incident prompted Benefis to upgrade security procedures at its facilities, including training employees to handle active shooter situations, according to the Great Falls Tribune, which reported that "danger presents itself in the form of patients who are drug addicted looking for an early prescription."

Patients Allege Mistreatment at Montana Pain Clinic

By Pat Anson, Editor

A Montana pain clinic is under fire from patients for abruptly stopping their opioid medication, forcing them to take expensive drug tests, and steering them towards invasive and potentially dangerous procedures.

Some former patients at the Benefis Pain Management Center in Great Falls also allege they have been unfairly labeled as addicts, which has made it difficult for them to find new doctors.

“I’ve never been treated so badly in my life as I have at Benefis, to the point that I terminated my care with them, because I couldn’t do it. I couldn’t be called an addict and a junkie anymore,” says Tami Duncan, a 50-year old woman who suffers from chronic back pain.

“I’m not going back. I am done with them,” says another former patient. “It’s like I was a junkie just looking for my next fix. And that’s not the case at all.”

“You become terrified of who you are going to see next and what they are going to say and do to you,” said a current patient. “The fear of losing my job and not to mention my sanity. The fear that I am going to be labeled an addict if I don’t do what they tell me to.”

“They do not care. They do not know their patients. They do not review the records,” another current patient said. “There is so much more. Billing errors, rarely treated like a person, the wait to see doctors, and then 15 minutes (with them) and you are gone.”

The Benefis pain clinic is part of Benefis Health System, a non-profit community-based health organization that operates a hospital and provides a wide variety of medical services in Great Falls, a city of over 58,000 people in north central Montana. With over 250 physicians and about 3,000 other employees, Benefis is the largest employer in the area outside of government.

“We have some of the finest nurses and Physician Pain Management specialists, with experience second to none. This experience combined with their compassion, provide a tremendous supportive atmosphere. Our pain management team aims to help people reduce and cope with pain,” Benefis says on its website.

Some patients disagree, saying Benefis doctors are quick to label a patient as non-compliant, which has led to patients being discharged from the clinic. In a rural state such as Montana, where options for pain care are limited, that is not a threat to be taken lightly.

“Any questions or requests can be seen as combative. To try and protect ourselves we were recording our appointments. Somehow it was found out and there are now signs everywhere stating no recording or photos,” a patient told PNN.

“We are not allowed to have anyone come into the appointment with us. I am being bounced around to different providers. There is no stability. I am still receiving meds but at a fraction of what they were. To say that I am hurting would be an understatement.”

“Our clinic does not suddenly discontinue opioid prescriptions for patients unless we feel it is unsafe to continue prescribing them,” said Katrina Lewis, MD, a Benefis pain management specialist. “We have patients that have been on pretty high doses of opioids for many years but are not experiencing much relief from pain anymore and their quality of life is suffering significantly.  

A SIGN POSTED AT THE BENEFIS PAIN CLINIC

“We have to do what is medically responsible and safe for our patients. Opioids are incredibly powerful drugs. Given the choice between a patient potentially dying and a patient going into withdrawal, we have to pick withdrawal.”

In an age of opioid hysteria and misleading headlines about an overdose epidemic fueled by painkillers, pain patients around the country – including many who have been stable and compliant on opioid medication for years – are seeing their doses cutback or eliminated. Some have been discharged by doctors who are leery of scrutiny by the DEA and no longer want to treat chronic pain.

What sets the disgruntled patients at Benefis apart from everyone else is that they have formed a support group for each other. And some are speaking out publicly against a provider they feel has shamed and abandoned them. For this story, PNN interviewed over a dozen current and former patients, including some who asked to remain anonymous.

Physician Assistant Fired

Many of the problems at the Benefis pain clinic can be traced back to the firing of Rodney Lutes, a popular 68-year old physician assistant (PA) who – until he was let go -- was treating as many as 1,000 pain patients.  

RODNEY LUTES, PA

“I was thunderstruck. It totally blindsided me. I thought I was doing everything I could for the patients,” says Lutes about his firing in early March.

Lutes was told he was “no longer a good fit” at the clinic and that his position was being eliminated. He believes the real reason was that some of his patients were on high doses of opioids that exceeded clinic policy.

“They didn’t come to me and say, ‘Hey Rod, you need to fall in line here and start reducing these people.’ There was no warning whatsoever,” said Lutes. “The majority of the patients were doing very well. You always have some patients who aren’t doing well and you try to adjust their medications. I had a number of those. But otherwise I felt that the patients were doing very well on the doses they were on.”

“We respect our employees’ privacy rights and consequently cannot comment on the details of Rodney Lutes employment with Benefis,” says Keri Garman, Director of Corporate Communications at Benefis.

There is no record of any disciplinary action against Lutes by Montana’s Board of Medical Examiners. He has been licensed as a PA in the state since 1991.

“He’s compassionate and understanding. I’ve never met anybody else like him in my life,” says Tami Duncan, a patient of Lutes for 20 years. “And Benefis is crucifying that man, along with his patients.”

Duncan was on relatively high doses of oxycodone and MS-Contin for chronic back pain caused by herniated and bulging discs, arthritis and fibromyalgia. She’s also had as many as 60 epidural injections, nerve blocks and other "interventional" procedures, which not only failed to stop her back pain, but may have given her adhesive arachnoiditis, a progressive and chronic inflammation of spinal nerves that she was recently diagnosed with.

“Sometimes it feels like I’m standing in a pot of hot boiling water all day,” says Duncan. The first thing she was told by her new doctor at Benefis was that he was taking her off opioids.

“He comes in and didn’t even look at my files, didn’t even look at my record. And he told me, ‘Well Mrs. Duncan, the game plan is we’re taking you off all your medications and then we’ll terminate your care.’” she recalled. “He didn’t know anything about what was wrong with me. Didn’t know I had nerve conduction tests done to show all the nerve damage I have in both of my legs. He basically came out and said, ‘All you patients all need to go into treatment. You’re addicts.’"

“There are many scenarios that may warrant discontinuation of a particular regimen for the benefit of the patient.  Opioids can have many negative side effects for patients,” said Dr. Lewis in a lengthy statement for PNN prepared by Benefis. “We understand that this can be unsettling for patients who have been with a provider for a long period of time and who are accustomed to their care plan.”

Duncan started looking for a new pain doctor and immediately ran into problems. When she visited a pain clinic in her hometown of Havre, she was turned away without an exam or review of her medical records.

“The RN proceeded to tell me that I was a junkie, those are her words, that I was an addict and the only thing that was wrong with me is that I needed to go to treatment,” she said. “I’ve called all over the state trying to find a different pain doctor. Nobody will take me. Benefis has called every doctor in the state of Montana saying not to take any of Lutes’ patients.”

Duncan cites a letter she received from Benefis, which states: “All care providers in our community have been made aware of the changes in our clinic and with what is going on with PA Lutes’ patients.”

“It is our standard practice to send a note to referring physicians within our own health system and community to let them know of changes to the providers practicing in our clinic.  The letters never indicate the reason a person is no longer with our organization,” Kathy Hill, Benefis’ Chief Operating Officer said in the statement. “Community providers had many patients calling with concerns about whether they would be able to get in with a new provider soon enough to avoid a lapse in their medications.

“Whether or not to prescribe opioids to any patient is at the discretion of the provider. Providers were not urged either way.”

‘Nobody Will See Pain Patients’

Regardless of the reason, many former patients of Lutes are having trouble finding new doctors, a not uncommon experience in rural areas where healthcare choices are limited.

“Nobody in Great Falls will see any pain patients. I’m just sitting here in limbo doing nothing but being in pain,” said a former patient who decided to leave Benefis after her opioid medication was stopped. The doctor who replaced Lutes persuaded her to have an epidural, a decision she now regrets.  

“They’re forcing everybody to get injections,” says Adrienne Barnoski, another former patient. She and her husband Joseph, who has severe back pain, had been treated by Lutes for years.

“I’m not going to have any injections on my back after what my husband has gone through. It sometimes makes things worse,” she said.

Epidural injections have been used for decades to relieve pain during childbirth, but in recent years injections of a steroid into the epidural space around the spinal cord have increasingly been used to treat back pain.  The shots have become a common and sometimes lucrative procedure at pain clinics, where costs vary from as little as $445 to $2,000 per injection. Critics say the injections are risky, overused and often a waste of money.

“An epidural steroid injection is an invasive procedure. It has its risks. And I think a patient always has the right to decline an invasive procedure,” says Lutes. “I’ve had a couple of patients tell me (that they were told) to do epidural steroid injections and if they didn’t do the injections they were no longer going to be prescribed any medications. To me, that’s kind of like blackmail.  

“My patients are being treated very, very poorly. It’s horrible. I’ve had calls from patients or their spouses, very concerned the patient was going to commit suicide. It just scares me to death. And these were patients that were functionally doing great. And now they’re being told, sorry, we’re taking your medication away from you.”

Benefis says it does not pressure patients into having invasive procedures, but admits there could have been communication problems between doctors and their patients.

"This is not a policy or an expectation in any way. While we expect patients to be active participants in getting better, there is never a mandatory procedure,” said Nikki Phillips, BSN, Clinic Office Manager at Benefis Neurosciences. “We do our best to care for our patients and regret that this transition has been difficult for some. We realize we have opportunities to improve our communication with patients and will be working on that as a team moving forward.”

“The decision of whether or not to prescribe opioids to a patient is in no way related to their decision to have or not have other interventional procedures,” said Dr. Lewis. “Unfortunately there are some patients who come into the clinic with a preconceived notion that opioids are the answer for them, whether because of past practice within the medical community or other reasons, and overcoming that preconceived notion can be challenging.”

A major challenge for the patients who remain at Benefis is paying for their urine drug tests, which can cost as much as $1,500 and are not always covered by insurance.  For the past two years, Benefis has been working with a drug laboratory over 2,000 miles away in Georgia, one with a questionable past and a very uncertain future. For more on that part of the story, click here.

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.

Researchers Warn Against Opioid Backlash

By Pat Anson, Editor

The backlash against opioid medication has gone too far and is depriving chronic pain patients of a treatment many have used successfully for years, according to a commentary published in a prominent medical journal. The article also questions the use of the term “opioid epidemic” in describing the nation’s festering drug problem.

“The movement to virtually eliminate opioids as an option for chronic pain refractory to other treatments is an overreaction,” wrote Kurt Kroenke, MD, and co-author Andrea Cheville, MD, in JAMA. “Many patients currently receiving long-term opioids were started when opioids were still considered a viable treatment option and if satisfied with their pain control and using their medications appropriately should not be unilaterally compelled to wean off opioids.”

Kroenke is a research scientist at the Regenstrief Institute and a professor at the Indiana University School of Medicine. Cheville is a professor and chair of research in the Department of Physical Medicine and Rehabilitation at the Mayo Clinic. She was recently elected to the National Academy of Medicine.

Kroenke and Cheville say many of the medications recommended as safer alternatives to opioids, such as acetaminophen and NSAIDs, provide little pain relief and have risky side effects. Others, such as pregabalin, gabapentin and antidepressants, may work for some pain disorders but have little benefit for others.

“Many patients respond better to one analgesic than another, just as patients with other medical conditions have differential medication responses,” they wrote. “Given the small analgesic effect on average of most pain drugs, the few classes of analgesic options, and the frequent need for combination therapy, eliminating any class of analgesics from the current menu is undesirable.”

Kroenke and Cheville say only a small minority of pain patients who start using opioids go on to use them long-term, yet medical literature and the mass media are filled with references to the so-called “opioid epidemic.”

“Excessive use of phrases like opioid epidemic should be avoided. An epidemic generally suggests a disease that is widespread and usually highly contagious rather than limited to a minority of those exposed,” they said. “Most patients receiving an initial opioid prescription do not proceed to chronic use and among the subset that do use long-term opioids, the majority neither misuse nor experience an overdose.

“An unintended consequence of excessive concerns raised about opioids could be an increasing reluctance among clinicians to prescribe even small amounts of opioids for a limited time for acute pain, including for patients discharged from the emergency department, those who are recuperating from surgical procedures, or persons with severe dental pain.”

A bill recently introduced in Congress would strictly limit opioids to just 7 days for acute pain, a prescription that could not be renewed. Maine, New Jersey, Ohio and several other states are adopting similar measures to limit opioid prescribing.

Kroenke and Cheville say few long-term studies have been conducted on the safety and effectiveness of any pain medications, and more research is needed on alternative therapies like cognitive behavioral therapy and medical marijuana before opioids are abandoned as a treatment option.

“Clinicians must be careful of replacing the opioid epidemic with a marijuana epidemic,” they warned. “Imperfect treatments do not justify therapeutic nihilism. A broad menu of partially effective treatment options maximizes the chances of achieving at least partial amelioration of chronic pain.”

Lyrica and Neurontin Linked to Opioid Overdoses

By Pat Anson, Editor

British researchers say two drugs commonly prescribed as alternatives for opioid pain medication are linked to a rising number of heroin overdose deaths in England and Wales.

Pregabalin and gabapentin belong to a class of nerve medications known as gabapentoids. They were originally developed to treat epileptic seizures, but are increasingly prescribed to treat neuropathy, fibromyalgia and other chronic pain conditions. The drugs are sold by Pfizer under the brand names Lyrica (pregabalin) and Neurontin (gabapentin).

Researchers at the University of Bristol reported in the journal Addiction that opioid overdose deaths in England and Wales involving gabapentoids increased from less than one per year prior to 2009 to 137 deaths in 2015. The increase coincided with a surge in pregabalin and gabapentin prescribing in Wales and England, from one million prescriptions in 2004 to over 10 million in 2015.   

Researchers say the increased prescribing has made the drugs easier to obtain and abuse, and addicts have found they enhance the effects of heroin. Experiments on laboratory mice found that pregabalin slows respiratory depression, increasing the risk of an opioid overdose.

"It is important that doctors and people dependent on opioids are aware that the number of overdose deaths involving the combination of opioids with gabapentin or pregabalin has increased substantially and that there is evidence now that their concomitant use - either through co-prescription or diversion of prescriptions - increases the risk of acute overdose deaths,” said Matthew Hickman, a Professor of Public Health and Epidemiology in the University of Bristol's School of Social and Community Medicine.

The idea that Lyrica and Neurontin are being abused may be surprising to many patients and doctors, but the drugs are increasingly being used by addicts. In a small 2016 study of urine samples from patients being treated at pain clinics and addiction treatment centers, over one in five patients were found to be taking gabapentin without a prescription.

“The high rate of misuse of this medication is surprising and it is also a wakeup call for prescribers. Doctors don’t usually screen for gabapentin abuse,” said Poluru Reddy, PhD, medical director of ARIA Diagnostics in Indianapolis. “These findings reveal that there is a growing risk of abuse and a need for more robust testing.”

High Risk of Abuse in Prisons

Gabapentin and pregabalin are also being abused by inmates. Jeffrey Keller, MD, chief medical officer of Centurion, a private correctional company, says both drugs have a high abuse potential.  

“Gabapentin is the single biggest problem drug of abuse in many correctional systems,” Keller recently wrote in Corrections.com. “There is little difference (in my opinion) between Lyrica and gabapentin in both use for neuropathic pain or for abuse potential.”

Why would someone be so desperate to abuse them?

“If you are addicted, or even if you just like to get high once in a while, and you can’t obtain your preferred drugs of abuse because you are incarcerated, these are the drugs that can serve as an alternative in a pinch,” Keller wrote.
“It is critically important for medical professionals in corrections to know which seemingly benign drugs have the potential to be abused and diverted. Even if a particular inmate doesn’t care about getting high himself, he can still profit by selling these drugs to others who are. Vulnerable inmates can be (and are) bullied into obtaining these drugs for distribution.”

Gabapentin is approved by the FDA to treat epilepsy and neuropathic pain caused by shingles. It is also prescribed “off-label” for depression, migraine, fibromyalgia and bipolar disorder. About 64 million prescriptions were written for gabapentin in the U.S. in 2016, a 49% increase since 2011. Gabapentin is not scheduled by the DEA as a controlled substance.

Pregabalin is a Schedule V controlled substance, which means the DEA considers it to have a low abuse potential. Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, epilepsy, post-herpetic neuralgia caused by shingles and spinal cord injury. It is also prescribed off label to treat a variety of other conditions. Lyrica is Pfizer’s top selling drug, generates over $5 billion in annual sales, and is approved for use in over 130 countries.

The CDC’s opioid prescribing guidelines recommend both pregabalin and gabapentin as alternatives for opioids, without saying a word about their potential for abuse or side effects.

“Selected anticonvulsants such as pregabalin and gabapentin can improve pain in diabetic neuropathy and post-herpetic neuralgia. Pregabalin, gabapentin, and carbamazepine are FDA-approved for treatment of certain neuropathic pain conditions, and pregabalin is FDA approved for fibromyalgia management,” the guidelines state.

Opioids vs. NSAIDs for Chronic Pain

 By Roger Chriss, Columnist

The latest shot in the debate over opioids versus non-steroidal inflammatory drugs (NSAIDs) for chronic pain has been fired, with the Minneapolis Star Tribune reporting on a new study that found “patients with chronic pain fared no better with the potentially addictive painkillers than they did with non-opioid meds.”

The research was conducted by Erin Krebs, MD, who is investigating the efficacy of medications for osteoarthritis aspart of a study called the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE).

(Editor's note: Dr. Krebs appeared in a lecture series on opioid prescribing that was funded by the Steve Rummler Hope Foundation, which is the fiscal sponsor of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.)

Her research involved 240 veterans who were treated for back, hip and knee pain with either opioids or non-opioids for 12 months. She presented her findings recently at the Minneapolis VA Medical Center and the Society of General Internal Medicine.

"For long-term treatment of chronic back pain and osteoarthritis pain, non-opioid medication therapy is superior to opioid therapy for both pain and side effects,” Dr. Krebs said.

A summary of the SPACE research states that the “findings showed no significant advantage of opioid therapy compared with non-opioid medication therapy.”

Naturally, critics of opioid prescribing weighed in.

“If pain doctors still think these medicines are effective, then they have a lot of explaining to do and their competence and professionalism deserve to be challenged,” said Chris Johnson, MD, who is a board member of PROP as well as the Steve Rummler Hope Foundation.

But the study did not show that opioids were ineffective, only that non-opioids were more effective in this particular study. Thus, pain doctors are justified in claiming they are effective. Of course, so are NSAIDs, but this is not a new or surprise finding. Similar results have been obtained before, though only in shorter-term studies.

Dr. Krebs’ results are an important addition to our understanding of which medications are useful for certain types of pain management. In some cases, NSAIDs may be better than opioids, and in other cases, opioids may be better.

But a response like the one from Dr. Johnson is another example of over-generalization and simplification of a complex medical result, and how anti-opioid activists often spin research findings to fit their agendas.  

It also insults the expertise of physicians like Roger Chou, MD,  a Professor at Oregon Health & Science University’s School of Medicine and one of the lead authors of the CDC guidelines; and Sean Mackey, MD, Chief of the Division of Pain Medicine at Stanford University and immediate past president of the American Academy of Pain Medicine.

In a recent Medscape interview, Dr. Chou said, "I don't think there's anything inherently wrong with maintaining somebody on low doses of opioids, as long as it's doing what it's supposed to in terms of helping their pain and function and not causing harm." 

And in a recent Vox interview, Dr. Mackey said, "The fact is if you go looking, there’s clearly data out there that opioids improve pain. These drugs would have never been approved by the FDA if they didn’t."

More importantly, statements like Dr. Johnson’s ignore the difficult challenges that people with chronic pain conditions face.

"Everything we know about pain is that this is a complex biopsychosocial phenomenon,” said Dr. Chou.

Or as Forest Tennant, MD, put it in Practical Pain Management: “A major point to be made about painful genetic diseases is that pain will almost always worsen as the patient ages.”

Chronic Pain is a Complex Problem

Chronic pain management is thus a long-term endeavor requiring as many tools as possible. What works for one person may be ineffective or even contraindicated in another person. NSAIDs may cause intolerable levels of nausea or gastrointestinal pain, and can be contraindicated in some patients because of kidney disease or bleeding disorders. A major study released this week also found that NSAIDs increase the risk of a heart attack.

The converse also holds. Some people do not tolerate opioids well, have too much brain fog or get constipated. And opioids may be contraindicated in a person with respiratory illness or a history of substance abuse. So having an effective alternative such as NSAIDs is important.

Thus, the “risk profile” of each person must be considered. No medication is perfectly safe. According to the FDA, as many as 20,000 people die from NSAID use every year.

At the same time, opioids have risks. Practical Pain Management reported in 2013 that mortality was higher in patients receiving opioids than other analgesics. The risk of addiction to opioids is well-publicized and makes good headlines, but in chronic pain patients it is less than 5 percent.

The unfortunate reality is that pain management is often a lifelong necessity for people who suffer from chronic pain disorders. Such people don’t have the luxury of ideological debates or moralistic disputes. They need a pain toolkit that is as well-equipped as possible, and they have to deal with medication trade-offs in order to address their medical problems.

Prescribing decisions are best left to experienced physicians who know their patients and the medical conditions they have, and can work with them on the risks and benefits of opioids and NSAIDs.

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 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.

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.

NSAIDs Raise Risk of Heart Attack Within Days

By Pat Anson, Editor

Taking prescription strength non-steroidal anti-inflammatory drugs (NSAIDs) raises the risk of a heart attack as soon as the first week of use, according to a large new study published in The BMJ.

An international teams of researchers analyzed data from eight studies involving nearly 450,000 patients in Canada, Finland and Germany -- 61,460 of whom had a heart attack. They found that taking any dose of NSAIDs for one week, one month, or more than a month was associated with an increased risk of myocardial infarction. Researchers estimated that the overall risk of a heart attack was about 20 to 50% higher when using NSAIDs.

"Given that the onset of risk of acute myocardial infarction occurred in the first week and appeared greatest in the first month of treatment with higher doses, prescribers should consider weighing the risks and benefits of NSAIDs before instituting treatment, particularly for higher doses," wrote lead author Michèle Bally, PhD, an epidemiologist at the University of Montreal Hospital Research Center.

The NSAIDs of particular interest to the researchers were ibuprofen, diclofenac and naproxen, as well as the COX-2 inhibitors celecoxib and rofecoxib. COX-2 inhibitors work differently than traditional NSAIDs, by targeting an enzyme responsible for pain and inflammation.

“All NSAIDs, including naproxen, were found to be associated with an increased risk of acute myocardial infarction. Risk of myocardial infarction with celecoxib was comparable to that of traditional NSAIDS and was lower than for rofecoxib. Risk was greatest during the first month of NSAID use and with higher doses,” Bally wrote.

Several previous studies have also found that NSAIDs and COX- 2 inhibitors raise the risk of a heart attack, but the exact cause is unknown. Researchers at the University of California Davis reported last year that NSAIDs impaired the activity of cardiac cells in rodents.  

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are in so many different pain relieving products, including over-the-counter cold and flu products, that health officials believe many consumers may not be aware how often they use NSAIDs. 

In 2015, the U.S. Food and Drug Administration ordered that stronger warning labels be put on NSAIDs to indicate they increase the risk of a heart attack or stroke. The warning does not apply to aspirin.

“There is no period of use shown to be without risk,” said Judy Racoosin, MD, deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products. “Everyone may be at risk – even people without an underlying risk for cardiovascular disease.”

The BMJ study was published the day after Canada released new guidelines that recommend NSAIDs as an alternative to opioid pain medication. The Canadian guideline makes no mention of the health risks associated with NSAIDs, but focuses on their “cost effectiveness.”

“NSAID-based treatment may have lower mean costs and higher effectiveness relative to opioids,” the new guideline states. “Naproxen-based regimens in particular may be more cost effective compared to opioids and other NSAIDs, such as ibuprofen and celecoxib.”

Opioid guidelines released last year by the U.S. Centers for Disease Control and Prevention, which the Canadian guideline was modeled after, also recommend NSAIDs as an alternative to opioids, but acknowledge the medications “do have risks, including gastrointestinal bleeding or perforation as well as renal and cardiovascular risks.”

Despite those risks, the CDC cited the low cost of NSAIDs and other non-opioid treatments as an “important consideration” for doctors.

“Many pain treatments, including acetaminophen, NSAIDs, tricyclic antidepressants, and massage therapy, are associated with lower mean and median annual costs compared with opioid therapy,” the CDC guideline states.

Canadian Opioid Guideline Modeled After CDC’s

By Pat Anson, Editor

Canada this week is officially adopting new guidelines for the prescribing of opioid pain medication that are very similar to those released by the U.S. Centers for Disease Control and Prevention a little over a year ago.

And, like the CDC guidelines, there is controversy over the role played by addiction treatment specialists and anti-opioid activists in drafting them.

The Canadian guideline, developed at the National Pain Centre at McMaster University and published in the Canadian Medical Association Journal, contains 10 recommendations for treating non-cancer chronic pain, most of them focused on reducing the use of opioid medication.

"Opioids are not first-line treatment for chronic non-cancer pain, and should only be considered after non-opioid therapy has been optimized," said Jason Busse, PhD, lead investigator for the guideline and an associate professor of anesthesia at McMaster University’s School of Medicine.  "There are important risks associated with opioids, such as unintentional overdose, and these risks increase with higher doses."

Nearly 1 in 5 Canadians suffer from chronic pain and Canada has the second highest rate of opioid prescribing in the world. Opioid overdoses are soaring in Canada, as they are in the United States, but increasingly the deaths involve illegal opioids such as heroin and illicit fentanyl, not prescription painkillers.

The new guideline recommends that non-drug therapies, such as exercise and cognitive behavioral therapy, and non-opioid medications such as non-steroidal anti-inflammatory drugs (NSAIDs), be used first in treating patients with chronic pain. It is recommended that opioids only be prescribed if patients do not respond to non-opioid treatments, and only if they do not have a history of substance abuse or a psychiatric disorder.

The guidelines also suggest that initial doses of opioids be limited to no more than 50 mg morphine equivalents daily (MED), and strongly recommend that doses not exceed 90 mg MED. The previous Canadian guideline suggested a ceiling of 200 mg MED. For patients who already exceed 90 mg MED, the guideline recommends the gradual tapering of opioids to the lowest effective dose or to discontinue opioid treatment altogether.

"The opioid epidemic has serious consequences for families and communities across Canada. We are committed to working with our partners to ensure a comprehensive response to this public health crisis, including supporting physicians in improving prescribing practices. I applaud the work that went into updating the prescription opioid guideline, and I urge healthcare professionals to apply the recommendations when prescribing these types of medications," said Jane Philpott, Canada's Minister of Health, in a statement.

A major difference with the CDC guideline, which is intended only for primary care physicians, is that the Canadian version applies to all prescribers, including family physicians, pain specialists and nurse practitioners.

The Canadian guideline was also developed with more transparency than the CDC guideline, which was initially drafted in secret meetings by an unidentified panel of experts.  Leaks later revealed that the panel included several academics and addiction treatment specialists, but only one retired doctor with experience in pain management.

PROP Involved in Canadian Guideline

Four advisory panels involving over 50 clinicians, academics, patients and “safety advocates” helped draft the Canadian guideline. Among them were three board members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played a key role in drafting the CDC guidelines: PROP Vice-President Gary Franklin, MD, Mark Sullivan, MD, and David Juurlink, MD.

Juurlink, an academic toxicologist at Sunnybrook Health Sciences Centre in Toronto, had an influential role on the Canadian Guideline Steering Committee; while Franklin and Sullivan, both of them Americans affiliated with the University of Washington, served on the Clinical Expert Committee.

Juurlink and Sullivan disclosed their involvement with PROP in their conflict of interest statements, while Franklin did not specifically name the group.

“These guidelines, which appear to be influenced by the extremely flawed and biased guidelines by the CDC in the United States, written by a small group of anti-opiate crusaders with strong ties to a large drug rehab chain, seem to reflect more attention to people with addictions and not people with pain,” said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada, in written comments to the guideline.

PROP's founder and Executive Director, Andrew Kolodny, MD, was until recently chief medical officer of Phoenix House, which runs a chain of addiction treatment facilities in the U.S.

A news release on the guideline produced by McMaster University emphasizes that experts with “diverse views on the role of opioids” participated in drafting them and only those “without important financial or intellectual conflicts of interest” were allowed to vote on the recommendations.

Ulmer says the guidelines should have focused on improving pain education for physicians, which is limited in medical schools in both Canada and the U.S.

“Pain patients feel strongly the authors and policy makers behind these guidelines have missed another golden opportunity to create real change in this area of medicine. They would have impacted pain medicine far more positively if they had used their resources to develop forward thinking educational programs and incorporate them into the curricula in our teaching hospitals,” Ulmer wrote.

“By putting forth guidelines like this, at this time, to influence (or control) a profession that has little education and understanding about chronic pain is myopic and similar to the last attempt at guidelines will simply encourage more physicians to dump pain patients they now have. Or is that the real goal?”

One of the many unintendend consequences of the CDC guidelines in the United States is that pain patients are losing access to treatment. A recent survey of over 3,100 patients by PNN and the International Pain Foundation found that over 60 percent had a hard time or were unable to find a doctor willing to treat their chronic pain. Over 90 percent believe the CDC guidelines have harmed patients and worsened the quality of pain care. 

Although the CDC guidelines are voluntary and only intended for primary care physicians, they are being implemented and treated as mandatory by many prescribers, insurers, and federal and state agencies. Critics worry the same thing could happen in Canada.

“No guideline can account for the unique features of patients and their clinical circumstances, and the new guideline is not meant to replace clinical judgment. Patients, prescribers and other stakeholders, including regulators and insurers, should not view its recommendations as absolute,” wrote Drs. Andrea Furlan of the Toronto Rehabilitation Institute, and Owen Williamson of Monash University in Australia, in an editorial published in the Canadian Medical Association Journal.

British Columbia adopted its own mandatory version of the CDC guidelines nearly a year ago, and made them a legally enforceable standard of care for all prescribers. The move has yet to slow the rising tide of drug overdoses in British Columbia, which are now occurring at a rate of four deaths every day. Most of the overdoses are blamed on illicit fentanyl and other street drugs, not prescription opioids.

Hydrocodone Prescriptions Continue Falling

By Pat Anson, Editor

For the fifth year in a row, fewer prescriptions for the opioid painkiller hydrocodone were dispensed in the U.S. in 2016, according to a new report by the QuintilesIMS Institute, which tracks prescription drug use and spending.

The report adds further evidence that the nation’s overdose epidemic is being fueled by illegal opioids such as heroin and illicit fentanyl, not prescription painkillers.

About 7 million fewer prescriptions were filled last year for hydrocodone, which is usually combined with acetaminophen in Vicodin, Lortab, Lorcet, Norco, and other hydrocodone combination products.

As recently as 2012, hydrocodone was the #1 most widely dispensed medication in the nation, with 136 million prescriptions filled. Since then, hydrocodone prescriptions have fallen by over a third, to 90 million prescriptions.

Hydrocodone now ranks fourth, behind the thyroid drug levothyroxine (Synthroid), the blood pressure medication lisinopril (Zestril), and the statin atorvastatin (Lipitor).

Hydrocodone was reclassified by the DEA as a Schedule II controlled substance in 2014, making it harder to obtain. Opioid guidelines released last year by the CDC also probably had an impact, although hydrocodone prescriptions were falling long before the CDC and DEA acted.

HYDROCODONE PRESCRIPTIONS IN U.S. (MILLIONS)

Source: QuintilesIMS Institute

Prescriptions for hydrocodone and other opioids are likely to fall even further in 2017, because the DEA plans to reduce the supply of almost every Schedule II opioid pain medication by 25 percent or more "to prevent diversion." The 2017 quota for hydrocodone is being reduced by a third, to 58.4 million prescriptions, which the DEA considers an adequate supply.

Overall, QuintilesIMS reported 13 million fewer prescriptions for pain medicines in 2016, “as restrictions on prescribing and dispensing become increasingly common and impactful.” The company includes both narcotic and non-narcotic treatments in its pain medicine category.

Over 7 million more prescriptions were written last year for gabapentin (Neurontin), a medication originally developed to treat seizures that is now widely prescribed for neuropathy and other chronic pain conditions.  About 64 million prescriptions were written for gabapentin in 2016, a 49% increase since 2011.

More prescriptions are also being written for ibuprofen, a widely used pain reliever available both by prescription and in over-the-counter drugs. About 44 million prescriptions were filled for ibuprofen in 2016, a 19% increase since 2012.

The shift in prescribing away from opioids is hardly a surprise to pain sufferers. According to a recent survey of over 3,100 patients by PNN and the International Pain Foundation, over 70% said they were no longer prescribed opioids or were getting a lower dose since the CDC guidelines were released. About half of the doctors and pharmacists we surveyed also said they were writing or filling fewer opioid prescriptions, or had stopped them altogether.  

“My doctor cut me off hydrocodone cold turkey last fall leading to an overnight in the hospital emergency room,” a patient with chronic back pain and anxiety told PNN. “For years I have been stable on a mix of hydrocodone and Valium. Last October my doctor said he would only fill one prescription and asked me to make a choice so I stayed with the Valium.”

“With the VA allowing me only 2 hydrocodone per day now, I get very little exercise and stay in bed a lot,” a 70-year old veteran wrote. “My quality of life has gone down considerably. Before the changes, I stayed quite active taking 4 hydrocodone a day.”

“I had an interventional pain management doctor scream at me that the guidelines were mandatory and he refused to write for any type of opioids even though I've been on the same level of hydrocodone for several years,” another patient said.

“I took hydrocodone pain medicine for 25 years as the doctor proscribed. Never called in for more, now I'm having to go a pain doctor and get steroid shots every 3 months,” wrote a patient with lives with chronic back pain.

Overall spending on prescription drugs in the U.S. reached $323 billion in 2016, a 4.8% increase that is less than half the rate of the previous two years. The QuintilesIMS report blames the slowdown in growth on increased competition among drug makers and efforts to limit price increases.

“New medicines introduced in the past two years continue to drive at least half of the total growth as clusters of innovative treatments for cancer, autoimmune diseases, HIV, multiple sclerosis, and diabetes become accessible to patients,” said Murray Aitken, Senior Vice President and Executive Director, QuintilesIMS Institute.

Better Analysis Needed on Non-Medical Use of Opioids

By Willem Scholten, PharmD MPA, Guest Columnist

A few months ago, the medical journal World Psychiatry published an article that focused on the global non-medical use of prescription drugs, particularly psychoactive substances such as opioids.

Unfortunately, the two authors -- Dr. Silvia Martins and Dr. Lilian Ghandour -- ignored the distinction between prescription and prescribed opioids, adding unnecessary confusion to the already complex debate about access to pain treatment. Further, Dr. Martins said in the Washington Post that the non-medical use of psychoactive substances could turn into a pandemic if we are not careful.

Both authors are affiliated with Columbia University’s Mailman Institute of Public Health, which claims to work in the interest of underserved people in developing countries. Access to effective pain treatment in developing countries is already now more difficult than in the U.S.

Elsewhere, I have demonstrated that access to prescribed opioids for adequate pain treatment is a problem for 5.5 billion people living in countries where opioid analgesics are not available or inaccessible for patients in need.

In most countries, the per capita consumption of legitimately prescribed opioid analgesics (as officially reported to the International Narcotics Control Board) remains much lower than in the U.S. and Canada, in extreme cases even up to 50,000 times lower.

Distinction Between “Prescribed” and “Prescription” is Key

There is a vast difference between prescription and prescribed opioids. Prescription opioids are intended to be prescribed as medicines. Prescribed medicines are actually prescribed by a physician and dispensed by a pharmacy.

About 75% of fatal overdoses from prescription opioids in the U.S. occur in people who have not been prescribed opioids during the three months preceding their deaths. Thus, the majority must have obtained these prescription opioids on the black or gray market.

Without referencing the data, Drs. Martins and Ghandour claim that prescription opioids are causing serious problems in other parts of the world. However, data from the European Monitoring Centre for Drug and Drug Addiction and the European Drug Report indicate that diversion of prescription opioids is not a serious problem in Europe. In other regions of the world, per capita prescription of opioids is very low.

Drs. Martins and Ghandour claim a high prevalence of non-medical use of prescription opioids in Saudi Arabia. However, those medicines are hardly ever prescribed in that country and medical consumption rates are only about 2.5 % of the U.S. volume. Therefore, Saudi Arabia’s non-medical use of prescription opioids can hardly originate from prescribed opioids.

Unfortunately, World Psychiatry refused to publish a letter I wrote with other experts which addressed the misunderstandings stemming from Drs. Martins and Ghandour’s article.

PROP and the Anti-Opioid Lobby

The anti-opioid lobby in the U.S. does not shy away from using arguments not based on facts, just like Drs. Martins and Ghandour in their article. For example, Physicians for Responsible Opioid Prescribing (PROP) perpetuates the mistaken conflation of prescription and prescribed opioids, advocating in the U.S. against the legitimate medical prescribing of opioid analgesics. PROP tries to justify its position using false statistics, as I demonstrated in a recent publication.

Moreover, PROP leadership participated in drafting the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. PROP Executive Director Dr. Andrew Kolodny disclosed his involvement, but PROP President Dr. Jane Ballantyne and PROP Vice President Dr. Gary Franklin did not list the group as a relevant conflict of interest on their disclosure forms.

The Steve Rummler Hope Foundation is the “fiscal sponsor” of PROP. Its vision is “a world where individuals with chronic pain receive integrated care focused on wellness rather than drugs.” For patients with moderate or severe pain, this can hardly be an effective and humane treatment. PROP’s close ties with the Steve Rummler Foundation are revealed by Dr. Kolodny’s and Dr. Ballantyne’s membership on its medical advisory committee.

Policies Should Balance All Public Health Interests

Indeed, it is correct to attend to the non-medical use of psychoactive substances. However, the situation outside the U.S. is really different. In many countries, patients have no access to adequate pain management. Measures to address non-medical use of opioids should not hamper access to effective pain management.

Policymakers in countries with a low per capita medical opioid consumption and low prescription rates should first analyse how prescription opioids that have not been prescribed enter circulation. The relationship between the non-medical use of prescription opioids and illicitly produced substances such as heroin should also be taken into consideration. Then, appropriate interventions to halt the diversion should be developed.

In parallel, policymakers should develop policies aimed at ensuring adequate provision of pain treatment as recommended by the World Health Organization. Optimal public health outcomes can only be attained when policies to minimize non-medical use are balanced with policies to maximize access to adequate pain management. Crafting such policies entails correctly distinguishing between prescribed and prescription opioids.

Willem Scholten, PharmD MPA, is an independent consultant for medicines and controlled substances at Willem Scholten Consultancy in the Netherlands. This has included work for DrugScience, Grünenthal, Jazz Pharmaceuticals, Mundipharma, Pinney Associates and the World Health Organization. Dr. Scholten is also a board member of International Doctors for Healthier Drug Policies.

He wishes to acknowledge Dr. Katherine Pettus for her contribution to this article.

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.

Will Pain Patients Participate in Drug Take Back Day?

By Pat Anson, Editor

Tomorrow is National Prescription Drug Take Back Day, an annual effort by the U.S. Drug Enforcement Administration to give people an opportunity to safely dispose of their unneeded and expired medications.

Last year the DEA and its local law enforcement partners collected nearly 900,000 pounds of unwanted medication – about 447 tons – at almost 5,400 collection sites in all 50 states.

“These results show that more Americans than ever are taking the important step of cleaning out their medicine cabinets and making homes safe from potential prescription drug abuse or theft,” said DEA Acting Administrator Chuck Rosenberg in a news release.

One of the main goals of the DEA is to get patients to dispose of unneeded opioid medication, to prevent the drugs from being stolen, shared or sold.

But with opioid medciation becoming harder to obtain due to federal and state guidelines – and the DEA itself reducing the supply of hydrocodone, oxycodone, and other painkillers by 25 percent or more --   are chronic pain patients going to participate in Drug Take Back Day?

A recent survey of over 3,100 patients by Pain News Network and the International Pain Foundation suggests that many will not. And that government efforts to limit the supply of opioids have turned many responsible patients into hoarders.

Nearly one in four patients – 22 percent – say they are hoarding opioid medications because they’re not sure if they’ll be able to get them in the future.

Nearly half say they are being prescribed a lower dose since the CDC released its controversial opioid guidelines, and almost one in four say they are no longer prescribed any opioids.

“The CDC guidelines have led to a lot of confusion and fear for patients and their doctors. If anything, I ask for more pain medication now because I don't know how much longer I'll be able to obtain it,” one patient wrote.

“I never abused my opiates and in fact have hoarded 30 precious pills,” said another patient.

“I am 65 years old, well educated, and very disabled by (fibromyalgia). I endure the pain, for as long as possible, (and only) then take the meds due to having to hoard the medication,” wrote another.

“It's a no win situation," said a patient. "To be able to get proper relief from a new injury or if surgery comes up, one must hoard enough to treat the additional pain or suffer through it.”

Although the supply of opioid medication has been in decline for years, the news media often makes it sound like painkillers are still being given out like candy, often relying on outdated or inaccurate information that doesn't reflect the current environment.

“The amount of prescription opioids consumed has quadrupled since 1999, and deaths are even higher. Since eight out of ten new heroin users began by abusing prescription painkillers, and most get their pills from family and friends, controlling access to the pills becomes increasingly important,” Judy Stone, MD, wrote in a Forbes article promoting Drug Take Back Day.

Yes, Dr. Stone, it is true that opioid overdoses are soaring, but in recent years that is primarily due to heroin and illicit fentanyl, not prescription opioids. Even the CDC admits that painkillers are no longer driving the opioid epidemic.

The DEA also tells us that less than one percent of legally prescribed painkillers are diverted, which means that 99% of pain patients are responsible about their use and storage of pain medication. Only a small percentage of patients become addicted to opioids and even fewer go on to use heroin.

All of which isn’t to say that Drug Take Back Day is a bad idea. But let’s not use it as another opportunity to stigmatize chronically ill patients who happen to need pain medication.

To find a drug collection site near you, click here.