The Opioid Blame Game

By Roger Chriss, Columnist

Nearly 40 years after it was published, a short letter to the editor in The New England Journal of Medicine is today being blamed by various media outlets for having “kicked off” or “fueled” or “sparked” the opioid epidemic.

The one paragraph letter, written by researchers at Boston University Medical Center, has attracted media attention because of a new letter to the editor by Canadian academics Pamela Leung, Erin Macdonald, MD, PhD, Irfan Dhalia, MD, and David Juurlink, MD, PhD. They claim that the 1980 letter “was heavily and uncritically cited as evidence that addiction was rare with long-term opioid therapy.”

The authors are not the first to notice this. The New Yorker made the same claim in 2013, to little effect.

Now, however, the media has latched onto the 1980 letter’s statement that “addiction is rare in medical patients with no history of addiction,” by declaring it to be the spark that ignited an explosion of opioid overdoses and deaths.

If only it were that simple.

The opioid epidemic has already been blamed on OxyContin and Purdue Pharma, drug seeking pain patients, physician overprescribing and pill mills, and even a small study by Russell Portenoy, MD, in 1986.

But conspicuously absent are many other contributing factors, including:

• Managed healthcare looking for cheap treatment options
• Health insurers pushing to reduce healthcare costs
• Employers expecting workers to return to work sooner
• Patients wanting a quick pain cure

Another commonly cited villain is the campaign to treat pain as the "5th Vital Sign.” But that did not occur in a vacuum. The rise of chronic pain paralleled increasing levels of acute pain, for reasons such as:

• Better trauma care for car crash and gunshot victims
• Early and aggressive cancer care
• Increasing rates of diabetic neuropathy and amputation
• More injection therapy and surgery to treat damage and deterioration in the spine and joints

Medical care improved in many important ways in the 1980’s, including the advent of minimally invasive surgery and chemotherapy for a wide variety of cancers, as well as the discovery of drugs that turned once deadly diseases like AIDS and leukemia into chronic conditions that could be medically managed. There have also been many well-intentioned attempts to treat increasingly common degenerative diseases and disorders that may have caused more pain in some patients.

In other words, there is plenty of blame to go around. But media coverage ignores these larger issues.

Instead, CNN draws a parallel between the 1980 letter and a lawsuit filed last week by Ohio’s Attorney General against five opioid manufacturers. And the CBC’s coverage includes a link to a 2011 YouTube video produced by the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), perhaps because David Juurlink himself is on the PROP Board of Directors. An old lecture on the evils of opioids is beside the point here

The real question here is: Does finger pointing at a NEJM letter from 1980 help people today who are suffering from opioid addiction?

The research literature on opioid addiction in the 1970’s and 80’s strongly resembles today’s efforts. Even high school health classes back then discussed methadone clinics and medication-assisted treatment, the importance of long-term maintenance therapy, and the value of safe injection sites and needle exchange programs for heroin users.

This leads to a far more important question: Why aren’t we using these treatments more widely?

This blame game isn’t helping opioid addicts. As media reports identify the 1980 letter as another target of blame for the opioid crisis, we should be asking why we’ve made so little progress since then in treating addiction.

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.

New Drug Testing Guideline Warns Against Fraud

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Utah Raid Uncovered Large Fentanyl Pill Ring

By Pat Anson, Editor

A drug bust in a Utah home last November has uncovered one of the largest counterfeit pill operations in U.S. history.

This week a federal grand jury in Salt Lake City indicted six individuals for manufacturing nearly 500,000 pills laced with illicit fentanyl that were disguised to look like the painkiller oxycodone and the anti-anxiety drug alprazolam (Xanax). The counterfeit pills were distributed throughout Utah and the United States to customers who ordered them online.

Fentanyl is a powerful synthetic opioid that it is 100 times more potent than morphine and 50 times more potent than heroin. In recent years, illicit fentanyl has been blamed for thousands of overdose deaths in the U.S. and Canada.

“What we feared and hoped somehow would stay away has arrived in spades,” said Brian Besser, the DEA’s agent in charge in Utah. “Fentanyl is as dangerous as it gets.”

According to documents filed in federal court, the pill ring was created by Aaron Shamo and Drew Crandall, both Utah residents who worked together at eBay, but quickly grew to include the other conspirators. Prosecutors say the defendants purchased pill presses, dies and stamps so the counterfeit pill markings would match those of legitimate pharmaceutical drugs. Some items were purchased legally and others, such as fentanyl and alprazolam, were illegally imported from China

The fake pills were sold on a “dark net online store” at a significant profit. Once sold, Shamo and Crandall used their co-conspirators to package the pills and ship them to customers. In less than a year, the operation mailed 5,606 drug orders totaling $2.8 million, according to court documents.

“Shamo’s customer base was extremely comprehensive and widespread, touching every corner of the United States,” Besser said. “It touched large cities and rural communities.”

The round blue tablets manufactured by the pill ring were offered for sale online as oxycodone 30mg tablets. The tablets were debossed with “A 215” on the bisected side, with an “M” on one side and a “30” above the bisect on the other side. The indictment alleges the defendants did not use oxycodone at all in the manufacturing process, but instead used illicit fentanyl.

Federal agents arrested Shamo last November. During a raid on Shamo’s suburban Salt Lake City home, agents discovered a pill press capable of manufacturing several thousand pills an hour. Agents also seized 70,000 pills and $1.2 million in cash stuffed in garbage bags.

Crandall fled to Australia with his girlfriend and was in Laos when agents raided Shamo’s house. He was arrested last month in Hawaii. A summons will be issued for the other four conspirators for their initial appearances in federal court.

Research Uncovers Why Some Pain Meds Don’t Work

By Pat Anson, Editor

An international team of researchers may have discovered why some pain medications are inneffective: they target receptors on the surface of nerve cells that have moved out of reach.

Their findings, published in the journal Science Translational Medicine, may lead to the development of a new class of pain medication that is more potent and less prone to side effects than opioids and non-steroidal anti-inflammatory drugs (NSAIDs).

"Opioids and NSAIDs do not work for everyone and have unacceptable side effects, particularly when used over a long period of time," said Nigel Bunnett, PhD, a professor of surgery and pharmacology at Columbia University Medical Center.

"However, previous efforts to develop more effective analgesics have been stalled by our limited understanding of the mechanisms that allow nerves to sense and transmit pain signals."

Many pain medications work by targeting protein receptors on the surface of nerve cells that transmit pain signals. One receptor – known as the neurokinin 1 receptor (NK1R) -- causes pain and inflammation when activated.

In a series of laboratory experiments on rodents, Bunnett and his colleagues discovered that NK1R, when stimulated by pain, quickly moves from the cell surface to inside the cell membrane, where it continues to function outside the reach of pain medication. Researchers found that when they added a lipid (fat molecule) to painkillers that can cross the cell membrane, they effectively blocked NK1R and provided potent and durable pain relief to the rodents.

"From these experiments, we have demonstrated that designing NK1R inhibitors that are capable of reaching the endosomal network within nerve cells may provide much longer-lasting pain relief than currently available analgesics," said Bunnett. "We think that modification of many existing compounds, as we did with NK1R inhibitors, may have the potential to enhance the effectiveness of many different classes of medications."

The next step for researchers is to see if the same results can be found in humans. If proven, it could mean that current pain medications could be redesigned to make them more effective.

"This is a proof-of-concept study that shows that we can re-engineer current pain drugs and make them more effective. The challenge is now to translate the technology into human clinical trials. This is a complex and challenging path – but the ultimate benefits to patients with nerve pain are potentially highly significant," said Dr. Meritxell Canals of Monash Institute of Pharmaceutical Sciences at Monash University in Australia.

The study was supported by grants from Australia’s National Health and Medical Research Council, the Australian Research Council, and Takeda Pharmaceuticals.

Marijuana Medication: Hope or Hype?

By Pat Anson, Editor

A Las Vegas company that is developing a new cannabis-based treatment for chronic pain has lost money since its inception and there is “substantial doubt” about its ability to survive, according to reports filed with the Securities and Exchange Commission (SEC).

But don’t give up on GB Sciences just yet, says its new chairman and CEO.

“We’re not as financially lame as you might suspect,” John Poss told PNN. “We’ve really done some interesting and groundbreaking research into cannabis.”

Last week GB Sciences issued a press release touting an application by its subsidiary, Growblox Life Sciences, for a patent on new treatments for chronic pain and heart conditions. The company claims to be developing “novel pain formulations” that are substantially free of delta-9 tetrahydrocannabinol (THC), the psychoactive ingredient in cannabis.

"These new chronic pain and heart formulas adhere to GB Science's strategy of commercializing complex mixtures of cannabis-derived compounds whose pharmaceutical activity does not require THC,” Poss said in the news release.

But a review of GB Sciences’ most recent quarterly report with the SEC could raise some doubts among pain patients and investors about whether the company has the resources to develop a cannabis medication. At the end of 2016, GB Sciences had no revenue and over $28 million in debt and liabilities.

“These factors, among others, raise substantial doubt about the Company's ability to continue as a going concern,” the quarterly report says.

But Poss maintains GB Sciences turned a corner in March after raising $9 million from investors. A marijuana grow facility in Las Vegas has also come on line and will soon be producing revenue. Poss thinks the company will be breakeven in cash flow by early next year and could launch a small pilot study of its cannabis medication.  

“Either we have something or we don’t. And we’ll find out within a year. If we have something or at least a strong indication that we have something, then our ability to raise money to do a formal clinical trial is greatly enhanced,” said Poss, who hopes to eventually partner GB Sciences with another larger company.

“Before we make bold statements about spending $100 million, we need to spend half a million and find out if it works, which not everyone can do. And we can do that.”   

GB Sciences’ stock (GBLX) trades on the over-the-counter “Pink Sheet” market for about 26 cents a share. Historically, the company paid its executives, creditors, and partners with millions of new shares, stock options and warrants, which diluted the value of existing shares. It also gave the company a reputation as a “pump and dump” operation, which Poss says he is working hard to change.

Where is Cannabis Science’s Pain Patch?

Another financially challenged company is California-based Cannabis Science, which claims to be developing a variety of cannabis-based pain therapies. When we first told you about this “fundamentally unsound company” last November, it had just released a press release announcing plans to develop a cannabis-based skin patch to treat fibromyalgia and diabetic neuropathy. 

In February, another press release was issued by Cannabis Science saying the company was working on the “final packaging” of the pain patch and would be distributing it to marijuana dispensaries in California “very soon.”

In March, a third press release said the pain patches “are about to hit the market.”

There’s been no further word from Cannabis Science about the pain patch, although the internet is full of stories about the “revolutionary” pain patch “that delivers powerful pain-fighting medicine through the skin and into the bloodstream.” There’s even a creepy video on YouTube in which a robotic computer-generated voice claims “there’s a strong possibility that the patches even cure these health problems.”

Which would be terrific news – if the patches actually existed. Calls and emails to the company asking for an update on the patch were not returned. 

At the time of its first press release on the pain patch, Cannabis Science stock (CBIS) was trading for less than six cents a share. Three months later – no doubt fueled by the hype over its pain patch -- the stock doubled in value to nearly 13 cents a share. During that time, company insiders sold over 12,000,000 shares for over $500,000.  

That’s not a bad take for executives working for a company that generated only $9,263 in revenue during all of 2016 and posted an operating loss of nearly $10 million.

“At this time, our ability to generate any significant revenues continues to be uncertain.  There is substantial doubt about our ability to continue as a going concern,” Cannabis Science says in its annual report to the SEC, which was filed last month.

“The Company is undercapitalized, and will be reliant on outside financing from sales of securities or issuance of debt instruments.  Management expects many traditional lenders will be reluctant to provide the Company with capital in light of its financial condition and the nature of its expected business; so that any financing activities will likely be expensive and result in dilution to stockholders of the Company.”

All of this should be no surprise to people familiar with Cannabis Science CEO Raymond Dabney, who is no stranger to accusations of stock manipulation. In 2005, Dabney admitted issuing 22 bogus news releases to promote another penny stock in Canada. For that he received a five year trading ban from British Columbia’s Securities Commission, according to Forbes and the Vancouver Sun.

At various times in its history, Cannabis Science has gone under the name Patriot Holdings, National Healthcare Technology, Brighton Oil & Gas, and Gulf Onshore.

“I'm not sure if Cannabis Science is a biotech firm, an oil and gas exploration company, an educational university or a pot distributor, the only thing I am certain of is that Cannabis Science is in the business of moving money from public investors to executives' pockets,” wrote John Brody Gay in a lengthy analysis published by Seeking Alpha, an investing website.

Gay and other analysts say Cannabis Science is a classic pump and dump penny stock that produces little revenue, only a steady stream of press releases to promote its business activities, which never seem to come to fruition.

Often other websites are hired by pump and dumpers to publish their press releases or write glowing reviews about a company known as “advertorials.” The publicity generates a flurry of interest in the company’s stock, which is when executives and other insiders often sell their shares.

In 2014, the SEC issued an investor alert about marijuana stock scams, warning specifically about false and exaggerated claims made in press releases. The advice still holds true today for investors, as well as pain patients.

“Fraudsters often exploit the latest innovation, technology, product, or growth industry – in this case, marijuana – to lure investors with the promise of high returns.  Also, for marijuana-related companies that are not required to report with the SEC, investors may have limited information about the company’s management, products, services, and finances.  When publicly-available information is scarce, fraudsters can more easily spread false information about a company, making profits for themselves while creating losses for unsuspecting investors,” the SEC said.

In March, the SEC charged the founder of a California--based marijuana company with fraud for falsely touting “record” revenue numbers in press releases.

Medbox founder Vincent Mehdizadeh bragged in a text message that “the only thing we are really good at is public company publicity and stock awareness.  We get an A+ for creating revenue off sheer will but that won’t continue.” 

Mehdizadeh settled the SEC charges by agreeing to pay $12 million in penalties.

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.

Can Vitamin D and Good Sleep Reduce Pain?

By Pat Anson, Editor

Vitamin D supplements, along with good sleeping habits, could help manage chronic pain from fibromyalgia, rheumatoid arthritis, back pain and other conditions, according to a new study.

The importance of vitamin D – the “sunshine vitamin” – in maintaining bone strength and overall health has long been known.  But recent research has focused on the role it plays in inflammation, musculoskeletal pain and sleep disorders.

“Vitamin D status seems to have an important role in the bidirectional relationship observed between sleep and pain,” said senior author Dr. Monica Levy Andersen in the Journal of Endocrinology. “We can hypothesize that suitable vitamin D supplementation combined with sleep hygiene may optimize the therapeutic management of pain-related diseases, such as fibromyalgia."

Andersen and her colleagues at Universidade Federal de Sao Paulo in Brazil reviewed 35 clinical studies of vitamin D, and concluded that vitamin D supplements could increase the effectiveness of pain treatments by stimulating an anti-inflammatory response.

"This research is very exciting and novel. We are unraveling the possible mechanisms of how vitamin D is involved in many complex processes, including what this review shows - that a good night's sleep and normal levels of vitamin D could be an effective way to manage pain," said Sof Andrikopoulos, assistant professor at the University of Melbourne and Editor of the Journal of Endocrinology.

Sources of Vitamin D include oily fish and eggs, but it can be difficult to get enough through diet alone. Ultraviolet rays in sunlight are a principal source of Vitamin D for most people.

Several recent studies have found an association between chronic pain and low levels of Vitamin D in the blood.  Researchers at National Taiwan University Hospital found low levels of serum vitamin D in over 1,800 fibromyalgia patients. Danish researchers have also found an association between lack of sunlight and multiple sclerosis.

But some question quality of the studies and whether Vitamin D supplements do any good.

“Evidence does not support vitamin D supplementation for the treatment of multiple sclerosis and rheumatoid arthritis or for improving depression/mental well-being,” wrote Michael Allan, a professor of Family Medicine and director of Evidence Based Medicine at the University of Alberta in the Journal of General Internal Medicine.

Allan says much of the research is of low quality. He doesn’t dispute the overall health benefits of Vitamin D – such as building strong bones and teeth -- but thinks taking supplements is unnecessary and could even be harmful in large doses.

"The 40 year old person is highly unlikely to benefit from vitamin D," said Allan. "And when I say highly unlikely, I mean it's not measurable in present science."

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.

Walk a Mile in My Shoes Before You Limit Opioids

By Craig Bowden, Guest Columnist

I am 46 years old and have had a very good life until the last few years, when chronic pain stole all of my professional aspirations, and put the love of my family and my wife to an extreme test.

For the last 25 years I've been in the communications industry, mostly involved with fiber optic technology. I also worked in a metal casting foundry, which is when I had a severe motorcycle accident that gave me a concussion, shattered my right arm at the elbow, and left me with many small fractures and bone chips in my wrists.

The pain was intense, but I never complained about it. I followed doctor’s orders in terms of medications and physical therapy, and it still required 5 surgeries before my right arm had some limited function. I never focused on the pain, I focused on recovery. Although this happened over 20 years ago, I still live with the pain from those injuries every day.

Needless to say, my foundry days were done and I needed to find a career that would work with my limited right arm. 

CRAIG BOWDEN

Over the years, I've been involved in a number of other accidents, including a head-on crash at an intersection where the oncoming driver was trying to beat a red light, swerved to miss another vehicle and hit my car head on at 60 mph. That crash broke two of my ribs and smashed my knees up pretty bad.

Years later, I broke my left wrist in a slip/fall accident. It happened so fast and broke my wrist in the worst possible way. Fortunately, I was able to get patched up again.

The reason I share these stories is because I want you to understand that I'm not an addict, nor will I ever be. Pain medication was something I never abused. I only needed relief to get a few hours of sleep or to spend time with my kids. I used pain medication sparingly because I didn't like the way it made me feel in the head. I mostly used ice and survived just fine.

But bigger problems were on the way.

As years passed, I became somewhat of an expert in the field of fiber optics. I traveled and worked with many companies across the U.S. I also started my own fiber optic business in 2003 in my garage. It was a bumpy start, but soon we were selling over $6 million annually and facing huge opportunities. Then I hit a wall. The pain wall.

I was working on a project when I had sharp acute pain in my lower left abdomen. It was very intense, but being no stranger to pain (and surrounded by clients), I pushed through and nobody was any wiser that I was suffering. I was sweating uncontrollably, shaking all over, dizzy and even slurring some of my speech. I continued to work 3 more days before finally seeing my primary care doc.

They put me through a day’s worth of tests such as ultrasound (looking for hernia), HIDA scan (gallbladder) and others until they finally got me in for a cat scan. Bam! Bad news. I had a perforated colon that required immediate antibiotics and emergency surgery. I had been living for almost 5 days with a severe sepsis infection and everyone agreed that I was lucky to have survived. But I didn't complain about the pain.

Over the next several years, I endured 8 more abdominal surgeries, plus many other hospital admissions for strangulated bowel or bowel rest, along with countless other visits to ERs with uncontrolled pain.

As an unwanted byproduct of all these surgeries, I developed "ARD" or Adhesion Related Disorder, also known as Adhesions Disease. Adhesions are like scar tissues and can cause organs to stick together like glue. Most people develop some form of adhesion post-surgery, but for some reason my body just keeps churning out adhesions like an assembly line.

Many of the surgeries I've had were exploratory, or in other words: "We don't know what's causing all the pain so we need to look around.” Once the doctors cut me open, I'd be on the operating table for 10-12 hours while they cut away the fibrous adhesions. I became very aware of the early warning signs of a blockage or strangulated bowel.

I am very pragmatic when it comes to pain. I believe that a "1" on the pain scale is when you stub your toe on a table leg and a "10" is the point at which I would black out from excessive pain (which has happened to me twice). I've had numerous instances of a 9/10 pain scale and would be screaming uncontrollably in the ER.

Many of my hospital visits helped get the pain under control, but when I went home, I used pain drugs sparingly. I always recovered from the surgeries in 40 to 60 days and went right back to working 80-100 hour a week. I never gave a thought to the pain meds once I was up and running again.

Who are these people who think using oxycodone for pain control is a gateway to drug abuse? Using their logic, I should be a serious heroin and crack abuser by now, but I've never even tried illegal drugs.

In 2015, my surgeon put me on high doses of fentanyl and oxycodone, enough to kill a "normal" person from respiratory failure.  Two years later I’m still alive, have successfully weaned myself to a lower dose and I'm not an addict. So my primary care physician and my pharmacy shouldn't treat me like one! But the CDC guidelines have everyone under a microscope, so they're cutting back access to people in genuine pain. 

I only have 6 feet of small intestine remaining, which is inside a dense ball of adhesions. Operating on it would be very risky and could cause pancreatitis. There is not enough small bowel to properly absorb food, so I take many vitamins and supplements as well as motility and pain meds. I had to sell my company, which was heartbreaking, but I simply couldn't run it anymore. My wife stayed with me 24 hours a day, every day, while I was hospitalized.

I now attend a specialty clinic that uses a blend of massage, myofacial holds, physical therapy and strong palpation on the abdomen to take down adhesions and loosen my tissues so I can move. I feel certain this amazing treatment has kept me out of surgery. In terms of pain, my very best day is a 3 or 4 on the pain scale and my worst can spike to 7 or 8 at times.

I’ve thought about ending things with a bullet to the head countless times. But I just can't insult my wife, kids, family and friends who stuck with me through all this by taking the easy way out.

Chronic pain patients like myself should not be vilified as criminals, but the CDC guidelines have set in motion a vast effort to control the flow of opioids. Doctors are leery to prescribe pain medication, pharmacists don't want to fill the scripts and they all look at patients with a glare of mistrust.

I'd give ANYTHING to give real, severe and unrelenting pain to some of these CDC bureaucrats and see how they tolerate it like I do every day. They should walk a mile in my shoes first.

Craig Bowden lives in Florida with his family.

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.

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.

The 4 A’s That Can Help Relieve Chronic Pain

By Barby Ingle, Columnist  

I often hear from pain patients who say that they have tried everything to help lower or relieve their pain levels. Many times what they mean is that their healthcare provider did all they could, and they got minimal or no relief and gave up.

We must realize that providers don’t have all the answers, insurance doesn’t cover all the options that may help, and there are new treatments and therapies that may lower your pain. Many of these treatment modalities are not covered by insurance – so providers may not even offer them. Access to them is limited unless you know your options and create a plan to get them.

Many of these treatment modalities are not covered by insurance – so providers may not even offer them. Access to them is limited unless you know your options and create a plan to get them.

In my next few columns I’m going to focus on some of these treatments, starting with the 4 A’s: acupressure, acupuncture, aromatherapy and art therapy.  

Acupressure

When it comes to acupressure, you can go to a practitioner or you can learn to do the techniques on yourself at home for free. The practitioner works with your pressure points, which are known as meridians. Putting pressure on these meridian points can reduce muscle tension, improve circulation and stimulate the release of endorphins, which are natural pain relievers. All can help lower pain levels.

They are also said to work on your body’s energy field, mind, emotions and spirit. A session with a practitioner lasts about an hour, but you can learn the techniques and do them on your own or with a caregiver.

During the session, you’ll usually lay on a flat comfortable massage table or bed. Some of the pressure points in your hands can be treated while sitting and watching a movie or TV show.

The pressure point that works best for me to calm my mind, improve memory, relieve stress, lower fatigue, and reduce my migraines and insomnia is known as the Third Eye Acupressure point.

Acupuncture

Acupuncture is a little more invasive than acupressure. Due to having a small nerve fiber disease, it is not the best option for me, but I know others who love it.

Acupuncture practitioners insert very small needles through your skin at acupuncture/meridian points. Some potential side effects can be temporary soreness, minor bleeding or bruising at the needle sites. If the needle is pushed in too deeply, it can damage muscles and organs. These are rare complication, but make sure you use an experienced practitioner.

Lower back pain is the number one reason people seek this form of treatment, and there are hundreds of clinical studies that show acupuncture can be beneficial for musculoskeletal issues like back and neck pain.

It can also help with nausea, migraines, depression, anxiety and insomnia, all challenges we can face as pain patients. There is promising evidence acupuncture helps with arthritis, spinal stenosis and inflammation.

Although relief is typically short-term for acupuncture and many other treatments, it can still give the patient back some quality of life.

Aromatherapy

Have you ever smelled something that took you back to a time and place when good things happened in your life? Like apple pie reminding you of July 4th celebrations as a child? Or pumpkin pie bringing back memories of Thanksgiving dinner? Or good times raking up the leaves in the yard?

Aromatherapy can help you get in a good mood for meditation. I use it for migraines and taking the edge off my pain levels. You can use essential oils that help with specific challenges you are facing. You just massage them into your skin or put a dab on your temples. I also use a scented light in my house to keep positive vibes flowing.

This type of therapy has been around for many years, but started to become popular in the 1980’s. Lotions, candles, oils and teas can fill your house with good smells and memories to take the edge off your pain levels. Some promote physical healing, emotional healing, relaxation, and calming properties.

When using a practitioner who combines massage with aromatherapy, the session lasts about an hour and usually involves essential oils. This way your skin absorbs the oils and you also breathe their aroma at the same time. Plus, you experience the physical therapy of the massage itself.

Evidence as to how aromatherapy works is not entirely clear. But it provides relief for many different conditions, including psoriasis, rheumatoid arthritis, cancer pain, headaches, itching, insomnia, constipation, anxiety, and agitation. Studies have shown that chronic pain patients require fewer pain medications when they use aromatherapy.

Aromatherapy products can be inexpensive and are more attainable for low income and underinsured patients.

Art Therapy

There are many forms of art therapy, from music, dancing and writing to painting, sculpting and even just watching someone else perform. One of my favorites for dystonia is working on impossible puzzles.

Art therapy can enhance one’s mood, improve emotions, and reduce stress and depression. If we can get these challenges under control, then the stress hormones and chemicals they produce in our body that aggravate pain can be lessened.

Art therapy can also help heal emotional injuries. Think of it as a form of mindfulness where we develop our capacity for self-reflection, which can alter behavior and negative thinking patterns. These forms of expression can be done at home, while on a car ride, in a quiet place during a trip or even at a rock concert as you dance and sway to the beat of the music.

Like aromatherapy, music can help bring back positive memories and get our minds off pain. I believe music is the most accessible and productive art therapy for lowering pain levels.

These techniques may be strange to you, but remember to keep an open mind and realize that there is more you can do in between doctors’ appointments to make your days better and more purposeful.

Whether you choose any of these four treatment modalities or find another that is right for you, keep looking for those things in your life that you have control over and have access to. Find ways to make the most out of life despite the physical and mental pain you may be experiencing.

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

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

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%).

An Epidemic of Undertreated Chronic Pain

By Roger Chriss, Columnist

The undertreatment of chronic pain is fast becoming another “epidemic” in America.  As the CDC guidelines, state laws and regulations, and federal agencies like the DEA push to reduce opioid prescribing, chronic pain patients are being forced to reduce dosages, change medications or make do without pain medication at all.

It may be difficult to believe that chronic pain is undertreated. After all, media reports on the so-called opioid epidemic make it seem like opioids are everywhere.

“Before launching into hysteria that the recent, small drops in opioid prescribing reflect a ‘war on pain patients,’ we should recognize that U.S. consumption dwarfs that of other developed countries,” Keith Humphreys, PhD, a professor of psychiatry at Stanford University, wrote in The Washington Post.

But the focus should not be on overall consumption. It should be on whether opioid medications for chronic pain actually work.  And they do, for many patients.

“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,” Kurt Kroenke, MD, and co-author Andrea Cheville, MD, recently wrote in JAMA

But tragically, this is already happening. Painful conditions are increasingly undertreated.

Nursing 2017 notes that “many patients with sickle cell disease are undertreated and labeled as drug seekers due to their chronic pain.”

A 2016 article in Pain Research and Management found that “painful diabetic neuropathy is poorly assessed for and treated in primary care.”

Reuters Health recently reported that in a large study of 1.4 million nursing home residents, roughly two out of five had intermittent or chronic pain. “Among the residents with persistent pain, about 6 percent received no medication at all and another 32 percent didn’t get enough drugs to properly address their symptoms,” Reuters said.

Fox News reported on a nationwide survey that found 34 percent of physicians believe restricting opioid prescribing may actually be hurting people with chronic pain.

"If you open the discussion publicly, you see the carnage that is happening to people in pain because of these rules,” David Nagel, MD, a pain management specialist in New Hampshire told WMUR-TV.

Moreover, a recent survey of over 3,000 pain patients by PNN and iPain found that 23% reported they were no longer receiving opioid prescriptions and 47% were on a lower dose. Most significantly, 84% reported having more pain and a reduced quality of life.

Demonizing opioids can endanger lives. A Utah woman said her husband suffered from severe cancer pain, but was reluctant to take opioids because he didn’t want doctors “prescribing heroin” to him. He finally relented and started taking opioids when his pain became unbearable.

“My husband would have died from pain without opioids. The same doses that would kill a healthy person were life-saving for him,” Julieann Selden wrote in an op-ed in the Salt Lake Tribune. "The increasingly prevalent anti-opioid rhetoric in Utah, while helpful to some, damages others. The addiction concerns are justified but should be balanced with an emphasis on individualized medical care."

“Our state and federal representatives must consider the needs of the people who use opiates as prescribed when enacting laws or rules for doctors to follow,” Dennis Conklin wrote in a letter to the Chicago Tribune. “People who suffer from severe chronic pain must be allowed access to opiates in order to continue to maintain a reasonable quality of life.”

But this lifeline is under attack. Unnecessarily and inappropriately. Chronic pain patients have a low risk of developing a substance use disorder, yet federal and state opioid guidelines, along with close scrutiny of doctors by the DEA, are having a chilling effect. Widespread fear and confusion about the overdose epidemic and opioid medications are causing chronic pain conditions to be poorly treated.

Chronic pain patients rely on opioid medications to maintain a reasonable quality of life in the same way that people with epilepsy rely on anti-seizure medication or people with low thyroid function rely on thyroid replacement pills. So if they seem defensive about their medication — the “hysteria” that Dr. Humphries is so quick to dismiss — it’s only because they do not want to lose their last line of defense against pain.

The current backlash against opioids for pain management must end before we have another epidemic on our hands.

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.

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.