Low Dose Naltrexone a ‘Game Changer’

By Alex Smith, Kaiser Health News

Lori Pinkley, a 50-year-old from Kansas City, Mo., has struggled with puzzling chronic pain since she was 15.

She has had countless disappointing visits with doctors. Some said they couldn’t help her. Others diagnosed her with everything from fibromyalgia to lipedema to the rare Ehlers-Danlos syndrome.

Pinkley has taken opioids a few times after surgeries, but they never helped her underlying pain. Recently she joined a growing group of patients using an outside-the-box remedy: naltrexone. It is typically used to treat addiction to opioids or alcohol, in pill form or as a monthly shot.

As the medical establishment attempts a huge U-turn after two disastrous decades of pushing long-term opioid use for chronic pain, scientists have been struggling to develop safe, effective alternatives.

When naltrexone is used to treat addiction in pill form, it’s prescribed at 50 milligrams. But chronic pain patients say it helps their pain at doses of less than a tenth of that.

Low-dose naltrexone (LDN) has lurked for years on the fringes of medicine, and its zealous advocates worry it may be stuck there. Naltrexone, which can be produced generically, is not even manufactured at the low doses that seem best for pain patients.

Instead, patients go to compounding pharmacies or resort to DIY methods — YouTube videos and online support groups show people how to turn 50 mg pills into a low-dose liquid.

Some doctors prescribe it off label even though it’s not FDA-approved for pain.

University of Kansas pain specialist Dr. Andrea Nicol recently started prescribing LDN to her patients, including Pinkley. Nicol explained that for addiction patients it works by blocking opioid receptors — some of the brain’s most important feel-good regions. So it prevents patients from feeling high and can help patients resist cravings.

At low doses of about 4.5 mg, however, naltrexone seems to work differently.

“What it’s felt to do is not shut down the system, but restore some balance to the opioid system,” Nicol said.

Some of the hype over low-dose naltrexone has included some pretty extreme claims with limited research to back them, like using it to treat multiple sclerosis and neuropathic pain or even using it as a weight-loss drug.

In the past two years, however, there’s been a significant increase in new studies published on low-dose naltrexone, many strengthening claims of its effectiveness as a treatment for chronic pain, though most of these were small pilot studies.

Dr. Bruce Vrooman, an associate professor at Dartmouth’s Geisel School of Medicine, authored a recent review of low-dose naltrexone research.

Vrooman said that, when it comes to treating some patients with complex chronic pain, low-dose naltrexone appears to be more effective and well-tolerated than the big-name opioids that dominated pain management for decades.

“Those patients may report that this is indeed a game changer. It may truly help them with their activities, help them feel better.”

— Dr. Bruce Vrooman

“Those patients may report that this is indeed a game changer,” Vrooman said. “It may truly help them with their activities, help them feel better.”

So how does it work? Scientists think that for many chronic pain patients the central nervous system gets overworked and agitated. Pain signals fire in an out-of-control feedback loop that drowns out the body’s natural pain-relieving systems.

They suspect that low doses of naltrexone dampen that inflammation and kick-start the body’s production of pain-killing endorphins — all with relatively minor side effects.

Drug Companies Not Promoting LDN

Despite the promise of naltrexone, its advocates say, few doctors know about it. The low-dose version is generally not covered by insurance, so patients typically have to pay out-of-pocket to have it specially made at compounding pharmacies.

Advocates worry that the treatment is doomed to be stuck on the periphery of medicine because, as a 50-year-old drug, naltrexone can be made generically.

Patricia Danzon, a professor of health care management at the Wharton School at the University of Pennsylvania, explains that drug companies don’t have much interest in producing a new drug unless they can be the only maker of it.

“Bringing a new drug to market requires getting FDA approval, and that requires doing clinical trials,” Danzon said. “That’s a significant investment, and companies — unsurprisingly — are not willing to do that unless they can get a patent and be the sole supplier of that drug for at least some period of time.”

And without a drug company’s backing, a treatment like low-dose naltrexone is unlikely to get the promotional push out to doctors and TV advertisements that has made household names of drugs like Humira and Chantix.

 “It’s absolutely true that once a product becomes generic, you don’t see promotion happening, because it never pays a generic company to promote something if there are multiple versions of it available, and they can’t be sure that they’ll capture the reward on that promotion,” Danzon said.

The drugmaker Alkermes has had huge success with its exclusive rights to the extended-release version of naltrexone, called Vivitrol. In a statement for this story, the company said it hasn’t seen enough evidence to support the use of low-dose naltrexone to treat chronic pain and therefore is remaining focused on opioid addiction treatment.

Lori Pinkley said it’s frustrating that there are so many missing pieces in the puzzle of understanding and treating chronic pain, but she, too, has become a believer in naltrexone.

She’s been taking it for about a year now, at first paying $50 a month out-of-pocket to have the prescription filled at a compounding pharmacy. In July, her insurance started covering it.

“I can go from having days that I really don’t want to get out of bed because I hurt so bad,” she said, “to within a half-hour of taking it, I’m up and running, moving around, on the computer, able to do stuff.”

A recent review by British researchers found that LDN is safe to use and more clinical studies are needed on its potential uses. PNN readers have shared their positive experiences using LDN to treat Interstitial Cystitis and fibromyalgia.

The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website.

This story is part of a partnership that includes KCUR, NPR and Kaiser Health News, a nonprofit news service covering health issues. KHN is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Arthritis Foundation Releases First CBD Guideline

By Pat Anson, PNN Editor

The Arthritis Foundation has become the first major patient advocacy group to release guidelines on the use of cannabidiol (CBD) to treat arthritis pain.  

About 54 million Americans have been diagnosed with arthritis. According to a recent national survey, 79 percent of arthritis patients are currently using CBD, have tried it in the past, or are considering it.

CBD infused products – from edibles to lotions to beverages -- are rapidly going mainstream, even though there is little scientific evidence to support their use. There has also been little guidance for consumers on what products to use or in what doses — until now.

“We are intrigued by the potential of CBD to help people find pain relief and are on record urging the FDA to expedite the study and regulation of these products,” the Arthritis Ffoundation said in a statement.

“While currently there is limited scientific evidence about CBD’s ability to help ease arthritis symptoms, and no universal quality standards or regulations exist, we have listened to our constituents and consulted with leading experts to develop these general recommendations for adults who are interested in trying CBD.”  

CBD is largely extracted from a hemp, a marijuana strain that has only trace amounts of THC, the active ingredient that makes people high.

"Millions of people in the U.S. are likely trying to use cannabinoids to treat pain, and many are doing this in ways that might cause more harm than good, especially when they use high doses of THC," said Daniel Clauw, MD, a professor of anesthesiology at the University of Michigan who was one of the experts the foundation consulted.

"It's important that the Arthritis Foundation has taken a stand on CBD,” Clauw said in a statement. “Right now, it appears to be fairly safe and might help certain types of pain. It's far better to give this guidance, even if preliminary, because otherwise people will have no guidance whatsoever." 

DRUG POLICY ALLIANCE

The new guideline is largely cautionary and does not explicitly recommend CBD as a treatment, stating only that it “may help” with arthritis-related symptoms such as pain, insomnia and anxiety.

When taken in moderate doses, experts say CBD has no major safety issues, although it may interact with some drugs commonly taken for arthritis, such as naproxen (Aleve), celecoxib (Celebrex), tramadol (Ultram), gabapentin (Neurontin), pregabalin (Lyrica) and some antidepressants.

The Arthritis Foundation recommends taking CBD in oral sprays or tinctures so the liquid can be taken under the tongue and be absorbed directly into the bloodstream.

Experts say a “go slow” approach is best, starting with a few drops twice a day and increasing the dose gradually over a period of weeks until an effective dose is reached.

The guideline strongly discourages inhaling or vaping CBD because of the risk of respiratory problems. It also discourages taking CBD in edibles, such as gummies and cookies, because the dosing is unreliable. Experts say the effectiveness of topical lotions and creams with CBD is unclear because they often contain other ingredients.

Other key takeaways from the guideline:

• CBD should never be used to replace disease-modifying drugs that help prevent permanent joint damage in inflammatory types of arthritis.

• CBD use should be discussed with your doctor in advance, with follow-up evaluations every three months or so.

• Buy from a reputable CBD company that has each batch tested for purity, potency and safety by an independent laboratory and provides a certificate of analysis.  

Unlike prescription drugs approved by the Food and Drug Administration, the manufacturing process for CBD products is not subject to FDA review, and there has been no FDA evaluation of their effectiveness, proper dosage, how they could interact with drugs, or whether they have side effects. 

The Federal Trade Commission recently warned companies that make CBD products to stop making unsubstantiated claims that cannabidiol can be used to treat arthritis and other chronic pain conditions.

Former Director of U.S. Pain Foundation Questions Misuse of Funds

By Pat Anson, PNN Editor

A former board member of the U.S. Pain Foundation is raising questions about how former CEO Paul Gileno was able to misappropriate over $2 million in funds from the Connecticut-based non-profit. 

Gileno pleaded guilty to fraud and tax evasion charges in June and is awaiting sentencing.  Federal prosecutors say Gileno used donated funds in the charity’s bank account to write checks to himself and other people for his own personal benefit. The money was used to pay Gileno’s mortgage, car payments, loans to his brothers, and a visit to Universal Studios in Orlando, Florida. The misuse of funds allegedly went undetected for three years.

“I still find it difficult to believe that nobody else who’d been in upper management of the foundation for several years, knew anything regarding the going out and coming in of money/funds,” former board member Suzanne Stewart recently wrote in her blog.

Stewart was a volunteer “ambassador” at U.S. Pain before she was appointed to the board in January, 2018 – a tumultuous time in the charity’s history, as the extent of the misuse of funds was just becoming known. Stewart resigned from the board 8 months later and has remained relatively silent about her board experience, until now.

Stewart wrote in her blog that she was initially excited to join the board, but soon realized something was amiss when she called another board member.

“I called to ask her a few questions, such as: ‘What was it like, being on the Board? What do we do as Board Members etc?’ She laughed & told me that ‘there was no real Board of Directors’. She added that they’d never even had a board meeting!” said Stewart, who lives with Complex Regional Pain Syndrome and other chronic pain conditions.

SUZANNE STEWART

“I was a bit disappointed at hearing this news. But it was soon confirmed. The Board of Directors of the US Pain Foundation, were actually just photographs on the USPF website, prior to January, 2018. There was no true Board of Directors. There had been no board meetings or elections.”

Gileno founded the Connecticut Pain Foundation in 2006 after he was disabled by a back injury. In 2011, he launched U.S. Pain and registered as a charity in the state. Connecticut state law requires non-profits to have annual board meetings and to elect their directors and officers.

“So I’m guessing there was there no secretary or treasurer? I’m guessing this means that nobody had to get permission to write checks?” Stewart asks. “Didn’t they have to answer to anyone about how or where to spend donation monies? How does the President, Vice President & Executive Director & other upper management, not know what & where money is coming in and/or going out?”

According to an audit and U.S. Pain’s tax returns, Gileno misappropriated over $2,055,000 from the charity from 2016 to 2018.  Nicole Hemmenway, the current acting CEO, was vice-president and board chair at the time. Two other longtime board members, Wendy Foster and Ellen Lennox Smith, still serve as directors. And Lori Monarca remains as Executive Office Manager, according to U.S. Pain’s website.

Only Gileno has been charged with a crime.

“It seems to me that when upper management realized that things had somehow gotten out of hand and that the USPF might be slipping away, they decided to get lawyers and accountants involved in an attempt to ‘fix’ a situation that they’d created. It seemed to have finally become something larger that they could no longer handle alone,” Stewart wrote.

“Over the following months, I found out what a mess things were and I immediately wanted to resign. I was advised by one of the attorneys, that ‘it wouldn’t look good’ for USPF, if anyone on the Board resigned during that time.”

The board asked for and received Gileno’s resignation in May 2018, although it wasn’t publicly disclosed until December that “financial irregularities” were behind his sudden departure.

Gileno did not comment on Stewart’s post, but praised her work as a patient advocate.

“I can say that I have always admired Suzanne and she is an amazing advocate and I respect her dearly. She has an amazing and supportive husband and family,” Gileno said in an email.  

‘The Very Last Straw’

Stewart eventually resigned because she was unhappy with decisions being made by Hemmenway and the rest of the board. A redacted version of Stewart’s resignation letter was posted on her blog, in which she complained about being “left in the dark” and not knowing “where money is going or where it comes from.”

“The very last straw for me was when the Interim CEO & the rest of the Board, contemplated not telling the USPF ‘In-person’ support group leaders that they were no longer covered by insurance. I was the only Board member who said that I’d have no part of that,” wrote Stewart, who did not respond to a request for comment from PNN for this story.

Hemmenway also did not respond to a request for comment. In a statement last December, she said that Gileno “repeatedly misled and concealed information from the Board of Directors and staff.”

Gileno maintains that he kept the board informed.

“They are trying to cover their asses for being (an) inadequate board I guess,” Gileno told PNN last year. “I never misled them. They were part of U.S. Pain for over 10 years and I talked with them daily. Nicole and I were close like a brother and sister and I never hid one thing.”

Whether the board knew about the misuse of funds or not, nonprofit experts say board members have a fiduciary responsibility to provide oversight and know how money is being spent. 

“U.S. Pain board members claim they did not know about their former CEO’s misuse of funds. This, however, does not change the fact that they should have known, and are, in fact, required by law to have controls in place to ensure those funds are used for the benefit of its stakeholders,” says Stefanie Lee Berardi, a patient advocate and grant writer who worked in nonprofit management.

“Serving on a board of directors is a great opportunity to contribute your time and talent to non-profit organizations who are doing great work. However, you should know that when you accept that position, you have a legal responsibility to use good judgement when making decisions on behalf of the organization, to put the organization’s interests before your own, and to ensure the organization is legally compliant.”

Gileno remains under investigation by the Connecticut Attorney General’s office, which may seek a court order to prevent him from ever serving again as a nonprofit officer or director.

Under state law, a Superior Court Judge could remove non-profit directors “engaged in fraudulent or dishonest conduct or gross abuse of authority or discretion,” but no such action against U.S. Pain appears likely.

“As much as we would like to have seen their entire board ousted, the truth of the matter is that the only way that happens is if the state shuts them down. So far, with the completion of their audit, they have likely done enough to satisfy the state,” said Berardi, who thinks U.S. Pain should find new directors and officers to manage the organization. 

“If we are looking at best practices for board management, they absolutely should have a comprehensive plan for recruitment, induction, development, and succession. These board functions should be enumerated in the bylaws, updated at regular intervals, and formally adopted,” she said. “Recruiting ‘new blood’ should just be regular order.” 

(Update: On October 1, 2019 U.S. Pain announced the appointment of Shawn Dickens to its board of directors, filling the seat vacated by Suzanne Stewart nearly a year earlier.)

At one time, U.S. Pain claimed to be the nation’s largest pain patient advocacy group, with over 90,000 members and nearly a quarter of a million social media followers. It was a dubious claim, as the non-profit later admitted having only 15,000 people on an email subscriber list.  

According to the audit and U.S. Pain’s 2018 tax return (the organization’s 2016 and 2017 returns were delinquent and filed late), the charity spent over $1.2 million last year on salaries, employee benefits, lawyers, accountants, tax penalties and business losses – including a failed attempt to operate a bakery.

Should Heroin Be Used to Treat Addiction?

By Pat Anson, PNN Editor

Some Canadian doctors are using novel approaches to treat opioid addiction, everything from safe injection sites to opioid vending machines to prescription heroin.

A new proposal would take the concept a step further by establishing the first clinical guideline for using hydromorphone and pharmaceutical grade heroin to treat people with severe opioid use disorder. The idea is to provide a safer supply to opioid addicts who currently use illicit heroin, counterfeit pills and other street drugs, which are often laced with fentanyl.

"Offering injectable opioid treatments is an effective way for clinicians to address the toxicity of the fentanyl-adulterated drug supply and help people achieve stability so they can focus on other aspects of their lives to get well, such as housing, employment, and connecting with family," says Dr. Christy Sutherland, Medical Director of PHS Community Services Society in Vancouver, BC.

Sutherland is one of the co-authors of the guideline, which is published in the Canadian Medical Association Journal. In 2018, nearly 4,500 Canadians died from opioid overdoses, with about 75% of the deaths involving fentanyl, a synthetic opioid that’s become a scourge on the black market.

"Opioid use disorder is a public health emergency nationwide; unfortunately, resources for the treatment of opioid addiction have been scarce and guidelines outlining best practices for innovative treatments have been lacking. This guideline is a blueprint for health practitioners to step up and provide evidence-based care," says Dr. Nadia Fairbairn, British Columbia Centre on Substance Use and the University of British Columbia, Vancouver, BC.

Heroin is classified as a Schedule I controlled substance in the United States, making it illegal to prescribe. But pharmaceutical grade heroin (known as diacetylmorphine) is legal in Canada, UK and several other European countries.

Studies have found that heroin-assisted treatment is effective in treating opioid addiction in patients who have failed at other treatment methods, such as methadone.

Under the proposed guideline, injectable heroin (diacetylmorphine) and hydromorphone (Dilaudid) could be used to treat severe opioid addiction in patients who do not respond to oral medication or use illicit injectable opioids.

It would be up to each Canadian province to decide whether to adopt the guideline.

Pharmaceutical heroin and safe injection sites are controversial issues in the U.S. But a recent analysis by the RAND Corporation advocates their use to combat opioid addiction.

“Given the increasing number of deaths associated with fentanyl and successful use of heroin-assisted treatment abroad, the U.S. should pilot and study this approach in some cities,” said Beau Kilmer, co-director of the RAND Drug Policy Research Center. “This is not a silver bullet or first-line treatment. But there is evidence that it helps stabilize the lives of some people who use heroin.”

What About Pain Patients?

Pain patient advocates in Canada were taken aback by the proposal to liberalize the use of heroin to treat opioid addiction. Opioid pain medication is increasingly difficult to obtain in Canada, as it is in the United States, because of restrictive guidelines.

“It is indeed shocking. Pain patients continue to be marginalized, stigmatized, ignored and left to suffer,” said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada.  “I do think it is ridiculous to say opioid use disorder is a public health emergency. The population they are addressing no doubt has to be addressed, but in terms of numbers it is minuscule to those suffering pain, yet the number of dollars expended for both is just out of whack.

“People suffering pain cannot obtain help or even maintain access to medication they have been stable on for years. Something is sadly wrong. What is a public health emergency is the epidemic of undertreated chronic pain. They should get their blinders off. We have well over 1 million Canadians suffering from high impact pain, yet they are pretty much marginalized.”

One of those Canadians is Dan Wallace, a retired military veteran and police detective who lives with chronic knee and shoulder pain.

“I applaud the efforts made and others that are contemplated for the near future that would allow those who are addicted to obtain legally prescribed heroin that would keep them from the tainted street drug supply,” Wallace said. “Where I have a problem is with the complete dismissal of medical care to the many legacy patients who were previously prescribed opioids to manage their pain.”

Wallace used opioid medication for over 20 years before being tapered. He now has trouble walking and sleeping because of what he calls “a tortuous and cruel degree of pain.”

“I and others like me aren’t looking for a handout of free heroin because we haven’t been able to control ourselves and have become addicts. No one deserves to be treated like throw-away patients yet pain patients are just that. Why is it that their lives matter while simultaneously ours do not?” Wallace asks.

“I have never abused any substance in my life. Does my suffering ever help a single person who will now be getting prescribed heroin so they don’t have to buy illegal street drugs? Health Canada should be deeply ashamed at the needless suffering, disability, and deaths of pain patients they have caused.”

The Opioid Risk Tool Has Been Weaponized Against Pain Patients

By Dr. Lynn Webster, PNN Columnist

I was surprised and deeply disappointed to learn this week that people have been denied opioid prescriptions due to their responses on the Opioid Risk Tool (ORT).

As a guest on the DPP Rally Talk Show with Claudia Merandi, I heard from a caller who told me that her doctor denied her an opioid prescription based on her ORT answers.

One particular answer seems to have caused the caller’s problem: She acknowledged her history of experiencing preadolescent sexual abuse. Apparently, the doctor used that as a reason to deny her access to opioid medication to treat her pain. This is a terrible misapplication of the tool.

The ORT is a self-assessment tool I developed and published about 15 years ago. It was developed at a time when we didn’t know the rate of opioid abuse in patients who were prescribed an opioid for noncancer pain. We needed a tool to help evaluate whether the risk of potential harm from opioids outweighed the good.

I never intended for doctors to use the ORT to determine who should or shouldn’t be prescribed an opioid. My goal was to help doctors identify patients who were at increased risk of misuse and addiction, so that they could receive more careful observation during treatment.

Since abuse and addiction are diagnosed by observing atypical behaviors, knowing which patients are at greatest risk for displaying those behaviors is useful in establishing appropriate levels of monitoring for abuse.

I was not alone in the belief that it was critical to assess patients for their risk potential.

In 2009, the American Pain Society and American Academy of Pain Medicine published a guideline for opioid prescribing. Its first recommendation stated: “Prior to initiating COT (chronic opioid therapy), clinicians should conduct a history, physical examination, and appropriate testing, including an assessment of risk of substance abuse, misuse, or addiction.”

Then, in 2016, the Centers for Disease Control and Prevention’s opioid-prescribing guideline recommended that “before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms.”

Several other opioid prescribing guidelines also recommended assessing patient risk before initiating therapy. These included the Washington State Department of Health, Utah Clinical Guidelines on Prescribing Opioids for Treatment of Pain, the American Society of Interventional Pain Physicians (ASIPP) Opioid Guidelines, and others.

Risk Factors for Opioid Abuse

Assessing the risk of developing opioid abuse is based on genetic and environmental factors, just as it is with other diseases. Accordingly, the ORT includes questions about family and personal history of substance abuse, since both areas contribute to genetic and environmental factors. 

Genetics are estimated to contribute between 50 to 60% of an individual's vulnerability to opioid addiction. By contrast, genetics contribute only about 30% to a person's vulnerability to marijuana.

A person with one addiction is seven times more likely to develop an addiction to a different class of drugs, so genetics plays a major role in determining who will and who will not develop an opioid use disorder (OUD). Additionally, life experiences -- which are part of one’s environment -- also play a role.

The ORT asks if there is a history of experiencing preadolescent sexual abuse. Studies indicate that preadolescent sexual abuse is believed to result in something clinically similar to post traumatic stress disorder (PTSD).

The National Institute of Drug Abuse (NIDA) has reported that 30 to 60% of women who are undergoing drug abuse treatment suffer from PTSD. One treatment center in New York City reports that more than 90% of women treated for substance abuse had experienced sexual or traumatic abuse. 

According to another NIDA report, victims of rape were 10 times more likely to have abused heroin and other stimulants than the general population. A study in 2000 also showed that a history of preadolescent sexual abuse tripled the risk of drug use disorders.

Many other studies have corroborated these studies, showing that preadolescent sexual abuse is a risk factor for substance abuse later in life. The most important of these is the seminal CDC-Kaiser Permanente Adverse Childhood Experience Study.

A Cruel Misapplication of ORT

Environmental and genetic factors should influence how closely a patient's opioid use is monitored. However, a history of experiencing preadolescent sexual abuse does not mean a person will necessarily develop an OUD. It is only a risk factor. It does not determine the outcome of using opioids, although it may partially indicate the level of monitoring, support, and education that would be appropriate.

It is a cruel misapplication of the ORT to use a background of sexual abuse as the only criterion to assess whether a patient should receive opioid therapy. The ORT is an important tool in mitigating harm that prescribing opioids could cause. It should not be weaponized to justify denying people in pain appropriate therapy. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find him on Twitter: @LynnRWebsterMD. 

The information in this column 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.

How Awareness Can Help Calm Your Pain

By Dr. David Hanscom, PNN Columnist

Anxiety and anger are major aspects of the chronic pain experience. In this state, your mind is full of racing thoughts and vivid imagery, and it’s hard to focus on anything but you and your pain.

They block your awareness of other’s needs. It becomes a challenge for friends, family, and coworkers – anyone – to connect with you. If you’re touchy and constantly on edge, it’s exhausting for others to be in your presence.

Having a good support system is an important part of your recovery from chronic pain because positive relationships have a calming effect. But now you are driving people away.

Awareness is a powerful and necessary tool in breaking through this barrier. What you are not aware of can and will control you.

I have found it helpful to look at awareness from four different perspectives: environmental, emotional, judgement and ingrained thought patterns.

Environmental awareness is placing your attention on a single sensation – taste, touch, sound, temperature, etc. What you are doing is switching sensory input from racing thoughts to another sensation. This is the basis of mindfulness – fully experiencing what you are doing in the moment.

I use an abbreviated version that I call “active meditation,” which is placing my attention on a specific sensory input for 5 to 10 seconds. It is simple and can be done multiple times per day.  

Emotional awareness is more challenging. It often works for a while, but then it doesn’t. When you are suppressing feelings of anxiety, your body’s chemistry is still off and full of stress hormones. This translates into physical symptoms.

Allowing yourself to feel all of your emotions is the first step in healing because you can’t change what you can’t feel. Everyone that is alive has anxiety. It is how we survive.

Judgment is a major contributor to creating mental chaos in our lives. Dr. David Burns in his book “Feeling Good” outlines 10 cognitive distortions that are a core part of our upbringing. Some of them include:

• Labeling yourself or others

• “Should” thinking – the essence of perfectionism

• Focusing on the negative

• Minimizing the positive

• Catastrophizing

• Emotional reasoning

Becoming aware of these errors in thinking allows you to substitute more rational thought patterns.

Ingrained thought patterns are the most problematic to be aware of. Recent neuroscience research has revealed that thoughts, concepts and ideals become embedded in our brains and are just as real to you as the chair you are sitting in.

That is why people engage in aggressive behavior when their belief systems are challenged. We are all programmed by our past. Your thoughts and beliefs are your version of reality.

Becoming Aware of Your ‘Unawareness’

The first step in becoming aware is realizing that you are unaware. This never ends because there will always be areas of our thinking and behavior that are not consistent with the needs of the situation. 

When I look back on my life’s journey, one of the most disturbing aspects of it is realizing the extent of my unawareness. For instance, when I was in my full-blown obsessive mode, I didn’t have a clue. I recall one time when a friend referred to my “obsessive nature.”  I didn’t know what the word really meant and was certain it didn’t apply to me.

How can you tap into your unawareness? One way is to look for cues in certain behaviors and attitudes, which may mean we’re out of touch with how we’re feeling.  Some examples: 

• Having a rigid opinion about almost anything: religion, politics, someone’s character, etc.

• Being told you are stubborn or “not listening”

• Interrupting someone to offer an opinion before you’ve heard theirs

• Insisting on being right.

• Thinking about something besides what you are doing.

• Judging yourself or others negatively or positively.

• Feeling anxious or angry

• Giving advice when not asked for it

• Thinking you are wiser than your children

• Acting on impulse.

This list is infinite. If one or more resonates with you, it’s probably time to take a step back so that you can respond appropriately to a given person or situation. This is the essence of awareness.

Another clue of unawareness -- not listening -- is one that I discovered with others’ help. My weakness in this area became readily apparent when I attended a parents’ meeting at my daughter’s school.

I will preface this story by saying that I had always considered myself a good listener. It was one of my major personal identities. My wife has not always agreed with that viewpoint. Of course, I did not listen to her.

At the parents’ meeting, we did an exercise where we had to write down on a piece of paper a characteristic that another parent could “work on.”  We could write to two parents anonymously.

Most parents received one or two slips of paper. I received twelve (out of 18) that all said the same thing: “David, you don’t know how to listen.”  

That was a very difficult moment for me. I found it extremely hard to not become defensive. But how could I disagree with 12 people?  I came to accept that they were right, especially in retrospect. It was a trait that I truly could not see. I simply had to trust a group of people who I knew did not have an agenda and had my best interests at heart. 

After that meeting, I came to realize how not listening had interfered with my general awareness. It’s one of the central tenets of awareness: You cannot be aware if you cannot listen.

Practicing Awareness

Understanding and practicing awareness is the first step in reprogramming your brain. It’s the easiest technique to explain and the most difficult to consistently use. Environmental awareness is the foundational first step and spending as much time as possible doing “active meditation.” Regardless of where you are in your journey, being fully aware of stimuli coming into your brain will help calm you down.

When you are ready for the second level of emotional awareness, simply watch your emotions pass by and then pull yourself back into seeing, hearing and feeling, as quickly as possible. It is a little challenging, as emotions often evoke powerful reactions. Training yourself to be with these feelings instead of fighting them is a learned skill and may require some support from a professional.

The third level – judgement -- is a lifetime journey. The key is to be persistent in not judging yourself or others. A good starting point is understanding than whenever you place a positive or negative judgment on someone else, you have simply projected your view of yourself onto the other person. As you become aware of these cognitive distortions, you will be able to regain control of your life.

Remember that in the fourth level of ingrained patterns, it is impossible to see yourself through your own eyes. This is where resources such as psychologists, good friends, spouses, children, and seminars have to be utilized. The key is being willing to listen.

Becoming aware of everyone and everything around you is much more interesting and enjoyable than merely expressing and reinforcing your own views on life day in and day out.  

Dr. David Hanscom is a spinal surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery.

In his book Back in Control, Hanscom shares the latest developments in neuroscience research and his own personal history with pain.

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.

Acetaminophen Linked to Hyperactivity and Behavior Problems in Children

By Pat Anson, PNN Editor

A new study is adding to the growing body of evidence linking maternal use of acetaminophen to hyperactivity and other behavioral problems in children. Acetaminophen – which is more commonly known as paracetamol outside the U.S. – is the world’s most widely used over-the-counter pain reliever.

British researchers have been following over 14,000 children born in 1991 and 1992 who are enrolled in the Avon Longitudinal Study of Parents and Children. The children’s health, cognitive skills, temperament and behavior were regularly evaluated as they grew older.

Children with mothers who regularly used acetaminophen in mid to late pregnancy were more likely to be hyperactive, less adaptable and to have conduct problems in their pre-school years. The attention and hyperactivity issues appear to lessen by age 7, although boys exposed to the drug were more likely to have conduct problems until age 9.

“We have shown that paracetamol consumption between 18 and 32 weeks gestation was associated with adverse trends in pre‐school child behaviour, but the associations were no longer present by the end of primary school (age 10‐11 years). Boys appeared to be more susceptible than girls to possible behavioural effects of the drug,” researchers reported in the journal Paediatric and Perinatal Health.

Acetaminophen is used by over half the pregnant women in the United States and European Union. It is the active ingredient in Tylenol, Excedrin, and hundreds of pain medications.

Previous studies have linked maternal use of acetaminophen to asthma, autism and attention deficit disorder (ADHD) in children, as well as early puberty and slow language development in girls.

“Our findings add to a series of results concerning evidence of the possible adverse effects of taking paracetamol during pregnancy such as issues with asthma or behaviour in the offspring,” said lead author Professor Jean Golding of the University of Bristol.

“It reinforces the advice that women should be cautious when taking medication during pregnancy and to seek medical advice where necessary.”

Despite the findings, the UK’s National Health Service (NHS) maintains that it is “usually safe” for pregnant women to use paracetamol.

“Paracetamol has been used routinely during all stages of pregnancy to reduce a high temperature and for pain relief. There's no clear evidence it has any harmful effects on an unborn baby,” the NHS says on its website.

The FDA’s warning label for acetaminophen cautions people about the risk of liver damage and other side effects, but does not specifically warn pregnant women about using the pain reliever. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

Do Doctors Care?

By Katie Burge, Guest Columnist

Tell me... exactly when did it become acceptable for physicians to not only harm, but to actually contribute to a patient's demise by denying adequate, necessary medical care? 

I'm referring to the rising death rate among chronic pain patients, whose doctors have yielded to political pressure and reduced their patients’ doses of pain medication to the point that they are virtually useless or refused to continue prescribing pain medication at all -- regardless of diagnosis or need -- because they fear regulatory action if they continue treating pain with opioids.  

Am I missing something? Under the Hippocratic Oath, aren't physicians supposed to strive to do no harm?  Or should we just start calling it the Hypocritical Oath when it comes to people in pain?

You might think that denying opioids to folks can only be a positive thing, but for those of us who suffer from severe, round-the-clock pain that only responds to opioids, this scenario is a nightmare.  Losing access to the only thing that lessens your pain can feel like a death sentence. And in some cases, it is.

Being forcibly tapered off opioids and then having to cope with the full brunt of your pain causes extreme stress, which can lead to heart attack and stroke.  Even worse, it causes some patients to lose hope of ever attaining help and commit suicide.

This almost happened to me last year. The really shocking thing is when I told a couple of my doctors that I was becoming increasingly suicidal because of pain, they just ignored me.

I guess they felt like if they acknowledged the reasons for my depression, they might have to address my pain. That is unacceptable to many physicians nowadays. I call this the "Ostrich" School of Medicine — where the doctors bury their heads in the sand whenever the topic of chronic pain comes up.

Many doctors have become so desensitized to pain and suffering that they seem to believe they're absolved of any responsibility when presented with a patient whose chronic pain is so severe that it only responds to opioids. They'll fall all over themselves trying to get away from us.

My longtime family doctor refuses to even discuss my chronic pain. And when pain management specialists see the catalog of all my conditions, they visibly cringe. It’s as though I make them feel threatened, when the real threat comes from bumbling bureaucrats attempting to prove that they aren't completely impotent when it comes to dealing with the opioid epidemic.

A major truth about the opioid epidemic is that these bureaucrats can't do a damn thing about recreational drug use, but they want their constituents to believe they can. So in a lame attempt at proving their political prowess, they put the squeeze on pain management physicians and blame vulnerable pain patients for other people's opioid abuse.

What really makes my jaw drop in astonishment is the fact that most doctors simply kowtow to this bureaucratic lunacy without even trying to advocate for their patients or their own right to treat patients to the full extent of their education and experience. Doctors should never be put in the position of having to choose between incarceration and providing compassionate medical care.

There aren't many courageous physicians left who will help somebody like me.  I did eventually find one who gives me about half the medication I need to get through a month and be able to function. This enabled me to survive my “suicidal” level of pain, but I wouldn't actually call it living. 

My round-the-clock pain is being treated with a short-acting opioid that I'm only allowed to take once every 8 hours, because the doctor says he's not "allowed" to prescribed the long-acting, time released opioids anymore. These extended relief medications provide much better, more even relief -- often at a lower dose than the immediate release, short-acting opioids.

My current drug regimen creates kind of an evil roller coaster effect, where I'm okay for 3 or 4 hours and then the pain spikes for the next 4 hours until I can take another dose. And then the roller coaster takes off all over again.

Over the past 20 years, I've tried every traditional and alternative treatment known to medical science. Some have been beneficial and some have not, but I've learned what is safe and effective for me. I just wish my doctor would take my word for it. I know I'll never be pain free and surgeons say they're unable to "fix" me, so pain management is the only option I have left.

I am alive today due to a combination of God's grace and the adrenaline created by a combination of righteous indignation and an intense passion to help other pain patients and educate the public about chronic pain.

If you are a pain patient or you love a pain patient, please speak up and be counted if you're not getting the treatment you deserve. Never give up!

Katie Burge lives in Mississippi. Katie has degenerative disc disease, spinal stenosis, spondylolisthesis, failed back syndrome, stenosis, osteoarthritis and fibromyalgia. 

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

The information in this column 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.

Mother Who Lost Son to OxyContin Vindicated by Purdue Settlement

By Mark Kreidler, Kaiser Health News

In the 15 years since she lost her son to a single OxyContin pill, Barbara Van Rooyan has had but one up-close look at the people representing the company that made it.

It was in a small courthouse in Abingdon, Va., where Van Rooyan and other relatives of OxyContin victims gathered for a sentencing hearing in 2007. Three executives of Purdue Pharma had pleaded guilty to federal charges related to their misbranding and marketing of the powerful opioid. The company had pleaded guilty as well.

Van Rooyan and the others in her group spoke during the sentencing, giving voice to their grief and their pain. They wanted the executives sent to jail for knowingly expanding an opioid crisis fast engulfing the country.

Instead, Purdue paid fines totaling $634 million. The executives served no time. The company was allowed to continue aggressively marketing its product, and the following year, sales of OxyContin reached $2 billion.

From 1999 to 2017, more than 700,000 people in the U.S. died of drug overdoses, according to the Centers for Disease Control and Prevention. In 2017, nearly 68% of the more than 70,000 recorded overdose deaths involved opioids, mostly illicit opioids such as fentanyl and heroin.

“I never really thought a whole lot about evil before this all happened,” Van Rooyan said recently, seated on a couch in the living room of her Irvine, Calif., home. “But to see this kind of malevolence or disregard for human life — I don’t know what else to call it but evil.”

The outcome in that Virginia courthouse was a far cry from last week’s news of a tentative mass settlement of many of the 2,000-plus lawsuits against the company, which could total upward of $12 billion and result in Purdue’s dissolution.

The potential settlement amount would include $3 billion from the Sackler family, owners of Purdue, whose fortune is estimated at $13 billion. The family has amassed that money over the past two decades, largely by selling OxyContin, an opioid painkiller.

‘The Lid Is Off’

Van Rooyan’s Purdue experience is a story of deception, sadness and frustration — yet when she tells it now, she emits a surprising spark of energy. That’s because Van Rooyan, part of the unlikely group of citizens who repeatedly took flailing swings at Purdue Pharma, is watching the giant fall.

Van Rooyan, who has studied the cases against Purdue closely, sees the paradox in the proffered settlement: Much of the payout would be financed by profits from the continued sale of OxyContin, under a new company that would be formed following a Chapter 11 bankruptcy.

But in some regard, she said, Purdue Pharma’s complicity in the opioid crisis has finally emerged into the general public’s view. “The world really knows now. They get it,” she said. “The lid is off, and all this stuff is bubbling out.”

That wasn’t the case on the night of July 4, 2004, when Van Rooyan and her husband, Kirk, got the call that changed their world. Barbara, then a professor of counseling at Folsom Lake College near Sacramento, was told that her son, Patrick Stewart, lay in a San Diego hospital, in a medically induced coma from which he was unlikely to emerge.

Patrick, a graduate of Oak Ridge High School in El Dorado Hills, Calif., and San Diego State University, died at age 24.

His friends told Barbara they had attended an Independence Day party at which someone offered her son an OxyContin pill, telling him it “was kind of like a muscle relaxant and it was FDA approved, so it was safe,” she said. Patrick, who had also consumed a couple of beers, was opioid intolerant and suffered respiratory failure in his sleep.

Barbara Van Rooyan holds picture of her son, Kirk

“At the time,” Van Rooyan said, “all I knew about Oxy was that Rush Limbaugh had been addicted to it.”

She was about to learn a lot more.

OxyContin Abuse

Van Rooyan channeled her grief through intense research into Oxy’s vast potential for damage despite the company’s sales pitches to the contrary. A slow-release pain treatment with a heavy dose of the narcotic oxycodone, it could be easily crushed or dissolved for a more intense and addictive high. Rampant abuse already had begun to be reported, particularly in the Appalachian area, author Beth Macy wrote in her national bestseller “Dopesick.”

Later in 2004, Van Rooyan found Ed Bisch, a Philadelphia man who had begun a website to expose Oxy abuse in the wake of his teenage son’s death. The following year, Van Rooyan and her husband, a plastic surgeon, petitioned the Food and Drug Administration to require that OxyContin be made more abuse-resistant, and that its use be strictly limited to severe pain.

“This was an exhausting process, which she and Kirk did as a labor of love to try to save others,” Bisch recalled.

Van Rooyan became the California arm of a grassroots movement known as RAPP — Relatives Against Purdue Pharma. The group, originally just four in number, protested at physician meetings funded by pharmaceutical companies and testified before Congress. Van Rooyan enlisted the help of U.S. Sen. Dianne Feinstein (D-Calif.), who wrote the FDA on her behalf and later sent Van Rooyan a letter of commendation.

But most members of Congress did not reply to Van Rooyan’s letters, she said. The FDA said its review needed more time — which turned out to be eight years. By then, Purdue already had reformulated OxyContin to make it more abuse resistant and to renew its patent, but the FDA declined to restrict its use to managing severe pain.

Van Rooyan pressed on, but for a long while, the opioid crisis felt to her like a topic hiding in plain sight. And fighting Purdue while still grieving the loss of son Patrick was taking a toll.

“Her determination was tireless,” Bisch said, “but eventually the frustration burned us out.”

And then came the turn.

A rash of high-profile opioid overdoses and deaths, from actor Heath Ledger to Tom Petty to Prince, put the topic squarely in the public eye — and 15 years after the death of Van Rooyan’s son, Purdue Pharma and other drugmakers were suddenly on the run.

(Editor’s note: Ledger, Petty and Prince all died from a lethal mix of opioids and other drugs that were apparently obtained on the street.)

Wants Purdue Settlement Spent on Treatment

Van Rooyan tracks every development related to Purdue, including a lawsuit in New York that alleges members of the Sackler family have been offloading their fortunes into private or offshore accounts to shield them from a settlement.

But she’s not out for vengeance. Her goals have changed.

“Do I want the records to be public? Do I want these people to have their business shut down? Yes, I do,” she said. “But more than vindictiveness, I want that money of theirs to go to treatment and rehab. If that happens, something good can come out of it.”

If she has a regret, it is that the case in Virginia ended in 2007 with no more than a fine. “If that result had been different — if people had gone to jail — it could have changed the trajectory of this,” she said.

Ana Venegas for KHN

But momentum finally appears to be gathering, and Van Rooyan finds herself identified as one of the trailblazers of the anti-OxyContin movement. She spends little time dwelling on that. Instead, she quotes her younger son, Andrew, who told her, “We didn’t want any of this — this is just the hand we were dealt. We need to play the cards the best we can.”

“She’s just a really strong person,” said Kirk Van Rooyan, who has been with Barbara throughout the ordeal, though he is not Patrick’s biological father. “There have been times when I’d think to myself, ‘How would I be doing if I were in her shoes?’ And the answer usually is, ‘Not as well as she’s doing.’”

Van Rooyan, a longtime artist, now spends much of her time volunteering with veterans in Orange County, Calif., helping them get back into the workforce and using art therapy to help them express themselves.

The art is special to Van Rooyan, she said, because it is part of what saved her in the aftermath of her son’s death.

“Patrick was the one who suggested I take my first class,” she said. After a few delays, she finally enrolled. It was about a month before that Fourth of July in 2004.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Lessons from ‘Fentanyl, Inc.’

By Roger Chriss, PNN Columnist

The new book “Fentanyl, Inc.” by investigative journalist Ben Westhoff takes a close look at illicit fentanyl, synthetic drugs and the overdose crisis.

Westhoff tracks the history of fentanyl, interviews “Dark Net” drug dealers and infiltrates Chinese chemical manufacturing firms as a prospective buyer. He explores how the production, sale and use of illicit drugs has evolved with the creation of fentanyl and other new psychoactive substances (NPS).

Westhoff starts with a brief history of opioids and the overdose crisis, saying that the “vast majority of legitimate users of OxyContin and other opioid medicines receive the intended benefit.”

But addiction and overdose became real problems, due in part to misbranding by Purdue Pharma, Insys Therapeutics and other drug companies, as well as missed regulation by the FDA and DEA.

Fentanyl itself was first developed by Paul Janssen in 1960 as a surgical anesthetic. As Westhoff notes, “Without this compound and its analogue, sufentanil, open-heart surgery would not be possible.”

But fentanyl and other newly developed synthetic compounds quickly escaped into the wild. Westhoff explains how fentanyl powder mixed with heroin became known as China White, “the first popular, illicit drug synthesized by a rogue chemist that was new, rather than simply a copy of something already on the medical market.”

These new chemicals entered a changing world. Westhoff describes how the new drug trade grew for the same reasons the economy grew – the increased speed of communications, Internet technology, improved shipping, relaxed trade barriers and the relentless search for higher profit margins.

Illicitly manufactured fentanyl is produced, sold and used outside of standard medical care. In fact, most drug abusers don’t even want fentanyl, but it’s often cut into the drugs they seek, such as heroin, meth, cocaine and counterfeit pills. Other times they’ll get fentanyl because nothing else is available and they fear withdrawal.

‘Drug Policy In Shambles’

The supply lines for illicit fentanyl and other synthetic opioids are clear, too. A small amount is made in the United States or comes into the country on planes or boats. Most commonly, however, it enters in the mail from China or is smuggled across the border from Canada or Mexico.

Westhoff ultimately goes to the source, talking to Chinese manufacturers of fentanyl precursors and to Dark Net drug resellers. He listens to Chinese sales staff explain how the fentanyl precursors are not technically illegal in China and so can be sold as desired, and interviews a Dark Net dealer who justifies his work as a form of harm reduction.

Westhoff is unstinting in his criticism of China: “There is little doubt that China is undercutting its publicity stated goal of stopping the export of dangerous drugs for illicit use. That’s because the country actively encourages the export of fentanyl and fentanyl precursors—and even synthetic cannabinoids—through its tax code and high-tech subsidies.”

But other countries may be worse still. While China has been at least somewhat responsive to American requests to control its chemical industry, India has failed to schedule synthetics and fentanyl precursors to stop their production. Mostly, however, he says that America is not equipped to deal with synthetic drugs.

“Today, US drug policy is in shambles. Our laws—and those in countries around the world—simply weren’t ready for the NPS revolution,” he writes.

In other words, there is no way to control supply anymore. That leaves prevention, harm reduction, and treatment. Westhoff describes the efforts of drug education campaigns like DanceSafe, Energy Control and Drogart, and novel drug treatment ideas like safe injection sites and prescription-grade heroin.

“Curbing the tide of US opioid deaths will require sweeping new public-health initiatives, including treatment programs and campaigns to educate everyone, from users and medical providers to teachers and police, about the drugs’ dangers,” Westhoff says.

He also recognizes that drug use and addiction occur in a broader context. Many drug users are coping with childhood trauma or have a mental health disorder.

The main lesson of “Fentanyl, Inc.” is that we are facing a drug overdose crisis that involves new substances, new usage patterns and new drug markets. We’re not dealing with a single chemical like alcohol or a plant like cannabis. Nor are we just dealing with medical practice gone wrong. Instead, we’re facing something new, and we need to adapt.

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 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.

Stop Demonizing the ‘Holy Trinity’

Lynn Kivell Ashcraft, Guest Columnist    

If we are to have any hope of a rational, scientific discussion about the issues involved in both pain management and addiction treatment, we need to end patient shaming and the use of sensational language that has no basis in clinical practice.

First on my list is to stop using the term “Holy Trinity” when referring to the use of multiple medication classes to manage pain. It is a sensational propagandizing use of terminology that has no place in any meaningful clinical discussion.

Holy Trinity was a term coined by law enforcement when discussing the behavior of addicts. The original Holy Trinity – the so-called “Houston Cocktail” -- referred to the simultaneous ingestion of the short acting drugs hydrocodone (Vicodin), alprazolam (Xanax) and carisoprodol (Soma) by addicts. Other combinations of opioids, muscle relaxants and anti-anxiety drugs such as benzodiazepines are also used.

“The cocktail is commonly known on the black market as the ‘holy trinity’ and is particularly sought-after by addicts, but is also particularly dangerous,” is how the DEA describes the drugs in criminal complaints, search warrants and training guides.  

SOURCE: DEA TRAINING GUIDE

Taken together, the three drugs can be risky and cause respiratory depression, overdose and death. But when used under medical supervision, they enable individuals with painful and disabling conditions to improve their quality of life and restore bodily functions.

Holy Trinity was never used originally to refer to any medication combination prescribed by physicians caring for pain patients. But with the advent of the opioid crisis, the term is being used as a scare tactic by law enforcement and even some medical providers to deny patients a combination of medications previously used successfully.

The unintended consequence of this careless usage has been the deaths and needless renewal of pain and disability for patients who were being safely prescribed these medications.  

There is no one-size-fits-all treatment for chronic severe centralized pain. In fact, the current Pain Management and Dosing Guide from the American Pain Society lists opioids plus other central nervous system depressants and valium (a diazepine) as potential treatments for neuropathic pain.

It is well acknowledged that successful treatment often requires polypharmacy regimens tailored to the needs of individual patients to achieve pain relief and provide quality of life. The potential risks of using multiple medications can be reduced by prescribing both long-acting forms of these drugs and by directing patients to take them separately. 

To use the Holy Trinity as an inflammatory term is to demonize certain medications that have been abused by addicts while being used successfully by intractable pain patients. The use of this derogatory term has caused the undeserved transference of the deeply held negative societal bias against “addicts” onto some of the frailest and medically complex patients, many of whom are struggling to achieve some quality of life. 

According to the CDC, about 20 percent of adults in the U.S. have chronic pain and 8 percent have severe “high impact” chronic pain that frequently limits their life or work activities. The 2011 Institute of Medicine report puts the number of Americans with pain at 100 million, which is more than those living with diabetes, heart disease and cancer combined.

The difference between the two reports highlights some of the issues with using and understanding statistics.  However, no matter which report you use, both numbers represent a staggering number of Americans living in pain who deserve effective treatment.

Let’s lose the term Holy Trinity and allow doctors to prescribe whatever medications they deem necessary for the restoration of function and the relief of pain in their patients. Name calling and the use of disrespectful terminology doesn’t solve either the problem of addiction or the problem of pain.

Lynn Kivell Ashcraft is an Analytic Software Consultant and writer who lives in Arizona. Lynn has lived with chronic intractable pain for almost 30 years and works with Dr. Forest Tennant as part of the Arachnoiditis Research and Education Project. 

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

Overdoses Linked to Fake Pain Pills Draw Little Attention

By Pat Anson, PNN Editor

A mysterious lung illness linked to marijuana vaping has drawn nationwide attention this week. The CDC said there were 6 confirmed deaths and 380 cases of the illness, which one doctor warned was “becoming an epidemic.”

Even the White House has gotten involved in the vaping crisis, with President Trump calling for a ban on flavored e-cigarettes. “People are dying with vaping,” Trump said.

Meanwhile, an even more deadly health crisis continues to spread, drawing relatively little attention from the nation’s media and federal officials. Counterfeit blue pills made with illicit fentanyl are killing Americans from coast to coast.

This week, health officials in California’s Santa Clara County announced that 9 fatal overdoses have been linked to counterfeit oxycodone pills since January, including the recent deaths of a 15 and 16-year old.  

Local law enforcement has seized a large number of the blue tablets, which have an “M” stamped on one side and a “30” on the other side. They are virtually indistinguishable from real oxycodone.

“The extent of circulation of these fake pills is unknown; however, they had been consumed by several of the people who died,” Santa Clara Public Health Director Sara Cody, MD, said in a statement. 

“Many opioid pills, which are made to look like real prescription medications, are now made by counterfeiting organizations. These pills are not prescribed, stolen, or resold by or from verified pharmaceutical companies, and there is no connection between their appearance and their ingredients. Many patients may not be aware of the risks of taking a pill that does not come directly from a pharmacy.”  

Mexican Oxy

The overdoses in Santa Clara County are not an isolated situation. Over 700 miles away, the Yakima County Coroner’s Office in Washington State warned that three recent deaths involved fake oxycodone pills with the same distinctive markings. Yakima is used as a major distribution center by Mexican drug cartels.

"Most of the time it comes from Mexico, but we haven't been able to pinpoint exactly which batch it's from and who is actually dealing it," said Casey Schilperoort, a spokesperson for the Yakima County Sheriff's Office.

Known on the street as “Mexican Oxy,” the pills were also found at the scene of four fatal overdoses near San Diego over the summer.  Ports of entry near San Diego are major transit points for counterfeit oxycodone smuggled in from Mexico. The pills are usually transported in vehicles, often by legal U.S. residents acting as couriers. They sell on the street for $9 to $30 each and have spread across the country.

In February, New York City police announced the seizure of 20,000 fake oxycodone pills. Overdose deaths in New York City are at record levels and fentanyl is involved in over half of them. Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine.

This week federal prosecutors in Cleveland indicted ten people for trafficking in fake oxycodone and other illegal drugs. The leader of the drug ring, Jose Lozano-Leon, allegedly directed operations using a cell phone smuggled into his Ohio prison cell.

Prosecutors say Lozano spoke frequently with the co-defendants and others to arrange drug shipments from Mexico to northeast Ohio. The ring allegedly specialized in counterfeit oxycodone.

"In Ohio and other parts of the country, we are seeing an increase in these blue pills that at first glance appear to be legitimately produced oxycodone, but in fact are laced with fentanyl,” said DEA Special Agent in Charge Keith Martin.

Ironically, the indictments were filed in the same federal courthouse where a major lawsuit against opioid manufacturers and distributors is expected to get underway next month.  

Chronic Pain Accelerates Dementia

By Dr. Lynn Webster, PNN Columnist

In 2017, JAMA Internal Medicine published a study that found older people with chronic pain experience faster declines in memory and are more likely to develop dementia.  While prior research had shown a link between chronic pain and brain damage, this was one of the first studies to specifically suggest that chronic pain can cause dementia.

The authors reported that people aged 60 and over with persistent pain experienced a 9.2% more rapid decline in memory score when compared to people of the same age without chronic pain. This means that people with chronic pain may experience more difficulty in managing their finances, medications and social connections.

Dementia is a chronic condition of the brain that involves memory, personality and judgment. It is not a disease; it is a symptom of one or more diseases.

There are many types of dementia. Alzheimer’s disease is considered to be the most common.

Dementia usually worsens over time if the underlying disease remains static or progresses, as is the case with many chronic pain conditions.

There are an estimated 20 million Americans with high impact (the most severe) chronic pain who may be experiencing accelerated decline in cognition due to their pain. The amount of dementia appears to be associated with the severity and duration of chronic pain. Undertreated or untreated chronic pain may accelerate dementia.

Chronic pain affects an even larger percentage of elderly adults (one in three) than the general population. Since the prevalence of chronic pain increases with age, the probability of experiencing dementia increases as well. However, the reasons for that go beyond aging itself.

Seniors are more likely to take multiple medications that can contribute to mental confusion. On average, elderly people take five or more prescriptions. They may also use over-the-counter medications, which adds to potential drug-associated mental compromise.

Opioids, in particular, have been implicated in cognitive impairment. However, a study published in 2016 suggests there is no difference in cognitive decline between people on opioids and those on nonsteroidal anti-inflammatory drugs. The study's implication is that pain, not opioids, leads to cognitive impairment.

Brain Fog

Chronic pain appears to affect the function and structure of the hippocampus. This is the region of the brain that involves learning, memory, and emotional processing.

One explanation for the mental decline associated with chronic pain is that various areas of the brain compete for attention. Attentional impairment compromises memory by diverting attention to the areas of the brain processing pain. In effect, the brain is multi-tasking and favoring the processing of pain over cognition. This may, in part, explain the clinical phrase “brain fog.”

The Australian Broadcasting Company's "All in the Mind" website explains that pain damages the brain in several ways, including a change in the size of the thalamus and a decrease in the amount of a neurotransmitter (gamma-aminobutyric acid) the brain produces. In other words, chronic pain changes the brain structurally and functionally.

The prefrontal cortex is the part of the brain responsible for executive functions, such as cognition, social behavior, personality, and decision-making. It is also the part of the brain that modulates pain.

According to "All in the Mind," some researchers believe that chronic pain decreases the volume of the prefrontal cortex. Over time, brains damaged by pain lose the ability to handle pain — along with some of the personality attributes that make us who we are.

Brain Damage Can Be Reversed

The good news is that the brain damage caused by chronic pain can be reversed, at least to some extent. Unfortunately, the elderly are less likely to recover from dementia caused by chronic pain as compared with younger patients.

If pain is adequately treated, the brain may be able to regain its ability to function normally. A 2009 study of patients with chronic pain due to hip osteoarthritis showed reversal of brain changes when their pain was adequately treated. 

People who don’t have their acute pain managed are more likely to develop chronic pain. It is postulated that the changes in the brain that occur with chronic pain begin with the onset of acute pain. There is also some evidence that an individual’s genes may influence who is at greatest risk for developing brain damage from chronic pain and who is least likely to recover from it. 

Many people have criticized the concept of assessing pain as the 5th vital sign, and have called it a contributing factor for the opioid crisis. As I have said, pain may not be a vital sign, but it is vital that we assess it. Asking patients about their pain is critical to providing interventions that can mitigate the consequences of undertreated pain, including dementia. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find him on Twitter: @LynnRWebsterMD. 

The information in this column 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.

One in Four Adults in England Take Addictive Meds

By Pat Anson, PNN Editor

Nearly 12 million people – about one in four adults in England -- are taking addictive prescription drugs to treat depression, anxiety, insomnia or chronic pain, according to a new review by Public Health England (PHE).

The review takes a cautionary view on the use of five drug classes – opioids, antidepressants, benzodiazepines, gabapentinoids, and so-called “z-drugs” such as zolpidem, zopiclone and zaleplon.

“The medicines we looked at help to make millions of people every year feel better and recover from their illness. Doctors can prescribe them because there is good evidence that they work, but they do have some risks,” the PHE report found.

Benzodiazepines, z-drugs, opioids and gabapentinoids are associated with dependence and withdrawal, while there’s a risk of withdrawal with antidepressants. When the drugs are taken in combination or in high doses, there is also risk of respiratory depression and overdose.  

About half the patients prescribed the drugs in England had been taking them for at least a year — a sign of dependence. But the report cautions doctors not to abruptly discontinue the drugs and to taper them gradually, if at all.

“There is a view that a sub-population of chronic pain patients can be prescribed long-term opioids at relatively stable doses so that their analgesia and functioning can be maintained with good adherence and tolerable side-effects,” the report found.

“We do not want to put anyone off safely using medicines that could help them. Stopping or limiting the use of medicines could also cause harm, including increasing the risk of suicide or making people try to get medicines or illegal alternatives from less safe sources, such as illegal websites or drug dealers.”

Increasing Use of Antidepressants and Gabapentinoids

Antidepressants were prescribed to about 7.3 million people in England or 17% of the adult population. Opioids were prescribed to 5.6 million patients, followed by gabapentinoids (1.5 million), benzodiazepines (1.4 million) and z-drugs (1 million). Prescriptions for opioids, benzodiazepines and z-drugs are dropping, while the use of antidepressants and gabapentinoids is growing. 

Gabapentinoids such as pregabalin (Lyrica) and gabapentin (Neurontin) were originally developed to treat epilepsy, but the drugs are increasingly prescribed in the UK to treat neuropathy and other types of chronic pain. PHE researchers found only marginal evidence that they are effective for pain and alarming signs that they are being misused. 

“Gabapentinoids have come to be used for a wider range of indications than is supported by the evidence or their licensing, and they have sometimes been prescribed in place of opioids or benzodiazepines in the likely-mistaken belief that they are less liable to misuse or dependence, and lack of awareness of the withdrawal problems that can arise when prescribing is stopped,” the report said. 

Prescriptions for opioids and gabapentinoids were 1.6 times higher in parts of England with more poverty. People in poor areas are also more likely to be prescribed medicines for longer periods. Prescription rates for women are about 1.5 times higher than for men. Prescription rates also increased with age.

DEA Proposes More Cuts in Rx Opioids

By Pat Anson, PNN Editor

For the fourth consecutive year, the U.S. Drug Enforcement Administration is proposing steep cuts in the supply of hydrocodone, oxycodone and three other opioid painkillers classified as Schedule II controlled substances.

In a notice published today in the Federal Register, the DEA proposes to reduce production quotas for hydrocodone by 19 percent and oxycodone by 9 percent in 2020. The supply of hydromorphone, oxymorphone, and fentanyl would also be cut.

“The aggregate production quota set by DEA each calendar year ensures that patients have the medicines they need while also reducing excess production of controlled prescription drugs that can be diverted and misused,” acting DEA Administrator Uttam Dhillon said in a statement.

“DEA takes seriously its obligations to both protect the public from illicit drug trafficking and ensure adequate supplies to meet the legitimate needs of patients and researchers for these substances.”

In setting annual production quotas for controlled substances, DEA considers various factors such as medical need, estimates of retail consumption based on prescriptions, and forecasts from opioid manufacturers. Added to the mix this year is diversion.

The five opioids being cut are subject to special scrutiny under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, known as the SUPPORT Act, which was signed into law by President Trump on October 24, 2018. The law requires DEA to estimate the amount of diversion of the five opioids and “make appropriate quota reductions.”

The agency estimated that 57 kilograms – about 125 pounds – of oxycodone were diverted or stolen in 2018, along with 24 kilograms (53 pounds) of hydrocodone. There was diversion of relatively small amounts of fentanyl, hydromorphone and oxymorphone last year.   

Cuts Began in 2016

The DEA first began cutting the supply of opioids in 2016 during the Obama administration and the trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third by 2021.

If approved, the 2020 production quotas would amount to a 60 percent decrease in the supply of hydrocodone since 2016 and a 48 percent cut in the supply of oxycodone.

While overdoses involving prescription opioids have been declining, they’ve been offset by a growing number of deaths attributed to illicit fentanyl, heroin and other street drugs. “Mexican Oxy” – counterfeit oxycodone pills laced with fentanyl – are being trafficked throughout the United States and are blamed for overdoses from New York City to San Diego.

In addition to the five opioids, the DEA is setting production quotas on more than 250 Schedule I and II controlled substances. The agency is proposing to increase the amount of marijuana that can be produced for research by almost a third, from 2,450 kilograms in 2019 to 3,200 kilograms -- almost triple what it was in 2018. The increase reflects growing interest in marijuana research.

Public comments on the DEA proposal will be accepted until October 10. To make a comment online, click here. The agency will publish another notice later in the year on its final decision and begin informing drug manufacturers of their quota allotment.