Low Dose Opioids Ineffective for Acute Lower Back and Neck Pain

By Pat Anson, PNN Editor

A low dose of prescription opioids works no better than a placebo in relieving acute lower back or neck pain, according to a new study in Australia.  

The blinded, placebo-controlled trial was relatively small – just 345 participants – but was unusual because patients were followed for up to a year, a rarity for a clinical trial that studies pain.  Half the participants received a combination of oxycodone and naloxone for six weeks at a low daily dose of 20mg or about 30 morphine milligram equivalents (MME). The other half received placebo tablets that looked similar to oxycodone.   

It's important to note that the study only included people with mild or moderate pain of less than 12 weeks duration -- not the severe, long-term back and neck pain caused by degenerative disc disease, spinal injuries, arthritis, and other chronic conditions. Participants were excluded if they had that type of pain.  

The study findings, published in The Lancet, showed no significant difference in pain severity between the opioid and placebo groups. On a scale of zero to 10, the average pain score was 2.8 in the opioid group after six weeks, compared to 2.3 in the placebo group. After a year, the average pain score was 2.4 in the opioid group, versus 1.8 in the placebo group. 

Pain Severity Over 52 Weeks

THE LANCET

Researchers say patients who received opioids had a slightly higher risk of opioid misuse at the end of the study, a finding based on a mental health survey that screens patients for drug related behavior.

“Our findings show that even judicious, short-term use of an opioid conferred no benefits in pain reduction and led to a small increase in pain at the medium-term and long-term compared with placebo. The opioid group had worse quality-of-life mental health scores than the placebo group,” researchers reported. “Although no difference was found in overall time to recovery, more people in the placebo group recovered in the first 14 days compared with those in the opioid group.”

Most medical guidelines recommend exercise and over-the-counter pain relievers for short-term back or neck pain, with opioids only used as a last resort. The authors of the Lancet study say even that limited use is inappropriate.

“Opioids should not be recommended for acute back and neck pain, full stop,” said lead investigator Christine Lin, PhD, a professor in the School of Public Health at University of Sydney. “Not even when other drug treatments are not able to be prescribed or have not been effective for a patient.”

The Lin study is somewhat similar to the 2018 Krebs study, which found that low doses of oxycodone were no more effective than over-the-counter pain relievers in treating chronic back and osteoarthritis pain. Critics say the Krebs study was biased from the start and this one is no better.

“They generalise enormously,” Michael Vagg, MD, Dean of Pain Medicine at the Australian and New Zealand College of Anaesthetists, told the Medical Republic. “They studied oxycodone and naloxone in a modified-release formulation. But modified-use opioids have never been on-label for use in acute pain and they are not recommended as such… to which I and everyone in pain medicine would say ‘We figured that out ages ago’. That’s not how you use opioids in acute pain.

“In layman’s terms, they’ve done a study where they tried to look at doing push-ups to help with back pain and then they’ve decided that all exercise is no good for the back pain.”

Lower back pain is the world’s leading cause of disability and neck pain is the fourth largest, but there is surprisingly little evidence about the best ways to treat them.

A previous study published in The Lancet by an international team of researchers found that lower back pain was often treated with bad advice, inappropriate tests, risky surgeries and painkillers. The authors said there was limited evidence to support the use of opioids for low back pain, and epidural steroid injections and acetaminophen (paracetamol) were not recommended at all. Most patients responded better to physical and psychological therapies that kept them active.

Australian Guideline Calls for Safer Opioid Tapering

By Pat Anson, PNN Editor

Public health experts in Australia have released what is being called the first international guideline to help primary care doctors safely reduce or stop prescribing opioids to adults with chronic non-cancer pain.

The Guideline for Deprescribing Opioid Analgesics contains 11 recommendations developed by a panel of general practitioners, pain specialists, addiction specialists, pharmacists, nurses and physiotherapists. The guideline emphasizes slow and individualized tapering for patients when long-term opioid use does not improve their pain and quality of life or when they experience adverse side effects. Tapering is not recommended for anyone nearing the end-of-life.

“Internationally, we were seeing significant harms from opioids, but also significant harms from unsolicited and abrupt opioid cessation. It was clear that recommendations to support safe and person-centred opioid deprescribing were required,” said lead author Aili Langford, PhD, a pharmacist and Research Fellow at Centre for Medicine Use and Safety, Monash University.

Millions of pain patients in the U.S. were tapered or cut off cold turkey after the CDC released its 2016 opioid prescribing guideline. Both the American Medical Association and the FDA warned that rapid tapering was causing “serious harm” to patients, including withdrawal, uncontrolled pain, substance abuse and suicide.

In response to that criticism, the revised 2022 CDC guideline took a more cautious approach to tapering, recommending a dose reduction of just 10% a month, a much slower rate than the 10% a week that the agency previously recommended.

The U.S. Department of Veterans Affairs and Department of Defense (VA/DoD) also modified their approach to tapering, which at one time called for tapers of up to 20% every four weeks.  The updated VA/DoD guideline says there is “insufficient evidence to recommend for or against any specific tapering strategies.”

The Australian guideline doesn’t get caught up in fractions or percentages. It simply calls for “gradual tapering” that is tailored to each patient’s needs and preferences. A key recommendation is to discuss tapering as early as possible with patients, to develop a plan when they are first prescribed opioids.  

“Shared decision-making and ensuring that patients have ways to manage their pain are essential when a deprescribing plan is being discussed,” said Liz Marles, MD, a general practitioner and clinical director at the Australian Commission on Safety and Quality in Health Care.  

“These new guidelines further support appropriate use of opioid analgesics and how to safely prescribe and stop prescribing them. They ask clinicians to consider reducing or stopping opioids when the risk of harm outweighs the benefits for the individual.”

One in five adults in Australia have chronic pain, but few actually wind up taking opioids long-term. The guideline authors estimate that only 5% of opioid “naive” patients become long-term users, well below misleading claims by anti-opioid activists that over 25% of pain patients develop opioid dependence or opioid use disorder.

“I am curious to know how many people who are on chronic opioid therapy feel a need to be tapered,” said Lynn Webster, MD, a pain management expert and Senior Fellow at the Center for U.S. Policy.  “Only 5% of opioid-naïve patients remain on opioids for 3 months or longer. Considering the fact that about 10% of the population has severe enough pain to affect quality of life, this statistic argues against the theory that just being exposed to an opioid leads to chronic opioid use.”

Webster says most of the recommendations in the Australian guideline are practical, but he’s concerned that some of the evidence used to support them is “misunderstood and misleading.”

“They make it abundantly clear that tapering should not be forced and that there are serious consequences to forced tapering. But they also use the common yet flawed statement that there is little evidence that opioids are effective for chronic non-cancer pain. Of course, the lack of evidence is not evidence,” Webster said.

Although opioids have been used for thousands of years for pain relief, the clinical evidence for or against their use remains thin. Most of the evidence used to support the Australian guideline was deemed by the authors to be insufficient, unclear or weak. Only one of the 11 tapering recommendations was supported by evidence of “moderate certainty.”

Burden of Pain: How the CDC and DEA Criminalized Medicine

(Jay K. Joshi, MD, is a primary care physician in Indiana who spent nearly a year in prison after pleading guilty to prescribing opioids without a “legitimate medical need” to an undercover DEA agent who was posing as a pain patient. Joshi now regrets that guilty plea and is trying to vacate his conviction due to alleged DEA misconduct.

While in prison, Joshi began writing “Burden of Pain: A Physician’s Journey through the Opioid Epidemic.” His book is a cautionary tale about misguided public health policy and overzealous law enforcement, which often portray doctors as drug dealers and patients as addicts.

PNN editor Pat Anson recently spoke with Joshi, who is practicing medicine again and hopes to regain his license to prescribe opioids. This interview has been edited for content and clarity.)

JAY K. JOSHI, MD

Anson: Dr. Joshi, who is your book intended for and what is the main message you're trying to send?

Joshi: The book really is for the general public and those that have a vested interest in helping to rectify misguided federal policy, as it pertains to not just the opioid epidemic, but the overdose crisis as a whole.

My main message is that we have to understand that healthcare has a lot of uncertainty and complexity. And if we just use simplified rubrics, like cookie cutter medical guidelines or restrictive laws, we're going to create unintended consequences. It's time that we start to re-examine clinical decisions and health policy as a whole, so that we can make better informed decisions.

Anson: Do you think the general public has a good understanding of the opioid crisis and what caused it? Or is there misinformation going around that they've bought into?

Joshi: I would say there's a strong degree of misrepresentation among policymakers, who should have known better before and certainly should know better now. I think the narrative of opioid prescriptions running amok and creating this overdose crisis is a story that’s taken on a life of its own.

Did prescription opioids contribute to the overdose crisis that we see now? Yes. Was it the main driving factor? No. But there were trends in drug use and drug policy through the 2000’s and 2010’s that falsely conflated prescription opioids with illicit opioids. Policymakers should now understand that there are fundamental differences in how opioids are abused versus how they're used in a proper clinical setting.

Anson: Given what's transpired over the last few years, with overdoses soaring from illicit fentanyl and opioid prescriptions declining, do you think policymakers now know better?

Joshi: You know, in life as a general rule of thumb, often you learn more about what a person doesn't say, than what they do say. And this kind of hollow resonance in connecting fentanyl overdoses to previous manifestations of the overdose crisis to me is a glaring omission of responsibility from federal policymakers at the CDC level and law enforcement at the DEA and state level.

They’ve failed to acknowledge that the current fentanyl crisis is a manifestation of restrictive and overly simplified opioid policies that began nearly a decade ago. And I think the fact that people are not correlating that when the data clearly shows it indicates there is a willful understanding and a willful intent to not accept responsibility for prior failures and opioid policies.

Anson: Do you think the CDC and the DEA made the fentanyl crisis worse?

Joshi: It's difficult to say because when you use the word “worse,” then you almost have to apply some sort of causality. I like to look at the overdose crisis a little differently.

Did the CDC with their opioid policy guidelines contribute to the trends and overdoses that we're seeing now? Yes. By not recognizing that the guidelines would be codified into law and policy, and deliberately affect clinical decision making. They're not taking accountability for all the damaging effects. So, by that logic, you can say the CDC made the opioid epidemic worse.

But I would instead reframe it to say the CDC needs to better educate itself. What you see from them is a conflation of words, reflecting a lack of proper understanding. That's how I would define the revised 2022 CDC opioid prescribing guideline.

They talk a lot about nuances. They talk a lot about “uncertainty,” although not using that word as much as I believe that they should. But then eventually they revert to the same policy trend of creating overly simplified stipulations using morphine milligram equivalents (MME) as this rubric of clinical care, even though it was never intended to be used as a clinical decision-making tool.

The CDC needs to be better aware of its own conflicts of interest in the leadership making policy decisions. We can go down line by line looking at these individuals and assessing their conflicts of interest. And I certainly have seen things that would be quite alarming for anybody who values scientific objectivity.

But I feel like when you go down that pathway, you're simply entrenching people in their own lease, meaning the CDC will simply double down and say,”No, what we're doing is right” and the DEA will simply double down and say,” No, what we're doing is right.”

Anson: Do you think the CDC should even have an opioid guideline?

Joshi: It is odd that a public health organization would get involved with something that has, for all intents and purposes, a direct patient to physician relevancy. It's hard for me to understand how the CDC initially thought that when the guidelines made it a public health issue. It was almost as if it became a self-fulfilling prophecy.

The CDC felt like prescription opioids were a public health issue, and therefore created guidelines that affected the patient-physician relationship, thereby creating undue stigmatization in a clinical encounter that should otherwise be based upon a foundation of trust and respect.

And by doing so, they almost exacerbated the overdose crisis into a public health issue. It's very difficult to understand why they felt like those guidelines would help, as opposed to focusing on keeping prescription opioids within the framework of the patient-physician encounter, as it already had been.

I guess they were looking at rising overdose rates and conflated illicit opioids, heroin and fentanyl with prescription opioids. I'm not sure where that direct line of logic really came from. It's difficult to really justify that.

Anson: And what about the DEA? As you very well know, a lot of doctors have stopped prescribing opioids or have really scaled back the doses that they give to patients, because they don't want to go to prison like you did.

Joshi: Definitely, and I can understand that. What's interesting is that I've had direct engagements with DEA officers, and from my perspective they lack the necessary understanding of prescription opioids and the benefit it provides patients. They lack the healthcare context.

What the DEA does is correlate the clinical encounter with what you would see in a routine drug transaction. In their eyes, having a hammer as the only tool, everything looks like a nail. So the drug dealer in Mexico running Chinese products through a drug cartel entering the United States is cognitively equivalent to a physician treating patients with chronic pain.

They don't have the ability to discern context and the role clinical need plays in how patients are treated. And I think that really does an injustice to both the patients and the physicians, because effectively the only tool the DEA has to address prescription opioid use is fear. And when you use fear in the clinical context, you’ve harmed the most vulnerable patients. It's a shame that the DEA is not acknowledging this.

I wrote an op/ed in Medpage Today about a month ago, in which I asked the DEA to take a stance on harm reduction. Many medical societies talk about how harm reduction is a better overall policy to help patients. But medical societies are not implementing the laws, the DEA is implementing the laws.

So regardless of how high-minded the policies may be, unless implementation of the policies aligns with intent, you're not going to have patients being treated the way that they should be. And I think what the DEA really needs to do is to assess its role in the clinical encounter and make honest determinations on whether they have the capabilities to understand clinical need for opioids as it pertains to patients with chronic pain or acute pain. I think the DEA is lacking in that capacity.

Anson: Is the DEA practicing medicine? They say they don't.

Joshi: I know. And I disagree. I would say that the DEA is very much involved in the practice of medicine. If you are influencing clinical decisions through fear, you are engaging in the practice of medicine.

What is clinical medicine? If you present to me with headache and vision changes, and I checked your vitals and see that you have extremely high blood pressure, I'm going to consider you as somebody in hypertensive crisis. I'm making that decision based upon the facts presented to me and then, based upon that decision, I will implement a certain form of treatment. Clinical medicine is a series of decisions made in the face of uncertainty.

Should I trust my blood pressure monitor that the readings are correct? Should I trust you when you say that you have a headache and vision changes? How much of that uncertainty is simply assumed to be true when any clinical decision is made?

Now, the moment you incorporate fear into that clinical decision making, you're influencing how the decisions are made and the eventual course of clinical action.  So very much the DEA is practicing medicine, and I would greatly appreciate if they were honest about that.

Anson: You've obviously given this a lot of thought and, at the same time, you don't sound that bitter about what happened to you. Why is that?

Joshi: You know, when I was in federal prison, I was extremely depressed. I lost my medical practice. I lost my freedom. But I always felt like, in the end, things would turn out right and the truth would come out. Whether that was a delusional belief sitting in a federal prison, I don't know. But I held onto that belief.

It's through that belief that I improved my writing abilities and hand wrote the first version of “Burden of Pain.” It’s through that belief that I regained my medical license and was reinstated as a Medicare provider.

I don't feel bitter because I feel that I have a responsibility to patients and to physicians who might be going through similar situations. And if I can behave in a certain way that is productive, that can turn what I went through into an overall good for patients and for society as a whole, then I’ll feel like what I went through was worth it.

“Burden of Pain” and other books are featured in PNN’s Suggested Reading section.

DEA Ending Lenient Telehealth Rules in November

By Arielle Zionts, KFF Health News

Federal regulators want most patients to see a health care provider in person before receiving prescriptions for potentially addictive medicines through telehealth — something that hasn’t been required in more than three years.

During the COVID-19 public health emergency, the Drug Enforcement Administration allowed doctors and other health care providers to prescribe controlled medicine during telehealth appointments without examining the patient in person. Controlled medications include many stimulants, sedatives, opioid painkillers, and anabolic steroids.

The emergency declaration ended May 13, and in February, the agency proposed new rules that would require providers to see patients at least once in person before prescribing many of those drugs during telehealth visits.

Regulators said they decided to extend the current regulations — which don’t require an in-person appointment — until Nov. 11 after receiving more than 38,000 comments on the proposed changes, a record amount of feedback. They also said patients who receive controlled medications from prescribers they’ve never met in person will have until Nov. 11, 2024, to come into compliance with the agency’s future rules.

The public comments discuss the potential effects on a variety of patients, including people being treated for mental health disorders, opioid addiction, or attention-deficit/hyperactivity disorder. Thousands of commenters also mentioned possible impacts on rural patients.

Opponents wrote that health care providers, not a law enforcement agency, should decide which patients need in-person appointments. They said the rules would make it difficult for some patients to receive care.

Other commenters called for exemptions for specific medications and conditions.

Supporters wrote that the proposal would balance the goals of increasing access to health care and helping prevent medication misuse.

Special Referrals for Rural Patients

Zola Coogan, 85, lives in Washington, Maine, a town of about 1,600 residents northeast of Portland. Coogan has volunteered with hospice patients and said it’s important for very sick and terminally ill people in rural areas to have access to opioids to ease their pain. But she said it can be hard to see a doctor in person if they lack transportation or are too debilitated to travel.

Coogan said she supports the DEA’s proposed rules because of a provision that could help patients who can’t travel to meet their telehealth prescriber. Instead, they could visit a local health care provider, who then could write a special referral to the telehealth prescriber. But she said accessing controlled medications would still be difficult for some rural residents.

“It could end up being a very sticky wicket” for some patients to access care, she said. “It’s not going to be easy, but it sounds like it’s doable.”

Some health care providers may hesitate to offer those referrals, said Stefan Kertesz, a physician and professor at the University of Alabama at Birmingham whose expertise includes addiction treatment. Kertesz said the proposed referral process is confusing and would require burdensome record-keeping.

Ateev Mehrotra, a physician and Harvard professor who has studied telehealth in rural areas, said different controlled drugs come with different risks. But overall, he finds the proposed rules too restrictive. He’s worried people who started receiving telehealth prescriptions during the pandemic would be cut off from medicine that helps them.

Mehrotra said he hasn’t seen clear evidence that every patient needs an in-person appointment before receiving controlled medicine through telehealth. He said it’s also not clear whether providers are less likely to write inappropriate prescriptions after in-person appointments than after telehealth ones.

Mehrotra described the proposed rules as “a situation where there’s not a clear benefit, but there are substantial harms for at least some patients,” including many in rural areas.

Beverly Jordan, a family practice doctor in Alabama and a member of the state medical board, supports the proposed rule, as well as a new Alabama law that requires annual in-person appointments for patients who receive controlled medications. Jordan prescribes such medications, including to rural patients who travel to her clinic in the small city of Enterprise.

“I think that once-a-year hurdle is probably not too big for anybody to be able to overcome, and is really a good part of patient safety,” Jordan said.

Jordan said it’s important for health care practitioners to physically examine patients to see if the exam matches how the patients describe their symptoms and whether they need any other kind of treatment.

Jordan said that, at the beginning of the pandemic, she couldn’t even view most telehealth patients on her computer. Three-fourths of her appointments were over the phone, because many rural patients have poor internet service that doesn’t support online video.

The proposed federal rules also have a special allowance for buprenorphine, which is used to treat opioid use disorder, and for most categories of non-narcotic controlled substances, such as testosterone, ketamine, and Xanax.

Providers could prescribe 30 days’ worth of these medications after telehealth appointments before requiring patients to have an in-person appointment to extend the prescription. Tribal health care practitioners would be exempt from the proposed regulations, as would Department of Veterans Affairs providers in emergency situations.

Many people who work in health care were surprised by the proposed rules, Kertesz said. He said they expected the DEA to let prescribers apply for special permission to provide controlled medicine without in-person appointments. Congress ordered the agency to create such a program in 2008, but it has not done so.

Agency officials said they considered creating a version of that program for rural patients but decided against it.

Denise Holiman disagrees with the proposed regulations. Holiman, who lives on a farm outside Centralia, Missouri, used to experience postmenopausal symptoms, including forgetfulness and insomnia. The 50-year-old now feels back to normal after being prescribed estrogen and testosterone by a Florida-based telehealth provider. Holiman said she doesn’t think she should have to go see her telehealth provider in person to maintain her prescriptions.

“I would have to get on a plane to go to Florida. I’m not going to do that,” she said. “If the government forces me to do that, that’s wrong.”

Holiman said her primary care doctor doesn’t prescribe injectable hormones and that she shouldn’t have to find another in-person prescriber to make a referral to her Florida provider.

Holiman is one of thousands of patients who shared their opinions with the DEA. The agency also received comments from advocacy, health care, and professional groups, such as the American Medical Association.

The physicians’ organization said the in-person rule should be eliminated for most categories of controlled medication. Even telehealth prescriptions for drugs with a higher risk of misuse, such as Adderall and oxycodone, should be exempt when medically necessary, the group said.

State Laws Burden Patients

Some states already have laws that are stricter than the DEA’s proposed rules. Amelia Burgess said Alabama’s annual exam requirement, which went into effect last summer, burdened some patients. The Minnesota doctor works at Bicycle Health, a telehealth company that prescribes buprenorphine.

Burgess said hundreds of the company’s patients in Alabama couldn’t switch to in-state prescribers because many weren’t taking new patients, were too far away, or were more expensive than the telehealth service. So Burgess and her co-workers flew to Alabama and set up a clinic at a hotel in Birmingham. About 250 patients showed up, with some rural patients driving from five hours away.

Critics of the federal proposal are lobbying for exemptions for medications that can be difficult to obtain due to a lack of specialists in rural areas.

Many of the public comments focus on the importance of telehealth-based buprenorphine treatment in rural areas, including in jails and prisons.

Rural areas also have shortages of mental health providers who can prescribe controlled substances for anxiety, depression, and ADHD. Patients across the country who use opioids for chronic pain have trouble finding prescribers.

It also can be difficult to find rural providers who prescribe testosterone, a controlled drug often taken by transgender men or people with various medical conditions, such as menopause. Controlled medications are also used to treat seizures, sleep disorders, and other conditions.

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Why You Shouldn’t Be Afraid to Ask for Help

By Barby Ingle, PNN Columnist

We all have lives to lead and sometimes we must focus on ourselves before we can help others. There's nothing wrong with that.

But what if your health (or lack thereof) prevents you from accomplishing something good for yourself and others? What can we do to become more independent and productive while living with a chronic pain condition or disease? 

Here are three things to consider:

1. Social isolation is not healthy

2. Independence can be healthy

3. It's okay to ask for help  

One of the people in my life is the most independent person I know. “Em” only asks for help when she needs it, but often fails to recognize when the need arises. If Em asked for help more often, things might have gone differently in her life and been much easier.

I've been thinking about this recently. I've been balancing my need for independence as a person in pain with my desire to be more open with people. We all want to feel more independent from our caregivers, family and friends. But we also want to stay connected. Seeing some of the challenges in Em’s life reminds me to ask for help more often.

In my books and columns, I have freely shared my life experiences, tips, tools and resources to help others. That helps me feel open and transparent, but it's usually about things I have been through and already found solutions for. When faced with a new challenge, I recognize that I isolate more than I should.

Like my friend Em, I need to find more ways to connect and ask for help when needed. We all need support from others, even if it's just someone listening or offering advice on handling a situation.

When I’ve asked for help, it didn't always go how I envisioned. I may have asked the wrong person for support or had expectations I put on that person that they could not live up to. I had to learn to be okay with the service they offered, rather than be upset and sad when they could not provide what I expected.

The more I learned about their strengths and what they could do, the better I felt asking for their assistance. Asking for help shows that I trust them enough to let them into my world. When you ask for help, you are not weak. You are human.

Asking is not always easy. You have to stop pretending that you can handle everything yourself and that everything is fine. You need to accept the support of your friends and family without feeling like you’re burdening them or making them feel bad about themselves. Asking shows them how much they mean to you.

Here is an excellent example of a recent conversation I had with Em about a friend who wanted to be more social and live life more fully. Em recognized her own limitations. 

"She asked me to meet with her more regularly. Saying she needs people in her life at this difficult time. I am unable to 'be there' for people. I am okay with hanging out occasionally, but I barely have the energy to do basic things each day," Em told me.

My response to Em was this:

"I get it. Explain that you are a chronically ill patient and enjoy connecting when you are up to it, but physically hanging out or texting, talking and engaging cognitively takes a toll on your energy and health. You understand her desire to remain social and the life challenges it takes to follow through. You do best by text, when you have the flexibility and health to answer. You understand her need to be flexible too. She will be in your prayers. Tell her not to be upset if you have to turn down an invite. It doesn't mean you don't want to connect, just that you will participate when you can." 

We must learn how to manage our emotions better so that they don't rule our lives. That means taking a step back so that we don't make decisions while in the middle of a panic attack or depressive episode. And sometimes we just need to hear the answer and decide what to do with it.

Asking for help is complex and we won’t always get what we want. At the same time, we have to step out of our discomfort to make social connections, take down our protective walls, and connect with humanity. Being your best advocate, having others in your life, and maintaining boundaries will help you live life to the fullest. 

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and best-selling author on pain topics. Barby has received over 25 awards for her advocacy efforts. You can follow her at www.barbyingle.com.   

Drugmakers Are Abandoning Cheap Generics

By Arthur Allen, KFF Health News

On Nov. 22, three FDA inspectors arrived at the sprawling Intas Pharmaceuticals plant south of Ahmedabad, India, and found hundreds of trash bags full of shredded documents tossed into a garbage truck.

Over the next 10 days, the inspectors assessed what looked like a systematic effort to conceal quality problems at the plant, which provided more than half of the U.S. supply of generic cisplatin and carboplatin, two cheap drugs used to treat as many as 500,000 new cancer cases every year.

Seven months later, doctors and their patients are facing the unimaginable: In California, Virginia, and everywhere in between, they are being forced into grim contemplation of untested rationing plans for breast, cervical, bladder, ovarian, lung, testicular, and other cancers. Their decisions are likely to result in preventable deaths.

Cisplatin and carboplatin are among scores of drugs in shortage, including 12 other cancer drugs, attention-deficit/hyperactivity disorder pills, blood thinners, antibiotics and opioids. Covid-hangover supply chain issues and limited FDA oversight are part of the problem, but the main cause, experts agree, is the underlying weakness of the generic drug industry.

Made mostly overseas, these old but crucial drugs are often sold at a loss or for little profit. Domestic manufacturers have little interest in making them, setting their sights instead on high-priced drugs with plump profit margins.

The problem isn’t new, and that’s particularly infuriating to many clinicians. President Joe Biden, whose son Beau died of an aggressive brain cancer, has focused his Cancer Moonshot on discovering cures — undoubtedly expensive ones. Indeed, existing brand-name cancer drugs often cost tens of thousands of dollars a year.

But what about the thousands of patients today who can’t get a drug like cisplatin, approved by the FDA in 1978 and costing as little as $6 a dose?

“It’s just insane,” said Mark Ratain, a cancer doctor and pharmacologist at the University of Chicago. “Your roof is caving in, but you want to build a basketball court in the backyard because your wife is pregnant with twin boys and you want them to be NBA stars when they grow up?”

“It’s just a travesty that this is the level of health care in the United States of America right now,” said Stephen Divers, an oncologist in Hot Springs, Arkansas, who in recent weeks has had to delay or change treatment for numerous bladder, breast, and ovarian cancer patients because his clinic cannot find enough cisplatin and carboplatin.

Results from a survey of academic cancer centers released June 7 found 93% couldn’t find enough carboplatin and 70% had cisplatin shortages.

“All day, in between patients, we hold staff meetings trying to figure this out,” said Bonny Moore, an oncologist in Fredericksburg, Virginia. “It’s the most nauseous I’ve ever felt. Our office stayed open during covid; we never had to stop treating patients. We got them vaccinated, kept them safe, and now I can’t get them a $10 drug.”

The 10 cancer clinicians KFF Health News interviewed for this story said that, given current shortages, they prioritize patients who can be cured over later-stage patients, in whom the drugs generally can only slow the disease, and for whom alternatives — though sometimes less effective and often with more side effects — are available. But some doctors are even rationing doses intended to cure.

Isabella McDonald, then a junior at Utah Valley University, was diagnosed in April with a rare, often fatal bone cancer, whose sole treatment for young adults includes the drug methotrexate. When Isabella’s second cycle of treatment began June 5, clinicians advised that she would be getting less than the full dose because of a methotrexate shortage, said her father, Brent.

“They don’t think it will have a negative impact on her treatment, but as far as I am aware, there isn’t any scientific basis to make that conclusion,” he said. “As you can imagine, when they gave us such low odds of her beating this cancer, it feels like we want to give it everything we can and not something short of the standard.”

Brent McDonald stressed that he didn’t blame the staffers at Intermountain Health who take care of Isabella. The family — his other daughter, Cate, made a TikTok video about her sister’s plight — were simply stunned at such a basic flaw in the health care system.

At Moore’s practice, in Virginia, clinicians gave 60% of the optimal dose of carboplatin to some uterine cancer patients during the week of May 16, then shifted to 80% after a small shipment came in the following week. The doctors had to omit carboplatin from normal combination treatments for patients with recurrent disease, she said.

ISABELLA MCDONALD AND HER FATHER, BRENT

On June 2, Moore and her colleagues were glued to their drug distributor’s website, anxious as teenagers waiting for Taylor Swift tickets to go on sale — only with mortal consequences at stake.

She later emailed KFF Health News: “Carboplatin did NOT come back in stock today. Neither did cisplatin.”

Doses remained at 80%, she said. Things hadn’t changed 10 days later.

Generics Manufacturers Are Pulling Out

The causes of shortages are well established. Everyone wants to pay less, and the middlemen who procure and distribute generics keep driving down wholesale prices. The average net price of generic drugs fell by more than half between 2016 and 2022, according to research by Anthony Sardella, a business professor at Washington University in St. Louis.

As generics manufacturers compete to win sales contracts with the big buyers, including wholesale purchasers Vizient and Premier, their profits sink. Some are going out of business. Akorn, which made 75 common generics, went bankrupt and closed in February.

Israeli generics giant Teva, which has a portfolio of 3,600 medicines, announced May 18 it was shifting to brand-name drugs and “high-value generics.” Teva notified the FDA earlier that month that it was discontinuing production of oxycodone tablets, a move that could exacerbate shortages of opioid pain medication.   

Lannett Co., with about 120 generics, announced a Chapter 11 reorganization amid declining revenue. Other companies are in trouble too, said David Gaugh, interim CEO of the Association for Accessible Medicines, the leading generics trade group.

The generics industry used to lose money on about a third of the drugs it produced, but now it’s more like half, Gaugh said. So when a company stops making a drug, others do not necessarily step up, he said.

Officials at Fresenius Kabi and Pfizer said they have increased their carboplatin production since March, but not enough to end the shortage. On June 2, FDA Commissioner Robert Califf announced the agency had given emergency authorization for Chinese-made cisplatin to enter the U.S. market, but the impact of the move wasn’t immediately clear.

Cisplatin and carboplatin are made in special production lines under sterile conditions, and expanding or changing the lines requires FDA approval. Bargain-basement prices have pushed production overseas, where it’s harder for the FDA to track quality standards. The Intas plant inspection was a relative rarity in India, where the FDA in 2022 reportedly inspected only 3% of sites that make drugs for the U.S. market.

Sardella, the Washington University professor, testified last month that a quarter of all U.S. drug prescriptions are filled by companies that received FDA warning letters in the past 26 months. And pharmaceutical industry product recalls are at their highest level in 18 years, reflecting fragile supply conditions. The FDA listed 137 drugs in shortage as of June 13, including many essential medicines made by few companies.

Intas voluntarily shut down its Ahmedabad plant after the FDA inspection, and the agency posted its shocking inspection report in January. Accord Healthcare, the U.S. subsidiary of Intas, said in mid-June it had no date for restarting production.

Asked why it waited two months after its inspection to announce the cisplatin shortage, given that Intas supplied more than half the U.S. market for the drug, the FDA said via email that it doesn’t list a drug in shortage until it has “confirmed that overall market demand is not being met.”

Prices for carboplatin, cisplatin, and other drugs have skyrocketed on the so-called gray market, where speculators sell medicines they snapped up in anticipation of shortages. A 600-milligram bottle of carboplatin, normally available for $30, was going for $185 in early May and $345 a week later, said Richard Scanlon, the pharmacist at Moore’s clinic.

“It’s hard to have these conversations with patients — ‘I have your dose for this cycle, but not sure about next cycle,’” said Mark Einstein, chair of the Department of Obstetrics, Gynecology and Reproductive Health at Rutgers New Jersey Medical School.

Should Government Step In?

Despite a drug shortage task force and numerous congressional hearings, progress has been slow at best. The 2020 CARES Act gave the FDA the power to require companies to have contingency plans enabling them to respond to shortages, but the agency has not yet implemented guidance to enforce the provisions.

As a result, neither Accord nor other cisplatin makers had a response plan in place when Intas’ plant was shut down, said Soumi Saha, senior vice president of government affairs for Premier, which arranges wholesale drug purchases for more than 4,400 hospitals and health systems.

Premier understood in December that the shutdown endangered the U.S. supply of cisplatin and carboplatin, but it also didn’t issue an immediate alarm, she said. “It’s a fine balance,” she said. “You don’t want to create panic-buying or hoarding.”

More lasting solutions are under discussion. Sardella and others have proposed government subsidies to get U.S. generics plants running full time. Their capacity is now half-idle. If federal agencies like the Centers for Medicare & Medicaid Services paid more for more safely and efficiently produced drugs, it would promote a more stable supply chain, he said.

“At a certain point the system needs to recognize there’s a high cost to low-cost drugs,” said Allan Coukell, senior vice president for public policy at Civica Rx, a nonprofit funded by health systems, foundations, and the federal government that provides about 80 drugs to hospitals in its network. Civica is building a $140 million factory near Petersburg, Virginia, that will produce dozens more, Coukell said.

Ratain and his University of Chicago colleague Satyajit Kosuri recently called for the creation of a strategic inventory buffer for generic medications, something like the Strategic Petroleum Reserve, set up in 1975 in response to the OPEC oil crisis.

In fact, Ratain reckons, selling a quarter-million barrels of oil would probably generate enough cash to make and store two years’ worth of carboplatin and cisplatin.

“It would almost literally be a drop in the bucket.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Every Brain Has Unique ‘Pain Fingerprint’

By Pat Anson, PNN Editor

They say no two fingerprints or snowflakes are alike. The same may also be true about pain perception.

UK researchers say brain waves -- called gamma oscillations – vary so much from person to person they could be called “pain fingerprints.” That may explain why there is such wide variability in how we feel pain and respond to it.

Scientists at the University of Essex subjected 70 people to brief touch and pain stimulation with a laser, while their gamma oscillations were monitored with an electroencephalogram (EEG), a test that measures electrical activity in the brain using small electrodes attached to the scalp.

The study findings, published in the Journal of Neurophysiology, showed that every participant’s gamma waves had distinct patterns when stimulated, with major differences in the timing, frequency and location of the gamma oscillations. Some had no gamma response when subjected to pain, while others had a large response. 

“Not only, for the first time, can we pinpoint the extreme variability in the gamma response across individuals, but we also show that the individual response pattern is stable across time,” said lead author Elia Valentini, PhD, a Senior Lecturer in the Department of Psychology and Centre for Brain Science, University of Essex. 

“This pattern of group variability and individual stability may apply to other brain responses, and characterizing it may allow us to identify individual pain fingerprints in the activity of the brain.” 

JOURNAL OF NEUROPHYSIOLOGY

Previous studies of how pain changes gamma waves focused on group data, while overlooking individual differences. As a result, some scan results were discarded as background noise, leading to false conclusions.  

The new study found that every participant’s gamma waves were highly individual and “remarkably stable.” It’s not clear why there is such variation between individuals, but Valentini hopes his study will change the way gamma oscillations are measured in future research. 

“I think we need to go back to square one because past findings on the relationship between pain and gamma oscillations do not represent all the participants,” he said. “Our results indicate that current EEG measures do not reflect the complex reality of the diverse individual response patterns to brief pain and touch experiences.”

New research could lead to a better understanding of how we perceive and manage pain. Instead of one-size-fits-all therapies, future treatments could be tailored to our individual “pain fingerprints.”

Head-to-Head Migraine Study Ends in Tie

By Pat Anson, PNN Editor

An unusual head-to-head competition between two migraine prevention drugs has ended in a virtual tie. There were no substantial differences in effectiveness between Emgality and Nurtec, according to preliminary results from a clinical trial released by Eli Lilly, the maker of Emgality.

Emgality and Nurtec both inhibit calcitonin gene-related peptides (CGRP), a protein that causes migraine pain, but their delivery systems are different. Emgality is injected once a month, while Nurtec is an oral medication taken every other day made by Biohaven Pharamceuticals, a subsidiary of Pfizer.

Eli Lilly launched the trial in late 2021, enrolling 575 participants in a Phase 4, double-blind, placebo-controlled study evaluating the efficacy and safety of Emgality (galcanezumab) and Nurtec (rimegepant) for 3 months in adults with episodic migraine.

The so-called CHALLENGE-MIG trial was a bold and somewhat risky move by Lilly, as it seeks to gain more market share in the highly competitive $2 billion U.S. migraine market.

In a statement, Lilly said Emgality did not meet the study's primary goal, which was statistical superiority to Nurtec in achieving at least a 50% reduction in monthly migraine headache days. The response rates of patients and safety profiles of both drugs were similar.

Lilly said Emgality was superior to Nurtec in some secondary outcomes, but didn’t disclose what they were. The company would only say that Emgality helped prevent migraines, as it has in previous studies.  

"These results bolster our knowledge of Emgality's ability to work quickly and help patients improve their quality of life with less frequent dosing," Anne White, executive vice president of Eli Lilly, said in a press release. "Reducing the frequency of migraine headache days can help people experience more freedom from the burden of this debilitating neurological disease and get back to participating in the daily activities that matter most to them."

Final result from the CHALLENGE-MIG trial won’t be posted until later this year.

“Nurtec ODT is the first and only medication approved as both an acute treatment for migraine and a preventive treatment for episodic migraine in adults. It offers flexibility to patients in treating their migraines and is the leading prescribed oral CGRP receptor antagonist,” Pfizer said in a statement. “We are confident in the efficacy and tolerability profile of Nurtec ODT as demonstrated in the clinical trials and the well-established patient preference for oral agents over injectables.

First approved by the FDA in 2018, CGRP inhibitors are the biggest innovation in migraine treatment in decades. They are also expensive, whether taken by pill or injection.

The listed cash price for Emgality is $679 for a single injection or $8,148 annually; while 8 tablets of Nurtec cost $1,011 or about $23,000 a year. Costs to patients will vary, depending on insurance coverage, copay assistance programs and rebates.

Patients Who Received Opioids During Surgery Had Better Outcomes

By Pat Anson, PNN Editor

As pressure grows on the Biden Administration to implement the NOPAIN Act and require Medicare to pay higher costs for non-opioid pain relievers during surgery, a new study shows that restricting the use of opioids during surgical procedures may do more harm than good.

Researchers at Massachusetts General Hospital (MGH) analyzed the health records of over 61,000 patients who had surgery under general anesthesia at MGH, and found that those who received opioids were less likely to experience post-operative pain and needed fewer opioids during recovery.

The study findings, published in in JAMA Surgery, showed that surgery patients who were given the opioids fentanyl and hydromorphone had less pain, lower rates of persistent opioid use, and fewer opioid prescription refills. They were also less likely to have chronic pain 12 months after surgery.

Researchers were particularly surprised to find that patients who received higher doses of fentanyl had fewer chronic pain diagnoses and needed fewer opioid prescriptions 30, 90 and 180 days after surgery.

“We were surprised by the extent to which intraoperative administration of opioids was associated with medium- and long-term outcomes. This may relate to the fact that if inadequate amounts of opioids are administered in the operating room, patients may emerge from general anesthesia in pain, a phenomenon that has a known association with persistent postsurgical pain,” wrote lead author Patrick Purdon, PhD, Department of Anesthesia, Critical Care, and Pain Medicine at MGH.

“The main implication of this study is that in the drive toward overall reduction of opioid usage in surgical pain management in the US, the role of intraoperative nociception in determining postoperative pain may have been overlooked to the detriment of patient outcomes.”

Researchers say their findings underscore the importance of ensuring that patients don’t emerge from general anesthesia in pain, not only for their short-term wellbeing, but to prevent long-term opioid use.

“The opioid crisis is a major motivator for mitigating the risks of opioid usage,” said co–first author Laura Santa Cruz Mercado, MD, an anesthesiology resident at Beth Israel Deaconess Medical Center and former research fellow at MGH. “But appropriate opioid administration in the operating room may reduce total opioid usage after surgery.”

Lobbying for Early Implementation of NOPAIN

Although previous studies have found that the risk of opioid misuse or overdose after surgery is rare, pressure on U.S. hospitals to reduce their use of opioids has resulted in a 50% decrease in opioid prescribing after surgery.  

Supporters of the NOPAIN Act would like it to decrease further and faster. Passed by Congress late last year, the Act requires the Centers for Medicare and Medicaid Services (CMS) to expand reimbursement policies for non-opioid treatments in outpatient surgical settings, starting in 2025. Supporters of the bill have launched a campaign to have the timetable moved up to 2024.

“Healthcare leaders must help CMS understand the inevitable damage that will result if the agency does not implement the policy in 2024. Millions of Americans will be put needlessly at risk of opioid addiction for another year,” Nirav Amin, MD, an orthopedic surgeon at Pomona Valley Hospital in Pomona, CA, wrote in a recent op/ed in Healthcare Dive. “The policy will incentivize greater use of non-opioids by creating separate reimbursements for the administration of these therapies.”

Unmentioned in Amin’s column is that he’s been paid over $360,000 in recent years as a consultant for Pacira BioSciences, a company that stands to directly benefit from the NOPAIN Act. Pacira makes Exparel, an expensive injectable formulation of bupivacaine, a non-opioid analgesic used to treat post-operative pain.

Bupivacaine is a generic drug that only costs about $35 a vial, while Exparel is priced 10 times higher, at $365 a vial. According to two recent studies that Pacira claimed were “false and misleading,” Exparel works no better than the much cheaper bupivacaine products.

Pacira has made over $32 million in various payments to Amin and other doctors to help promote Exparel, according to Open Payments, a CMS database that tracks industry payments to healthcare providers. Pacira is also bankrolling Voices for Non-Opioid Choices, an advocacy group that is leading the campaign for early implementation of the NOPAIN Act.

Pacira is also very active politically, spending over $2.6 million on lobbying and campaign donations since 2018, according to OpenSecrets. In 2019, Pacira hired former New Jersey governor and current presidential candidate Chris Christie as a consultant for $800,000 and lucrative stock options. At the time, Christie had recently chaired President Trump’s opioid commission, which recommended that Medicare and Medicaid reimbursement policies be changed to encourage hospitals to use more non-opioid pain relievers.

Painfully Stepping Over the Line

By Cynthia Toussaint, PNN Columnist

For decades, people have described me as indefatigable, super-human strong and the ultimate survivor. Or the one filled with surprises and miracles. Well-intended compliments that have moved me and, during dark times, spurred me on. But now these tributes vex me because I don’t know if I can live up to them.

Maybe I’m just tired of fighting the impossible.

My latest cascade of battles began in 2019, after getting a breast cancer diagnosis and not knowing whether I’d choose treatment due to Complex Regional Pain Syndrome (CRPS). While pushing back on my oncologist’s recommendations, she pulled out all stops in an effort to convince me to fight for my life. She asked, “Can you imagine yourself not doing treatment and regretting it?”

I furrowed my brow and replied, “I’m more concerned that I’ll do treatment and regret living with the damage afterward.”

I was terrified that cancer care, in all its cutting, burning and poisoning glory, would ignite a red-hot mess of CRPS, sending me back to my bedridden days and zeroing out any quality of life I’d clawed back over the decades.

I drew the line. To move forward with treatment, I had to have a life worth living at the other end.

I chose to only do chemo and miraculously lucked out, cancer and pain-wise. When my cancer returned a year and a half later, it appeared I’d skated by again, until I didn’t. While the immunotherapy knocked the tumor out in short order, little did I know that with each infusion my immune system was amping up to push me over the line, but in a way far worse than I could have imagined.

By mid-March, my lap swimming, my go-to for health and freedom, became a painful hell. I couldn’t push off during flip-turns, one leg barely kicked and my neck screamed in agony each time I turned for a breath. I had no choice but to quit.

Soon walking was near impossible: slow, labored and almost shuffling. My knees swelled to the point they wouldn’t allow me to get up from a chair or couch. Frantically, my partner, John, got a raised seat so I could use the toilet. I started losing weight because the pain in my jaw made eating torturous.

Screaming often through the days and nights, I felt hatchets and icepicks throughout my body, grinding glass replaced my joints. When I could sleep, I woke often with fever and chills.                   

After scads of labs, internet research and clinical assessments, I’ve learned that I’m the proud owner of a brand, spankin’ new disease: Reactive Inflammatory Arthritis. I’m now living the experience I feared most, the place where I told myself I couldn’t, wouldn’t go. I’ve stepped over the line, terrified it’s a one way ticket.      

To dampen the inflammation and stabbing pain, hell, just to get me moving, my doctors put me on low-dose naltrexone and prednisone (the latter I swore up and down I’d never revisit.) For that blessed comfort, the cost is mighty. I’m zonked out and joyless while insomnia, constant dizziness and the constipation-diarrhea seesaw zap my quality of life.

With the drug relief, I’m mercifully dipping into a warm therapy pool where I can move, walk and swim some, offering vague hope of recovery. But I see the troubled look in the eyes of my Y friends, the wish that their feisty, frothy friend would reemerge. I can’t help but wonder if they’re playing witness to my slow down and out.         

In my darkest hours, when the arthritic pain makes me question whether I can survive another five minutes, I rock with anger that my tumor’s gone. That was my ticket out. The jokes on me as I live the cancer-free dream. Cue the laugh track. I’m not living and free is nowhere to be found.

When my better angels reappear, I remember why I fought twice, tooth and nail, to see another day. I want to live, to love, and to see the beauty all around me. I want to continue to be a force for good.

Ahh, but that pesky line. I’ve got to get back over it. Or do I? When I got sick 40 years ago, I swore I wouldn’t live on if I couldn’t continue my showbiz career. I was utterly convinced life wouldn’t be worth a damn without it. Yet, here I am, staring down that line again. Maybe, MAYBE there’s some wiggle room one more time.     

I imagine all of us who’ve lived with high-impact pain over the long haul have drawn that line. Then later, took out an eraser and drew it again, renegotiating the terms. At another time, when we drop below, we grasp and beg as we slowly, savagely eek back over. Or not. It’s ever changing, tied to the whims of fate and will.

Maybe the line just gives us an illusion of control. Maybe it’s a frenemy, something that keeps us company whether we’re above or below.

This I know. I’m scared and tired while I stare down my new mountain. I’ve lost cherished independence, that may or may not return, requiring John to be on call at all times. We’re two generations removed since the last time I had to fudge the line, and what if my cancer returns? How many more comebacks can I stage?

Last night, I spewed anger with a close girlfriend, bristling that my impossibles never quell, despite being a good person. At that moment, something awoke in me. I was surprised to feel that old spark in my belly – which has me thinking that anger is serving me well right now.

It was so powerful when Heather commented, “I wouldn’t bet against you.”

I’ve learned that the best way to predict the future is by looking at the past. By that yardstick, I’ve always toed the line, come hell or high water. But like every other climb, I’ll decide what’s good enough, in my time, in my space.

Maybe I can live with that. 

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has lived with Complex Regional Pain Syndrome and 19 comorbidities for four decades, and has been battling cancer since 2020. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.”

I’m Already Well Aware

By Mia Maysack, PNN Columnist

If I did not cling to my optimism for dear life, I'd scoff at the concept of an awareness month such as June being nationally recognized as Migraine & Headache Awareness Month.

That’s due to the fact I am someone who has lived with a daily reminder of intractable pain for over two decades. It isn’t those of us who can directly relate to the pain experience that are in need of awareness.

I feel many “awareness” efforts are limited or fall short in terms of gaining recognition for a specific cause or reason. People typically don’t concern themselves with issues that don’t directly affect or impact them.

Someone who hasn’t ever had a migraine couldn’t possibly understand how it differs from a regular stress headache. Furthermore, somebody who does experience an occasional migraine still cannot fathom what it would be like to have one on a more constant basis.

What transpires within and throughout our individual lenses of the world is real to us and valid, though different from others. That doesn’t lessen the next person’s experience as being anything less than our own.    

There have been some who have thought of my claims about illness are disingenuous. But the reality is that I actually learned to “fake” wellness, in an effort to create a sense of fulfillment and meaning in my life, despite the hand I’ve been dealt.

Others claim those of us who live with pain should be able to “fix” ourselves, once we acknowledge things like a childhood trauma; or that if we adopt “sufficient water intake” and “sleep hygiene” for example, all will be well.

Although I believe there’s some merit to those suggestions, and that they come from a decent, well-meaning place --- if it were that simple, I would be healed by now, along with millions of others who endure similar circumstances.

For a lot of us, we’ve had to come to terms with the fact that there may not be anything out there to give us back the life we once had or wanted. That’s because we’ve already attempted and tried just about everything in search of pain management or relief.

Often, we’re unable to obtain access to options that might ease our suffering because that process can be a grueling one and often has a ripple effect of further complications, along with a multitude of hoop jumping. That’s why I’ve mostly refrained from making it a habit to ask for professional help. Instead, I have worked on acceptance, as there are not many things that anyone else can do for me.   

Relentless and untreatable ailments in any form are going to take a toll, but I hold steady to the concept of “pain” being a worldwide experience that each and every one of us can relate to in some way or another. Each of us have had moments when we’d do just about anything to have the discomfort end.

But instead of embracing the potential for common ground, we as a society tend to label people, when the cure is to be found in seeing and treating one another as fellow human beings. We never truly know where a person may be in regards to their mental health or quality of life, and need not make this already challenging existence any more difficult for ourselves or each other.

Given the extent I’ve witnessed how our healthcare system fails us, I had to choose to not identify with the victim mentality or wait any longer for answers elsewhere.  Ultimately, I stumbled upon empowerment in owning my situation, by tending to myself in ways that I am able. That was my education in self-awareness.

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. She is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill. 

What If Pain Had a Color?

By Carol Levy, PNN Columnist

What if your pain had a color? Not a color picked to honor an awareness day or month, but an actual color?

I could walk into the doctor's office. “I understand you have pain. Where is it located?” he’d ask. I’d point to the area. It was a bright chartreuse, as blinding as a neon sign.

“Oh yes. You definitely have pain. Let's see what we can do about that,” the doctor would say.

Wouldn’t that be simpler, easier? Unfortunately, it isn’t.

After the trigeminal neuralgia pain started near my eye, I was referred to a neuro-ophthalmologist. Our first meeting did not go well. The level of pain, the resulting disability, and its effect on me made it hard to tell my story in a calm and thoughtful way.

Stopping to collect my emotions, gather my thoughts and make sense of what made no sense, I started and stopped, my words coming in fits and starts. I struggled to control my emotions and not cry.

After a few minutes he stopped me. “Stop being so schizophrenic in how you're telling me your story,” he said. “Your pain is the result of anxiety.”

I didn't understand what he meant. No pain like mine could just be the result of nerves. He wrote a prescription for an anti-anxiety drug, but that only increased my stress, and the anger I felt towards the pain and medical profession.

Undaunted and with hope unfettered, I kept the next appointment. Again, he listened. He still seemed unimpressed with my pain and my story. But his interest was piqued by a birthmark on my forehead directly over the area of the pain. He noticed it would turn a brighter shade of red during various times of the appointment.

I was prissy back then. I hated cursing and embarrassed easily. He was not averse to using profanity, and just one or two words was too much for me. When he cursed, the birthmark would turn bright red. That changing of color and in the way my pain was triggered changed his feeling about my pain. He seemed more interested in it.

“I think it's time we bring you into the hospital,” he told me.

In those days, a doctor at a teaching hospital would be trailed by medical students, interns and residents. Like goslings imprinting on their mother, they followed the doctor everywhere.

When the group came to my room, the doctor wanted them to see how and when the birthmark changed color. He explained to them it was an outward sign of a neurovascular birth defect that he believed was the cause of my pain.

It was a teachable moment and the doctor liked milking it. He knew how easily I was embarrassed and how that would change the coloring of the birthmark. To get it to turn bright red, he jokingly threatened to expose himself (this was in the 1970’s). Immediately it changed color. I was so embarrassed.

It got to the point where all he had to say was, “I'm going to…” And like Pavlov’s dog, the birthmark turned bright red. He did that trick for his lot of ducklings, who were amazed.

My pain still did not have a color, but the changing color of the birthmark showed a visible, anatomic reason for it. It made my pain more real to others. If not for the birthmark and the trick of turning it off and on, the correct treatments might not have been tried.

Cancer patients have lumps or growths. Jaundice turns you yellow. Us? We have nothing but our word. Until pain has a color, our word has to be enough.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

Mood Disorders May Be Early Sign of Chronic Fatigue

By Pat Anson, PNN Editor

Anxiety, depression and other mood disorders have long been associated with fibromyalgia, irritable bowel syndrome (IBS), and chronic fatigue syndrome (CFS). That’s not altogether surprising, since the three chronic illnesses cause body pain, insomnia, fatigue, and other stressful symptoms that can trigger a psychological reaction. No one likes being sick, after all.  

But a large new study found that psychiatric disorders preceded the development of fibromyalgia, IBS and CFS in about a quarter of the people who have the conditions – more than those who suffer from similar chronic illnesses. Anxiety and depression were significantly more common in people who were later diagnosed with chronic fatigue.

"This work provides evidence that for many people, a wide variety of physical and psychological factors are associated with these debilitating conditions," says Francis Creed, a professor emeritus of psychiatry at The University of Manchester.

Creed analyzed over two years of health data from over 120,000 people who participated in the Dutch Lifelines cohort study; comparing the data of people with fibromyalgia, IBS and CFS to those with diabetes, inflammatory bowel disease (IBD) and rheumatoid arthritis. The latter group had similar symptoms and served as a control.

Creed’s findings, recently published in the journals PLOS ONE and Frontiers in Psychiatry, showed that psychiatric disorders were more common (17–27%) in the first group than in the control group (10.4–11.7%).

General anxiety disorder (GAD), panic disorder, dysthymia, major depressive disorder (MDD) and agoraphobia were particularly more common in people who were later diagnosed with CFS.  

PLOS ONE

Creed says a number of physical and mental health issues may be at work in the development of fibromyalgia, IBS and CFS. He favors a holistic approach to treating them, including a mental health evaluation.   

"When people suffering from CFS/ME, IBS and fibromyalgia come into contact with health professionals, negative attitudes can sometimes get in the way of treatment. but by understanding these complex conditions better, the stigma and mystery around them can be eased," he said.

"Although there are symptomatic treatments which may help these unexplained disorders, we should aim to understand fully their underlying causes. There are probably several different ways they may develop; a whole range of physical and mental factors are probably involved. Treatment approaches will become more effective as our understanding of the causes improves."

Association is not causation, and it’s important to note that about three-quarters of the people who developed fibromyalgia, IBS and CFS did not have any mood disorders prior to the onset of their illnesses.   

Creed says future research and clinical work should focus on possible interactions between psychiatric disorders and other behavioral variables to identify the true role of anxiety and depression in chronic illness.

Chemotherapy and Opioid Shortages Impacting Cancer Care

By Pat Anson, PNN Editor

Over two-thirds of cancer centers in the U.S. are reporting shortages of methotrexate and other drugs used in chemotherapy, according to a survey by the National Comprehensive Cancer Network (NCNN).

Methotrexate is a versatile drug that prevents cells from dividing. It was originally developed to treat cancer, but is also widely used to treat autoimmune and neurological conditions such as lupus, rheumatoid arthritis, migraine and multiple sclerosis.

The NCNN surveyed 27 cancer centers across the U.S. in late May, and found that 67% of them were reporting shortages of methotrexate. Most centers are also reporting chronic shortages of carboplatin and cisplatin, chemotherapy agents that are widely used in cancer treatment. The shortages have resulted in treatment delays or forced doctors to modify their treatment plans using other drugs.

"This is an unacceptable situation. We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now," Robert Carlson, MD, CEO of NCCN, said in a statement. "We were relieved by survey results that show patients are still able to get life-saving care, but it comes at a burden to our overtaxed medical facilities." 

Drugs shortages in the U.S. are currently near record levels, primarily due to shipping delays and other disruptions caused by the pandemic. But the shortage in chemotherapy agents largely stems from a halt in production at a plant in India operated by Intas Pharmaceuticals. FDA inspectors found quality-control violations at the plant late last year and the agency recently slapped an import alert on the company. The agency is working with drug makers in China to make up the difference.

The FDA added methotrexate injectable solution to its drug shortage list in March. Supplies are currently limited and the shortage is not expected to end until December 2023. No shortages are currently reported for methotrexate tablets.

Hydrocodone Shortage

In addition to chemotherapy drugs, some drug makers are also reporting shortages of opioid pain medication. The American Society of Health-System Pharmacists (ASHP) recently added hydrocodone-acetaminophen combinations – commonly known under the brand names Vicodin and Norco-- to its own drug shortage database.

Generic drug makers Amneal, Camber, KVK-Tech, Major and Rhodes currently report shortages of 5 mg, 7.5 mg, and 10 mg hydrocodone tablets. None of the companies provided a reason for the shortage or an estimate for when it might end. Many of the same drug makers reported shortages of oxycodone in March.

The limited supply of opioids is also affecting cancer patients. The University of Utah Health system recently informed its drug wholesaler that it was adding 50 new beds to its cancer clinic and would be needing more pain medication to treat the extra patients.

“And the wholesaler said, ‘Well, let's just wait until we start receiving your orders to increase the amounts that you're going to buy,’” said Erin Fox, PharmD, Senior Pharmacy Director at University of Utah Health, which tracks drug shortages for the ASHP. “We're unable to be proactive. We're trying to think ahead. And we don't want to have that situation where we we're getting very close to running out or not having enough. That's basically what our wholesaler says has to happen.”

“We wish that we could fix all these things, but we don't make the medicines and we can't tell someone that they must make medicines. There are some things that are out of our control,” FDA Commissioner Robert Califf, MD, said in a recent interview with Medscape.

The Drug Enforcement Administration, in consultation with the FDA, sets the annual production quotas for opioids and other controlled substances. The DEA reduced this year’s supply of oxycodone and hydrocodone by about 5 percent, after being advised by FDA that demand for Schedule II opioids would decline. Since peaking a decade ago, DEA production quotas have fallen by 65% for oxycodone and 73% for hydrocodone.

Massage Therapists Ease Pain of Hospice Patients — But Are Hard to Find

By Kate Ruder, KFF Health News

Ilyse Streim views massage for people in hospice care as “whispering to the body through touch.”

“It’s much lighter work. It’s nurturing. It’s slow,” said Streim, a licensed massage therapist.

Massage therapy for someone near the end of life looks and feels different from a spa treatment. Some people stay clothed or lie in bed. Others sit up in their wheelchairs. Streim avoids touching bedsores and fresh surgery wounds and describes her work as “meditating and moving at the same time.”

She recalled massaging the shoulders, hands, and feet of one client as he sat in his favorite recliner and watched baseball on TV in the final weeks of his life.

“When you’re dying and somebody touches you without expectation of anything in return, you just get to be,” said Streim.

Massage therapists like Streim, who specializes in working with people who are dying or have an advanced form of cancer or other illness, are rare. Fewer than 1% of therapists specialize in hospice or palliative care massage, according to research by the American Massage Therapy Association, although many more may periodically offer massage for hospice patients.

Streim has a private practice in Lafayette, Colorado and her clients pay her out-of-pocket, as Medicare and private insurance typically don’t cover massage therapy. She also volunteers as a hospice massage therapist four hours a month.

It’s common for hospice organizations to use volunteer therapists for treatments, though some massage therapists, with physicians backing them, are pushing for paid positions as part of medical teams working alongside nurses and social workers.

In the hospice unit at Palo Alto VA Medical Center, in Palo Alto, California, for example, massage therapists have been integral members of the multidisciplinary team for decades, said VJ Periyakoil, a professor of medicine at Stanford University and the founding director of its palliative care education and training program.

The covid-19 pandemic made the recruitment of specialists for this intimate work, both paid and volunteer, more difficult, as the pool of massage therapists shrank amid school closures and exits from the profession. There are up to 10% fewer massage therapists today than before the pandemic, according to Les Sweeney, president of Associated Bodywork & Massage Professionals.

“It’s still hard for us to hire and recruit therapists,” said Kerry Jordan, operations director at Healwell, a nonprofit that trains and employs massage therapists to work in hospitals in the Washington, D.C., area.

‘We Need to Get More Therapists’

For three weeks in April 2020, licensed massage therapist Cindy Spence, who works at Faith Presbyterian Hospice in Dallas, could not massage patients due to the state’s lockdown orders. Then, the state granted an allowance for massage therapists like her, working in medical settings under supervision, to resume giving massages. But it took several months for many therapists to return to work, and some didn’t return at all, Spence said.

“The pandemic was not kind to massage therapists,” Spence said. “And so we have lost a lot of people like me who are of an age and experience level that would really be called to and suitable” for oncology, hospice, and palliative massage.

“We need to get more therapists trained,” she said. She described receiving several calls each month from people who have found her name online. It has become harder since covid to find a therapist to refer them to, Spence said.

At TRU Community Care, which operates in several locations in Colorado, Volunteer Services Supervisor Wendy Webster said massages are a top request from patients and their families, but they’re limited in how many sessions they can offer, with only two volunteer massage therapists. (A third volunteer did not return after the pandemic.)

Finding new massage therapist volunteers is challenging, said Webster, in part because they can earn money in other settings and “they’re coming to us for free.” Thirty years ago, TRU Community Care’s nonprofit status was the norm, but now the majority of hospices are for-profit, with growing investment from private equity.

Despite that shift, hospices still rely heavily on volunteers. Medicare pays for at least six months of hospice for a patient on the condition that providers use volunteers for at least 5% of the patient-care hours worked by paid staff and contractors. Sometimes, those volunteer hours are filled by massage therapists.

“All hospices, not-for-profit or for profit alike, should aim to include medically-trained massage therapists as part of best holistic care,” Hunter Groninger, a professor of medicine at Georgetown University who directs palliative care at MedStar Washington Hospital Center in Washington, D.C., wrote in an email. Employing these specialists is beneficial and does not diminish the important service of volunteers, particularly in end-of-life care, he added.

Benefits of Massage

More studies on the impact of specialized massage could enact changes in the field, said Cal Cates, founder and executive director of Healwell, which, since 2009, has trained 500 therapists in hospital-based and oncology massage, as well as in how to work collaboratively with doctors and nurses.

In a recent clinical trial of 387 patients in palliative care at MedStar, including some nearing the end of their lives, Groninger, Cates, Jordan, and other co-authors found that massage therapy improved quality of life.

Despite new research on the benefits of massage, Cates said, many hospices bring on volunteers who don’t have advanced training, because hospices may not know that specialized training — such as the kind Healwell offers — exists.

Streim, who paid for her own classes in oncology and lymphatic massage, said that investment in education qualified her for a six-year career as an oncology massage therapist at Good Samaritan Medical Center’s Center for Integrative Medicine in Lafayette and later her private practice. She teaches classes in adapting massage for the elderly and those with illnesses at Boulder Massage Therapy Institute. In her 39 years as a therapist, Streim has done it all: volunteer, staff, entrepreneur, teacher.

Like Streim, Spence has continually redefined her role. She began in private practice before becoming an employee of a large hospice agency in which she traveled across nine counties in Texas, giving thousands of massages to people dying in their homes, assisted living communities, and skilled nursing homes. Today, at Faith Presbyterian Hospice, she is one of three licensed massage therapists on staff and fully integrated as an employee of the organization, which has more than 100 patients.

“Those of us who do this work have made big investments in our profession and I’m glad to see that we can be paid for it,” she said.

Spence collects data on how patients rate their pain on a scale of 1 to 10 before and after a massage. Most fall asleep during the massage, which she takes as an indication their pain has lessened or they became more relaxed. Of those who stay awake, almost all say their pain subsided significantly or went away completely.

That kind of positive engagement with providers is more urgent than ever since the pandemic, Groninger said. Spence agreed: “The pandemic taught us all, in a very painful way, what it’s like to be deprived of human touch and human connections.”

Sometimes the nursing staff at Faith Presbyterian will roll a bed out onto the patio so a patient can hear the sounds of nature and the fountain gurgling during Spence’s massage. There is more teasing and laughter than she would have imagined. For patients unable to speak, Spence watches their reactions carefully: a deep exhalation or the face and body softening. Sometimes it’s tears running down their cheeks.

“It’s profound, helping someone find safe breaths along this very difficult dying journey,” she said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues.