Sickle Cell Patients Make Difficult Choices About Fertility

By Farah Yousry, Kaiser Health News  

Teonna Woolford has always wanted six kids. Why six?

“I don’t know where that number came from. I just felt like four wasn’t enough,” said Woolford, a Baltimore resident. “Six is a good number.”

Woolford, 31, was born with sickle cell disease. The genetic disorder causes blood cells to become misshapen, which makes it harder for blood to carry oxygen and flow throughout the body. This can lead to strokes, organ damage, and frequent bouts of excruciating pain.

Sickle cell disease affects an estimated 100,000 people in the U.S., and the vast majority of them are Black. Federal and charitable dollars dedicated to fighting sickle cell disease pale in comparison to what is spent to combat other, less common diseases that mostly affect white patients.

Physicians and researchers said the disease is a stark example of the health inequities that pervade the U.S. health system. A poignant expression of this, patient advocates said, is the silence around the impact that sickle cell disease has on fertility and the lack of reproductive and sexual health care for the young people living with the complex disease.

Woolford’s sickle cell complications have run the gamut. By the time she was 15, her hip joints had become so damaged that she had to have both hips replaced. She depended on frequent blood transfusions to reduce pain episodes and vascular damage, and her liver was failing.

“So many complications, infections, hospitalizations, and so by the time I graduated high school, I just felt defeated [and] depressed,” said Woolford, speaking from a hospital bed in Baltimore.

She had experienced a sickle cell pain crisis a few days earlier and was receiving pain medication and intravenous fluids.

In her late teens, Woolford sought out a bone marrow transplant, a treatment that enables the sickle-shaped cells in the patient’s body to be replaced with healthy cells from a stem cell donor. The procedure comes with risks, and not everyone is eligible. It also relies on finding a compatible donor. But if it works, it can free a person from sickle cell disease forever.

Teonna Woolford

‘You’re Probably Already Infertile’

Woolford couldn’t find a perfect match, so she enrolled in a clinical trial in which doctors could use a “half-matched” donor. As part of the bone marrow transplant, patients first receive chemotherapy, which can impair or eliminate fertility. Woolford hesitated. After all, her ideal family included six children.

When she told her doctor about her worry, his response crushed her: “This doctor, he looked at me, and he was like, ‘Well, I’ll be honest, with all the complications you’ve already had from sickle cell, I don’t know why you’re even worried about this process making you infertile because you’re probably already infertile.’”

Even if patients don’t have the transplant, sickle cell disease can damage their bodies in ways that can affect their ability to have children, according to Dr. Leena Nahata, a pediatric endocrinologist at Nationwide Children’s Hospital in Ohio.

For women, chronic inflammation and the sickling of blood cells in the ovaries can make getting pregnant harder. For men, sickled blood can jam inside the blood vessels of the penis, causing painful, unwanted erections that last for hours. This condition, called priapism, can damage sexual function and decrease sperm count. And it’s not just the disease. Researchers are evaluating how some widely used treatments may affect fertility — for example, by decreasing sperm count.

“It remains unclear how that translates directly to fertility outcomes but at least raises the concern that this may be an issue,” Nahata said. Even more concerning to Nahata were the results of a small study, which she co-authored, that showed some patients were unaware of the many fertility risks related to sickle cell disease.

Woolford said she was 19 and shocked when her doctor told her she was probably already infertile. But no one could be sure, so she held out hope that she might still undergo a procedure to preserve her fertility before having the chemotherapy required for the bone marrow transplant.

From extensive research, she learned that egg freezing could cost more than $10,000 and that her insurance wouldn’t cover it. She couldn’t afford to do it on her own. Woolford wondered whether she could find another way to pay for egg freezing. “So I started looking into financial resources,” she said. “And I saw all these foundations [that] give away grants. But you had to have a diagnosis of cancer.”

In the end, Woolford had the transplant without freezing her eggs. She said she felt that being cured would “be a fair trade-off to give up my dream of biological children.”

Unfortunately, the partial-match transplant did not work. Woolford’s body rejected it.

“So, here I am,” she said. “I am 30, still have sickle cell disease, and I’m infertile.”

Fertility Preservation and Reproductive Justice

A grim thought sometimes pops into Woolford’s mind: If she had cancer instead of sickle cell disease, her dreams of having biological children might still come true.

The first description of sickle cell disease in medical literature was published over a century ago. Because most sickle cell patients in the U.S. were Black, it quickly became labeled as a “Black disease.” And with that came a legacy of systemic racism that still affects patients today.

Black patients tend to have less social capital and fewer resources, said Dr. Lydia Pecker, a sickle cell disease researcher and an assistant professor of medicine at Johns Hopkins University. For fertility treatment, the resources available to cancer patients differ starkly from those available to sickle cell patients.

“There are any number of foundations, large and small, that help support and pay for fertility preservation for people with cancer,” Pecker said. “Those foundations actually work with fertility preservation centers to negotiate lower rates for affected people.”

Clear clinical guidelines state that children who have cancer and are going through chemotherapy should be referred for fertility preservation. Children with sickle cell disease going through transplants are exposed to chemotherapy, too, “but we don’t really have guidelines like that yet for people with sickle cell disease,” Pecker said.

It’s not a perfect comparison, she added, because the kinds of chemotherapy drugs used in pediatric cancer are different from the chemotherapies used in sickle cell treatment. But fertility preservation can be crucial when there is any risk of treatment-associated fertility impairment, Pecker said. Without clear and widely adopted clinical guidelines, sickle cell patients may not be referred to appropriate care.

Pecker said current medical practice forces sickle cell patients to make a difficult choice. “You can have treatment or you can have fertility,” she said. But in cancer care, she said, the thought is: You can have treatment and you can have fertility.

In the U.S., health insurance coverage for fertility preservation and treatment is not guaranteed and varies from state to state. Only 12 states have laws that mandate fertility preservation coverage for patients who undergo treatments that could imperil their ability to have biological children — usually referred to as iatrogenic treatments — like chemotherapy or radiation.

After Woolford’s transplant failed, the disease continued its assault on her body. And Woolford has had to come to terms with the impossibility of ever having a biological child. She launched a nonprofit, the Sickle Cell Reproductive Health Education Directive, to raise awareness of fertility issues at medical conferences and among patients. A future goal is to provide financial grants to sickle cell patients struggling to pay for fertility preservation and treatments.

Most days, Woolford finds the work empowering. On other days, she admitted, it reminds her of the bleak reality that she will probably never conceive a child.

“It’s really hard because I don’t think a lot of people realize that I’m fighting for something that I didn’t have access to,” she said.

At this point, she said, it’s no longer a medical justice fight. It’s a reproductive justice one.

Reporting for this story was supported by the USC Annenberg Center for Health Journalism’s Impact Fund for Reporting on Health Equity and Health Systems. It was produced in partnership with Side Effects Public Media, WFYI, and Kaiser Health News.

Persistent Pain Worsens Physical Function and Mental Health in Seniors

By Pat Anson, PNN Editor

Having persistent pain in your senior years is very common and contributes to declines in physical function and mental health, according to large new study that calls for more proactive treatment of pain in older adults.

“The findings from this study point to the importance of access to effective treatment for persistent pain in older adults and the need for additional research in chronic pain to optimize quality of life,” said lead author Christine Ritchie, MD, Director of the Mongan Institute Center for Aging and Serious Illness at Massachusetts General Hospital.

Ritchie and her colleagues analyzed health data for nearly 5,600 Medicare beneficiaries aged 65 and older who participated in the National Health Aging Trends Study from 2011 to 2019. Nearly 39% of participants reported having “persistent pain” and almost 28% had “intermittent pain.”  Only about a third of older adults (33.5%) reported having no “bothersome pain.”

Researchers found that seniors with persistent pain were more likely to report depression and anxiety, and to have three or more comorbid conditions such as a heart attack, stroke or cancer than those with intermittent or no pain. They were also more likely to have lower scores for mood and self-care activities such as eating, hygiene and dressing.

Perhaps the only good news is that differences were not found in cognitive impairment or dementia between those with and without persistent pain.

“This study is the first to include a representative sample of older Americans that demonstrates meaningful declines in physical function and well-being among those with persistent pain,” researchers reported in the Journal of the American Geriatrics Society.

“Given the high prevalence of persistent pain and its negative effects on both function and well-being, domains of the lived experience highly valued by older adults, it is incumbent on clinicians to prioritize strategies to effectively address their persistent pain.”

The researchers said many older adults lack access to effective nonpharmacological therapies and receive little guidance from primary care physicians about pain treatments.

Participants with persistent pain were more likely to be female, low-income, have limited education, and to be living alone – findings that mirror those of a 2020 study that found less-educated, working class Americans had higher rates of pain, social isolation, drug abuse, disability and suicide.  

A recent study in the UK found that having chronic pain in middle age significantly raises the chances of having pain and poor overall health in your senior years.

Hypermobility Linked to Depression and Anxiety at Young Age

By Madora Pennington, PNN Columnist

The teenage years are difficult for almost everyone, but even more so for teens with hypermobile joints, a condition known as hypermobility. Their joints have an excess range of motion, and some can literally bend their arms, legs and fingers backward.

Jess — who asked that we not use her last name — had always noticed she was extremely flexible. By the time she was a teenager, Jess had crushing fatigue and anxiety. She obsessed over her grades like a perfectionist and developed an eating disorder. Her terrible anxiety caused her to self-medicate, as she did all she could to keep up with her peers.

Eventually, it all became too much. Jess had to leave high school and finish her degree through proficiency testing. Not until age 19 was she finally diagnosed with Ehlers-Danlos Syndrome (EDS), a disease that weakens connective tissue in the joints and causes hypermobility.

Hypermobility in early life is normal. All babies and children are highly flexible, which most eventually outgrow. But for some children, hypermobility is permanent. Excessively loose joints are a feature common to many inherited disorders like EDS, wherein the body cannot make connective tissue that is stable and strong. In essence, the "glue" holding their bodies together is flawed and weak.

Extremely flexible people like Jess may be seen by their peers as having interesting or cool skills, like doing contortionist tricks or excelling in yoga. But hypermobility is a severe health problem that can lead to mental health issues.

"Hypermobility affects one in four people in the UK. Like other musculoskeletal conditions, it can have a profound and far-reaching impact on life, causing daily pain, fatigue and often disrupted sleep," says Dr. Neha Issar-Brown, Director of Research and Health Intelligence at the UK-based charity Versus Arthritis. "Previous studies in adults have shown that you are more likely to suffer from anxiety if you have hypermobility, and that the daily toll of painful symptoms can lead to depression.”

A new study in BMJ Open found a similar link in adolescents. To see if there is an association between hypermobility, anxiety and depression in late adolescence, researchers at Brighton and Sussex Medical School evaluated over 14,000 teens with joint hypermobility.

At age 14, their hypermobility was scored, which is done by measuring the degree to which various joints hyperextend or bend past the point where they should. Then, at age 18, the participants answered surveys about depression and anxiety. Pain, a common complication of hypermobility, was also taken into account. The participants' heart rates were also studied.

"Many psychiatric problems, including depression and anxiety, start before the age of 25. It is therefore important to identify the factors that may increase the risk for these disorders. Being aware of the link between hypermobility and depression and anxiety means that we can work on developing appropriate and effective treatments," said lead author Dr. Jessica Eccles, Department of Neuroscience, Brighton and Sussex Medical School.

Eccles and her colleagues found that young people with joint hypermobility were more likely to have depression and anxiety, and their psychiatric symptoms were also more severe. Joint hypermobility was more common in females than males, but it was only among males that hypermobility increased the risk for depression.

"This study has highlighted the need for more targeted and bespoke support for hypermobile teenagers, particularly girls," says Lea Milligan, CEO of the UK-based advocacy organization MK Mental Health Research. "The findings don't just show the need for support for this group of individuals, but also demonstrate the importance of research that takes a whole mind, body brain approach to health and uses longitudinal studies to improve our understanding of which demographics are at higher risk of depression and anxiety.”

Why hypermobile people suffer from more psychopathologies may be due to a dysregulation of the nervous system called dysautonomia, which is very common among those with loose joints. Their poorly regulated nervous systems cause a rapid increase in heart rate when they rise to stand, when it should remain constant. This inability of the body to maintain a smooth and consistent heart rate when posture changes has also been associated with anxiety.

Rapid heart rates and poor cardiovascular regulation also occur when someone has anxiety and depression. The higher a person's resting heart rate, the more psychological symptoms tend to follow. Those with depression tend to have different skin temperatures, breathing rates, and a lower variability in heart rate.

Complaints from UK parents with hypermobile children motivated this study. They encountered healthcare providers that were ignorant of the complications and challenges of hypermobility and dismissed their concerns. More awareness and education are needed to help these families, and this study is a step in that direction.

Madora Pennington is the author of the blog LessFlexible.com about her life with Ehlers-Danlos Syndrome. She graduated from UC Berkeley with minors in Journalism and Disability Studies. 

Employers Use Co-Pay Assistance Programs for Costly ‘Nonessential’ Drugs

By Julie Appleby, Kaiser Health News

Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”

The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.

“It really gave us no choice,” said Sutton, of Woodinville, Washington. She added that “every single FDA-approved medication for juvenile arthritis” was on the list of nonessential benefits.

Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.

Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.

Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance — which, they say, could be the difference between an employer offering coverage to workers or not.

It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.

Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs — often called “specialty” drugs because of their high prices or the way they are made — are unnecessary.

Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs, Klein said.

Gaming the System to Save Money

Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.

In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort.

Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, New York.

The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.

In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.

“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Illinois, a federally funded hemophilia treatment center.

The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.

Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed — and sometimes unexpected bills for consumers.

“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error, she said.

Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tennessee, whose clientele includes employers that use variations of these programs.

Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.

Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.

If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mann said. Patient groups noted that some specialty drugs may not have any alternatives.

Patients Caught in the Middle  

How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.

“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.

J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”

Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts. None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.

In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”

Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.

In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”

In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.

For Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.

So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.

Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”

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

My Story: Why We’re Fighting the DEA

By Louis Ogden, Guest Columnist

I have been troubled by severe and chronic intractable pain since childhood, beginning at age 6.  I am now 72 years old. My earliest memories of pain are of aching in my legs so bad I remember crying myself to sleep.  My parents took me to doctors who said the aches were “growing pains” that would go away as I got older. 

My pain gradually got worse as I grew older and expanded to be body-wide. The worst pain of all was in my neck and upper back, along with incredibly severe head pain. It felt as if my skull was being crushed in every direction. I first remember having the head pain at age 12, but doctors had no answers for my parents and me. 

I finally got a diagnosis of fibromyalgia from a family doctor in 1990 at age 40. I can still remember his exact words when I asked him if there was anything he could give me for the pain.   

"Yes I could, but I won't because it would require opioids and you would be a junkie within two weeks,” the doctor said.  

I carried on with my life, usually with a tin of Excedrin in my pocket that I took to get me through each day. I did have many symptoms of fibromyalgia and it was good to finally have a diagnosis, but it didn’t seem to explain the crushing head pain.  

The pain grew so bad in my 40’s that I could no longer stand to do the demanding physical work required of an electrician and was forced to retire early. 

I was couch-bound most of the time and went on a 13-year search to find a solution to this painful existence. 

I saw many physicians and tried many treatments and medications, including opioids. Unfortunately, none of the therapies or medications eased my pain to tolerable levels. 

LOUIS and kristen OGDEN

Finding Relief With High Doses

In 2010, I sought out more aggressive pain care using high-dose opioid therapy as a last resort.  Dr. Forest Tennant of California took over my care. I think it was at my third appointment with Dr. Tennant when he told my wife Kristen and I that I probably would not have a very long life. I was 60 when he told us that bad news, but I am now 72 and still kicking thanks to his treatment protocol.   

After a thorough review of my medical records, a physical evaluation and various assessments, Dr. Tennant prescribed OxyContin, as well as oxycodone and morphine for breakthrough pain. He titrated me up to where I was comfortable and enjoying the highest quality of life I’d ever had as an adult.  The daily dose I was taking was close to 3,000 morphine milligram equivalent (MME), which is considered quite high. 

For 8 years, I continued on that same regimen. I did not need, nor did I ask for a higher dose, as I was doing great on the daily dose as stabilized.  

Dr. Tennant eventually diagnosed me with Arachnoiditis and Ehlers-Danlos Syndrome (EDS). These rare, but very painful syndromes account for my body-wide, complex, constant and severe pain, including the crushing head pain. I believe I inherited EDS from my mother, her mother, and the maternal line of descent going back at least 6 generations. The exact causes of my need for such high doses of opioids may never be proven, but probably include anomalies of absorption, metabolism and receptor damage due to EDS.  

Once titrated up to an effective dose, I was a very happy, well-adjusted person with a good quality of life, no longer couch-bound in agony and once again able to participate in social activities and perform household chores. My medicine enables this, and I have no sensation of pleasure or “high” of any kind. In fact, people that I meet have no idea that I am on a very high dose of opioids. I do not slur my words, nor am I disoriented. 

The DEA Gets Involved  

After Dr. Tennant was forced into retirement by the DEA in 2018 over unsubstantiated allegations of drug trafficking, I moved on to another doctor in California who kept lowering my dose. It left me not feeling well enough to stay active and enjoy my life, so I moved on to become a patient of Dr. David Bockoff, who assured me at my first appointment that he would do his best to help my pain.  He increased my dose to a level that allowed me to be much more comfortable.   

As PNN has reported, the DEA last month suspended Dr. Bockoff’s registration to prescribe opioids and other controlled drugs, which soon led to the death of one of his patients. Danny Elliott was so distraught over losing his pain medication that he committed suicide, along with his wife Gretchen. The Elliotts were friends of ours and confidants, as we have dealt for years with many of the same problems finding appropriate pain care.  

I am also now facing a life with no pain control and the very serious complications of withdrawal and untreated constant, severe pain.  This situation is very frightening to me, as my blood pressure may spike and I could possibly die of heart failure, an aneurysm or a stroke when/if I run out of medicine.   

The families of several of Dr. Bockoff’s patients, including my wife and I, have pooled our resources and retained the services of an experienced, well-qualified attorney who views our case as a violation of our civil rights. To the best of our knowledge, this is the first time that abandoned pain patients have fought back in such a manner.  If we prove our case with the DEA, the suspension order that prevents Dr. Bockoff from prescribing our medications could be lifted and we will get our good doctor back.   

If we do not win at this stage, we will take our case to the next legal step. In the meantime, some 240 patients of Dr. Bockoff are left with no help and no access to life-saving medications.   

It is my understanding that a few more pain management physicians are considering leaving their practices in the near future. As a result, thousands of additional pain patients may soon lose their lifelines to the medications they so desperately need to function. The DEA has a lot of blood on its hands, with possibly more to come. 

Louis Ogden and his wife Kristen live in Virginia. Dr. Tennant and the Tennant Foundation give financial support to Pain News Network and sponsor PNN’s Patient Resources section.  

Do you have a “My Story” to share? Pain News Network invites other readers to share their experiences about living with pain and treating it. Send your stories to editor@painnewsnetwork.org

Can Fentanyl Be Made Safer?

By Pat Anson, PNN Editor

Illicit fentanyl has been public health enemy #1 in the United States since 2016, when the DEA first declared there was a "fentanyl crisis" and warned that overdose deaths would increase due to the growing trade in street drugs laced with the potent synthetic opioid. That prediction sadly came true, as illicit fentanyl is now involved in about 71,000 U.S. overdose deaths a year. 

A team of scientists says it can reverse that trend by using sodium to make fentanyl far less dangerous, yet still effective in treating pain. 

“In its current form, fentanyl is like a weapon of mass destruction,” says Vsevolod Katritch, PhD, a computational biologist at the USC Michelson Center for Convergent Bioscience. “Our new collaborative work suggests that we could redesign the drug in such a way that we convert this frequent overdose killer to a much more benign but still effective analgesic.”

Katritch and colleagues at Washington University in St. Louis and Stanford University have published a study in the journal Nature demonstrating that chemically linking sodium to fentanyl can alter the way fentanyl binds to opioid receptors in the brain. In tests on laboratory mice, the modified drug was still an effective pain reliever, but didn’t have as many risky side effects. 

“We are desperately looking for ways to maintain the analgesic effects of opioids, while avoiding dangerous side effects such as addiction and respiratory distress that too often lead to death. Our research is still in its early stages, but we’re excited about its potential for leading to safer pain-relieving drugs,” Susruta Majumdar, PhD, an associate professor of anesthesiology at Washington University, said in a statement.,.

In modifying fentanyl with sodium, researchers developed a variation of the drug that still binds to mu-opioid receptors -- known as G-protein coupled receptors -- but also engages with a sodium ion binding site. That alters the pathway through which fentanyl reduces pain, making it possible for the drug to maintain most of its analgesic effects while also reducing the risk of respiratory depression leading to an overdose.

“The idea that the sodium ion, something we find in table salt, could modulate the activity of G-protein coupled receptors, such as these opioid receptors, is not new, but our group appears to be the first to successfully alter the chemistry of fentanyl so that it interacts with the sodium site on the receptor,” says Majumdar, who believes the same technique can be used in other medications, including other opioids, to make them safer.  

“Almost one-third of all drugs currently on the market — from blood pressure drugs to diabetes drugs to analgesics like fentanyl — bind to various G-protein coupled receptors, so it may be possible to make many drugs more effective, and to limit their side effects, by altering how they bind with such receptors.”

Researchers say further study is needed to prove that their altered version of fentanyl will work in humans, but they believe they've found a way to potentially improve its safety and those of other painkillers.

The research appears promising and may someday benefit pain patients, but it overlooks a simple fact: most of the fentanyl that is killing people is illicitly produced. And the clandestine labs, drug cartels, pill pressers and drug dealers responsible for the vast majority of overdoses will have no interest in adding sodium to their counterfeit pills and other fentanyl-laced drugs to make them safer.

The Nature study also perpetuates some longstanding myths about the overdose crisis, calling fentanyl and other prescription opioids a "major public health concern due to their adverse side effects."

But as pain management expert Dr. Lynn Webster pointed out in a 2019 PNN column, calling fentanyl a "weapon of mass destruction" is a bit of an overreach. Fentanyl has been legally used for decades -- safely and effectively -- as a surgical analgesic, and in transdermal patches and lozenges intended for patients with severe pain from cancer and other intractable pain conditions.

"Each of these new uses of fentanyl exposed millions of Americans to the drug without evidence of an inordinate degree of harm if it was used as directed," Webster wrote. "The opioid crisis is now largely driven by nonpharmaceutical fentanyl and fentanyl analogs, not prescription fentanyl."

Few pain patients who use fentanyl as directed become addicted or overdose, although many do become dependent on the drug to continue working, perform simple household chores, maintain personal hygiene, and have some quality of life. Modifying prescription fentanyl with sodium to make it safer might benefit some of those patients, but it will likely have no effect on the fentanyl crisis or prevent many overdoses.

Should Older Adults Risk Major Surgery?

By Judith Graham, Kaiser Health News

Nearly 1 in 7 older adults die within a year of undergoing major surgery, according to an important new study that sheds much-needed light on the risks seniors face when having invasive procedures.

Especially vulnerable are older patients with probable dementia (33% die within a year) and frailty (28%), as well as those having emergency surgeries (22%). Advanced age also amplifies risk: Patients who were 90 or older were six times as likely to die than those ages 65 to 69.

The study in JAMA Surgery, published by researchers at Yale School of Medicine, addresses a notable gap in research: Though patients 65 and older undergo nearly 40% of all surgeries in the U.S., detailed national data about the outcomes of these procedures has been largely missing.

“As a field, we’ve been really remiss in not understanding long-term surgical outcomes for older adults,” said Dr. Zara Cooper, a professor of surgery at Harvard Medical School and the director of the Center for Geriatric Surgery at Brigham and Women’s Hospital in Boston.

Of particular importance is information about how many seniors die, develop disabilities, can no longer live independently, or have a significantly worsened quality of life after major surgery.

“What older patients want to know is, ‘What’s my life going to look like?’” Cooper said. “But we haven’t been able to answer with data of this quality before.”

In the new study, Dr. Thomas Gill and Yale colleagues examined claims data from traditional Medicare and survey data from the National Health and Aging Trends study spanning 2011 to 2017. (Data from private Medicare Advantage plans was not available at that time but will be included in future studies.)

Invasive procedures that take place in operating rooms with patients under general anesthesia were counted as major surgeries. Examples include procedures to replace broken hips, improve blood flow in the heart, excise cancer from the colon, remove gallbladders, fix leaky heart valves, and repair hernias, among many more.

More Complications

Older adults tend to experience more problems after surgery if they have chronic conditions such as heart or kidney disease; if they are already weak or have difficulty moving around; if their ability to care for themselves is compromised; and if they have cognitive problems, noted Gill, a professor of medicine, epidemiology, and investigative medicine at Yale.

Two years ago, Gill’s team conducted research that showed 1 in 3 older adults had not returned to their baseline level of functioning six months after major surgery. Most likely to recover were seniors who had elective surgeries for which they could prepare in advance.

In another study, published last year in the Annals of Surgery, his team found that about 1 million major surgeries occur in individuals 65 and older each year, including a significant number near the end of life. Remarkably, data documenting the extent of surgery in the older population has been lacking until now.

“This opens up all kinds of questions: Were these surgeries done for a good reason? How is appropriate surgery defined? Were the decisions to perform surgery made after eliciting the patient’s priorities and determining whether surgery would achieve them?” said Dr. Clifford Ko, a professor of surgery at UCLA School of Medicine and director of the Division of Research and Optimal Patient Care at the American College of Surgeons.

As an example of this kind of decision-making, Ko described a patient who, at 93, learned he had early-stage colon cancer on top of preexisting liver, heart, and lung disease. After an in-depth discussion and being told that the risk of poor results was high, the patient decided against invasive treatment.

“He decided he would rather take the risk of a slow-growing cancer than deal with a major operation and the risk of complications,” Ko said.

Still, most patients choose surgery. Dr. Marcia Russell, a staff surgeon at the Veterans Affairs Greater Los Angeles Healthcare System, described a 90-year-old patient who recently learned he had colon cancer during a prolonged hospital stay for pneumonia.

“We talked with him about surgery, and his goals are to live as long as possible,” said Russell. To help prepare the patient, now recovering at home, for future surgery, she recommended he undertake physical therapy and eat more high-protein foods, measures that should help him get stronger.

“He may need six to eight weeks to get ready for surgery, but he’s motivated to improve,” Russell said.

Not Enough Surgeons

The choices older Americans make about undergoing major surgery will have broad societal implications. As the 65-plus population expands, “covering surgery is going to be fiscally challenging for Medicare,” noted Dr. Robert Becher, an assistant professor of surgery at Yale and a research collaborator with Gill. Just over half of Medicare spending is devoted to inpatient and outpatient surgical care, according to a 2020 analysis.

What’s more, “nearly every surgical subspecialty is going to experience workforce shortages in the coming years,” Becher said, noting that in 2033, there will be nearly 30,000 fewer surgeons than needed to meet expected demand.

These trends make efforts to improve surgical outcomes for older adults even more critical. Yet progress has been slow. The American College of Surgeons launched a major quality improvement program in July 2019, eight months before the covid-19 pandemic hit. It requires hospitals to meet 30 standards to achieve recognized expertise in geriatric surgery. So far, fewer than 100 of the thousands of hospitals eligible are participating.

One of the most advanced systems in the country, the Center for Geriatric Surgery at Brigham and Women’s Hospital, illustrates what’s possible. There, older adults who are candidates for surgery are screened for frailty. Those judged to be frail consult with a geriatrician, undergo a thorough geriatric assessment, and meet with a nurse who will help coordinate care after discharge.

Also initiated are “geriatric-friendly” orders for post-surgery hospital care. This includes assessing older patients three times a day for delirium (an acute change in mental status that often afflicts older hospital patients), getting patients moving as soon as possible, and using non-narcotic pain relievers. “The goal is to minimize the harms of hospitalization,” said Cooper, who directs the effort.

She told me about a recent patient, whom she described as a “social woman in her early 80s who was still wearing skinny jeans and going to cocktail parties.” This woman came to the emergency room with acute diverticulitis and delirium; a geriatrician was called in before surgery to help manage her medications and sleep-wake cycle, and recommend non-pharmaceutical interventions.

With the help of family members who visited this patient in the hospital and have remained involved in her care, “she’s doing great,” Cooper said. “It’s the kind of outcome we work very hard to achieve.”

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

Stopping Rx Opioid Therapy Raises Risk of Overdose

By Pat Anson, PNN Editor

Discontinuing opioid therapy for people with chronic pain raises the risk of a patient dying from an overdose, according to a new Canadian study that calls for better guidance for healthcare providers on the risks associated with abrupt tapering.

Researchers analyzed the medical histories of over 14,000 pain patients in British Columbia who were on long term opioid therapy from 2014 to 2018 – a period when physicians in Canada and the United States were being urged to restrict opioid prescriptions due to a worsening overdose crisis. The vast majority of patients studied were either tapered to a lower dose or their opioid treatment was discontinued, regardless of whether they showed signs of opioid use disorder (OUD).  

The study findings, published in PLOS Medicine, show that discontinuing opioid therapy for pain was associated with increased overdose risk. The association was even stronger for the small minority of patients diagnosed with OUD. In total, 530 people in the study (3.8%) experienced either a fatal or non-fatal overdose, with 120 of them dying.

“Our findings underscore the need for healthcare providers and policymakers to carefully consider potential unintended adverse effects of discontinuing opioid treatment for chronic pain when developing prescribing interventions and making practice decisions,” wrote lead author Mary Clare Kennedy, PhD, a Research Scientist with the BC Centre on Substance Use and a Research Fellow at the University of British Columbia.

“Given the harms of opioid treatment discontinuation identified in this and past studies, non-consensual and abrupt discontinuation of opioid treatment for pain is contraindicated in almost all instances.”

Kennedy and her colleagues were unable to determine what substances were involved in the overdoses, but they believe some patients who had their opioid therapy stopped may have resorted to illicit fentanyl and other street drugs to manage their pain, withdrawal and other symptoms. Over 73% of the overdose deaths that occurred in British Columbia during the study period involved fentanyl.

Previous studies have also found that opioid tapering raises the risk of an overdose and mental health crisis. A study published last year in JAMA found that tapered patients were 68% more likely to be treated for opioid withdrawal, drug overdose or alcohol intoxication, and they were twice as likely to experience depression, anxiety or a suicide attempt.

The FDA warned in 2019 that rapid tapering or abrupt discontinuation of opioids could result in serious harm to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.

‘Reckless Mistreatment of Patients’

Despite this growing body of evidence, forced tapering and opioid discontinuation continues – some of it caused by the heavy-handed tactics of law enforcement. Over 200 pain patients were recently cut off from opioids after their California doctor had his DEA license suspended without warning. One patient and his wife died by suicide within a week of the DEA’s action.

“Not only are we collectively causing harm, we are failing to stop causing harm even when we agree that we're causing it, which is actually worse,” says Stefan Kertesz, MD, an associate professor at the University of Alabama at Birmingham, who is leading a study of pain patient suicides.

Kertesz says regulators, insurers, journalists and law enforcement have misinterpreted overdose studies to suggest that opioid prescribing, particularly at higher doses, was the root cause of the overdose crisis.  

“Many clinicians and policymakers engaged in aggressive extrapolation that went far beyond the data. Many journalists and legal plaintiffs described the prescriptions in a way that aggravated matters. They made dose into a fetish, a performance metric, and a threshold for law enforcement,” Kertesz told PNN. “Dose based quality metrics, payor standards and legal investigation thresholds incentivize reckless mistreatment of patients.

“My ultimate question is when will agencies like the National Committee for Quality Assurance, the Office of Inspector General, and law enforcement actually come to appreciate the evidence in play?”

It took six years, but the CDC recently revised its 2016 opioid guideline to include specific language warning of the dangers of tapering or discontinuing opioids.

“Clinicians should avoid abrupt discontinuation of opioids, especially for patients receiving high dosages of opioids, should avoid dismissing patients from care, and should ensure appropriate care for patients with pain and patients with complications from opioid use,” the revised guideline states.

Steroid Injections May Worsen Knee Arthritis

By Pat Anson, PNN Editor

Two new studies are raising doubts about a commonly used treatment for knee osteoarthritis, a progressive and painful condition found in many older adults. Corticosteroid injections in the knee are often used to relieve osteoarthritis pain by reducing inflammation in the joint, with the relief lasting for days, weeks or sometimes months.

But a new long-term study by researchers at the University of California, San Francisco (UCSF) found that corticosteroid injections appear to worsen the progression of knee osteoarthritis compared to patients who received injections of hyaluronic acid, a polymer gel that acts as a lubricant and shock absorber.

UCSF researchers followed 210 patients with knee osteoarthritis (OA). Seventy of the patients received injections of either corticosteroids or hyaluronic acid, while the rest received no injections and served as a control group. MRI scans were performed on all participants at the start of the study and again two years later, focusing on the meniscus, bone marrow lesions, cartilage, joint effusion and ligaments.

“This is the first direct comparison of corticosteroid and hyaluronic acid injections using the semi-quantitative, whole organ assessment of the knee with MRI,” said Upasana Upadhyay Bharadwaj, MD, a research fellow in the Department of Radiology at UCSF.

In findings presented this week at the annual meeting of the Radiological Society of North America (RSNA), Bharadwaj reported that corticosteroid injections were significantly associated with the progression of knee OA, specifically in the lateral meniscus, lateral cartilage and medial cartilage.

Hyaluronic injections were not associated with the progression of knee OA. Patients who received hyaluronic acid showed a decreased progression of osteoarthritis, specifically in bone marrow lesions, compared to the control group. 

The findings are important because osteoarthritis is the most common form of arthritis, causing progressive joint damage and thinning of cartilage.  Over 32 million U.S. adults have knee OA, and about 10% of them receive corticosteroid or hyaluronic injections.

“While both corticosteroid and hyaluronic acid injections are reported to help with symptomatic pain relief for knee osteoarthritis, our results conclusively show that corticosteroids are associated with significant progression of knee osteoarthritis up to two years post-injection and must be administered with caution,” Bharadwaj said. “Hyaluronic acid, on the other hand, may slow down progression of knee osteoarthritis and alleviate long term effects while offering symptomatic relief.

“Knowing the long-term effects of these injections will help osteoarthritis patients and clinicians make more informed decisions for managing the disease and the pain it causes.”

In a second study presented at the RSNA’s annual meeting, researchers at the Chicago Medical School compared X-ray images of 50 patients with knee OA who received injections of corticosteroids to 50 patients who received injections of hyaluronic acid. Another 50 patients who had no injections served as a control group. Like the UCSF study, X-rays of all patients were taken at the start of the study and again two years later.

The findings mirrored those found in the first study. Patients injected with corticosteroids had significantly more osteoarthritis progression, including medial joint space narrowing, a hallmark of the disease.

“Even though imaging findings for all patients were similar at baseline, the imaging hallmarks of osteoarthritis were worse two years later in patients who received corticosteroid injections compared to patients who received hyaluronic acid injections or no treatment at all,” said Azad Darbandi, a researcher and medical student.

“The results suggest that hyaluronic acid injections should be further explored for the management of knee osteoarthritis symptoms, and that steroid injections should be utilized with more caution.”

The Mayo Clinic recommends that corticosteroid injections be limited to once every six weeks, and that knee OA patients receive injections no more than three or four times a year.

There was a third long-term study presented at the RSNA meeting that debunked another common treatment for knee OA: non-steroidal anti-inflammatory drugs (NSAIDs). UCFS researchers found that NSAIDs worsen inflammation and weaken cartilage in patients with osteoarthritis, contributing to a painful joint condition called synovitis. MRI imaging at the start of the study found joint inflammation and cartilage quality were worse in patients taking NSAIDs, and their knee joints deteriorated even more after four years. 

Spinal Cord Stimulators Fail to Reduce Opioid Use

By Pat Anson, PNN Editor

A large new study is raising questions about the long-term effectiveness of spinal cord stimulators and whether they really help patients reduce their use of opioids and other pain treatments.

Researchers at the University of California San Francisco (UCSF) School of Medicine analyzed health data for 1,260 patients who received permanent stimulators and found that — when compared to a control group — the devices did not reduce their use of opioids, epidurals, corticosteroid injections or radiofrequency ablation after two years. About a fifth of the patients experienced complications so severe the devices had to be removed or revised.

Spinal cord stimulators (SCSs) are considered an invasive treatment of last resort for people with chronic back or leg pain, because the devices have to be surgically implanted near the spine and connected to batteries placed under the skin. The implants send electrical impulses into the spine to mask pain.

About 50,000 SCSs are implanted annually in the U.S. and their use is growing – in part because of the belief they’ll reduce the need for opioids and other pain therapies.

But UCSF researchers found that SCS patients actually filled more opioid prescriptions after one year than a control group of pain patients (CMM) who did not get the devices. The use of other medications and procedures by SCS patients declined slightly after one year, but there were no significant differences between the two groups after two years.

“The lack of reduction in pharmacotherapy, epidural and facet corticosteroid injections, and radiofrequency ablations at 2 years among patients receiving SCS compared with those receiving CMM suggests that SCS was providing insufficient pain relief to forego other therapies or improve rates of depression or anxiety, as prescriptions for these drug classes did not decline,” lead author Sanket Dhruva, MD, an Assistant Professor of Medicine at UCSF, wrote in JAMA Neurology.

“Because most patients still had their permanent SCS in place at 2 years, some may receive prolonged benefit from this modality, although we were not able to identify this through reductions in opioid use or nonpharmacologic pain interventions.”

Researchers also found that the total cost of care was about $39,000 higher for SCS patients in the first year, while health costs were similar for the two groups in the second year.

‘Sobering Insights’

"The findings appear to belie the popular belief that SCS may result in reduced opioid medication usage or overall fewer physician visits in the years immediately following device implant," wrote Prasad Shirvalkar, MD, and Lawrence Poree, MD, both from the UCSF Division of Pain Medicine, in an accompanying editorial.

“Using robust propensity matching, the present study provides sobering insights that SCS does not appear to reduce chronic opioid use or the utilization of health care resources compared with CMM in the first 2 years after implant. We believe this will help mitigate excessive enthusiasm of SCS as a panacea for chronic pain syndromes and illuminate biases of SCS hype cycle that can possibly be fueled by industry-related conflicts of interest.”

Stimulators are no longer limited to patients with chronic back, neck and leg pain. Last year the FDA expanded the use of SCSs to include pain from diabetic neuropathy. Stimulators are also now being used on patients with Complex Regional Pain Syndrome (CRPS).

A 2018 study by a team of investigative journalists found that SCSs have some of the worst safety records of medical devices tracked by the FDA. A 2020 FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief. The review also identified nearly 500 deaths linked to the devices, along with nearly 78,000 injuries and 30,000 device malfunctions.

Cannabis Works No Better Than Placebo in Pain Studies

By Pat Anson, PNN Editor

The placebo effect is responsible for much of the pain relief experienced by participants in clinical trials of cannabis, according to new analysis that also found a “strong positive bias” in media coverage of the studies.

Researchers at the Karolinska Institute in Sweden analyzed the results of 20 placebo-controlled studies of cannabis products involving almost 1,500 people with chronic pain conditions. The cannabis products were administered as pills, sprays, oils, smoke or vapor; and most of the studies were conducted in the United States, UK or Canada.

Researchers found that many participants reported significant pain relief, but there were no differences in pain reduction between those who used cannabis products and those who used a placebo, a sham treatment that should have no effect.

“There is a distinct and clinically relevant placebo response in studies of cannabis for pain,” says Filip Gedin, PhD, a researcher in the Department of Clinical Neuroscience at Karolinska and lead author of the study published in JAMA Network Open.

Gedin and his colleagues also examined coverage the 20 studies received in the news media using Altmetric, a method of evaluating mentions in the media as either positive, negative or neutral. They did not identify the publishers of the 136 news articles that were analyzed or provide any examples of their coverage.

Researchers found that the cannabis studies received much greater media attention than other clinical studies and tended to be more positive, regardless of what the studies’ outcomes actually were. The media coverage of cannabis was so positive, in fact, that researchers wonder if it might influence findings in future studies.  

“The positive media attention and wide dissemination may uphold high expectations and shape placebo responses in future trials, which has the potential to affect the outcome of clinical trials, regulatory decisions, clinical practice, and ultimately patient access to cannabinoids for pain relief,” Gedin wrote. “We therefore consider this question to be of high importance, as the positive reporting toward cannabinoids regardless of study quality and effect size may subsequently lead to increased expectations that may ultimately influence the outcomes in clinical trials.”

The placebo effect is a well-documented but poorly understood condition in which a patient responds to a sham drug or treatment that should have no therapeutic value. A 2018 study at Northwestern University, for example, found that about half of patients who took a sugar pill they thought was an analgesic had a 30% reduction in pain – a level considered good enough for an actual painkiller.    

In another study, researchers identified some participants as “placebo responders” who are more likely to respond to a sugar pill because their brains react differently – which may explain why some patients find a medication effective and others don’t.    

Whatever the cause, researchers at the Karolinska Institute say more effort is needed to understand the placebo effect and how media coverage could make it even more potent.

“We cannot say with 100% certainty that media coverage is responsible for the high placebo response observed in our review,” Gedin wrote in an op/ed published in The Conversation.

“But given placebos were shown to be just as good as cannabis for managing pain, our results show just how important it is to think about the placebo effect and how it can be influenced by external factors – such as media coverage. For treatments, such as cannabinoids, that receive a lot of media attention, we need to be extra rigorous in our clinical trials.”

Insurers Can Cause Pain Too

By Victoria Reed, PNN Columnist

Having chronic pain or illness means that you likely take multiple medications and go to the doctor often. That means dealing with your insurance carrier to get claims filed and paid.

One of the medications that I use for my rheumatoid arthritis is quite expensive. In fact, many of the biologics commonly prescribed for RA and other autoimmune conditions are very pricey, costing thousands of dollars a month depending on insurance. Before starting a biologic, it usually needs to be pre-approved by your insurance company.

This pre-approval process can delay or even stall treatment altogether.  With RA, insurers usually require that you to try a particular biologic or disease modifying anti-rheumatic drug (DMARD) before you are approved for a more expensive one. This red tape can and does cause harm to patients as they wait for the insurance review, which can take up to three or four weeks.

During that time, doctors can treat patients with steroids or pain medications, which can help keep symptoms at bay. However, the biologics are primarily what keeps the disease from causing destructive and permanent damage.

Insurance companies are businesses, like any other, and their goal is to make money. But as they look for cheaper medication options and create red tape, the delay can literally leave you in more pain while you wait for a decision. Unfortunately, insurers control the purse strings and sometimes they seem to have more say in a patient’s care than doctors themselves.

Recently, I tried to complete a refill of my biologic medication, Actemra, through the specialty pharmacy that I use. I ordered it online and waited for the email confirmation of shipping, but after a few days I noticed that it didn’t arrive. I contacted the pharmacy’s customer service department to inquire about its status and was told that the required pre-approval had not been done by my doctor’s office: No medication would be shipped until that paperwork was completed.

I then contacted my doctor’s office to advise them of the delay and requested that they complete the required paperwork. Then I patiently waited. After nearly two weeks of being without my medication, the shipment finally arrived. Two weeks can seem like a lifetime if you’re in severe pain!

This pre-approval requirement makes no sense to me, as I’ve been taking Actemra for many years. RA is a lifelong condition that does not go away or get better on its own. Medications to control the condition are usually taken for the duration of your life. So why would my doctor need to submit pre-approval paperwork every six months?                   

Money! It’s as simple as that. Insurers look for ways to delay or avoid paying for an expensive medication..  

I’m sure I’m not the only one experiencing this. Cancer patients also must deal with their insurance company’s control over what drugs they can take to save their lives or improve their quality of life. My father lived with cancer for many years before he passed. Even towards the end of his life, the issue of what meds he was allowed to have was front and center, controlled and dictated by his insurer.

Patients can die because an insurance company refused to pay for a drug that they deemed too expensive. They prioritize profit over people’s lives and have far too much control over patient care.

If you find yourself in a battle with your insurance company over a medication that your doctor prescribed, you do have some options.  You don’t have to just accept a denial. Most insurers allow you to appeal an adverse decision, and sometimes they will change their minds after an appeal or receipt of additional supporting documentation.

You can also request that your doctor send a letter of medical necessity, which would document your need for the drug. In addition, you can request that the insurer do a physician level peer-to-peer review. This is a review that is used by insurance professionals to determine whether to uphold the denial of coverage for a particular medication or claim.

Sometimes utilizing these additional avenues will result in your medication being allowed. Still, any delay in treatment could be detrimental to your health or cause you additional pain while you wait through the appeal process. Some people may find it easier to just take a cheaper drug recommended by the insurer.

Chronic pain sufferers have enough to deal with on a daily basis and we don’t need the additional stress of engaging in a battle with our insurance carriers. Nor do we need unnecessary red tape delays, which are solely designed to save the insurer money.

Patients may not have the energy, time or knowledge to navigate the tricky tactics insurers use to pad their bottom line – which is where a patient advocate could help. Advocates can negotiate with the insurer on your behalf, and can also help you communicate with your medical providers and set up appointments. They can be close friends, family members, spouses or even someone from an organization, such as the Patient Advocate Foundation.

They say it takes a village to raise a child. We also need a village of resources to deal with chronic illness and all of the hassles that come with it.

Victoria Reed lives in northeast Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis. 

12 Holiday Gifts for Caregivers and the People They Care For

By Pat Anson, PNN Editor

How do you take care of yourself when you feel overwhelmed taking care of someone with a disabling chronic illness? Can an anti-inflammatory diet help prevent migraines? What is “ableism” and how does it harm the disabled? Will they ever find a cure for long covid?

The answers to these and other questions can be found in our annual holiday gift guide. If you’re a healthcare provider, caregiver or you live with chronic pain and illness -- here are 12 books that would make great gifts over the holidays. Or you can always “gift” one to yourself.

Click on the book’s cover to see price and ordering information. PNN receives a small amount of the proceeds -- at no additional cost to you -- for orders placed through Amazon.

The Long Haul: Solving the Puzzle of the Pandemic’s Long Haulers

This timely book by Ryan Prior looks at how the Covid-19 pandemic left millions of people around the world with chronic fatigue, pain and other disabling symptoms. Many of these “long haulers” are now fighting for recognition and treatments for a puzzling new disease that could be challenging the healthcare system for decades to come.

Self-Care for Caregivers

In this handbook for caregivers, Susan White offers tips on how to maintain good physical and mental health, and how to avoid feeling angry, lonely and frustrated. Regular self-care is vital for caregivers, and means finding time to relax, rejuvenate and reconnect with others.

I’m Fine: A Practical Guide to Life with Chronic Pain

After a series of failed spinal fusions, author Toni Woodard has lived with chronic back pain for over 25 years. In this book, she describes how physical and emotional pain can impact work, relationships and mental health, and shares some simple practical lessons on how to manage pain and still enjoy life.

Raising Lazarus

The sequel to Dopesick, Beth Macy’s latest book takes a more nuanced approach to the opioid crisis, briefly acknowledging that many pain patients were harmed by the backlash against opioid medication. But Raising Lazarus primarily deals with Purdue Pharma’s corporate greed and the ongoing struggles of working-class people in Appalachia to overcome addiction and a healthcare system that doesn’t work for them.

The Migraine Relief Plan Cookbook

Author Stephanie Weaver spent years researching and interviewing migraine sufferers and healthcare providers about ways to relieve migraine pain through good nutrition. The result is this cookbook, filled with over 100 anti-inflammatory recipes for meals, snacks and drinks — all designed to help manage migraines, headaches and chronic pain.

Clinical Diagnosis and Treatment of Adhesive Arachnoiditis

It’s fair to say most doctors don’t know what adhesive arachnoiditis (AA) is, much less how treat it, which is why Dr. Forest Tennant wrote this handbook about the chronic and debilitating inflammatory disease of spinal nerves. The book will help clinicians understand the various causes of AA; how to diagnose it through lab tests, MRIs and patient symptoms; and how to treat AA through hormone therapy, good nutrition and medication.

The Nurse Practitioners’ Guide to Autoimmune Medicine

Dr. David Bilstrom wrote this book primarily to help healthcare providers diagnose and treat autoimmune disease — but patients will find it easy to understand. Chapters explore symptoms and diagnostic testing, as well as the stress, toxins, and hormone and vitamin deficiencies that cause autoimmune problems. Bilstrom takes a holistic approach to treatment, emphasizing diet and lifestyle changes over antibiotics and medication.

Wildest Hunger

The fourth in a series of paranormal crime novels by Laura Laasko, who lives with Ehlers-Danlos and Chronic Fatigue Syndrome. Laasko believes chronic illness is poorly represented in fiction, so many of her characters are given invisible illnesses like EDS to help educate readers about what it’s like to have a disability and manage its symptoms.

Year of the Tiger: An Activist’s Life

A collection of essays on living with disability by Alice Wong, founder and director of the Disability Visibility Project. Wong is a fierce critic of “ableism” — systemic discrimination and prejudice against disabled people, who are often defined and devalued by society for what they can’t do, as opposed to what they can.

Tao Calligraphy: To Heal and Rejuvenate Your Back

Dr. Master Zhi Gang Sha introduces readers to the ancient Chinese healing art of calligraphy, which professes to transform health, relationships and all aspects of life through positive energy and spirituality. This book focuses on healing back pain — and comes with QR codes that readers can scan to access videos that will help them rejuvenate their backs. Some reviewers claim just putting the book on their backs gave them pain relief!

The Hard Sell: Crime and Punishment at an Opioid Startup

Journalist Evan Hughes lays bare the inside story of Insys Therapeutics, a pharmaceutical startup that deceived insurers, corrupted doctors, and used brazen sales tactics to market Subsys, a potent and expensive fentanyl spray. The scheme made a fortune for Insys until federal investigators began looking into hundreds of overdose deaths and prosecuted company executives for drug trafficking.

The Song of Our Scars: The Untold Story of Pain

Chronic pain was a “distant, hazy concept” for Dr. Haider Warraich until he began experiencing it himself after a severe back injury. In this book, he explores the cultural and medical history of pain from ancient Greece through modern times — concluding that today’s healthcare system is broken and leaves many patients with chronic pain worse off than they were before.

These and other books and videos about living with chronic pain and illness can be found in PNN’s Suggested Reading section.

Treating Long Covid Still a Mystery

By Blake Farmer, Kaiser Health News

Medical equipment is still strewn around the house of Rick Lucas, 62, nearly two years after he came home from the hospital. He picks up a spirometer, a device that measures lung capacity, and takes a deep breath — though not as deep as he’d like.

Still, Lucas has come a long way for someone who spent more than three months on a ventilator because of covid-19.

“I’m almost normal now,” he said. “I was thrilled when I could walk to the mailbox. Now we’re walking all over town.”

Dozens of major medical centers have established specialized covid clinics around the country. A crowdsourced project counted more than 400. But there’s no standard protocol for treating long covid. And experts are casting a wide net for treatments, with few ready for formal clinical trials.

It’s not clear just how many people have suffered from symptoms of long covid. Estimates vary widely from study to study — often because the definition of long covid itself varies. But the more conservative estimates still count millions of people with this condition.

For some, the lingering symptoms are worse than the initial bout of covid. Others, like Lucas, were on death’s door and experienced a roller-coaster recovery, much worse than expected, even after a long hospitalization.

RICK LUCAS

Symptoms vary widely. Lucas had brain fog, fatigue, and depression. He’d start getting his energy back, then go try light yardwork and end up in the hospital with pneumonia. It wasn’t clear which ailments stemmed from being on a ventilator so long and which signaled the mysterious condition called long covid.

“I was wanting to go to work four months after I got home,” Rick said over the laughter of his wife and primary caregiver, Cinde.

“I said, ‘You know what, just get up and go. You can’t drive. You can’t walk. But go in for an interview. Let’s see how that works,’” Cinde recalled.

Rick did start working earlier this year, taking short-term assignments in his old field as a nursing home administrator. But he’s still on partial disability.

Why has Rick mostly recovered while so many haven’t shaken the symptoms, even years later?

“There is absolutely nothing anywhere that’s clear about long covid,” said Dr. Steven Deeks, an infectious disease specialist at the University of California-San Francisco. “We have a guess at how frequently it happens. But right now, everyone’s in a data-free zone.”

Researchers like Deeks are trying to establish the condition’s underlying causes. Some of the theories include inflammation, autoimmunity, so-called microclots, and bits of the virus left in the body. Deeks said institutions need more money to create regional centers of excellence to bring together physicians from various specialties to treat patients and research therapies.

No Cure or Treatment

Patients say they are desperate and willing to try anything to feel normal again. And often they post personal anecdotes online.

“I’m following this stuff on social media, looking for a home run,” Deeks said.

The National Institutes of Health promises big advances soon through the RECOVER Initiative, involving thousands of patients and hundreds of researchers.

“Given the widespread and diverse impact the virus has on the human body, it is unlikely that there will be one cure, one treatment,” Dr. Gary Gibbons, director of the National Heart, Lung, and Blood Institute, told NPR. “It is important that we help find solutions for everyone. This is why there will be multiple clinical trials over the coming months.”

Meanwhile, tension is building in the medical community over what appears to be a grab-bag approach in treating long covid ahead of big clinical trials. Some clinicians hesitate to try therapies before they’re supported by research.

Dr. Kristin Englund, who oversees more than 2,000 long covid patients at the Cleveland Clinic, said a bunch of one-patient experiments could muddy the waters for research. She said she encouraged her team to stick with “evidence-based medicine.”

“I’d rather not be just kind of one-off trying things with people, because we really do need to get more data and evidence-based data,” she said. “We need to try to put things in some sort of a protocol moving forward.”

It’s not that she lacks urgency. Englund experienced her own long covid symptoms. She felt terrible for months after getting sick in 2020, “literally taking naps on the floor of my office in the afternoon,” she said.

More than anything, she said, these long covid clinics need to validate patients’ experiences with their illness and give them hope. She tries to stick with proven therapies.

For example, some patients with long covid develop POTS — a syndrome that causes them to get dizzy and their heart to race when they stand up. Englund knows how to treat those symptoms. With other patients, it’s not as straightforward. Her long covid clinic focuses on diet, sleep, meditation, and slowly increasing activity.

But other doctors are willing to throw all sorts of treatments at the wall to see what might stick.

At the Lucas house in Tennessee, the kitchen counter can barely contain the pill bottles of supplements and prescriptions. One is a drug for memory. “We discovered his memory was worse [after taking it],” Cinde said.

Other treatments, however, seemed to have helped. Cinde asked their doctor about her husband possibly taking testosterone to boost his energy, and, after doing research, the doctor agreed to give it a shot.

“People like myself are getting a little bit out over my skis, looking for things that I can try,” said Dr. Stephen Heyman, a pulmonologist who treats Rick Lucas at the long covid clinic at Ascension Saint Thomas in Nashville.

He’s trying medications seen as promising in treating addiction and combinations of drugs used for cholesterol and blood clots. And he has considered becoming a bit of a guinea pig himself.

Heyman has been up and down with his own long covid. At one point, he thought he was past the memory lapses and breathing trouble, then he caught the virus a second time and feels more fatigued than ever.

“I don’t think I can wait for somebody to tell me what I need to do,” he said. “I’m going to have to use my expertise to try and find out why I don’t feel well.”

DR. STEPHEN HEYMAN

This story is from a reporting partnership that includes WPLN, NPR, and Kaiser Health News, a national newsroom that produces in-depth journalism about health issues.

How Racial and Ethnic Disparities Affect Pain

By Madora Pennington, PNN Columnist

Much of the race-related research on chronic pain in the United States only compares Black and White Americans, leaving out many other ethnic groups and demographics.  

In an attempt to broaden our understanding of who experiences pain and why, researchers culled through eight years of public surveys conducted by the CDC and the U.S. Census Bureau from 2010 to 2018. These National Health Interview Surveys gathered information from White, Black, Hispanic, Asian, Native American and multiracial Americans, giving us new insight into the role of race in pain prevalence. 

“People often tend to think about pain as a personal issue or personal struggle, but it’s really a broad social and societal issue,” says Anna Zajacova, PhD, a sociology professor at the University of Western Ontario and lead author of Beyond Black vs White, a study recently published in the journal PAIN.       

In addition to race, Zajacova and her colleagues looked at socioeconomic factors such as education, family income, home ownership and whether someone was born in the U.S. or abroad.  They found that racial disparities in pain are far larger than previously recognized, with Native Americans nearly five times more likely to have severe pain than Asian Americans. Hispanics, Whites and Blacks fell between the two extremes.

Severe Pain Prevalence

• 2.4% Asian Americans

• 5.0% Hispanics

• 6.8% Whites

• 7.6% Blacks

• 8.7% Multiracial Adults

• 11.1% Native Americans

Why is there so much disparity between races? Researchers found that Asian Americans collectively had the highest levels of education and family income, giving them a socioeconomic advantage that may explain their lower pain prevalence. Native Americans, on the other hand, tend to be the most socioeconomically disadvantaged ethnic group, which is likely a factor in their high pain prevalence.

“We really need to understand what is causing the high pain among Native American and multiracial adults, and what factors protect Asian Americans from reporting high pain on average. This question will require delving into upstream causes such as discrimination, resulting stress and corollary health impacts, as well as the role of protective factors such as community and individual resilience,” Zajacova told PNN. 

While socioeconomic factors play a role, they're not always a deciding one. Hispanics reported less severe pain than White Americans despite having fewer socioeconomic advantages, indicating that other factors may be involved.

One may be place of birth. Researchers found that immigrants reported significantly less pain than native-born adults. Since about half of Hispanic adults are foreign born, that may help explain their lower incidence of pain -- or at least a reluctance to report it. 

Researchers say we need a better understanding of the racial, ethnic, social and economic issues that contribute to chronic pain if we ever hope to manage it.   

“The biopsychosocial model of pain predicts that people marginalized by social conditions would experience more pain. Our foundational results show more nuanced patterns, in which some minoritized groups show higher pain prevalence than Whites, whereas others show lower prevalence,” Zajacova wrote.

“Given that pain is arguably the most prevalent and costly public health condition in the United States, enhanced knowledge of racial and ethnic disparities in pain is urgently needed to inform policy decisions and focus efforts at population-level prevention and intervention.” 

Madora Pennington is the author of the blog LessFlexible.com about her life with Ehlers-Danlos Syndrome. She graduated from UC Berkeley with minors in Journalism and Disability Studies.