Patients Squeezed in Fight Over Costly Infusion Drugs

By Samantha Liss, KFF Health News

Health insurers and medical providers are battling over who should supply high-cost infusion drugs for patients, with the tussle over profits now spilling into statehouses across the country.

The issue is that some insurers are bypassing hospital pharmacies and physician offices and instead sending more complex drugs through third-party pharmacies. Those pharmacies then send the medications directly to the medical provider or facility for outpatient infusing, which is called “white bagging,” or, more rarely, to patients, in what is called “brown bagging.” That shifts who gets to buy and bill for these complex medications, including pricey chemotherapy drugs.

Insurers say the policies are needed because hospital markups are too high. But hospitals argue that adding an intermediary results in unnecessary risks and delays, and they say some insurers have their own or affiliated pharmacy companies, creating financial motives for controlling the source of the medications. The patients, meanwhile, are left to deal with the red tape.

Paula Bruton Shepard in Bolivar, Missouri, is among those caught in the middle. Flares of lupus, an autoimmune disease, rob Shepard of her mobility by attacking her joints. She relies on monthly infusions to treat her symptoms.

PAULA SHEPARD

But at times, she said, her treatments were delayed due to UnitedHealthcare’s white bagging infusion policy. And interruptions to her treatments exacerbated her symptoms.

“I once had to use a toilet lift and it was kind of demoralizing to say, ‘I’m a 50-year-old woman and I have to use a toilet lift,’” Shepard said of the medication delays.

This is a tug of war over profits between insurers and medical providers, said Ge Bai, a professor of accounting and health policy at Johns Hopkins University. While insurers claim the arrangement reduces costs, she said, that doesn’t mean insurers pass along savings to patients.

“I don’t think we should have more sympathy toward one party or the other,” Bai said. “Nobody is better than the other. They’re all trying to make money.”

The savings from white bagging can be significant for expensive infusion drugs, according to a report from the Massachusetts Health Policy Commission. For example, Remicade, used to treat a variety of inflammatory diseases, including Crohn’s, cost on average $1,106 per unit in 2015 under hospitals’ traditional buy-and-bill system, the commission found in its review of state claims data. That same drug cost an average of $975 per unit under white bagging, a 12% savings.

But the report also found patients, on average, faced higher cost sharing — what they are responsible for paying — for Remicade and other drugs when white bagging was used. While some patients had only modest increases to their costs under the policy, such as $12 more for a medication, the review found it could mean much greater cost sharing for some patients, such as those on Medicare.

Delays in Care

At Citizens Memorial Hospital in rural Bolivar, more than 1 in 4 patients who receive regular infusions are being forced to use an outside pharmacy, said Mariah Hollabaugh, the hospital’s pharmacy director. Shepard was among them.

Even if the hospital has the exact drug on the shelf, patients must wait for a separate shipment, Hollabaugh said, potentially interrupting care. Their shipped drugs may sometimes be unusable when the doctor needs to change the dosage. Or the medicine comes in a nondescript package that doesn’t get immediately flagged for the pharmacy, potentially subjecting the drugs to damaging temperature fluctuations. For patients, that can mean delays in care.

“They’re in pain, they’re uncomfortable,” Hollabaugh said. “They may be having symptoms that don’t allow them to go to work.”

Siteman Cancer Center, led by physicians from Washington University School of Medicine in St. Louis, has confronted the same issue. But the cancer center’s size has helped it largely avoid such insurer policies.

John DiPersio, a Siteman oncologist and researcher who led the university’s oncology division for more than two decades, said Siteman reluctantly allows white bagging for simple injectables but refuses to accept it for complicated chemotherapies. It does not accept brown bagging. Occasionally, he said, that means turning patients away.

“You’re talking about cancer patients that are getting life-threatening treatments,” DiPersio said, referring to the dangers of chemo drugs, which he said can be fatal if used improperly. “It doesn’t make any sense to me. It’s all stupid. It’s all lunacy.”

At least 21 states, including Missouri, introduced some form of white or brown bagging legislation during the most recent legislative session, according to the American Society of Health-System Pharmacists. And in the past two years, the trade group said, at least 13 states have already enacted restrictions on white bagging, including Arkansas, Louisiana, and Virginia.

ASHP has created model legislation to limit insurers from requiring the practices as a condition of coverage.

“This is a major issue,” said Tom Kraus, a vice president at the trade group. “We see this as central to our ability to coordinate patient care.”

At the heart of the tension is an often-litigated federal program that allows certain hospitals and the clinics they own to purchase drugs at deep discounts. The 340B program, named for a section of the law that created it, allows hospitals to buy certain drugs for much less — sometimes for a total cost of a single penny — than what they are later paid for those drugs. Hospitals are not required to pass along 340B savings to patients.

The program was intended to help hospitals spread scarce resources further to treat patients in poor and vulnerable communities, but it has morphed into a means of enriching hospitals and their affiliated clinics, researchers said in a 2014 Health Affairs report. Hollabaugh said many rural facilities such as Citizens rely on the revenue generated from the 340B drugs to subsidize infusions that have no profit margin.

The number of participating hospitals and their affiliated outpatient clinics has increased significantly since the 340B program was created in 1992. More than 2,600 of the nation’s roughly 6,100 hospitals were participating in the 340B program as of January 2023. That gives them access to discounts that can knock off as much as 50% of a drug’s cost, according to the Health Resources & Services Administration, which oversees the program.

‘People Got Greedy’

The insurance industry argues that hospital markups, especially when made on top of those discounts, have gotten out of control.

“The fact is, people got greedy,” Shannon Cooper, a lobbyist for Blue Cross and Blue Shield of Kansas City, said during a Missouri state Senate hearing in March.

Markups are not unique to 340B hospitals, said Sean Dickson, who helps lead pharmaceutical policy for AHIP, a trade group formerly known as America’s Health Insurance Plans. The markups thrusted on commercial plans are “widely out of line” with what Medicare will pay, he said, and that is driving up costs without providing additional value.

Legislation that targets white bagging hinders an insurer’s ability to rein in such costs, Dickson said, especially when an area lacks competition.

“What we're really trying to focus on here is putting pressure on those markups that are not related to cost or safety,” Dickson said.

Anthem Blue Cross and Blue Shield lobbyist David Smith testified during the March hearing in Missouri that even the idea of white bagging elicited a quick response and that almost every major hospital system in the state said they would drop their prices and come back to the negotiation table.

For now, Citizens Memorial Hospital and other Missouri medical facilities will have to continue to tango with the insurers: Legislation to limit white and brown bagging did not pass during the Missouri General Assembly’s recent session.

Shepard, though, won’t need such legislation.

UnitedHealthcare had been sending her lupus infusion through other pharmacies on and off since 2021, unwilling to cover the drugs if they came from Citizens’ in-house pharmacy. Shepard had to authorize each shipment before it was sent. If she missed the monthly call, she said, it was a “bureaucratic mess” trying to get the medication shipped.

“We are driving unnecessary costs out of the health care system to help make care more affordable, while also maintaining drug safety, effectiveness and quality of care,” UnitedHealthcare spokesperson Tony Marusic wrote.

But after KFF Health News inquired about Shepard’s case, Marusic said UnitedHealthcare stopped white bagging Shepard’s medication to “prevent potential delays in shipping.” And during her latest infusion in June, her hospital was again able to supply Shepard’s medication directly.

“I'm just so relieved,” Shepard said. “I don't have to take phone calls. I don't have to reply to emails. I just show up.”

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

Hydrogel Shows Promise as Treatment for Arthritic Joints

By Pat Anson, PNN Editor

An experimental hydrogel that helps regenerate bone and cartilage tissue is showing promise as a treatment for arthritic joints, according to new research by Chinese and Canadian scientists. The gel is biodegradable and mimics the articular cartilage found in knee and hip joints.

In tests on laboratory animals, researchers say the gel showed signs of repairing articular cartilage 12 weeks after being implanted in rabbits, with no gel remaining and no rejection by the animals’ immune systems, according to findings published in the journal Nature.

Further animal testing is needed, but if the hydrogel proves useful in human trials, it could be used someday as an alternative to knee and hip replacement surgery. About one in four adults in the United States have some form of arthritis, which causes thinning of cartilage and progressive joint damage. Many resort to risky joint repair and replacement procedures.

“Cartilage is tricky,” says senior author Dr. Hongbin Li, a professor in the University of British Columbia’s department of chemistry. “Articular cartilage repair represents an important medical challenge because naturally speaking, it doesn’t repair itself.”

A delicate balance is needed to make biodegradable cartilage implants tough and stiff enough to support muscle-bearing tissues. They can’t be too stiff, or they’ll break when bent too far. Conversely, if they are too soft, they may not be useful in a joint.

In animal studies, researchers say a stiffer version of the gel had better results than a softer version, because it formed a scaffold that was more compatible with bone and cartilage tissue. That provided a physical cue to the body for tissue regeneration.

Dr. Linglan Fu holding the hydrogel

“This just shows how complex this area of research is, and the need to take into account the many different physical and biochemical cues and factors when designing these scaffolds,” says co-author Dr. Qing Jiang, a professor and surgeon at Nanjing University.

The research team used a new approach to stiffen biomaterials in the gel without sacrificing toughness, by physically entangling the chains of a protein.

“These entangled chains can move, which allows energy, for instance, the impact from jumping, to be dissipated, just like shock absorbers in bikes. In addition, we combined this with an existing method of folding and unfolding proteins, which also allows for energy dissipation,” says first author Dr. Linglan Fu, who conducted the research as a doctoral student at UBC’s department of chemistry.

The resulting gel is tough, able to resist slicing with a scalpel, and is more stiff than other protein-based hydrogels. Its ability to resist compression was among the highest achieved by any such gel, according to researchers, who say it compared favorably with actual articular cartilage. The gel was also able to rapidly recover its original shape after compression, as real cartilage does.

Researchers at Duke University are also working on an experimental hydrogel to replace damaged knee cartilage. The gel is made with thin sheets of cellulose fibers infused with a water absorbing polymer, creating a Jello-like material that is surprisingly strong. The cellulose fibers act like the collagen in natural cartilage, giving the gel strength when pulled or stretched.  

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.”

Women, Children and Some Ethnic Groups at More Risk from NSAID

By Pat Anson, PNN Editor

Health experts have known for over a decade that diclofenac, a non-steroidal anti-inflammatory drug (NSAID), raises the risk of heart failure, stroke and other cardiovascular problems. Because of that, oral formulations of diclofenac are only available by prescription in the U.S. and some European nations, although the drug is still widely available as an over-the-counter pain reliever in Asia, Africa and the Middle East.

“Most patients who are using diclofenac have arthritis, and many of them are at risk of heart disease,” says Bhagwat Prasad, PharmD, an associate professor in the Washington State University College of Pharmacy and Pharmaceutical Sciences. “So there is a concern that taking diclofenac may be putting them at even greater risk of cardiovascular events such as heart attack and stroke.”

Prasad is senior author of a study, recently published in the journal Clinical Pharmacology & Therapeutics, that found women, children and some ethnic groups are more at risk from diclofenac because they have low levels of an enzyme that helps metabolize the drug in their intestines.

The enzyme – known as UGT2B17 – is present at much lower levels in women than in men, which helps explain why there are more reports of women suffering heart damage after taking diclofenac. UGT2B17 is mostly absent in children under the age of nine.

Ethnic differences also play a role. In studies on human liver and intestinal samples, WSU researchers found that up to 90% of people of Japanese descent lack the gene for the enzyme, compared to just 20% of Caucasian people.

“No one knew why this heart toxicity is happening in some individuals,” said first author Deepak Ahire, a graduate student in the WSU College of Pharmacy and Pharmaceutical Sciences. “Our study showed, for the first time, that UGT2B17 is important in diclofenac metabolism and suggests that differences in UGT2B17 expression are what makes people’s response to diclofenac so variable, leading to toxicity in some whereas for others the drug simply does not work.”

Ahire and his colleagues hope to confirm their findings in a clinical trial. They also want to work with large hospitals to further study the connection between diclofenac and patients with heart problems. One way they suggest to reduce the risk of cardiovascular problems is to use genetic testing to screen patients who may have problems metabolizing diclofenac.

According to the FDA’s Adverse Events Reporting System, there have been over 27,000 serious medical cases involving diclofenac since 2010, including 2,827 deaths. The number of U.S. cases has tripled in recent years, with women involved in nearly twice as many adverse events as men.

In 2020, the FDA approved the use of diclofenac in Voltaren, a topical OTC gel that contains a small dose of diclofenac absorbed through the skin. The WSU study involved higher dose diclofenac tablets that are taken orally and absorbed in the digestive system. About half the prescriptions written for diclofenac in the U.S. are for tablets.

A large 2018 study in Denmark found that people who used diclofenac were 50 percent more likely to have cardiovascular problems within 30 days of taking the drug than those who took nothing. The risk of gastrointestinal bleeding was also higher. The authors of that study recommended that diclofenac not be available OTC and should only be prescribed with prominent warning labels.

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.

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. 

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. 

NSAIDs May Worsen Arthritis Inflammation

By Pat Anson, PNN Editor

Ibuprofen, naproxen and other non-steroidal anti-inflammatory drugs (NSAIDs) are often recommended as safer and more effective pain relievers than opioids. As evidence, anti-opioid activists often cite a 2018 study that found NSAIDs worked “significantly better” than opioids in reducing pain intensity for patients with osteoarthritis.

That study by VA researcher Erin Krebs, MD, is cited nearly a dozen times in the newly revised CDC opioid guideline, which recommends that patients avoid opioids and use topical or oral NSAIDs for osteoarthritis pain.

But according to a new long-term study, NSAIDs may actually worsen inflammation and weaken cartilage in patients with knee osteoarthritis, contributing to a painful joint condition called synovitis.

“The goal of our study was to analyze whether NSAID treatment influences the development or progression of synovitis and to investigate whether cartilage imaging biomarkers, which reflect changes in osteoarthritis, are impacted by NSAID treatment,” says lead author, Johanna Luitjens, MD, a postdoctoral scholar in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco.

“NSAIDs are frequently used to treat pain, but it is still an open discussion of how NSAID use influences outcomes for osteoarthritis patients. In particular, the impact of NSAIDs on synovitis, or the inflammation of the membrane lining the joint, has never been analyzed using MRI-based structural biomarkers.”

Luitjens and her colleagues enrolled 277 people with moderate to severe osteoarthritis who used NSAIDs for at least one year, comparing them to a control group of 793 patients who were not treated with NSAIDs. All participants underwent an MRI of the knee at the start of the study and had another MRI four years later. 

The results showed no long-term benefits from NSAID use. The initial MRIs found joint inflammation and cartilage quality were worse in the participants taking NSAIDs, and their knee joints deteriorated even more after four years. 

“In this large group of participants, we were able to show that there were no protective mechanisms from NSAIDs in reducing inflammation or slowing down progression of osteoarthritis of the knee joint,” said Luitjens, who will present her findings next week at the annual meeting of the Radiological Society of North America (RSNA).

Luitjens says there are two possible reasons for the ineffectiveness of NSAIDs. One is that the anti-inflammatory effects of NSAIDs may not be sufficient to prevent synovitis. It’s also possible that patients with synovitis who use NSAIDs may be more physically active due to pain relief, which could have worsened their synovitis. 

In either case, Luitjens believes more evidence is needed to support the continued use of NSAIDs as a treatment for osteoarthritis.

“The use of NSAIDs for their anti-inflammatory function has been frequently propagated in patients with osteoarthritis in recent years and should be revisited, since a positive impact on joint inflammation could not be demonstrated,” she said.

The 2018 Krebs study did not look at how NSAIDs affected joint inflammation. It focused mainly on pain intensity, function and quality of life, and found few differences between opioids and NSAIDs, leading Krebs to conclude that opioids were “not superior” to NSAIDs. As my late colleague Roger Chriss pointed out, researchers also found no harmful effects in patients who took opioids for a year. There was no opioid misuse, addiction or overdoses — a detail rarely mentioned in news coverage of the study.

Osteoarthritis is a joint disorder that leads to thinning of cartilage and progressive joint damage. Knee osteoarthritis is quite common and affects over 250 million people worldwide. Nearly 40 percent of Americans over the age of 45 have some degree of knee osteoarthritis.

How Inflammation Can Lead to Chronic Pain

By Drs. Prakash Nagarkatti and Mitzi Nagarkatti, University of South Carolina

When your body fights off an infection, you develop a fever. If you have arthritis, your joints will hurt. If a bee stings your hand, your hand will swell up and become stiff. These are all manifestations of inflammation occurring in the body.

We are two immunologists who study how the immune system reacts during infections, vaccination and autoimmune diseases where the body starts attacking itself.

While inflammation is commonly associated with the pain of an injury or the many diseases it can cause, it is an important part of the normal immune response. The problems arise when this normally helpful function overreacts or overstays its welcome.

Generally speaking, the term inflammation refers to all activities of the immune system that occur where the body is trying to fight off potential or real infections, clear toxic molecules or recover from physical injury. There are five classic physical signs of acute inflammation: heat, pain, redness, swelling and loss of function. Low-grade inflammation might not even produce noticeable symptoms, but the underlying cellular process is the same.

Take a bee sting, for example. The immune system is like a military unit with a wide range of tools in its arsenal. After sensing the toxins, bacteria and physical damage from the sting, the immune system deploys various types of immune cells to the site of the sting. These include T cells, B cells, macrophages and neutrophils, among other cells.

The B cells produce antibodies. Those antibodies can kill any bacteria in the wound and neutralize toxins from the sting. Macrophages and neutrophils engulf bacteria and destroy them. T cells don’t produce antibodies, but kill any virus-infected cell to prevent viral spread.

Collateral Damage

Additionally, these immune cells produce hundreds of types of molecules called cytokines – otherwise known as mediators – that help fight threats and repair harm to the body. But just like in a military attack, inflammation comes with collateral damage.

The mediators that help kill bacteria also kill some healthy cells. Other similar mediating molecules cause blood vessels to leak, leading to accumulation of fluid and influx of more immune cells.

This collateral damage is the reason you develop swelling, redness and pain around a bee sting or after getting a flu shot. Once the immune system clears an infection or foreign invader – whether the toxin in a bee sting or a chemical from the environment – different parts of the inflammatory response take over and help repair the damaged tissue.

After a few days, your body will neutralize the poison from the sting, eliminate any bacteria that got inside and heal any tissue that was harmed.

Inflammation is a double-edged sword. It is critical for fighting infections and repairing damaged tissue, but when inflammation occurs for the wrong reasons or becomes chronic, the damage it causes can be harmful.

Allergies, for example, develop when the immune system mistakenly recognizes innocuous substances – like peanuts or pollen – as dangerous. The harm can be minor, like itchy skin, or dangerous if someone’s throat closes up.

Chronic inflammation damages tissues over time and can lead to many noninfectious clinical disorders, including cardiovascular diseases, neurodegenerative disorders, obesity, diabetes and some types of cancers.

The immune system can sometimes mistake one’s own organs and tissues for invaders, leading to inflammation throughout the body or in specific areas. This self-targeted inflammation is what causes the symptoms of autoimmune diseases such as lupus and arthritis.

Another cause of chronic inflammation that researchers like us are currently studying is defects in the mechanisms that curtail inflammation after the body clears an infection.

While inflammation mostly plays out at a cellular level in the body, it is far from a simple mechanism that happens in isolation. Stress, diet and nutrition, as well as genetic and environmental factors, have all been shown to regulate inflammation in some way.

There is still a lot to be learned about what leads to harmful forms of inflammation, but a healthy diet and avoiding stress can go a long way toward helping maintain the delicate balance between a strong immune response and harmful chronic inflammation.

Prakash Nagarkatti, PhD, and Mitzi Nagarkatti, PhD, are Professors of Pathology, Microbiology and Immunology at the University of South Carolina. They receive funding from the National Science Foundation and the National Institutes of Health.

This article originally appeared in The Conversation and is republished with permission.

FDA Warns Amazon and Walmart About Selling Misbranded Drugs

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has issued another warning to consumers not to purchase or use dietary supplements marketed for pain relief under the brand names “Artri” or “Ortiga” due to potentially dangerous pharmaceutical ingredients. Use of the products has led to liver toxicity and at least one death, according to the agency.

The FDA issued its first first warning about the supplements in January and followed up with a second warning  in April. The latest warning includes Amazon, Walmart and another retailer that continued to sell the supplements, which are marketed with claims that they treat arthritis and osteoarthritis, restore cartilage, and stop joint deterioration.

In a warning letter sent to Amazon last week, the FDA said it had purchased Artri and Ortiga supplements through its website and had them delivered through the company’s delivery service.

Laboratory testing confirmed the supplements purchased through Amazon contained diclofenac, a non-steroidal anti-inflammatory drug (NSAID), and dexamethasone, a corticosteroid used to treat inflammatory conditions.

Neither drug is mentioned on product labels, which list ingredients such as glucosamine and turmeric. The FDA warned Amazon that introducing or delivering a misbranded drug is a violation of federal law.  

“Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction. Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations,” the FDA letter states.

Similar warning letters were sent to Walmart and Latin Foods Market, which had previously issued voluntary recalls for the supplements, but still continued to sell them.

It appears the Artri and Ortiga supplements have now been removed from the websites of all three companies. The supplements were being marketed primarily to Spanish-speaking consumers, with claims they are “highly effective in restoring cartilage” and “fights arthritis.”  

Diclofenac raises the risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal bleeding and damage. When used long term or in high doses, dexamethasone and other corticosteroids can result in serious withdrawal symptoms if a consumer suddenly stops taking them. Both drugs can also interact with other medications.

The FDA encourages healthcare providers and patients to report side effects involving use of the products to its Adverse Event Reporting System. .

Newly Discovered Gut Bacteria Linked to Rheumatoid Arthritis

By Meagan Chriswell, University of Colorado Medicine

Rheumatoid arthritis affects 1 in 100 people worldwide. It causes inflamed, painful and swollen joints, often in the hands and wrists, and can lead to loss of joint function as well as chronic pain and joint deformities and damage. What causes this condition has been unknown.

In our recently published study, my colleagues and I found an important clue to a potential culprit behind this disease: the bacteria in your gut.

Rheumatoid arthritis is an autoimmune condition, meaning it develops when the body’s immune system starts to attack itself. Proteins called antibodies, which usually help fight off viruses and bacteria, begin to attack the joints instead.

The origins of the antibodies that cause rheumatoid arthritis have been an area of study for many years. Some research has shown that these antibodies can start forming at sites like the mouth, lung and intestines over 10 years before symptoms arise. But until now, it was unclear why researchers were finding these antibodies in these particular areas.

We wanted to investigate what could trigger the formation of these antibodies. Specifically, we wondered if bacteria in the microbiome, a community of microorganisms that live in the intestines, might be the ones activating the immune response that leads to rheumatoid arthritis.

Since microbes commonly live at the same sites as the antibodies driving rheumatoid arthritis, we hypothesized that these bacteria could be triggering the production of these antibodies. We reasoned that though these antibodies were meant to attack the bacteria, rheumatoid arthritis develops when they spread beyond the intestines to attack the joints.

First, we sought to identify the intestinal bacteria targeted by these antibodies. To do this, we exposed the bacteria in the feces of a subset of people at risk for developing rheumatoid arthritis to these antibodies, allowing us to isolate just the bacterial species that reacted and bound to the antibodies.

We found that one previously unknown species of bacteria was present in the intestines of around 20% of people who were either diagnosed with rheumatoid arthritis or produce the antibodies that cause the disease.

As a member of the Cherokee Nation of Oklahoma, I suggested we name this species Subdoligranulum didolesgii (“didolesgii” means arthritis or rheumatism in Cherokee) as a nod to the contributions that other Indigenous scholars have made to science as well as the fact that rheumatoid arthritis affects Indigenous people at a higher rate than other populations.

Subdoligranulum didolesgii has not been detected in the feces of healthy people before, and it is currently unknown how prevalent this bacteria is in the general population.

We also found that these bacteria can activate specialized immune cells called T cells in people with rheumatoid arthritis. T cells drive inflammatory responses in the body, and have been linked to the development of different autoimmune diseases.

These findings suggest that these gut bacteria may be activating the immune systems of people with rheumatoid arthritis. But instead of attacking the bacteria, their immune system attacks the joints.

Why This Bacteria?

It is still unknown why people with rheumatoid arthritis develop an immune response to Subdoligranulum didolesgii. But we think it may be the culprit when it comes to rheumatoid arthritis because this bacteria is found only in the intestines of people with rheumatoid arthritis, and not in the intestines of healthy people.

While many immune responses happen in the intestines, they are usually self-contained and do not spread to other areas of the body. However, we believe that a particularly strong intestinal immune response against Subdoligranulum didolesgii could allow antibodies to bypass the intestinal “firewall” and spread to the joints.

To confirm our hypothesis, we gave mice an oral dose of Subdoligranulum didolesgii and monitored their reaction. Within 14 days, the mice began to develop joint swelling and antibodies that attacked their joints.

My colleagues and I hope this research can shed light on the origins of rheumatoid arthritis. Our next goal is to discover how common these bacteria are in the general population and test whether the presence of these bacteria in the gut may lead to the development of rheumatoid arthritis in people.

It’s important to note that antibiotics are unlikely to be helpful treatment for the microbiomes of patients with rheumatoid arthritis. Although Subdoligranulum didolesgii may be triggering an autoimmune response for some people with rheumatoid arthritis, antibiotics eliminate both helpful and harmful bacteria in the gut. Additionally, removing the bacteria won’t necessarily stop the immune system from attacking the joints once it has started.

Nevertheless, we believe that these bacteria can be used as tools to develop treatments for rheumatoid arthritis and hopefully ways to prevent disease from happening in the first place.

Meagan Chriswell is a MD/PhD Candidate in Immunology at the University of Colorado Anschutz Medical Campus. She does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article.

This article originally appeared in The Conversation and is republished with permission.

Epstein-Barr Virus Linked to Autoimmune Conditions

By Dr. Forest Tennant, PNN Columnist 

The Epstein-Barr virus (EBV) is a herpes virus that normally resides after infection as an organism in the epithelial tissues of the throat and lymphocytes. Most humans carry the virus and blood tests will often show low levels of EBV antibodies.  

Recent research has determined that in some people, for unknown reasons, the virus will reactivate and/or produce antibodies that carry toxic elements to tissues in the body such as the spinal cord. EBV infected lymphocytes can then cross the blood brain barrier and enter the brain, spinal cord and spinal fluid.  

This situation is now referred to as “EBV autoimmunity” and is reported by multiple medical institutions and researchers to be a major, causative factor in multiple sclerosis, systemic lupus, rheumatoid arthritis, and about 2% of the world’s cancer cases.  

Autoimmunity and Arachnoiditis 

Adhesive Arachnoiditis (AA) has long been known to be an inflammatory disease in which cauda equina nerve roots become adhered by adhesions to the arachnoid lining of the spinal canal. We have also long suspected that autoimmunity was a factor in AA, but until now there has been no compelling reason for this belief. 

In our review of over 800 confirmed cases of AA by magnetic resonance imaging (MRI), along with medical history and symptoms, a single fact emerged. Almost all cases had multiple herniated or protruding intervertebral discs prior to the development of AA. These discs were often in both the cervical and lumbar-sacral regions of the spine.  

Epidural injections, spinal taps or surgery often appeared to accelerate the development of AA. But further research revealed that most persons with MRI-documented AA had other medical conditions known to be common in persons with autoimmune disease. These included: burning mouth or feet, small fiber neuropathies, fibromyalgia, carpal tunnel, Hashimoto’s thyroiditis, Sjogren’s (dry eyes), Raynaud’s, irritable bowel, migraine, temporal mandibular joint pain (TMJ), chronic fatigue, arthritis, Tarlov cysts, mast cell conditions, and POTS. Persons with a genetic connective tissue disease of the Ehlers-Danlos Syndrome type were also significantly affected.  

From this we concluded that AA is usually a late-stage component of a multisystem, autoimmune, inflammatory disease. 

Between our realization that AA is associated with multiple medical conditions and the discovery that EBV causes significant autoimmunity, we began EBV testing in persons with MRI-documented AA. Essentially every case showed very high (sometimes above laboratory testing ability) antibody levels. Some showed evidence of EBV reactivation. Another finding has been that some persons with AA have high levels of cytomegalovirus, other strains of herpes, and/or Lyme. 

EBV is now known to cause a multitude of autoimmune conditions. Our studies indicate that AA is a late-stage development of an autoimmune disorder at least partially caused by EBV. This discovery leaves us little option but to recommend that each person with AA determines if they have multiple autoimmune manifestations including herniated discs and, if so, seek EBV antibody testing and become knowledgeable about control measures. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from an updated bulletin recently issued by the Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

New Treatment Offers Hope for Lupus Patients

By Dr. Eric Morand, Monash University, Australia

When real patients have unprecedented positive outcomes to a new treatment, it’s tempting to talk about it as “breakthrough” for medical science. This describes the excitement around a new report from researchers in Germany of a radical new treatment for lupus.

The patients in the study – five people with severe lupus – went into remission following pioneering CAR T-cell treatment, which uses genetically altered cells.

What is lupus, why is this such big news, and what could it mean for other patients and diseases?

Around 5 million people are affected by some form of lupus worldwide. The most common form of lupus is technically known as systemic lupus erythematosus. Though not widespread, it is more common than multiple sclerosis (MS). Both are “autoimmune” diseases where the immune system attacks its owner instead of the germs it is supposed to fight.

MS is an autoimmune disease where the immune system attacks nerve tissue. In contrast, lupus can affect any organ in the body. Treatments for lupus have been so poor for so long that even wealthy and famous people with the disease – like pop star and actor Selena Gomez – have had organ failure resulting in the need for a kidney transplant. A lot of complicating factors have made it hard to improve outcomes for people with the disease.

Firstly, the variety of tissues lupus can affect means no two patients are exactly alike. Diagnosis is hard and often delayed. This also means we researchers have to deal with a lot of complexity as we try to work out what is causing the disease. This clinical variability makes measuring improvement in response to treatment difficult, and many clinical trials have likely failed due to measurement issues.

Second, there is variation between patients in which part of the immune system goes wrong. This means different patients will need different treatments – and we still do not know with certainty how to get this right. But progress is happening fast.

Innate and Adaptive Immunity

The immune system is in two parts, innate and adaptive.

The “innate” immune system responds fast but non-specifically to viruses and other germs that hit the body with a slug of germ-killing inflammatory proteins. The “adaptive” immune system is slower but more precise. It swings into action after the innate immune system and provides long lasting defense against the invading germ.

When you are vaccinated against a disease (such as COVID), the fever and aches you might get in the first day or two is your innate immune system at work. But the long-lasting protection from antibodies is provided by a part of your adaptive immune system, a key part of which is delivered by cells called “B cells”.

In lupus, both parts of the immune system are involved, and both have been successfully used to develop medicines. Earlier this year, the Therapeutic Goods Administration approved anifrolumab, a drug which blocks “interferon”, a crucial protein made by the innate immune system.

Another drug which works on B cells of the adaptive immune system, called belimumab, was approved a few years ago. Unfortunately, neither drug is on Australia’s Pharmaceutical Benefits Scheme yet, so access is extremely limited.

However, we now know that interferon and B cells are both important, and so very strong treatments that almost completely eradicate either could be useful. That is where this potential new treatment comes in.

Already Used to Treat Cancer

Treatments to destroy B cells are used in cancers like lymphoma. The most powerful of these uses CAR-T cells, which train a type of natural cell to be an assassin of the B cell.

CAR-T medicines are highly complex to make, and extremely expensive – but they work.

T cells are collected from the blood, then re-engineered in a special laboratory.

Now, this new report shows targeting B cells using this approach could be effective in lupus too. Building on a first-ever patient treated in this way by the same group a year ago, doctors in Germany created a “homemade” CAR-T treatment and used it in five patients with severe lupus.

Remarkably, all five patients had near complete eradication of disease, allowing them to stop conventional medicines, like steroids, with potentially harmful side effects.

What This Means for Other Patients

So what does it mean for patients in Australia? Well, most centres aren’t able to make their own CAR-T treatments, so delivering this potential treatment will require a commercial approach.

However, it might be quicker to market than other treatments in development as it takes a proven approach into a new disease, rather than being new from the ground up.

One day we might even be able to extend such treatments to other autoimmune diseases, like MS, where B cell-directed treatments have been helpful, as well as in lupus.

This would need to be balanced against risk. Importantly, short term side effects of CAR-T treatment (which include brain and bone marrow problems) can be severe. For this reason, such a treatment would only be used for the most severe cases in which standard treatments have failed, like the patients in the German trial.

Long-term side effects are also unknown at this time, and of course suppressing the immune system so profoundly in the setting of a pandemic is not without major risks.

Formal trials of a commercial CAR-T medicine for lupus are in the advanced planning stages already, and Australia is likely to be front and centre of these due to our lupus expertise and trial-friendly regulatory environment. With all these advances, we can at last tell our patients, and our friends and family with lupus, that there is light at the end of what has been a very long tunnel.

Eric Morand, MD, is a clinical rheumatologist and Head of the School of Clinical Sciences at Monash Health, Monash University in Australia.  Dr. Morand consults with companies involved in lupus drug development, including Novartis and AstraZeneca. He receives funding from Australia’s National Health and Medical Research Council and Lupus Research Alliance US, and is a Director of Rare Voices Australia.

This article originally appeared in The Conversation and is republished with permission.

Older Adults Look Beyond Western Medicine for Help With Joint Pain

By Pat Anson, PNN Editor

Most older Americans use over-the-counter pain medication and exercise to manage their joint pain, according to a large new survey of adults over age 50. Marijuana, opioids and non-steroidal anti-inflammatory drugs (NSAIDs) were rated the most effective pain relievers among those who used them.

The survey of 2,277 adults aged 50 to 80 was conducted online and over the phone early this year as part of the University of Michigan’s National Poll on Healthy Aging. It found that many older adults looked beyond conventional Western medicine for help with their joint pain, but few talked to their doctors about it.

Eight out of ten people (80%) with joint pain said they were confident they could manage it on their own. The survey found that two-thirds (66%) used over-the-counter pain relievers such as NSAID’s or acetaminophen.

The vast majority (89%) also used non-pharmacologic treatments to manage their symptoms, including exercise (64%), massage (26%), physical therapy (24%), splints or braces (13%), and acupuncture or acupressure (5%).

One in four (26%) said they take supplements, such as glucosamine, chondroitin and turmeric, while 11% use cannabidiol (CBD) products and 9% use marijuana.

Only a minority use prescription-based treatments, such as non-opioid pain relievers (18%), steroid joint injections (19%), oral steroids (14%), opioids (14%) and disease-modifying anti-rheumatic drugs (4%).

NATIONAL POLL ON HEALTHY AGING

“There are sizable risks associated with many of these treatment options, especially when taken long-term or in combination with other drugs. Yet 60 percent of those taking two or more substances for their joint pain said their health care provider hadn’t talked with them about risks, or they couldn’t recall if they had,” said Beth Wallace, MD, Assistant Professor of Internal Medicine at Michigan Medicine and a staff rheumatologist at the VA Ann Arbor Healthcare System.

“This suggests a pressing need for providers to talk with their patients about how to manage their joint pain, and what interactions and long-term risks might arise if they use medications to do so.”

Both NSAIDs and oral steroids have health risks, especially for older adults. Chronic NSAID use can worsen medical conditions such as hypertension, kidney disease, gastrointestinal bleeding and cardiovascular disease. Short-term use of oral steroids is associated with similar problems, as well as increased risk of developing diabetes, cataracts, insomnia, depression, and anxiety.

The risks are even greater if NSAIDs and oral steroids are taken together. Despite this, about one in four older adults taking oral steroids for joint pain said they had not discussed the potential risks with their provider.

Joint pain is common among older adults, including those who have not been formally diagnosed with arthritis. Nearly half of those surveyed reported joint pain that limited their daily activities, but few rated their symptoms as severe and most regarded joint pain as a normal part of aging.

Those with severe joint pain were somewhat fatalistic about it, with nearly half (49%) agreeing with the statement that “there is nothing a person with arthritis or joint pain can do to make their symptoms better.” Only 10% of those with mild joint pain agreed there was nothing they could do about it.

“Older adults with fair or poor physical or mental health were much more likely to agree with the statement that there’s nothing that someone with joint pain can do to ease their symptoms, which we now know to be untrue. Health providers need to raise the topic of joint pain with their older patients, and help them make a plan for care that might work for them,” said poll director Preeti Malani, MD, a Michigan Medicine physician who specializes in geriatrics and infectious diseases.

Why I Still Take Precautions Against Covid

By Victoria Reed, PNN Columnist

We are three years into the Covid-19 pandemic, and while life has still not returned to normal, it’s understandable for people to be tired of hearing about the virus and less concerned about catching it. Scientists know more about covid and have developed tools to treat and even prevent the most serious outcomes.

But many of us who are suffering from chronic illness or chronic pain are still wearing masks, practicing social distancing and taking other precautions.

As I go out and about in my daily life, I’ve noticed that mask use is somewhat minimal. People don’t seem to be as concerned about the virus and its variants, even as cases are skyrocketing again. I’m one of the few who still wears a mask in crowded indoor places, airplanes and restaurants.

Fortunately, I have not yet been infected with covid. I attribute that to always being cautious in public (sometimes even outside) and when around family members who I know aren’t taking precautions. Being vaccinated and boosted is another layer of protection I believe has helped me.

The choice to be vaccinated is a personal one and should not be looked at as a political issue or be a source of ridicule. The same goes for mask use. Sometimes people look at me funny because I still wear a mask, but I am “allowed” to do that, just as others are equally allowed to stop wearing theirs.

I don’t judge people who choose not to wear a mask, and conversely, I shouldn’t be judged for wearing one.

Part of my caution comes from having a dysfunctional and overactive immune system, which is altered by a medication I take to control symptoms of rheumatoid arthritis (RA). This medication suppresses a certain part of the immune system that is implicated in the development of RA.  Rheumatoid arthritis primarily attacks the joints, but can also attack the heart, lungs and eyes.

Having to take this particular med (commonly called a biologic), makes me more vulnerable to contracting all types of infection, including covid. It also makes it more difficult to recover from infections and can lead to serious or even deadly complications. 

In addition, the threat of possibly ending up with long covid, when symptoms linger for months or longer, is a concern of mine, especially since fatigue is a major part of long covid syndrome. Profound and disabling fatigue is also a feature of RA and fibromyalgia, so anything I can do to prevent another illness that causes fatigue is important to me. Even mild cases of covid can cause long covid, according to researchers.

Covid can also lead to physical complications. Studies have shown that the virus can cause neurological problems, difficulty breathing, joint or muscle pain, blood clots or other vascular issues, chest pain and unpleasant digestive symptoms.

Furthermore, the virus has been associated with increased psychological problems, such as depression and anxiety. The media has reported on the unfortunate suicides of people who had been suffering from long covid and were unable to get any relief besides ending their own lives.

In the long term, it remains to be seen how covid will affect the millions of us who are already suffering from chronic pain and illness. Fortunately, there are treatments that help with the symptoms and recovery for the majority of people who become infected. There are also medications that can save the lives of those who are at high risk of severe illness.

As more time passes, I’m sure other treatments will emerge, and I’m hopeful that as a chronic pain sufferer with multiple chronic illnesses, I will be okay if I do someday end up getting sick with covid.

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