FDA Shutting Down Fentanyl Access Program for Cancer Patients

By Pat Anson

The U.S. Food and Drug Administration is shutting down a pain management program that helped supply fentanyl medication to patients suffering from severe cancer pain.

In a notice published on the FDA’s website for its Transmucosal Immediate-Release Fentanyl Medicines (TIRF) program, the agency said that all TIRF medications “will be discontinued” on September 30.

The program was created due to the risks associated with fentanyl, a synthetic opioid 100 times more potent than morphine. The FDA has required a Risk Evaluation and Mitigation Strategy (REMS) for TIRF medications since 2011.

“Patients currently enrolled in the TIRF REMS may continue their TIRF therapy while supplies remain,” the FDA notice states. “Prescribers currently certified in the TIRF REMS may continue to prescribe TIRF therapy for their currently enrolled patients while supplies remain but must begin working with their patients to transition to other non-TIRF treatments.”

TIRF-REMS has also stopped accepting new applications from patients, prescribers, pharmacies and wholesale drug distributors. According to the FDA, 4,722 patients received a TIRF medication in 2017, but there are currently fewer than 150 patients getting them.

Illicit fentanyl is a notorious street drug that is involved in about 70% of fatal U.S. overdoses. But prescribed fentanyl has long been an essential medicine for patients suffering from surgical pain, breakthrough pain and cancer-related pain. It is also prescribed “off-label” for other types of severe pain.

FDA TIRF-REMS UPDATE

The FDA’s decision to end TIRF-REMS came after Cephalon, which is owned by Teva Pharmaceuticals, notified the agency in August that it was discontinuing production of Actiq, a fentanyl lozenge, and Fentora, a fentanyl buccal tablet. Both medications are absorbed into the bloodstream quickly through the mouth to provide immediate pain relief.  

(Update: On September 16, FDA published a brief statement confirming that TIRF medications are being discontinued, but said the TIRF-REMS program would continue operating while supplies last.

“The TIRF REMS will remain in place as long as the manufacturers’ new drug applications or abbreviated new drug applications are approved, regardless of the marketing status of the products,” the agency said. “FDA did not request this discontinuation. It is important to note that FDA does not manufacture medicine and cannot require a pharmaceutical company to make a medicine, make more of a medicine, or change the distribution of a medicine.”

Teva did not respond to requests for comment about the discontinuations. Actiq and Fentora are expensive medications. A supply of 30 Actiq 400 mcg lozenges costs about $3,500, while 28 tablets of Fentora 100 mcg will cost about $2,300.

“I had very few patients on these medications in the past, since no health insurers would actually pay for them,” said Chad Kollas, MD, a palliative care physician and pain policy expert. “I think it’s problematic that the TIRF-REMS website isn’t offering recommendations for an effective alternative approach for the patients currently using TIRF products.”

Opioid litigation and the risk of further liability may have influenced Teva’s decision to discontinue TIRF medication. The company agreed to pay $4.24 billion to settle allegations that it illegally marketed opioids and failed to prevent their diversion.

Last year, Teva discontinued production of immediate release oxycodone as part of a strategic shift away from less profitable generic drugs.

Selling Us Short With Long COVID

By Cynthia Toussaint, PNN Columnist

After four years of diligently following CDC guidelines to avoid COVID-19 like the plague, it finally caught up with me. And, like my doctors presumed, I now have Long COVID.

That being said, two months into what I was assured would be worse than a living death, I have to shake my head at how colossally the powers that be underestimate the toughness of women in pain.

After my partner John and I had to cancel a 2020 dream trip to Iceland due to my cancer and the COVID shutdown, we bunkered down because my doctors said I had no wiggle room with chemotherapy – and that likely saved my life.

When I had remission from cancer a second time in 2022, those same doctors shared that while the COVID virus might no longer end me, I’d surely get Long COVID, which would leave me barely able to breathe or move for the rest of my life. This was backed up by many articles and programs that I devoured. I felt doomed.

These were some of my darkest, most dire years – which says a hell of a lot. Already isolated for 44 years from profound disability caused by Complex Regional Pain Syndrome, I felt ever more the odd one out, still wearing a mask and saying no to virtually every invitation.

But with time, the expert prognosis wasn’t adding up – as I watched most of my friends with pain and other chronic illnesses get COVID, only to recover and return to their baseline of “normal.”

Iceland was still beckoning – it’s glaciers, waterfalls, active volcanoes, charming capital city, unique horses and white nights. Come spring this year, my desire trumped all else. I yearned to be amongst the living again, so John and I booked a trip for early June.

We followed the recommended CDC guidelines for travelers, only to land in Iceland sick as dogs. So much for playing by the rules!

Being out of country, we didn’t have any COVID tests, and because we weren’t on our deathbeds as promised, we assumed we’d picked up a run-of-the-mill flu bug.

Flinging off our high temps, chills and fatigue (to name just a few of our symptoms), there was no staying in bed slurping chicken broth and taking Tylenol for us. We muscled on through our trip – and fell in love with this other-worldly land.

Testing Positive

A couple days after our return, John took what I considered a pointless COVID test – and I was floored when he shouted that we’d joined the ranks of the infected by testing positive. More surprising, on day ten of what was supposed to be a worse-than-death sentence, I was functioning fairly well. I could breathe fine and was swimming most of my laps. No hospital, no ventilator, no ICU, no death certificate.

Yes, I’ll give the docs a point or two, if you’re keeping score at home. Eight weeks post-infection, I’ve developed the aforementioned Long COVID, which has triggered my chronic fatigue syndrome, accompanied by a litany of life-compromising symptoms that ebb and flow.

Sometimes I feel fine and other times I uncharacteristically fall asleep from post-exertion malaise. I’m burdened by debilitating migraines and dizziness, and am still hoarse and wonder when I’ll be able to sing clearly again. Still, unless something changes drastically, long-hauling didn’t come as advertised.   

So now I’ve moved from fear of the worst to hope for better days ahead. But with that hope, I’m still mightily pissed off.

I’m livid that doctors and researchers put me into a catastrophic, doomsday mindset during the pandemic. The picture they painted for people like me -- with high-impact chronic illness and a cancer diagnosis -- was black as ink, with no exceptions.

I lived accordingly with terror, dread, fear, high-anxiety and isolation-induced depression. Missed holiday events, get-togethers and no traveling rounded out the experience.

Not being around people, while going through cancer twice, was the apex of these dark years. That inhumanity strained my ability to heal when I needed it most.

Humans are social creatures and inclusion is how we’ve evolved so that we can feel safe, contented and well. Without connection, our mental health suffers, which is just as important as our physical health.

I’m now critically reassessing the necessity of my “bunkering years.” Were they needed? Or did I spend four and a half years of my hard-fought-for life alone for no damn good reason?

CYNTHIA GREETS A FRIEND IN ICELAND

I recently met two lovely women, both with pain and autoimmune issues, who recovered from Long COVID in less than a year, no worse for the wear. I wonder why none of the experts told me that recovery was a possibility, even a likely one. Why was I only given the worst-case scenario? Safe to say if I’d had the facts, I would have poked my head out of the hole far sooner than I did. And when you’re still in the red zone with cancer, every day, every outing COUNTS.

While it’s super hard to watch friends and family recover quickly from COVID, while I trudge on sick and with no end in sight, we with high-impact pain know our lot is always a ton more challenging than normies. That’s money in the bank, a sure bet. Luckily, we’re experts at suffering and coming out the other side.  

But let’s not bury the lead. I’m freer than I’ve been in years. These days I’m doing less mask wearing, so bring on the intimate get-togethers in a cramped, under-ventilated house (ok, ok, maybe after the summer surge next to an open window.) Hugging, kissing and touching those near and dear are back on my to-do list.

Before COVID, John would joke: “I always know when Cynth’s worked a room – because everyone’s got lipstick on their face.” Going forward, look out for the high-gloss and ruby red.       

Whoa, Nelly! Let me be clear. How one takes on COVID is an individual experience – and I respect everyone’s choice. I know women in pain who’ve never put a mask on or vaccinated, and others who plan to mask-up for the rest of their lives while counting the days till the next booster.

We all need to do what makes us feel safe. And, like me, sometimes our choices change with time and information.       

My smile has a deeper meaning these days. Exiting my Y just after our return from Iceland, a friend I adore at the front desk, Solange, excitedly commented, “You look much better, Cynthia!”

I had to laugh, while sharing that I was still getting over COVID. When she quizzically stared, it then hit me. I wasn’t wearing a mask!

A moment of wow struck us both. I’ve known this woman for two years and we’ve shared countless conversations, but that was the first time she’d ever seen my face.              

Women in pain, we’re tougher than the rest. The doctors, the researchers, the experts, the “know-it-alls” always seem to sell us short, either under-protecting because they think we make a mountain out of molehill – or over-protecting because they don’t think we know what’s in our own best interest.

Screw ‘em. They don’t get us, never will. And a once-in-a-century pandemic isn’t going to knock us out. That’s something to smile about.   

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 (CRPS) and multiple co-morbidities for over 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.” 

Study Raises Questions About Use of Opioids by Cancer Patients

By Pat Anson, PNN Editor

A new study led by researchers in Australia is raising questions about the effectiveness of prescription opioids in treating cancer pain, saying the evidence from clinical trials is inconclusive or “largely lacking.”

Opioids are a common treatment for cancer pain and are often considered indispensable, particularly near the end of life or in palliative care when pain can be most severe. Virtually all medical guidelines – including the CDC’s – specifically exempt cancer patients from any recommended limits on opioids.

But the new study, published in A Cancer Journal for Clinicians, rejects that long-held medical practice, suggesting that opioids work no better than a placebo in relieving cancer pain and that non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin may be just as good or better.

The study examined findings from over 150 clinical trials involving opioids and cancer, and found that most were not blinded or placebo-controlled. That’s a recurring issue in pain research due to the ethical issues involved in giving patients an ineffective or non-existent analgesic, particularly if they have a terminal illness. Although that shortcoming is widely understood and accepted – the authors of this new study view it as lack of evidence.

“Opioids are the most commonly used treatments for cancer pain management, and, although we might have assumed that there were placebo-controlled trials to support this widespread practice, our findings highlight that the evidence is largely lacking,” wrote lead author Christina Abdel Shaheed, PhD, Senior Academic Fellow at the University of Sydney School of Public Health, Faculty of Medicine and Health.

“There was an absence or paucity of placebo-controlled trials for some of the most commonly used opioid analgesics for cancer pain, including morphine, methadone, buprenorphine, fentanyl, hydromorphone, oxycodone, and tramadol.”

Ironically, Shaheed and her co-authors found that “weaker” opioids such as tapentadol and codeine may work better for cancer pain than the more potent opioids.

They also suggest that NSAIDs and antidepressants are more effective and have fewer side effects for someone with “background” cancer pain who is not nearing the end of life. In effect, they’re saying that opioids are only good if you’re dying.

“In practice, opioids are indispensable for intractable pain and distress at the end of life. What is worth highlighting is that non-opioids, particularly NSAIDs, are surprisingly effective for some cancer pain, and may avoid the problems of dependence and waning opioid analgesia over time,” said co-author Jane Ballantyne, MD, a retired anesthesiologist and professor at the University of Washington.

Ballantyne is Vice President of Clinical Affairs for Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that advised the CDC during the drafting of its controversial 2016 opioid guideline. Like several other PROP members, Ballantyne has worked as a paid expert witness for law firms involved in opioid litigation.

This is not the first time Ballantyne has said that opioids should be used more cautiously when cancer patients are not terminally ill. In 2007, she wrote an op/ed saying that cancer treatment and survival rates had improved so much that opioids should no longer be viewed as the go-to treatment for cancer pain.  

“Cancer was once an explosive, typically terminal disease and became the prototype for end-of-life opioid pain treatment. However, cancer is no longer such an explosive disease, and many cancer sufferers can now expect to have a prolonged, even normal, lifespan. They may need pain treatment, but this treatment should not be modeled on palliative care paradigms,” Ballantyne wrote.

Many cancer patients are already struggling to get pain relief. A recent study found the number of cancer patients seeking treatment for pain in U.S. emergency departments has doubled in recent years. Nearly half of those ER visits were deemed preventable -- meaning they could have been avoided if the patient has received proper pain care earlier.

Other studies have documented how opioid prescriptions and doses have declined significantly for U.S. cancer patients. The Cancer Action Network warned there has been “a significant increase in cancer patients and survivors being unable to access their opioid prescriptions.” 

Are you a pain patient who has trouble getting your opioid prescriptions filled? There’s still time to take PNN’s survey on how opioid shortages are affecting patients at pharmacies. Click here to take the survey, which should only take a few minutes.

Stem Cell Discovery Could Revolutionize Spine and Cancer Care

By Pat Anson, PNN Editor

The discovery of a new type of stem cell could revolutionize the treatment of spine disorders and slow the progression of some cancers, according to a groundbreaking study published in Nature.

Researchers from Hospital for Special Surgery (HSS) and Weill Cornell Medicine say the vertebral stem cells they found in human spines appear to play a key role in spinal health and in the metastasis of cancerous tumors as they spread through the body.

“There are two big takeaway discoveries that were made here. One is that we have discovered a stem cell that forms the spine and maintains the spine throughout life. This cell makes all the other cells that mineralize the spine,” said lead investigator Matthew Greenblatt, MD, associate professor of pathology and laboratory medicine at Weill Cornell Medicine.

“The second discovery here is that we found that this stem cell drives tumors. Breast cancer is what we focused on here, but likely also prostate cancer.”

Cancer experts have long believed that tumors metastasize to other parts of the body simply through blood flow. But Greenblat and his colleagues found that vertebral stem cells essentially attract cancer cells to the spine. That could explain why some cancers are first detected in the spine after they have metastasized from the breast, prostate and lung.

“Because we found that molecular ‘come here’ signal that's made by this spine stem cell, that gives us the ability to block that signal therapeutically. And that's something we're working on to try to prevent or treat established spine metastases,” Greenblatt told PNN.

Boosting Bone Health

Researchers say their discovery could also lead to breakthroughs in spinal health, by giving physicians a way to speed up recovery from spinal injuries and slow the progression of degenerative conditions such as osteoporosis, a disease that makes bones thinner, less dense and more likely to fracture.

For example, someone with degenerative disc disease could have their vertebral stem cells harvested, reproduced in a laboratory, and then reinjected to stimulate the growth of new bone. In animal tests, human vertebral stem cells helped laboratory mice form new bones in their spines.

“We can show that they formed basically little vertebral bones when those patient cells are put into mice, which really tells us that we found the right cell. And we can work with the cell transplant and retain stability to make new bone,” said co-author Sravisht Iyer, MD, a spine surgeon at HSS.

“I think kind of figuring out how to recruit the cells or how to how to encourage them to form more bone is going to be an important area or avenue of investigation for us, as a way to help people and protect people against what is a very morbid condition for them.”

Iyer says early treatment with vertebral stem cells could help someone with osteoporosis or a spine fracture, but wouldn’t necessarily benefit patients suffering from more advanced cases of bone loss.

“By the time people are presenting to us with spine pain, they usually have some element of compressive pathology or a degree of degeneration, which will likely require some intervention, whether that's surgery or epidural injection,” Iyer said.

“Where this work I think can really help push us forward is once you get those at-risk patients, they probably will need a surgery because a lot of degeneration is asymptomatic, and by the time they get to you they probably need something, but maybe you can prevent the second, third or fourth operation or intervention.”

More research and human studies are needed before the stem cells can be used in clinical settings to improve bone health and slow the metastasis of cancer cells. But researchers are excited by what they’ve learn so far.    

“We predict this discovery will lead to the targeting of these cells to disrupt the function and ultimately reduce the spread of cancer to the spine," said Greenblatt.

My Story: A Bone Cancer Survivor’s Search for Pain Relief

By Kristen Hernandez

The past three weeks have been the most challenging since my cancer diagnosis 20 years ago. Shortages of opioid pain medication have taken their toll, costing me weeks of productivity, mental and physical anguish, and a negative bank account.

When I was 25, I had a different life -- a career as a corporate travel consultant for RCA Records in New York City. I clawed my way out the ghettos of the Bronx and into corporate America, and purchased my first home in the suburbs of Long Island.

But everything changed when I was diagnosed with an insidious and rare form of bone cancer called Chordoma. It’s a literal one-in-a-million disease, with just one in every million individuals diagnosed with it each year.

The type of Chordoma that chose me is extremely rare, due to the tumor’s location: it was housed inside the L3 vertebra of my lumbar spine. And it was extraordinarily painful.

KRISTEN HERNANDEZ

Because Chordoma doesn't respond to chemotherapy or radiation, surgery is the only treatment. To save my life, surgeons reconstructed my spine, replacing a vertebra with a titanium cage and filling it with bone graft from my hip.

They also replaced a spinal disc with two more titanium cages, adding 16 rods and 20 screws for reinforcement.

My spine today resembles a nightmarish ladder that Tim Burton might have created.

After eight reconstructive spinal surgeries, I was given a miraculous drug called OxyContin. Doctors did not think I’d ever walk again because they needed to sever the nerves to my legs so that they could remove the cancer-infected bone.

Because of OxyContin, I was able to take my first step and eventually walk. This was in 2005, at the beginning of the so-called opioid crisis.

Once I relocated to Florida, pain management doctors refused to prescribe OxyContin to me, fearing lawsuits and scrutiny from law enforcement. Regardless of how much I protested, I was dismissed as if I was the problem, instead of having a problem.

At the time, pill mills were everywhere in Florida. They were places where if you had cash, you could get any medication. It’s also why there’s a such stigma today against chronic pain sufferers.

Eventually, I found a legitimate pain management doctor in Fort Lauderdale. Instead of OxyContin, he changed my regimen to a fentanyl patch, along with oxycodone/acetaminophen tablets (Percocet) for breakthrough pain, essentially replacing one opioid with two. That was my pain management routine for the past twelve years, until recently.

When I went to a Walgreens pharmacy this past June, I was shocked to hear, “Sorry, oxycodone is on back order, and we have no idea if or when it’s coming back.”

Opioid Shortages

Shortages of oxcodone, hydrocodone and other opioids are increasing around the country. And there is zero advance notice from pharmacies about when a prescribed medication will be available. Patients like me who suffer from severe pain are forced to go through withdrawal until the pharmacy restocks.

It’s a nightmare to deal with. Pain patients are usually not prepared for the sudden halt in medical care. Even the smallest disruption can have devastating effects, such as loss of productivity, reduced quality of life, and a diminished social life. Even smiling takes an effort.

Patients are always the last to know when there’s a problem with a prescription. Like thousands of others, I made frantic phone calls to my doctor, who scrambled to find an alternative medication. Without consulting me, he wrote a script for hydrocodone/acetaminophen (Vicodin), a medication I had never taken before. That’s when my three-week nightmare began. Because I wasn’t prepared to handle the ineffectiveness of hydrocodone for bone pain, my condition quickly began to decline.

Each morning, the first sensation I get feels like someone dug their elbow into my lower back all night long. It’s so fierce, it takes my breath away. Then, when I stand and all the titanium in my spine settles, the nerves hum in my legs and a crawling sensation shoots up and down, vibrating constantly.

As the morning coffee brews, I get the “poke” sensation. Due to a 200-pound weight loss, there’s a rod that sticks out of my thoracic spine area that rubs up against everything -- the bed, couch, office chair, car seat, everything. It’s miserable because it’s there forever.

Hydrocodone/acetaminophen tablets seem to exacerbate those symptoms, causing my body to swell and tighten into a ball of pressure, while the pain intensified. My productivity stopped and the bills began to pile up. Working while experiencing severe spinal and bone pain is nearly impossible.

After a recent candid discussion with my pain management doctor, we formed a “Plan B.” We’re trying oxycodone without acetaminophen to see if that works better. Having a backup plan with an alternate list of medications is essential with the shortages and fear-based drug culture we’ve found ourselves dumped into.

Government regulators and health policies have failed the people who suffer the most in this country, who often live with medical conditions they cannot control, like cancer. They’ve failed us time after time, filing lawsuits and adopting guidelines that make it harder for us to get prescription opioids – even though over 82% of opioid overdoses are caused by illicit fentanyl and other street drugs.

Patients who suffer from chronic pain all have one common goal: relief. When that relief is interrupted, and access to crucial therapies and drugs is denied, you leave us with few choices. We can either live our lives without pain relief or seek out riskier alternatives. Those are not good choices.

Kristen Hernandez is a freelance journalist and creative nonfiction writer living in South Florida. 

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.

Drugmakers Are Abandoning Cheap Generics

By Arthur Allen, KFF Health News

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

ISABELLA MCDONALD AND HER FATHER, BRENT

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

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

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

Generics Manufacturers Are Pulling Out

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

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

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

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

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

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

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

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

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

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

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

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

Should Government Step In?

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

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

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

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

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

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

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

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

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

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.”

Chemotherapy and Opioid Shortages Impacting Cancer Care

By Pat Anson, PNN Editor

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

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

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

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

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

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

Hydrocodone Shortage

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

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

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

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

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

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

Cannabis Helps Relieve Cancer Pain

By Pat Anson, PNN Editor

Good news for patients suffering from cancer pain or side effects from cancer treatment. Two new studies found that medical cannabis helps relieve cancer pain, and offer some lessons to non-cancer patients about which cannabis products might work best for them.

The first study involved 358 adult cancer patients enrolled in a cannabis registry created by the Quebec Medical College. The patients were being treated for a variety of different cancers and were referred to the registry by their doctors. The primary complaint of most was pain (72%), with others experiencing symptoms such as nausea, anorexia, weight loss, anxiety and insomnia.

Participants were assigned to one of three groups, using cannabis products that were high in tetrahydrocannabinol (THC), high in cannabidiol (CBD), or a balanced blend of THC and CBD. The cannabis was ingested orally, through inhalation or a combination of the two. Patients were monitored and assessed every three months for a year.

The study findings, published in the journal BMJ Supportive & Palliative Care, show that pain levels dropped significantly after 3, 6 and 9 months, with pain slightly worsening after 12 months. Patients using balanced THC-CBD products reported the most pain relief, and many were able to reduce their use of opioids and other medications.

A small percentage of patients suffered adverse events from cannabis, such as sleepiness, dizziness and fatigue. Only 5 patients had side effects so severe that they stopped using cannabis.

Researchers concluded that medical cannabis should have a role as a complimentary pain management option in cancer patients who don’t get adequate relief from conventional analgesics.

“We found MC (medical cannabis) to be a safe and effective treatment option to help with cancer pain relief. THC:CBD balanced products appear to perform better as compared with THC-dominant and CBD-dominant products. Furthermore, we observed consistent decreases in medication burden and opioid use in our patient population,” researchers said.

Less Pain = Better Cognition

The second study, by researchers at University of Colorado Boulder, involved 25 cancer patients being treated by oncologists at the CU Anschutz Medical Campus. The patients’ pain levels, sleep patterns, cognition and reaction times were assessed at the start of the study; and they were asked to select edible products from a cannabis dispensary, such as chocolates, gummies, tinctures and baked goods containing different ratios of THC and CBD.

After just two weeks of regular use, patients reported less pain, better sleep, and the unexpected benefit of improved cognition – they were able to think more clearly.

“When you’re in a lot of pain, it’s hard to think,” said senior author and cancer survivor Angela Bryan, PhD, a professor of psychology and neuroscience at CU Boulder. “We found that when patients’ pain levels came down after using cannabis for a while, their cognition got better.”

The improved cognition didn’t happen right away. Patients who used edibles rich in THC got high from it and their cognition initially decreased. But after a few days of regular cannabis consumption, a new pattern emerged. Patients reported improvements in pain, sleep and cognitive function, including reaction times.

“We thought we might see some problems with cognitive function,” said Bryan. “But people actually felt like they were thinking more clearly.”

Patients who ingested edibles high in CBD reported bigger improvements in sleep quality and pain intensity.

Bryan’s study, published in the journal Exploration in Medicine, is one of the first to assess the efficacy of cannabis purchased at dispensaries — rather than less potent government supplied cannabis or synthetic cannabis medications that are primarily used to treat nausea.

Bryan had just begun studying medical cannabis in 2017, when she was diagnosed with breast cancer. After surgery and chemotherapy, she looked to cannabis for pain relief as an alternative to opioids. Neuropathic pain is a common side effect from chemotherapy.

Bryan used her own customized regimen of potent THC products when pain was intense and took mostly CBD products when the pain was more manageable. She was not completely pain-free, but she didn’t take a single opioid during treatment. She hopes others will learn from her experience.

“I was extremely lucky because I had some knowledge about this. Most patients don’t,” Bryan said. “People are open to trying whatever they think might be useful, but there's just not much data out there to guide them on what works best for what.”

As many as 40% of U.S. cancer patients use cannabis, but only a third of doctors feel comfortable advising them about it.

A Window Into the Impossible: A Pain-Free Life

By Cynthia Toussaint, PNN Columnist

I recently experienced the miracle of living pain-free for a while, after 40 years of body-wide Complex Regional Pain Syndrome. I was astonished by what it felt like and what I learned about myself.   

In November, I had a serious cancer treatment complication, one that landed me in the hospital and forced me to suspend care. After stabilizing and returning home, I had to taper down from a course of high-dose prednisone, a corticosteroid, over eight weeks.     

The multitude of prednisone side effects were worse than I imagine hell to be, save one: my pain was gone. Okay, not gone-gone, but so damn near I forgot about it.

Yeah, you read that right. After decades of burning, radiating, life-upending, soul-crushing, never-ending, can’t-do-another-moment pain, it just wasn’t a thing anymore.     

Over the last decade or so, my life partner, John, has asked me on occasion, “What would you do if your pain just went away?”

That question pissed me off because pain has robbed me of my dreams. How dare it go away now, I would think, after destroying my life! Ebbing into my later years, I knew it was too late to reclaim what was gone. I decided it would hurt too damn much psychologically to lose my physical pain.  

I was stone-cold wrong. When the prednisone kicked in, it was nothing short of heavenly bliss to be without my constant agony. At first, it felt as though much of my lower body had been amputated, but in a good way. Poof, like magic, the tonnage of pain and heaviness were gone. Also, to my surprise, I had zero emotional fall-out.

I marveled in the miracle of standing, as this ability had been absent for many decades. I’ve spent countless hours, weeks and years staring at people in public, trying to figure out how they could stand and shift their weight without apparent torment or thought. After becoming a “shifter” myself while on prednisone, I had a clear, three-word answer: It doesn’t hurt.   

Not using my wheelchair was a trip because people stopped treating me like a child. Rather than literally gazing down with pity, they looked me straight on, eye level and all. They even asked me questions about myself, rather than disregarding the invalid while turning to John. That, in itself, was a game-changing reality, and I started to smell the sweet possibility of independence again.       

Every moment without pain was a miracle, blowing open my mind with new ideas and long packed away possibilities. For the first time, I seriously thought researchers would someday find a cure for CRPS. I mean, if they could switch much of my pain off virtually overnight, clearly science was on the edge of making this stick permanently.

If only.

Here’s the other side of the story I alluded to earlier. When my pain went away, it cruelly coincided with the most torturous time of my life. The price of high-dose prednisone was, for me, an existence worse than pain. I was in and out of psychosis, sleeping three to four hours a night with an irregular, pounding heartbeat, and a thousand other little shop of horrors. With that onslaught, my spirit broke. Add the perils of aggressive cancer and the fallout of a serious treatment complication, and the torture was just too much.

On New Year’s Eve, my 62nd birthday, I told God that if it was my time, I was ready to go. I didn’t think Cynthia was ever going to come back. “Please, please make my suffering stop,” I begged.

To my surprise, and most I know, I clawed my way back after completely tapering off the prednisone. My new miracle has me living in gratitude, despite my old pain rushing back with a vengeance, leaving me with a GOAT of a pain flare. I writhe through much of my days and nights, feeling the burning hatchet sear my joints. But, dammit, I’m me again, and, like all flares, this too shall pass.      

Thankfully, I’m strong enough to be back on chemo as the benefits of self-care are once again paying off in spades. Adding to the good news, my recent CT/PET scan came out negative. “No Evidence of Disease” to be precise! These days when I pray, I don’t ask God to take me, but rather to keep me on this glorious earth.             

I got a glimpse into the other side, the miracle of being pain-free. But the cost of losing me was too high. Heck, science tells me I’d no longer care about my pain if I got a lobotomy. No thanks.

I’m back to not wasting precious energy speculating about a possible cure. If it comes, fantastic, but I have no expectations, and accept and embrace the reality of what is right now.

Though my pain is often wretched and dark, I long ago embraced it as part of my authentic self. And to stay true to one’s self, there sometimes comes a great cost.

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 (CRPS) and 19 co-morbidities 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.”

Emergency Room Visits Soar for Cancer Patients Needing Pain Relief

By Pat Anson, PNN Editor

The number of cancer patients seeking treatment for pain in U.S. emergency departments has doubled in recent years, according to a large new study that further documents the harm caused to patients by misguided efforts to reduce opioid prescribing.

The study, conducted by a team of cancer researchers, looked at health data from 2012 to 2019 for millions of patients who had a cancer diagnosis and were not in remission.  Of the 35 million visits made to an emergency department (ED) by those patients, over half were deemed preventable – meaning the visits could have been avoided if the patient has received proper care earlier.

By a wide margin, pain was the most likely reason for a preventable ED visit. The number of cancer patients who went to an ED for poorly controlled pain rose from nearly 1.2 million in 2012 to 2.4 million in 2019. About a quarter of them had pain so severe they were admitted.  

“Consistent with previous studies, we found that pain was the most common presenting symptom (36.9%) in ED visits among patients with cancer and that the number of patients with cancer who visited an ED because of pain more than doubled over the study period,” lead author Amir Alishahi Tabriz, MD, a research scientist at the Moffitt Cancer Center in Florida, reported in JAMA Network Open.

“A possible explanation could be the unintended consequences of the efforts within the past decade to decrease overall opioid administration in response to the opioid epidemic.”

“I am not at all surprised by their result, as they are consistent with what I’m hearing from colleagues across the U.S.,” says Chad Kollas, MD, a palliative care physician and longtime critic of the 2016 CDC opioid guideline, which discouraged the prescribing of opioids for pain.

The CDC guideline was only intended for primary care physicians treating non-cancer pain, but it was quickly adopted throughout the U.S. healthcare system, including the field of oncology. Previous studies have documented how opioid prescriptions and doses declined for cancer patients, with the Cancer Action Network warning in 2019 that there has been “a significant increase in cancer patients and survivors being unable to access their opioid prescriptions.”

One of the most egregious cases involved April Doyle, a California woman with Stage 4 terminal breast cancer.  In 2019, Doyle posted a tearful video online after a pharmacist refused to fill her opioid prescription. She died about a year later, after the cancer metastasized into her lungs, spine and hip. 

“Unfortunately, the systematic misapplication of the 2016 Guideline created harms for patients due to reduced access to pain care and increased risk of suicide after nonconsensual or excessively rapid opioid tapers. These harms are predictable features of policy changes based on misguided calls for unfocused reductions in opioid prescribing,” Kollas told PNN.

Even if a cancer patient goes to an emergency room for pain relief, the odds of them — or any other patient — getting an opioid is dwindling. A new study by the National Center for Health Statistics found that the percentage of ED visits that ended with an opioid prescribed at discharge fell from 21.5% in 2010 to just 8.1% in 2020.

‘I Blame the CDC’

After years of complaints and bureaucratic delays, the CDC finally revised its opioid guideline in 2022 to more explicitly exclude patients undergoing cancer treatment, palliative care and end-of-life care. But many cancer patients felt it was too little, too late.

“My Mother had stage 4 terminal lung cancer. She was in horrible bone pain and her cancer doctor told her to take Tylenol for pain. We made several trips to the ER in the middle of the night just to manage her pain,” one woman told us. “She could not even enjoy her last moments on this earth with her family because of horrible cancer pain. As it spread all over, I could not help her. I am a nurse who watched her die miserably and I blame the CDC.”

“I live with stage 4 cancer and can't get any pain medication. I can't get any doctors to help me treat my pain,” another nurse told PNN. “My experience helps me understand why people become suicidal because they can't live with the pain anymore.”

“Stop making doctors afraid to treat pain adequately! I need a higher strength opioid for my chronic pain and my doctor will not up my strength because of that fear,” said another patient. “My husband has Stage 4 cancer and they refuse to up his strength as well. This is a crime against humanity!”

“Over the past decade, there has been a seismic shift in prescribing practices and sharp declines in access to these medications for patients with cancer.”

— Dr. Andrea Enzinger, Harvard Medical School

In another large study that looked at racial and ethnic disparities in the treatment of Medicare patients with advanced cancer, researchers saw a steady decline in opioid prescriptions and a rapid expansion in urine drug testing from 2007 to 2019. Their findings, published in the Journal of Clinical Oncology, show that less than a third of late-stage cancer patients received an opioid for pain control in 2019 and only 9.4% received a long-acting opioid near the end of life.

Black and Hispanic cancer patients were less likely to receive opioids than their White counterparts. They were also more likely to get smaller doses than White patients.

"Over the past decade, there has been a seismic shift in prescribing practices and sharp declines in access to these medications for patients with cancer,” said lead author Andrea Enzinger, MD, a gastrointestinal oncologist and assistant professor at Harvard Medical School. “Our findings are startling because everyone should agree that cancer patients should have equal access to pain relief at the end of life."

Finding Peace While Fighting Cancer

By Cynthia Toussaint, PNN Columnist

It’s the damnedest thing. Despite this month being my 40-year anniversary with high impact pain, and while I battle an aggressive breast cancer recurrence, people tell me that I look healthy and happy.

Stranger still, I feel more grounded and centered than ever. In fact, I’m down-right peaceful. So much so, when I recently saw my osteopath, she said that I no longer needed her treatment because I was “in the flow.”  

After delving deep into this disconnect, I’ve unearthed the workings that have brought me to this sacred place. And now that I’m here, I plan to protect my peace.

To start, I’ve learned to neutralize platitudes and their associated shame. When people blow by the gravity of my cancer recurrence by assuring me that staying positive will save the day, I politely dismiss their cliché as unhealthy and unrealistic.

There’s no one alive who could face a second round of breast cancer without being mad as hell. That being said, I’ve given myself permission to move through the five stages of grieving – denial, anger, bargaining, depression and acceptance – which has allowed me to come to an authentic level of positivity… and peace.  

Also, I’ve taken control of my cancer care. This is a big deal. After listening to my oncologist’s by-the-book treatment plan, I shared that, while well-intended, I thought his recommendations would kill me.

Instead, he and I sought guidance from trusted sources, and agreed on a plan that was tailored to my individual needs, including the complications that Complex Regional Pain Syndrome present. I won’t lie to you, the treatment is at times brutal. But I’m choosing it, and with control comes peace. 

And there was a miracle.

With the synergy of my current treatment (low dose chemo, immunotherapy infusions and a robust dose of self-care), my tumor quickly dissolved from the size of a ping pong ball to one that can’t be found. Wearing a Cheshire cat grin, my oncologist recently shared that in his 45-year career he’s never seen such a response.

So how did my body do that? Yes, the med cocktail certainly played its part, but I’m convinced that finding peace is my secret sauce to healing.

Besides taking control of my medical care, I’ve become religious about upping my terrain-game for the healthiest body and mind. I’ve switched to a vegan diet with lots of fish, committed to an hour-long workout each morning, get in bed early to promote deep sleep, and have radically reduced my stress by identifying and removing toxic people from my life. These are the self-care strategies we hear of time and again, and for good reason. When practiced, they work! 

Letting Go of Trauma

For more peace, I’ve vastly upped my game by adding a “paths-less-taken” approach.

Like most of us with pain, I suffered much childhood trauma, the foundation of my un-wellness. I’m working diligently on trauma release using various methods, one being forgiveness. Through daily visualization and meditation, I’m practicing the art of letting go of trespasses.

Instead of allowing anger and hurt to turn into psychic stagnation, I acknowledge the negative emotion, thank it for lessons learned, and send it on its way. Forgiveness is a choice, and I’ve decided to free myself from poisonous energy so I can move forward with peace.

I often remind myself that when a person is cruel, it’s not about me, but rather a challenge they’re experiencing on their life path. And when I can, though still a work-in-progress, I light a candle and wish them well.

Most surprising, I recently stumbled upon my biggest trauma-releasing, peace-inducing tool, as I intuitively knew this blast-from-the-past would move my wellness ahead by eons.

Several months ago, I surprised myself by bringing my grandmother, who passed long ago, into my visualizations. Soon other long-gone relatives arrived. Of particular interest was my Aunt Grace, who continues to lead my healing rituals. Grace died a couple decades before I was born, but I’ve always felt a bond so close, I’ve dedicated my life work to her. She is my guide and my angel.

I now understand that our connection comes from sharing similar traumas. We were both the “fixers” of impossibly broken families and both got profoundly ill at 21. Tragically, Grace died from leukemia. Mine was a different death when CRPS ravaged my body.

Through arduous work and by facing hard truths, I now see that, like Grace, most of my ancestors suffered profound trauma, and by sharing their genes, I’ve inherited the injury that binds me to disease. Science calls this epigenetics.

By healing the wounds of my ancestors through rituals, I’m healing myself. Additionally, I’m breaking cyclical familial patterns by not passing along the burden of traumatic energy to those I engage with.

These seemingly “woo woo” rituals appeared novel – hell, I thought I’d invented a breakthrough therapy! That was until I described them to an integrative trauma expert who shared that “Ancestral Healing” is a real thing, scientifically proven and all.

Life is precious. So is our life preserving, life enhancing peace. Whether I’m on my way out now or have 30 more years of kick in me, I’m focusing on protecting this essential resource. 

I’m convinced that most of our pain, physical and emotional, springs from inner tumult driven by deep wounds, many of them handed down. Through intentional work and practice, we can quell that upset and find peace. Then the challenge is to hold our peace sacred, to protect it from internal and external “vampires” that aim to trip it up.

My mom turned 90 last month and is suffering from advanced Alzheimer’s, I believe brought on by trauma. That trauma has passed down to me, seeding a lifetime of illness.

I recently spent time with Mom at her new memory center, and later that day delighted in meeting my newest grand-niece named after this beautiful, generous and loving woman.

I hope that by healing the wounds our ancestors couldn’t, I’ll help this li’l darling have a pain-free, peace-filled life, one she can, in turn, hand down.            

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 (CRPS) and 19 co-morbidities 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.”

Fewer Opioids and Weaker Doses for Cancer Patients

By Pat Anson, PNN Editor

Another study has documented how opioid guidelines over the past decade have led to fewer and weaker opioid prescriptions for cancer patients --- even though the treatment guidelines typically state they are not intended for patients suffering from cancer pain.

In findings recently published in PLOS ONE, researchers at Johns Hopkins Bloomberg School of Public Health and the University of Michigan analyzed pharmacy claims for up to 53 million privately insured U.S. adults from 2012 to 2019. During that period, opioid prescribing fell from 49.7% to 30.5% for people with chronic non-cancer pain (CNCP) and from 86% to 78.7% for people with cancer.

While the drop in prescribing appears minor for cancer patients, a closer look at the numbers shows a significant decline in high dose prescriptions and in the number of days opioids were prescribed.

In 2012, for example, the average daily dose for a cancer patient was 62.4 morphine milligram equivalents (MME). By 2019, that had fallen to 44.7 MME – a decline of over 28 percent.

The percentage of cancer patients getting over 90 MME — a ceiling recommended by the CDC for chronic non-cancer pain — fell from 26.2% to just 7.6% -- a 71 percent decrease.

The average number of days per year a cancer patient received opioids also fell, from 34.8 days to 22.3 days – a 36 percent decline.

“While clinical guidelines continue to endorse prescription opioid treatment for cancer-related pain, declines in receipt of any opioid prescription were observed for people with cancer diagnoses, though these declines were smaller in magnitude than those observed among people with CNCP diagnoses. Future research is needed to understand the clinical implications of this decline, as well as observed decreases in MME/day and days’ supply of opioid prescriptions, among cancer patients,” researchers reported.

In short, cancer patients are getting smaller and fewer doses of opioids, which researchers admit could be making their cancer pain worse. However, they stopped short of sounding the alarm over that trend and suggest it could be beneficial – by helping to reduce the risk of cancer patients overdosing.  

“On the one hand, this finding may signal a cooling effect on opioid prescribing that could contribute to poorly controlled cancer pain. On the other hand, this finding may suggest reductions in high-risk opioid prescribing practices, such as high dosage prescribing, which are shown to contribute to increased risk of opioid overdose death among cancer patients,” they wrote.

Oncology experts have been warning for years that opioid prescribing guidelines are being misapplied to cancer patients, even to women with advanced breast cancer.

In 2019, a Rite Aid pharmacist refused to fill an opioid prescription for April Doyle, a California woman with Stage 4 terminal breast cancer.  A tearful video she posted online went viral and the pharmacy apologized to Doyle, who later died.

That same year, the Cancer Action Network warned there has been “a significant increase in cancer patients and survivors being unable to access their opioid prescriptions.” One out of four said a pharmacy had refused to fill their prescriptions and nearly a third reported their insurer refused to pay them.

Part of the confusion about what’s appropriate for cancer pain is that the CDC’s opioid guideline says the recommendations are intended for patients “who have completed cancer treatment, are in clinical remission, and are under cancer surveillance only.”  Experts say the inclusion of cancer survivors is a mistake because it is not uncommon for pain to persist long after the cancer is treated or even because of the treatment itself.  

A revised draft version of the CDC guideline attempts to clear up some of the confusion by explicitly stating the recommendations are not intended for patients undergoing “cancer pain treatment” and for those in palliative or end-of-life care. The updated version of the CDC guideline is expected to be published late this year.

Inflation Squeezes Families Dealing With Chronic Illness

By Heidi de Marco, Kaiser Health News  

Deborah Lewis rose from bed before dawn and signed in to her phone so she could begin delivering fast food, coffee and groceries to residents in this western patch of the Mojave Desert where test pilot Chuck Yeager broke the sound barrier generations ago.

Lewis prayed she would earn $75, just enough to fill the tank of her Kia sedan so she could drive her 8-year-old daughter, Annabelle, 80 miles south to Los Angeles to receive her weekly chemotherapy treatment for acute lymphoblastic leukemia. Just a year ago, the same tank of gas would have cost $30 less.

After a full shift as a gig worker, the mother had earned close to what she needed. “It took a lot longer than I thought,” she said.

High inflation is hitting families across the nation. According to the U.S. Bureau of Labor Statistics, consumer prices in July were up 8.5% from a year earlier, one of the biggest increases in recent decades. The Bureau of Economic Analysis found that consumers are spending the most on housing and utilities, food, and medical care.

For millions of families living with chronic diseases — such as heart disease, diabetes, and cancer — or other debilitating conditions, inflation is proving a punishing scourge that could be harmful to their health. Unlike dining out less or buying fewer clothes, many patients don’t have a choice when it comes to paying for medicine, medical supplies and other ancillary costs. Some must drive long distances to see a specialist, and others must adhere to a strict diet.

“Chronic disease patients are usually on the front lines of seeing a lack of supplies or an increase in out-of-pocket costs,” said Paul Conway, chair of policy and global affairs for the American Association of Kidney Patients.

Health care has grown increasingly unaffordable. Half of adults report having difficulty paying their health costs, according to KFF polling. One-third say they or a family member has skipped recommended medical treatment in the past year because of the cost, and one-quarter of adults report rationing pills or leaving prescriptions unfilled.

Inflation has squeezed families further by driving up the price of gas and food, as well as medical products such as needles and bed-wetting pads. Health care costs have risen 5.1% since July 2021, and medical commodities — which include prescription and over-the-counter drugs, medical equipment and supplies — are up 3.7%.

Inflation is particularly detrimental to the health of low-income patients; studies have found a strong link between poverty and health. According to the California Budget & Policy Center, more than half of California households making $50,000 or less struggle to pay for food, housing, and medical costs.

For Deborah Lewis and her husband, Spencer, their concerns about the rising cost of gas have never been about skimping on summer travel or weekend getaways. It’s about making sure they have enough gas to drive Annabelle to Children’s Hospital Los Angeles for chemotherapy and other medications delivered through a port in her chest.

The family relies on Spencer’s disability check, which he receives because he has Ehlers-Danlos syndrome, a hereditary disorder that causes him severe joint pain. He also copes with broken discs in his spine and a cyst pushing against his spinal nerves. In January, he stopped working as a pest control technician, shifting more financial responsibilities to his wife.

The disability check covers rent and utilities, leaving Deborah’s freelance work to cover gas. They also get $500 a month from Miracles for Kids, which helps families with critically ill children.

On a June morning, Deborah packed snacks for the drive ahead as Annabelle, wrapped in her favorite blanket, waited on the couch. Most of her long blond hair has fallen out because of her treatments.

The night before, Deborah spent $73.24 to fill up at Costco. The average price of a gallon of gas in California remains above $5.

Before they left, Deborah learned the couple carried a negative balance in their checking account. “I have so much on my plate,” she said.

The family has already delayed health care for one family member: Their dog, a Doberman pinscher named Chief, skipped a vet visit for a mass pushing up his intestines.

AnNABELLE AND HER MOTHER, DEBORAH LEWIS (khn IMAGE)

Politicians are keenly aware of inflation’s leaching effects. In October, most California households will receive “inflation-relief checks” of up to $1,050 to help offset the high cost of gas and other goods under a budget Gov. Gavin Newsom signed in June.

But health experts worry that even with the one-time aid, affordability could become a life-or-death issue for some Californians. For example, the price of insulin can range from $300 to $400 per vial without insurance.

“We’ve seen a number of patients living with diabetes and on a fixed income greatly impacted by rising inflation,” said Matthew Freeby, an endocrinologist and director of the UCLA Gonda Diabetes Center. “Both Type 1 and Type 2 diabetes typically require multiple prescription medications that may already be costly. Patients have had to choose between day-to-day finances and their lifesaving medications, such as insulin or other treatments.”

Inflation is also a challenge for people who depend on certain foods as part of their health care regimen, especially with food prices up 10.9% in the past year.

Toyan Miller, 60, an integrative nutritional health practitioner from San Dimas, California, has been diagnosed with vasculitis and Hashimoto’s thyroiditis, two autoimmune diseases that cause inflammation. Miller’s medically tailored diet requires gluten-free, organic food. Miller said she’s dipping into her savings to afford the average of $300 she spends each week on groceries. Last year, she spent about $100 less.

“The avocado mayonnaise price freaked me out,” she said. “It used to be $8. Now, it’s $16.99.”

Even those who are healthy may find themselves helping family or friends in need.

In the mountainous Los Angeles neighborhood of Laurel Canyon, Shelley Goldstein, 60, helps her parents, both in their 90s, pay for items, such as incontinence products, not covered by health insurance. Goldstein’s father was recently diagnosed with Alzheimer’s disease and lives in a retirement community with his wife, Doris.

“Those are basic things, but that’s like $70 a month between the two of them,” said Goldstein, who works as a speaking coach. “That’s a lot.”

Goldstein worries about how much more of her parents’ health costs she’ll have to shoulder since they are pensioners on fixed incomes.

“What keeps me up at night right now is what’s to come,” she said. “There’s two of them. My parents’ increased need for pads, meds, and other medical support increases as their health declines.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues. This story first published on California Healthline, a service of the California Health Care Foundation.

Be Careful What You Wish For: Cancer Is Not a Way Out From Pain

By Cynthia Toussaint, PNN Columnist

When my oncologist recently spewed the worst word I’ve ever heard -- “recurrence” -- everything in my mind sped up and stopped at the same time. I made a brutal fight for my life in 2020 against Triple Negative Breast Cancer, but came up short.   

Now launching my second battle, a misguided myth disheartens me. Many of us with pain say things like, “I wish I’d been lucky and gotten cancer instead, because with cancer you either die or get better.”

WRONG! I now see this thinking as a cop out, a “poor me” pity party and gross disrespect for those who fight for their lives.

Let me break the suspense. If you ever get the Big C, it will not deliver you from your suffering. You won’t be jumping up and down with glee because your pain problems are over. Like the rest of us, you’ll take on the fight of your life and your pain will quickly take a back seat.  

Here’s more upending news about the “deliverance” mythology: With all of cancer’s apparent “perks” (abundant research, unending sympathy, bountiful support, etc.), it’s anything but the ticker-tape parade of arm-locked togetherness. In reality, an aggressive cancer diagnosis is a new brand of isolating, hellish suffering with death as a probable outcome.

Then there’s this: Cancer fetches a morbid world of trespasses. Many project their fears by pummeling us with religious fervor. It’s unsettling to receive pious magazines and missives about the new body I’ll soon have, the one without pain. Friends and people I don’t know remind me of how lucky I am to be nearing death’s door, because the other side will be paradise.

A head’s up! With cancer, even more than being in a wheelchair, one becomes public domain, open to an onslaught of good intentions delivered with a heaping side of judgement.

And there are the bizarre jealousies. I can’t believe I’m writing this. Have you ever noticed that many in the pain world compete? It’s all too often about who’s the sickest, who’s agonizing most. When you go to the front of the line with cancer, people can get cruel because you’re hailed as the winner of the “Can’t Get Worse Than This” award. Well, three cheers for me!

Soul-Sapping Support

Most heartbreaking, just when I thought my support system couldn’t atrophy further, people have scurried. A number of my close friends who stayed through my decades of pain have stunningly distanced themselves or pulled away altogether. Friends that I believed were strong enough to withstand anything, my rocks, crumbled.

And, ah yes, the platitudes. If I hear “You got this” one more time, I may lose whatever I still got. “Good luck” while walking away has become code for “I’m not strong enough for this scene, but I hope you can keep yourself above ground.”

Then there’s the classic, “If you just think positively, everything will be fine.” Far from it. Faking positivity is the most energy-draining, soul-sapping activity known to humankind.   

Have you ever heard the term, “scanxiety”? If not, that’s because you haven’t had cancer with its phobic-driving medical scans that endlessly loom. It may surprise you (it did me!) to learn that cancer falls into the chronic illness category, a potentially terminal co-morbidity. Even if you hit the jackpot of remission, you’re doomed to a life of fearful obsession over the possibility of recurrence. With cancer, I guarantee you’ll never, ever again be gifted a moment of real peace.        

For these reasons, and the many I don’t have room to share, I implore you to stop thinking that cancer is the way out of pain. To the contrary, if you’re ever diagnosed with a life-threatening malignancy, you’ll be praying for the good ol’ days. Just as I do.

Also, it’s an insult. There are many of us, fighting for our lives and weathering horrendous therapies just to have one more shot -- therapies that often leave us with increased life-long pain. So, please check yourself the next time you have the impulse to blithely state how people with cancer are the lucky ones.

I’m ashamed of the things I used to think and say. I was wrong and out of line. I apologize to all, past, present and future, who had, have or will have courage I didn’t honor.

Sorry for the finger-wagging. I know we’re struggling to cope with the day-to-day torture of our pain, along with the dread that our suffering will likely go on till we’re no longer. But desiring worse isn’t the answer. I guess I’ve seen too much now to put up with ignorance and lack of self-worth. Cancer does that to you, especially the second time around.

This boils down to the power of thoughts and words. I believe they have the sway to make us sick or well. Choose them wisely, and be careful what you wish for.

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 (CRPS) and 19 co-morbidities 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.”