“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
Things are getting interesting with the Fed AG office and President Biden and his use of Executive Orders to impose his beliefs on states and trying to override and invalidate the SCOTUS recently ruling on the states have the authority to determine the issues around abortion. It appear that AG Garland in trying to apply or enforce Biden’s Executive Order concerning the states’ rights to determine what is – or is not – allowed in their state in regards to abortion.
It would appear that the Biden’s EO and AG Garland is attempting to use Federal non-discriminating rules. The video below talks addresses the person experiencing harm for failure of a healthcare professional to provide appropriate care. The paragraph below is from Biden’s EO. The chronic pain community has documentation that the failure of a prescriber to properly address a pt’s pain – resulting in under/untreated pain, can result in numerous complication of preexisting comorbidity issues and/or causing the pt to have new/additional comorbidity issues.
Could it be extrapolated that the existing CDC 2016 opiate dosing guidelines and the soon to be published 2022 CDC opiate dosing guidelines are violating the pt’s right to appropriate care ? Could major healthcare corporations ( hospitals, insurance/PBM, chain pharmacies ) imposing some sort of limitation on what their policies and procedures that requires/forces their employees to force reduction and/or impose daily dosing limits.
The chart below elaborates on the health complications on pts because of under/untreated pain and the hyperlink below explains that the MME system has no science nor double blind studies supporting the appropriateness in pain management, especially for those pts suffering from chronic pain.
The Control Substance Act states that NO ONE can prescribe a controlled substances to a pt without doing a in person physical exam and one of the basics of the practice of medicine is the starting/changing/stopping a pt’s therapy. Could one come to the conclusion that all of these entities are both violating the Controlled Substance Act and practicing medicine without a license.
Should all those chronic pain pts who have their pain meds reduced, limited or stopped, begin to file complaints with the AG Garland’s office, for failure to comply with FED non-discrimination rules ? While Biden’s EO is primarily dealing with the abortion issue… his EO talks about providers not complying with non-discrimination rules.
Ensure that healthcare providers follow federal non-discrimination laws:
That could include helping providers who are unsure of their obligations now that the Supreme Court has overturned Roe v. Wade; meeting with providers to explain their obligations as well as the consequences of not complying with non-discrimination rules; and “issuing additional guidance or taking other appropriate action in response to any complaints or reports of non-compliance with federal non-discrimination laws.”
It is pathetic how they use the English Language… they talk about less opiate Rxs and then in the next sentence they talk about DEATHS TIED TO THE MEDICATIONS – they didn’t say “deaths tied to opiate medications” and then they get to the next sentence with the statement that “STUDIES SUGGEST “. I would bet that a study could be done that would SUGGEST that people that die in motorcycle accidents started out riding bicycles.
Should our government make decision that could affect the lives and quality of life of tens of millions of our citizens based on a study that SUGGESTS a particular outcome. The CDC, has stated that there is an estimated 15,000/yr deaths from the use/abuse of NSAIDS… Each year 100,000 die from the use/abuse of the drug alcohol and 450,000 die from the use/abuse of Nicotine and neither of these meds have a valid medicinal use. Maybe because there is a very healthy tax revenue stream attached to those two “drugs”.. is the reason that – as a society – we accept all those deaths ?
Opioid prescriptions have fallen about 40% in the last decade amid restrictions by hospitals, insurers and state officials. But deaths tied to the medications remain at 13,000 to 14,000 per year.And studies suggest people who become addicted to opioids continue to start with prescription opioids, before switching to cheaper heroin and illegally made fentanyl.
‘We still have a really huge problem’: FDA’s promised ‘sweeping’ opioid review faces skeptics in Congress and among patient advocates
Senate Democrat Joe Manchin of West Virginia says he requested an update in April on the FDA’s progress toward policy recommendations but didn’t receive a response
As U.S. opioid deaths mounted in 2016, the then-incoming head of the Food and Drug Administration promised a “sweeping review” of prescription painkillers in hopes of reversing the worst overdose epidemic in American history.
Dr. Robert Califf even personally commissioned a report from the nation’s top medical advisers that recommended reforms, including potentially removing some drugs from the market. But six years later, opioids are claiming more lives than ever, and the FDA has not pulled a single drug from pharmacy shelves since the report’s publication. In fact, the agency continues putting new painkillers on the market — six in the last five years.
Now Califf is back in charge at the FDA, and he faces skepticism from lawmakers, patient advocates and others about his long-promised reckoning for drugs such as OxyContin and Vicodin, which are largely blamed for sparking a two-decade rise in opioid deaths.
“All the concerns that we had at the time on opioids are still there. We still have a really huge problem,” said Richard Bonnie, a University of Virginia public health expert who chaired the committee that wrote the report.
Bonnie and his co-authors say the FDA seems to have incorporated several of their recommendations into recent decisions, including a broader consideration of a drug’s public health risks. But they say there is more to be done.
In an interview with the Associated Press, Califf said a new internal review of opioids has been underway for months and that the public will soon “be hearing a lot more about this.” While the review will look at past FDA decisions, Califf suggested the focus will be on future policy.
“It seems like people love sort of looking back and fault-finding, but I’m much more interested in learning so we can go forward and make the best decisions for what we need to do today,” said Califf, who split his time between Duke University and working for Google after leaving the FDA in 2017 following President Donald Trump’s election.
The 453-page report issued five years ago this month by the National Academies of Sciences laid out a strategy for reducing overprescribing and misuse of opioids, with particular focus on the FDA.
At the center of the recommendations was a proposal for the FDA to reassess the dozens of opioids being sold to determine whether their overall benefits in treating pain outweigh their risks of addiction and overdose. Those that don’t should be removed from the market, the group said.
The lack of swift action underscores the glacial pace of federal regulation and the legal obstacles to clawing back drugs previously deemed safe and effective. “It’s really hard for the agency to get a drug taken off the market once it’s been approved,” said Margaret Riley, a University of Virginia food and drug law professor who consulted on the report.
Last year, U.S. overdose deaths soared to a record of 107,000, driven overwhelmingly by fentanyl and other illegal opioids.
‘The question to me is whether the agency will actually have the gumption to use those tools to start pulling drugs.’
— Margaret Riley, University of Virginia
Opioid prescriptions have fallen about 40% in the last decade amid restrictions by hospitals, insurers and state officials. But deaths tied to the medications remain at 13,000 to 14,000 per year. And studies suggest people who become addicted to opioids continue to start with prescription opioids, before switching to cheaper heroin and illegally made fentanyl.
Dr. Robert Califf gathers his documents at the adjournment of a committee hearing on his nomination as commissioner of the Food and Drug Administration. AP/Manuel Balce Ceneta/File
“If Dr. Califf is serious about addressing the drug epidemic, the FDA should immediately implement” the report’s recommendations, Sen. Joe Manchin of West Virginia said in a statement.
Manchin told the AP that he requested an update in April on the FDA’s progress on the recommendations but didn’t receive a response. He was one of five Democrats from hard-hit opioid states who voted against Califf’s confirmation in February.
In response to questions about the recommendations, the FDA provided a list of actions it has taken on opioids, some which predated the report. The agency said it has acted on “nearly all” of the recommendations, by enhancing prescriber education and labeling, convening meetings and improving data collection.
“I think what you’ve seen is the agency grabbing at some of the low-hanging fruit and only to a certain level,” Riley said.
Despite heightened scrutiny, the FDA continues putting new painkillers on the market. Many of the drugs have formulations designed to make them harder to misuse, such as hard-to-crush coatings that discourage snorting or injecting.
Califf has said the FDA is bound by its regulations: Companies need only show that their drugs work better than a placebo, and the agency can’t require new opioids to be safer or more effective than ones already on the market. He told Senate lawmakers in April that doing so might require legislation from Congress.
One of the report authors disagreed. “I think the FDA has a lot of flexibility at this point to say, ‘Look, given these circumstances we don’t think that a placebo-controlled trial would be adequate,’ ” said Dr. Aaron Kesselheim, a lawyer and professor of medicine at Harvard Medical School.
As for older opioids like OxyContin, Califf says that as the agency gets more evidence on opioids’ risks, it will “aggressively look at relabeling.”
But delays in getting that evidence illustrate just how slowly the FDA process moves. It’s been nearly 10 years since the agency required makers of long-acting opioids to conduct a dozen studies of their drugs’ risks and effectiveness.
The main clinical trial looking at opioids for chronic pain has been delayed since 2019, due to repeated changes to its design. And results from seven other studies released in 2020 don’t give a clear picture of whether the drugs are truly safe and effective for long-term use.
“We’ve got to have the data, and we can’t accept excuses that it’s hard to do,” Califf said. “That’s not going to be acceptable.”
Riley said the data the FDA is seeking will be critical to providing the evidence needed to remove opioids from the market, which would likely face years of industry pushback.
“The question to me is whether the agency will actually have the gumption to use those tools to start pulling drugs,” Riley said. “Do they have the will to do it?”
Rudy Sanzana, a friend of more than 30 years, hugs Gabriella Walsh one last time before she dies through medical aid on July 16 in Santa Paula. “I just feel like I’m going on a trip,” Gabriella said calmly.
Gabriella Walsh knew she wanted to die on a Saturday.
She’d settled on July 16, dressing that morning in a flower crown and a T-shirt with a picture of a dragonfly, an image that had comforted her in recent weeks. She took a deep inhale from a bottle of lavender oil and listened to a playlist of sea sounds.
Earlier in the morning, friends and family nuzzled up against her in bed. Rest easy, they told her, and keep wandering.
“I just feel like I’m going on a trip,” she said calmly. Two women sit on a bed and one holds a phone Melanda Woo, left, embraces Gabriella a few hours before Gabriella dies through medical aid. (Dania Maxwell / Los Angeles Times)
Within two hours, she would drink a fatal dose of medications prescribed under California’s death-with-dignity law, which allows some terminally ill patients to request drugs to end their lives. The option had given her profound comfort in her final weeks — as had knowing that, in the end, she’d have Jack Barsegyan, the registered nurse who managed her hospice care, and Jill Schock, a death doula, at either side of her bed.
“My Jack and Jill,” she often called them.
Born Gabriela del Carmen Torres Acosta on the first Friday of 1958, death was, perhaps, her earliest memory, thus stripping away much of her fear of it.
When she was 2, she stumbled upon her grandfather slumped lifeless in the hallway of their family home in Quillota, Chile, an agricultural community north of the capital. A few months later, a chance illness — gorging on so many strawberries that she got severe diarrhea — led to an appointment where a doctor discovered that a small opening in her heart had never closed properly after her birth. She soon underwent open-heart surgery.
Another five years passed, and during their bedtime ritual, her father asked her to let their hug linger, sensing it might be their last.
“Este puede ser nuestro último abrazo.” A framed photo of a little girl and man A photograph of Gabriella and her father was one of the last mementos she had on display in her home before dying. (Dania Maxwell / Los Angeles Times)
He died of a stroke within hours, and his body was transported home from the hospital, as was often the custom then. Once the adults cleared out of the living room, she dragged a chair next to her father’s body, which was covered by a sheet, and rested her small hand on his shoulder. She sat with him for what felt like an hour.
“I had no fear,” she recalled. “I was neutral.”
In junior high, she and her mother moved from Chile to Sherman Oaks, where they reunited with Gabriella’s oldest sister. She now had a new home, a new language and a slightly new name — “Gabriella” with two Ls after officials misspelled it on immigration paperwork.
After graduating from Van Nuys High School — where she met a group of girlfriends she stayed close with through the years — she got a job as a medical assistant helping a podiatrist who worked at convalescent homes. The patients often looked unkempt and rarely had visitors.
“That’s not how I want to have my last days,” she thought, then 19.
Before long, a co-worker introduced Gabriella to her brother, who became Gabriella’s husband. They wed at a chapel on Topanga Canyon Boulevard. A little over a year later, when she was 23, she gave birth to a little girl she named after actress Natalie Wood. She felt immediately in awe of her daughter, but also deeply unprepared to be a mother.
Through the years, she worked in advertising and as a personal assistant and, later in life, as an interpreter and translator. She was, for a time, a born-again Christian, a faith she followed her ex-husband into and left around the time they separated. Later came a yogi phase, another she described as a Buddhist vibe, and then, in the end, nothing at all.
She was long guided by a spirit of wanderlust — a word she had tattooed onto her left wrist in her late 50s. She’d always despised monotony, put off by the idea of being too tied down to a single place. She rarely considered the future or the longer-term impacts of quick decisions — her allegiance was to the now and the immediate next. No matter where she was, or whom she was with, she always itched for new adventure and opportunity.
“If there was a chance of something — some connection, some job, some friendship — it was, ‘I’m in. I’m all in,’” recalled her longtime friend Kathy Menzie.
Gabriella lived, for a time, in Miami and Australia, and traveled through Mexico, Guatemala, Costa Rica and the Caribbean, where she sailed on a boat called the Knauty Knott. In the mid-2000s, she visited Amsterdam with an employer-turned-friend who was researching cannabis and steroids in bodybuilders. Maybe she’d return when she was older, she thought, knowing that the Netherlands had a death-with-dignity law on the books.
In her final weeks, while paring down belongings, she found a folded piece of graph paper with names and short descriptions of long-ago lovers.
A list Gabriella made details the many places she has lived and visited. The 47th address she lived at was her last, a studio her friend let her stay in rent-free.
(Dania Maxwell / Los Angeles Times)
Of all her experiences, her purest joy came in 2003, when her daughter picked her up at Los Angeles International Airport after Gabriella had spent several months working in Melbourne. The moment she first locked eyes with her granddaughter, then 3 months old, felt transcendent.
“Just magical.”
By the fall of 2021, Gabriella had retired — arthritic pain in her wrists made typing for translation gigs painful — and she yearned to travel.
She did her best to stash away savings from her $1,100-a-month Social Security payments and started sketching an itinerary: three months in Spain, one in Ireland, a few weeks in Chile or Australia. She rented a flat in the Spanish city of Alicante, a friend’s hometown, and purchased a plane ticket for Dec. 27.
On Dec. 9, she went in for a routine mammogram and, minutes later, a radiology oncologist was explaining, in a calm tone, that aggressive cancer in her right breast had “blown out” to her lymph nodes.
Gabriella feels around the tumors in her right breast after a shower. She had just booked a flight for a months-long adventure, beginning in Spain, when she learned she had aggressive breast cancer that soon metastasized into bone cancer. She canceled the trip, moved into a friend’s home and made plans for medical aid in death.
(Dania Maxwell / Los Angeles Times)
The words looped in her mind. She sobbed alone in her car and drove straight to her general practitioner’s office, asking them to set her up with an oncologist.
Insurance calls blurred together and she canceled her trip. With her plan to move out of her current residence in motion, she needed to find a new place, which filled her with anxiety. But soon an old friend offered to let her stay with him at his home in Valencia for a few months.
A PET scan showed tumors on her spine, sternum and hip. Fifteen in total — now officially bone cancer, her oncologist explained at an appointment in March. Prognosis, she knew, was an imperfect science, but she recalled the oncologist saying he thought she had six to eight months to live. She could do hormone therapy, which might slow the progression.
“My life, my body, my death. It’s just my time.”
— Gabriella Walsh
She didn’t want to extend her life, she told him, but to prioritize the quality of the time she had left. In her final months, she shared freely with family and friends about her decision to pursue California’s End of Life Option Act, a law that took effect six years ago, after then-Gov. Jerry Brown, a former Jesuit seminary student who wrestled with the decision, ultimately revealed his support in a public letter.
“In the end,” he wrote, “I was left to reflect on what I would want in the face of my own death.”
Gabriella rubs CBD lotion on her legs to help with pain relief.
(Dania Maxwell / Los Angeles Times)
The law, which was updated in January to streamline some red tape for patients like Gabriella, makes California one of only 10 states, as well as the District of Columbia, to permit medical aid in dying. Despite the leeway written into the California law — physicians can decline to prescribe the fatal cocktail of medications and patients who receive the drugs don’t ultimately have to take them — Gabriella quickly learned that the measure still has many vocal detractors.
June 27, 2022
In mid-May, Schock informed her that a group representing Christian doctors had filed a federal lawsuit against California Atty. Gen. Rob Bonta and other state officials, hoping to invalidate parts of the updated law. Schock and Barsegyan, the nurse at Physicians Preferred Hospice who managed Gabriella’s care, rushed to secure her medications before the next court hearing, which was ultimately postponed. At one point, Gabriella said, her general practitioner even called to plead with her.
“You have to fight. You’re a fighter.”
Conversations like that were uncomfortable, but Gabriella was resolute. The decision gave her a profound peace — a final freedom that she hoped would one day be afforded to people in every state.
“My life, my body, my death,” she said. “It’s just my time.”
The first days after her diagnosis felt like fog.Her mind floated back to the strawberries that may well have saved her life as a toddler and the time, years later, when she was hospitalized with severe heat exhaustion while training for a 5K. She daydreamed about getting a blue parrotlet — maybe she’d name him Freedom and have him released into the sky after she died — and she cherished visits with her daughter and two grandchildren.
Gabriella walks to her front door to pick up a fentanyl delivery. The fentanyl, administered through a patch on her arm, relieves the extreme pain she feels from 15 tumors throughout her body.
(Dania Maxwell / Los Angeles Times)
She learned to steady herself with a cane, knowing that even a short fall could shatter her brittle bones, and she reflected on life lessons that had long eluded her — the way, unless she had a specific goal, she struggled to manage money and how hard she found it to assert her own needs if she thought it would let someone else down.
She caught up with relatives in Chile, reminisced with her ex-husband and began drafting notes to family members she still had unresolved feelings toward. She sometimes craved sopaipillas, a doughy treat commonly eaten on rainy days in Chile, and often thought about Brandon — whom she’d become the legal guardian of several years earlier after her former brother-in-law, who raised the then-teenager, had died — and how he could make her laugh in any circumstance, even this one.
“I’ve lived a magical life,” she said one afternoon in March. “What else can I ask of life?”
Friends flew in from Atlanta, Colorado, Spain and locals showed up with sushi and Krispy Kreme doughnuts and CBD oil for her aching knees. They laughed and cried and sometimes she gave them tarot readings.
Gabriella sings with a group of friends she’s known since high school, Collette Hillier, Linda Fey and Kathy Menzie, on May 21. Later Hillier sent Gabriella a text: “I’ve admired you and your courage but I’ve never admired you as much as I have this month.” Moments like these feel like living funerals for Gabriella, an opportunity for people to say goodbye while she is still alive.
(Dania Maxwell / Los Angeles Times)
On April Fools’ Day, she moved to the 47th — and final — address she’d call home. Menzie, her longtime friend whom she met as a teenager, had offered to let her live for free in a small studio adjacent to her stepfather’s home in Santa Paula. Menzie lived in a separate guest house next door.
When Gabriella first walked in, light shone through the window, casting an abstract, golden shape onto a baby blue comforter. Menzie had set out yellow tulips, Gabriella’s favorite, and dark chocolate with almonds.
July 7, 2022
“What a blessing,” Gabriella whispered.
Menzie zipped in to clear a few final things from a bookshelf, and as she scooped up a Nativity set, two figurines tumbled to the carpet.
“Jesus and Mary!” she shouted.
“No, that’s Joseph,” Gabriella teased.
They both threw their heads back in laughter. Someday soon, Menzie said, I want to take you to the Cajun spot down the street for beignets. Or maybe we’ll get pedicures or go to trivia night?
“We gotta do it sooner rather than later, girl,” Gabriella said.
Soon, the tumor on her hip stung so much it was hot to the touch, and when she lay down to watch TV, a mass along her spine squished like an about-to-burst water balloon. She nibbled on sardines and water crackers or berries with maple syrup, and her painkillers constipated her so badly that the discomfort sometimes triggered anxiety attacks.
Gabriella has her vitals taken by Jack Barsegyan, a nurse who manages her hospice care.
(Dania Maxwell / Los Angeles Times)
Her hospice team upped the dosage of her fentanyl patch, which helped. A few days later, Schock visited.
The 36-year-old death doula, whom Gabriella hired to walk alongside her in her final months, used to work as a chaplain in an emergency room, but disliked the realm of sudden death — a place, where on a Saturday shift she’s never forgotten, a young father who didn’t know he was allergic to bees died of anaphylactic shock after being stung at his son’s soccer game. Cancer was unrelenting — she’d watched it kill her own father in 2015 — but at least patients had the chance to say goodbye.
“What are you doing with this time to get joy out of life?” Schock asked Gabriella during a visit in April.
Walking along the beach sounded taxing, but she would enjoy sitting by the waves. And after a few days of wanting to be alone, she felt up for visitors.
“It’s OK to be more antisocial,” Schock told her. “That’s actually a part of the dying process.”
Gabriella was still experiencing nuggets of joy and they were all tied to connection — a five-hour meal at Nobu in Malibu, seeing Dave Chappelle at the Hollywood Bowl, the friend who knew she ran cold and mailed her an electric blanket.
Gabriella rests in her Santa Paula studio. She said that she was never afraid of death or dying, but that the loneliness she sometimes felt after being diagnosed with terminal cancer was difficult.
(Dania Maxwell / Los Angeles Times)
But she didn’t like where her mind went when she was alone. Detached and exhausted, listening to music became painful, transporting her to lighter times, so she zoned out to audiobooks and binged “The Lincoln Lawyer” on Netflix.
She often fixated on not wanting to burden the people in her life, fearful of asking for too much. And yet, she wanted more — more visits and calls and connections. Feeling disconnected from her dying body, she removed her fentanyl patch for a week.
“I needed to feel.”
Every inch of her small frame, including her hair, ached and scrubbing shampoo into her scalp exhausted her. She pulled up the calendar on her phone, checking to see what she had coming up in the weeks ahead — a loved one’s birthday — but after that she was clear. She called Schock.
Elidia Elizarraraz, a hairdresser down the street from Gabriella, gives her a kiss while blow-drying her hair. Elizarraraz offered the service twice a week, telling Gabriella to pay whatever she could afford. “Generosity comes from places you would least expect,” Gabriella said.
(Dania Maxwell / Los Angeles Times)
“I’m having a really hard time just waiting around,” she told her. “Can I set a date?”
All the paperwork had gone through; she could set any day now.
“Any date?”
“Any.”
“July 16.”
Until then, she felt as if she was traveling on standby — now, she said, she knew what time she needed to board.
“Just like any other trip I’ve taken.”
A few mornings later, her hairdresser-turned-friend Rebecca Rincon visited with two bottles of prosecco.
“Hey, babe,” Gabriella greeted her.
Rincon wondered aloud if Gabriella believed in an afterlife. She’d gone back and forth through the years, Gabriella said, but now she didn’t think she did.
“I really feel that once I fall asleep, it’s lights out.”
Rincon thanked her for speaking so freely about death — an example she’d tried to follow recently when broaching the topic with her own parents.
Gabriella’s friend Rebecca Rincon, left, consoles her while talking about the day she went in for a mammogram and came out diagnosed with an aggressive breast cancer. Teasing Gabriella about the afterlife, Rincon asked Gabriella to “show up to me in the form of a free drink from a stranger at a bar.”
(Dania Maxwell / Los Angeles Times)
“You’re gonna be a teacher beyond this realm.”
“I hope so,” Gabriella said. “I have no idea what’s on the other side.”
Just don’t pull at my feet while I sleep, Rincon teased her.
Another friend had recently asked her not to tickle him at night, Gabriella said, and someone else told her they hoped she would show up to them as a dragonfly landing on their nose.
If I ever get a free drink from a stranger at a bar, Rincon told her, I’ll know it’s you. Gabriella’s eyes twinkled.
“Te quiero mucho,” Rincon told her. I love you.
“Y yo a ti.” I love you too.
Small moments like these always felt to Gabriella like a living funeral, an opportunity to listen in on the things loved ones might normally save for a eulogy.
“It’s been a gift to be able to die in this way.”
Many nights, she reread a text message she got from a high school friend, Collette Hillier, telling her that she’d long felt closer to her than most anyone in her life — even her husbands. She’d always admired her courage, but never more than now.
“There will never be another you,” the message said.
Gabriella wept every time she read it.
On days when she had the energy, she sorted her possessions into piles — her old matchbook collection for her granddaughter and a silver pendant from Easter Island for Hillier. She prepared a box for Brandon, filling it with his old high school essays and a bracelet a friend gave her from Indonesia.
“I’ll need to hear your voice. Your laugh.”
— Collette Hillier
On the first day of her final month, Gabriella stayed in bed past noon.
Her arms throbbed so much at night that she sometimes dreamed of cutting them off. Menzie knocked, walking in with buttered toast, scrambled eggs and strawberries.
“Thank you, babe.”
Gabriella picked at the plate, mentally preparing for a goodbye video call with her longtime therapist.
Gabriella has one last session with the therapist she has seen off and on for more than a decade. “I just feel like time is moving really slowly,” she told her therapist.
(Dania Maxwell / Los Angeles Times)
Time was moving so slowly, she told her therapist, and she was eager for July 16. She cried as she explained that friends were planning to fly in ahead of that day.
“I’m not surprised at all,” her therapist said tenderly.
“Know I love you and know I thank you so much,” Gabriella told her.
“I love you too,” her therapist said.
Gabriella blew her a kiss and hung up.
A few days later, Hillier visited from San Luis Obispo. They drove to Ventura and sat on a bench overlooking the Pacific.
Gabriella had been coming to this exact spot since the ’70s — once to decompress for a week in her 20s, countless times to push her mother in a wheelchair up and down the promenade and, again, a few weeks earlier for a final visit with Brandon.
Her friendship with Hillier had ebbed and flowed through the years, through busy patches, but whenever Hillier was in trouble, she always leaned on Gabriella.
“My guardian angel,” she whispered, pulling her tightly to her chest.
They sat silently for a moment, staring out at the ocean that they both respected so deeply. Their feet dangled and spun in small circles like they were young girls again. Beach girls, just as they’d always been.
A random thought popped into Hillier’s mind — the type of small, silly thing she loved to bounce off Gabriella — and when she shared it Gabriella laughed so hard her entire body shook. That laugh.
There will never be another you
Hillier had started to keep all her voicemails.
“I’ll need to hear your voice. Your laugh.”
On her drive to Santa Paula on July 16, Hillier hit more traffic than she’d expected. She knew Gabriella planned to ingest the medication around noon and started to worry she might not make it in time to say goodbye. Then a dragonfly landed on her windshield, calming her nerves.
In Santa Paula, she turned down Main Street and passed a hair salon before walking to Gabriella’s studio, which was tucked behind a gate. Friends and family had gathered beneath a pergola. When Hillier walked into the studio, Gabriella handed her a small square photo they’d taken together at Santa Monica Pier when they were 19.
Between her final goodbyes, Gabriella held her phone, trying to figure out how to delete her email account and deactivate her Instagram. She’d meant to do it sooner, but never quite felt up to it. She spent some alone time with her daughter and snuggled in bed with her niece and granddaughter.
Gabriella’s friendship with Hillier had ebbed and flowed through the years, through busy patches, but whenever Hillier was in trouble, she always leaned on Gabriella.
(Dania Maxwell / Los Angeles Times)
Barsegyan asked if she was feeling any anxiety. About a 5 out of 10, she said, so he gave her something to calm her nerves. When he walked up several minutes later holding a small, red vial, he reminded her — as he had many times before — that she didn’t have to drink the medication, but that if she did it would end her life.
She nodded.
Schock fed her three spoonfuls of mango sorbet, which Gabriella had picked out several weeks earlier, knowing it would soothe her throat from the stinging medication. Barsegyan handed her the vial, and without hesitation, she put it to her lips, swigging it down in three confident pulls. She looked up at the ceiling, smiling softly.
Gabriella takes a fatal dose of medications prescribed through California’s death-with-dignity law with her death doula, Jill Schock, right, feeding her spoonfuls of mango sorbet between sips.
(Dania Maxwell / Los Angeles Times)
Gabriella rests on her bed next to Schock on July 16. When Gabriella was diagnosed with terminal cancer she did not consider life-extending treatments but rather the quality of the time she had left.
(Dania Maxwell / Los Angeles Times)
She died at 1:38 p.m. She was 64.
A day earlier, she’d been burrowed into a seat at the movie theater with Menzie and another dear friend since high school, Melanda Woo, on her left and a friend who’d flown in from Spain on her right.
She’d recently listened to “Where the Crawdads Sing” on audiobook, so when she heard the film adaptation would be released on July 15, she knew she wanted to see it.
As the lights dimmed, Gabriella tucked one hand in the other, twiddling her thumbs. She stared up at the previews, all with release dates well after she’d be gone. The lights dropped one final increment and a blue heron soared over a shoreline. As the camera panned through a lush marshland, a voiceover played.
A swamp knows all about death, and doesn’t necessarily define it as tragedy.
Gabriella watched intently as the story of a young woman’s loves and losses unfolded on the screen. The film ends with an aerial shot of the protagonist dead in a boat floating in the marsh that she loved so deeply. Then it cuts to a wide shot of small blinking lights and the voiceover returns.
Gabriella smiles as the closing credits of “Where the Crawdads Sing” play at a movie theater where she was joined by her dear friends, Fina Martínez Tortosa, Melanda Woo and Kathy Menzie, left to right, on her last full day of life.
(Dania Maxwell / Los Angeles Times)
I am the marsh now. I am a firefly. That’s where you’ll always find me, way back yonder, where the crawdads sing.
As the credits rolled, Gabriella put her pointer fingers into the corners of her eyes and wiped away two small tears. As the other movie watchers filtered out, her friends’ cries began to crescendo. When the music finally cut out, the sound of their heaves filled the theater.
Gabriella sat misty-eyed, but silent, tight in their embrace.
If you view the utube video link at the end of this, what you will discover that this particular pain pt is dealing with a very rare painful disease. In the entire USA there could be upwards of 700 total pts dealing with these disease. According to the video the only potential management for pts dealing with this disease – currently there is no cure for pts dealing with this disease – is LOW IMPACT EXERCISE/ACTIVITY. So if one of these pts have their pain management meds dramatically reduced… Typically they lose the ability to do LOW IMPACT EXERCISE/ACTIVITY. In this particular pain pt, they become – to use the pt’s own words –I am totally bedridden and need help to regain my quality of life.
I AM SUFFERING FROM THE FORCED TAPER THAT HAS BEEN CAUSING MY INCURABLE DEBILITATING BONE DISEASE TO SPREAD FURTHER DOWN MY SPINE = IT IS INHUMANE WHAT IS BEING DONE TO ME!! Imagine living with a rare genetic bone disease that has no cure and causes excruciating pain. Then imagine the medication that effectively alleviated that pain for 29 years is abruptly tapered and you are forced to take only half the dosage your body has become dependent on. Not only is the pain unbearable, but the resulting stress placed on the body prevents you from exercising or participating in physical therapy, which is vital to someone with Ochronosis/Alkaptonuria (AKU) to prevent chronic joint pain and inflammation. AKU is known as “Black Bone Disease” because it turns bones black and brittle. It is the oldest metabolic disease on earth and has even been found in female Egyptian mummies! After being diagnosed with AKU, I was placed on a very high dosage of morphine to stop my body from producing Homogentisic Acid (HGA). People like me born with AKU are missing an enzyme that prevents them from fully breaking down HGA. At high levels, HGA devours my bones, turning them black and stripping the cartilage and cushions between them. My former physician of 32 years identified morphine as a pain medication that helped without causing side effects. I was able to function again and live a decent life, in spite of having a debilitating disease. But in 2017, the CDC opioid guideline was adopted in Hawaii as state law, and my doctor was driven out of practice. I cannot find a doctor to replace him. They all see my need for morphine, but they do not want to risk their livelihoods by taking me on as a patient. I am being harmed by the state and no one will do anything to help me! Due to the morphine being reduced to half of my original dosage, the HGA accumulation has eaten two holes into my heart valves, resulting in a life-threatening heart condition. HGA has also spread to my upper cervical spine, my lower cervical spine, along with my liver and kidneys. I have endured irreparable damage by being forced off my old dosage of medication in such an inhumane manner. Every doctor I have been referred to has refused to accept me as a patient once they look over my medical records and see I have a rare genetic bone disease that requires opioids. Only when I was forced on a lower dosage did AKU start to spread. I have had four failed surgeries on a non-operative disease, and no doctor wants to put their livelihood on the line to help keep this disease from hurting me more! I have never abused drugs or alcohol in any form. I have comprehensive medical records, including MRIs and x-rays documenting my illness and treatment history. It will also show that for 29 years on the original morphine dose, my liver stayed strong and clean, compared to a patient who has been on a toxic medicine like Suboxone that is just as addictive, as well as, being severely damaging to the liver and kidneys. I am being tortured for only taking what was prescribed to me. FIRST,DO NO HARM, I HAVE BEEN VERY BADLY HARMED BY THIS OPIOID CRISIS FORCED OFF A MEDICINE THAT GAVE ME QUALITY OF LIFE< TO NOW BEING BED RIDDEN BY BEING FORCED OFF IT WHEN IT HAD DONE NO HARM TO ME! Please help me obtain the help I need before this disease spreads even more than it has. I am totally bedridden and need help to regain my quality of life. I pray that a revision of CDC guideline will allow doctors to do their jobs again without being persecuted, and will give me back my life so that I can grow old with dignity. Legitimate pain patients who had never abused drugs are getting treated like addicts, demonized for taking prescribed medicines from licensed doctors. Please watch this video if you have any questions about my disease:https://www.youtube.com/watch?v=7PpQU3wrdlM&t=30s
After the U.S. Supreme court overruled Roe v Wade last month, ripples have been felt throughout U.S. healthcare, with doctors claiming that the new restrictions threaten lives.
As part of this, in States where abortion is banned or now more severely restricted, multiple people with arthritis and other rheumatoid conditions have reported that they can no longer get their prescriptions filled, forcing them to try to find other medications to help manage their conditions.
Most of the people reporting they have been denied refills of their medication are women and there are suggestions that this is violating federal anti-sex discrimination laws. On the 14th of July, the Department for Health and Human Services said it was investigating the reports and communicating with pharmacies to remind them of their duties.
“We are committed to ensuring that everyone can access health care, free of discrimination. This includes access to prescription medications for reproductive health and other types of care,” said Xavier Becerra, Health and Human Services Secretary said on the 14th in a statement.
Methotrexate can be used to terminate pregnancies and is the most common drug used to treat ectopic pregnancy, where the fetus develops outside of the womb and is non-viable, as well as life-threatening for the pregnant individual. But methotrexate can also be used in therapy for certain types of cancer, working by reducing the amount of a nutrient called folate a cell can use, preventing it from growing and replicating itself.
“Methotrexate is an essential drug for oncologists,” said Julie R. Gralow, MD, FACP, FASCO, Chief Medical Officer of the American Society of Clinical Oncology (ASCO). “It is an essential chemotherapy agent for the treatment of multiple cancers including both adult and pediatric acute lymphoblastic leukemia and osteosarcoma,” Gralow added.
Methotrexate is also used to treat certain types of lymphoma, cancers which have spread from elsewhere to form tumors on the meninges-thin layers of tissue which cover the brain and occasionally breast and head and neck cancers. But so far, at least, prescribing issues affecting patients with arthritis do not appear to be affecting patients with cancer who need treatment with methotrexate.
“We have certainly heard concerns about this possibility, but we have not yet heard of a case where a patient with cancer has been denied methotrexate. We are communicating regularly with our members so that we have the most current information about the realities of delivering cancer care,” said Gralow.
However, it is not only methotrexate which may get caught up with the new anti-abortion laws in several states. Many cancer treatments are not compatible with pregnancy and on difficult occasions where a pregnant individual is diagnosed with cancer, one choice is to elect to have an abortion to allow treatment to proceed.
“ASCO’s singular focus is assuring every individual with cancer is able to receive high quality, equitable, evidence-based cancer care. For pregnant patients with cancer, the option to terminate a pregnancy is an important component of high-quality cancer care. We will continue to do everything within our means to ensure patients have access to equitable, evidence-based cancer care,” said Gralow.
The Supreme Court decision is still very recent and many of the ripple effects of the ruling have yet to be felt. Gralow says that ASCO is regularly reaching out to their volunteers and state societies to better understand what is happening on the ground in states where abortion is now banned or strictly limited.
“Patients must be able to trust their doctors. We are concerned that the Dobbs ruling creates uncertainty and confusion that can undermine this trust and the doctor-patient relationship, threatening patient access to potentially lifesaving, life-extending, or palliative treatment,” said Gralow.
when I first started working in a pharmacy – the summer of 1967 – there was no DEA, there were no PBM’s. Nearly all the Rx meds were brand name and everyone pay CASH for their prescriptions. The average Rx price was in the $4.00 range. Of course, the Brand Name Pharmas did all the R&D on new meds – as they do today. Generic companies do little/no R&D for new medications. If one took the average Rx price back in 1967 and apply the Consumer Price Index and/or Cost of Living Adjustment to that price. All things remaining the same, the average Rx price today should be in the $30 range – instead of pushing $70 as they are today, with 85%-90% of all Rxs being generics.
If somebody has taken the time, I have not seen it published. The two biggest changes in prescription market between 1967 and today is that today the PBM industry controls abt 90% of the pricing of all prescriptions and – to a certain degree – what medications the pt gets their insurance to pay for and the 85%-90% of all Rxs dispensed is now generics. I would suspect that one would find that the increase of the average Rx price would track the increase in the per-cent of all prescriptions that the PBM industry paid for over that time frame.
So, how does the part of the pharma industry in charge of footing the bill for all the R&D of new meds pay for all that expense when their meds are only 10%-15% of all prescriptions ? Charge a ARM & a LEG for a brand name med, don’t forget the PBM’s will demand up to 75% of the AWP (Average Wholesale Price) as a discount, rebate and/or kickback from the Pharma. The graphic below, demonstrates in what pockets the $$ you pay for your Rx really goes.
One pt I saw posted the other day on FB, that they called customer service for goodrx and they answered OptumRx customer service – part of United Health insurance. Yep, it appears that the 4-5 major PBM’s are behind those CASH DISCOUNT Rx CARDS.
Critics say Mark Cuban’s pharmacy isn’t tackling the big issue: brand-name drugs
Mark Cuban’s pharmacy, Cost Plus Drug Co., has hundreds of drugs marked at discounted prices, but some pharmacy experts say there’s a larger problem that needs fixing, CNBC reported July 28.
The online pharmacy launched in January with about 100 drugs, and by its one-year anniversary, plans to have more than 1,500 medications, according to the company’s website. The business model, which allocates for a $3 pharmacy dispensing fee, $5 shipping fee and a 15 percent profit margin with each order, aims to uproot the pharmaceutical industry, which has faced criticism for years about its opaque business practices.
Gabriel Levitt, the president of PharmacyChecker, a company that monitors the cheapest drug prices, told CNBC there’s more to be done.
“As much as I support the venture, what they’re doing does not address the big elephant in the room,” Mr. Levitt said. “It’s really brand-name drugs that are increasing in price every year and forcing millions of Americans to cut back on medications or not take them at all.”
Brand-name drugs are 80 percent to 85 percent more expensive than generics since brand-name drugs have to repeat clinical tests to prove efficacy, according to the FDA. Cost Plus Drug Co. only offers generics. Mr. Cuban told CNBC he hopes to sell brand-name medications “within six months,” but added that it’s a tentative timeline.
NEW YORK, July 28 (Reuters) – New York on Thursday sued CVS Health Corp (CVS.N) for allegedly forcing hospitals that serve low-income patients to pay millions of dollars to access discounted prescription drugs, violating state antitrust law.
In a lawsuit filed in state court in Manhattan, New York Attorney General Letitia James said CVS group abused its market power by requiring hospitals and clinics to use a CVS subsidiary, Wellpartner, to fill prescriptions for discounted drugs at CVS pharmacies.
“While safety net health care providers are tackling public health crises and helping underserved communities, CVS is robbing them out of millions of desperately needed funds that could improve patient care,” James said in a statement.
“These allegations are without merit and we will defend ourselves vigorously,” CVS said in a statement.
The lawsuit centers on so-called safety net providers, which are eligible for discounted drugs because they serve predominantly lower-income patients under a federal program known as 340B.
Most providers contract with outside companies to administer their 340B programs, which requires extensive recordkeeping to comply with federal rules. CVS bought Wellpartner, a third-party 340B administrator, in 2017.
James’ lawsuit said that CVS then began refusing to contract with providers that did not use Wellpartner to obtain 340B benefits. Because 340B rules forbid providers from steering patients away from particular pharmacies, the providers were forced either to start using Wellpartner, or to forego 340B discounts when patients chose to fill their prescriptions at CVS.
Many providers already had contracts with other 340B administrators, but most switched to Wellpartner for all their 340B prescriptions, even those not filled at CVS, because it was not economical to pay two contractors, the lawsuit said.
James is seeking a court order blocking CVS from requiring providers to use Wellpartner, and an unspecified amount of money damages.
This appears to be another bill/law that Congress plans on passing, when they don’t understand what they are really dealing with. All out pt meds are provided by Part D and/or Medicare-C (advantage). Which are all FOR PROFIT INSURANCE COMPANIES. The Feds pay these companies a fixed $$/pt/month and the insurance company has got to figure out — how to spend less than they are paid for my the feds to provide medications to Medicare folks. The PBM industry already negotiates prices with the pharmas and as the graphic below demonstrates the Insurance/PBM industry keeps the “lion’s share” of those discounts to pad their bottom lines. The top 5 PBM’s are owned by insurance companies, if those PBM’s are forced to share those discount/rebates/kickbacks with pts, I expect that pts will see higher premiums, deductibles and co-pays. Even perhaps they will be forced to use the PBM’s mail order facility are in the case of CVS Health – be forced to have their Rxs filled at one of their community/retail pharmacies or their mail order. Other PBM may “make a deal” with one of the chain pharmacies where the pts can get their Rxs filled and get some coverage by Part D or Medicare-C.. This article mentions some undefined “certain prescription drugs” that they will be seeking LOWER PRICES ON.
What tax hikes are in the Manchin-Schumer reconciliation bill?
Under the bill, the government would have the power to negotiate with drugmakers in order to lower prices for certain prescription drugs. The proposal would cap what seniors on Medicare pay out of pocket for drugs each year at $2,000.
If pharmaceutical companies raise the prices of their drugs more than the rate of inflation, pharmaceutical companies would be required to rebate Medicare.
VANCOUVER, British Columbia — The place where Chris gets his fentanyl is bright and airy, all blond wood and exposed brick. The staff is friendly and knowledgeable about the potency of the pills he can crush, cook and inject.
Soft pop music played, and an attendant spritzed a bit of Covid-cautious spray on his seat before he settled into a booth on a recent afternoon with a couple of red-and-yellow pills, a tourniquet, a tiny candle and a lighter.
“The best thing about this is the guarantee: I can come in here four times a day and get it,” Chris said. He no longer spends all of his waking hours in a frantic scrabble of panhandling and “other stuff” to scrape up the cash to pay a dealer. He won’t get arrested — and he won’t overdose and die using a drug that is not what it is sold as.
This fentanyl dispensary is legal, and Canada’s public health system finances it.
It is the latest and perhaps most radical step in a city that has consistently been at the leading edge of experiments in “harm reduction,” an approach to reducing deaths and severe illness from illicit drugs by making the drugs safer for people who use them. Harm reduction, even in basic forms such as the distribution of clean needles, remains deeply controversial in the United States, although the concept has been gaining fitful support as overdoses rise, including from the Biden administration.
Biden’s Drug Czar Is Leading the Charge for a ‘Harm Reduction’ Approach
Experts describe the president’s drug control strategy as the most progressive since Richard Nixon appointed the nation’s first drug czar in 1971.
July 26, 2022
But the breadth of Vancouver’s services and interventions is almost unimaginable in the United States, less than an hour’s drive to the south. Supervised injection sites and biometric machines that dispense prescription hydromorphone dot the city center; naloxone kits, which reverse overdoses, are available free in every pharmacy; last year, a big downtown hospital opened a safer-use site next to the cafeteria, to keep patients who are drug users from leaving in order to stave off withdrawal.
And since April, Chris, a wiry, soft-spoken 30-year-old who wanted to be identified by only his first name to protect his privacy, has received pharmaceutical-grade fentanyl through the dispensary, which sells to those who can pay and provides free drugs through the program’s operational budget to those who cannot.
The new program aims to provide a safer alternative to the fentanyl available on the streets, where the supply is increasingly lethal and is responsible for most of the overdose epidemic that was declared a public health emergency here six years ago.
Dr. Christy Sutherland, a board-certified addiction medicine specialist who set up the program, said its goal was, first, to keep people from dying, and, second, to help bring stability to their lives so that they may think about what they might want to change.
Chris started using pills recreationally in his teens, then moved to heroin. But the heroin supply in Vancouver was taken over about a decade ago by fentanyl, an opioid that is 50 to 100 times as potent and thus far more profitable for the cartels that sell it.
Chris has been using illicit drugs since he was a teenager. “The best thing about this is the guarantee: I can come in here four times a day and get it,” he said.Credit…Jackie Dives for The New York Times
Wistaria Burdge, right, a nurse, helped Ken Elliott apply a bandage after injecting heroin at the Crosstown Clinic. Credit…Jackie Dives for The New York Times
Overdose deaths have surged in British Columbia since the start of the Covid pandemic, as they have across the rest of North America. Some 2,200 people died of overdoses in the province last year, among the 115,000 lives lost to drugs in Canada and the United States during that time. The mounting toll has spurred communities to search for new solutions, and this city has tried more of them, faster, than anywhere else.
Understand fentanyl’s effects. Fentanyl is a potent and fast-acting drug, two qualities that also make it highly addictive. A small quantity goes a long way, so it’s easy to suffer an overdose. With fentanyl, there is only a short window of time to intervene and save a person’s life during an overdose.
Stick to licensed pharmacies. Prescription drugs sold online or by unlicensed dealers marketed as OxyContin, Vicodin and Xanax are often laced with fentanyl. Only take pills that were prescribed by your doctor and came from a licensed pharmacy.
Talk to your loved ones. The best way to prevent fentanyl use is to educate your loved ones, including teens, about it. Explain what fentanyl is and that it can be found in pills bought online or from friends. Aim to establish an ongoing dialogue in short spurts rather than one long, formal conversation.
Learn how to spot an overdose. When someone overdoses from fentanyl, breathing slows and their skin often turns a bluish hue. If you think someone is overdosing, call 911 right away. If you’re concerned that a loved one could be exposed to fentanyl, you may want to buy naloxone, a medicine that can rapidly reverse an opioid overdose and is often available at local pharmacies without prescription.
Vancouver’s experiments have government support and are paid for by the public health system on the expectation that they will save not only lives but also taxpayer dollars — in reduced emergency services and hospitalizations.
But there is concern from both the general public and some addiction medicine specialists here. They say that the latest efforts go too far, diverting resources from proven treatments to experiments that have not been shown to reduce drug use or save lives, and risking an increase in the numbers of both users and deaths. Supplying drugs is for criminals, not health clinics, they say.
“These are highly potent substances that produce quite a bit of harm,” said Dr. Launette Rieb, an addiction medicine physician who has worked for decades with drug users in Vancouver. “When access increases, costs go down and perception of risk goes down.”
Evidence of the effectiveness of these interventions in saving lives is limited, she said.
A clinical trial in Vancouver found that providing injectable heroin to patients who had not responded to other forms of treatment helped them reduce their use, stay tied to health care and improve their quality of life, compared with users who were given methadone. Another found a similar benefit from prescribed hydromorphone. Research on the fentanyl program has just begun but will track whether it shows a similar benefit, which could justify expanding it.
In June, British Columbia received an exemption from federal drug laws that will allow the province to decriminalize individual possession of up to 2.5 grams of hard drugs, starting early next year. The police will no longer confiscate small amounts of drugs, and no user will be required to seek treatment to avoid arrest, but drug trafficking and production will still be crimes.
The decriminalization is a significant step beyond Canada’s legalization of cannabis use in 2018. Proponents say it should be a first move toward a regulated government supply of all drugs as the best way to respond to growing toxicity, which is the immediate cause of overdose deaths.
The lobby of the Vancouver Area Network of Drug Users, a peer support organization.Credit…Jackie Dives for The New York Times
Injection booths at St. Paul’s Hospital in Vancouver, the first hospital in Canada to offer an overdose prevention site in-house.Credit…Jackie Dives for The New York Times
Fentanyl has largely displaced heroin and the opioid painkillers Dilaudid and OxyContin as the illicit drug most used in Vancouver, a shift underway throughout North America. It is also often cut into other drugs, including non-opioid prescription medications such as the attention deficit disorder medicine Adderall, which is sold on the street as a stimulant. Its potency and users’ inability to know what they are buying or how strong it will be have led to the huge surge in overdoses.
Dr. Sutherland, an effervescent, fast-talking 41-year-old, is the medical director of a social service agency called the PHS Community Services Society. It serves the Downtown Eastside, a neighborhood that has long been the site of intense drug use and advocacy by and for drug users. It was home to North America’s first needle exchange, first supervised injection site and first prescription heroin program.
Dr. Sutherland said she was tired of responding to overdoses on the sidewalk outside her clinic, knowing that if she could go back in time 10 minutes and give people safer drugs, she wouldn’t be trying to save their lives.
She began her medical practice working with homeless people. She said that those patients, and others living on the social margins, shifted her thinking on drug use from “Drugs are bad and are outlawed to keep people safe” to seeing addiction as a disease that she could help people overcome. Now she takes it one step further with a view that is gaining traction in British Columbia: There will always be people who use drugs, so all drugs — not just alcohol and tobacco — should be regulated by the government and sold in a controlled, legal market.
“Treatment and recovery is not the answer to a toxic drug supply. Getting rid of the toxic drug or giving alternatives to the toxic drug supply is,” she said. “You can start there and talk about treatment and recovery down the road a bit.”
It’s not realistic to think that people will abstain from substances, she said, and so the role of the state should be to keep substances safe and take access out of the hands of organized crime.
Dr. Christy Sutherland, the medical director of the PHS Community Services Society, at the Columbia Street Community Clinic in Vancouver.Credit…Jackie Dives for The New York Times
Medication and injection supplies for a patient. Patients can buy drugs with a prescription or obtain them through a taxpayer-funded drug program.Credit…Jackie Dives for The New York Times
Back in 2010, Dr. Sutherland began prescribing what is called opiate agonist therapy, or medication-assisted treatment, to patients who were using street drugs. That includes methadone, Suboxone and Kadian, long-acting opioids that satiate the craving for an opiate without providing the high. She helped stabilize many users and connect them with treatment to stop using altogether. But some intended to keep using, and the therapy failed for others, and Dr. Sutherland concluded that what those users needed was safer drugs.
So she started to provide a replacement for the street drugs, first Dilaudid, then fentanyl patches, and, now, the fentanyl capsules. Her project purchases the fentanyl from a pharmaceutical manufacturer, and a local pharmacy compounds it, with dextrose and caffeine as buffers. The pills are sold at $10 a hit, priced to match the street rate exactly.
Dr. Sutherland writes a prescription for the drug, and patients buy it; if they can’t pay, the program covers the cost.
When nurses enroll new participants in the program, they increase the dose over days to find exactly what the patients need to replace what they use on the street. Participants use the drugs under supervision at first, to make sure they have the amount they need to avoid withdrawal (and no more, so that there is no risk they will sell excess on the street). Then, they can take the drugs off-site to use.
The Opioid Crisis
From powerful pharmaceuticals to illegally made synthetics, opioids are fueling a deadly drug crisis in America.
Youth Deaths: Young people are turning to social media to find prescription pills. But drugs found this way are often laced with deadly doses of fentanyl.
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Chris has been a daily user of illicit drugs since he was a teenager. He receives 30,000 micrograms of fentanyl at the dispensary each day. That is vastly more than would kill a nonuser — a doctor would typically prescribe about 50 micrograms temporarily to manage pain — but, after years of use, it is what Chris needs to feel a quick rush of euphoria and prevent withdrawal. He said he hoped to return to working soon and then would start buying from the program, the way he would patronize a liquor store.
Dr. Sutherland expects that patients such as Chris may gradually reduce the amount they use, because they’re not worried about how they will score the next hit to keep the agony of withdrawal — being “dope sick” — at bay.
Lisa James personifies the anticipated benefit of programs like this. Ms. James, who is 53, spent 18 years addicted to heroin. For the first eight, every day began the same grim cycle: She’d go out in the morning and steal from stores, then pass the merchandise to her boyfriend, who would resell it and use the money to buy heroin. He’d bring it home, where she was waiting anxiously, already nauseated and twitchy with dope sickness.
“Doctors would all say the same thing, ‘Go to detox and go to meetings,’” Ms. James said. “And when you’re that far down in it, that’s like a lifetime away. You can’t even imagine getting through two days, never mind going into detox.”
Erin Elliot, left, and Lisa Santucci, both nurses, prepared drugs for distribution to patients at the fentanyl clinic.Credit…Jackie Dives for The New York Times
Lisa James obtains prescription heroin every day from the Crosstown Clinic.Credit…Jackie Dives for The New York Times
Ms. James failed repeatedly at treatment. What turned her life around wasn’t quitting heroin but rather receiving pure medical-grade heroin from the Crosstown Clinic, which is run by the British Columbia health care system and provides the drug free of charge. When she was taken on as a client there a decade ago, Ms. James stopped stealing, stopped hustling and was able to set down the constant terror of wondering if she would be able to buy the next hit. She got a job, and the Crosstown staff helped her find an airy apartment in the suburbs to share with her daughter.
She may one day stop using heroin, she said, but she doesn’t need to decide that now. “With this program, even if I have to keep using something to stay off street drugs, I’m willing to do that,” she said. “I feel really lucky to live here.”
But critics of this and other safer-supply initiatives reject this idea, arguing that opioid use disorder is a brain disease and one that can be effectively treated. Dr. Annabel Mead, a Vancouver addiction specialist, said her initial hesitancy about safer-supply programs — should a doctor whose first rule is “do no harm” give out highly addictive drugs? — had been reinforced by the growing number of children she sees at B.C. Children’s Hospital who have overdosed.
She said that a hydromorphone dispensing program, set up to try to help people with addictions to isolate during Covid lockdowns, was partly to blame for a surge in teen use: Drug users prescribed Dilaudid are selling pills to young people and using the money to buy fentanyl that has the potency they are used to, she said.
In the meantime, she added, the province is spending too little on abstinence-based treatment; there is a nine-month waiting list for the main residential women’s treatment program. Many skeptics of safer supply here argue that treatment that aims to help people stop using is being shortchanged, but British Columbia’s 2021 budget designated $330 million for new treatment and recovery services for substance use, which was an increase. The total far outweighs the spending on safer supply.
Some people say the steps in Vancouver don’t go far enough. The Crosstown Clinic has 116 people on its prescription heroin and Dilaudid programs. Dr. Sutherland thinks she can supply about 100 people with fentanyl, for now. Several hundred people are also receiving safer drugs through their pharmacy under prescribing guidelines that the provincial government loosened in the first days of the pandemic, when supervised injection sites were closed.
Donald MacPherson, director of the Canadian Drug Policy Coalition and a professor at Simon Fraser University, says Vancouver’s harm-reduction projects don’t go far enough. “Incrementalism kills,” he said.Credit…Jackie Dives for The New York Times
An overdose prevention site at the Vancouver Area Network of Drug Users.Credit…Jackie Dives for The New York Times
“Harm-reduction services are like a candle for lighting something, a tiny intervention into this monstrous toxic cesspool of fentanyl and its analogues,” said Donald MacPherson, director of the Canadian Drug Policy Coalition and professor at Simon Fraser University.
He added, “We need to do something big.” The rate of death demands much more sweeping intervention, he said. “The incremental is no good. No more pilot projects.”
Dr. Bonnie Henry, British Columbia’s health officer, said there was little choice but to move incrementally.
“Incrementalism is the only way it’s going to work,” she said. “We have to evaluate it, and the evaluating has to be done independently by somebody who’s not committed to seeing it fail or to seeing it succeed.”
At the same time, she is part of a community that includes government, researchers, doctors and drug users, all trying to envision what a new, safe, regulated market could look like. “People don’t deserve to die because of the toxicity of the street supply,” she said. “So how else can we help?”
Newswise — In a new study, Johns Hopkins Medicine researchers tested more than 100 topical cannabidiol (CBD) products available online and at retail stores, and found significant evidence of inaccurate and misleading labeling of CBD content. The study also revealed that some of these nonprescription products contained amounts of delta-9-tetrahydrocannabinol (THC), the main active ingredient in cannabis that can cause a “high,” including some products that claimed to be free of THC.
“Misleading labels can result in people using poorly regulated and expensive CBD products instead of FDA approved products that are established as safe and effective for a given health condition,” says study lead author Tory Spindle, Ph.D., assistant professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine.
According to the National Institutes of Health’s National Center for Complementary and Integrative Health, CBD and THC are the most commonly known compounds in the plant Cannabis sativa. A key difference between the two is that THC can produce a psychoactive “high” effect at high doses, whereas CBD doesn’t.
Under the Agriculture Improvement Act of 2018 (the Farm Bill), CBD products that contain less than 0.3% of THC are not considered federally illegal substances. This has made CBD products particularly popular and widely available to consumers virtually anywhere, but it also makes it difficult for the FDA to address unapproved claims and mislabeling. However, Spindle notes, “Recent research has shown that people who use CBD products containing even small amounts of THC could potentially test positive for cannabis using a conventional drug test.” This has not been determined for topical CBD products, but the authors are currently studying it.
For the study, the research team purchased 105 CBD topical products — including lotions, creams and patches — online and at brick-and-mortar retail locations in Baltimore, Maryland, in July and August 2020. Products were tested using a technology called gas chromatography-mass spectrometry to identify the actual amount of CBD and THC they contained.
Only 89 (85%) of the 105 tested products listed the total amount of CBD in milligrams on the label. Of the 89 products, 16 (18%) contained less CBD than advertised, 52 (58%) contained more CBD than advertised and 21 (24%) were accurately labeled. On average, the in-store products contained 21% more CBD than advertised and the online products contained 10% more CBD than advertised, though CBD label accuracy varied widely across products.
THC was detected in 37 (35%) of the 105 products, though all were within the legal limit of 0.3%. Four (11%) of those 37 were labeled as “THC free,” 14 (38%) stated they contained less than 0.3% THC and 19 (51%) did not reference THC on the label.
Of the 105 products, 29 (28%) made a therapeutic claim, mostly about pain/inflammation, 15 (14%) made a cosmetic/beauty claim (e.g., that they alleviate wrinkles or nourish/improve skin) and 49 (47%) noted they were not FDA approved. The other 56 (53%) products made no reference to the FDA. “It’s important to note that the FDA has not approved CBD products to treat any of the conditions advertised on the products we tested,” says Spindle, who also is a faculty member at the Johns Hopkins Cannabis Science Laboratory.
“The variability in the chemical content and labeling found in our study highlights the need for better regulatory oversight of CBD products to ensure consumer safety,” says Ryan Vandrey, Ph.D., professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine and the study’s senior author. Such regulation, the authors believe, would ensure CBD products meet established standards for quality assurance so consumers can make informed decisions about product selection and are not misled by unproven therapeutic or cosmetic claims. The study authors also caution that people should check with their health care practitioner before starting any CBD regimen.
In addition to Spindle and Vandrey, other researchers who contributed to the study include Dennis Sholler and Edward Cone from the Johns Hopkins University School of Medicine, Timothy Murphy and Mahmoud ElSohly from ElSohly Laboratories, Ruth Winecker from RTI International, Ronald Flegel from the Substance Abuse and Mental Health Services Administration (SAMHSA) and Marcel Bonn-Miller from the Canopy Growth Corp.
This research was supported by the Substance Abuse and Mental Health Services Administration (SAMHSA).
COI: Tory Spindle has served as a consultant for Canopy Health Innovations, Ryan Vandrey has been a consultant or received honoraria from Canopy Health Innovations, MyMD Pharmaceuticals, Mira1a Therapeutics, Syqe Medical Ltd. and Radicle Science, and Marcel Bonn-Miller is employed by the Canopy Growth Corp. The other authors declare no conflicts of interest.
Things are getting interesting with the Fed AG office and President Biden and his use of Executive Orders to impose his beliefs on states and trying to override and invalidate the SCOTUS recently ruling on the states have the authority to determine the issues around abortion. It appear that AG Garland in trying to apply or enforce Biden’s Executive Order concerning the states’ rights to determine what is – or is not – allowed in their state in regards to abortion.
Gabriella Walsh knew she wanted to die on a Saturday.
“Este puede ser nuestro último abrazo.”
