Email steve@steveariens.com 502-938-2414
Pay Attention
Where the insurance/pbm industry uses PAs to pad their bottom line – CLICK HERE
I didn’t have the time to convert each page to a *.jpg so that I could display them directly in a blog post, so they are all available in *,pdf format on the hyperlink above
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We are quickly approaching a precipice like many other chronic pain pts. A few months ago, our PCP of almost 30 yrs told us that he is retiring the end of 2026. We have already interviewed a couple of practices only to get “I’m not comfortable prescribing that much opioids – and that was on ME, and what I take is minuscule compared to what Barb takes. For the short term, we have pulled back about looking for a new PCP. Barb is scheduled to have her implanted pump refilled next month and will see if our pain doc will consider writing her oral opioids for her. She has called the office and asked that he would return her call, but I guess that he is to important to return pt’s calls, but we will be able to get to talk to him – eye ball to eye ball – when she goes in to get her pump refilled.
Last month, the independent that we have patronized for the last 8+ yrs was out of one of Barb’s oral opioids and the wholesaler had no inventory. The fellow that owns this independent has another pharmacy in town and they had enough to fill Barb’s med. I called the HQ of the wholesaler he uses and after some back and forth with the staffer at the wholesaler he agreed to tell me about their inventory level on the particular medication that Barb needed. I asked him how many different generic pharmas did they normally stock – NINE DIFFERENT COMPANIES. I asked, how much inventory do you have on hand for the particular med/strength that Barb needed. His answer was – ZERO on all nine pharmas. We are now one month later and between his two pharmacies – they have a total of 10 tablets.
Yesterday I call all four TV station in Louisville,KY. We live in what is called the Metro Louisville, KY area, but we are on the north side of the Ohio river in Indiana. Louisville/Jefferson county is a uni-gov and Louisville is the LARGEST city in the state of KY. All 4 of the major TV stations (ABC, CBS,FOX, NBC) are based in Louisville. All their antennas – in what is called “the antenna farm” which is near where we live is about 500-600ft higher in altitude than Louisville. This gives these TV stations much larger coverage area for their signals. There TV signal reaches an estimated 2-3 million people.
I called each station and asked them if they are getting any calls from people not able to get their pain medications at the local pharmacy. Their answer was universally the same NOPE! Does this suggest why the media only talks the DEA’s talking point(s)?
They all agreed to give me their email address to send them information and below is the email that I send. I marked each each email as HIGH PRIORITY and for me to be notified when the email was opened. Last night I got my first email notice that one of my emails was opened, but it was not from one of the email domains that I had sent. The domain was @hearst.com that the email was opened from. Hearst corp owns the CBS (WLKY) affiliate in Louisville.
I wonder if other chronic painers called their local TV channels and asked the questions “have you received any calls from people not being able to get their pain medications”? What kind of answers would those that did would get?
This is the opioid settlement I spoke with you about, the hyperlink was created by a Kaiser retired nurse and that below the hyperlink is what I got from perplexity.ai about the same settlement. https://www.pharmaciststeve.com/wp-content/uploads/2023/11/kaiser.pdf
There are an estimated 100 million chronic pain pts and within that number there is a 25-35 million subset of chronic pain pts that are labeled as high impact or intractable chronic pain pts, whose intensity of their pain is at the higher end of the 1-10 pain scale and many healthcare professionals consider a pain intensity > 5 on that scale to be a torturous level of pain.
This is a video that showed up on my facebook page today https://www.facebook.com/kathaav/videos/1125692909317845
I don’t know this woman, but I am a pharmacist and a chronic pain consultant/advocate and she shared it on my FB page today
https://www.facebook.com/pharmaciststeve/
This is not an isolated case, because of that agreement
Certainly. Here is a summation of the opioid settlement between the attorneys general (AGs) of 46 states and the three major drug wholesalers (AmerisourceBergen, Cardinal Health, and McKesson), with additional context regarding the broader opioid litigation landscape:
Parties Involved:
Settlement Amount:
Participation:
Purpose and Use of Funds:
Non-Financial Terms:
Effective Date:
April 2, 2022 was the scheduled effective date for the settlement, following court-ordered consent judgments4.
Exclusions:
This settlement was part of a larger effort to resolve thousands of lawsuits brought by state and local governments against pharmaceutical companies for their alleged role in fueling the opioid crisis. The settlement with the three major distributors and Johnson & Johnson was valued at $26 billion, with the distributors responsible for $21 billion of that total123. The settlement was designed to provide a stable source of funding for opioid crisis abatement programs across the country.
Historic Settlement: The $21 billion (plus $5 billion from J&J) represents one of the largest civil settlements in U.S. history regarding public health.
Community Impact: The majority of funds are dedicated to opioid crisis response, treatment, and prevention.
Industry Oversight: The settlement mandates new transparency and monitoring requirements for opioid distribution.
No Admission of Liability: The companies did not admit wrongdoing, but agreed to pay to resolve litigation and support communities affected by the opioid epidemic13.
This settlement marked a significant milestone in efforts to address the opioid crisis through large-scale, coordinated legal action and funding for public health initiatives.
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Rite Aid is closing its last bankruptcy with selling off their last 1,000 stores. A few years back they had abt 5,000 stores. Walgreens it is reported that they are selling the entire chain off to some investment firm. 10-15 yrs ago Walgreens was worth 100 billion, but this deal is reported to be for 10 billion. I would not be surprised to see the investment firm to close a lot of stores and/trying to consolidate various stores’ business into nearby Walgreen stores. Just in the last year or so, Walgreens stated that they were going to 25% of their 8600 stores.
https://www.newsweek.com/cvs-closing-270-stores-locations-impacted-2077982
Amid its ongoing restructuring efforts, CVS plans on closing hundreds more stores in 2025, which the company says will streamline operations and help it adapt to shifting consumer needs.
In its recent annual report, filed in February, CVS announced that it would be closing 271 retail stores in 2025 as part of its “enterprise-wide restructuring plan intended to streamline and simplify the organization.”
This follows the closure of around 900 locations between 2022 and 2024. A spokesperson for CVS told Newsweek that these closures will enable the company to optimize its “existing stores and pharmacies.”
The spokesperson said that the closures were based on several factors, including “population shifts, consumer buying patterns, store and pharmacy density, pharmacy care access, and community health needs.” This will enable the company to better meet customers’ needs and was not a response to industry pressures.
CVS has not released a list of locations that will be closed amid this strategic realignment, and declined to provide any details of which states or cities may be affected.
However, according to consumer-focused website The Krazy Coupon Lady, citing local news sources, 34 CVS locations have either already closed or announced scheduled closures in 2025:
Based on local news sources and social media, Newsweek identified additional CVS locations that have closed or announced closures since the beginning of the year:
A spokesperson for CVS told Newsweek: “Store closure decisions are based on several factors, including population shifts, consumer buying patterns, store and pharmacy density, pharmacy care access, and community health needs. We’re focused on ensuring we have the right kinds of stores and the right number of stores in the right locations. We’re closing locations strategically to better meet consumers’ health, wellness and pharmacy care needs – as announced more than three years ago – not in reaction to industry pressures.”
“Even after the realignment work, 85% of people in the U.S. will still live within 10 miles of a CVS Pharmacy,” they added.
CVS confirmed to Newsweek that, despite the closures, it intends to open 30 new pharmacy locations in 2025, including those inside Target stores.
Meanwhile, a new law signed by Arkansas Governor Sarah Huckabee Sanders last month seeks to prevent Pharmacy Benefit Managers, third-party firms that manage prescription drug benefits, from owning pharmacies. CVS has warned that the legislation could impact its 23 locations in Arkansas.
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“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,VP, Pharmacist
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When COVID-19 vaccines first became available, I made a deliberate choice for my family: we would not take the mRNA vaccines. In my opinion, these newer vaccines had insufficient research and clinical trial data behind them at the time.
However, there was a third option—the Johnson & Johnson/Janssen vaccine, which used viral vector technology that had been employed for decades in flu vaccine production. This established technology felt more familiar and trustworthy to me. We made sure to receive both doses of the J&J/Janssen COVID-19 vaccine.
What puzzled me later was something I rarely saw discussed publicly: when booster shots were rolled out, no J&J/Janssen boosters were made available. Only the two mRNA vaccines (Pfizer and Moderna) were offered as boosters. This left us in a difficult position, and ultimately, we decided not to get any additional COVID-19 vaccinations.
Fortunately, neither my spouse nor I contracted COVID-19—or if we did, our symptoms were so mild that we didn’t notice them.
Looking back, I didn’t have concrete scientific evidence against the mRNA vaccines at that time. What guided my decision was something more intangible: my instincts, combined with over 50 years of clinical experience as a pharmacist, were telling me to “just say no” to the mRNA vaccine boosters.
Since then, I’ve encountered numerous reports of adverse reactions to these vaccines, ranging from unwelcome side effects to more serious complications. While I can’t definitively say my caution was justified, I remain comfortable with the decision we made based on the information available to us at the time
https://www.uspharmacist.com/article/urticaria-risk-associated-with-mrna-covid19-vaccines
In a nationwide observational cohort study published in the Scandinavian Journal of Public Health, researchers sought to examine the correlation between mRNA vaccinations for COVID-19 and the risk of developing urticaria.
The study focused on Danish residents who had received at least one dose of an mRNA vaccine between December 2020 and July 2023, comparing this group with the general population from the prepandemic years (2017–2019). Patients received either one dose of Comirnaty (Pfizer-BioNTech; BNT) or the other FDA-approved COVID-19 mRNA vaccine (Moderna; MOD).
Participants without urticaria were observed from the vaccination date until one of the following occurred: a diagnosis of chronic or other types of urticaria; a COVID-19 infection; the end of the 90-day outcome risk period; death; emigration; or October 2023. The expected number of urticaria cases was estimated by indirectly standardizing the incidence rates of urticaria prior to the pandemic. Standardized incidence ratios (SIRs) along with their 95% CIs were calculated overall and within specific categories based on gender, age, and vaccine sequence.
The study encompassed 4,700,301 vaccinated individuals and 5,480,146 comparators from before the pandemic.
The results indicated that following vaccine product sequences, the SIRs (95% CI) were reported as 0.83 (0.71-0.96) for chronic urticaria and 1.14 (95% CI, 1.03-1.25) for other forms of urticaria.
Individuals following the recommended vaccine schedule for the MOD mRNA vaccine faced a three- to fourfold increase in the risk of chronic urticaria (SIR, 3.00; 95% CI, 2.27-3.88) and other urticaria types (SIR, 3.65; 95% CI, 3.06-4.31). Sensitivity analyses for dose-specific effects indicated a fourfold higher risk following the MOD vaccine sequence, while no increased risk was observed after the BNT vaccination.
The authors concluded, “Following the most recent mRNA vaccination dose, MOD vaccine schedule adherers had a higher than expected incidence of chronic and other types of urticaria. We found no association between BNT vaccination schedule and increased risk of urticaria.”
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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I have said for years that we are on the cusp of a “civil war”, but this civil war will not be a simple “us vs them” as our Civil War of the mid 1800’s. This one is going to be between “tribes”, “affinity groups”, and illegal immigrants from an untold number of countries on our planet.
Recently, Governor Josh Shapiro’s Pennsylvania Governor’s Residence was set on fire. Luckily, the Governor, his wife, and their FOUR CHILDREN were able to escape without any harm, but the first floor of the Residence was pretty trashed.
Now, an MN state Representative and his wife have been shot and killed, and a state Senator and his wife were shot/wounded. All happening at the victims’ homes.
RFK Jr wants to take the fluoride out of our water; maybe he should consider putting Lithium Carbonate in our water, it is classified as a mood stabilizer. In fact, Lithium Carbonate was discovered in an African tribe’s water supply, and none of the members of the tribe were dealing with any mental health issues.
As the LONE Democrat to support the June 12 bill, Hortman declared, “I did what leaders do… I stepped up and I got the job done for the people of Minnesota.” Her bold stand to protect taxpayers infuriated open-border radicals, and now police confirm her murder was POLITICALLY MOTIVATED! The suspect, a white male posing as a cop, left “No Kings” flyers linked to anti-Trump protests and a manifesto targeting Hortman and other Dems.
X users are LIVID: @FinalTelegraph says, “She paid the ultimate price for doing what’s right,” while @stbythec demands Dems “stop inciting violence.” The killer’s still at large—Brooklyn Park’s on LOCKDOWN! Share to honor Hortman’s bravery and BACK Trump’s fight to crush political violence! 
#MAGA #JusticeForMelissaMINNESOTA — A Minnesota state representative and her husband were shot and killed, and a state senator and his wife were shot and wounded in an “act of targeted political violence” at their homes early Saturday, Minnesota Gov. Tim Walz said.
A manhunt is now underway for the gunman who was impersonating a police officer, authorities said. The gunman attacked by knocking on the doors and asking the victims to come out, police said.
State Rep. Melissa Hortman, a Democrat, and her husband were shot and killed in what appears to be a “politically-motivated assassination,” Walz said at a news conference.
“She was a formidable public servant,” the governor said of his friend. “She is irreplaceable.”
State Sen. John Hoffman, a Democrat, and his wife were both shot multiple times and underwent surgery, the governor said.
“We’re cautiously optimistic they will survive this assassination attempt,” Walz said.
The two shooting locations are a few miles away from each other in Champlin and Brooklyn Park, just north of Minneapolis.
Hoffman and his wife were shot around 2 a.m. in Champlin, Superintendent of the Bureau of Criminal Apprehension Drew Evans said.
After Hoffman was shot, officers were heading to pro-actively check on Hortman when they encountered the suspect at Hortman’s home around 3:35 a.m., Evans said.
The officers found a person who was dressed as a police officer — wearing a vest and a badge, and with a Taser and other equipment — at the door, coming out of Hortman’s house, police said.
The suspect fired at the officers; gunfire was exchanged and the suspect was able to escape and flee on foot, authorities said.
The suspect’s vehicle — which looked like a police vehicle, including police lights — was in Hortman’s driveway, authorities said.
A list of other possible targets was retrieved from the suspect’s vehicle, authorities said. Police said the list had “many lawmakers,” including the victims.
Security resources have been dispatched to protect those people named on the list, authorities said.
The gunman did say something to the victims, police said, but authorities did not reveal what that was.
FBI Deputy Director Dan Bongino said the agency is “fully engaged on the ground in Minnesota and is working in collaboration with our local and state partners.”
Attorney General Pam Bondi said she’s “closely monitoring developments in Minnesota after what appears to be a targeted attack against state lawmakers.”
“This horrific violence will not be tolerated and will be prosecuted to the fullest extent of the law,” she said in a statement.
Sen. Amy Klobuchar, D-Minn., called the victims close friends and said they’re “devoted to their families and public service.”
“This is a stunning act of violence. I’m thankful for all the law enforcement who are responding in real time,” she said. “My prayers are with the Hortman and Hoffman families.”
Hortman was the former Speaker of the Minnesota House of Representatives.
Democratic National Committee Chair Ken Martin, formerly the Minnesota Democratic party chair, said he’s friends with both Hoffman and Hortman.
Martin wrote on social media that he’s “completely heartbroken” and “praying hard for both families.”
With the manhunt ongoing, police are urging community members to be cautious. Police warned, if an officer comes to your door, call 911 to confirm that the officer is supposed to be there.
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Former doctor William Husel broke down on the witness stand during testimony in his defamation trial against his former employer as he told a jury about the day he learned he was charged with prescribing fatal doses of medicine to patients.
The former Mount Carmel doctor began his testimony on June 9 and continued into Tuesday, June 10. It’s the first time he has testified in public about the care he provided to his patients while at Mount Carmel.
The 49-year-old is suing Mount Carmel, its parent company, Trinity Health Corporation, and Mount Carmel’s former CEO, Ed Lamb, for defamation. He says public statements the hospital made about him related to his prescribing fatal doses of opioids to patients did irreparable damage to his reputation, career and personal life.
In a 2022 criminal trial, Husel was acquitted of wrongdoing in many instances. Prosecutors eventually dropped several remaining charges against him, but he had previously stated that he was only providing comfort care to suffering patients.
Attorneys for the hospital spent part of their time questioning Husel, laying a foundation to establish that he had a history of accusations of over-prescribing medication to patients before his indictment.
Husel, who paused to compose himself several times as he became emotional, told a jury about the impact Mount Carmel’s statements, beginning in January 2019, had on his life and the lives of his wife and their two daughters.
He said the first inkling he had that something might be wrong was on the evening before Mount Carmel’s first public statement. Husel testified a nurse called him and told him, “D-Day was coming, and it’s going to be really bad.”
Husel said the following day, after the first medical malpractice suit was filed against him by a patient’s family and Mount Carmel’s public statement, he opened his Facebook account to find more than 1,000 messages, many of them hateful.
“They said I was a serial killer, that I should rot in prison, that I should be buried under the prison,” Husel said.
While Husel did not address any of Mount Carmel’s statements specifically, he said he couldn’t comprehend why the families of patients he had cared for were suing him.
“Why would I do CPR on someone, save their life and then an hour later intentionally kill them,” Husel said.
Husel also described having reporters try to get a comment from him about the lawsuits and being pointed at or talked about when he went to restaurants or stores — something he says continues to happen to this day.
Husel told the jury that he and his wife, Mariah, live in her parent’s home, which he described as a “double-wide trailer” with two bedrooms and a bathroom. He said he does not work, while his wife is working full-time and working towards a Master’s degree, and he often sleeps on the floor.
Husel also testified about the day he learned a grand jury had indicted him on 25 counts of murder. He said he got a call from his attorney, who wouldn’t tell him what charges he was facing. Husel cried as he talked about watching his children taking a bath that night, knowing he would be turning himself in to police the next day.
“I started thinking I’m never going to see my kids again,” Husel said.
Eleven of the 25 murder charges were later dismissed. A Franklin County jury found Husel not guilty of the remaining 14 charges after a 2022 trial. A month after the trial’s conclusion, Husel voluntarily surrendered his medical license, which the Ohio Medical Board then permanently revoked.
Powell Miller, an attorney for the hospital system, began cross-examining Husel on June 10, asking him about findings the state medical board had made when suspending Husel’s license in 2019. Those findings, shown to the jury, include that Husel gave “inappropriate and excessive” doses of medication to multiple patients who died within minutes of receiving the doses of fentanyl.
Mount Carmel’s public statements said Husel’s dosing was “significantly excessive and potentially fatal.”
Cross-examination is expected to continue on June 10.
Prior to being questioned by the hospital system, Husel testified about the death of 82-year-old Melissa Penix, who died on the last night Husel worked in the ICU before the hospital placed him on leave.
“Why are you crying,” Husel’s attorney asked.
“Just because it was my last night at work there,” Husel said. “When I started thinking about the husband crying and not wanting to let her go, it makes me sad to think about that.”
Husel described wanting to make Penix comfortable and avoid suffocation, what her family said was her “greatest fear in life.” Husel ordered a 2,000 microgram dosage of fentanyl for Penix, who died five minutes later.
Husel was fired in December 2018 amid concerns about the dosages of fentanyl he was prescribing for patients taken off life support.
Husel is seeking $18 million in damages, which his attorneys have said is an estimate of the amount of money Husel would have made as a doctor.
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https://who13.com/news/iowa-gov-reynolds-signs-bill-to-reform-pharmacy-benefit-managers/
DES MOINES, Iowa (KCAU) — Iowa Gov. Kim Reynolds signed a bill Wednesday aimed at bringing changes to pharmacy benefit managers, also known as PBMs.
The legislation, Senate File 383, aims to help prevent more independent and rural pharmacies from closing their doors in the Hawkeye State.
PBMs are the middlemen between health insurance companies and pharmacies. Whenever you fill a prescription, the PBM determines how much the pharmacy actually gets paid for dispensing your medication.
In recent years, that amount has sometimes been less than what it costs the pharmacy to fill a prescription, forcing them to either refuse the fill, or take a financial loss.
Senate File 383 would attempt to prevent that by adding requirements for how much pharmacies must be reimbursed for filling medications, to ensure they get paid a fair price.
It also adds other patient protections, like preventing PBMs from hitting you with a monetary penalty if you choose a non-preferred pharmacy, or requiring you to use a mail-order pharmacy service to use your insurance coverage.
As of Wednesday, a total of 32 states have passed similar legislation, according to the Iowa Governor’s Office.
Opponents of the measure have argued the bill would increase health insurance premiums, but supporters maintain that in states that have previously passed similar legislation, that has not come to pass.
Governor Reynolds released a statement Wednesday explaining her reasoning for signing the bill. In part, it says, “The new bill takes steps toward addressing these challenges by targeting PBM practices that harm both patients and independent pharmacies. Local pharmacies, especially in rural areas, are vital to community health and local hospitals but are being driven out by opaque, one-sided contracts.”
You can read the governor’s full statement here.
The Iowa Pharmacy Association applauded the bill’s passage Wednesday. CEO Kate Gainer said, “Governor Reynolds’ leadership and the Iowa Legislature’s bipartisan support of SF 383 sends a powerful message that the health of Iowa communities comes first. For too long, PBMs have put profits over patients, contributing to the closure of more than 200 pharmacies in Iowa since 2014. This law gives us the tools to level the playing field and protect access to care, especially in rural areas.”
The Iowa Association of Business and Industry, however, opposed the bill’s signing, releasing a statement saying, “ABI is disappointed in today’s action. ABI testified at every turn in favor of legislation that would support small independent pharmacies in Iowa. The bill that the Governor signed today is not that. Senate File 383 includes expensive, unneeded provisions that are going to drive up the costs of pharmacy services in Iowa without any discernable improvement in patient care. Iowans – including businesses and employees – will bear these costs at the pharmacy counter and in the structure of their health care plans. This is an additional headwind in an already challenging business environment. Now law, ABI will take every opportunity to mitigate the increased costs on our members and their team members throughout Iowa.”
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Has anyone noticed that PBMs are running TV commercials about how they can save everyone money on their prescriptions. What they don’t say is that while you MAY pay less out of pocket. Your insurance company may pay multiple times what it would cost them if you pay for your prescription and you send in a claim to get reimbursed.
Below is some information on how opaque the insurance/PBM industry’s financial disclosures are, and all of these companies are publicly traded companies.
Over the years, there have been several times when bureaucrats have tried to set up some sort of bureaucratic oversight mechanism to on the PBMs, and every time the PBMs industry brings out its “dog & pony show” about how much more pts will end up paying for their prescriptions if the PBM industry has some bureaucratic oversight and regulations that if the PBM industry was not able to control the prices of prescriptions, all the community pharmacies would jack-up their prices and they would make some profits that the PBM industry would loose.
Who would imagine that inserting numerous middlemen into our Rx distribution system? Each with their own operating overhead and interest in generating a net profit, and they could save EVERYONE some money. Apparently, the majority of bureaucrats and many at the top of many large corporations believed the PBMs “dog & pony show”.
Let me search for specific information about mail-order pharmacy revenues and profits for the major PBMs.Let me search for more specific information about mail-order pharmacy revenues and profits.Based on my searches, I can provide some general information about mail-order pharmacy revenues, though specific profit breakdowns by mail-order operations are not typically disclosed separately by the major PBMs.
Market Size and Growth:
The same “Big Three” PBMs that dominate the overall market also control most mail-order pharmacy operations:
While specific mail-order profit margins aren’t typically disclosed separately, we know that:
The challenge with providing exact mail-order specific revenue and profit figures is that:
The mail-order pharmacy segment represents a significant and rapidly growing portion of the overall PBM business, with the market expected to triple in size over the next 7-8 years, but specific revenue and profit breakdowns for this segment remain closely guarded by the major PBMs.
I’ll search for current information about the top 5 Pharmacy Benefit Managers (PBMs) and their financial performance.Let me search for more specific financial data on the major PBM companies.Based on the search results, I can provide information about the top PBMs and their financial scale, though specific profit breakdowns by PBM division are not always separately reported since these are parts of larger healthcare conglomerates.
The “Big Three” that dominate ~80% of the market:
Additional major players: 4. Humana Pharmacy Solutions/CenterWell 5. MedImpact Healthcare Systems (largest privately-held PBM)
UnitedHealth Group (includes OptumRx):
Overall PBM Market:
Key Context:
The challenge with providing exact PBM-specific revenue and profit figures is that these businesses are integrated into much larger healthcare companies. The total addressable market for PBMs is approaching $600 billion annually, with the top three controlling about 80% of that market. However, the parent companies (CVS Health, Cigna, UnitedHealth) don’t always break out PBM-specific profit margins in their public filings, as these operations are strategically integrated with their insurance and healthcare delivery businesses.
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https://www.medpagetoday.com/hematologyoncology/chemotherapy/115929
JoEllen Zembruski-Ruple, while in the care of New York City’s renowned Memorial Sloan Kettering Cancer Center, swallowed the first three chemotherapy pills to treat her squamous cell carcinoma on Jan. 29, her family members said. They didn’t realize the drug could kill her.
Six days later, Zembruski-Ruple went to Sloan Kettering’s urgent care department to treat sores in her mouth and swelling around her eyes. The hospital diagnosed oral yeast infection and sent her home, her sister and partner said. Two days later, they said, she returned in agony — with severe diarrhea and vomiting — and was admitted. “Enzyme deficiency,” Zembruski-Ruple texted a friend.
The 65-year-old, a patient advocate who had worked for the National Multiple Sclerosis (MS) Society and other groups, would never go home.
Covered in bruises and unable to swallow or talk, she eventually entered hospice care and died March 25opens in a new tab or window from the very drug that was supposed to extend her life, said her longtime partner, Richard Khavkine. Zembruski-Ruple was deficient in the enzyme that metabolizes capecitabine, the chemotherapy drug she took, said Khavkine and Susan Zembruski, one of her sisters. Zembruski-Ruple was among about 1,300 Americans each year who dieopens in a new tab or window from the toxic effects of that pillopens in a new tab or window or its cousin, the IV drug fluorouracil known as 5-FU.
Doctors can test for the deficiencyopens in a new tab or window — and then either switch drugs or lower the dosageopens in a new tab or window if patients have a genetic variant that carries risk. The FDA approved an antidote in 2015opens in a new tab or window, but it’s expensive and must be administered within 4 days of the first chemotherapy treatment.
Newer cancer drugs sometimes include a companion diagnostic to determine whether a drug works with an individual patient’s genetics. But 5-FU went on the market in 1962 and sells for about $17 a dose; producers of its generic aren’t seeking approval for toxicity tests, which typically cost hundreds of dollars. Doctors have only gradually understood which gene variants are dangerous in which patients, and how to deal with them, said Alan Venook, MD, a colorectal and liver cancer specialist at the University of California San Francisco.
By the time Zembruski-Ruple’s doctors told her she had the deficiency, she had been on the drug for 8 days, said Khavkine, who watched over his partner with her sister throughout the 7-week ordeal.
Khavkine said he “would have asked for the test” if he had known about it, but added “nobody told us about the possibility of this deficiency.” Zembruski-Ruple’s sister also said she wasn’t warned about the fatal risks of the chemo, or told about the test.
“They never said why they didn’t test her,” Zembruski said. “If the test existed, they should have said there is a test. If they said, ‘Insurance won’t cover it,’ I would have said, ‘Here’s my credit card.’ We should have known about it.”
Guidance Moves at a Glacial Pace
Despite growing awareness of the deficiency, and an advocacy group made up of grieving friends and relatives who push for routine testingopens in a new tab or window of all patients before they take the drug, the medical establishment has moved slowly.
A panel of the National Comprehensive Cancer Network, or NCCN — specialists from Sloan Kettering and other top research centers — until recently did not recommend testing, and the FDA does not require it.
In response to a query from KFF Health News about its policy, Sloan Kettering spokesperson Courtney Nowak said the hospital treats patients “in accordance with NCCN guidelines.” She said the hospital would not discuss a patient’s care.
On Jan. 24, the FDA issued a warningopens in a new tab or window about the enzyme deficiency in which it urged healthcare providers to “inform patients prior to treatment” about the risks of taking 5-FU and capecitabine.
On March 31 — 6 days after Zembruski-Ruple’s death — the network’s expert panel for most gastrointestinal cancers took a first step toward recommending testing for the deficiency.
Worried that President Trump’s FDA might do nothing, Venook said, the panel — whose guidance shapes the practices of oncologists and health insurers — recommended that doctors consider testing before dosing patients with 5-FU or capecitabine.
However, its guidance stated that “no specific test is recommended at this time,” citing a lack of data to “inform dose adjustments.”
Sloan Kettering “will consider this guidance in developing personalized treatment plans for each patient,” Nowak told KFF Health News.
The new NCCN guidance was “not the blanket recommendation we were working toward, but it is a major step toward our ultimate goal,” said Kerin Milesky, a public health official in Brewster, Massachusetts, who’s part of an advocacy group for testing. Her husband, Larry, died 2 years ago at age 73 after a single treatment of capecitabine.
European drug regulatorsopens in a new tab or window began urging oncologists to test patients for deficiency in May 2020. Patients with potentially risky genetics are started on a half-dose of the cancer drug. If they suffer no major toxicity, the dose is increased.
A Lifesaving Ultimatum?
Emily Alimonti, a 42-year-old biotech salesperson in upstate New York, chose that path before starting capecitabine treatment in December. She said her doctors — including an oncologist at Sloan Kettering — told her they didn’t do deficiency testing, but Alimonti insisted. “Nope,” she said. “I’m not starting it until I get the test back.”
The test showed that Alimonti had a copy of a risky gene variant, so doctors gave her a lower dose of the drug. Even that has been hard to tolerate; she’s had to skip doses because of low white blood cell counts, Alimonti said. She still doesn’t know whether her insurer will cover the test.
Around 300,000 people are treated with 5-FU or capecitabine in the United States each year, but its toxicity could well have prevented FDA approval were it up for approval today. Short of withdrawing a drug, however, U.S. regulators have little power to manage its use. And 5-FU and capecitabine are still powerful tools against many cancers.
At a January workshop that included FDA officials and cancer specialists, Venook, the NCCN panel’s co-chair, asked whether it was reasonable to recommend that doctors obtain a genetic test “without saying what to do with the result.”
But Richard Pazdur, MD, the FDA’s top cancer expert, said it was time to end the debate and commence testing, even if the results could be ambiguous. “If you don’t have the information, how do you have counseling?” he asked.
Two months later, Venook’s panel changed course. The price of tests has fallen below $300 and results can be returned as soon as 3 days, Venook said. Doubts about the FDA’s ability to further confront the issue spurred the panel’s change of heart, he said.
“I don’t know if FDA is going to exist tomorrow,” Venook told KFF Health News. “They’re taking a wrecking ball to common sense, and that’s one of the reasons we felt we had to go forward.”
On May 20, the FDA posted a Federal Register noticeopens in a new tab or window seeking public input on the issue, a move that suggested it was considering further action.
Venook said he often tests his own patients, but the results can be fuzzy. If the test finds two copies of certain dangerous gene variants in a patient, he avoids using the drug. But such cases are rare — and Zembruski-Ruple was one of them, according to her sister and Khavkine.
Many more patients have a single copy of a suspect gene, an ambiguous result that requires clinical judgment to assess, Venook said.
A full-gene scan would provide more information but adds expense and time, and even then the answer may be murky, Venook said. He worries that starting patients on lower doses could mean fewer cures, especially for newly diagnosed colon cancer patients.
Power Should Rest With Patients
Scott Kapoor, MD, a Toronto-area emergency room physician whose brother Anil, a much-loved urologist and surgeon, died of 5-FU toxicity at age 58 in 2023, views Venook’s arguments as medical paternalism. Patients should decide whether to test and what to do with the results, he said.
“What’s better — don’t tell the patient about the test, don’t test them, potentially kill them in 20 days?” he said. “Or tell them about the testing while warning that potentially the cancer will kill them in a year?”
“People say oncologists don’t know what to do with the information,” said Karen Merritt, whose mother died after an infusion of 5-FU in 2014. “Well, I’m not a doctor, but I can understand the Mayo Clinic report on it.”
The Mayo Clinic recommends starting patients on half a dose if they have one suspect gene variant. And “the vast majority of patients will be able to start treatment without delays,” Daniel Hertz, PharmD, PhD, a clinical pharmacologist from the University of Michigan, said at the January meetingopens in a new tab or window.
Some hospitals began testing after patients died because of the deficiency, said Lindsay Murray, of Andover, Massachusetts, who has advocated for widespread testing since her mother was treated with capecitabine and died in 2021.
In some cases, Venook said, relatives of dead patients have sued hospitals, leading to settlements.
Kapoor said his brother — like many patients of non-European origin — had a gene variant that hasn’t been widely studied and isn’t included in most tests. But a full-gene scan would have detected it, Kapoor said, and such scans can also be done for a few hundred dollars.
The cancer network panel’s changed language is disappointing, he said, though “better than nothing.”
In video tributesopens in a new tab or window to Zembruski-Ruple, her friends, colleagues, and clients remembered her as kind, helpful, and engaging. “JoEllen was beautiful both inside and out,” said Barbara McKeon, a former colleague at the MS Society. “She was funny, creative, had a great sense of style.”
“JoEllen had this balance of classy and playful misbehavior,” psychotherapist Anastatia Fabris said. “My beautiful, vibrant, funny, and loving friend JoEllen.”
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