Health
How a Company Makes Millions Off a Hospital Program Meant to Help the Poor
Soon after being diagnosed with metastatic breast cancer, Virginia King sat in an outpatient clinic in Santa Fe, N.M, while a nurse injected her with a powerful drug to slow damage to her spine, where the disease had spread.
Even though the drug had a list price of about $2,700, the hospital that owned the cancer center billed Mrs. King’s insurance company $22,700. Her insurer paid $10,000, but the hospital wanted more.
She got a bill for over $2,500 — “more than half my take-home salary for a month,” said Mrs. King, 65.
She had unknowingly sought care from a hospital that participates in a federal program allowing it to buy drugs at a steep discount and charge patients and insurers a higher amount, keeping the difference.
The intention behind the program was for a small number of safety-net providers to have access to affordable drugs and be able to expand their care for needy patients. But instead, the program has exploded: Now, more than half of nonprofit hospitals in the United States take part. While some providers say it has helped keep their doors open, others — especially large nonprofit health systems — have been accused of maximizing payouts and swallowing the profits.
The program’s escalation has driven up health care costs for employers, patients and taxpayers, studies show.
In 2023, for instance, New York changed the way it administers drug benefits for Medicaid patients, in part because the state had discovered the cost of the federal program had increased by more than 200 percent over three years, said Amir Bassiri, the state’s Medicaid director.
“The numbers and the growth were staggering,” he said. “We all bear the cost.”
Along the way, one little-known middleman has been cashing in, The New York Times found.
The company, Apexus, has worked behind the scenes to supercharge the program, according to interviews with current and former employees and emails, internal reports and other documents.
Twenty years ago, the federal government chose Apexus to manage what was then a small program, negotiating with drug distributors and manufacturers to secure better prices and access to medications. But Apexus is allowed to collect a fee for almost every drug sold under the program, giving the company an incentive to help hospitals and clinics capture as many prescriptions as possible:
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Its “purchasing optimization team” shows hospitals how they can make more money by buying different drugs.
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A certification program and an Apexus-run “university” trains providers in boosting earnings.
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Apexus employees give advice that broadly interprets the rules of the program so hospitals can claim additional patients and drugs.
Apexus was on track to double its revenue from 2018 to 2022, projecting $227 million that year, according to a 2022 internal memo written for the directors of Apexus’ parent corporation and reviewed by The Times. The company costs relatively little to operate and has enjoyed profit margins above 80 percent, according to that memo and three former employees.
In a statement, Apexus said it simply executed its government contract and did not contribute to the growth of the program, called the 340B Drug Pricing Program. “The drivers of growth are multifaceted,” the statement said.
But in the 2022 memo, the president of Apexus, Chris Hatwig, posed a question: “Are there other areas for program expansion within 340B that we are not thinking about?”
Government officials have told Apexus to focus solely on administering the program and not to influence drug purchases. But Apexus leaders have sometimes ignored that request, according to two complaints filed with a government watchdog and six current and former employees, speaking on the condition of anonymity because they feared professional or legal retribution.
In its statement, Apexus said it was “fully transparent” with the Department of Health and Human Services and had never breached its contractual obligations.
The Health Resources and Services Administration, an agency within H.H.S. that oversees the program, declined to answer detailed questions from The Times. But in a statement, a spokeswoman said the agency “conducts rigorous oversight of all contracts,” and “to our knowledge, Apexus has not violated” its contract. Regulators and leaders of the company meet frequently to discuss the company’s work and prevent conflicts of interest, the spokeswoman said.
The growth of 340B has drawn criticism for years from Congress, drugmakers and employers, who say it has added to ballooning health care costs. But the role of Apexus has largely gone unexamined.
“They’ve got a license to hunt,” said Marsha Simon, who as a staff member of a congressional committee helped write the bill that authorized the program.
$66 Billion in Sales
Established in 1992, the 340B program essentially requires pharmaceutical manufacturers to offer discounts on outpatient drugs to hospitals and clinics that treat a greater share of low-income and uninsured patients.
The hospitals then can charge insurers and patients the standard price and keep the profits. Although the money is supposed to encourage care for impoverished patients, there are few rules to enforce that.
Patients rarely know they are part of this system. Their prescriptions can be counted as 340B when they get outpatient treatment at a hospital or clinic that qualifies for the program, regardless of the patients’ own income or insurance status. The provider can continue to make money off the patients’ future outpatient prescriptions, even if they get them somewhere else.
Apexus has had contracts to handle the program since the early 2000s. The government does not pay Apexus — instead, drugmakers and distributors pay the company a small percentage of sales.
Based in Irving, Texas, it is a subsidiary of Vizient, a private business owned by hospitals that negotiates a range of health care discounts. Apexus was established as a small nonprofit in 2007 but became a for-profit company in 2014.
Around the same time, 340B began to explode for a number of reasons. More hospitals qualified for the program after the Affordable Care Act expanded the number of people on Medicaid. Other health care systems qualified after acquiring hospitals and clinics in poor areas. Some, already eligible for 340B, bought up practices that used high-margin drugs, like oncology clinics. And a government rule change meant hospitals could make money from prescriptions filled at a greater number of pharmacies.
A decade ago, sales of 340B drugs were $12 billion. In 2023, they reached a high of $66 billion.
Fighting the program’s growth has become a top priority for drugmakers, as well as some employers and insurers.
In North Carolina, prescription drug spending for state employees jumped almost 50 percent from 2018 to 2022. A report in May from the state treasurer’s office found that 340B was partly to blame: Hospitals that participated in the program billed the state health plan far more than hospitals that did not — almost 85 percent more for certain cancer drugs. In one example, hospitals bought a drug commonly used to treat melanoma for an average of $8,000 but billed the state $21,512.
In some cases, costs are passed along to patients.
Mrs. King, the cancer patient in New Mexico, refused to pay her $2,500 bill, and the hospital, Christus St. Vincent, sent it to collections in July.
After The Times asked about the bill last month, a spokeswoman for Christus St. Vincent said the charge was “a misunderstanding and has been resolved,” adding that the drug program helped the hospital provide charity care and reinvest in cancer treatment and primary care.
Mrs. King switched to a free-standing oncology clinic that does not qualify for the federal drug program. That clinic billed her insurance $8,000 for the injection, about a third of what Christus St. Vincent had charged. Her responsibility was nothing.
An Ever-Growing Portfolio
Ms. Simon, who helped draft the legislation creating 340B, said the government chose an outside contractor like Apexus in order to negotiate with distributors and drugmakers on behalf of small hospitals and clinics without a lot of buying power.
But regulators and Apexus have expanded that role, allowing the company to build a highly profitable business off the program and the loosely written statute that authorized it. The company has been “aggressive” in helping health care facilities maximize their revenue from the program, said Shawn Gremminger, chief executive of the National Alliance of Healthcare Purchaser Coalitions, which represents employers who buy health insurance for more than 45 million people in the United States.
“This is a government contractor, and the goal of the government should not be, ‘How do we make more money for 340B providers?’” said Mr. Gremminger, whose organization has pushed for the program to be overhauled.
Over the past two decades, Apexus has adapted its business model to harness 340B’s tremendous growth. A 2022 PowerPoint presentation obtained by The Times showed that Apexus employees received bonuses if the company increased its revenue each year.
With exclusive access to sales data, Apexus’ “purchasing optimization team” will analyze a hospital system’s drug-buying habits and compare them with those of their competitors, according to four current and former employees. In some cases, Apexus will suggest that a hospital buy more 340B drugs or tweak its inventory in ways that can churn more cash.
Apexus declined to answer detailed questions about its optimization team, but said in a statement that the company “only provides technical assistance” in keeping with regulations.
Apexus also holds “340B University” events to help providers and others in the health care industry understand the program, and it fields questions through a national call center. But the rules governing the program are ambiguous, and Apexus offers broad interpretations, according to four current and former employees.
For instance, one of the thorniest issues is which patients can be claimed by hospitals for discounted drugs. The further a hospital casts its net, the more patients and drugs it can include under the program, and the more money it can make. Apexus has advised hospitals that they can mine records as far back as 36 months for eligible patients they may have missed, two of those employees said.
Similarly, Apexus employees have showed hospitals how to maximize the number of pharmacies they work with, boosting the number of prescriptions that can qualify for discounts, those employees said.
In its statement, Apexus said those examples were inaccurate but would not say how. It added that the company encouraged “conservative and responsible stewardship” of the 340B program, and that all information it provided was approved by regulators.
A spokeswoman for H.R.S.A. said it reviewed materials prepared by Apexus but declined to comment on that specific advice.
The company has developed other ventures that have brought in revenue:
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About eight years ago, Apexus began selling a $750 course for people to become “certified experts” in 340B.
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It started a business to give hospitals better access to specialty drugs — for conditions like cancer, H.I.V. and autoimmune diseases — which are major drivers of 340B’s growth. That company, Acentrus, helped hospitals and clinics provide data to manufacturers in exchange for deeper discounts and access to those drugs. It was sold last year.
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The company charges 3 percent in fees for a line of generic drugs that are managed and provided by drug distributors, according to former employees. Apexus simply provides access to the health systems.
For the last decade, Apexus has earned millions of dollars on drug purchases made outside the 340B program: Because not all outpatient drugs qualify for 340B discounts, hospitals must stock their pharmacies with medication purchased through different channels. Apexus acts as a middleman, making fees off those transactions.
That has frustrated drugmakers and competitors. In 2021, the drug manufacturer Baxter wanted to sell non-340B drugs to hospitals without going through Apexus, according to emails obtained under public-records laws. But government regulators would not allow it, a spokeswoman for Baxter said.
In early November, Premier, the main competitor to Apexus’s parent company, Vizient, sued the federal government over these sales. The setup, the suit argued, forces hospitals to pay higher prices for those non-340B drugs and drives revenue to drug manufacturers and Apexus.
In its statement, Apexus said its federal contract did not preclude it from developing other businesses, as long as they were not in conflict with the terms of the agreement.
Regulators were aware of these ventures, the company said, noting that its specialty drug business, Acentrus, was in “no way associated with” the 340B program. The 2022 company memo, however, said Acentrus “resulted in an additional $20 million” in revenue within the 340B program.
H.R.S.A. declined to comment on the scope of its authority over Apexus and whether it knew about all the company’s revenue-generating arms.
Criticized, but Pushing Ahead
About six years ago, Krista Pedley, then the director of the H.H.S. office in charge of 340B, reprimanded Apexus leaders in a Skype meeting, saying it was acting more like a sales-driven business than a program administrator. She reminded them that Apexus’ role was not to help 340B grow, according to five former or current employees familiar with the meeting.
For about a month afterward, regulators reviewed any communication Apexus had with health care facilities to make sure the company didn’t overstep, the employees said.
But that did not seem to dampen the company’s pursuits. (In an email, Ms. Pedley said she did not recall that meeting, and noted that her former office met regularly with Apexus.)
In 2021, an unnamed Apexus employee filed a complaint with H.H.S.’s Office of Inspector General, an internal watchdog, saying the company was “always trying to grow the program.” The company, the employee wrote, had hired “sales-type” staff to influence hospitals’ drug-purchasing decisions.
The complaint said that regulators did not understand Apexus’ business, and that employees had been told by company leaders to describe its work as “education.”
Another anonymous complaint, filed in 2022, echoed the allegation that Apexus had hired staff to help shape hospitals’ purchasing decisions, and said it was using “data in ways to drive revenue for itself, without asking (or asking and disregarding) the government’s opinion.”
Apexus declined to answer specific questions about the meeting with Ms. Pedley, but said The Times’s account was a “mischaracterization of our day-to-day, collaborative discussions” with the agency.
Apexus rejected the allegations in the anonymous complaints and said it had been unaware of them until The Times provided it with copies. The spokeswoman for H.R.S.A. said that it, too, had been unaware of the complaints.
In interviews, four current and former employees said that for years, Mr. Hatwig, Apexus’ president, acknowledged that regulators did not want the company to develop sales-focused arms of the business but encouraged his staff to do so anyway, saying that the government would not know.
Apexus denied that, saying that “everyone at Apexus understands the expectation that they conduct themselves and perform their work in an ethical and compliant manner.”
Julie Tate and Carson Kessler contributed research.
Health
Breakthrough GLP-1 implant promises major weight-loss benefits for pets
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The world’s first GLP-1 weight loss treatment is being administered for pets on an experimental basis.
The first cat was successfully dosed in the MEOW-1 study of OKV-119 – an investigational “ultra-long acting” GLP-1 implant, which, according to a press release, is being developed for weight management in cats.
OKAVA Pharmaceuticals, the San Francisco-based manufacturer of the medication, said the landmark clinical study of the “first-in-class” device could have “profound” implications for diabetes, kidney disease, healthy aging and longevity in pets.
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The implant allows for continuous delivery of a GLP-1 receptor agonist, improving cardio-metabolic health and potentially “enhancing quality of life” while extending it, according to the release.
Once it is available, the single implant may be administered during a routine visit to a cat’s veterinarian, with guaranteed delivery of the medication for up to six months.
The OKV-119 implant guarantees administration of the drug for six months. (iStock)
The MEOW-1 trial marks the first of its kind for clinical investigation of weight loss in cats and dogs, following the breakthrough of GLP-1 use in humans for the management of obesity and diabetes.
OKAVA CEO Michael Klotsman, Ph.D., wrote in a statement that caloric restriction, or fasting, is “one of the most well-established interventions for extending lifespan and improving metabolic health in cats.”
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“But it’s also one of the hardest to maintain,” he said. “OKV-119 is designed to mimic many of the physiological effects of fasting — improved insulin sensitivity, reduced fat mass and more efficient energy metabolism — without requiring significant changes in feeding routines or disruption of the human-animal bond that often centers around food.”
Future research will consider weight management in dogs, the researchers said. (iStock)
The MEOW-1 study aims to evaluate the safety, tolerability and efficacy of the weight-loss medication in overweight or obese cats. The results will guide future clinical development, as well as a similar study in dogs, according to the researchers.
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Dr. W. Chris Hummel, a veterinarian at Lovet Pet Health Care in Phoenix, Arizona, who was not involved in the study, confirmed that several GLP-1 drugs are under investigation in domestic animals.
A GLP-1 treatment for cats does not require changes in feeding that may disrupt human-animal bonding, the researchers stated. (iStock)
“Preliminary evidence suggests that GLP-1 and GLP-like drugs can be effective alternative therapies for diabetes mellitus, otherwise known as sugar diabetes,” he told Fox News Digital. “Diabetes mellitus is one of the fastest-growing diseases in cats and dogs, largely on the heels of the pet obesity epidemic.”
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“The medications are given by injection, so long-acting combinations are currently being investigated for efficacy and duration,” Hummel added. “The data is still early, but promising.”
Health
Who Should Be Allowed a Medically Assisted Death?
Ron Curtis, an English professor in Montreal, lived for 40 years with a degenerative spinal disease, in what he called the “black hole” of chronic pain.
On a July day in 2022, Mr. Curtis, 64, ate a last bowl of vegetable soup made by his wife, Lori, and, with the help of a palliative care doctor, died in his bedroom overlooking a lake.
Aron Wade, a successful 54-year-old stage and television actor in Belgium, decided he could no longer tolerate life with the depression that haunted him for three decades.
Last year, after a panel of medical experts found he had “unbearable mental suffering,” a doctor came to his home and gave him medicine to stop his heart, with his partner and two best friends at his side.
Argemiro Ariza was in his early 80s when he began to lose function in his limbs, no longer able to care for his wife, who had dementia, in their home in Bogotá.
Doctors diagnosed A.L.S., and he told his daughter Olga that he wanted to die while he still had dignity. His children threw him a party with a mariachi band and lifted him from his wheelchair to dance. A few days later, he admitted himself to a hospital, and a doctor administered a drug that ended his life.
Until recently, each of these deaths would have been considered a murder. But a monumental change is underway around the world. From liberal European countries to conservative Latin American ones, a new way of thinking about death is starting to take hold.
Over the past five years, the practice of allowing a physician to help severely ill patients end their lives with medication has been legalized in nine countries on three continents. Courts or legislatures, or both, are considering legalization in a half-dozen more, including South Korea and South Africa, as well as eight of the 31 American states where it remains prohibited.
It is a last frontier in the expansion of individual autonomy. More people are seeking to define the terms of their deaths in the same way they have other aspects of their lives, such as marriage and childbearing. This is true even in Latin America, where conservative institutions such as the Roman Catholic church are still powerful.
“We believe in the priority of our control over our bodies, and as a heterogeneous culture, we believe in choices: If your choice does not affect me, go ahead,” said Dr. Julieta Moreno Molina, a bioethicist who has advised Colombia’s Ministry of Health on its assisted dying regulations.
Yet, as assisted death gains more acceptance, there are major unresolved questions about who should be eligible. While most countries begin with assisted death for terminal illness, which has the most public support, this is often followed quickly by a push for wider access. With that push comes often bitter public debate.
Should someone with intractable depression be allowed an assisted death?
European countries and Colombia all permit people with irremediable suffering from conditions such as depression or schizophrenia to seek an assisted death. But in Canada, the issue has become contentious. Assisted death for people who do not have a reasonably foreseeable natural death was legalized in 2021, but the government has repeatedly excluded people with mental illness. Two of them are challenging the exclusion in court on the grounds that it violates their constitutional rights.
In public debate, supporters of the right to assisted death for these patients say that people who have lived with severe depression for years, and have tried a variety of therapies and medications, should be allowed to decide when they are no longer willing to keep pursuing treatments. Opponents, concerned that mental illness can involve a pathological wish to die, say it can be difficult to predict the potential effectiveness of treatments. And, they argue, people who struggle to get help from an overburdened public health service may simply give up and choose to die, though their conditions might have been improved.
Should a child with an incurable condition be able to choose assisted death?
The ability to consent is a core consideration in requesting assisted death. Only a handful of countries are willing to extend that right to minors. Even in the places that do, there are just a few assisted deaths for children each year, almost always children with cancer.
In Colombia and the Netherlands, children over 12 can request assisted death on their own. Parents can provide consent for children 11 and younger.
Denise de Ruijter took comfort in her Barbie dolls when she struggled to connect with people. She was diagnosed with autism and had episodes of depression and psychosis. As a teenager in a Dutch town, she craved the life her schoolmates had — nights out, boyfriends — but couldn’t manage it.
She attempted suicide several times before applying for an assisted death at 18. Evaluators required her to try three years of additional therapies before agreeing her suffering was unbearable. She died in 2021, with her family and Barbies nearby.
The issue is under renewed scrutiny in the Netherlands, where, over the past decade, a growing number of adolescents have applied for assisted death for relief from irremediable psychiatric suffering from conditions such as eating disorders and anxiety.
Most such applications by teens are either withdrawn by the patient, or rejected by assessors, but public concern over a few high-profile cases of teens who received assisted deaths prompted the country’s regulator to consider a moratorium on approvals for children applying on the basis of psychiatric suffering.
Should someone with dementia be allowed assisted death?
Many people dread the idea of losing their cognitive abilities and their autonomy, and hope to have an assisted death when they reach that point. But this is a more complex situation to regulate than for a person who can still make a clear request.
How can a person who is losing their mental capacity consent to dying? Most governments, and doctors, are too uncomfortable to permit it, even though the idea tends to be popular in countries with aging populations.
In Colombia, Spain, Ecuador and the Canadian province of Quebec, people who have been diagnosed with Alzheimer’s disease or other kinds of cognitive decline can request assessment for an assisted death before they lose mental capacity, sign an advance request — and then have a physician end their life after they have lost the ability to consent themselves.
But that raises a separate, challenging, question: After people lose the capacity to request an assisted death, who should decide it’s time?
Their spouses? Their children? Their doctors? The government? Colombia entrusts families with this role. The Netherlands leaves it up to doctors — but many refuse to do it, unwilling to administer lethal drugs to a patient who can’t clearly articulate a rational wish to die.
Jan Grijpma was always clear with his daughter, Maria: When his mind went, he didn’t want to live any more. Maria worked with his longtime family doctor, in Amsterdam, to identify the point when Mr. Grijpma, 90 and living in a nursing home, was losing his ability to consent himself.
When it seemed close, in 2023, they booked the day, and he updated his day planner: Thursday, visit the vicar; Friday, bicycle with physiotherapy and get a haircut; Sunday, pancakes with Maria; Monday, euthanasia.
All of these questions are becoming part of the discussion as the right to control and plan one’s own death is pushed in front of reluctant legislatures and uneasy medical professionals.
Dr. Madeline Li, a Toronto psychiatrist, was given the task of developing the assisted-dying practice in one of Canada’s largest hospitals when the procedure was first decriminalized in 2015. She began with assessing patients for eligibility and then moved to providing medical assistance in dying, or MAID, as it is called in Canada. For some patients with terminal cancer, it felt like the best form of care she could offer, she said.
But then Canada’s eligibility criteria expanded, and Dr. Li found herself confronting a different kind of patient.
“To provide assisted dying to somebody dying of a condition who is not happy with how they’re going to die, I’m willing to assist them, and hasten that death,” she said. “I struggle more with people who aren’t dying and want MAID — I think then you’re assisting suicide. If you’re not dying — if I didn’t give you MAID, you wouldn’t otherwise die — then you’re a person who’s not unhappy with how you’re going to die. You’re unhappy with how you’re living.”
Who has broken the taboo?
For decades, Switzerland was the only country to permit assisted death; assisted suicide was legalized there in 1942. It took a further half century for a few more countries to loosen their laws. Now decriminalization of some form of assisted death has occurred across Europe.
But there has recently been a wave of legalization in Latin America, where Colombia was long an outlier, having allowed legal assisted dying since 2015.
Paola Roldán Espinosa had a thriving career in business in Ecuador, and a toddler, when she was diagnosed with A.L.S. in 2023. Her health soon deteriorated to the point that she needed a ventilator.
She wanted to die on her terms — and took the case to the country’s highest court. In February 2024, the court responded to her petition by decriminalizing assisted dying. Ms. Roldán, then 42, had the death she sought, with her family around her, a month later.
Ecuador has decriminalized assisted dying through constitutional court cases, and Peru’s Supreme Court has permitted individual exceptions to the law which prohibits the procedure, opening the door to expansion. Cuba’s national assembly legalized assisted dying in 2023, although no regulations on how the procedure will work are yet in place. In October, Uruguay’s parliament passed a long-debated law allowing assisted death for the terminally ill.
The first country in Asia to take steps toward legalization is South Korea, where a bill to decriminalize assisted death has been proposed at the National Assembly several times but has not come to a vote. At the same time, the Constitutional Court, which for years refused to hear cases on the subject, has agreed to adjudicate a petition from a disabled man with severe and chronic pain who seeks an assisted death.
Access in the United States remains limited: 11 jurisdictions (10 states plus the District of Columbia) allow assisted suicide or physician-assisted death, for patients who have a terminal diagnosis, and in some cases, only for patients who are already in hospice care. It will become legal in Delaware on Jan. 1, 2026.
In Slovenia, in 2024, 55 percent of the population who voted in a national referendum were in favor of legalizing assisted death, and parliament duly passed a law in July. But pushback from right-wing politicians then forced a new referendum, and in late November, 54 percent of those who voted rejected the legalization.
And in the United Kingdom, a bill to legalize assisted death for people with terminal illness has made its way slowly through parliament. It has faced fierce opposition from a coalition of more than 60 groups for people with disabilities, who argue they may face subtle coercion to end their lives rather than drain their families or the state of resources for their care.
Why now?
In many countries, decriminalization of assisted dying has followed the expansion of rights for personal choice in other areas, such as the removal of restrictions on same-sex marriage, abortion and sometimes drug use.
“I would expect it to be on the agenda in every liberal democracy,” said Wayne Sumner, a medical ethicist at the University of Toronto who studies the evolution of norms and regulations around assisted dying. “They’ll come to it at their own speed, but it follows with these other policies.”
The change is also being driven by a convergence of political, demographic and cultural trends.
As populations age, and access to health care improves, more people are living longer. Older populations mean more chronic disease, and more people living with compromised health. And they are thinking about death, and what they will — and won’t — be willing to tolerate in the last years of their lives.
At the same time, there is diminishing tolerance for suffering that is perceived as unnecessary.
“Until very recently, we were a society where few people lived past 60 — and now suddenly we live much longer,” said Lina Paola Lara Negrette, a psychologist who until October was the director of the Dying With Dignity Foundation in Colombia. “Now people here need to think about the system, and the services that are available, and what they will want.”
Changes in family structures and communities, particularly in rapidly urbanizing middle-income countries, mean that traditional networks of care are less strong, which shifts how people can imagine living in older age or with chronic illness, she added.
“When you had many siblings and a lot of generations under one roof, the question of care was a family thing,” she said. “That has changed. And it shapes how we think about living, and dying.”
How does assisted dying work?
Beyond the ethical dilemmas, actually carrying out legalized assisted deaths involves countless choices for countries. Spain requires a waiting period of at least 15 days between a patient’s assessments (but the average wait in practice is 75 days). In most other places, the prescribed wait is less than two weeks for patients with terminal conditions, but often longer in practice, said Katrine Del Villar, a professor of constitutional law at the Queensland University of Technology who tracks trends in assisted dying
Most countries allow patients to choose between administering the drugs themselves or having a health care provider do it. When both options are available, the overwhelming majority of people choose to have a health care provider end their life with an injection that stops their heart.
In many countries only a doctor can administer the drugs, but Canada and New Zealand permit nurse practitioners to provide medically assisted deaths too.
One Australian state prohibits medical professionals from raising the topic of assisted death. A patient must ask about it first.
Who determines eligibility is another issue. In the Netherlands, two physicians assess a patient; in Colombia, it’s a panel consisting of a medical specialist, a psychologist and a lawyer. The draft legislation in Britain would require both a panel and two independent physicians.
Switzerland and the states of Oregon and Vermont are the only jurisdictions in the world that explicitly allow people who are not residents access to assisted deaths.
Most countries permit medical professionals to conscientiously object to providing assisted deaths and allow faith-based medical institutions to refuse to participate. In Canada, individual professionals have the right to refuse, but a court challenge is underway seeking to end the ability of hospitals that are controlled by faith-based organizations and that operate with public funds to refuse to allow assisted deaths on their premises.
“Even when assisted dying has been legal and available somewhere for a long time, there can be a gap between what is legal and what is acceptable — what most physicians and patients and families feel comfortable with,” said Dr. Sisco van Veen, an ethicist and psychiatrist at Amsterdam Medical University. “And this isn’t static. It evolves over time.”
Jin Yu Young in Seoul, José Bautista in Madrid, José María León Cabrera in Quito, Veerle Schyns in Amsterdam and Koba Ryckewaert in Brussels contributed reporting.
Health
New baldness treatment shows dramatic hair-regrowth gains in major trial
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A new experimental scalp treatment called clascoterone has shown strong results in helping reduce male-pattern hair loss (also known as androgenetic alopecia, or AGA).
Experts call the results promising, claiming that this could be the first new approach to reversing hair loss in decades.
Conducted by Cosmo Pharmaceuticals in Ireland, the two large, late-stage trials — named Scalp 1 and Scalp 2 — enrolled a combined total of 1,465 men across the U.S. and Europe, according to a press release.
EXPERIMENTAL SERUM SHOWS PROMISE IN REVERSING BALDNESS WITHIN 20 DAYS
Participants either used the topical solution or a placebo under randomized conditions. The main measure of success was “target-area hair count” (TAHC), an objective count of hairs in a defined scalp area.
The topical solution works by blocking the action of dihydrotestosterone (DHT) — a hormone that causes genetically sensitive hair follicles to shrink — directly at the follicle receptor rather than affecting hormones system-wide, according to Cosmo Pharmaceuticals.
Cosmo Pharmaceuticals reported strong phase 3 results for clascoterone in treating male-pattern hair loss. (iStock)
This localized approach attempts to address the biological root cause of AGA without exposing the body to additional hormones.
In the Scalp 1 group, clascoterone showed a 539% relative improvement in hair count compared with the placebo group. The participants in Scalp 2 showed a 168% relative improvement, the release stated.
“We really don’t have a very effective cream or lotion for hair loss, so this may be valuable for widespread clinical use.”
One study showed “statistical significance” in patient-reported outcomes, while the other showed a “favorable trend,” the release noted. When data from both trials were combined, the improvement was described as “statistically significant” and aligned with the counted-hair results.
“For decades, patients have had to choose between available treatment options with limited efficacy or safety issues due to systemic hormonal exposure, often resulting in patients not treating their hair loss at all,” Maria Hordinsky, M.D., from the University of Minnesota’s Department of Dermatology, said in a statement sent to Fox News Digital.
HAIR-LOSS DRUG TIED TO SUICIDES, DEPRESSION AND ANXIETY IN GLOBAL STUDY
“These findings show the potential for clascoterone 5% topical solution to change that equation by delivering real, measurable regrowth with negligible systemic exposure,” added Hordinsky.
Patient-reported outcomes — how study participants perceived their hair growth — were also positive.
If approved, the treatment would be the first new approach in nearly three decades. (iStock)
“I think this is promising,” Marc Siegel, M.D., senior medical analyst for Fox News, told Fox News Digital. “We really don’t have a very effective cream or lotion for hair loss,” added the doctor, who was not involved in the study.
Minoxidil lotion, one of the most widely used, FDA-approved topical treatments, generally has limited effectiveness, Siegel noted. “So, this may well be valuable for widespread clinical use.”
Potential limitations and risks
Siegel, who was not involved in the trials, referenced the study’s claim that the only side effect was “local irritation,” and said the medication appeared to be generally safe.
Safety and tolerance of the drug appeared to be comparable to the placebo group. Side effects were minimal and occurred at similar rates in both the active and placebo groups, with most found to be unrelated to the drug, according to the researchers.
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The researchers noted that the improvement in the study participants was in comparison to the placebo group in the study — it doesn’t guarantee that men will grow five times more hair than with other treatments.
Safety outcomes for the medication were similar to placebo, with no unexpected adverse effects, the researchers said. (iStock)
Each individual’s results depend on how much hair they had at the start, and without the full data, it’s unclear how much visible growth most men will achieve.
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“You do need to watch out for allergic reactions, and in rare cases, adrenal insufficiency, since the cream is an anti-androgen,” Siegel cautioned. This means because this treatment blocks androgens (male hormones), it could slightly affect the adrenal glands, which help the body manage stress hormones.
Full data, including long-term results and detailed absolute hair-count changes, are still pending regulatory review. (iStock)
Also, these are top-line results, as more detailed data — including long-term durability, variation between different degrees of hair loss and extended safety over 12 months — have yet to be released.
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If approved, this would be the first scalp treatment that works by blocking DHT right at the hair follicle — the first of its kind made specifically for male hair loss, the company says.
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Cosmo plans to complete a full 12-month safety follow-up by spring 2026 before submitting the medication for regulatory approval in the U.S. and Europe.
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