Trump Signs Executive Order Speeding Up Research On Using Psychedelics For Mental Health
'lead a happier life'
Florida doctor indicted after allegedly removing wrong organ in fatal surgery with 'catastrophic blood loss'
A Florida doctor has been indicted in connection with the death of a 70-year-old man after authorities said the surgeon removed the wrong organ during surgery and caused "catastrophic blood loss" that killed the patient.
Dr. Thomas Shaknovsky, 44, was indicted this week by a grand jury on a charge of second-degree manslaughter in connection with the death of William Bryan of Muscle Shoals, Alabama, according to police.
'This heartbreaking loss has devastated the family of William Bryan, and we are seeking justice for this senseless tragedy.'
The Pensacola News Journal reported that Bryan and his wife, Beverly, were visiting their rental property in Okaloosa County, Florida, when he suddenly began experiencing pain on the left side of his body, according to the family's law firm.
The couple went to Ascension Sacred Heart Emerald Coast Hospital in Miramar Beach, Florida.
William was admitted to the hospital for further testing after doctors found a potential issue with his spleen, the law firm said.
The Florida Department of Health said the patient wanted to utilize medication management for his spleen issue instead of undergoing surgery.
However, Shaknovsky allegedly "continued to pressure" the patient to undergo surgery to remove his spleen, despite the man "repeatedly" saying that he didn't want the surgery.
The Walton County Sheriff's Office said in a statement that the alleged victim was scheduled to undergo a laparoscopic splenectomy on Aug. 21, 2024, which is a spleen removal surgery.
The health department said that operating room staff members were concerned about the procedure "being done so late in the day since they only had a skeletal crew" and that "splenectomies were complicated procedures that could quickly deteriorate and were not regularly performed" at the facility.
The Florida Department of Health also noted that Shaknovsky "arrived at the hospital approximately an hour late" for the surgery scheduled for 4 p.m.
Investigators said Shaknovsky removed the patient's liver instead of his spleen.
The health department's report stated, "Immediately after performing the dissection, Patient W.B. began to severely hemorrhage and went into cardiac arrest. Operating room staff members observed a significant amount of blood pouring out, immediately disrupting visibility in the field."
The health department noted, "Spleens and livers are anatomically distinct, have different consistencies, and are different colors. Additionally, the spleen is located on the left side of the abdomen, while the liver is on the right side."
The report said, "The staff looked at the readily identifiable liver on the table and were shocked when Dr. Shaknovsky told them that it was a spleen. One staff member felt sick to their stomach."
Bryan was pronounced dead at the hospital.
The Walton County Sheriff's Office said, "Dr. Shaknovsky removed the victim's liver instead of his spleen, resulting in catastrophic blood loss and the patient's death on the operating table."
Dr. Shaknovsky told the staff that the patient died from a ruptured splenic artery aneurysm, according to the report.
The Florida Department of Health said a pathologist confirmed the organ tissue removed was an intact liver.
The report revealed that the "medical examiner observed that patient W.B.'s spleen and its attachments were untouched and in the normal position, his liver was missing, and his inferior cava had been severed."
The health department pointed out, "The vena cava is the largest vein in the body and brings deoxygenated blood from the body back to the heart for new oxygen. The inferior vena cava connects the liver to the heart."
"Additionally, the medical examiner noted that there was no evidence of a ruptured splenic artery aneurysm," the report proclaimed.
The report claimed that Shaknovsky dissected Bryan's inferior vena cava, "resulting in the bleeding event that precipitated his death."
"Dr. Shaknovsky claims that due to his shock and the chaos of the situation, he was unable to properly identify the organ he removed and assumed it must be the spleen," according to the health department.
The sheriff's office stated, "The grand jury found probable cause to charge that the actions taken in the operating room constituted criminal conduct under Florida law."
Shaknovsky was arrested in Miramar Beach and transported to the Walton County Jail.
Walton County Sheriff Michael Adkinson said, "Our duty is to follow the facts wherever they lead, without fear or favor."
Adkinson added, "The grand jury has spoken, and our responsibility is to ensure the charges are carried out through the proper legal process."
The deceased man's widow, Beverly Bryan, told NBC News, "When I tell people what happened, it still sounds too awful to be true that that could happen."
Pensacola-based law firm Zarzaur Law P.A. filed a lawsuit against Shaknovsky and Ascension Sacred Heart Emerald Coast in January 2025.
A spokesperson for Ascension Sacred Heart Hospital Emerald Coast told NBC News, "Dr. Shaknovsky was never a Sacred Heart Emerald Coast employee and has not practiced at any of our facilities since August 2024."
The spokesperson continued, "We remain focused on upholding the standards our patients and community expect of us."
Authorities claim that two other patients of Shaknovsky experienced surgery mishaps, including one man who died after surgery.
In May 2023, a 58-year-old man went to the Ascension Sacred Heart Emerald Coast Hospital to get an adrenalectomy, which is the surgical removal of one or both adrenal glands.
The emergency suspension order stated, "During the surgery, Dr. Shaknovsky removed a portion of Patient G.D.'s pancreas instead of the adrenal gland."
Following the surgery, the removed tissue was sent for pathological analysis, according to the Florida Department of Health.
A pathologist examined the purported adrenal gland specimen, which was actually tissue from the patient's pancreas, the order revealed.
"In response to the allegations, Dr. Shaknovsky claimed that the adrenal gland had 'migrated' to a different part of the body," the order said.
The State of Florida Department of Health said the patient "suffered from long-term, permanent harm as a result of Dr. Shaknovsky's error."
Florida Department of Health records show that Shaknovsky in August 2024 settled a malpractice claim for $400,000 in connection with the May 2023 case.
Another one of Shaknovsky's patients died following a procedure, according to authorities.
NBC News reported that the Alabama Board of Medical Examiners said Shaknovsky removed part of a patient's intestine during a procedure in July 2023, which caused a gastrointestinal perforation during which a hole develops in the intestine.
The patient was transported to the ICU shortly after the surgery and died, according to NBC News.
In September 2024, Florida Surgeon General Joseph Ladapo ordered the emergency suspension of Shaknovsky's medical license.
The Florida Department of Health currently lists the status of Shaknovsky's medical license as "retired," and the license expired on March 31, 2026.
Public records show his license in New York was temporarily suspended in May 2025.
The Alabama Board of Medical Examiners filed a court order to temporarily suspend Shaknovsky's medical license shortly after Bryan's death.
Citing records, the Washington Post reported that Shaknovsky voluntarily surrendered his medical license in Alabama after the board attempted to revoke his license.
The New York Times reported that Shaknovsky is scheduled for an arraignment in Walton County Circuit Court on May 19.
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RFK Jr. turns the tables on Democrats and reveals 1.5M illegal aliens unlawfully received Medicaid
Health and Human Services Secretary Robert F. Kennedy Jr. corrected the record during his testimony before Congress on Friday morning after Democrat lawmakers spread false information about the Trump administration's health care policies.
'It is the Democratic policy to benefit billionaires.'
Kennedy appeared before the House Education and Workforce Committee to answer questions about the HHS' priorities.
Following his opening statement, Chairman Tim Walberg (R-Mich.) posed the first question to Kennedy, asking whether he was "responsible for the measles outbreak."
Kennedy acknowledged that he had been accused of that but said the accusation was "not science-based."
"The measles outbreak began in January 2025, before I took office. ... The measles outbreak is not an American phenomenon; it is global," he replied.
He explained that in 2025, the U.S. had approximately 2,200 measles cases, while Mexico had more than three times that amount, despite having one-third of the U.S. population. Canada reportedly had twice as many cases, even though its population is just one-eighth of that of the U.S. In Europe, the number of cases was nearly 10 times that in the U.S., despite having twice the U.S. population, Kennedy said.
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"Two little girls died tragically in the Mennonite community in Texas. Mennonites have not vaccinated since 1796. So, this has nothing to do with me," Kennedy stated.
He mentioned attending the funeral of one child and spending the day with the family of the other.
"Both of them told me that when they took their children to the hospital, they were treated as pariahs. They were shamed. They were not given proper treatment. Both families believed their daughters, and their own doctors believe, their daughters could have been saved if the hospital gave them proper treatment," Kennedy continued.
"There's a lot of people in this country who, for religious reasons or other reasons, are not gonna vaccinate. And I believe that we need to treat them with compassion and understanding and empathy and get them the treatments they would get anywhere else in the world except for this country," he added.
Kennedy was later questioned by Rep. Greg Casar (D-Texas), who pressed the secretary about "kicking 15 million Americans off of their affordable health care."
"Have you met with everyday Americans who have lost their health insurance just this last year?" Casar asked.
"I meet with everyday Americans every day," Kennedy replied. He also noted that he spoke with the advocacy community "on virtually everything that we regulate" and "more tribes and tribal leaders than any HHS secretary in history."
Casar then asked whether Kennedy had met with Americans who would be impacted this year by "cuts to Medicaid."
"There are no cuts to Medicaid. ... We are increasing Medicaid spending by 47% over the next 10 years. ... How is that a cut? That is only a cut in Washington, D.C.," Kennedy responded.
RELATED: 'Rogue' Biden judge blocks critical pieces of RFK Jr.'s vaccine reform
Casar ignored Kennedy's comments and pushed forward with his line of questioning.
"Have you met with any of the 1.4 million people who have lost their health insurance just this last year from dropping off of Obamacare?" he asked.
"They're almost all illegal immigrants. ... We found 1.5 million illegal immigrants illegally collecting Medicaid," Kennedy remarked.
Casar attempted to corner Kennedy into admitting he had dedicated time to meet with billionaires but not with everyday Americans. However, Kennedy repeatedly denied this and turned it back around on Casar by slamming Democrats for Obamacare.
"It is the Democratic policy to benefit billionaires," Kennedy said. "The insurance companies' stocks raised by 1,000% after Obamacare was passed. The money was not going to Americans; it was going to them."
"It was you who did it," Kennedy declared.
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Euthanasia and the lie of the 'good death'
The term euthanasia literally means “good death.” The word is constructed from the Greek eu (good) and thanatos (death) — the same root that inspired the name of the Marvel villain Thanos, whose vision of “balance” required mass death.
The language itself tells you everything. Dress death up as “good,” and you can begin to sell it to failed socialist medical systems as a desirable cure-all.
Euthanasia, often called “doctor-assisted suicide,” has been thrust back into public view by developments in countries like Canada and Spain. What we are seeing is not compassionate medicine. It is the quiet normalization of despair.
A culture that cannot tell its weakest members, 'Your life is worth living,' will eventually tell them, 'Your death is preferable.'
Consider the case of Noelia Castillo in Spain.
Castillo, just 25 years old, had endured profound suffering. As a minor, she was in mental health care. As an adult, she was the victim of sexual assault multiple times. After a suicide attempt following the second assault, she was left paralyzed from the waist down. In that condition, she requested euthanasia.
Her father pleaded with the courts to deny the request, arguing that her mental health made such a decision unsound. The courts disagreed. The state approved her death.
A young woman, failed repeatedly by those entrusted to care for her, was ultimately offered death as the solution.
Even more troubling, British pianist James Rhodes publicly appealed to her to reconsider, offering to cover her medical costs. His plea underscores what the system refused to admit: Castillo did not need death; she needed care.
And Castillo herself admitted as much. In an interview, she essentially asked: If I cannot access health care, am I then entitled to access death care?
That question exposes the entire moral collapse. She was denied meaningful treatment in her socialist system but granted state-funded death as the solution to her suffering.
The Canadian example
If Spain reveals the logic of euthanasia, Canada demonstrates its trajectory. In Vancouver, Miriam Lancaster went to the emergency room for back pain. Instead of being treated, she was offered medically assisted suicide.
Death does cure back pain. It cures everything by eliminating the patient. Failed socialist medicine jumped at the chance to raise its cure statistics.
Thankfully, Lancaster refused. She later received proper treatment and went on to continue traveling the world. Had she accepted the offer, a solvable medical issue would have become a state-sanctioned death and she would have been “cared for” right into the grave.
Then there is the case of Jennyfer Hatch, a 37-year-old Canadian woman suffering from Ehlers-Danlos syndrome, a painful connective tissue disorder. Hatch became the face of a euthanasia promotional campaign titled "All Is Beauty," a three-minute film celebrating her final days before medically assisted death.
Let that sink in: a commercial for suicide.
And yet Hatch admitted privately that she chose euthanasia not because her condition was untreatable but because obtaining adequate medical care in Canada’s system was too difficult.
The myth of 'compassionate' systems
We have long been told by progressives that socialized medicine would deliver universal care, eliminate wait times, and treat every patient with dignity. Instead, it is increasingly offering a different solution: eliminate the patient.
The logic is brutally simple. If you cannot heal the sick, you can always reduce the number of sick people. These socialists saw the story of Thanos as a “how to.”
People have always been capable of taking their own lives. A system that merely facilitates suicide adds nothing of value. It does not heal; it does not restore; it simply institutionalizes despair. It admits it offers no meaning in life to those who suffer.
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What is a good death?
At the heart of this debate is a deeper question: What do we mean by a good death?
For modern secular societies, the answer is increasingly clear: a good death is a painless one. It is an escape from suffering.
But this definition collapses under scrutiny.
First, it ignores the most basic philosophical question, one raised memorably by Hamlet: “What dreams may come when we have shuffled off this mortal coil?” If death is not the end, if judgment awaits, then euthanasia is not an escape but a gamble of the highest stakes. It the solution urged by demons looking forward to claiming another soul.
Second, it misunderstands the nature of a good life.
A life free from all pain is not a noble life. It is not the life we admire, nor the life we aspire to. Our stories, our heroes, and our deepest intuitions all tell us the same thing: Meaning is forged through suffering.
Imagine a hero who, one-third of the way through the story, says, “This is too hard. I think I’ll end my life to avoid the suffering ahead.” That is not a hero. It is a failure.
Suffering, rightly understood, is not meaningless. It teaches perseverance, discipline, and faith. It refines character.
As Scripture teaches, “Add to your faith virtue, to virtue knowledge, to knowledge self-control, to self-control perseverance …” (2 Peter 1:5-6).
A pain-free life is not the highest good. A life shaped by truth, virtue, and endurance aimed at eternal life of knowing God is our chief and highest good.
The real crisis
The rise of euthanasia is not ultimately about medicine. It is about worldview.
Societies that reject God are left with no ultimate purpose, no transcendent hope, and no reason to endure suffering. When affluence fails and suffering remains, the only consistent answer left is escape.
A culture that cannot tell its weakest members, “Your life is worth living,” will eventually tell them, “Your death is preferable.” From hating God, the culture naturally moves to hating neighbors. It is a moral collapse described in Romans 1:31. The people become heartless and ruthless.
A better hope
The answer to suffering is not death. It is redemption.
Only a worldview grounded in the reality of God can make sense of suffering without surrendering to it. Only Christ offers not merely relief from pain, but restoration, meaning, and eternal hope. He can heal our physical pain, but more importantly, he can forgive our sin and restore our communion with God.
The growing acceptance of euthanasia should force us to confront the emptiness of the alternatives.
If death is our only answer, then we have already lost. But if life has meaning, then suffering is not the end of the story.
And that is the difference between despair and hope.
My son is fighting for his life. The FDA doesn't seem to care.
I’ve been fighting Duchenne muscular dystrophy for 40 years. My brothers Angelo and Antonio died from it at ages 20 and 22, respectively. Antonio died in 2015, when my son, Ryu, was barely a toddler and had already been diagnosed with the same terminal illness.
My childhood memories are of praying for my brothers, caring for them with my mother, and Mom taking all five of her kids to church almost every day. I always asked God to heal my brothers, and — after Ryu was born — I added him to those prayers.
I’ve been saying the same prayer for help and to be able to lend my voice for over 40 years.
But I also went to God with another prayer — I asked that He would open the door that allowed me to share our family’s story. I didn’t know what that looked like, or when it would come, but I trusted in it.
This year, that prayer was answered when I was asked to speak out not just on behalf of my brothers and son, but for every family that feels isolated because of a terminal rare disease.
I visited Washington, D.C., to share my story with lawmakers from both parties as well as patient advocates and to ask them to push the Food and Drug Administration to stop standing in the way of drugs like Elevidys, the only gene therapy treatment for my son’s illness.
The advocacy worked. I can’t say how much my own small voice, speaking up for the first time, helped, but so many people speaking out made a difference.
The first indicator was when the Center for Biologics Evaluation and Research Director Dr. Vinay Prasad announced his resignation from the FDA just a week later — he leaves this month. Prasad blocked treatments, with the support of FDA Commissioner Marty Makary, that could have helped kids like Ryu all across the country to live.
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I’m just a mom. But we recently celebrated Easter, where a carpenter saved the world. He overcame the establishment of His time, which was willing to throw the vulnerable and sick to the side. He fell, but He didn’t falter — I hope to follow His example.
As we were approaching Holy Thursday this year, Ryu was having a hard evening. He needed his Bipap machine to help his lungs function, as he so often does. But he looked at me — my 14-year-old wheelchair-bound boy who is the happiest kid I know — and said, “Mom, this sucks. But what you’re doing makes it a lot easier.”
My story may not matter to FDA Commissioner Makary, who seems to have forgotten about Ryu and thousands of other kids like him. But God sees every hair on our heads. He named us before our parents knew us. And sometimes, like Gabriel told the prophet Daniel, prayers are answered long before we see their fruition.
I’ve been saying the same prayer for help and to be able to lend my voice for over 40 years. To the world, Antonio and Angelo may be long deceased, but they are the foundation for how my husband and I have cared for Ryu. And God has allowed me to carry their stories from my home in El Paso to our nation’s capital.
Commissioner Makary and Dr. Prasad may have forgotten that their job is to save lives, but God seems to have different plans. He’s just getting started with me in spreading His good news, and so far it has been amazing.
But I’m also not surprised, because I knew God would take care of it all.
Editor’s note: This article was originally published in the Christian Post.
More than 76,000 Canadians have been killed through MAID. One province has had enough.
The Canadian federal government under former Prime Minister Justin Trudeau legalized medically assisted suicide nationwide in 2016.
As critics predicted, the state-facilitated suicide program — referred to as medical assistance in dying — was grossly liberalized in a short of period of time, maximizing both the number of accepted rationales and the number of those killed.
The province of Alberta appears keen to rein in Canada's sick experiment and protect its would-be victims, especially ahead of the Carney government's planned MAID eligibility expansion next year.
Background
In its first year, MAID offed 1,108 Canadians. That number tripled the following year, and by 2021, the number of Canadians killed by their government had climbed to over 10,000 in a single year.
'MAID should not be a substitute for robust health care.'
The Canadian government revealed in its latest MAID report that a total of 16,499 people were euthanized under the program in 2024, accounting for over 5% of all deaths in Canada that year. Of those euthanized, at least 4.4% nationally were not terminally ill. In Alberta, the number was 4.6%.
By the end of 2024, the number of Canadians who have died through MAID crested 76,000.
Originally, MAID applicants had to be 18 or older and suffering from a "grievous and irremediable medical condition" causing "enduring physical or psychological suffering that is intolerable" to them.
Within years, the country's eugenicist-founded health care system had given the green light to effectively execute those struggling with anxiety, autism, depression, economic hardship, PTSD, and other survivable issues.
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Persons suffering solely from a mental illness will be eligible for MAID beginning March 17, 2027.
Alberta takes action
Alberta Attorney General Mickey Amery, who is also the justice minister of the ruling United Conservative government, introduced legislation last month — the Safeguards for Last Resort Termination of Life Act — that would "increase oversight, introduce necessary safeguards, and provide greater clarity around eligibility requirements for medical assistance in dying ... in the province."
The bill would, among other things, prohibit MAID in Alberta for: persons under 18; persons whose sole underlying medical condition is a mental illness; individuals lacking the capacity to make their own health care decisions; and advance requests.
It would also prohibit euthanasia for individuals whose natural death is not reasonably foreseeable; restrict the display of MAID propaganda; empower health practitioners and institutions to refuse participation in the euthanasia regime; and bar Alberta health professionals from referring individuals for MAID eligibility assessments outside the province.
The legislation would also introduce penalties for doctors and nurses who violate the proposed provincial rules.
"Canada has the fastest growing death rates in the world when it comes to MAID. Far from being an option of last resort, MAID is now the fifth leading cause of death in Canada," Amery told the Alberta Legislature last week. "The country is currently projected to reach its 100,000th death by MAID in June, becoming the first nation in the modern era to measure its total assisted deaths in the six figures, more than the totals of any other jurisdiction with some form of legal, doctor-assisted death."
Alberta Premier Danielle Smith said in a statement, "Those struggling with severe mental health challenges need treatment, compassion and support, not a path to end their life at what may be their lowest moment. In Alberta, a patient whose sole underlying condition is mental illness will not be eligible for MAID."
'The state refusing to fund and provide a killing service is the baseline.'
Rebecca Vachon, health program director for the Canadian think tank Cardus, said in a statement, "We support the adoption of these enhanced protections for Albertans and urge all legislators to work collaboratively to implement them."
While the Catholic Bishops of Alberta underscored that "the Church teaches that 'euthanasia and assisted suicide are always the wrong choice,'" they similarly characterized the bill as an important step in the right direction, stating, "A just society is one that protects the vulnerable, upholds the dignity of every person, and chooses to accompany them in times of illness and dying. The Alberta government is taking some significant steps that respect these necessary values."
Gabrielle Peters, a disabled writer and co-founder of Disability Filibuster, recently noted in a piece for the Macdonald-Laurier Institute,
The state refusing to fund and provide a killing service is the baseline we build from. Without that, there is simply no foundation. If disability — and only disability — makes one killable, then why would a state build the infrastructure, policies, and programs necessary to support disabled life? Particularly when one is an expense and the other represents considerable cost-saving?
Some euthanasia advocates have joined state media in framing the life-affirming legislation in negative terms.
The Canadian Civil Liberties Association, for instance, suggested that the legislation "would significantly restrict access to medical assistance in dying ... and undermine constitutionally protected rights."
Michael Trew, Alberta's former chief addiction and mental health officer, recently wrote that the bill "amounts to taking away choice from many who are fully competent" and that "this loss of choice INCREASES pain and suffering."
Like Blaze News? Bypass the censors, sign up for our newsletters, and get stories like this direct to your inbox. Sign up here!The quiet rule making health care worse for American families
Most Americans don’t spend much time thinking about health care policy. They don’t have to. They feel it every year when premiums rise, deductibles climb, and another chunk of their paycheck disappears into a system that rarely seems to work in their favor.
American health care is expensive, confusing, and quietly disempowering. Money moves constantly — from workers to employers to insurers to administrators and eventually to providers — but too rarely stays with the people who earned it. When the bills arrive, families are told what they owe, not what they saved or controlled.
A system that won’t let people save for their own medical needs is not protecting them. It is protecting itself.
That should bother us.
Health savings accounts were designed to fix part of this imbalance by giving people something rare in modern health care: ownership. An HSA lets individuals set aside money for medical expenses, invest it if they choose, and carry it with them year after year. The money is theirs. It doesn’t expire. It isn’t reassigned. Institutions do not manage it on their behalf.
Ownership changes behavior. People who control their own money plan differently. They ask questions. They think long-term. They stop acting like passive participants in a system that treats them as cost centers instead of decision-makers.
Yet millions of Americans are barred from opening an HSA.
Not because they don’t need one or cannot afford health care. It’s simply because the law says they are not allowed.
Under federal rules written more than two decades ago, HSA eligibility is tied to a narrow category of insurance plans. As a result, more than 140 million Americans — including many with traditional employer coverage and rising out-of-pocket costs — are blocked from saving for health care the way they save for retirement or education.
In no other area of American life do we accept a rule that says: You may pay continually, but you may not save.
No one is barred from opening a retirement account because of the kind of pension an employer offers. No one is blocked from saving for college because of where a child goes to school. Yet in health care — often the largest and most unpredictable expense a family faces — ownership remains conditional.
That is no accident. It’s the predictable result of a system built around institutions rather than individuals. Complexity gets rewarded. Intermediaries profit from it. Ordinary people are expected to navigate the maze without meaningful control over the dollars they contribute.
Prices often remain opaque until after care is delivered, which means families learn what something costs only when the bill arrives — too late to make an informed choice.
The result is a system where spending rises, trust erodes, and prevention gets talked about far more than it gets practiced.
Expanding access to health savings accounts would not solve every problem in health care. But it would address one of the most basic ones: the absence of real personal agency.
The fix is not complicated. It requires trusting people with their own money.
Every American should be able to open an HSA, regardless of insurance type.
This is not a call for a new entitlement or government program. HSAs are privately owned accounts. They rely on responsibility, not mandates. They rest on a simple belief: When people have control, most will use it wisely.
That assumption may feel unfashionable in modern policymaking. It still reflects how Americans live. People save for retirement. They save for education. They save for emergencies. Health care should not be the lone exception — especially when the costs are so high and the stakes so personal.
A system that won’t let people save for their own medical needs is not protecting them. It is protecting itself.
If we want health care that costs less and works better, the answer is not more management. It is more ownership.
The real question is not whether Americans can be trusted with their health care savings. It is why we have spent so long pretending they can’t.
FDA caution is starting to look like cruelty to sick kids
Biomedical research has produced extraordinary breakthroughs that have saved countless lives. But too many promising drugs now stall in federal review, and children with rare diseases are paying the price.
I’m a bioscientist. My work has focused on how healthy cells function and how that knowledge can be applied to therapeutic enzyme development. I’ve spent my career working inside the disciplines that move a treatment from lab bench to patient: protocol design, reproducibility, evidence standards, and layered human testing to ensure safety.
Is this simply bureaucracy doing what bureaucracy does? Or are rare pediatric therapies effectively facing a higher bar inside the system?
Standards, evidence, and process matter. But so does urgency.
Children with rare diseases do not live on regulatory timelines. They lose function month by month — speech, mobility, independence, even the ability to breathe on their own.
Of the more than 6,800 known rare diseases, about 70% begin in childhood. Better-known examples include Duchenne muscular dystrophy, Gaucher disease, and cystic fibrosis.
Developing therapies for these children is difficult, expensive, and slow even under the best conditions. Treatments such as Ultragenyx’s UX111 for Sanfilippo syndrome, Sarepta’s Elevidys for Duchenne, and Regenxbio’s RGX-121 for Hunter syndrome can take decades to develop, years to move through trials, and still more time to reach the children who need them.
That reality makes avoidable regulatory delay even harder to defend.
Too often, applications do not stall because the underlying science has failed. They stall over manufacturing or procedural concerns — in many cases, issues that are fixable and not directly tied to whether the therapy is clinically helping patients. Those delays can undermine the purpose of the FDA’s accelerated approval pathway, which exists to move critical treatments to patients faster while additional data is collected.
As a scientist, I was particularly troubled by the FDA’s recent rejection of a promising Hunter syndrome treatment and by yet another clinical hold placed on its development despite positive trial results.
That raises an uncomfortable question: Does the review process itself need review?
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The approval path for UX111 is another example. The therapy went through the rigorous biologics license application process, only to be delayed by a manufacturing hold.
Elevidys offers a similarly painful lesson. More than 1,200 Duchenne patients received the treatment over three years. Then, after two non-ambulatory patients (including one with underlying complications) tragically died, the FDA pulled the treatment from all patients, leaving families crushed and panicked.
Children are waiting too long for access to potentially life-changing therapies.
Yes, medical breakthroughs have increased. But so have regulatory burdens tied to approval and release. By the time many of these therapies reach the market, a decade or more has passed. In rare pediatric disease, that delay has a name: time children do not have.
Sometimes, it is their entire lifetime.
Manufacturing processes can be improved. Facilities can be upgraded. Paperwork can be corrected.
Lost neurons and muscle fibers cannot be replaced.
FDA leaders, along with Congress and the White House, should push for a smarter accelerated approval process — one that allows multiple requirements to be addressed simultaneously when appropriate, instead of serially dragging out timelines. If regulatory review had moved more efficiently, the Sanfilippo treatment might have cleared on its original 2025 approval timeline. Duchenne patients might not have lost access to the only available gene therapy. Hunter syndrome patients might not still be waiting.
This debate is not about abandoning safety or efficacy standards.
Ultragenyx has said manufacturing improvements are addressable and not directly related to product quality. Sarepeta responded to FDA concerns over Elevidys by requesting black-box warnings while allowing treatment to continue for ambulatory patients. In the RGX-121 Hunter syndrome case, the FDA rejected the use of a long-accepted biomarker (cerebrospinal fluid) used in the trial.
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These decisions do not help children with rare diseases. Timely, science-based approvals would.
And the stakes go beyond today’s patients. Regulatory efficiency also affects whether companies continue investing in rare-disease therapies at all. Orphan drug development requires major upfront investment, long timelines, and often poor financial returns. In many cases, these programs are closer to philanthropic science than blockbuster pharma economics.
When developers face repeated slowdowns across different diseases, sponsors, and technologies for reasons unrelated to core clinical safety or efficacy, the signal to the market is clear: Don’t take the risk.
That is how innovation gets smothered.
At some point, the pattern at the FDA becomes impossible to ignore. Is this simply bureaucracy doing what bureaucracy does? Or are rare pediatric therapies effectively facing a higher bar inside the system?
Those are scientific and ethical questions that deserve honest answers.
Accelerated approval does not mean lower standards. It means applying standards intelligently. It means allowing earlier access while confirming evidence continues to accumulate. It means recognizing that “wait and see” is not neutral. It is a choice that guarantees disease progression in children who cannot afford delay.
Good science and compassion are not competing values. We can maintain rigor and still act with urgency.
The FDA has the authority. The science is moving. The children cannot wait.
Accelerated approval is not cutting corners. It is using every tool we have to save time families do not have.
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