RealClearHealth Articles
FDA Should Practice the Science It Preaches
The FDA has plenty of advice for pharmaceutical companies. It publishes guidance documents, establishes scientific expectations, and expects drug developers to explain themselves when they take a different approach. Companies spend years and millions of dollars designing development programs around those expectations. But who holds FDA to the same standard?
The question takes on particular urgency when the patients are children. Pediatric drug development isn't a matter of adjusting an adult dose for body weight. Developing organs respond differently to medicines, and some adverse effects may...
Congress Should Remove the Barriers to Direct Primary Care
Congress recently made it easier for Americans to pay their doctors directly. But federal rules still prevent their health insurance from counting those payments toward a patient's deductible or out-of-pocket maximum.
Direct Primary Care (DPC) offers a simple alternative to conventional primary-care: patients pay a fixed monthly fee directly to their physician in exchange for routine primary-care services, often without insurance claims or billing departments. For patients with high-deductible health plans (HDHP), the arrangement could be particularly useful, pairing routine primary care with...
Pancreatic Cancer Finally Has a Breakthrough
One of my patients, a woman in her 60s with pancreatic cancer, came to me looking for a clinical trial. She received a new drug before its approval, through an expanded access program, and stayed on it when it reached the market. She still asks what comes next, hopeful that American innovation will give her more chances. In more than two decades as an oncologist, I have learned that time is never merely a number: it can mean celebrating your daughter’s wedding, spending another Thanksgiving with your family, or meeting a new grandchild for the first time.
Few diagnoses make that truth...
Hospital Consolidation Must Be Judged on the Merits, Not the Politics
Hospital consolidation has become a popular target in the debate over rising healthcare costs. Critics argue that mergers reduce competition, increase prices, and leave patients with fewer choices. These are legitimate concerns. But they do not justify treating every hospital merger as bad healthcare policy before examining its likely effects.
The question is not whether hospital consolidation is inherently good or bad. It is whether a particular transaction will improve or undermine competition, affordability, access, and quality. Hospital mergers should be judged on their individual merits,...
The Vitamin Alibi: FDA Must End the Compounding Charade
Who knew that adding a vitamin to a knockoff weight-loss drug could turn regulatory evasion into personalized medicine? Apparently, some pharmaceutical compounders did. And they've built a business around it.
The shortage of FDA-approved GLP-1 medicines created an opening for compounders to meet legitimate patient needs. But shortages end, and so do the legal justifications that accompany them. For businesses determined to keep selling copies of blockbuster medicines, the solution was remarkably convenient: add a little vitamin B12 or B3, call the product customized, and carry on.
The FDA has...
Hidden Litigation Funding Faces Growing Scrutiny
Three years ago, when the U.S. House Oversight Committee held its hearing on third-party litigation funding, reform felt like a distant goal. Outside investors were quietly bankrolling mass tort lawsuits against medical device makers; the public had no way to know who was paying, and courts had few tools to ask.
Today the picture looks very different. From state capitals to Capitol Hill, lawmakers of both parties are shining a light on the money behind the litigation, and the momentum is real. That matters for the patients and their families who rely on medical technology and for the...
Responsible Healthcare Investment Requires Clear Lines
A recent article in the Wall Street Journal highlighted newly introduced federal legislation that would restrict the role of private equity in healthcare by closing loopholes. There are meritorious components of this legislation. Physicians—not investors, hospital executives, insurers or anyone else—should make decisions about patient care. Bad actors should be held accountable. Financial incentives should never override clinical judgment. And provisions of the Stop Corporate Takeovers of Physicians Act that strengthen physician autonomy, including restrictions on physician...
It's Time Psychiatry Treated the Brain Like Every Other Organ
Show up at a doctor's office with a cough, and your account of the problem is only the beginning. A cough could be a lingering cold, bronchitis, COVID or the first sign of something in the lungs worth catching early. The doctor will listen to your chest, check your blood oxygen saturation level, and if necessary order a chest X-ray. Walk in with chest pain and a cardiologist connects you to an EKG (electrocardiogram) and watches your heart's electrical activity draw itself across a screen. Modern medicine runs on objective measurement. Yet psychiatry remains a striking exception.
PTSD, one of...
Rare Disease Patients Need Better Science, Not More Regulatory Ritual
The FDA has spent years trying to fit rare disease drug development into regulatory models that weren't designed for rare diseases. Its new Framework for Rare Disease Review suggests the agency is finally prepared to confront the consequences.
It's also an exciting beginning for Karim Mikhail, the new director of the FDA's Center for Biologics Evaluation and Research (CBER). Mikhail takes charge of a center responsible for evaluating some of the most complex medical technologies ever developed. He has an early opportunity to demonstrate that scientific flexibility is an essential part of...
Patients Deserve 340B Reform
Nearly half of U.S. adults struggle to afford healthcare, according to new polling. For cancer patients and their families, those financial pressures too often force impossible choices about treatment, medication, and household finances during the very moments they need support most.As policymakers search for ways to lower costs, expanding a little-known federal charity program designed to help low-income patients might seem like an appealing solution.But expanding the program, which some big hospitals have long used to charge patients hefty markups on prescription drugs, would only...
The Pandemic Is Never Really Over
America's experience with COVID-19 left us with an odd result. We pulled off something scientifically extraordinary and came out of it with less confidence in many of the institutions responsible for making it happen.
In less than a year, scientists, regulators and manufacturers developed, tested, reviewed and began distributing vaccines against a virus that medicine hadn't even known existed. That wasn't a shortcut. It was the payoff from decades of work in mRNA, immunology, viral vectors and related technologies, coupled with a willingness by government and industry to dispense with some of...
Biosimilar Regulation Has Not Kept Up with the Science
Some of the most expensive medicines in America are also the ones patients can least afford to go without. Biologic drugs are used to treat life-threatening and debilitating conditions including cancer, autoimmune diseases, and other serious illnesses. When these medicines cost tens or even hundreds of thousands of dollars a year, competition is not an abstract economic concern. It can determine whether patients can afford treatment.
Unlike conventional drugs, which are usually chemically synthesized and can often be copied exactly, biologics are complex medicines generally produced from...
This World Mental Health Day: Helping Kids Starts with Trauma-Informed Care
I was adopted out of foster care. I don’t lead with that often, but it’s the reason youth mental health has my full attention. I know how much a child’s future can hinge on whether the adults around them notice what’s really going on, at the right moment, and know how to respond. As we approach World Mental Health Day, I've been thinking a lot about what it truly means to support young people and ensure they can access mental health resources in ways that meet them where they are.
As a dad, and as chief operating officer of the Blue Cross Blue Shield Association...
The Next Step for 'Food Is Medicine' Is Beyond the Hospital Walls
A healthier hospital meal tray is important, but the food patients can access after they walk out the hospital door may matter even more.
This summer, the U.S. Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) called on hospitals nationwide to make nutrition a greater part of patient care. Encouraging hospitals to serve healthier food is an important step. But if we want nutrition to make a meaningful difference in America's chronic disease crisis, the opportunity cannot end at the hospital cafeteria.
It must extend into the communities that...
Americans Want Care at Home. Congress Has a Chance to Protect It.
Care at home providers have a simple message for Congress: Americans want access to care at home. Whether getting back on their feet after a long hospital stay or nearing the end of life, Americans overwhelmingly choose to receive care at home versus in an institutional setting. It’s time our healthcare policy reflects that demand.
Yet, recent policies – from broad-brush bans on new home health and hospice providers to years of unpredictable Medicare and Medicaid payment cuts – have made this pillar of our country’s healthcare system increasingly unstable. At the same...
Overdose Deaths Declining: HHS Continuing the Momentum
Overdose deaths have inflicted a terrible toll on American families and communities. For years, the trend line seemed relentlessly grim. That is beginning to change.
Overdose fatalities fell 26.2% from 2023 to 2024, and the latest provisional data from the Centers for Disease Control and Prevention (CDC) predicts 67,798 drug overdose deaths over the last 12 months ending in March 2026 which is a 12.3% decline from the same period a year earlier.
Those numbers do not mean the crisis is over. Tens of thousands of Americans are still dying from drug overdoses. But the direction has changed, and...
Healthy Workers Keep America’s Ports Moving
The United States economy meets the world at the port. Nearly everything on our store shelves, the food and goods our farmers and manufacturers sell abroad, and the energy that powers the country moves across our docks. Activity along the Houston Ship Channel alone supports more than 3.5 million American jobs. When our ports run well, the country runs well.
But ports don’t run themselves - thousands of workers are the basis of the movement of goods in the economy. They are only as strong as the longshoremen, crane operators, truck drivers, mechanics, and terminal workers are. And...
Patients First Act: Protecting Choice and Taxpayers
Americans prefer independent physician practices over corporate-owned hospitals by nearly a five-to-one margin. But despite patient preference, only 18% of physicians are practicing medicine in physician-owned settings, a new low amid high rates of hospital consolidation.
Why is independent medicine disappearing, despite its popularity? Government policy is a significant part of the problem. Medicare’s payment system leaves independent physicians dependent on reimbursement rates set in Washington, and those payments are repeatedly subject to scheduled reductions and temporary...
Tackling Alzheimer's Starts with a Focus on Latinos
Alzheimer’s doesn’t see color or speak a language. But getting a diagnosis and care does.If you identify as Latino, chances are you have seen the disease and the disparities that come with it up close. Growing up in southeast Los Angeles, Alzheimer’s and other forms of dementia were unspoken fixtures in my everyday life. My mom was a nurse and case manager at Alta Med Health Services, Inc., caring for elderly Latinos in East Los Angeles. I watched her help countless patients navigate not just Alzheimer’s, but all the other health issues that accumulate in poor...
Two Kidney Transplants. What MFN Means for My Third
The Trump administration's latest round of voluntary drug-pricing deals has put Most Favored Nation pricing back in the headlines. I understand the appeal. I have spent my life depending on medicines to stay alive, and I know what it feels like when care becomes unaffordable.
But patients like me also know that a lower price means little if the medicine is delayed, denied, or never developed.
My kidneys failed when I was six. At seven, I received my first transplant, donated by my mom. It allowed me to live a normal life through high school. But over time, my body began rejecting the...
