RealClearHealth Articles
America Needs Its Mid-Sized Biotech Companies
When Americans think about medical innovation, they usually picture either a startup working out of a laboratory or a pharmaceutical giant bringing drugs to market. But some of the most important work in medicine happens between those two extremes.
Mid-sized biotechnology companies are the often-overlooked backbone of America's life sciences sector. They are large enough to run clinical trials, attract serious investment, and employ thousands of highly skilled workers. Yet they remain entrepreneurial enough to pursue bold scientific ideas, challenge conventional thinking, and take risks that...
Prescription Drug Costs Loom in Midterms
With the votes counted, Texas Attorney General Ken Paxton has secured the Republican nomination for Senate, dispatching incumbent Senator John Cornyn and declaring that "change was on the ballot" in Texas. With the primary settled, Paxton turns to face Democrat James Talarico in November 2026, and the issues that will define that race will not be relitigated grievances from the Republican primary. They will be decided at the kitchen table over unpaid bills, prescription bottles, and household budgets that no longer stretch to the end of the month under failed Democratic policies of the...
You Really Want Your Radio Operator to Be Vaccinated
May 1776, the United States lost the battle of Quebec [JG1] and retreated south because so many of the Continental troops contracted smallpox, while the Red Coats of the British Army were largely immune. Combat ineffective. Mission failure. Arguably, if not for smallpox, Canada might not be an independent country and we would have more States north of the Saint Lawrence River.
In the Franco-Prussian War of 1870-71, the unvaccinated French Army suffered 125,000 smallpox casualties[JG2] , compared to the vaccinated Prussian Army’s 8,400 cases. Guess who won.
In the Boer War of...
Hospitals Face No Consequences for Hiding Prices
Imagine leaving a hospital with your newborn child only to learn your bill was $24,000 more than what it would have been at another hospital in the same area. This is the reality for some patients in the San Francisco area—and it is not unique. Across the country, identical procedures have wildly different prices depending on where patients receive care, and patients have almost no way of knowing those prices in advance. Federal transparency rules exist, but their penalties are minimal and rarely enforced.
Without meaningful price transparency, patients cannot comparison shop for care...
The FDA’s Rare-Disease Problem Isn’t Delay. It’s Trust.
The FDA’s recent closed-door roundtable with more than a dozen rare-disease advocacy groups hinted at a real reset after a stretch that many patients and families experienced as opaque, inconsistent, and nearly impossible to navigate.
The question now is whether that message will survive contact with actual approval decisions. Senior leaders stressed re-engagement, stronger science, broader use of patient-experience data, and renewed openness to outside input. Patient advocates answered with a blunt list of concerns: narrow labeling, slow reviews, refuse-to-file decisions, inconsistent...
ALS Breakthroughs Are Within Reach
This ALS Awareness Month, lawmakers and regulators face a pivotal moment in the fight against ALS. For the first time in history - following decades of stagnancy - breakthroughs in ALS science, policy, and coordination are beginning to align. But we need swift action from Congress and the FDA to continue pushing urgently so that progress can benefit those who need it most. I AM ALS - the largest national movement to end ALS - has been encouraged by action from our champions in Congress. We are hopeful that leaders in Washington will pass the Accelerating Access to Critical Therapies for ALS...
The FDA’s AI Double-Talk
It’s budget season in Washington, and the Trump Administration’s FY2027 FDA request contains a welcome idea: a Clinical Trial Notification Pathway, a risk-based, expedited alternative for some early-stage studies. FDA says the current process is duplicative and time-consuming, and has helped push early-stage preclinical and Phase 1 work to China and Australia. Give the Administration credit. It has recognized that outdated regulation can cost the U.S. competitiveness in strategically important areas.
But the same competitiveness logic applies to another frontier that matters at...
The Next Ebola Vaccine: Learning Lessons from Covid
As Ebola fears again spread beyond Africa, the world faces a familiar question: How best to react to the threat? What lessons from past threats, including Covid-19, can we apply?
These days, of course, mechanisms aimed at thwarting contagious diseases are controversial, from quarantines to personal protective equipment to vaccines.
And yet the potential danger of Ebola is not controversial, it is actual. According to the Centers for Disease Control and Prevention, the virus has broken out two dozen times in the last half-century, across broad swathes of Africa. The World Health...
Congress Should Demand Evidence on Drug Patents, Not Metaphors
This week, a House Judiciary subcommittee will revisit familiar accusations about pharmaceutical patents and drug prices. Testimony will likely invoke two concepts: that drug companies create patent "thickets" to thwart generic competition, and "evergreen" patents to extend exclusivity and keep prices high.
Decades of evidence tells a different story: generic competition routinely arrives years before all patents associated with a medicine expire, and over 90% of prescriptions in the U.S. are filled with generics. Generic competition is robust, and the system is working as intended.
If...
The FDA Needs a Diagnostician, Not a Doctor
The next Commissioner of the Food and Drug Administration does not need to be a physician. But he does need to be a diagnostician.
The FDA's biggest challenges today are not clinical. They are organizational. The agency must restore confidence in its decisions, attract and retain the best scientific talent, keep pace with innovations that are transforming medicine, and ensure that patients have timely access to safe and effective therapies. Those are leadership challenges and that's why Jim O'Neill would make an outstanding FDA Commissioner.
Having served at the FDA as an Associate...
The FDA Commissioner’s Job Isn’t Practicing Medicine, It’s Building Trust.
As Washington considers who should next lead the Food and Drug Administration (FDA), there will be a familiar temptation to focus on credentials. Should the Commissioner be a physician? A scientist? A lawyer? A policy expert?
As a former Secretary of the U.S. Department of Health and Human Services (HHS) and former FDA Commissioner, we know that more important to the role than any credential is understanding and being able to skillfully navigate policy, politics, and public service.
The FDA Commissioner does not need to be the nation’s doctor-in-chief. FDA already has physicians,...
Taking Back Control
There ought to be at least one issue in American life that rises above partisan reflex: the health of the American people.
Republicans, Democrats, and independents may disagree on taxes, spending, regulation, and the size of government. But every one of us should want the same basic things from our healthcare system: better access, better outcomes, lower costs, and more confidence.
Yet in the wealthiest nation on earth, despite building the most expensive healthcare system in history (costing more than $15,000 per person per year, nearly one-fifth of our national economy) Americans live...
RFK and HHS Making Major Strides to Improve Physician Nutrition Education
For decades, physicians have complained that nutrition education in medical school is woefully lacking. While recent data suggests that all medical schools now claim to cover some nutrition content, many medical students still report receiving less than two hours across all four years of medical school. That model may have served us in the 1960s when the AMA first identified the need for more nutrition education, but poor nutrition is now estimated to cost the United States more $1.1 trillion in health care spending annually.
This explosion in spending, paired with a shift in patient and...
When the Illness Ends, But the Symptoms Don’t
When an illness strikes, most patients and doctors have the same expectation: treat it, recover, and return to normal. But that’s not always what happens. If you know or care about someone who never quite recovered from an illness—or if it’s you—this will sound familiar. Pain that lingers. Disturbed sleep. Constant fatigue. Persistent brain fog. The constellation of symptoms can take hold for months, years, or even decades.
Invisible, complex conditions like fibromyalgia, chronic fatigue syndrome (ME/CFS), and Long COVID are increasingly understood...
Congress Should Remember the Children Before Cutting Research Funding
The halls of Congress are currently weighing the future of biomedical research funding. As that debate unfolds, one question deserves more scrutiny than it is getting: what happens to rare disease patients if we eliminate the research tools that make their treatments possible? And what happens to American scientific leadership if we regulate those tools out of existence while our chief geopolitical rival races to fill the void?
The push to ban or severely restrict animal testing has grown louder in recent years, and some of those arguments carry merit in narrow contexts. However, when...
A Giant Job: Trump's Crackdown on Medicare Fraud
American taxpayers and Medicare beneficiaries are victims of massive fraud.
The Government Accountability Office, a congressional watchdog agency, has recently estimated that taxpayers lost between $233 billion to $521 billion to fraudsters just between 2018 and 2022. Moreover, in 2025, congressional investigators reported that COVID-19 fraud in the unemployment insurance program alone amounted to $191 billion, and much attributable to transnational criminal organizations.
Fraudsters not only bilk taxpayers funding government programs, they also directly harm the patients...
Retatrutide and America’s New Bootlegger Economy
Americans once associated bootlegging with bathtub gin, counterfeit liquor, and criminal syndicates exploiting Prohibition-era loopholes. Eliot Ness built his reputation chasing criminal networks that profited by selling dangerous, unregulated alcohol to consumers who had no idea what was in the bottle. Nearly a century later, America faces a biotech version of the same racket — only today’s bootleggers wear wellness-brand hoodies, operate through anonymous peptide websites, telehealth-style storefronts, influencer-driven social media channels, and online marketplaces selling...
Awareness Is Just the Beginning
May is Vasculitis Awareness Month. For patients, their families, the physicians, and other clinicians who treat them, and the researchers who seek to find answers and cures, it is a time to step up and speak out about this condition and the toll it takes on more than 100,000 patients in the US. Vasculitis is complicated, it’s not just one condition, but rather a grouping of rare disorders. Vasculitis causes the immune system to attack healthy blood vessels, narrowing and weakening them and causing inflammation and even organ damage. Diagnosis can be difficult and delayed as symptoms can...
The Invisible Front: Bridging the Data Divide Against Biological Sabotage
President Trump has a long list of vital foreign policy challenges on his plate these days. His energy, time and focus are rightly dedicated to the crises that dominate the attention of world leaders and our international media.
There is, however, another dangerous threat to the United States, one that lurks below the surface: China’s ongoing and accelerating use of biological weapons that could lead to significant loss of life and major disruption to our way of life.
For decades, the United States has viewed biological threats through the lens of public health—a...
Oz Is Cracking Down on Waste, Fraud, and Abuse. Medicare Advantage Should Be Next.
Centers for Medicare & Medicaid Services Administrator Mehmet Oz has made reducing waste, fraud, and abuse a central focus of the Trump administration's healthcare agenda. No program needs it more than Medicare Advantage.
Medicare Advantage helps millions of seniors and people with disabilities find flexible health insurance plans that traditional Medicare can’t provide. But broken incentives in the program have allowed insurers to extract billions of taxpayer dollars in improper payments, with no corresponding improvement in care.
If U.S. Department of Health and Human...
