When claims are made that one of the most widely used medications during pregnancy may cause autism, the public understandably pays attention. Scientists, healthcare professionals, and even judges, however, must ask: What does the evidence actually show?

That question is now before the U.S. Court of Appeals for the Second Circuit in New York.

The court is reviewing whether to revive more than 500 lawsuits brought by parents alleging that prenatal acetaminophen exposure caused their children’s autism or attention deficit hyperactivity disorder (ADHD).

In 2023, U.S. District Judge Denise Cote correctly excluded key expert testimony supporting those claims, concluding that they failed to meet the reliability requirements under Federal Rule of Evidence 702.

Rule 702 requires judges to ensure that expert testimony presented to juries is grounded in sufficient data, reliable methodology, and a sound application of those methods to the facts of the case. In other words, courts must act as gatekeepers to prevent speculative or methodologically unsound scientific claims from being treated as fact.

Now, plaintiffs are asking the appellate court to reverse that ruling.

The Second Circuit’s decision will test judges’ authority to prevent questionable scientific claims from reaching a jury before they satisfy established reliability standards.

This judicial gatekeeping role is essential. When expert opinions are admitted without rigorous scrutiny, litigation can amplify assumptions that have yet to meet the standards of the broader scientific community.

One reason the plaintiffs’ expert testimony was dismissed is the issue of confounding variables. Neurodevelopmental conditions such as autism and ADHD have strong genetic components. Disentangling whether a condition stems from a medication exposure or from shared familial and hereditary factors is extraordinarily complex.

None of this means the question should not continue to be studied. But when the vast majority of high-quality studies find no causation between prenatal acetaminophen use and neurodevelopmental conditions, careful gatekeeping must be exercised.

This case’s potential impact on public health makes gatekeeping even more important.

Acetaminophen is one of the most widely used medications in the world and remains the only generally recommended pain and fever reliever during pregnancy when used as directed. That guidance reflects decades of regulatory review and clinical experience.

Several studies have reported an increased likelihood of birth defects and other adverse outcomes from untreated maternal fever. Physicians routinely advise pregnant patients to treat significant fevers promptly because unmanaged fever itself can pose risks to fetal development.

If pregnant women avoid acetaminophen based on unproven claims, they may turn to alternatives such as ibuprofen or aspirin, which carry known risks later in pregnancy, including potential complications affecting fetal kidney development.

By upholding the gatekeeping responsibility of judges under Rule 702, the Second Circuit can reaffirm that scientific claims must meet established thresholds before being presented as reliable proof in court.

Dear Representative/Senator,

We appreciate your leadership in advancing President Trump’s agenda to reduce government spending and restore accountability by reining in bureaucracy and rooting out waste, fraud, abuse and mismanagement in Washington.

That work is essential, and as you move forward to build on your success for the remainder of the 119th Congress, there is a clear opportunity to deliver more meaningful results by eliminating the Center for Medicare and Medicaid Innovation (CMMI).

CMMI was created in the Affordable Care Act with a narrow mandate to test limited payment “models” for Medicare, Medicaid, and the Children’s Health Insurance Program that would reduce costs and improve care. The Congressional Budget Office originally projected that CMMI would save $2.8 billion between 2011 and 2020. Instead, it lost $5.4 billion during that period and is projected to lose another $1.3 billion by 2030.

A June 2021 report found that only four of 174 CMMI models sufficiently met the required standards of reduced spending or improved quality to be expanded across Medicare nationwide.   Common sense dictates that any federal program with such an abysmal rate of success should not be given any further opportunity to waste the taxpayers’ money.

Yet CMMI’s defenders argue the agency will eventually “get better.” Fifteen years of failure prove otherwise. No private enterprise with this record would be allowed to continue operating, let alone expand its authority.

Rather than correcting course, CMMI has expanded the scale, scope, and coerciveness of its models. They interfere with the decisions of doctors and patients about the best course of care, and override policy decisions made by Congress. They also disrupt care delivery and burden providers with administrative complexity and undermine patient choice.

CMMI has a guaranteed source of funding that gives unelected bureaucrats broad authority to make healthcare policy decisions without any obligation to succeed. The lack of accountability and transparency and disregard for outcomes are costly for taxpayers and dangerous for patients.

CMMI is a failure. It is time for Congress to shut it down.

Sincerely,

Tom Schatz
President
Council for Citizens Against Government Waste

James L. Martin
Founder and Chairman
60 Plus Association

Tim Chapman
President
Advancing American Freedom

Saulius Anuzis
President
American Association of Senior Citizens

Phil Kerpen
President
American Commitment

Dee Stewart
President & CEO
Americans for a Balanced Budget

Grover Norquist
President
Americans for Tax Reform

Rebecca Weber
CEO
Association of Mature American Citizens

Melissa Ortiz
Founder & Principal
Capability Consulting

Anthony Zagotta
President
Center for American Principles

Ryan Ellis
President
Center for a Free Economy

Jeff Mazzella
President
Center for Individual Freedom

Ginevra Joyce-Myers
Executive Director
Center for Innovation and Free Enterprise

Andrew Langer
Executive Director
Coalition Against Socialized Medicine

Bob Johnson
Senior Advisor
Commitment to Seniors

Jeremy Nighohossian
Senior Fellow & Economist
Competitive Enterprise Institute

James Edwards
Executive Director
Conservatives for Property Rights

Gerard Scimeca
Chairman
Consumer Action for a Strong Economy

Joel White
President
Council for Affordable Health Coverage

Eunie Smith
President
Eagle Forum of Alabama

George Landrith
President
Frontiers of Freedom

Beverly Gossage
President
HSA Benefits Consulting

Carol Davis
Chair
Illinois Conservative Union

Tom Giovanetti
President
Institute for Policy Innovation

Brian Balfour
Senior Vice President of Research
John Locke Foundation

Seton Motley
President
Less Government

Colin Hanna
President
Let Freedom Ring

Tim Jones
Former Speaker
Missouri House of Representatives
Founder
Leadership for America Institute

Pete Sepp
President
National Taxpayers Union

Tami L. Fitzgerald J.D.
Executive Director
NC Values Coalition

Sally C. Pipes
President & CEO
Pacific Research Institute

Drew White
Founder & CEO
Palisade Policy Group

Paul Gessing
President
Rio Grande Foundation

Trent England
Executive Director
Save Our States

Karen Kerrigan
President & CEO
Small Business & Entrepreneurship Council

Kerri Toloczko
Founder & Chair
Southwest Florida Center-Right Coalition

David Williams
President
Taxpayers Protection Alliance

Paul Teller
President
Teller Strategies

Bob Carlstrom
President
The Carlstrom Group

Kent Kaiser
Executive Director
Trade Alliance to Promote Prosperity

Steve Moore
Co-Founder
Unleash Prosperity Now

Kevin Riffe
Chairman
West Virginia Center-Right Coalition

When claims are made that one of the most widely used medications during pregnancy may cause autism, the public understandably pays attention. Scientists, healthcare professionals, and even judges, however, must ask: What does the evidence actually show?

That question is now before the U.S. Court of Appeals for the Second Circuit in New York.

The court is reviewing whether to revive more than 500 lawsuits brought by parents alleging that prenatal acetaminophen exposure caused their children’s autism or attention deficit hyperactivity disorder (ADHD).

In 2023, U.S. District Judge Denise Cote correctly excluded key expert testimony supporting those claims, concluding that they failed to meet the reliability requirements under Federal Rule of Evidence 702.

Rule 702 requires judges to ensure that expert testimony presented to juries is grounded in sufficient data, reliable methodology, and a sound application of those methods to the facts of the case. In other words, courts must act as gatekeepers to prevent speculative or methodologically unsound scientific claims from being treated as fact.

Now, plaintiffs are asking the appellate court to reverse that ruling.

The Second Circuit’s decision will test judges’ authority to prevent questionable scientific claims from reaching a jury before they satisfy established reliability standards.

This judicial gatekeeping role is essential. When expert opinions are admitted without rigorous scrutiny, litigation can amplify hypotheses that have yet to meet the standards of the broader scientific community.

One reason the plaintiffs’ expert testimony was dismissed is the issue of confounding variables. Neurodevelopmental conditions such as autism and ADHD have strong genetic components. Disentangling whether a condition stems from a medication exposure or from shared familial and hereditary factors is extraordinarily complex. Critics argue that some of the underlying acetaminophen studies from the plaintiffs’ witnesses did not sufficiently control for these inherited influences, raising the possibility that correlation was mistaken for causation.

Additionally, the expert analyses combined autism spectrum disorder and ADHD outcomes despite their distinct diagnostic criteria. Putting autism and ADHD into the same analysis can make a weak relationship look stronger on paper, even though the conditions aren’t the same so don’t necessarily have the same causes.

Many of the observational studies relied heavily on retrospective, self-reported medication use, sometimes years after pregnancy. Such designs introduce the potential for recall bias. In addition, large, well-controlled studies that have not found a causal relationship were not given comparable weight in the experts’ conclusions.

None of this means the question should not continue to be studied. But when the vast majority of high-quality studies find no causation between prenatal acetaminophen use and neurodevelopmental conditions, careful gatekeeping must be exercised.

This case’s potential impact on public health makes gatekeeping even more important.

Acetaminophen is one of the most widely used medications in the world and remains the only generally recommended pain and fever reliever during pregnancy when used as directed. That guidance reflects decades of regulatory review and clinical experience.

Several studies have reported an increased likelihood of birth defects and other adverse outcomes from untreated maternal fever. Sustained elevated maternal temperature is not benign. Physicians routinely advise pregnant patients to treat significant fevers promptly because unmanaged fever itself can pose risks to fetal development.

Discouraging acetaminophen use without causal evidence of autism is incredibly risky. If pregnant women avoid acetaminophen based on unproven claims, they may turn to alternatives such as ibuprofen or aspirin, which carry known risks later in pregnancy, including potential complications affecting fetal kidney development.

By upholding the gatekeeping responsibility of judges under Rule 702, the Second Circuit can reaffirm that scientific claims must meet established thresholds before being presented as reliable proof in court.

If those standards weaken, unproven claims could influence public behavior in ways that put mothers and babies at risk.

The Second Circuit now has an opportunity to reinforce a simple but essential principle. In both law and public health, scientific standards matter.

Running a small business is hard, and that’s especially true for doctors running private practices. Like any small business owners, they’re navigating payroll, expenses and overhead. Add on the bureaucratic red tape and chronic underpayments that come with billing Medicare and it’s a wonder that doctors have the time and resources to see patients at all.

If we want to improve the health of Americans and make it easier to access care, not harder, it’s time for Congress to prioritize protecting private practice. Instead, we’ve seen the government picking winners and losers. These market distortions only contribute to our nationwide healthcare shortage, and the problems in Texas are especially worrying.

According to the Texas Public Policy Foundation, a conservative think tank, the state “is projected to be short 10,330 doctors by 2032.” It estimates that more than six million Texans live in areas with shortages of health providers and notes that “37 counties lack a single primary care doctor.” Also: “To make matters worse, 15 percent of Texas’ primary care physicians are 65 years old or older and getting ready to retire.”

Part of the blame must rightly fall on Medicare’s flawed physician payment system — known as the Medicare Physician Fee Schedule, or MPFS. Unless addressed, the structural problems inherent in the fees that Medicare will pay could force local, independent community doctors to stop accepting Medicare patients or even go out of business altogether.

At the heart of the issue is the fact that Medicare drastically underpays independent physicians for the care they provide. According to data from the American Medical Association, payments to physicians through the MPFS have been on a slow and steady decline for decades. Since 2001, Medicare payments to physician practices have fallen by 33% (adjusted for inflation). By failing to tie physician payments to the inflation in the cost of running a practice, the federal Centers for Medicare and Medicaid Services is forcing smaller physician practices to do more with less.

As Medicare payments become increasingly inadequate to sustain independent physician practices, many are being forced to reduce their staff or the range of services they provide, turn away Medicare patients or exit the profession entirely. The other alternative is to accept a buyout from a large health system or hospital. But those tend to be farther away from home, feel less personal and charge patients and taxpayers more.

In any case, limited payment is driving physicians out of private practice en masse. In 2024, only 42% of physicians worked in the private setting, a nearly 20 percentage point decrease from 2012. With fewer options for care, the strain on existing physician practices and wait times for patients continue to grow. According to a recent survey, patients must wait an average of 31 days for a physician appointment in major metropolitan areas such as Dallas-Fort Worth and Houston. That’s an increase of 19% since 2022 and 48% since 2004. These long waits can undermine patient outcomes and lead to even worse health complications.

Congress must address these concerns and put the fee schedule back on a sustainable, stable path forward to strengthen and protect local physician practices as well as access to care for patients.

After five straight years of cuts, lawmakers recently approved a slight increase for doctors in 2026, but it doesn’t address the cuts physicians are facing this year. Nor does it ensure reimbursements in future years will adequately reflect the rising cost of care.

Moving forward, lawmakers must pass legislation that ties payments through the MPFS to inflation — as with other Medicare provider payment systems. By doing so, Congress can provide the support and resources physicians need to keep their doors open and continue serving their patients and communities. Fortunately, Texas Sen. John Cornyn recently said that he hopes doing so is “high on the agenda.”

With the clock ticking, Texas’ leaders in Washington should help level the playing field for physicians throughout the Lone Star State and across the country. The sooner they fix this broken Medicare payment system, the better off we will all be.

Washington has a lot of work to do on health care. The current battle on Obamacare subsidies is a stark reminder of that fact.

While that issue is divisive, there are opportunities to find consensus on health care such as protecting Medicare’s home health benefit, which is widely supported by Americans of all backgrounds and political persuasions.

As one of the most popular parts of Medicare, home health care allows patients to recover in the comfort and safety of their homes, typically after a hospitalization, or receive care to prevent hospitalization. This is good news for patients who don’t want to move to a nursing home or other institutional setting. And importantly, it eases pressure on crowded hospitals and saves the Medicare program (and taxpayers) money by delivering care in a cost-effective setting.

Despite the obvious fiscal, clinical, and human benefits of keeping people at home as they age, Medicare continues to cut funding for this highly valued program. Just last month, Medicare finalized another round of cuts to home health care in 2026.

Patients are already feeling the negative cascade from cuts to the program by the last Administration. By continuing to pull the rug out from under home health providers, fewer patients will be able to access the home health services they need, leading to worse outcomes for patients and virtually guaranteeing higher costs down the road. Fewer home health options mean more patients kept in hospitals, longer nursing home stays, and even more pressure on an already overburdened health system.

Patients who don’t receive home health care see 35% higher hospital readmissions and experience 43% higher mortality rates. That’s devastating for families, and costly for taxpayers. Every additional hospital admission or nursing home stay drives Medicare spending higher. Frankly, that’s a terrible deal for everyone involved, and it makes no sense when Washington is already staring down unsustainable deficits.

There’s another serious problem: years of funding cuts choke competition and push small businesses out of the market, with rural markets bearing the brunt of it. On top of stubbornly high inflation, Medicare cuts to home health threaten to force some home health providers to shut their doors altogether, adding to the more than 1,000 home health agency closures in recent years.

Texas shows exactly what’s at stake. More than 380 home health agencies in our state have closed since 2019. In that same period, over 233,000 Texas patients lost access to home health care. And nearly half of all patients referred for home health after a hospitalization never received it. That’s not because doctors don’t recommend home health care – it’s because there aren’t enough providers left to deliver it.

On top of this, the government’s own actuaries project that by 2027, nearly half of the remaining providers will be operating in the red. That’s a recipe for consolidation and collapse. Instead of encouraging a competitive, patient-driven marketplace, home health agency doors close, leaving some rural Texans and communities without any home-based care options at all.

The federal government should not be in the business of picking winners and losers in the healthcare marketplace.

While the Centers for Medicare & Medicaid Services has taken some steps recently to work with home health stakeholders to address steep cuts to the benefit, a long-term policy solution is needed to make home health sustainable for our aging society.

The bottom line is simple: families want their loved ones to age at home. And they want access to Medicare home health services to make that possible.

A Big Mac costs more in San Francisco than it does in Baton Rouge. And it costs more in Switzerland, but less in Mexico. 

Some prices vary from moment to moment. Your Uber ride could cost three different prices within the same hour, depending on demand. And of course, on any given flight passengers on the same flight may have paid a dozen different prices, depending on when they purchased.

Even a pint of strawberries might have different prices at the same grocery store, depending on the week or even the day that you shop.

This is called differential pricing, or dynamic pricing, and it’s how markets work to match customers with products and services based on supply and demand.

But when government steps in and tries to control pricing, market mechanisms get disrupted, supply and demand is set aside, both consumers and producers are harmed.

Americans generally pay more for name-brand prescription drugs (though NOT for generics) than those in other countries, but only partially because of differential pricing. It’s mostly because other governments exert price controls on drugs. The problem is not that Americans pay too much; it’s that other countries pay too little. They distort their prices, which causes distortions in our prices.

The solution to this is to insist that foreign countries bear more of their share of drug prices, and this can only be done through trade agreements. But of course, these days we’re into blowing up trade agreements, not strengthening them.

But instead of insisting that other countries pay a fair price for drugs, the Trump administration is advocating the opposite—importing foreign price controls to the U.S. The Trump administration doesn’t like importing underwear from Vietnam but loves the idea of importing Vietnam’s price controls on pharmaceuticals.

Specifically, the Trump administration is pushing Congress to include in its budget reconciliation package a provision that would limit the Medicaid reimbursement price to what other countries pay. They’re calling this MFN, or “Most Favored Nation” pricing, which is ironic, since the Trump administration decries the extension of Most Favored Nation status to China. You would think the acronym would be toxic.

Drug manufacturers already lose money due to the Medicaid reimbursement formula, but importing foreign price controls would squeeze them even further. In the current populist moment, putting the squeeze on drug manufacturers might feel good, and Congress might save a little money, but there are unseen costs.

A critical concept in market economics is “the seen versus the unseen.” It’s easy to see the supposed benefits of price controls, but they are short-term, and ignore the unseen impact of reduced investment, less innovation, and delayed or even forgone treatments and cures.

Implementing MFN for Medicaid drug reimbursement would be a long-term structural disaster in exchange for perceived short-term benefits. There are better ways to address our entitlements crisis, and Congress should pursue them.

Many critics of the U.S. health care system claim the tragic murder of UnitedHealthcare CEO Brian Thompson is understandable because health insurance companies occasionally refuse to cover certain medical treatments. And they often assert that if the country were to embrace a U.K. or Canadian-style government-run health care system, no one would be denied care. Those critics are either misinformed or intentionally trying to deceive the public, because government-run health care systems frequently delay or deny needed medical care. 

It’s true the U.S. health care system has many problems — problems made much worse by the Democrats’ Affordable Care Act (ObamaCare). The primary reason for our dysfunctional health care system is the convoluted economic incentives imposed on it. But that’s a topic for another day. 

The goal today is to demonstrate, by relying on stories from the media and professional organizations, that those preferred government-run health care systems have serious problems. 

Last February CNN reported, “Tens of thousands of nurses and nearly 12,000 ambulance workers went on strike Monday over pay and working conditions in the biggest walkout in the 75-year history of Britain’s National Health Service (NHS).” The story continues, “At the end of November, a record 7.2 million patients in England were waiting for non-urgent medical treatment. … This spans diagnostic tests and scans, procedures such as hip and knee replacements, but also cardiac surgery, cancer treatment and neurosurgery.” 

The New England Journal of Medicine (NEJM) reports that in May and June “junior doctors held 3- or 4-day strikes — and senior doctors have scheduled similar action.” But even before the strikes started, the NEJM says, “The Royal College of Emergency Medicine estimated in December that 300 to 500 people were dying each week because of these delays.” (Emphasis added.)

Important point: Care delayed is often care denied. 

What’s the reason for the strikes? “The primary contributor is long-term underinvestment in health services.” In a government-run system, the government sets the country’s health care budget. That budget competes with other valid claims on taxpayer money, such as defense, education and welfare. As a result, the health care system is always underfunded, affecting the availability and quality of care. 

For example, the NHS doesn’t provide certain prescription drugs widely available in the U.S. because it considers them too expensive. The BBC reports, “A 40-year-old woman who was denied a life-extending cancer drug because it is not available in Wales has died.” 

Interestingly, many U.K. patients are buying private health insurance and going to private doctors. CNN cites a website designer who “decided to take out private medical insurance after waiting nine months to see a specialist on the NHS.” It’s a growing trend. “Bupa a health insurer added 150,000 new UK health insurance customers in 2022, while rival VitalityHealth has seen a 20% rise in customers over the past year to more than 900,000.” 

So even as progressive U.S. politicians are saying we need to move to a government-run system to ensure universal coverage to quality care, many of those who are under the British system are fleeing it for private health insurance. 

Is Canada a more successful model? In Canada, patients must go through their general practitioner (GP) to see a specialist, and the wait times can be extensive. The Vancouver-based Fraser Institute has been tracking Canadian wait times for decades and just released its most recent report: “In 2024, physicians across Canada reported a median wait time of 30.0 weeks between a referral from a GP and receipt of treatment. Up from 27.7 in 2023. This is 222% longer than the 9.3 week wait Canadian patients could expect in 1993.” 

But at least once a patient sees a specialist, care is delivered quickly, right? “After seeing a specialist, Canadian patients waited 6.3 weeks longer than what physicians consider to be clinically reasonable (8.6 weeks).”  

What about diagnostic tests? “Patients also suffered considerable delays for diagnostic technology: 8.1 weeks for CT scans, 16.2 weeks for MRI scans, and 5.2 weeks for Ultrasound.” 

If a Canadian loses his general physician it can take months or even years to be accepted by a new one, which can mean no referrals to a specialist. That happened to a young Nova Scotia, Stage 3 cancer patient who, through tears, explained in a video appeal to Nova Scotia’s premier, “At 33, I am in menopause because when my tumour was a polyp I did not have access to a family doctor for two years and the ERs wouldn’t help me.” And she challenges the premier, “I dare you to take a meeting with me, and explain to me, and look into my eyes and tell me that there is no health-care crisis …” 

Progressives and media pundits are raising concerns that once in office President-elect Donald Trump will seek revenge against his critics and political opponents. But there are different kinds of revenge, and nominating Dr. Jay Bhattacharya to head the National Institutes of Health (NIH) is the right kind of revenge. 

The media have become almost obsessed with what they consider the potential for Trump retribution. Here’s a Politico reporter’s warning: “For years, Trump has peppered his speeches and social media posts with vengeful calls for his political opponents, his critics and members of the media to be prosecuted, locked up, deported and even executed. In the waning weeks of the 2024 campaign, he escalated those promises of retaliation to a fever pitch.” 

Do you think “deportations” and “executions” might be hyperbole? Trump had plenty of critics his first term in office, and I can’t recall any of them being executed or deported — or even locked up. 

In fact, the only one who’s been politically prosecuted repeatedly by the Justice Department and state and city officials is … Trump. 

By nominating Bhattacharya to head the NIH, Trump is taking the high road to revenge: first, by naming an eminently qualified person to head the organization and, second, by replacing the arrogant, believe-our-science elitists running the government’s pandemic response with a person they regularly disparaged. 

Bhattacharya’s curriculum vitae (an academic term for resume) is impressive. He’s a Stanford University professor who is both a medical doctor and epidemiologist and has a Ph.D. in economics. His 27-page CV lists 152 peer-reviewed articles, 63 non-peer-reviewed articles, eight books and reports, and 15 book chapters. He has applied for and received multiple research grants from the NIH and knows that institution well. 

Perhaps most importantly, he and two other academics — Dr. Martin Kulldorff, then a professor of medicine at Harvard University, and Dr. Sunetra Gupta, an epidemiologist at Oxford University — coauthored the Great Barrington Declaration. Published on Oct. 4, 2020, the document challenged the COVID-19 pandemic guidance coming from the NIH and the Centers for Disease Control and Prevention (CDC). 

That document, which now has 940,000 signatures from medical and health policy experts from around the world, argued that Washington and state governments should have taken a less-restrictive approach to the pandemic. They claimed that government-imposed lock downs, forcing employees and children to “shelter in place” and ridiculing anyone who disagreed was an ill-considered overreaction. 

The Declaration begins, “As infectious disease epidemiologists and public health scientists we have grave concerns about the damaging physical and mental health impacts of the prevailing COVID-19 policies, and recommend an approach we call Focused Protection.” 

Under Focused Protection, “The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk.” 

Questioning the official guidelines led to Bhattacharya’s life being “completely overturned.” He told the Wall Street Journal, “I couldn’t eat or sleep for months.” There were death threats and “some very, very nasty attacks.” Some of his colleagues stopped talking to him and even crossed the street to avoid him. 

But it turns out that the Declaration largely got it right, and even some of his harshest critics now grudgingly concede that mistakes were made. 

The good news is that Bhattacharya intends to bring important reforms to the NIH and its numerous centers and sub-agencies. He will take a different approach than Dr. Francis Collins, who was the former head of the NIH, and the self-assured, permit-no-dissent Dr. Anthony Fauci, who was the public face of the government’s response to the pandemic. That would be the man who once said those who questioned him were really criticizing science because “I represent science.” 

Indeed, it appears Bhattacharya will be the anti-Fauci, which is exactly what the agency — and the country — needs. 

It’s hard to overstate how much damage the NIH and CDC’s pandemic response has done to their credibility and the public’s trust. When anyone raised serious questions about the government’s responses, they were dismissed and demeaned as “science deniers.” That goes double for some Democratic politicians, including President Biden and then-House Speaker Nancy Pelosi (D-Calif.). 

As Bhattacharya observes, the public now sees “the scientific establishment as essentially an authoritarian power sitting over them, rather than as a force for good.”  

Bhattacharya intends to return to the scientific basics of open dialogue, innovation and verification.  

So, it’s remarkable that a widely distinguished and unquestionably qualified scientist who was branded as a scientific heretic will now lead, and reform, the institution that demeaned him and others. If this is the kind of “revenge” Trump has in mind, we need more of it.

You may be thinking, “When was health insurance in America ever great?” Point taken, but at least there was a time when health insurance was more affordable and individuals were better able to buy what they wanted, not what the government demanded. And the good news is Republicans can take steps toward getting us moving in that direction again. 

For 30 years Democrats have tried to make health insurance “affordable” — or even “free” if Sen. Bernie Sanders (I-Vt.) got his way — by expanding government control. Yet it has never been so expensive, costing about $24,000 for a family of four in 2023. 

The federal government had largely stayed out of the health insurance market until President Bill Clinton (D) tried to push through a massive restructuring of the health care system in 1993-1994. That effort failed, but Congress eventually passed the Health Insurance Portability and Accountability Act (HIPAA) of 1996, the State Children’s Health Insurance Program (SCHIP) in 1997, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the Affordable Care Act (ObamaCare) in 2010. While those laws had some good components, they greatly expanded the government’s role in, and the cost of, health insurance. 

The incoming Republicans almost certainly can’t repeal ObamaCare, but there are several steps they could implement that would improve health insurance options. 

Free up Association Health Plans. Efforts to allow trade associations to offer self-funded health insurance coverage, like large employers offer, finally succeeded in the Tax Cuts and Jobs Act of 2017. That change allowed associations to bypass some of the restrictions and mandates imposed on traditional health insurance. But giving individuals and organizations more control over their health insurance is not what Democrats want. So the Biden administration’s Department of Labor issued a rule imposing more restrictions on AHPs.  

The incoming Congress should reverse those restrictions and give AHPs maximum flexibility.   

Embrace large Health Savings Accounts. Health Savings Accounts (HSAs) allow employers or individuals to deposit money into a tax-free savings account that can be used to pay for small and routine health care expenditures. HSAs are combined with high-deductible health insurance — paid for by the employer if it’s a group plan — that covers the large expenses. Since the money in HSAs belongs to the individual, they provide an economic incentive for the individual to be a value-conscious shopper in the health care marketplace.  

Michael Cannon of the Cato Institute has promoted an expansion of the HSA concept: large HSAs. The employer could deposit the total amount the company is spending on an employee’s health coverage into an HSA, and the employee can then decide how to distribute that money: buying into the employer’s health plan or choosing an individual policy or purchasing no insurance at all. The idea is to give the money to the employee and let the individual decide how to spend it. 

Deregulate short-term health policies. The insurance industry has long offered short-term health policies — usually lasting three to six months — that were primarily intended to provide very basic coverage when a person or family is temporarily uninsured, like when changing jobs. 

These plans were intended to provide coverage for a major accident or illness, but not to cover routine care or regular expenses like prescriptions. The application process was quick and easy, and the plans didn’t cost much. But they also didn’t cover preexisting conditions.  

Once ObamaCare took effect, millions (including my wife) lost their individual coverage because their plans weren’t qualified under the new law. Many people shifted to short-term policies, which were more affordable. But Presidents Obama and Biden didn’t want people escaping their health insurance paradise and so imposed regulations to limit how long a person could have a short-term policy. 

Republicans need to permanently remove the short-term policy restrictions and give health insurers the flexibility to create policies that the public wants and needs. 

Repeal some of the ACA’s mandates. ObamaCare mandated insurance cover more health care services, making it more expensive. But not everyone wants or needs that additional coverage. A 60-year-old couple likely doesn’t need maternity care or birth control coverage. Teetotalers don’t need alcohol and drug-abuse counseling. Removing mandates frees up insurers to offer coverage that individuals, not the government, want. 

Let insurers underwrite policies again. Obama misled the country about insurers denying people coverage for a preexisting condition. Neither Medicare nor Medicaid nor employers could deny coverage based on a preexisting condition (though employees might have to wait a few months). The relatively small number of individuals with pre-existing conditions trying to buy their own coverage in the individual market could be denied coverage, but most states had a high-risk pool that would provide them with coverage options.  

Some high-risk pools worked better than others. So, any reform that incorporated them would need to include a “best practices” provision. But they were an effective safety net. 

Republicans probably can’t remake the health insurance system, but they can reform it by allowing insurers more freedom and giving consumers more choices. Republicans will get a lot of grief and handwringing from Democrats and the media for trying, but they may find that the public is ready for a change.  

Another “lame duck” political season is upon us.
 
This is the point where some try to shoehorn their pet bill into any available vehicle, while others are doing everything they can to stave off the passage of a bill they dread. But, in fact, usually nothing happens in a lame duck session except absolutely necessary omnibus funding bills or tax extenders, because legislators are more than ready to move on from current frustrations and try again next January.
 
This lame duck, however, there is a critical need to pass a fix to Medicare’s physician reimbursement system, since an automatic cut in payments to physicians takes effect January 1^st.
 
You might not have much sympathy for doctors taking a pay cut. But it’s Medicare patients, and the Medicare system itself, that face disaster if the automatic cuts aren’t addressed.
 
Doctors across the country are still recoiling from the 2024 round of Medicare physician pay cuts. As a result, many physician practices—particularly smaller, independent ones operating in rural and other underserved areas— face insurmountable financial challenges that make it more and more difficult to keep their doors open.

Problems within the Medicare physician payment system are not new. However, they have gotten worse in recent years as the Baby Boomers age. Policymakers must get to work to address longstanding issues that threaten to destabilize Medicare.
 
Unlike all other Medicare provider types, including hospitals, hospices, and skilled nursing centers, physicians are the only ones who do not receive annual, inflation-based Medicare payment updates. As a result, many independent physicians and smaller practices feel they have little choice but to limit the number of Medicare patients they serve, or to stop seeing Medicare patients altogether.
 
Long term, Congress needs to pass long-term reform of the Medicare Physician Fee System (MPFS) to help stabilize the system. But right now, in the next five weeks, Congress can begin the process by preventing a further automatic cut in MPFS payments on January 1^st.
 
Medicare is a flawed program, and IPI has lots of ideas on how to fix the system. But if we do nothing, pressure will build to replace it with Medicare for All or a similar socialized health care scheme. A growing number of seniors will need care in the future as Americans live longer and the Baby Boomer Generation continues to age. Lawmakers need to protect physician practices, and increase patient access, and help keep our entire healthcare system strong. Instead of ceding the issue to Big Government progressives who call for socialized medicine, our leaders in Washington must fix the broken MPFS to strengthen Medicare for years to come.

As President Joe Biden and Democratic presidential nominee Kamala Harris tour the country touting cuts in prescription drug prices, the real costs will be in cures never invented. And you can already see that trend not only in drug companies cutting back on new-medicine development, but also in employee downsizing and the decline of small biotech and life-science companies where many of tomorrow’s drugs are developed today.

The lifeblood of medical innovation is research and development (R&D) spending. Innovator pharmaceutical companies spend billions of dollars every year identifying, developing, testing and, hopefully, releasing potential cures. The vast majority of those drugs won’t make it through the U.S. Food and Drug Administration approval process. Those that do have greatly improved or saved countless lives. 

But the R&D process isn’t cheap, and the number of approved drugs can vary significantly by year. For example, the FDA approved 55 new drugs in 2023 (the second-highest annual number) but only 37 in 2022 and 50 in 2021. 

Most of those newly approved drugs were years, if not decades, in the making. And once they are released their patents may have only eight-to-10 years left before they are ripe for generic competition. 

While speakers at the Democratic National Convention tried to portray presidential nominee Kamala Harris as some type of cross between Perry Mason, Jack McCoy and Mother Teresa, the overriding theme at the convention and until the election is freedom. But don’t be fooled. Democratic strategists made it very clear months ago that they shifted to the freedom theme as a marketing strategy because it sells well.

As the Wall Street Journal’s Molly Ball reported last December, abortion rights advocates have “changed their message.” And the article’s subtitle explains why: “Supporters of abortion access have emphasized ‘freedom’ and ‘values’ in successful campaigns in red-leaning states, with more to come in 2024.” 

We saw the “more to come” at the convention, and we’ll hear it frequently until the election.  

Ball points out, “Abortion-rights activists rarely use the term ‘pro-choice’ anymore, preferring to talk about people’s ‘freedom to decide.’” We heard that message from several convention speakers.  

As one Democrat told Ball, “‘The messaging we were using wasn’t working, and we knew we had to get at deeper emotions, versus what people say they think.’” Democrats discovered the term freedom resonated with lots of people, especially with independents and seniors.   

Democratic pollster Angela Kuefler added that Democrats “can seize on the success of the ‘freedom’ message and tie it to other issues, such as Republicans’ attempts to limit books in school libraries or gender-reassignment treatments.” 

How do you know that Democrats are deceptively using the term freedom to sell their agenda? Because there are lots of fundamental freedoms they have no intention of allowing Americans to enjoy. Here’s some of them: 

Am I free not to have health insurance? Even though Barack Obama’s convention speech boasted of “every woman’s right to make her own health care decisions,” that doesn’t include decisions about health insurance. His Affordable Care Act (ObamaCare) mandated that everyone have health insurance, whether they wanted it or not. And not just any insurance, but the health insurance he and Democrats chose for us. Bill and Hillary Clinton also mandated health insurance coverage in their failed 1993-94 attempt at health insurance reform. 

Am I free not to be vaccinated? Not according to President Biden. “We’ve been patient. But our patience is wearing thin, and your refusal has cost all of us,” Biden announced at the White House in September of 2021. He mandated federal employees and contractors, the military, hospitals and employers (with 100 or more employees) get the COVID-19 vaccine — and he would have made it a universal mandate if he could.  

The issue here isn’t the safety and effectiveness of the vaccine; I got both shots and the initial boosters as soon as I could. The point is that Democrats repeatedly lecture the rest of us that people should be allowed to control their own health care — except, it turns out, when it comes to certain vaccines.  

Am I free not to drive an electric vehicle? Not if environmentalists and Green New Dealers have their way. The Environmental Protection Agency and several states are forcing carmakers to transition to electric-vehicle production, phasing out the production of new cars that use fossil fuels. As the Wall Street Journal editorialized last March, “auto makers will have no choice but to limit gas-powered, and increase EV, production to meet the EPA mandates. The only ‘choice’ Americans will have in the future is electric.” 

Am I free not to send my children to the public school of the government’s choosing? Not if Democrats take the White House and Congress. They have made their opposition to school vouchers, and even charter schools, very clear and, bowing to the teachers’ unions, would likely try to eliminate any type of school choice. 

Am I free to go to church or synagogue during a pandemic? Not if Democratic vice-presidential candidate Tim Walz is in charge. Even though the Minnesota governor told the convention, “In Minnesota, we respect our neighbors and their personal choices that they make,” Walz shut down houses of worship during the pandemic and kept them closed much longer than most states.  

Do I have the freedom, if I’m a young lady, to compete in sports only against biological females? Not in Walz’s world. When Minnesota Republicans introduced a bill that would ban transgender athletes from playing on sports teams matching their gender identity, as opposed to their biological sex, Walz threatened to veto it. 

Convention speakers waxed eloquent on the freedom theme. But it was mostly a marketing ploy. They know Americans revere their God-given and constitutional freedoms and want to preserve them. So, Democrats are couching everything they want to do in the guise of freedom. What they aren’t saying is how many long-cherished freedoms Americans will lose if Democrats take control. 

What are the economic policies being proposed by Vice President Kamala Harris, the Democratic presidential nominee? We don’t actually know what “Kamalanomics” looks like because the veep has been more focused on offering platitudes with attitude. Will Kamalanonics be similar to Bidenomics? Or is it just Bidenomics on steroids?  

So far, her campaign website has zero policy proposals, so that’s no help. But you can buy a Harris-Walz camo hat the media have been effusing over. Wait until someone tells the candidates that “camo” is short for camouflage, which is something typically worn by hunters and soldiers who carry…guns. 

Probably the best we can do at this point is drill down on her platitudes. 

Harris recently said at a campaign rally, “We fight for a future with affordable housing, affordable health care, affordable child care, paid leave.” So let’s start with those. 

Housing: Housing costs have risen significantly under the Biden-Harris administration. There are several factors behind those increases, including house prices, rising interest rates and insurance costs, property taxes, etc. Fortunately, a recent paper from Harvard University’s Joint Center for Housing Studies looked at monthly payments for a median-priced home, including taxes and insurance. It estimates the current monthly payment at $3,096. That’s down from about $3,300 in mid-2023, but significantly higher than $2,100 at the beginning of the Biden-Harris administration.

In short, all-in monthly housing costs have increased about 50 percent under Biden-Harris. No wonder the president and now Harris have started talking about addressing high housing costs. They realize it’s an election-year liability.

The way to lower housing costs is to reduce regulations, allow builders to charge a fair price that covers costs and makes a profit, and reduce interest rates (which the Federal Reserve Bank will likely do soon). But Harris would almost certainly do the opposite, increasing regulations and attempting to impose price controls, which would lead to fewer houses and higher prices. 

Health care: Virtually all progressives want a government-run, single-payer health care system. That includes Harris. 

She was quick to support Sen. Bernie Sanders’ (I-Vt.) “Medicare for All” bill when she was in the Senate, though that title is misleading. The bill does not put everyone in the federal Medicare program. Rather, the government takes over the health care system, raising taxes to pay for it. You would not be able to keep your employer-provided health insurance nor opt out of the government system. “Kamalacare” would likely be very similar.   

Now would be a good time to recall humorist P.J. O’Rourke’s famous observation, “If you think health care is expensive now, wait until you see what it costs when it’s free.” 

Before you decide on whether Kamalacare is a good idea, look at the challenges in the two countries most often pointed to as models for U.S. reform: England and Canada.  

Childcare: Progressives don’t want to reduce the cost of childcare. Rather, they want the private sector or government to pay for it. Indeed, the Biden-Harris CHIPS and Science Act requires companies taking government subsidies to “include child care plans that meet the Department of Commerce’s standards for affordable, accessible, reliable, high-quality care that is responsive to employees’ needs.”  

The way Harris would make childcare “affordable” is by having the government hand out even more money directly to families, or by attaching strings to corporate subsidies so that companies pay for it. 

Paid leave: What is it with progressives’ obsession with paying people not to work?  According to the Department of Labor, “Thirteen states and the District of Columbia have laws that create paid family and medical leave programs for eligible workers.” In addition, many employers provide paid leave. But Harris wants to create a new federal entitlement program. 

The Green New Deal: Harris fully embraces the Green New Deal, a massive social justice program disguised as a way to save the planet from greenhouse gases. As the New York Times explains, “Supporters of the Green New Deal also believe that change can’t just be a technological feat, and say it must also tackle poverty, income inequality and racial discrimination.”

But Biden-Harris, like Obama-Biden before them, have poured trillions of taxpayer dollars into their green dreams, and yet consumers are increasingly shunning electric vehicles and numerous subsidized green energy companies have either gone belly up or soon will. 

Fiscal Policy: Here’s one facet of Kamalanomics you can be sure of. She will increase federal spending at an even faster rate than Biden and try to pay for it with higher taxes. If you liked Biden’s  $8 trillion total in annual deficits and $35 trillion federal debt, you’ll love Harris. 

There are obviously many as-yet unannounced policy positions, and you can be sure they all will give the government much more control over our choices and our lives. But Harris will likely stick to unoffensive platitudes as long as voters, and especially the media, don’t demand specifics. 

President Joe Biden just announced his latest executive action to gain votes. He plans to allow certain undocumented immigrants who have been in the U.S. for at least 10 years and married to a U.S. citizen to receive temporary legal status, which will permit them to legally work. While there are economic benefits to allowing them to work legally, there are also costs. And one of those costs will be the expansion of Affordable Care Act (ObamaCare) subsidies for health insurance.

The White House explains: “Those who are approved after DHS’s Department of Homeland Security case-by-case assessment of their application will be afforded a three-year period to apply for permanent residency. They will be allowed to remain with their families in the United States and be eligible for work authorization for up to three years.”

The White House says this action will affect some 500,000 undocumented spouses of U.S. citizens and some 50,000 noncitizen children of the undocumented spouses. 

In general, illegal immigrants are not eligible for ObamaCare and its taxpayer-provided subsidies. However, “lawfully present noncitizens” and green-card holders are eligible (as are certain other classes of noncitizens). 

It is likely that the large majority of these families are in the middle- or lower-income brackets, so they will qualify for taxpayer-subsidized coverage. Under ObamaCare, households with annual income between 100 percent and 400 percent of the federal poverty level may qualify for a subsidy. For a family of two today, that’s income between $20,440 and $81,760. For a family or four, it’s between $31,200 and (amazingly) $124,800. Given that the median household income in the U.S. is about $75,000, you can see why the large majority of those affected by Biden’s executive order will qualify for a full or partial subsidy.

According to the Kaiser Family Foundation, in 2023 the government spent $90.4 billion on ObamaCare tax credits for 14.3 million enrollees, with the average monthly tax credit being $527 — or $6,324 per year. Thus, the upper limit of the annual cost of Biden’s scheme is about $3.5 billion (multiplying 550,000 by the annual average tax credit cost).

But wait! On May 3, Biden announced that about 100,000 immigrants who were brought to the U.S. as children — i.e., those in the Deferred Action for Childhood Arrivals, or “Dreamers” — will now be eligible to join ObamaCare and receive the subsidies. That’s an additional upper-limit expense of about $632.4 million. 

Call it a little more than $4 billion per year for the two executive orders combined.

But that’s the upper limit. It likely will be less. Some noncitizen spouses will have health coverage through their citizen spouses’ employer. Others may decline coverage if they don’t want, or can’t afford, to pay their share of the premium. And others, especially young healthy immigrants, just may not see the need for health insurance. 

But some of the newly eligible noncitizens may choose to go with family coverage if the citizen-spouse doesn’t have it. 

We can only make estimates of how much Biden’s two executive orders will cost taxpayers. There’s just too much we don’t know about the families involved and their preferences.

What we can say is Biden’s plan will make the federal budget deficit even bigger. As the Wall Street Journal points out, “CBO Congressional Budget Office projects that this year’s budget deficit will clock in at roughly $2 trillion, some $400 billion more than it forecast in February and $300 billion larger than last year’s deficit.” 

That missed forecast is not due to CBO’s bad estimating skills, but can be attributed to Biden’s additional spending.

The Journal adds, “CBO says deficits will stay nearly this high for years, and the total over the next decade is now expected to total $21.9 trillion ….” Incidentally, about $211 billion of that $400 billion increase is Biden’s newest student-loan forgiveness program.

The shame in Biden’s latest immigration ploy is that “Dreamers” and long-time undocumented spouses living in the U.S. are the most sympathetic of those residing in the country illegally. Congress needs to address the problem, but Washington is too broken to do anything about immigration or immigrants. 

Moreover, Biden’s decision to do something by executive order — rather than going through the constitutionally-prescribed process of negotiating with Congress and passing a law — will only exacerbate the current disfunction.

The White House and the Environmental Protection Agency (EPA) are denying that recent EPA regulations are meant to mandate that everyone switch from gas-powered to an electric vehicle (EV). Don’t you believe ’em. Progressive elites rely on the power of government to force you to do what they think you should be doing. In other words, autocrats gonna mandate. 

We’ve seen this movie before. Recall that the Affordable Care Act (ObamaCare) went into effect 10 years ago. One key component of ObamaCare that caused so much resentment was the mandate that everyone have health insurance. 

And not just any ‘ole insurance, but the insurance that President Obama and his fellow Democrats thought you should have. Millions of Americans who had very good, affordable health insurance they liked (including my wife) lost that coverage because progressive elites didn’t think it was good enough. Those who didn’t have ObamaCare-qualified coverage had to pay a penalty.  

Republicans eventually passed legislation that zeroed out the penalty, making the health insurance mandate moot. Yet the health insurance industry didn’t collapse. Yes, the cost of health insurance has risen significantly since 2014 — in contradiction to all the Democratic promises of how much cheaper it would be — but that’s in part because of all the coverage mandates imposed by ObamaCare. 

Or how about the COVID-19 vaccine? The vast majority of Americans lined up to get the vaccine as soon as it was available, with about 1 million a day being vaccinated when Joe Biden took office. But vaccine enthusiasm waned as boosters increased and time passed, so Biden imposed a vaccine mandate (or the taking of a weekly test) on government employees and contractors, the military, health care workers, nursing homes and private sector businesses with 100 or more employees — an estimated 84 million Americans. 

He would have mandated more but the U.S. Supreme Court stepped in. The court upheld the vaccine mandate for health care workers and nursing homes that receive Medicare or Medicaid funds, but struck down the mandate on businesses, asserting the government overstepped its authority — something the Biden administration does regularly. 

Now, Biden and his EPA are taking steps to mandate everyone driving an EV in the near future. Only this time, the administration is using what we might call a “back door mandate.”  

Biden has been handing out billions of taxpayer dollars to the car manufacturers to induce them to transition to EVs. And while they acquiesced, consumers didn’t get the memo. They still want gasoline-powered trucks and SUVs. 

So the EPA is progressively increasing restrictions on tailpipe emissions, in effect making it difficult or impossible for carmakers to make gasoline-powered vehicles that comply with government restrictions. Thus, the government isn’t mandating you have an EV, it’s just making it nearly impossible for you to buy anything else. 

The justification for the EV mandate is similar to that behind the vaccine mandate: The enthusiasm for EVs has waned. Car dealers can’t sell them, so the manufacturers are dropping the prices. Hertz recently dramatically cut its inventory of EV rental cars because no one wanted them. 

Declining EV demand is a problem for Biden, progressives and environmentalists because — like health insurance and the COVID-19 vaccine — they think they know what’s best for you and the country. In their minds, saving the planet may require twisting some arms. 

It is a hallmark of the progressive mentality that if the public won’t do what progressives think best, they will use the power of government to force the public to do so. We saw it with ObamaCare, COVID-19 vaccines, EVs and many other issues — e.g., the mandated use of ethanol in gasoline. And they may be coming for your gas stove next.  

As Wall Street Journal columnist Kimberley Strassel recently wrote, “Today’s Democratic Party is entirely dedicated to the proposition that all Americans should be told how to live.” 

If they continue down that path, they should consider changing their name from Democrats to Autocrats. 

The Department of Justice recently announced that eBay has “agreed to pay $59 million and to enhance its compliance program to resolve allegations that it violated the Controlled Substances Act (CSA) in connection with thousands of pill presses and encapsulating machines that were sold through its website.” Those pill-press purchases are just one more sign that drug counterfeiting operations are on the rise, and consumers should be very aware of these dangerous scams.
 
The purchasers of the pill presses and encapsulating machines are almost certainly criminals who plan to produce counterfeit versions of prescription drugs currently on the market.
 
At least that’s what the DoJ thinks. “‘Through its website, eBay made it easy for individuals across the country to obtain the type of dangerous machines that are often used to make counterfeit pills. Our investigation revealed that some of these machines were even sold to individuals who were later convicted of drug related crimes,' said U.S. Attorney Nikolas P. Kerest for the District of Vermont."
 
Of course, one of the primary ingredients put into these counterfeit pills is fentanyl, which is wreaking havoc on so many lives these days. DEA Administrator Anne Milgram says, “Fentanyl—pressed into fake pills that look like real prescription medications—is killing Americans. Drug traffickers buy the tools to make fake pills, like pill presses, online.”
 
People buy these pills often persuaded they are the same drug being sold in U.S. pharmacies, only at a much lower price. And a bipartisan group of U.S. politicians has perpetuated this idea.
 
In the past, the fakes were produced by criminals, often operating in foreign countries such as China. The purchase of the pill presses through eBay implies more criminals are now operating domestically. Selling fake pills laced with fentanyl that look like brand-name drugs can be very profitable—and very deadly.
 
For decades the Institute for Policy Innovation has been warning about counterfeit and compromised drugs bought online.
 
When we highlighted the risks counterfeit drug sites posed, their defenders often replied “show me the bodies.” We said there were some and there would be more if the online fakes continued to appear. Today, there are, sadly, lots of dead bodies, and more coming.
 
And if an explosion of fake pills wasn’t bad enough, criminals are now producing fake injectable drugs, primarily the new weight-loss drugs Zepbound (Eli Lilly) and Wegovy (Novo Nordisk). Making large-molecule, injectable drugs is more complicated and more costly for legitimate manufacturers. And demand is outstripping supply, opening the door for criminals to sell to unsuspecting consumers.
 
Counterfeit drugs, whether pills or injectables, are dangerous. Consumers should always check with their doctor and rely only on legitimate, trusted sources.

Americans have long dreamed of a weight-loss drug that would help the pounds fall off. The good news is we now have those drugs. The bad news is the new drugs are in high demand, leading to short supplies. Plus, they can be expensive if insurance won’t cover them for weight loss. As a result, criminals are producing and selling counterfeit versions of the drugs that could have very serious side effects. 

No one should be surprised. Counterfeit prescription drugs are a decades-old problem. The fakes are usually produced in developing countries and sold online, claiming to be the same U.S. Food and Drug Administration (FDA)-approved drugs that you can buy at a U.S. pharmacy, only at a much lower cost. They may even claim to be coming from Canada. 

And it’s not just criminals making those assertions. A bipartisan group of politicians has made the same claims, even setting up state or municipal importation schemes to help patients buy prescription drugs, supposedly from Canada.

Virtually all of those schemes eventually failed, primarily for lack of use, though that hasn’t stopped new efforts. The importation failures are in part because the Affordable Care Act (ObamaCare), Medicare and Medicaid all have prescription drug coverage, so the allure of buying prescription drugs online from foreign sources has declined.  

But that’s changing with the growing demand for the new injectable weight-loss drugs: Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy. (Note: Lilly’s Mounjaro and Novo Nordisk’s Ozempic are approved only for diabetes, but have been prescribed off-label for weight loss.)

The FDA has seen a significant increase in trafficking of counterfeit versions of these weight-loss drugs and has begun seizing suspected counterfeits as well as counterfeit needles used to inject them. In January, the FDA published letters warning two online vendors to stop selling “unapproved versions” of the weight-loss drugs.

Drug manufacturers are also getting involved. Last October, Lilly announced it was suing 11 foreign-based online pharmacies to stop them from selling and distributing products supposedly having the active ingredients in Mounjaro. Reuters reports, “Lilly said testing of AustroPeptide’s an online pharmacy allegedly based in China product purporting to contain the Mounjaro main ingredient tirzepatide showed it actually was ‘nothing more than sugar alcohol.’” 

Lilly has also sued 10 U.S. medical spas, wellness centers and compounding pharmacies in several states that are selling products claiming to have the active ingredient.

In some cases, counterfeit drugs have little or none of the active ingredient. Indeed, they may contain chemicals that can harm the patient. In other cases, the drug may have been compromised by not keeping it refrigerated, putting it in an unsterile vile or bottle, or holding it long past its expiration date.

That’s why drug manufacturers and the FDA closely monitor a drug’s “chain of custody” to ensure it was made in an authorized facility and transported properly. When patients are harmed by fake drugs, they may blame, and maybe even sue, the manufacturer, even though the manufacturer had no role in making the counterfeit and warned against buying from unapproved sources. 

And it’s not just a U.S. problem. “In October, the European Medicines Agency warned injection pens ‘falsely’ labeled as diabetes medicine Ozempic had been found in the European Union and the U.K.” 

The World Health Organization (WHO) announced in January that “global shortages last year of popular diabetes medicines that are also used for weight loss, such as Novo Nordisk’s Ozempic, had been linked to rising reports of suspected counterfeits.” 

A further complicating factor: While millions may want the drugs for weight loss — Goldman Sachs analysts are predicting 15 million adult users by 2030 — diabetics will need the drugs, yet they are also facing shortages because of the increased demand.  

This fake-drug explosion could be a real threat to consumer safety. Patients need to take the FDA and WHO warnings seriously. I did a search for the drugs online and found websites claiming to have the drugs — even generic versions of the drug, which do not exist yet — for affordable prices. Some say you don’t need a prescription. They claim their “clinicians” are standing by to talk to you.  

Be sure you talk to your doctor before you take a chance on something that may be a counterfeit drug. And listen to Dr. Sajani Shah, chief of the Weight and Wellness Center at Tufts Medical Center in Boston: “You don’t know where you’re getting these medications — if you get them at all — how they’re being processed, if they’re sterilized, and you can become very sick,” said Shah. “You have to be really careful because things, especially that you inject into yourself, you could have a very detrimental effect on your health.”  

Last month, Children’s Hospital of Philadelphia experienced a measles outbreak when several unvaccinated children contracted the disease. The city’s public health department issued an alert on Jan. 4: “The City is working to identify everyone who may have been exposed, checking their vaccine status, warning them that they may have been exposed, and issuing quarantine and exclusion recommendations where necessary.”  

The alert explains the dangers children face: One in five unvaccinated people with measles is hospitalized. In addition, as many as one out of 20 children with measles gets pneumonia, and nearly one to three of every 1,000 children with measles will die from respiratory and neurologic complications. 

Dr. Paul Offit, director of the hospital’s Vaccine Education Center, told NBC News, “Measles is the most contagious of the vaccine-preventable diseases, so when you lower immunization rates, that’s the first disease to come back.”  

Sadly, immunization rates are declining, and the Biden administration deserves some of the blame.   

As pediatricians can attest, it’s getting harder to convince parents to vaccinate their kids against measles and other childhood diseases like mumps, polio and pertussis.  

Only 93 percent of kindergarteners had received an MMR (measles, mumps and rubella) vaccine in the 2021-2022 school year — below both the Centers for Disease Control and Prevention (CDC) target of 95 percent as well as the baseline of 94.7 percent for the last pre-pandemic school year. 

While states generally allow parents to exempt their children from recommended childhood vaccines — usually on religious grounds or for medical reasons — exemption requests have historically been extremely low.  

That’s changing. The CDC is reporting the highest U.S. exemption rate ever recorded. Even small immunization declines can lead to disease outbreaks.

A recent CDC report found that in 10 states (Alaska, Arizona, Hawaii, Idaho, Michigan, Nevada, North Dakota, Oregon, Utah and Wisconsin) more than 5 percent of children entering kindergarten were granted vaccine exemptions. In Idaho, the rate was 12 percent. “This is quite a jump,” the author of the CDC report, Ranee Seither, told NBC News. “Just three years ago, only two states had an exemption rate of more than 5%.”  

“It’s becoming much more challenging for me to convince people to get their kids vaccinated,” warns Dr. Jason Terk, a Texas pediatrician in an Association of American Medical Colleges article.“We will become reacquainted with some of these diseases that we thought were relegated to history.”  

While there has always been some level of vaccine skepticism, the remarkable success of many of the recommended vaccines in largely eliminating certain diseases, especially in children, tempered some of that skepticism. But COVID-19 changed all that.

Recall that six weeks before the 2020 presidential election, Joe Biden expressed his COVID-19 vaccine doubts, “I trust vaccines. I trust scientists. But I don’t trust Donald Trump. And at this point, the American people can’t, either.” The Associated Press reported, “Should they attack Trump’s vaccine claims too aggressively, Democrats risk further undermining public confidence in a possible lifesaving medicine while looking as though they are rooting against a potential cure.”  

Once Biden won the election, he and Democrats flipped. No longer was it the “Trump vaccine,” as the Biden administration shifted from skepticism to a vaccine mandate for businesses with 100 or more employees and later all federal employees, including the military.   

President Biden and other prominent politicians then oversold the benefits of the COVID vaccines. The president promised Americans “you’re not going to get Covid if you have these vaccinations” — a pledge that was patently untrue, given the nature of the virus and the emergence of breakthrough infections when he made the claim. Promises made, promises broken.  

Mandates and broken promises helped undermine public trust not just in the COVID shots, but of vaccines generally. Pew Research measured a significant jump in vaccine hesitancy across the political spectrum, as the share of Americans supporting MMR requirements for children decreased 12 percentage points from 2019 through 2023. Yet vaccines for early childhood diseases remain some of the safest and most effective medicines ever invented.  

Reasonable people can have questions about the COVID-19 vaccines, and be critical of the policies and often arrogant condescension of Dr. Anthony Fauci, and still support routine vaccines for children.   

For instance, Ben Shapiro, a major conservative voice, is highly skeptical of COVID-19 vaccines for children. And yet he believes in the efficacy of standard childhood vaccines. “I have kids who are 7, 5, and 1. I get the case for vaccinating — I’m extremely pro-vaccination generally,” he said on X (Twitter). 

American pediatricians have been using the MMR vaccine for more than 50 years. The measles-mumps-rubella vaccine was first combined in 1971, and a new combination that immunizes against chickenpox (varicella), called MMRV, first became available in 2005.  

The president deserves some of the blame for Americans’ increasing skepticism of vaccines. You can’t be a vaccine skeptic before an election and a vaccine hawk afterwards and not raise doubts among the public. Because of the administration’s flip-flops and overreach in combating COVID, we may be seeing needless outbreaks of several children’s diseases. 

America is experiencing the worst shortage of prescription medicines in nearly a decade. Patients and their physicians are struggling to obtain more than 300 drugs, mostly generics. 

Those fighting cancer are particularly at risk. In September, the White House sounded the alarm on widespread shortages of 15 cancer drugs, including three crucial generic chemotherapies. 

The shortfall has gotten so serious that President Biden just invoked a Cold War-era law called the Defense Production Act to bolster domestic drug manufacturing. The Biden administration will require certain U.S. manufacturers to ramp up production of essential drugs and medical products, beginning with materials for sterile injectable medicines.

In congressional hearings, some Washington lawmakers correctly identified the root cause of the problem -- namely, margins in the generic drug industry have dropped so low that many companies are pulling out. In May, Teva Pharmaceutical Industries, one of the world's largest makers of generic drugs, announced plans to shrink its generics business due to profitability concerns. Several generic manufacturers have gone belly-up in recent years.

As a result, half of generic drugs are now sourced from only one or two manufacturers. The slightest quality-control mishap, shipping delay, or demand surge can easily leave patients without the medicines they need. 

Unfortunately, drug shortages are likely to get much worse in the years ahead due to the actions of some of the very same legislators expressing concern about the current shortfall. 

Washington seems bound and determined to undermine the incentives that spur companies to develop and manufacture medicines -- not just generic ones, but novel treatments, too. Unless policymakers reverse course, patients can expect more trouble accessing lifesaving treatments. 

Consider just a few of the ongoing efforts to weaken the intellectual property protections that drug companies rely on to make investments in the medicines they bring to market.

President Biden just announced that he intends to upend a 40-year-old law, known as the Bayh-Dole Act, that promoted the collaboration of publicly funded university and medical school researchers and drug companies, and has led to some of the most innovative, life-saving drugs now on the market. If bureaucrats don't like the price of these drugs, they will take control of their patents. 

On the world stage, the Biden administration is contemplating a petition before the World Trade Organization that would render useless intellectual property protections for Covid-19 treatments. 

Meanwhile, Medicare officials have started implementing 2022's Inflation Reduction Act, which subjects certain brand-name medicines to price controls after they've been on the market just nine years -- regardless of how much time is left on those drugs' patent terms. That's a de facto attack on intellectual property protections. 

And speaking of price controls, both brand name drugs and generics are required by law to pay state Medicaid programs a rebate (read: kickback) based on a drug's Average Manufacturer Price. In addition, most states demand a "supplemental rebate" on top of the federal rebate, if the company wants the drug on the state's "Preferred Drug List," meaning the drugs most likely to be prescribed. All these efforts shrink profits, which can hit the already thin margins of generic drugs especially hard.

Together, these efforts undermine the core promise of IP protections -- that companies will have a limited time to earn a return on their inventions without others stealing the fruits of their labor. Such private property rights are enshrined in the Constitution and form the foundation of our modern economy. 

By undermining these property rights, policymakers are dramatically reducing the opportunity for companies to earn a return on their investments. 

Companies, like individuals, respond to economic incentives. If firms have little chance of earning a return on their investments, they won't make those investments in the first place. Less investment means fewer branded drugs and fewer generics. Drugs that are never invented never go generic.

Washington is alarmed, and rightly so, about shortages of generic drugs. Yet policymakers keep working to undermine the intellectual property protections and profit motive that drive drug development. Unless that changes, patients should expect more shortages in the years to come, and Washington will be the one to blame.

President Joe Biden is once again bypassing Congress’s constitutional check on executive power by unilaterally imposing a new provision to a 43-year-old law that has been debated and rejected numerous times.  

However, this time Biden’s scheme doesn’t just target the pharmaceutical industry, he’s threatening any and every industry, academic institution and researcher that receives even a whiff of federal funding.  

The bipartisan Patent and Trademark Act Amendments of 1980, also known as Bayh-Dole, allows universities, medical schools and research institutions to use federal funds for research to develop innovative technology and products. These institutions and inventors can then file patent applications, license their discoveries and try to generate revenue that can help cover the costs of university programs.   

But creating something of value in a university lab isn’t the same as manufacturing a product, pricing it and marketing it to the public. That’s why Bayh-Dole allows universities and research institutions to license their innovations to businesses that have the capital, manufacturing plants and marketing expertise to bring an innovation to market.  

The law has certainly benefited the prescription-drug industry, which has brought numerous, important drugs to market under Bayh-Dole. And researchers at universities and medical schools are working constantly to find the next life-saving drug. Drug companies often pay research institutions to license a discovery, and then invest hundreds of millions and even billions of dollars for the testing, clinical trials and manufacturing to bring the promising research to the public.   

But the drug industry is only one of many industries that have benefited from the law. The federal government provides research funds to a wide array of colleges and universities, research organizations and even private companies, focusing on health, energy, agriculture, science, technology and other areas. Think semiconductors, clean energy products such as batteries, gene-editing to improve drought-resistant crops, etc.  

But if a grant recipient has created an important new discovery or invention and, for some reason, hasn’t made a good-faith effort to bring it to market, Bayh-Dole permits the government to “march in,” seize the patent and license it to a company without the patent holder’s consent.  

These march-in rights are meant to ensure commercialization of a product. They were never meant to be a price-setting mechanism. Yet that’s exactly what Biden now wants to do.  

The White House “Fact Sheet” released on Dec. 7 states, “The Biden-Harris Administration believes taxpayer-funded drugs and other taxpayer-funded inventions should be available and affordable to the public.” (Emphasis added.) It’s that “other taxpayer-funded inventions” that should be a red flag to all researchers, universities and other research institutions.   

Bayh-Dole was intended to make inventions “available,” but “affordable” was never part of the deal. And that’s the part Biden hopes to change by executive fiat.  

While the prescription drug industry has been the one usually (though unsuccessfully so far) targeted for march-in rights, Biden has just opened the door to any and all taxpayer-funded research and innovation if bureaucrats don’t like the price.  

In short, there is no invention that receives — or has received — taxpayer funding, regardless of how miniscule the amount, that is safe from government takeover.   

Although the White House Fact Sheet and talking points imply that taxpayers are funding the lion’s share of the research that went into creating a new discovery or invention, taxpayer funding may represent only a fraction of the funds needed to develop, test and bring a new invention to market. Yet there is apparently no funding threshold below which the White House wouldn’t consider imposing march-in rights.  

In addition, special interests of all types would be lobbying bureaucrats and politicians, trying to convince them that products created under Bayh-Dole were unaffordable and should trigger the law’s march-in rights. We know that will happen because it has already happened several times with certain prescription drugs. The National Institutes of Health has denied those petitions because price considerations do not trigger march-in rights — at least, not yet. 

While the prescription drug industry and patients have a lot to lose if Biden’s price-control scheme is successful, they won’t be the only ones. Any research or invention, any patent, any college, university or other research institute that has any connection with taxpayer funding is threatened by Biden’s proposal. And that threat will have a huge negative impact on innovation.   

Who is going to invent if the government can come in, at the urging of special interest groups, and seize a patent just because the government doesn’t like the price? When the government goes marching in, innovation goes marching out.  

Donald Trump recently asserted on Truth Social “Obamacare sucks!!!” He’s right. The Affordable Care Act (ObamaCare) has failed to achieve any of President Barack Obama’s vaunted promises. Democrats know it, and yet they complain about the U.S. health care system’s problems and costs without ever acknowledging that’s ObamaCare. As we approach the law’s 10-year anniversary — it passed in 2010, but most insurance reforms started in 2014 — let’s revisit some of its failed promises. 

Perhaps Obama’s greatest whopper was “If you like your health care plan, you can keep it.” That claim by the president earned him Politifact’s 2013 “Lie of the Year.” Millions of Americans had individual (i.e., non-group) health coverage they liked, but lost it almost immediately — including my wife. Others after a year or two. And the reason was obvious. ObamaCare mandated new or expanded coverages that weren’t part of most individual health plans, so those plans weren’t qualified under the law’s mandate to have insurance. 

Did those mandates make health coverage more comprehensive? Yes, but they also made it much more expensive, which brings us to ObamaCare’s second major failure. 

Remember when Obama asserted that a family’s annual premium would drop by $2,500? In fact, you were lucky if your family premium went up by ONLY $2,500 over the next few years. Again, the reason was obvious. 

No one would believe a politician who claimed that new government-mandated regulations, features and amenities on new cars would lower car prices. The new features and amenities might be nice, they might even make a car safer, but they would increase a car’s cost. And that increase would price some people out of the market. 

The same is true of health insurance. Government insurance mandates come with a cost. And a lot of mandates come with a big cost. Recent news reports say employers will see their biggest premium increase in a decade in 2024, even after insurers have made multiple changes to their plans over the last decade to try and keep premiums down. 

We’ve all heard about “shrinkflation,” where companies during inflationary times reduce the size or amount of their products in an effort to minimize price increases. Health insurers did the same under ObamaCare. They raised deductibles significantly. They increased co-pays for doctors’ visits and prescription drugs. And many insurers shifted to co-insurance for expensive drugs, meaning the patient might pay hundreds of dollars out of pocket for a prescription that once cost a $25 or $50 co-pay. 

ObamaCare defenders might point to the low premiums paid by most individuals with coverage through the ObamaCare exchange. But that’s only because taxpayers, not the insured, are subsidizing most of their premium. 

Defenders might also claim the number of uninsured has dropped. Yes, but only because the law also greatly expanded Medicaid coverage for low-income individuals.

Medicaid covered 17.8 percent of the population in 2013, according to the Kaiser Family Foundation, but 21.2 percent in 2022. Employer coverage was about the same in both years.  

What about ObamaCare’s health insurance exchanges that were going to provide individuals buying their own coverage with lots of very affordable health plan options?  

In 2013, the year before ObamaCare’s health insurance exchanges began, 5.3 percent of the population bought individual (non-group) coverage, according to Kaiser. By 2022, it was 6.3 percent — a one percentage point increase. And the only reason the number is that high is taxpayers subsidize the coverage.  

The irony is that Democrats thought ObamaCare’s health insurance exchanges were the genius idea in the Affordable Care Act that would remake the health insurance system and move the country to near universal coverage. As of 2022, there were still some 26 million uninsured. 

ObamaCare imposed fewer tweaks on employer coverage, where nearly half the population gets its coverage. So it still functions reasonably well. But even there premiums have exploded, with the average family premium costing $24,000. And that’s the average, many employer plans cost much more. 

Democrats’ efforts to remake health insurance through ObamaCare has only made many of the problems worse. Insurance is much more expensive, millions lost coverage they wanted to keep, and millions are still uninsured. While Democrats, like Trump, regularly complain that the health insurance system sucks, they refuse to acknowledge that system is the ObamaCare law they praised and voted for. 

Americans are already unhappy with the cost of prescription drugs. They may get a whole lot unhappier when they learn of a new report detailing how some companies game the system at patients’ expense.

The nonpartisan Government Accountability Office (GAO) just released an investigation into the prescription drug industry. It shows just how much some Medicare insurance plans and pharmacy benefit managers (PBMs) are ripping off patients, leaving little doubt that it’s time for Congress to step in.

Nearly 50 million Medicare recipients are enrolled in Part D, a voluntary program in which private insurance companies provide beneficiaries with drug coverage. For some drugs, usually the more expensive ones, Part D plans may require patients to a coinsurance fee — a percentage of the cost of a medication — out of pocket. Most seniors believe their coinsurance is based on what the insurance company pays for drugs. It turns out that’s often not the case.

In fact, the GAO report found that as a group, Part D patients paid four times more than insurers for many drugs.

How is that possible? Insurance companies set coinsurance fees based on different “tiers” and a medication’s “list price”– i.e., the full, published cost of a drug. But, insurers may pay much less because PBM middlemen negotiate discounts and rebates from the drug manufacturers in exchange for favorable placement on formularies, which are the insurers’ lists of preferred medicines.

Consider a drug with a $400 monthly list price. After discounts and rebates, the insurer may pay just $50 for a one-month supply. Yet the insurer calculates the patient’s out-of-pocket share as a portion of the $400 list price, not the $50 the company actually pays. If the coinsurance were 20%, the patient would pay $80 at the pharmacy rather than $10 (i.e., 20% of $50).

Thus, the patient would pay the insurer $30 more than the insurer paid for the drug after discounts and rebates. And that’s over and above the Part D insurance premiums, which are supposed to be covering the insurer’s cost.

The GAO report says that in 2021, Medicare enrollees spent $21 billion on 79 of the 100 drugs receiving the most rebates. But after rebates and discounts, the health plans paid only $5.3 billion for those same medications.

It’s not clear how much of this profit the insurance company may kick back to the PBM because the industry is purposely opaque. The murkiness is made worse by the fact that three major health insurers — Aetna, Cigna, and UnitedHealthcare — or their parent companies own the three biggest PBMs — CVS Caremark, Express Scripts, and OptumRx, respectively. Together, they control nearly 80% of the U.S. market for prescription drugs.

To be sure, insurers and PBMs say they pass at least some of the discounts and rebate savings on to patients through slightly lower Part D premiums. Yet the current practices place the greatest financial burden on the Medicare recipients with the most medical needs, and may make the difference between whether or not a cash-strapped patient adheres to a regimen of lifesaving medication.

In effect, the sickest patients who require the costliest drug treatments are cross-subsidizing the premiums of healthier plan members who aren’t dependent on expensive drugs.

The new study also revealed the way the PBM system contributes to price inflation. Since a rebate is a portion of the list price, PBMs can bank bigger rebates from drug makers for newer, higher-priced drugs. Thus, there is an economic incentive for PBMs to design formularies that favor the more expensive medicines.

The report found that nearly a quarter of Part D plans cover rebate-paying, brand-name medications but omit some cheaper, clinically equivalent generic versions from their formularies. These practices not only restrict competition and patient choice, but pressure drug companies to keep prices higher so that they can afford to pay ever-higher rebates.

Ironically, the current system makes it appear that drug manufacturers are profiting from high drug prices when they often receive only a small portion of their list prices because of the discounts and rebates.

These practices probably won’t be fixed without legislation that realigns the economic incentives. One proposal, the Patients Before Middlemen Act, would mandate that PBMs receive flat, transparent service fees rather than compensation based on the cost of drugs.

It’s time to reform a system that costs patients, taxpayers, and the entire American health care system far more than it should. More transparency has a way of lowering costs for patients — and the country.

Pancreatic cancer takes a devastating toll on American families. It's the third most common cause of cancer death in the United States, despite not being among the 10 most frequently diagnosed. The five-year survival rate is just 12%. And for the more than half of patients who are diagnosed at stage 4, that prognosis is an even dimmer 3%.

In August, researchers at Kansas City University made a potential breakthrough that could change that. They developed a therapy that prevents tumor cells from replicating by targeting the non-cancerous cells surrounding them, and they have applied for research grants that would enable them to start clinical trials.

But that's just the beginning. For the drug to actually reach patients, the university will almost certainly need to partner with a pharmaceutical company that can turn its research into a full-fledged treatment, mass-produce it, and market it to the public. 

Unfortunately, that may never happen. 

That's because the Biden administration is considering whether to abuse a 43-year-old law, the Bayh-Dole Act, by unilaterally relicensing any patents on drugs developed at Kansas City University and other academic labs across the country if that research received any amount of federal funds. Such a move would permanently upend America's entire scientific research ecosystem and gravely imperil patients' access to life-saving medicines.

For most of the 20th century, the government retained the patent rights on any academic discoveries that benefited from federal grants, regardless of the amount of money. At one point, the government held nearly 30,000 patents, but fewer than 5% of those patents were licensed to firms for commercialization. As a result, thousands of life-changing discoveries gathered dust.

The bipartisan Bayh-Dole Act of 1980 fixed that stagnation by permitting universities and other research institutions to retain their patents and license them, even if government funds helped support the research. Proceeds from these licensing deals help fund the institutions that developed them.

Bayh-Dole is indisputably one of the greatest U.S. legislative success stories. The law has been responsible for nearly $2 trillion in additional U.S. economic output, supporting over 6 million jobs in the process. Over 15,000 innovative startup companies have launched thanks to Bayh-Dole and the public-private cooperation it encourages. 

Cancer patients, in particular, benefit enormously from these public-private partnerships. Among dozens of other revolutionary treatments, Bayh-Dole is responsible for the late-stage melanoma drug Yervoy, landmark leukemia therapy Gleevec, and T-cell drugs for colon cancer, breast cancer, and Hodgkin's lymphoma.

And Bayh-Dole protections don't stop with cancer treatments -- or even medical research. The same goes for high-definition television, search algorithms, and even Honeycrisp apples, along with many other non-medical discoveries.

Thanks to Bayh-Dole, universities can license their researchers' discoveries to private firms that have the resources and expertise to turn them into usable products. University researchers rarely have the know-how or desire to commercialize such discoveries themselves. 

However, if a university licenses a patent to a company, and then the company doesn't commercialize it, Bayh-Dole gives the federal government the right to "march in" and relicense the patent to a different company that will. But the system has worked so well that march-in rights have never been needed.

Even so, cynical activists have invented a new interpretation, and use, for the march-in provision. They claim the government can march in on already-commercialized drug patents and relicense them to other companies to make knockoff versions. Indeed, a recent petition urged the government to march in on the patents for Xtandi, a prostate cancer drug developed with federal support. 

In March, the National Institutes of Health rejected that petition, as it has all similar petitions in the past. In both Republican and Democratic administrations, federal agencies have agreed that Bayh-Dole does not give the government the power to revoke licenses for a commercialized product, just because critics don't like the price. 

The Biden administration is encouraging the activists, creating a working group that's weighing whether "different factors, including price" may influence march-in assessments. 

Such a drastic change could obliterate confidence in the Bayh-Dole system. Investors would be reluctant to back efforts to commercialize promising discoveries -- whether they're drugs or other technologies -- if government officials can effectively dictate the price on any resulting products. 

It's no exaggeration to say that a cure for cancer depends on strong patent protections. The Bayh-Dole system has worked remarkably well. Yet the Biden administration seeks to break what has never been broken.

There will be a number of unintended consequences as a result of President Joe Biden’s open-border policies. One of them will be a dramatic rise in the number of people without health insurance.
 
The number of uninsured was about 27.6 million in 2022. But with millions of undocumented immigrants entering the country—and no end in sight—they will vastly increase the number of uninsured, likely putting new strains on the health care system.
 
Census Bureau surveys of the uninsured do not consider immigration status. That’s why I use the phrase “the number of uninsured” rather than “uninsured Americans.” Estimates of the uninsured include everyone residing in the country whether legally or not.
 
Undocumented immigrants are not eligible for government health insurance programs such as Medicaid, the Children’s Health Insurance Plan (CHIP), or Obamacare subsidies. Most have little or no income, and it can take months or years to receive a work permit, if ever. Thus, they have few options to work in the regular economy, and very few if any purchase their own coverage.
 
According to the Kaiser Family Foundation, “As of 2021, there were 44.7 million immigrants residing in the U.S., including 20.8 million noncitizen immigrants and 23.9 million naturalized citizens.” Kaiser includes undocumented immigrants in its “noncitizen” category. Some of those undocumented immigrants may be eligible for coverage through, say, a documented family member with employer coverage. But most remain uninsured.
 
Enter the Biden border crisis.
 
U.S. Customs and Border Protection reports 2.7 million encounters with migrants in 2022 and 2.8 million encounters through last August. And that doesn’t include the hundreds of thousands of illegal migrants who avoided or evaded an encounter with CBP. So, we could easily be looking at 5 million to 6 million newly uninsured people in the country in the last two years.
 
In years past, those crossing the southern border were mostly younger, single men, often working in labor-intensive jobs—and so were generally healthy and needed little or no medical care.
 
CBP reports an increasing percentage of the recent migrants are families with children. Children and young mothers do need medical care. And since under federal law hospitals must treat uninsured individuals who show up at the emergency room, regardless of ability to pay, most of those increased health care costs will fall on the states or county public health systems.
 
As the number of uninsured rises, we will likely see progressive Democrats claim the existing health care system is failing and it is time for a government-run system that covers everyone. Ironically, it is their open-border policies that are creating the additional strain.

Remember when then-President Barack Obama—and echoed by virtually every elected Democrat and most of the mainstream media—promised that the Affordable Care Act (Obamacare) would fundamentally change the health insurance market, vastly increasing the number of insured Americans while dramatically lowering the cost of coverage? You likely won’t be surprised to learn that didn’t happen.
 
A new study from Daniel Cruz and Greg Fann of the Paragon Health Institute shows just how far short Obamacare has fallen from its lofty promises.

 
Let’s start with coverage. According to Paragon, “Federal spending on the ACA exchanges, totaling $60 billion in 2021, resulted in an increase of 1.6 million Americans covered under private insurance. Overall, employer coverage dropped by 1.3 million enrollees, and non-group coverage increased by 2.9 million enrollees.”
 
So non-group coverage (where individuals buy their own coverage) went up but employer coverage went down. The net increase in private coverage was 1.6 million.
 
But aren’t we told that the number of uninsured has dropped under the ACA? Yes, but that’s because the ACA expanded Medicaid eligibility. “Of the 19 million additional Americans with health coverage after the ACA was implemented, 17.4 million were covered under the newly eligible Medicaid expansion group,” according to Paragon. The 1.6 million difference (19M-17.4M) were those with private coverage mentioned above. CBO had projected an insured increase of 25 million Americans, with roughly half of them (about 12.5 million) receiving private coverage.
 
Now, as to affordability. If you are one of the relatively few—at least when compared to the Democrats’ and Congressional Budget Office’s predictions—who buy taxpayer-subsidized coverage through an Obamacare exchange, you likely have very affordable premiums.
 
“Affordable,” that is, to the insured, not taxpayers. “ACA exchange spending of $60 billion in 2021 cost taxpayers $36,798 per additional private insurance enrollee ($20,739 per additional non-group enrollee), more than triple CBO’s original projections of $10,538 and $6,850, respectively.”
 
Ironically, coverage is often not affordable to the insured either. According to the Kaiser Family Foundation, “This year the average individual annual deductibles in bronze, silver, and gold plans sold on HealthCare.gov are $7,481, $4,890, and $1,650, respectively.”
 
Nothing says affordable like a $7,500 or $4,900 per-person deductible.
 
It is true that millions of Americans have enrolled in Obamacare, receiving coverage they did not have before. It is also true that it has cost taxpayers far more and increased coverage by far fewer than Democrats promised.

And so it starts. President Joe Biden has released the list of the first 10 prescription drugs—available in the Medicare Part D and Medicare Advantage programs—targeted for price controls under the Inflation Reduction Act. But this is only the first step in Democrats’ decades-long effort to control the price of virtually everything—goods, services and labor. Except, of course, the price of big government.

You will be hearing a lot of Democratic chest-thumping over the next few weeks. For example, former Speaker of the House Nancy Pelosi said, “House Democrats have been in this fight for a long, long time. Our Inflation Reduction Act marks a monumental victory in this effort: at long last, Medicare now has the power to negotiate lower prices for prescription drugs.”

And most of the media will mindlessly echo her claim. But it isn’t a “negotiation,” and was never intended to be. Bureaucrats will decide what they think is a fair price for each targeted drug, with the number of drugs growing in future years. The drug company can come back with a counteroffer. There is a little back and forth, but the government eventually tells the drug company how much it will be allowed to charge.

But what if the drug company disagrees? Can it walk away? That’s what happens in actual negotiations. Here is how the Kaiser Family Foundation describes how the “negotiations” (read: price-control) process works: “If an agreement on the maximum fair price is not reached by August 1 2024, manufacturers may be subject to an excise tax, which will be administered by the IRS, as specified in the Inflation Reduction Act.”

So, what would that “excise tax” look like? Bloomberg Law explains: “Under the law, companies that decline to participate in the program or don’t comply with the maximum fair price ultimately set by Medicare will have to pay taxes that start at 65% of the US sales of a product. The fines would increase by 10% every quarter, with a maximum of 95%.”

In other words, if a drug company doesn’t accept the government’s set price, the company will have to pay taxes equal to 65 percent of U.S. sales of that drug. That is not 65 percent of profits, mind you—that’s 65 percent of all revenue the company receives from the sale of that drug. But it doesn’t stop there. The fine increases 10 percentage points every quarter until the government is taking 95 percent of all revenue from the drug.

So, a drug company’s options are to accept the government’s price or give the government 95 cents of every dollar of that drug’s sales. That’s not a negotiation, that’s extortion—or blackmail.

Several of the drug companies, as well as the Chamber of Commerce, are fighting back by filing suit in an effort to stop the process and let the courts weigh in. The six lawsuits that have been filed so far are arguing that these price controls violate the First, Fifth and Eighth Amendments to the Constitution.

The resolution will likely take some time and may well end up before the Supreme Court—where it is crucial that the justices slam the door shut on Biden’s and the Democrats’ price control efforts, because going after the drug companies is only the first step toward imposing price controls on products and services in the wider economy.

Their strategy has been to identify an industry that provides a widely used product and accuse the companies involved of price-gouging, then take every available opportunity to repeat the message. Enlist the media to provide a megaphone, which it will eagerly do. Then campaign on passing legislation that would stop the “greedy” companies from charging so much.

Drug companies are the current targets. But the same tactics have been used against oil and natural gas producers, health insurers, credit card companies and others. And they will be used again.

These efforts are not about achieving fair prices, and never have been. They are about having the government dictate prices to a wide range of companies and industries. They are about control, not competition, and using that control for their own benefit.

Once politicians and bureaucrats control prices, they can control the companies. The process goes like this: “What’s that, Mr. CEO, you don’t think I’m allowing you to charge enough for your product (or service)? You know, we have a committee meeting coming up. I sure hope one of my colleagues doesn’t propose lowering the set price even more. Incidentally, did I mention I am up for reelection and that I have a new political action committee?”

August 18, 2023

Dr. Lyric Jorgenson
Acting Associate Director for Science Policy
National Institutes of Health
Office of Science Policy
6705 Rockledge Dr. #750
Bethesda, MD 20817

Dear Director Jorgenson:

I appreciate the opportunity to comment on the importance of private sector investment in prescription drug research and development and its relationship to NIH funding. 

The Institute for Policy Innovation is a non-profit, non-partisan public policy “think tank” based in Irving, Texas, and founded in 1987 to research, develop and promote innovative and non-partisan solutions to today’s public policy problems. IPI is supported wholly by contributions from individuals, businesses and non-profit foundations. 

By way of background, I am a resident scholar with IPI. I am also a past president of the Health Economics Roundtable for the National Association for Business Economics, the largest trade association of business economists. And I currently serve as Chair of the Texas Advisory Committee to the U.S. Commission on Civil Rights. 

Comparing Federal Funding for Research and Development: The Pharmaceutical Industry vs. the Clean Energy Industry

There is a small but vocal and influential group of people who have increasingly pushed the narrative that most research and development funding for prescription drugs in the United States comes from the government. While the federal government does provide some funding, primarily for initial drug research—as well as medical devices and other health care-related research—the private sector pharmaceutical companies provide the lion’s share of R&D funding.

At a House Committee on Oversight and Reform meeting in January 2019, U.S. Representative Alexandria Ocasio-Cortez (D-NY) claimed, “the public is acting as early investor, putting tons of money into the development of drugs that then become privatized, and then they the public receive no return on the investment that they have made.” Similar assertions have been made by other progressive elected officials and think tanks.

It’s a strange argument given that this very week President Joe Biden toured the country boasting the one-year anniversary of the Inflation Reduction Act (IRA), which is pouring hundreds of billions of taxpayer dollars into funding basic research and development for various types of clean energy projects and products.

For example, Reuters reports, “While the biggest impacts will begin in 2024 and 2025, there have been more than 270 new clean energy projects announced since its the IRA passage, with investments totaling some $132 billion, according to a Bank of America analyst report.” And that’s just the beginning.

Goldman Sachs recently released a report claiming the real cost of the IRA over 10 years will be $1.2 trillion, more than three times the initial estimate of $391 billion. According to Goldman, its estimate includes “electric vehicles (difference: $379 billion), green energy manufacturing ($156 billion), renewable electricity production ($82 billion), energy efficiency ($42 billion), hydrogen ($36 billion), biofuels ($34 billion) and carbon capture ($31 billion).”

We should also mention $39 billion in taxpayer-provided funding for the semiconductor industry—which has many very profitable companies—provided in the CHIPS and Science Act, which passed last summer.

The president and other progressives refer to all of these taxpayer-provided subsidies as “investments.”

Countless for-profit companies, with many wealthy investors (and political donors), will benefit from these taxpayer-provided subsidies. Some of those companies may survive and reap hefty profits. Most will likely end up filing for bankruptcy, as the electric bus company Protera has recently done. And yet we never hear progressives complain that taxpayers may “receive no return on the investment that they have made” in clean energy.

While the government will use the subsidies to impose regulatory strings on the receiving companies, there is no indication yet that the government intends to impose price controls on the clean energy companies, as the White House proposes to do with prescription drugs.

In fact, the clean energy industry, with all of its branches, could not survive without massive government subsidies. The U.S. pharmaceutical industry has thrived for decades almost entirely on private sector funding. And the health of patients around the world has benefited from those investments.

How much has the pharmaceutical industry invested? About $1.1 trillion since 2000. But the funding pace is accelerating. While members of the Pharmaceutical Research and Manufacturers Association (PhRMA) invested $50.7 billion in R&D in 2010, that annual investment doubled to $102.3 billion by 2021.

Determining how much the National Institutes of Health (NIH) provides in basic research funding is complicated because money is fungible and can be used for a number of purposes that may or may not directly result in the discovery of a new molecule.

A 2019 study titled “Public sector financial support for late stage discovery of new drugs in the United States: cohort study” found, “Over the 10 year study period 2008-2017, the FDA approved 248 drugs containing one or more new molecular entities. Of these drugs, 48 (19%) had origins in publicly supported research and development and 14 (6%) originated in companies spun off from a publicly supported research program.”

A 2020 research paper titled “Public research funding and pharmaceutical prices: do Americans pay twice for drugs?” reviewed several studies, concluding:

“Detailed case studies reveal that public support has played at least some role in virtually all of the 26 most clinically and commercially significant drugs and drug classes approved over the past several decades. … But in a large majority of cases, the public sector’s contribution to new drugs has been in the form of early scientific findings, unrelated to current or potential applications. The public sector supported key basic research for 19 of the 26 ‘transformative’ drugs and drug classes cited above, contributed to the actual discovery of a new therapy in just 11, and could claim sole discovery credit in only four cases.”

So, yes, NIH funding plays a role in basic research, but it’s the innovator pharmaceutical companies that take a new molecule, or sometimes just a concept, and turn that into a product, guide it through the often very expensive clinical trials and time-consuming FDA approval process, manufacture the new drug, package, distribute and market it to health care providers and patients.

Of course, there are a number of factors that determine whether those drugs will actually make it to market. The Congressional Budget Office says, “Only about 12 percent of drugs entering clinical trials are ultimately approved for introduction by the FDA.”

No one reimburses the drug companies for the 88 percent of drugs entering clinical trials that don’t make it to market. And of those that do make it to market, only a handful are very profitable. But it is those very profitable drugs that cross-subsidize the ones that don’t make it to market. Yet it’s those profitable drugs that the government is targeting for price controls.

One more point. For the past two decades, the innovator drug companies have increasingly begun to target diseases that affect a relatively small percentage of the population—say, perhaps only 25,000 to 100,000 people—often referred to as “orphan drugs.” In those cases, the companies do not have the ability to spread the cost of creating those drugs over millions of patients. The smaller the patient population, the higher the cost, relatively speaking.

In conclusion, it is true the government funds some initial work in identifying new molecules and therapies. But that funding pales in comparison to the cost, time and effort it takes to bring a new drug to market. Most investigational drugs won’t make it. When that happens, it is the pharmaceutical industry and its investors who lose money, not taxpayers.

By contrast, the federal government is pouring hundreds of billions of taxpayer dollars into multiple clean energy projects. Most of those clean energy companies will fail. If a drug company were to fail, investors would lose their capital. When government-backed clean energy companies fail, taxpayer money is lost. If Rep. Ocasio-Cortez really wants to discover where “the public is acting as early investor,” but then “receive no return on the investment that they have made,” she should turn to the clean energy industry rather than the pharmaceutical industry.

Sincerely,

Merrill Matthews, Ph.D.
Resident Scholar
Institute for Policy Innovation

Bernie Sanders, call your office. It turns out government-run health care has some problems—a bunch of them.
 
Junior doctors in England’s National Health Service (NHS) recently went on strike for five days. Once they returned, senior doctors, who supervise the junior doctors and provide assistance and instruction when needed, went on strike for two days.
 
The strike, over low pay and working conditions, was widely supported. According to the BBC, 86 percent of the 20,000 senior doctors voted to strike over low pay, though emergency services and maternity services were excluded.
 
The Guardian also warns, “More than half a million appointments, operations and procedures have been postponed in England as a result of the wave of industrial unrest in the NHS.”
 
A statement from the British Medical Association (BMA) junior doctors committee said:
 
“With the 75th birthday of the NHS just days away, neglect of its workforce has left us with 7.4 million people on waiting lists for surgery and procedures, 8,500 unfilled doctors’ posts in hospitals, and doctors who can barely walk down the road without a foreign government tempting them to leave an NHS where they are paid £14 an hour for a country which will pay them properly.”
 
Those waiting lists aren’t a recent phenomenon.
 
This news clip from Sky News features an interview with a lady who laments the long waiting lists for patients who need medical care—a problem in the NHS for decades.
 
If you like waiting in lines, you will LOVE England’s government-run health care system.
 
While the U.S. health care system has its problems, at least there’s little chance health care in the United States will be taken over by the government, right?
 
Not so fast. With Medicare, Medicaid, the Veterans Administration and subsidies for the Affordable Care Act, the government already spends more than 50 cents of every dollar spent in health care.
 
Worse yet, medical students apparently think a government-run system would be much better.
 
Galen Institute President Grace-Marie Turner recently wrote about her experience speaking with U.S. medical students. After speaking to one group, she writes, “It would be an understatement to say they don’t accept the idea of a market-based system that would provide physician autonomy and patient choice. They see their futures as part of a single-payer, government-run health system.”
 
Even more concerning is this observation: “One student told me they have so far had nine hours of classes in how to use the proper pronouns with patients and colleagues, compared to only one hour of study on lung cancer.”
 
Your U.S. health care system of the future. Senator Sanders would be proud.