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Wednesday, April 16, 2025

UK Biobank responds to fears over Chinese access to NHS data

 Access to UK Biobank data by researchers based in China has sparked headlines in the UK about potential security concerns, but the risks have been overblown, according to the research organisation.

The concerns were first raised in The Guardian, which highlighted that one in five requests to access the data is from Chinese scientists, and comes as the medical records of half a million de-identified NHS patients are due to be integrated with the UK Biobank's repository of patient samples.

That has been held up as a key step in unlocking the power of the resource for medical research, but The Guardian said UK security service MI5 had warned that Chinese research teams may be instructed by intelligence agencies to "carry out work on their behalf."

Earlier this month, the UK government revealed a £600 million ($764 million) plan to create a centralised Health Data Research Service (HDRS) that will serve as a gatekeeper for researchers seeking access to anonymised NHS patient data – a move that has been welcomed by the biopharma industry.

Professor Sir Rory Collins, principal investigator and chief executive of UK Biobank, told The Guardian that all its 500,000 volunteers "have given explicit consent for researchers to study their de-identified health data, and many have emphasised the importance of their GP data being analysed."

The organisation is collecting only coded GP data about diagnoses, prescriptions, and referrals – never any confidential notes or letters – and removes all information that could identify individuals before sharing the data with vetted researchers.

It has previously maintained that adding GP data will "roughly double the cases of depression and dementia that can be identified, as well as allowing detection of less severe cases at an earlier stage."

One member of the UK Biobank's Participant Advisory Group (PAG), called Val, said: "As a participant of UK Biobank and member of the advisory group, I want our data to be available to scientists around the world. In order for the data to be productive, we need to allow access, and I am confident that UK Biobank has robust processes in place that ensures our data is secure and appropriately used and ultimately contributing to health improvements worldwide."

UK Biobank said that currently over 20,000 scientists in more than 60 countries are using its data for their research into health and disease.

Professor Sir John Hardy, group leader at the UK Dementia Research Institute at UCL, said: "Making data freely available is what drives progress and, as long as confidentiality is maintained, we should see this in that light."

He added: "It is unfortunate that US and Chinese researchers are the major users of [this] data, but this reflects the bureaucratic and financial hurdles facing UK researchers, which limited their effective access. That is what we need to change."

https://pharmaphorum.com/news/uk-biobank-responds-fears-over-chinese-access-nhs-data

Trump pledges drug price cuts – and action on 'pill penalty'

 President Donald Trump has signed an executive order aimed at lowering drug prices for Americans that includes a plan to do away with what the industry claims is a major flaw in the Biden era Inflation Reduction Act (IRA).

In his first term, Trump repeatedly slammed the high prices paid by American health systems and patients from medicines compared to other parts of the world, and mooted the notion of a system in which US prices would be set at the lowest available for a medicine overseas.

His latest order does not appear to go that far, but it does deliver a pledge to stop the pharma industry charging US patients "more than those in other countries for the exact same prescription drugs, often made in the exact same places."

Among the measures included in the plan are allowing US states to import medicines directly from countries with lower prices – which has raised fears of creating a vulnerability in the supply chain that could allow entry of counterfeit medicines and create shortages elsewhere – and changes to Medicare to improve its ability to provide higher-priced medicines to seniors.

The order also says the IRA – which introduced Medicare powers to negotiate drug prices with manufacturers – has a commendable goal, but is hamstrung by an "administratively complex and expensive regime" that will be simplified.

The administration intends to improve on the 22% in savings that the Biden administration achieved in the first round of negotiations, due to come into effect in 2026, according to a fact sheet distributed by the White House.

In one move that will please the drug industry, Trump has promised to do away with the detested 'pill penalty', a shorter window time for small-molecule drugs compared to biologics before they can become eligible for price negotiations – nine years versus 13 years, respectively.

That is a discrepancy that "threatens to distort innovation by pushing investment towards expensive biological products, which are often indicated to treat rarer diseases, and away from small molecule prescription drugs, which are generally cheaper and treat larger patient populations," according to the order.

Another element that will please pharma manufacturers is a re-evaluation of the role of middlemen like pharmacy benefit managers (PBMs) – whose activities are already under investigation by the Federal Trade Commission (FTC).

In January, the FTC issued a second report suggesting that PBMs' business processes "may inflate drug costs, squeeze independent pharmacies, and deprive Americans of affordable, accessible healthcare."

The order also includes provisions to clear a backlog of generic and biosimilar drug applications and further efforts to reduce the cost to uninsured and underinsured patients of essential medicines like insulin and epinephrine injectors.

https://pharmaphorum.com/news/trump-pledges-drug-price-cuts-and-action-pill-penalty

FDA clears first migraine DTx from Click Therapeutics

 Click Therapeutics' digital therapeutic (DTx) CT-132 has been approved by the FDA, becoming the first treatment of its type in the US for preventing attacks in people with episodic migraine.

The company said CT-132 can be prescribed for the preventive treatment of episodic migraine in patients 18 years of age and older and is intended for adjunctive use alongside drug-based treatments.

The approval is a boost for the DTx sector, which has seen a number of prescription therapies approved for marketing, but far fewer examples that have been commercially successful, in part because there is no dedicated, well-defined benefit category for these products in Medicare and Medicaid.

Some of the pioneers in the category – such as Pear Therapeutics and Better Therapeutics – were forced into administration after failing to build viable DTx businesses, while a wave of consolidation has also seen some players join forces to try to build stronger portfolios.

Click has participated in that M&A, picking up rights to Better's assets, including a prescription DTx in development for type 2 diabetes.

Its latest approval follows earlier green lights from the FDA for its Otsuka-partnered major depressive disorder (MDD) Rejoyn, and the AspyreRx app developed by Better, which was cleared in 2023.

It is based on the results of the 568-patient ReMMi-D trial, in which the mobile app achieved a statistically significant reduction in monthly migraine days after 12 weeks of treatment compared to a sham app when given on top of standard drug therapy such as triptans.

In the study, Click's DTx reduced the number of migraine days in a month by around three, roughly one day more than the control. To put that into context, episodic migraine is characterised by headaches that occur on fewer than 15 days per month. Above that level, patients are considered to have chronic migraine.

Click has also completed a second, smaller bridging study, called ReMMiD-C, which looked at patients on the newer class of CGRP inhibitors, and supported its application to the FDA.

"This marks a significant milestone for the more than 37 million adults in the US who live with migraine," commented Shaheen Lakhan, Click's chief medical and scientific officer.

"As a groundbreaking digital therapeutic for migraine prevention, CT-132 offers eligible patients a new path to reducing the burden caused by migraine, one they can access anywhere via an evidence-based mobile application on their smartphone, significantly improving accessibility and expanding care to patients."

https://pharmaphorum.com/news/fda-clears-first-migraine-dtx-click-therapeutics

Merck Eyes Oral Peptide Delivery With Cyprumed Deal Worth up to $493M

 

Merck has not disclosed which of its peptide therapies it plans to develop oral formulations for.

Merck on Tuesday entered into a nonexclusive licensing and option pact with Austrian biotech Cyprumed in a bid to make its peptide drugs orally available.

Details of the deal were scant. Merck will pay up to $493 million, a sum inclusive of the upfront fee plus development, regulatory and commercialization milestones of any product that may arise from the partnership.

In exchange for its investment, Merck will gain access to Cyprumed’s proprietary platform to develop novel oral formulations of the pharma’s peptide therapies, though Merck is tight-lipped about specifics. The company did not reveal how many and which of its assets it plans to make orally available. The pharma also did not disclose priority indications.

According to Tuesday’s news release, Cyprumed’s platform can be used on several types of peptides, including GLP-1 analogs, mini-proteins and macrocycles.

Under the terms of the agreement, Merck will also have the exclusive option to license Cyprumed’s technology for individual targets, in which case Cyprumed will be eligible for additional payments. Merck will be responsible for trialing these oral drug formulations and will take charge of their manufacturing and marketing.

According to its pipeline page, Merck has two peptide therapies in development: the late-stage enlicitide decanoate, being studied for high cholesterol, and the Phase II efinopegdutide, a dual agonist of GLP-1 and GIP receptors, to treat metabolic dysfunction-associated steatohepatitis (MASH).

Enlicitide decanoate, which blocks PCSK9, is already orally available. The pharma has five listed studies running for the asset under the CORALreef program. Merck is developing enlicitide decanoate in partnership with UCB Pharmaceuticals.

Meanwhile, efinopegdutide is delivered via a subcutaneous injection. Currently, Merck has four listed studies for the asset, including one that directly compares it with Novo Nordisk’s semaglutide, looking at the drugs’ ability to lower liver fat levels in patients with MASH.

Both the Cyprumed deal and the decision to study efinopegdutide in an obesity-adjacent indication fits with Merck’s strategy in the weight loss arena. At the 45th Goldman Sachs Healthcare Conference in June 2024, CEO Robert Davis said that the pharma will focus its R&D efforts on orals rather than injectables, and that it will prioritize drugs that deliver cardiometabolic benefits in addition to weight reduction.

“I think everything is couched in terms of obesity first,” Davis said at the time, noting that pharma then considers other health outcomes for “supporting the reimbursement within the broader obesity space.”

https://www.biospace.com/deals/merck-eyes-oral-peptide-delivery-with-cyprumed-deal-worth-up-to-493m

Trump emergency order will expedite permitting process for Enbridge Line 5 tunnel

 

  • The U.S. Army Corps of Engineers Detroit District said the proposed Line 5 oil and gas pipeline tunnel project under the Straits of Mackinac environmental review will be expedited.
  • Enbridge and the state of Michigan have sued each other over Whitmer's move to revoke the company's underwater easement.

The U.S. Army Corps of Engineers Detroit District, heeding an emergency order from President Donald Trump to expedite the review process for energy supply projects, will accelerate its permitting process for a proposed tunnel for an oil and gas pipeline under the Straits of Mackinac lake bottom.

The move on the Line 5 tunnel proposed by Canadian petroleum transport giant Enbridge drew immediate rebuke from environmental groups, who called it an unwise bypass of necessary reviews to protect the Great Lakes and the communities and economy built around them.

"Building a tunnel under the Great Lakes to house an outdated and dangerous pipeline is risky. Expediting that process is reckless," said Beth Wallace, climate and energy director for the nonprofit National Wildlife Federation. "The permitting processes exist for a reason. We cannot afford to bypass safety in order to line the pockets of a foreign oil company."

Built in 1953, Enbridge's Line 5 moves 23 million gallons of oil and natural gas liquids per day east through the Upper Peninsula, splitting into twin underwater pipelines on the Straits of Mackinac bottom, before returning to a single transmission pipeline through the Lower Peninsula that runs south to Sarnia, Ontario. Many have expressed concern about the aging pipes over several years, as anchor strikesmissing pipeline supports and loss of protective pipeline coating have been discovered.

An image from underwater inspections of Line 5 in the Straits of Mackinac shows an area of missing protective coating and exposed steel. State officials are concerned, because it appears this damage was caused during the installation of anchor supports for the pipeline, without any repair or reporting of the coating damage.

A 30-inch oil transmission line also owned by Enbridge ruptured in July 2010 in Marshall, spilling more than 1.1 million gallons of oil, fouling 38 miles of the Kalamazoo River and prompting a cleanup that took four years and more than $1 billion. Many fear a similar pipeline mishap on the Straits bottom, where Great Lakes Michigan and Huron meet, would be greatly more devastating.

Trump's order and the Line 5 timetable

Enbridge proposes to build a 21-foot diameter, 3.6-mile tunnel underneath the bed of the Straits of Mackinac to house a new, 30-inch diameter pipeline to move the oil and natural gas liquids. The tunnel pipeline would replace the twin pipes currently on the Straits bottom, Army Corps officials said.

On the first day upon resuming office, Trump on Jan. 20 signed an executive order declaring a national emergency, finding "the United States' insufficient energy production, transportation, refining and generation constitutes an unusual and extraordinary threat to our Nation's economy, national security and foreign policy." As part of the executive order, Trump called for federal agencies to "identify and use all relevant lawful emergency and other authorities available to them to expedite the completion of all authorized and appropriated infrastructure, energy, environmental and natural resources projects that are within the identified authority of each of the Secretaries to perform or to advance."

The environmental impact statement review process on the Line 5 tunnel project was begun by Army Corps in August 2022. On its website the Army Corps has posted that it expects to have a draft environmental impact statement out later this year, with a decision by early 2026. How that timeline has been impacted by Trump's emergency order was not immediately apparent.

Enbridge spokesman Ryan Duffy, in a statement, called the Line 5 tunnel project "critical energy infrastructure.""Enbridge submitted its permit applications to state and federal regulators five years ago — in April 2020 — for the Great Lakes Tunnel, a project designed to make a safe pipeline safer while also ensuring the continued safe, secure, and affordable delivery of essential energy to the Great Lakes region.

"In 2021 the State of Michigan issued its environmental permits for the tunnel project, and in 2023 the Michigan Public Service Commission approved placing the new pipeline segment in the tunnel as Line 5 crosses the Straits of Mackinac. However, the project still awaits action by the U.S. Army Corps of Engineers on an environmental impact statement and a permitting decision. Earlier this year, Enbridge re-applied for its state environmental permits which are set to expire in early 2026."

The nonprofit environmental organization Sierra Club are among the groups opposed to a review process speed-up on the Line 5 tunnel project.

"Fast-tracking the Line 5 tunnel puts us at risk for catastrophic damage. An oil spill would contaminate the water for tens of millions, cost billions of taxpayer dollars to clean up, and destroy Michigan fishing and tourism," said Sierra Club Michigan Chapter Director Elayne Coleman.

Gov. Gretchen Whitmer in November 2020 moved to revoke Enbridge's 1953 easement to utilize Straits of Mackinac bottomlands for Line 5, alleging that the company has failed to adhere to safety provisions required in the easement. Enbridge has defied the order, asserting that only the federal government has jurisdiction over such pipelines. The company and state have sued each other, with cases remaining pending in both federal and MIchigan courts.

Whitmer and Michigan's environmental regulatory agency, the Department of Environment, Great Lakes and Energy, must act to protect the state by denying the tunnel project a needed state clean water permit, said Sean McBrearty, campaign coordinator for Oil & Water Don’t Mix, a nonprofit coalition opposed to the Line 5 pipeline.

"We need full permitting for the Line 5 tunnel project, which means thoroughly vetting its environmental, economic, and social impacts," he said. "Anything short of that would be giving Enbridge — a corporation with a dangerous track record operating in Michigan — a blank check for a project that has no business getting built.” 

https://www.freep.com/story/news/local/michigan/2025/04/16/enbridge-line-5-straits-mackinac-oil-gas-pipeline-army-corps-trump/83095018007/

Trump Confronts Economic and Geopolitical Reality

 by Edward Ring

By the time this is published, everything may have changed, and that is to be expected. Throughout his career, well before and since becoming a politician, Trump has explicitly stated that he does not think it is always a good strategy to be predictable. And while markets love predictability, sometimes markets, and the systems propping them up, need disruption. This is such a moment.

Nobody should deny that the anxiety is genuine. An older friend of mine, well into his 70s, still working but ready to retire, is wondering how he and his wife will survive if their savings are wiped out. That’s true for all of us, but it begs the question: What if the painful restructuring we may be about to endure, and which may last for many years, is necessary to avoid an even worse fate?

Trump’s abrupt escalation of import tariffs goes well beyond violating the principles of comparative advantage, but we can start there. “Comparative advantage” is not all it’s cracked up to be. Repeated in business schools as if it were gospel since the 1980s, it goes something like this: “Wool is cheaper in Scotland, and wine is cheaper in France, so France should sell their wine to Scotland, and Scotland should sell their wool to France.” Everybody wins. Period. That’s the extent of it. That is the essence of free trade theory.

In the real world, though, policies that rely on “comparative advantage” doctrine as their moral justification have gotten pretty ugly. While overall economic growth may be maximized when every nation exports products that it produces most cost-effectively, the local impacts are not always benign. Nations that produce coffee at competitive global prices, for example, end up with valuable cropland converted from food production to coffee plantations. These coffee plantations are typically owned by multinational corporations that repatriate profits to low-tax nations elsewhere while buying off a small local elite that streamlines the regulatory environment. Meanwhile, the nation becomes dependent on imports for everything except coffee, and even the coffee ends up priced out of reach for the average citizen. Replace “coffee” with any specialty product, and all too often, the “gains of trade” translate on the ground into nations with seething, destitute populations dependent on accumulating debt and foreign aid.

These examples aren’t restricted to foreign nations, nor are they restricted to commodities. While American multinationals moved manufacturing overseas, in the process destroying millions of jobs and thousands of communities in America, it wasn’t just cheap wool, cheap wine, and dirt-cheap flat-screen TVs that were pouring into the country in exchange. We offshored our production of steel, our chip manufacturers, our pharmaceutical industry, and much more.

And even that devastation was tolerated for decades because its effects were mostly felt in what we now call rust belt states. Our service economy and tech sectors boomed, along with what was left of manufacturing, satiating a majority of the population that loved buying cheaper foreign imports. But this whole scheme could never go on forever. America’s trade deficit in 2024 was up to $918 billion, a new record. America’s cumulative trade deficit, nearly all of it incurred since 2000, is now estimated in excess of $17 trillion.

To balance the trade deficit, there is what economists call the “current account.” If dollars flow overseas for us to purchase foreign imports in excess of foreign nations spending dollars to purchase our exports, the surplus dollars are repatriated in the form of foreigners bidding up the prices for assets they purchase in America. A slight oversimplification would be that trade deficits equate to cheap flat screens and unaffordable homes. But there is another reason America has huge trade deficits. It floods the world with dollar-denominated transactions, and by permitting foreigners to buy American assets, we effectively collateralize our currency. And so long as America is for sale in this manner, that helps sustain the dollar as a hard currency.

That comes in handy. For 46 out of the last 50 years, Americans have logged federal budget deficits. So far, the dollar’s status as the dominant transaction and reserve currency of the world gives America’s federal government the ability to borrow money by selling Treasury Notes.

This is all well known and rehashed beyond the need to elaborate further. So, why are people acting like this was sustainable? How long can the global economic model rest on American trade deficits funding the military and industrial development of nations that, in some cases, aren’t even allies, with all of it balanced through foreign purchases of American assets? And how long will international demand for dollars finance federal budget deficits?

To understand why this had to come to a head, consider federal budget trends in recent years. In 2019, the last year of Trump’s first term, the federal budget was $4.4 trillion, with interest payments of $400 billion. For 2025, the first year of Trump’s current term, the projected federal budget is $7.0 trillion, with interest of just under $1.0 trillion.

What changed? While the COVID pandemic was used to justify massive infusions of stimulative federal cash into the economy, much of it probably necessary, why hasn’t spending been reduced since the pandemic’s impact has been over for at least two years? Are we supposed to just expect massive federal budget deficits year after year? Is it sustainable to log a federal budget deficit that has grown from an alarming $900 billion in 2019 to $1.9 trillion in 2025, more than twice as much?

A roughly accurate summary of the economic reality we confront is federal budget deficits of $2 trillion per year and trade deficits of $1 trillion per year. Trade deficits translate into growing foreign ownership of American assets. Federal budget deficits add up in the form of accumulating, interest-bearing national debt. In 2019, the interest payments on what at the time was $22 trillion in national debt had already reached $575 billion, at an average interest rate of 2.5 percent. By 2024, the national debt had skyrocketed to $35 trillion, an increase of $13 trillion in just six years. Interest payments in 2024 were $1.1 trillion, and the average interest rate had risen to 3.3 percent.

“Average” interest rate requires explanation. Ten-year treasury notes currently pay 4.4 percent. Interest rates have risen over the past few years. Imagine if that continues, and $35 trillion (or more) in treasury notes mature and are reinvested at 4.4 percent. That would raise the annual federal interest payment on the national debt to $1.5 trillion.

At what point does this become a crisis? And if we wait until there is another financial crisis, will we be able to borrow our way out of it again? No wonder Trump’s team is cutting bureaucracy and hoping to eliminate massive entitlements fraud. By every metric that matters, the size and obligations of the federal government have exploded in the last six years, and it can’t go on.

Which brings us to the geopolitical reality we must confront: the rise of China. No other nation has done more to finance the rapid industrialization of China than the United States. But now, the United States depends on China for critical minerals, electronic equipment, machinery, iron, steel, medical apparatus, organic chemicals, pharmaceuticals, and much more. Every year, the biggest percentage of our trade deficit is with China, over $300 billion in 2024. The Chinese invest this surplus in Treasury Notes but also use it to purchase strategic assets in the United States. And how has China treated us as we finance the meteoric rise of its economy?

Here is a transcript of comments made by noted investor and businessman Kevin O’Leary on CNN last week.

“I do business with China; they don’t play by the rules. They’ve been in the WTO for decades, and they have never abided by any of the rules they agreed to when they came in. They cheat, they steal, they steal IP, I can’t litigate in their courts, they take product, technology, they steal it, they manufacture it and sell it back here. This is not about tariffs anymore. Nobody has taken on China yet, not the Europeans, no administration, for decades. As someone who actually does business there, I’ve had enough. I speak for millions of Americans who have IP that has been stolen by the Chinese. I have nothing against the Chinese people, but the government cheats and steals and finally an administration that puts up and says, ‘enough.’”

O’Leary thinks Trump should impose 400 percent tariffs on China. Maybe that will get their attention. He also suggested that America, with what is still the biggest economy and biggest domestic market on earth, may not have this much economic leverage in the future. He’s right. Now is the time to exert economic pressure on China because a decade from now, it will be too late.

The Trump administration recognizes three realities that softer heads and wishful thinkers try to either deny or bury in nuance. (1) We are in a cold war with China, and if we don’t step up, we will lose. (2) We have hollowed out our manufacturing prowess, and that must change. Fast. (3) Federal spending is out of control; the trends are unprecedented and must be reversed.

This is the rest of the story. Tariffs are just the beginning salvos in a fight we can’t avoid any longer.

Back in 1986, Herbert Stein, an economist at the American Enterprise Institute, in reference to US federal debt, famously said, “If something can’t go on forever, it will stop.” That was 40 years ago, when America’s epic debt binge was still in its first decade. Since then, it has gone on and on, and as the numbers indicate, it has intensified in the last few years.

It will stop. The only question is when and how. One must forgive the anxiety that is triggered in so many because of our current administration’s attempts to confront the unsustainable. But for those calling themselves economists who now, with unwarranted certainty, decry Trump’s bold gamble as unnecessary or foolish, less charitable sentiments might be appropriate.

https://amgreatness.com/2025/04/16/trump-confronts-economic-and-geopolitical-reality/

Is DOGE Enough?

 President Trump’s Department of Government Efficiency is perhaps the most welcome wake-up call for the federal government—and its obscene spending habits—in decades. It is refreshing to see many overpaid, underworked, often-vacationing federal employees fretting about whether their cushy jobs will disappear, and to see at least one branch of the federal government working to rein in our massive deficit spending. All of this is long overdue.

Yet it remains to be seen whether DOGE will help jump-start a serious and sustained effort to restore fiscal sanity, or whether its high-profile efforts will wrongly convince Americans that enough has been done, and that we can stop worrying that the federal government is bankrupting the country. If the former happens, it will be an extraordinary and much-needed development; if the latter, it will provide further evidence that, as Lincoln warned us nearly two centuries ago, if our republic is to be destroyed, it will be destroyed from within.

There are already signs that DOGE might not be able to deliver as much as originally promised. 

Shortly before the election, Elon Musk said he thought it was possible to slice “at least $2 trillion” out of the current federal budget of roughly $7 trillion. Earlier this year, he said that “if we try for two trillion, we’ve got a good shot at getting one [trillion].” Last month, he told Fox News’s Bret Baier, “Our goal is to reduce the deficit by a trillion dollars,” or “to drop the federal spending from $7 trillion to $6 trillion.” If achieved, such a reduction might not be “the biggest revolution in government since the original revolution,” as Musk told Baier it might be, but it would still be a remarkable feat, cutting the deficit roughly in half. (Our national debt, however, would continue to rise, as the deficit—even if much lower—would add to our existing debt.)

DOGE’s prospects for success could hinge on how long Musk stays on the job. Recent reports suggest he might be leaving sooner rather than later. Trump reportedly told his cabinet members that Musk will be departing in a matter of weeks, which is consistent with reporting that he will leave “at the end of a 130-day stint as a special government employee” around the end of May. This would be a significant departure from what Musk told Fox Business host Larry Kudlow, who asked Musk on March 10, “You going to go another year?” and he replied, “Yeah, I think so.” White House Press Secretary Karoline Leavitt now vaguely says Musk will leave “when his incredible work at DOGE is complete.”

Without Musk, it’s hard to imagine DOGE sustaining the same momentum or hitting its lofty goal of cutting the federal deficit in half.

With or without Musk, however, there’s only so much DOGE can do. The branch of government on the other end of Pennsylvania Avenue—the one with the power of the purse—will eventually have to start doing its job. Congress has irresponsibly put so much federal spending on autopilot that we’re racking up historic deficits without legislators having to vote on most of that spending. 

Just how out of control is our autopilot spending? Consider that the Congressional Budget Office says that in Fiscal Year 2025, the federal government will collect $5.163 trillion in tax revenues and will spend $952 billion on net interest payments on the debt and $4.228 trillion on so-called “mandatory” outlays for a total of $5.180 trillion in autopilot spending—spending that Congress doesn’t control through the usual appropriations process. 

In other words, per the CBO, our autopilot spending alone will eat up all the revenues that the government collects this year, leaving it with a $17 billion shortfall. That’s a $17 billion deficit even before Congress votes to spend a single penny on such things as national parks, federal highways, or even national defense. So much for the Left’s claim that defense spending is fueling our deficits.

Nor are our deficits a result of the federal government’s having been too shy about taxing the American people. In real per capita dollars—which adjust both for inflation and for population growth—the federal government collected more than three and a half times as much money in 2021 as it did in 1947 (the first full fiscal year after World War II). It could have spent three times as much money per person—even in inflation-adjusted dollars—and still run a surplus. Instead, it spent nearly seven times as much. As should be clear to anyone not swimming in the federal swamp, our federal government has a massive spending problem.

Interest payments on the debt are now larger than our entire discretionary defense budget. So, if not for the profligate spending of prior generations, we could cover our defense costs with the money we now send to our creditors. Put another way, one out of every six dollars that Americans now pay in taxes essentially gets thrown into the trash—it goes to pay interest on the debt, not to buy anything. Americans would presumably like to have 17% of their tax bills back. By 2035, the CBO projects that 22% of Americans’ tax payments won’t go toward buying anything.

Most autopilot spending, however, doesn’t go toward interest payments on the debt. Most goes toward Social Security and, especially, federal health care programs like Medicare, Medicaid, and Obamacare. The former should be viewed very differently from the latter.

Social Security was designed with a dedicated revenue stream—Social Security payroll taxes—that has more than covered the program’s total costs over the past roughly 90 years. Yes, Social Security is expensive ($1.6 trillion this year), and it badly needs some relatively slight reforms—namely, slowly and incrementally raising the retirement age to reflect current demographic realities—to keep us from having to dip into general revenues to pay for it. But it’s not driving the deficit train.

Federal health care programs are the primary driver of our debt, as they are eating up huge and ever-increasing portions of our general tax revenues. This is because when President Lyndon Johnson spearheaded the passage of these Great Society programs and a Democratic Congress passed them into law, no one bothered to think much about how to pay for them. This is very different from Social Security. Indeed, only about one-third of Medicare’s costs are covered by Medicare payroll taxes, and none of Medicaid’s costs are covered through payroll taxes. This is why LBJ deserves the place of honor on the Mount Rushmore of debt.

Consider this stat (which my group, the American Main Street Initiative, highlighted in its Quick Hits): “The first year that Medicare spending visibly hit the books was 1967. From that point through 2020, Medicare and Medicaid cost a combined $17.8 trillion, while our combined federal deficits over that same span were $17.9 trillion. In essence, our deficit problem is a Medicare and Medicaid problem.”

As bad as that problem has been, however, it’s getting worse. In 1975, on the eve of the Bicentennial, we spent 7% of all federal tax revenues on Medicare and Medicaid combined. In 2025, on the eve of the Quarter-Millennial, we’re spending 31% of all federal tax revenues on just those two programs. By 2035, the CBO says we’ll be spending 35%—more than all discretionary spending combined, including all spending on defense, parks, highways, and everything else for which Congress appropriates funds through the usual budgetary process. 

In the face of these federal health care programs’ escalating costs, federal debt held by the public—the portion of the national debt that really matters, as it doesn’t involve the federal government merely borrowing money from itself—is now a whopping 14 times higher, even after adjusting for inflation, than it was in 1974. Lest anyone think that debt numbers can only go in one direction, that’s after we had cut our debt held by the public in half, in inflation-adjusted dollars, from the end of Fiscal Year 1946 to the end of FY 1974. We were halfway to being debt-free. Then Medicare and Medicaid really kicked in, and our debt skyrocketed.

With autopilot spending now eating up more than 100% of our tax revenues, and with federal health care programs consuming the largest share of that autopilot spending, we won’t be able to get a handle on our runaway deficit spending until we get serious about reforming those health care programs. As things stand now, our autopilot is set to fly the country into the ground.

Efforts to reform federal health care programs are politically impossible so long as both political parties aren’t serious about tackling the problem. In recent years, Republicans have been only marginally serious about addressing the deficit, and Democrats have been almost wholly unserious about doing so. This wasn’t the case as recently as 25 or 30 years ago. In the late 1990s, during the last period in which the federal government actually balanced its budget, both parties discussed serious, bipartisan reforms to these programs. Such efforts generally involved some form of “premium support,” which would use private competition to keep public costs down. But as Politico reports, these efforts were largely derailed when President Clinton opposed them in an effort to shore up his left flank in the wake of his tryst with White House intern Monica Lewinsky.

To turn the debt battleship around, we need to revisit that late 1990s playbook.

The need to get our deficits and debt under control is obvious and pressing. As recently as 2008, when Barack Obama and Joe Biden were running as a ticket for the White House, the largest inflation-adjusted deficits on record were—as one would expect—those we ran up during the three full fiscal years of World War II (1943, 1944, and 1945; the Japanese bombed Pearl Harbor after FY 1942 was already underway). Those WWII deficits now rank 14th, 15th, and 16th on the all-time list—and they’ll fall another spot once FY 2025 is finished. That’s right—we now run higher annual deficits on a routine basis, even after adjusting for inflation, than we did while fighting a two-front world war. 

This year’s deficit will more than double our highest deficit during WWII, and our deficits in 2020 and 2021 each more than quadrupled our highest WWII deficit—in fact, each surpassed our total deficit spending for the entire war. All of this is even after adjusting for inflation.

For those who prefer to look at debt as a percentage of the Gross Domestic Product—even though that partially masks the problem by only registering debt as increasing if it grows faster than the economy as a whole—the CBO writes of its projections over the next decade, “Debt held by the public rises each year,” “to 118 percent [of GDP] in 2035”—“surpassing its previous high of 106 percent of GDP in 1946” and reaching “an amount greater than at any point in the nation’s history.”

When Ross Perot ran for the presidency in 1992 and got 19% of the popular vote, largely by campaigning against profligate deficit spending under President George H.W. Bush, our national debt was $4 trillion. Thirty years later, it eclipsed $30 trillion. If it continues to rise at the same rate over the subsequent 60 years as it did during those 30, it will increase more than 50-fold and surpass $1.5 quadrillion. That’s how bad our deficit trajectory is—it can only be captured by using what sounds like a made-up number. (A quadrillion is a thousand trillions.)

So, we need DOGE—and hopefully Musk will stay on the job—but we also need a lot more than DOGE. We need serious statesmen to emerge to prevent a fiscal calamity.

 is President of American Main Street Initiative, a think tank for everyday Americans, and was Director of the Bureau of Justice Statistics at the U.S. Department of Justice from 2017–2021.

https://americanmind.org/salvo/is-doge-enough/