According to the Centers for Disease Control, as of March 18th, nearly 113 million Americans have received at least Covid-19 vaccination (two of the three available vaccines require two separate injections). The agency also reports that 12 percent of the US population is fully vaccinated and that about 2.4 million citizens are being vaccinated daily. 

But there is still room for improvement. Recent history suggests the fastest way to have more citizens vaccinated as quickly as possible is for the Food and Drug Administration to grant Emergency Use Authorization for more vaccines. The FDA granted EUA to Johnson & Johnson in late February, which significantly improved vaccine availability across much of the US.

Currently, there are three Covid-19 vaccines available in the US. Introducing a 4th produced by the drug producer AstraZeneca would be a welcomed addition. AstraZeneca’s vaccine boasts a similar effectiveness rate to Johnson & Johnson’s. It can also be stored at higher temperatures, making it easier to distribute to rural areas. 

However, a recent controversy surrounding the AstraZeneca vaccine could prevent it from reaching US patients.

According to various reports, 37 patients across Europe have reported experiencing pulmonary embolisms caused by blood clots after receiving the AstraZeneca vaccine. Blood clots are common and often easily treatable. However, large embolisms can serious or fatal not treated. 

Although nearly 17 million patients have received AstraZeneca’s vaccine with little evidence that it causes blood clotting, many countries across Europe have stopped administering it. Most recently, Sweden and Latvia joined Spain, Germany, France, and Italy in a rapidly expanding list of countries demanding more testing of the vaccine as a “precautionary measure.” 

The decision to halt vaccinations has many healthcare providers and public health experts frustrated. As physician and research fellow in Global Health at the University of Southampton Dr. Michael Head, states: 

“Halting a vaccine roll out during a pandemic has consequences. This results in delays in protecting people, and the potential for increased vaccine hesitancy, as a result of people who have seen the headlines and understandably become concerned. There are no signs yet of any data that really justify these decisions.” 

Sadly, such decisions are entirely predictable given the incentives government agencies, and other bureaucracies face to avoid (even slightly) risky choices. 

Unlike actors in the private sector who can profit handsomely from accurately assessing their actions’ risks and rewards, bureaucrats receive little reward for risk-taking. They could face considerable scrutiny for making mistakes. Consequently, government agencies tend to strongly overweigh the costs and under-appreciate the benefits when deciding whether to approve a vaccine or treatment option for patients.

This is even the case when approving a treatment could save many lives. As I’ve written in an article published in the Southern Economic Journal, after Moderna and Pfizer completed the vaccine EUA process, the FDA sought additional input from an advisory panel. The process delayed approving the vaccines for about two weeks, over which more than 30,000 Americans died from Covid-19. 

A similar event may be unfolding in Europe. As one BBC article reports, France and Poland are both re-enacting some lockdown measures after experiencing an increase in Covid-19 infections. Other European nations are experiencing a similar spike. If, as some speculate, these events serve a “cautionary tale for the United States,” our best course of action is to vaccinate as quickly as possible.

AstraZeneca has not formally submitted a EUA application to the FDA but was preparing to do so. Previously, many expected AstraZeneca’s vaccine to be available for US patients this April. However, with much of Europe demanding more testing before vaccinating its citizens, we can expect further delays and more lives lost. 

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While alarmingly high fatalities signify a time of immense suffering, recent developments suggest the worst of the pandemic may be behind us. Covid-19 fatalities, cases, and hospitalizations are decreasing. Many universities plan to offer more in-person instruction during this fall. Texas ended its lockdown and mask mandate. 

Some of these promising signs can be attributed to vaccination. According to the Wall Street Journal, over 100 million Americans have received at least one Covid-19 vaccine. Although the Pfizer and Moderna Covid-19 vaccines require two injections spaced two weeks apart, studies confirm that one injection provides effective immunity. Even as Covid-19 variants begin to appear across the US, t-cell tests confirm that the available vaccines can protect against mutations. 

While there are many reasons to be optimistic that the worst of the pandemic is behind us, there have also been several signs governmental powers granted during the pandemic may not return to pre-Covid levels. 

For example, Director of the US National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci announced that Americans may still need to wear face masks through the year 2022 and that CDC guidelines may not loosen by Independence Day despite drops in Covid-19 infections. More recently, Dr. Fauci urged Americans to “not get so fixated on this elusive number of herd immunity” even with millions of covid-19 vaccines administered daily. 

In another attempt to keep the economy stabilized during the pandemic, President Biden signed a $1.9 billion Covid-19 relief bill. However, as one Reason article notes, “Biden’s coronavirus relief package has almost nothing to do with the coronavirus.” The same article also notes much of the funding provided by the previous stimulus bill has not been spent. 

Some speculate a fourth Covid-19 relief bill may soon follow.

Federal agencies have also experienced an expansion of scope and authority stemming from the pandemic. Last October, the Department of Health and Human Services gained the authority to limit its agencies and operating divisions from enacting rules and regulations to slow down the approval of a Covid-19 vaccine. In another bizarre expansion of regulatory power, the Centers for Disease Control gained the authority to prevent residential evictions for non-payment of rent, “to prevent the further spread of Covid-19.”

These and other regulatory powers have little prospects of ever being retracted.

Unfortunately, powers granted to the government during a crisis are rarely revoked. In his pioneering book Crisis and Leviathan, economist and historian Robert Higgs explains the growth of government often displays a ratchet effect: expanding during a crisis but seldom returning to its pre-crisis level. Consequently, crises frequently expand the role and scope of government with little hope of containing it in the long run.

Pandemics and other public health crises are no exception to the ratchet effect. Writing last March as states began to shut down and the first Covid-19 spending bill was passed, Robert Higgs and Professor of Economics at George Mason University Don Boudreaux asked these hard-hitting questions:

“Will the quarantine of millions of people become a precedent? Will broad-scale distributions to the general population without a means test become an enduring public demand even when normal times return? Will the Fed’s exchange of trillions of dollars for rotten securities become a lasting feature of its monetary policy?”

Nearly a year later, we are getting our first glimpse of the answers. So far, history may be poised to repeat itself. 

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However, when the drugmakers conducted further analysis on a larger dataset, they found that aducanumab reversed Alzheimer’s symptoms in some patients. Other Alzheimer’s treatments can only (at best) delay symptoms.

After their discovery, Biogen and Eisai requested the FDA to allow aducanumab to continue in the approval process. Although the drugmakers’ method for demonstrating aducanumab’s effectiveness is unconventional, and was heavily scrutinized, the federal agency allowed the resumption of clinical testing. A year later, aducanumab received priority review authorization, making it eligible to advance through the approval process more quickly.

Many expected the drug to receive full approval by March 2021. Sadly, the pathbreaking treatment’s approval faces additional obstacles after an FDA panel voted not approve the drug. Citing “data inconsistencies,” the panel recommended additional efficacy testing, which will lengthen the approval process. Despite initially expediting aducanumab’s approval, the agency is now unlikely to decide until June at the earliest.

This three-month delay comes at a considerable cost to patients suffering from Alzeheimer’s. Every 65 seconds, someone in the United States develops this debilitating disease. With no known cure, Alzheimer’s causes an estimated 500,000 deaths per year. About 125,000 citizens will die from the disease during the three-month delay the FDA deferred making a decision on whether to approve aducanumab.

Before Covid-19, many medical researchers argued that Alzheimer’s disease was the next pandemic. Unless treatment and detection improve quickly, it still might be.

So, what can be done for the millions of Alzheimer’s patients waiting for the FDA to make its decision? One option is for the agency to issue Emergency Use Authorization for aducanumab.

EUAs allow drug producers and physicians to distribute unapproved treatments during public health emergencies. During the Covid-19 pandemic, EUA have been used extensively to provide treatment, testing, and vaccines to patients.

Given the alarming prevalence of Alzheimer’s disease and considerable absence of new treatments, why not grant patients the opportunity to prolong their lives like we have during the pandemic?

Although Alzeheimer’s and COVID-19 are vastly different diseases, the story of how remdesivir became the first FDA-approved drug to battle the latter is remarkably similar to the current aducanumab controversy.

Developed in 2014, remdesivir’s producer Gilead Sciences entered the drug into a randomized control experiment to help treat Ebola virus complications. Although remdesivir performed well during its pre-clinicals, it failed to meet efficacy standards set by the FDA. Fearing the drug would not be approved, Gilead Sciences removed it from the trial.

Two years later, clinical trials performed at the University of Alabama at Birmingham, Vanderbilt University, and the University of North Carolina found remdesivir provide successful treatment for SARS and MERS patients (both are caused by viruses are similar to the one causing Covid-19). But the FDA prevented remdesivir from advancing in the approval process because those conducting the clinical trials could not enlist enough patients the agency deemed necessary to complete the studies.

When Covid-19 spread to the United States in late January 2020, healthcare providers began requesting remdesivir as a last-resort treatment. It was just what the doctor ordered. The twice-rejected drug helped patients recover faster and stave off pneumonia and respiratory infections in severe Covid-19 cases.

By May 2020, as Covid-19 cases and deaths expanded rapidly across the country, the FDA granted remdesivir an EUA to treat severe cases. Shortly afterward, the U.S. government purchased nearly 500,000 doses (at the time, all of the world’s supply) of remdesivir to distribute across the country.

By November 2020, the FDA had fully approved remdesivir to treat Covid-19 despite the drug never having formally begun the agency’s approval process. Regardless of its unconventional start and unprecedented approval, remdesivir has saved countless lives and played a prominent role in battling the virus.

Aducanumab could provide similar relief for patients suffering from Alzheimer’s disease as remdesivir has provided for Covid-19. Why wait?

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While passing an unprecedented amount of executive orders in record time, President Biden also placed a moratorium on all regulations enacted by the Trump administration set to go into effect this year. While freezing laws passed under previous administrations is common, preventing a regulation designed to provide less expensive life-saving drugs has generated widespread criticism.

In August 2020, President Trump passed an executive order requiring federally qualified health centers to provide inexpensive insulin and EpiPens to low-income patients. The order specifically called on the Department of Health and Human Services to guide community health centers to offer these life-saving medications to patients in need.

The order was set to take place on January 22, 2021. However, President Biden’s regulatory freeze pushes back the start date to March 22, and possibly later.

An understandably frustrated public has likened the Biden administration’s actions to “deliberately causing insulin prices to go up.” Physician and U.S. Representative Andy Harris (R-MD) writes, “This action by the incoming Biden Administration proves that they support large corporate interests over my hard-working constituents.”

Some have come to President Biden’s defense. Noting that only about 9 percent of U.S. patients frequent community health centers where they commonly received heavy discounts on prescription drugs, President and CEO of the National Association of Community Health Centers Tom Van Coverden said in a statement, “health centers, bipartisan members of Congress, and leaders within the Department of Health and Human Services (HHS) have indicated that this rule will do more harm than good.”

But what are the current administration’s plans to address the high price of insulin? As one Forbes article notes, “less than you might think, at least initially.”

Hoping to fulfill his campaign promise to “protect and build on Obamacare,” President Biden’s primary focus is to reinstate legislation implemented through the ACA but removed under the Trump administration. If successful, the president will then likely turn his attention to drug pricing policy.

But doing “less” could be the best thing President Biden could do to lower insulin and other drug prices. History is clearly not on his side.

Political promises to lower drug prices date back to the Clinton administration. However, drug prices have increased steadily since at least 2001 despite countless policies and regulations enacted to lower them. Insulin prices have followed a similar trend.

Each administration since then has vowed to lower prescription drug costs. None have succeeded.

State-government level efforts to slash insulin prices have also fared poorly. In 2019, Colorado became the first state to cap insulin co-pays at $100 a month. The legislation required health insurance providers, rather than patients, to cover additional prescription costs. However, a 2020 opinion poll conducted eleven months after the legislation took place found that nearly 40 percent of Coloradoan diabetics who responded to the survey were still forced to “dangerous ration” their insulin for financial reasons.

These widespread and bi-partisan failures are not surprising. More government oversight and regulation into the prescription drug market raises the cost of producing drugs. These costs make drugs more expensive and prevent competitors from competing away profits. Both leave patients worse off.

As I have noted previously, the most successful examples of patients receiving inexpensive EpiPens and insulin in the United States come from competition for profits, not from regulation.

When EpiPen’s price rose to over $300 a pen in 2015, pharmacies began ordering Adrenaclick, a similar treatment selling for about $10. Facing declining market share, EpiPen was forced to lower its price to about $70. Similarly, Walmart pharmacies often provide insulin named Relion for $25 a vail to patients to compete with more modern (and much more expensive) insulins.

High insulin prices were one of the most contentious topics in the 2020 election, and President Biden will eventually face political pressure to do something about them. Let’s hope that time comes later rather than sooner.

The post President Biden Faces Longstanding Challenge to Lower Insulin Prices. Will He Succeed? appeared first on The Beacon.

To afford their vital medication and make financial ends meet, many people with diabetes ration their insulin. One STAT article finds that 25 percent of diabetics rationed their insulin at least once a year due to financial difficulties. When rationing isn’t enough and times are desperate, some people turn to black markets.

After repeated failed attempts from the federal government to lower insulin prices, state governments are taking matters into their own hands.

In May 2019, Colorado became the first state to cap insulin copayments. Under Colorado House Bill 19-1216, insulin prescription copays were capped at $100 a month, and health insurance providers are required to cover additional expenses. Applauding Colorado for becoming the first state to pass such a measure, Colorado Governor Jared Polis announced the law would “finally declare that the days of insulin price gouging are over.”

Other states have followed Colorado’s example. As of April 2020, Illinois, Maine, New Mexico, New York, Utah, Washington, West Virginia all passed legislation capping insulin copayments. Many more states are likely to join this list in 2021.

While politicians and advocacy groups are hopeful that capping insulin copays will provide diabetics with enough insulin to manage their blood glucose levels without breaking their bank accounts, I’m less optimistic.

Most legislation capping insulin copays has not taken full effect, but enough time has passed to examine the impact of Colorado’s capping legislation. The results paint a dismal picture.

As an article in the Denver Post notes, the insulin copay restrictions have failed to help many families better afford insulin. One reason that the legislation fails to account for the complexities of the insulin-diabetic treatment market. For example, many insulin-using diabetics use more than one type of insulin, a fact overlooked by the lawmakers. Confusion over whether insurance providers were expected to incorporate copay caps when the law took effect or when policies were renewed also left many policyholders no better off than they were before.

As of November 2020, eleven months after Colorado’s law took effect, one survey finds nearly 40 percent of diabetic Coloradoans still “dangerously ration” their insulin. Colorado legislators hope further regulation will eliminate “loopholes” in the law, but history is not on their side.

Colorado’s policy failure is predictable when we consider the patient and the insurance provider’s incentives. Lowering copay maximums transfers insulin costs from the patient to the insurance providers. Consequently, patients are likely to use more insulin. Facing higher operation costs, insurance providers must find ways to cut costs (including finding loopholes in laws) or raise insurance premiums. Although patients might pay less out of pocket for insulin, they will likely pay more for health insurance, face policy-related complications making it more difficult to getting insulin, or both.

Our neighbor to the north provides an example. Although Canada has a price cap on insulin and makes some insulins available over the counter, many of its diabetics still have to ration their insulin because policy efforts to curtail “stockpiling” or “panic buying” limit how much insulin patients are allowed to buy at a time.

The fundamental problem with policies that try to resolve high drug prices by dictating who should pay for them is that they fail to address why the drugs are expensive in the first place. The answer comes down to a lack of competition and protective regulations. As I noted in an op-ed I wrote in The Hill; insulin is least expensive in countries where drug producers aren’t protected from competition by onerous regulations and favorable drug policies.

Any policy efforts which do not address regulatory barriers to competition are treating the symptoms of why insulin is expensive, not the source. Let’s hope the new year brings new hope of desperately needed drug policy reform.

The post Capping Insulin Copays Won’t Cure Insulin Price Woes appeared first on The Beacon.

Thankfully, drug producers Pfizer and Moderna have developed highly effective Covid-19 vaccines. Last month, the Food and Drug Administration granted emergency use authorization for both vaccines. Both producers began distributing millions of doses immediately after receiving FDA authorization.

With two vaccines in hand, many have turned their attention to debating who should be vaccinated first. Some argue that medical professionals, who risk their health by caring for Covid-19 patients, should have access before the general public. Others hold that the elderly, those with pre-existing conditions, and others who face the most significant risk of dying if infected with Covid-19 should be vaccinated first.

Some, more radically, propose that race should be a factor in deciding who gets vaccine priority. As Harald Schmidt of the University of Pennsylvania’s Leonard Davis Institute of Health Economics argues, “Society is structured in a way that enables them [white people] to live longer. Instead of giving additional health benefits to those who already had more of them, we can start to level the playing field a bit.”

Before deciding what factor should determine who gets vaccinated first, we should ask the more fundamental question of who should be tasked with distributing vaccines. So far, the responsibility has fallen on the government, and even this early in the process there have been several red flags.

Although the U.S. government provided more than $10 billion in funding to developing a Covid-19 vaccine, it does not have a specific plan on distributing it, which has caused widespread confusion and frustration from the vaccine producers.

As one Business Insider article headlines, “Pfizer said it had millions of doses of vaccine sitting in a warehouse because the federal government hadn’t told it where to send them.” The article also noted,“Illinois, Washington, California, Georgia, Hawaii, and Nevada are getting about half the doses they expected.”:

Some errors in conducting a vaccination program of this size are unavoidable. However, the government’s woeful track record of providing and distributing urgently needed goods during the pandemic shows that such mistakes are the norm, not the exception. We should recall:

• When Covid-19 first reached the United States, the FDA and CDC stifled the development and distribution of Covid-19 test-kits so severely that only about 1,200 patients were tested between late January and mid-March. The FDA-permitted Covid-19 test during this time was developed by the CDC, and it frequently produced false-negative results due to manufacturing errors.
• Last March, the Trump administration offered Transportation Security Administration employees a stockpile of 5 million respirator masks. This was during a period when air travel had decreased 55 percent, and many hospitals faced crippling shortages of personal protective gear.
• President Trump sent a naval hospital boat with a 1,000 patient capacity to help hospitals in New York City overwhelmed with Coivd-19 patients. The vessel left a month later, after treating 182 patients (30 percent of whom did not have Covid-19).
• With federal support of $660 million dollars, the US Army Corp of Engineers constructed large-scale field hospitals across the country to prepare for hospitals becoming overwhelmed with Covid-19 patients. Unfortunately, “there wasn’t enough planning to make sure these field hospitals could be put to use once they were finished.” Many field hospitals remain empty, even when local hospitals are overwhelmed.
• After the drug remdesivir received emergency use approval to treat severe cases of Covid-19, the U.S. government purchased almost half a million doses (a nearly three-month global supply) to distribute to hospitals across the country. However, numerous articles report some hospitals to have a severe shortage of the drug (even driving them to ration who receives treatment) while other hospitals have an unhelpful surplus.

The arrival of a Covid-19 vaccine provides hope that we may reach herd immunity without endangering millions of lives. But utilizing this pioneering medical breakthrough and truncating the length of the pandemic depends on how well the vaccines are distributed. So far, not so good.

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Fearing the arrival of a second wave, several states reenacted various lockdown measures to curb spreading disease. Many European nations followed suit.

But necessity is the mother of innovation. And pathbreaking medical innovation has arrived.

On November 9^th, Pfizer announced it had developed a more than 90 percent effective COVID-19 vaccine. A week later, Moderna released clinical trial findings indicating its COVID-19 vaccine was 95 percent effective. Stanely Plotkin, the inventor of the rubella vaccine, found Moderna’s results to be “extremely encouraging” and “show that the platform really works... and considering the speed with which the platform was put into operation, it’s an excellent result.”

Federal regulators agreed. On December 11^th, the Food and Drug Administration’s advisory board granted emergency use authorization for Pfizer’s COVID-19 vaccine. Centers for Disease Control Director Dr. Richard Redfield gave similar approval shortly after, making a COVID-19 vaccine available to distribute.

Barring any unforeseen setbacks, Pfizer expects to produce 15 to 20 million vaccines by the end of the year, including 2.9 million doses in the next week. Moderna’s COVID-19 vaccine is also expected to receive approval soon, with the hopes of distributing another 20 million doses by the end of December.

Pfizer’s and Moderna’s swift development of an effective COVID-19 vaccine has generated widespread and well-deserved praise. An opinion piece in the Wall Street Journal argues the scientists who developed the vaccines deserve the Nobel Peace Prize for their discovery. An article in the Irish Examiner called the leadership of BioNTech, which partnered with Pfizer to develop the vaccine, “heroes of our time.”

Even more remarkable, according to an article published in New York magazine’s Intelligencer, is that Moderna’s vaccine was designed on January 13th, only two days after the virus’s genomic sequence was made public. This was even before COVID-19 reached the United States.

However, until the FDA approved the vaccine, it was not legally available to anyone not participating in clinical trials. This means, as the article’s title indicates, “we had the vaccine the whole time.”

A nearly eleven-month gap between the vaccine’s discovery and FDA approval is frustrating. Unfortunately, the FDA’s sluggishness to approve life-saving medication is nothing new even during a public health crisis.

From 2014-2016, the Ebola virus caused nearly 11,000 deaths across western Africa. Fortunately, scientists across the globe worked together to develop a vaccine in less than a year. The Ebola vaccine, however, did not receive FDA approval until 2019—four years after it was created.

But would medical scientists be able to quickly develop a safe and effective vaccine without the FDA’s oversight? Evidence from previous influenza pandemics suggests they can.

From 1957-1958, the 1958 influenza (often referred to as the Asian Flu) spread through the United States, infecting 20 million individuals and causing 116,000 deaths. At this time, the FDA held significantly less regulatory authority and did not regulate vaccines.

Similar to Moderna’s COVID-19 vaccine, medical scientists developed a vaccine for the 1958 influenza before the virus reached the United States. Without the FDA prolonging approval, cooperation between public health agencies and private vaccine developers were able to distribute 60 million doses of the vaccine during the first two months of the pandemic.

Consequently, hospitals were not overwhelmed and there was “no serious disruption of community life” during the 1957-1958 pandemic. As an article written at the time in the Journal of the American Medical Association noted, quick development, approval, and distribution of the vaccine “made it possible for a nation to organize in advance of an oncoming epidemic for the first time in history.”

The frustrating delay between the time when a COVID-19 vaccine was discovered and the day the FDA gave its approval should not overshadow the Pfizer and Moderna scientists’ remarkable achievement. Their pioneering discovery is truly phenomenal. However, acknowledging the harmfulness of the FDA’s delay in authorizing a COVID-19 vaccine can help implement better policy during future public health crises.

COVID-19 is deadly. But regulatory barriers can be, too.

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Azar’s orders curtail the regulation-issuing authority of 8 agencies and 11 operating divisions. Among these agencies is the Food and Drug Administration, whose regulatory influence encompasses an estimated 20 percent of all consumer products as of 2008.

Azar’s self-granting of decision-making authority has generated a considerable backlash. Among Azar’s most outspoken critics is former FDA Commissioner Scott Gottlieb, who, during a Face the Nation interview, stated the rulemaking change “makes no sense” and is a “distraction to FDA at a time when they should be focused on the COVID response.” Providing similar disapproval, Dr. Peter Lurie, President of the Center for Science in the Public Interest, called Azar’s decision a “power grab” that will lead to “inefficiency within government operations that is wholly unnecessary and likely to gum things up.”

Whether or not Azar’s consolidation of power is ill-timed, self-serving, or will “gum things up,” it’s upsettingly predictable.

Those holding high-ranking positions within government bureaucracies, including Secretary Azar, obtain more authority, prestige, resources, and capability to push their agendas by consolidating power. Crises, whether real or imagined, provide political figures opportunities to expand their discretionary authority under the guise of offering solutions to a concerned public.

Public health crises have provided avenues for the government to expand its role in regulating the healthcare sector throughout U.S. history. In the telling and alarming Independent Institute book Hazardous to Our Health: FDA Regulation of Healthcare Products, editor and contributor Robert Higgs documents numerous instances where the perceived threat of substandard healthcare products led to the creation and expansion of the modern FDA. From 1962 to the present day, the FDA gained the authority to oversee markets in drug effectiveness, medical products, drug advertising, tobacco products, e-cigarettes, among other goods.

Far from improving product safety and resolving public health scares, numerous studies have concluded the FDA commonly overregulates to the detriment of patients and healthcare providers. The most recent centralization of state authority within the healthcare sector is unlikely to fare any better.

Preventing the expansion of government power requires reluctance to grant it authority in the first place. Unfortunately, troubling and uncertain times make championing the case for limiting the state’s role a special challenge. The history of consolidated government power to counter public health crises shows a consistent pattern of providing cures worse than the disease.

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