The federal Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) must certify masks. The division of the CDC that certifies masks is the National Institute for Occupational Safety and Health (NIOSH), not the same as OSHA, the Occupational Safety and Health Administration.

On March 2, the FDA allowed “certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel,” during the coronavirus outbreak, “thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.” More than two weeks later, masks were still in short supply.

“In settings where facemasks are not available,” the CDC explains, health care personnel (HCP) “might use homemade masks (e.g., bandana, scarf) for care of patients with COVID-19 as a last resort.” Still, homemade masks are not considered personal protective equipment (PPE), “since their capability to protect HCP is unknown.” Homemade masks, the CDC explains, “should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face.”

Homemade masks would not be necessary if the CDC, with a budget of more than $6 billion, had a supply of masks readily available for mass distribution at the first sign of trouble. A federal agency tasked with disease “prevention” did not prevent the coronavirus outbreak, and judging by current conditions, the CDC fails to live up to the “control” part of its name.

In recent years, the CDC has been occupied with obesity, not strictly speaking a disease. Last December, the budget deal gave the CDC $25 million to study “gun violence,” which is not a disease either. That $25 million could supply many surgical masks to the public.

The problem with the CDC is not a lack of funding but bureaucratic ineptitude, an unhealthy condition at all times but particularly now, when the dearth of proper masks forces people to make their own. So as the CDC says, if you do sew up your own mask, remember to use a shield that extends below the chin and covers both sides of the face.

The post The Mask Madness of Big Government appeared first on The Beacon.

How much curve-flattening is necessary to avoid overloading a nation’s healthcare system? The answer has a lot to do with the system’s capacity.

For the COVID-19 coronavirus pandemic, most moderate-to-severe cases require patients be hospitalized in critical-care facilities, where the limiting resource is the number of beds available. Statista’s Niall McCarthy produced a “Chart of the Day” showing the available capacity of critical care beds in several nations.

Statista: The Countries With The Most Critical Care Beds Per Capita

A good question to ask is, why are so many of these nations so at risk of having their healthcare systems overwhelmed by coronavirus patients that elected government officials are very willing to throw their economies directly into recession with little-to-no public debate?

The answer is that most counties have either nationalized healthcare systems or single-payer systems that have chronically underinvested in their critical-care infrastructure in order to hold down their government’s healthcare costs.

Now they are having to adopt extreme measures in a desperate attempt to flatten their curves because they have all but ensured the inevitable failure of their healthcare systems to handle the pandemic.

Of all these systems, America’s heavily government-subsidized system is the one most open to market forces, which has enabled it to have the most investment per capita in the kind of critical care expected to be in heavy demand as the coronavirus spreads.

The nature of the viral infection will strain and perhaps overwhelm the U.S. healthcare system, but compared to other countries’ systems, it has the most capacity to be consumed before the breaking point might be reached.

It could be worse for the United States. In January 2020, Laura C. Myers, Gabriel Escobar and Vincent X. Liu shed light on the issue by publishing the journal article, “Goldilocks, the Three Bears and Intensive Care Unit Utilization: Delivering Enough Intensive Care But Not Too Much. A Narrative Review.” In it, they recognized that the high costs of critical care units are a high-visibility target for policymakers seeking to reduce the costs of American health care:

Intensive care units may be an attractive target for curbing healthcare spending in the United States. Experts have proposed reducing the supply of intensive care unit beds as one potential intervention to decrease cost [3,4,5]. They argue that excess supply of critical care beds increases intensive care unit use by patients who may not benefit from it.

In the coronavirus pandemic, such excess supply will give doctors the flexibility needed to accommodate larger numbers of patients requiring critical care, giving American hospitals options that other nations do not have. Myers et al. focus their discussion on how to triage patients to make maximum effective use of these still-limited critical-care resources within the United States.

Market forces provide powerful tools for allocating scarce resources to provide the greatest value. The more we use them, the better off we will fare.

The post Coronavirus and National Healthcare Rationing appeared first on The Beacon.

As Milton Friedman observed, temporary government measures often become permanent, and the commandeering of private property could easily mesh with the governor’s plans to impose government monopoly health care. As that unfolds, the coronavirus crisis is also impacting the criminal justice system. 

That system allows family members of crime victims to make impact statements in court and to show up at parole hearings, where they can confront convicted criminals face to face. For example, Doris Tate, mother of slain actress Sharon Tate, frequently appeared at parole hearings to keep her daughter’s murderer, Charles Manson disciple Susan Atkins, in prison.

According to a report in the Sacramento Bee, the California Department of Corrections and Rehabilitation (CDCR) is now barring family members of crime victims from attending parole hearings in person. The family members, and prosecutors, must appear by phone or video conference, but inmates’ attorneys can appear in person. Call it a separate-and-unequal approach.

The CDCR, headed by Newsom appointee Ralph Diaz, did not indicate when family members of crime victims would again be allowed to appear in person at parole hearings and confront criminals face to face. The ban is supposedly to maintain social distancing, but if families of crime victims perceived it as the latest government favoritism toward criminals it would be hard to blame them. 

Gov. Newsom has issued a “stay home” edict for all Californians, but has not tailored special measures for certain high-risk areas. For example, public urination and defecation poses serious health risks, but San Francisco District Attorney Chesa Boudin refuses to prosecute such “quality of life” crimes. The coronavirus crisis has not prompted Gov. Newsom, a former San Francisco mayor, to speak out against Boudin’s policy.

Sacramento mayor Darrell Steinberg, who heads Gov. Newsom’s homelessness task force, wants to move homeless people into hotels. Last September, public defecation contaminated and shut down the popular Tiscornia Beach, at the confluence of the American and Sacramento rivers. The city left the homeless in place and made little if any change in policy. Californians can be forgiven for skepticism about politicians’ sudden concern for public health.

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• It is revealing where the bureaucrats’ methods of business-as-usual obstruct the vital interests of regular Americans.
• The increased visibility allows the Trump administration to obliterate the regulations that provide little to no value for ordinary Americans.

Eliminating needless regulations unleashes the power of the private sector to address the problems from the coronavirus pandemic. A positive side effect is the reduction of the power wielded by the faceless bureaucrats who established these poorly considered regulations.

The many problems with coronavirus testing are a continuing source of new lessons about the degree of dysfunction in the federal bureaucracy.

Did you know, for example, that the Food and Drug Administration (FDA) was forcing the Centers for Disease Control to double test coronavirus samples? Propublica’s Lydia DePillis and Caroline Chen report on a directive that was meant to speed the government’s pandemic response, but slowed it instead:

The directive, issued by the U.S. Food and Drug Administration, requires that the Centers for Disease Control and Prevention, a sister agency, retest every positive coronavirus test run by a public health lab to confirm its accuracy. The result, experts say, is wasting limited resources at a time when thousands of Americans are waiting in line to get tested for COVID-19.

The duplicative effort is the latest obstacle that is slowing the federal response to COVID-19, which has infected more than 1,300 people and resulted in 38 deaths in the United States.

The Propublica article was published late in the afternoon on March 12, when the coronavirus case numbers were still very low compared to how they have since grown. The Trump administration responded by forcing the FDA to revise its directive, eliminating the needless duplication in testing as of March 15.

Another lesson about how the removal of federal regulatory barriers can unchain the private sector can be learned from a March 19 press release issued by Abbott Labs:

Abbott Laboratories, of Abbott Park, Ill., is the latest company to receive emergency use authorization (EUA) from the U.S. FDA for a test to detect SARS-CoV-2, the novel coronavirus responsible for the COVID-19 pandemic. The company said it is shipping 150,000 Realtime SARS-CoV-2 tests immediately to existing customers in the U.S., with plans to produce 1 million tests a week by the end of the month.

The announcement follows EUAs for SARS-CoV-2 tests developed by the CDC, Roche Holdings AG, the New York State Department of Health, Thermo Fisher Scientific Inc., Hologic Inc., Laboratory Corp. of America, Quidel Corp. and Quest Diagnostics Inc. Other companies have submitted COVID-19 tests to the FDA, including Becton Dickinson & Co. and Genmark Diagnostics Inc., and still are working to make testing available.

March 19 might seem very late for such an announcement, considering how long the coronavirus has been spreading. But what’s most notable in the press release is its long list of private labs seeking to develop coronavirus tests, labs that were held back by the FDA until its regulatory grip was involuntarily relaxed. Bloomberg’s Emma court reports:

On Feb. 29, after weeks of criticism from state health officials, the Food and Drug Administration lifted a key regulatory hurdle and let lab companies and hospitals more easily test patients for the virus. The government’s tight initial control over who could do diagnostic work has been called a “failing” by Anthony Fauci, the director of the U.S. National Institute of Allergy and Infectious Diseases.

Then, on Monday the agency went further, allowing states to clear tests from local labs—a move that will increase the number of tests, but give up part of the FDA’s role.

Just imagine how much better off the country would be if private labs hadn’t been obstructed for weeks by bureaucrats who couldn’t bear to see a loss in their power and control.

Here’s one last example about the power of entrepreneurship in the private sector and the role in regulations in obstructing it. Edgardo Zuniga, the founder of Maryland’s Twin Valley Distillers, which is best known for producing whiskey and rum, gave his employees permission to experiment with producing hand-sanitizer, an alcohol-based product that has come to be in short supply with the spread of the coronavirus.

After some fast-paced experimentation, they settled on a formulation they felt would work and approached the federal government for approval to sell it. Becket Adams of the Washington Examiner described what happened next:

As they messed around with the recipe, they also applied for a license to produce the sanitizer. They were approved almost immediately by the federal government, which, honestly, is a sentence I thought I would never write.

“The federal government said the application typically takes three weeks for approval. We got approval in two days,” the distillery’s general manager, Jonathan Shair, told the ABC affiliate.

What if the bureaucrats at the federal Alcohol and Tobacco Tax and Trade Bureau had held fast to a non-emergency regulatory mindset and took weeks to process the license for the distillery to introduce their new product? Obviously, there would be less hand-sanitizer available for people to buy, and what possible good could come from that?

This example of how fast things can happen in the absence of an excessive regulatory burden proves that many regulations simply exist to be in the way, failing to produce any positive outcome. It shouldn’t take an emergency to strip away regulatory barriers to progress that should never have existed in the first place.

The post Fighting Coronavirus by Breaking the Chains of Needless Regulation appeared first on The Beacon.

The FDA acknowledged this shortcoming in a regulatory notice which reads, “If a [regulatory] standard were to apply to cigarettes only, it could be substantially less effective.” But instead of heeding potential unintended consequences as a reason to refrain from regulation, the agency seems to be doubling down.

In response to pressures from several health advocacy groups, the FDA is taking action to “rein in the booming electronic cigarette industry.” The agency is particularly concerned that flavored e-cigarette juices instigate teens and youths to take up smoking. As FDA commissioner Scott Gottlieb expressed, “We are very concerned that we could be addicting a whole generation of young people” and, “this isn’t tolerable from a public health standpoint.”

As part of their effort to “address it,” the FDA is launching a vaping prevention campaign and has issued information requests to four e-cigarette companies. But these actions may be just the starting point for more restrictive regulations down the road. As one USA Today article notes, the FDA might consider banning flavored e-cigarette juices entirely.

To be fair, smoking is a deadly habit and e-cigarettes are particularly popular with younger smokers. According to the 2017 National Youth Tobacco Survey, about 12 percent of high schoolers and 3 percent of middle schoolers reported using e-cigarettes in the last 30 days.

But policy intentions cannot overshadow policy outcomes. Restricting access to e-cigarette flavored juices, similar to reducing nicotine levels in cigarettes, is unlikely to cut smoking rates.

Further, evidence suggests e-cigarettes are not the culprit Gottlieb and others suggest.

Although life-long smoking typically begins by high school, the 2014 National Survey on Drug Use and Health finds this trend extends back well before e-cigarettes were available. It is also difficult to imagine e-cigarettes are enticing younger generations to smoke when smoking rates are decreasing. E-cigarettes first entered the U.S. market in 2006. But the 2017 National Youth Tobacco Survey mentioned above finds that the number of middle and high school students using tobacco products decreased by 20 percent from 2011 to 2017.

More importantly, policies banning or restricting access to flavored e-cigarette liquids provides an incentive to seek out other nicotine products. These alternatives are likely to be less healthy (and possibly more addictive) than e-cigarettes. In fact, medical literature frequently finds e-cigarettes are a healthier alternative to many tobacco products and that many smokers use e-cigarettes to help them reduce tobacco consumption or to completely quit smoking. One estimate finds that switching from cigarettes to e-cigarettes could save 6.6 million lives over a 10-year period.

Despite the best of intentions, efforts to regulate vice frequently fail and can lead to harmful secondary effects for those they intend to help. Efforts to reduce smoking rates are a prime example. Sadly, the FDA seems to picking up the habit. Let’s hope it quits before it starts.

The post FDA Considers Regulating E-cigarette Juices appeared first on The Beacon.

• Life expectancy for the U.S. population in 2015 was 78.8 years, a decrease of 0.1 year from 2014.
• The age-adjusted death rate increased 1.2% from 724.6 deaths per 100,000 standard population in 2014 to 733.1 in 2015.
• The 10 leading causes of death in 2015 remained the same as in 2014. Age-adjusted death rates increased for eight leading causes and decreased for one.

The one death rate which improved was for cancer. So, we are “winning” that war, at least relatively speaking.

The entire decrease was for life expectancy at birth. Life expectancy at age 65 was unchanged from the previous year. In other words, children and working-age people are bearing the burden of this decline.

However, the worst (by far) contributor to the decline was an increase in deaths attributable to Alzheimer’s disease, which (although not described in the data brief) is concentrated in people 65 and older. These deaths accounted for almost half (47 percent) of the decline in age-adjusted mortality.

The only way this terrible increase in the burden of Alzheimer’s disease could not have reduced life expectancy at age 65 is if the elderly have enjoyed significant improvement in outcomes for cancer and other diseases.

The next worst contributor to the decline was “unintentional injuries,” which accounted for just under one-third of the increase in the death rate, and must almost certainly be concentrated among those under 65. Suicides also increased significantly, although they do not account for a large absolute share of deaths. Researchers often include both unintentional injuries and suicides as related outcomes for people suffering mental illness and homelessness.

Given the extreme safety of our modern American environment, it would be remarkable if the increase in deaths due to unintentional injuries were concentrated among mentally healthy people. The data brief suggests the harmful behaviors that have been observed increasing among white men are also happening in the rest of the population, because the decline in life expectancy happened for both sexes and all races.

The post U.S. Life Expectancy Drops First Time since 1993 appeared first on The Beacon.

[This piece was later published by Newsweek and the Foundation for Economic Education.]

“Absent the FDA, Americans would be healthier and happier.” —Robert Higgs

As I drove to work the other day, I heard a very interesting segment on NPR that featured a startup designing video games to improve cognitive skills and relieve symptoms associated with a myriad of mental health conditions. One game highlighted, Project Evo, has shown good preliminary results in training players to ignore distractions and stay focused on the task at hand:

“We’ve been through eight or nine completed clinical trials, in all cognitive disorders: ADHD, autism, depression,” says Matt Omernick, executive creative director at Akili, the Northern California startup that’s developing the game.

Omernick worked at Lucas Arts for years, making Star Wars games, where players attack their enemies with light sabers. Now, he’s working on Project Evo. It’s a total switch in mission, from dreaming up best-sellers for the commercial market to designing games to treat mental health conditions.

“The qualities of a good video game, things that hook you, what makes the brain—snap—engage and go, could be a perfect vessel for actually delivering medicine,” he says.

In fact, the creators believe their game will be so effective it might one day reduce or replace the drugs kids take for ADHD.

This all sounds very promising.

In recent years, many observers (myself included) have expressed deep concerns that we are living in the “medication generation,” as defined by the rapidly increasing numbers of young people (which seems to have extended to toddlers and infants!) taking psychotropic drugs. As experts and laypersons continue to debate the long-term effects of these substances, the news of intrepid entrepreneurs creating non-pharmaceutical alternatives to treat mental health problems is definitely a welcome development.

But a formidable final boss stands in the way:

[B]efore they can deliver their game to players, they first have to go through the Food and Drug Administration—the FDA.

The NPR story goes on to detail on how navigating the FDA’s bureaucratic labyrinth is akin to the long-grinding campaign required to clear the final dungeon from any Legend of Zelda game. Pharmaceutical companies are intimately familiar with the FDA’s slow and expensive approval process for new drugs, and for this reason, it should come as no surprise that Silicon Valley companies do their best to avoid government regulation. One venture capitalist goes so far as to say, “If it says ‘FDA approval needed’ in the business plan, I myself scream in fear and run away.”

Dynamic, nimble startups are much more in tune with market conditions than the ever-growing regulatory behemoth that is defined by procedure, conformity, and irresponsibility. As a result, conflict between these two worlds is inevitable:

Most startups can bring a new video game to market in six months. Going through the FDA approval process for medical devices could take three or four years—and cost millions of dollars.

In the tech world, where app updates and software patches are part of every company’s daily routine just to keep up with consumer habits, technology can become outdated in the blink of an eye. Regulatory hold on a product can spell a death sentence for any startup seeking to stay ahead of its fierce market competition.

Akili is the latest victim to get caught in the tendrils of the administrative state, and worst of all, in the FDA, which distinguished political economist Robert Higgs has described as “one of the most powerful of federal regulatory agencies, if not the most powerful.” The agency’s awesome authority extends to over twenty-five percent of all consumer goods in the United States and thus “routinely makes decisions that seal the fates of millions.”

Despite its perceived image as the nation’s benevolent guardian of health and well-being, the FDA’s actual track record is anything but, and its failures have been extensively documented in a vast economic literature. The “knowledge problem” has foiled the whims of central planners and social engineers in every setting, and the FDA is not immune. By taking a one-sized-fits-all approach in enacting regulatory policy, it fails to take into account the individual preferences, social circumstances, and physiological attributes of the people that compose a diverse society. For example, people vary widely in their responses to drugs, depending on variables that range from dosage to genetic makeup. In a field as complex as human health, an institution forcing its way on a population is bound to cause problems (for a particularly egregious example, see what happened with the field of nutrition).

The thalidomide tragedy of the 1960s is usually cited as to why we need a centralized, regulatory agency staffed by altruistic public servants to keep the market from being flooded by toxins, snake oils, and other harmful substances. However, this needs to be weighed against the costs of keeping beneficial products withheld. For example, the FDA’s delay of beta blockers, which were widely available in Europe to reduce heart attacks, was estimated to have cost tens of thousands of lives. Despite this infamous episode and other repeated failures, the agency cannot overcome the institutional incentives it faces as a government bureaucracy. These factors strongly skew its officials towards avoiding risk and getting blamed for visible harm. Here’s how the late Milton Friedman summarized the dilemma with his usual wit and eloquence:

Put yourself in the position of a FDA bureaucrat considering whether to approve a new, proposed drug. There are two kinds of mistakes you can make from the point of view of the public interest. You can make the mistake of approving a drug that turns out to have very harmful side effects. That’s one mistake. That will harm the public. Or you can make the mistake of not approving a drug that would have very beneficial effects. That’s also harmful to the public.

If you’re such a bureaucrat, what’s going to be the effect on you of those two mistakes? If you make a mistake and approve a product that has harmful side effects, you are a devil incarnate. Your misdeed will be spread on the front page of every newspaper. Your name will be mud. You will get the blame. If you fail to approve a drug that might save lives, the people who would object to that are mostly going to be dead. You’re not going to hear from them.

Critics of America’s dysfunctional healthcare system have pointed out the significant role of third-party spending in driving up prices, and how federal and state regulations have created perverse incentives and suppressed the functioning of normal market forces. In regard to government restrictions on the supply of medical goods, the FDA deserves special blame for driving up the costs of drugs, slowing innovation, and denying treatment to the terminally ill while demonstrating no competency in product safety.

Going back to the NPR story, a Pfizer representative was quoted in saying that “game designers should go through the same FDA tests and trials as drug manufacturers.” Those familiar with the well-known phenomenon of regulatory capture and the basics of public choice theory should not be surprised by this attitude. Existing industries, with their legions of lobbyists, come to dominate the regulatory apparatus and learn to manipulate the system to their advantage, at the expense of new entrants.

Akili and other startups hoping to challenge the status quo would have to run past the gauntlet set up by the “complex leviathan of interdependent cartels” that makes up the American healthcare system. I can only wish them the best, and hope Schumpeterian creative destruction eventually sweeps the whole field of medicine.

Abolishing the FDA and eliminating its too-often abused power to withhold innovative medical treatments from patients and providers would be one step toward genuine healthcare reform.

The post Game Developers Face Final Boss: The FDA appeared first on The Beacon.

One thing that keeps popping up among my pregnant friends is the question of whether to have a midwife deliver their baby at home or in a birth center, or seek the medical care of a doctor in a hospital when the time comes to deliver their little ones. For most of my friends, the choice is a doctor. For a few, however, the choice is midwife or bust.

My friend group appears to follow the typical statistics for birth in the United States. Of the approximately 4 million babies born annually in the U.S. (holy procreation, Batman!), about 99 percent of them take place in hospitals. The other one percent of births, however, occur outside of the hospital. While cases documented by TV shows like TLC’s “I Didn’t Know I was Pregnant” account for some of these births (yes, this is a real thing, and no, I don’t know how this happens either), many of these “more primitive” births are completely intentional. In fact, one recently launched TV show titled, “Born in the Wild,” documents women who choose to give birth to their children out in the woods.

This got me thinking. One percent of 4 million isn’t trivial—it’s still 40,000 babies annually. What’s more interesting is that this number used to be much higher—and not that long ago. In fact, Jimmy Carter was first U.S. President to be born in a hospital. In 1900, nearly all births occurred outside a hospital according to the Centers for Disease Control and Prevention. By 1970, the number of out-of-hospital births had fallen to one percent.

So what happened to home births and midwives? The most straightforward argument is that, as medical technology improved, midwives were replaced by more qualified, safer doctors. But that may not be all to the story. In fact, like so many other stories told on this blog and elsewhere, the disappearance of the midwife from childbirth appears to be the product of special interest groups and regulatory capture.

In the late 1800s physicians began to form an organized special interest group. At first, doctors marketed their labor and delivery services to wealthier, upper and middle-class families. Midwifery continued to be the default option for poorer women.

But like other special interest groups, doctors worked in conjunction with political actors to pass a variety of laws that argued midwives were uneducated and unsafe. Regulations like the Sheppard-Towner Maternity and Infancy Protection Act of 1921, combined with heavily regulated training and licensure programs, contributed to a sharp decline in the use of midwives throughout the U.S. Despite their historical use, midwives are now allowed to practice in varying degrees in only 27 states. In 23 states, midwives are banned outright.

Despite the rhetoric that midwives are inferior to doctors in regard to childbirth, this doesn’t seem to be the case—when it comes to normal-risk pregnancies. In fact, infant mortality risk for such births is practically indistinguishable between home births and hospital births. Home births also offer other possible benefits. Home births and births involving a midwife are much less likely to result in C-sections. Though common, such procedures put both mother and baby at risk. Women undergoing C-sections are more likely to experience infection, hemorrhaging, and take longer to recovery from delivery. Maternal mortality for babies born this way is also higher than it is for vaginal births. Babies delivered by C-section are more likely to have breathing problems, sustain an injury due to the procedure, and have lower APGAR scores (a test given to evaluate the health of newborns).

When asked why they selected a midwife and home birth over a hospital and doctor, women give numerous reasons. Most cite the aforementioned safety of home births and the decreased likelihood of C-sections and other medical interventions. Others stated they felt the former option offered more control over the experience, occurred in a more comfortable environment, and that they preferred their particular caregiver.

Source: nursingschoolhub.com

Ultimately, whether a child is brought into this world with the assistance of a midwife, doctor, etc. should be about choice—the parents’ choice. Unless someone presents significant evidence that midwives and other alternative birth environments produce systematic neglect or abuse, there is no objective reason why such practices should be more regulated than doctors, much less banned.

The fact is, the government has no place in the bedroom, or the delivery room. Hospital births and home births have different risks and benefits. Women and families, not special interests and government bureaucrats, should be able to weigh the pros and cons of these options and make a decision based on their personal convictions and circumstances.

The post What Happened to the Midwives? (Hint: Government) appeared first on The Beacon.