More Executive Orders Will Not Fix Healthcare

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Draconian measures to “flatten the curve” were implemented to prevent the healthcare sector from becoming overwhelmed with infected patients. Now, as many states reopen for business, it seems relatively few healthcare facilities are overwhelmed.

However, much of the healthcare industry is still struggling. Becker Hospital Review finds that more than 250 hospitals are furloughing employees to stay financially solvent. Medical practices are also experiencing significantly less patronage.

Private Enterprise Continues to Flatten the Curve

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A few weeks ago, I published an op-ed in The Hill entitled “Trust Private Enterprise to Flatten the Curve.” There I argued that markets, rather than the heavy hand of government, are our best hope to combat COVID-19. Between then and now, markets have continued to provide patients and healthcare professionals with urgently needed goods and innovative ways to reduce the burden of the pandemic on our health care system.

Governments Can’t Plan Economy’s Reopening

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President Donald Trump and governors around the country are clashing over who has the authority to decide when and how to “reopen” the economy. Yet government officials can’t know how to plan that reopening for precisely the same reasons that they can’t know how to plan an economy that’s already open.

Centrally planned economies have a 100-year history of stagnation, inefficiency, and shortages of basic consumer goods. It didn’t take a global health crisis to empty the shelves in Cuban or Venezuelan grocery stores. Mistakes made by central planners, who hold monopoly power over economic decisions, did that all on their own.

The future is necessarily uncertain. So, anyone forecasting supply and demand for a given product is bound to make mistakes. But market economies decentralize decision-making. The mistakes of some entrepreneurs are usually made up for by the correct actions of others, while profit-and-loss signals guide mistaken entrepreneurs to adjust their behavior.

The miracle of the market consists of this: allowing entrepreneurs, guided by prices, to make their own production decisions guarantees that our store shelves will be reliably stocked with a massive array of products. That’s how it’s been until recently.

The recent shortages are the result of a demand spike: consumers rushed to buy weeks’ supplies of some goods all at once. Government anti-price-gouging laws aggravated the situation, but most markets are working, and entrepreneurs are restocking the shelves.

Unfortunately, the health care sector is one of the most regulated sectors of the U.S. economy. Government planners limit the ability of entrepreneurs to discover better ways of providing health care—with predictable dismal results.

When the COVID-19 pandemic began in the United States, the Centers for Disease Control (CDC) exercised its monopoly power to produce tests and then botched their development. Numerous health entrepreneurs have developed new and more effective tests since the government relaxed the CDC’s monopoly.

Similarly, the Food and Drug Administration’s (FDA) safety and efficacy requirements impede entrepreneurs from bringing new drugs to market. But the FDA does not have a monopoly on the knowledge of what works. Doctors, patients, and entrepreneurial drug companies need the “right to try” in order to rapidly learn the best treatments. Fortunately, COVID-19 treatments and vaccines are getting special fast-track approvals, but the need for special approval illustrates the problem.

Hospitals have been ordered to cancel non-essential surgeries and appointments. Yet hospitals in most of the United States are not overrun with COVID-19 patients, and banning hospitals from their normal activities has dried up their revenue and resulted in their furloughing workers amidst the health crisis.

Clearly the health care sector needs to be freed from central planning.

As for the rest of the economy, federal, state, and local government officials will be coming forward with their own plans for when, how, and which businesses can open in the coming weeks. Each level of government will exert monopoly authority in its jurisdiction. But none of them knows how to structure the reopening.

Government planners at all levels need to cease giving us orders on how to run our economic and personal lives. Individuals need to be free to choose how to interact with others, including businesses. This, however, does not mean a return to the “normal” that existed before the COVID-19 pandemic.

Customers are now less likely to frequent, and employees are less likely to work for, businesses where health risks are high. As a result, business owners’ own profit-and-loss incentives will force them to absorb the cost of preventing a potential spread of COVID-19 in their establishments.

Entrepreneurs will balance these risks against the desires of people to make mutually beneficial exchanges. In short, entrepreneurs will be incentivized to discover the best ways to lower the risk of infection in their businesses in order to encourage people to deal with them.

Going back onto airplanes and into stores and restaurants will not be the same. However, the best solutions in each of these situations won’t be uniform everywhere. Thus, no government planner can know how to best reopen the economy. How consumers and employees respond needs to be discovered through the entrepreneurial market process. That can only happen if government planners liberate us to choose for ourselves.

Economy Prosperity or Pandemic Protection: Why Not Both?

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United States government officials previously estimated the COVID-19 virus would infect between 70 million and 150 million Americans, causing between 100,000 and 240,000 fatalities. Both estimates made the coronavirus the most devastating pandemic since the Spanish Flu (which some consider the deadliest pandemic ever).

But after re-examining the data, these estimates have been dramatically scaled back.

Cut Regulations and Get COVID-19 Drugs to Patients

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As the coronavirus pandemic continues to ravage the U.S. healthcare system, many healthcare professionals are struggling to find enough medical supplies to treat patients and to avoid becoming infected themselves. A recent New York Post article finds nurses working in a New York City hospital resorted to covering themselves with garbage bags because the hospital had run out of gowns. The nursing staff also ran out of medical masks and was forced to reuse disposable ones.

Not surprisingly, these makeshift solutions did not prevent these nurses from catching the coronavirus. One of them, an assistant nursing manager named Kious Kelly, recently passed away after becoming infected. Saddened and outraged, one nurse said, “Kious didn’t deserve this…The hospital should be held responsible. The hospital killed him.”

Drug Is Safe and Sometimes Works, Let All COVID-19 Patients Take It

In mid-March a Palo Alto, California, woman’s COVID-19 worsened to pneumonia while being treated at Stanford Hospital. She had already suffered from asthma and diabetes.

In a trial, doctors decided to give her the drug remdesivir, which has been well established as safe and used to treat Ebola. It worked; she’s now home recovering wonderfully.

The outstanding question is: Is it helpful for COVID-19? The answer is: Yes, at least for some coronavirus victims.

So why not let the drug be given to all COVID-19 patients rather than just in trials, as was the case with the Palo Alto woman’s trial? They have everything to gain and nothing to lose. The drug sometimes cures pneumonia and possibly prevents it in the first place.

Governmental medical science, tragically, does not work this way. The Food and Drug Administration requires that, before a drug can be prescribed, it must clear three sets of clinical trials to prove that it is safe and effective; that usually takes a year.

COVID-19 patients usually have anywhere from a few days to a few weeks to live or die. Why can’t patients with the coronavirus take remdesivir to see if it helps?FDA approval for efficacy is largely pointless.

I learned of this sad FDA policy the hard way. I was on the board of the Abigail Alliance that sued the FDA when a terminal cancer patient was denied the right to experimental drugs even though the FDA had found the them clinically safe and promising.

Our argument was that if we have a constitutional right to defend ourselves against an attacker, why can’t we have that same right of self-defense when the attacker is cancer? I based this logic on my own wife’s experience: she had terminal lung cancer and was given an experimental drug that extended her life and eliminated her chronic pain.

Our case was heard in the D.C. Circuit Court of Appeals on August 7, 2007. We lost and would likely lose today because the FDA still mandates three clinical trials to prove drugs safe and effective.

Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases cites frequently the necessity of this three-clinical-trial process referring to any other drug cure of the coronavirus as merely “anecdotal.”

Judge Judith Rogers supported our case and pointed out a cruel irony: In rejecting our appeal to extend cancer patients’ lives, said the judge, “the right to try to save one’s life is left out in the cold despite its textual anchor in the right to life.”

Chief Judge Douglas Ginsburg also supported our case. He argued: Do we have a constitutional “right to eat meat” when the Constitution is silent on the matter?

It is silent on drugs, which does not mean that we can’t take them. It is a right we are given by the Ninth Amendment: “The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people.”

It is tragic that a patient with COVID-19 and pneumonia or difficulty breathing cannot be given the remdesivir, which is safe and, in some cases, effective.

It sent the Palo Alto woman home rather than to the morgue.

Right-to-Try Laws Can Help Drugmakers Combat the Coronavirus

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President Trump recently announced he is extending social distancing guidelines to April 30th. He initially hoped to lift them by Easter. This is far from the first time he has changed his mind on how to best handle the coronavirus pandemic.

Although frustrating, the President’s indecisiveness is understandable. The United States recently surpassed China as the country with the most confirmed cases of COVID-19. Healthcare workers in many areas are overwhelmed, caring for infected patients. Public health experts continue to predict more infections and deaths in the near future.

Trust Private Enterprise to Flatten the Curve

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At the beginning of March, less than 100 cases of COVID-19 and two casualties had been confirmed in the United States. Coronavirus had since infected over 10,000 Americans, with a death toll of over 200.

The coronavirus is spreading at an alarming rate. Many are taking drastic measures to slow it down. But despite thousands of grounded flights, countless businesses and schools closing, and widespread commitment to “social distancing,” public health experts worry it will not be enough. If current trends continue, our health care system will be overwhelmed with infected and dying patients.

As panic escalates, many are calling for more government control to manage the pandemic. And government officials have answered the call by passing draconian measures.

Italy’s government has placed nearly 16 million citizens on lockdown, arresting thousands for traveling without state permission. France has mobilized 100,000 policemen to enforce its mandated lockdowns. Spain is taking a similar approach and recently nationalized all of its hospitals. Chinese government officials are forcefully removingcitizens from their homes to be quarantined.

We might be next. Political figures have called for the government to shut down businesses, use the military to manage hospitals, and take control of “crucial factories and industry.” President Trump has taken a big first step in this direction by invoking the Defense Protection Act to force businesses to produce medical goods that are in short supply.

These efforts are well intended, but they have their limitations, to say the least.

Italy’s lockdowns haven’t demonstrated much success. Recent headlines indicate that Italy is unable to treat older infected patients, who face the highest risk of dying. Further, research conducted by the Imperial College COVID-19 Response Team in the U.K. finds that the most effective ways to mitigate the spread of coronavirus do not involve government restrictions.

Lockdowns and other heavy-handed measures also severely damage our economy. Robin Brooks, the chief economist of the Institute for International Finance, believes the U.S. response to the coronavirus outbreaks will decrease GDP by 3.6 percent in the coming months.

So what’s the alternative?

Instead of pushing for more severe restrictions on our lives, we should look to markets to battle the pandemic.

Previously considered one of the countries most affected by the coronavirus, South Korea is now one of the few places in the world where new cases are in sharp decline. And this has happened without citywide lockdowns.

South Korea’s success is due to innovation. As the virus spread through China, the biotechnology company Seegene began developing tests. The company’s entrepreneurship has led to over 230,000 tests. South Koreans are also able to use mobile apps to track newly reported cases and highly contagious areas. During the height of the outbreak, coronavirus-tracking apps received more than 20,000 downloads per minute.

Inexplicably, private efforts to test for the coronavirus in the U.S. wereprohibited without certification from the Food and Drug Administration and Centers for Disease Control, which often took months. Until recently, only a few commercial labs were able to test for the coronavirus.

Not only did onerous regulations create a shortage of tests, but they also likely made the outbreak worse. As the virus first spread from Washington state, federal regulators ordered a private laboratory in Seattle to stop testing—even after it had submitted information indicating the virus was spreading. Washington state remains one of the hardest-hit parts of the country.

Thankfully, the FDA has since granted private laboratories the freedom to test for coronavirus. Testing has increased dramatically ever since. Popular retailers like Target, Walgreens, and CVS-Health are opening space for laboratories to make tests available to a concerned public.

FDA Should Expand Options for Coronavirus Patients

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The race is on to get medical supplies to struggling patients as COVID-19 continues to get worse. In repeated press conferences, the Trump administration has promised the continued, large-scale manufacture and delivery of products such as masks, gloves, and coronavirus tests. While President Trump rightly refuses to invoke the Defense Production Act to directly produce these supplies via nationalization, he has used the threat of this far-reaching statute to keep companies at maximum production. But all of the expedited manufacturing in the world won’t make much difference as the Food and Drug Administration (FDA) continues to drag its feet in inspecting, testing, and approving life-saving products and medicines. The agency must roll back the red tape holding up care for millions of Americans.

Needless to say, the FDA isn’t moving quickly enough to protect people during the coronavirus pandemic. After the Centers for Disease Control and Prevention bungled the early rollout of Coronavirus testing, the FDA waited weeks to allow laboratories across America to develop their own tests. But, even with this green light, the FDA continues to hold up the public health response to the pandemic. According to Washington Examiner journalist Tom Rogan, “At this very moment, stockpiles of masks, hand sanitizer, and other supplies are sitting in warehouses waiting for FDA inspectors to get around to them…I spoke to one significant medical supplier who talked to me on the condition of anonymity, for fear of FDA retaliation. In one location on the Pacific coast, this supplier has had more than 20 pallets of coronavirus-specific medical supplies waiting in a warehouse for five days. Yes, five days.” This couldn’t come at a worse time, as protective gear shortages are compromising care for the estimated 35,000 Americans who have the coronavirus.

For example, at Barnes Jewish Hospital in St. Louis, The New York Times reports that physicians undertaking invasive surgeries have had to use loose-fitting surgical masks in lieu of tight, recommended respirator masks. But fear not – the FDA “may consider expedited review of manufacturing site changes or premarket submissions” and companies are welcome to discuss mitigation approaches for products in shortages. While the FDA is committing to an “open door” approach, not much will happen unless the FDA allows boxes of critical supplies to be shipped to healthcare facilities and opened by experienced care providers. Since the agency is already permitting licensed pharmacists and doctors to make their own hand sanitizer, surely it isn’t a stretch to let doctors ascertain the quality of masks and gloves for themselves.

The clock is ticking for the FDA to prove to the nation that it’s willing to abandon the agency’s past risk aversion. There’s already plenty of discussion over expediting potential cures to the coronavirus, especially after President Trump tweeted on March 21 that anti-malaria drug hydroxychloroquine and antibiotic azithromycin “have a real chance to be one of the biggest game changers in the history of medicine” as a one-two punch. The agency recently allowed patients access to hydroxychloroquine (along with the investigational antiviral medication remdesivir) under its “compassionate use” framework, which allows patients with a serious or life-threatening illness access to experimental medications following a formal request process.

But the surge in requests for access to remdesivir has forced drug manufacturer Gilead to bar new requests following the treatment of just 250 patients. The company states that, “we are focused now on processing previously approved requests and anticipate the expanded access programs will initiate in a similar expected timeframe that any new requests for compassionate use would have been processed.”

Drug manufacturers such as Gilead are doing their best but are stymied by a bureaucratized system that prevents patients in harm’s way from getting access to promising medications. It’s time to let patients and their doctors come to informed decisions about how to treat a deadly disease without applications and middlemen getting in the way. Clinical trials are an absolute must, but in the meantime, countless patients have little to lose by giving medications such as hydroxychloroquine a try. The FDA should consider allowing the use of unapproved medications as long as patients sign a waiver and understand the risks.

The FDA should be leading the way in waiving inspection requirements and allowing greater use of promising drugs. Millions of lives depend on it.

The Mask Madness of Big Government

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As Newsweek reports, people are sewing their own face masks to protect themselves against the coronavirus. Readers might wonder why something as simple as a face mask might be in short supply. As it turns out, such masks are strictly regulated.

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.