• Tag Archives COVID-19
  • The COVID-19 Crisis Is the Result of Decades of FDA Misrule

    The COVID-19 pandemic is exposing how the US Food and Drug Administration puts Americans at increased risk of sickness and death. Decades of killing medical innovation and forcing industries offshore made this inevitable.

    Rightfully, many are questioning how things got this bad. As political stock rises in calls for change in Washington, Americans must watch out for any false debate that merely aims at rearranging deck chairs.

    The real debate should be over how best to downsize or abolish the FDA, which contributed greatly to the vulnerable state in which America now finds itself.

    The FDA is one of those many creatures of Congress that effectively wields legislative, executive, and judicial power, with almost no real accountability. It has grown mightily since its inception in 1906.

    Yet, thanks largely to its treatment in the media, many Americans have never imagined how the country might benefit from doing away with the bureaucracy. That may change now.

    The FDA’s most public failure is its most recent, the blocking of any private production of coronavirus test kits during the initial outbreak. How many Americans will pay the ultimate price for this policy remains to be seen.

    It wasn’t until March 16, over two weeks after the first American diagnosed with coronavirus died, that the FDA allowed private labs to have their testing kits approved by state agencies. By that time, about 5,145 people in the US had been infected, and at least 91 died.

    Sadly, the only test kits available before then were produced by the US Centers for Disease Control and Prevention. They didn’t work, but luckily for the CDC, government agencies are never held to the same standard the private sector is.

    Intrepid journalist James Bovard has documented for decades the FDA’s fatal flaws that pushed much of the American healthcare sector to foreign countries or out of business entirely. He traces this back to at least 1990, when Dr. David Kessler was made commissioner.

    As enforcer, Kessler employed tactics familiar in communist countries. His top enforcer of the Drug Surveillance Branch was quoted in a Washington University scholarly paper, saying,

    The old way is over. We used to say that if a company made certain changes, then we would probably not take any action. Now, we won’t. Now, even if they make the changes, they might end up in court. We want to say to these companies that you don’t know when or how we’ll strike. We want to eliminate predictability.

    Bovard notes the medical device industry was hit hard by Kessler’s FDA, citing an American Electronics Association survey that showed “40% [of medical device companies] reduced the number of U.S. employees because of FDA delays, 29% increased their investment in foreign operations, and 22% moved U.S. jobs overseas.”

    Securing those foreign-produced devices for Americans has not been easy. Tesla and SpaceX CEO Elon Musk took it upon himself to have around 1,000 respirators flown into Los Angeles from overseas, but their delivery was held up by the FDA.

    Despite the FDA’s best efforts, there are still incredibly productive companies making medical devices in America. The San Francisco-based company Nurx, Inc. announced a $181 coronavirus home test and a plan to send out 10,000 of them just four days after the FDA lifted some of its restrictions on private tests.

    However, Nurx was forced to cancel its product release, because the FDA so far refuses to curtail its restrictions on home tests.

    The lack of test kits are only half the story of America’s prolonged struggle with COVID-19. The other half is the over-regulation of medical treatments and medicines, which also dates back to at least the 1990s under Kessler.

    Kessler ordered that approved drugs should only ever be used for their original purpose. Even if the approved drug was found to cure or treat another ailment, the manufacturers were prohibited from informing doctors of the fact.

    It should be clear now why the mainstream media so reflexively maligned President Donald Trump for suggesting the anti-malaria medicine hydroxychloroquine could be used to treat coronavirus.

    The media has a long history of cheerleading for increased government intervention or simply running cover for the regulators.

    Take for instance this March 31 Bloomberg article with the headline: “Coronavirus Forces Cancer Trial Changes Patients Long Sought.” You have to read nine paragraphs before learning the FDA eased up on its clinical trial regulations. Is that what the headline suggests?

    “Coronavirus forces regulators to cut their own red tape to save face.” That’s the real narrative of the whole government response to coronavirus. Reporters aren’t lazy. Telling the truth would be easier than lying.

    The failures of the regulatory bodies and the media are piling up, but Americans may still recoil at the thought of outright ending the FDA. Any political leader who cares at all for public health must, at the very least, call for a drastic downsizing of the runaway bureaucracy.

    The types of prohibitive powers that the FDA exercises were once thought to require a constitutional amendment. Alcohol prohibition, after all, wasn’t instituted by a simple act of Congress, but instead was enacted through the Eighteenth Amendment.

    Shortly after the failure and repeal of alcohol prohibition, there was a dangerous shift in how Congress interpreted its powers under Article I Section 8 of the Constitution. The FDA might be the most egregious example of the consequences of this disastrous turn in history.

    The Congress cynically touted the Commerce Clause as a mandate to legislate beyond their limited, enumerated powers. As a result, the original purpose of the Commerce Clause, to ensure free trade between the states, was flipped into an unlimited power to prohibit commerce.

    This is how the FDA grew into its current monstrous form.

    In order to overcome the coronavirus crisis and to be fully prepared for the next public health episode, America must rid itself of the bureaucracy that has slowly choked out the greatest medical industry in the world.

    If Americans want to live in a truly free country, then there must be internal reform before any meaningful external reform. It begins with rolling back the FDA.


    Gavin Wax

    Gavin Wax is president of The New York Young Republican Club, an Associate Fellow at the London Center for Policy Research, and publisher of The Schpiel. His work has appeared in Townhall, The Daily Caller, The Hill, The Washington Examiner, The Federalist, Human Events, and Newsmax. He is a frequent guest on Fox News. You can follow him on Twitter @GavinWax

    This article was originally published on FEE.org. Read the original article.


  • Why Taiwan Hasn’t Shut Down Its Economy

    As the Austrian school of economics demonstrates in the calculation theory of socialism, no central planning body has the capacity to organize society based on coercive mandates. The main reason is that the central planner is unable to obtain all the necessary information to organize society in this way, as information has subjective, creative, dispersed, and tacit qualities. This principle is fully applicable to the containment of a pandemic. Individual responsibility along with transparency of information are crucial to stopping a pandemic. Taiwan makes a very good case for how individualism and voluntary cooperation work effectively in resisting the coronavirus pandemic.

    At the moment in Taiwan, the infection has been completely contained despite being one of the countries with the highest risk of suffering a pandemic, given that the Republic of China (ROC) is very close to the Chinese mainland (the People’s Republic of China (PRC)). Until January there were flights between Taiwan’s capital, Taipei, and the epicenter of Wuhan, China. However, as of March 21 there were only 153 infected at the same time that Europe, far away from the Chinese mainland, has more than ten thousand affected by the coronavirus. However, in Taiwan and other parts of Asia, including Singapore and Hong Kong, no massive mandatory quarantine or containment has been applied so far.

    How did Taiwan achieve this?

    The first cause of Taiwan’s success is the transparency of information, which stopped the rapid growth of infection. The containment in Taiwan has been carried out with relatively high transparency. As early as December 31 of last year the Ministry of Health and Welfare of Taiwan began to take serious the potential danger of the Wuhan pneumonia, informing citizens every day about the developing trends of the infection and its status. The information provided by the Taiwanese authority also includes whether the infected in Taiwan contracted the illness from overseas input, which helps people take measures to protect themselves in a timely manner. In the constant press conferences, the Taiwanese government provides different options and recommendation that people can choose to adopt voluntarily but are not imposed coercively. The abundant information provided continuously has allowed individuals to make their own informed and balanced decisions under conditions of uncertainty. In contrast, the governments of the European Union countries reacted slowly and as late as February did not provide sufficient information about the potential pandemic, making the situation difficult to handle.

    The type of quarantines established by the Taiwanese government are mostly self-quarantines. The Taiwanese government acknowledges that it is crucial to rely on people’s voluntary actions to resist the pandemic. As we have noted above, most cases of contagion in Taiwan come from outside and are almost always detected at the border.Taiwanese people’s voluntary self-protection is effectively suppressing the spread of the coronavirus in their country, and forced quarantines are usually for the most serious cases, for example, the infected Taiwanese evacuated from the Chinese mainland.

    One of the problems with the coronavirus has been maintaining a balance between economic activity and containing the infection. In this regard, different from what the southern European countries such as Italy and Spain do, the Taiwanese government’s policy is not to take preventive measures to stop the outbreak by impeding economic activities. Taking the schools as an example, the beginning of the course was delayed for two weeks at first. Currently schools’ policy is to take students, teachers, and workers’ temperaturesIf fevers are detected, classes in that school are suspended, but massive class suspensions do not occur. At the same time, online teaching is being encouraged, but is not being forced by the government. In many Taiwanese universities, online teaching is being promoted in order to let those who are not able to attend class in person to take courses. Although it is true that online education as a way to avoid infections has already been adopted in other countries, the peculiarity of Taiwan lies in the fact that it has not been imposed by government order. Not everyone is required to study online or telecommute, but there has been strong encouragement to do so. The government’s transparency of information has also given the Taiwanese enterprises the time they need to voluntarily prepare and adopt teleworking progressively. Other countries instead suddenly shut many businesses down through mandatory government orders, as Spain did on March 13, without giving enterprises and their workers time to prepare for quarantine.

    The Taiwanese government is controlling the spread of the infection with flexible policies, which leave much room for individuals to take initiative and make their own decisions. Each individual can take the most appropriate measures for their own situation, having their own incentives to be cautious. Likewise, the fact that the Taiwanese citizens have been warned since the beginning of the infection has created a generalized awareness to make the necessary preparations and has given citizens enough time to assume that they must make changes in their lives in order to avoid being infected.

    This flexibility in containment and transparency policies has led to a high degree of individual responsibility. Proof of this is not only in the population’s tendency to wear masks that the Taiwanese population, which can be observed in any means of communication, but also in the adoption of new ways of continuing daily activities so as to avoid contagion. Private sectors have also taken quick actions to protect their clients. Most residential buildings have at least one ethyl alcohol dispenser so that everyone who enters can disinfect his or her hands. For example, ethyl alcohol has been available in Uber cars for several weeks.

    To conclude, with transparency and diligence the Taiwanese government has avoided many problems. The key is that the Taiwanese government and the Taiwanese people understand that the individual’s own responsibility and actions are essential to suppressing the coronavirus pandemic, not a mandatory massive shutdown. This is what the world needs to learn.

    This article was reprinted from the Mises Institute. 


    Javier Caramés Sanchez

    Javier Caramés Sanchez is a PhD candidate in Chinese Literature at the National Taiwan University and a Spanish language teacher who lived in Taiwan for more than seven years. He received one master’s degree in Classical Philology at Salamanca University, Spain, and another one in Chinese Literature at National Taiwan University. He also taught courses at Tamkang University and National Taiwan University in Taiwan and at IE University in Spain.

    This article was originally published on FEE.org. Read the original article.


  • An Alternative to the Lockdown Strategy in the Fight Against Coronavirus

    The current coronavirus strategy of most governments is a recipe for a worldwide economic disaster. In many countries, the strategy of confinement and forcing shops to close is a sure-fire path to large-scale business failures. The cascade of economic and financial repercussions to come is likely to lead to another Great Depression.

    Italy, for example, already had a 135 percent debt-to-GDP ratio before the crisis. It is hard to imagine how it will be able to borrow more without a commitment from other European countries to jointly be responsible for more Italian debt—something the northern European countries are still strongly opposed to. The ECB is already printing money like crazy, and another Greece-like situation will make it ramp up the printing presses even more. We have been down this path many times before, where the cure is clearly much worse than the disease. The German hyperinflation of 1921-1923 created a resentful, impoverished middle class which ultimately led to Hitler’s rise to power.

    The coronavirus (SARS-CoV-2) that originated in China is highly contagious. More than 80 percent of the patients show only mild flu-like symptoms but for the remaining 20 percent, mostly the elderly or people with preexisting conditions, the virus can be life-threatening. To save lives short term, the entire population in Europe is currently being held under house arrest and many businesses have been put into a pre-liquidation state by no longer being able to realize a profit due to inactivity.

    The current strategy is not to stop the virus in its tracks but to spread out the contagion so that the peak is a level that will be more manageable for the health care system. Governments took the biased advice of health care professionals without a real weighing of all the pros and cons. This prolongation in time, however, will come at a steep economic and human cost.

    In the longer term, more lives will be lost if we continue this strategy. How many victims of financial ruin will end their own lives? In the modern era, for every one percent increase in the unemployment rate, there has typically been an increase of about one percent in the number of suicides. A study conducted by Brenner in 19791, found that for every 10 percent increase in the unemployment rate, mortality increased by 1.2 percent, cardiovascular disease by 1.7 percent, cirrhosis of the liver by 1.3 percent, suicides by 1.7%, arrests by 4 percent, and reported assaults by 0.8 percent (see here). How many lost lives out of 300 million in the USA does a 10 percent, 15 percent, 20 percent unemployment rate represent?

    The use of the free market gives another strategy to control the spread of the coronavirus. For example, we now have strong evidence from trials in France and China that in 75 percent of the cases a combination of two extremely well-known antimalarial drugs (hydroxychloroquine in combination with the antibiotic azithromycin) can bring the viral load down to nearly zero after just six days (complications usually arrive after the 6th day). These drugs could make the latent effects of the Wuhan virus as mild for 20 percent as the other 80 percent, and they were recently cleared for use.

    There are many other possible drug combinations that might offer similar results, but FDA and EMA regulations requiring long term testing make it much more difficult for these drugs to be available in time to treat the virus. Yet the world economy is at stake and we cannot sit and argue on the quality of the water while our house is burning down.

    An obviously better solution than sinking the world economy into a great depression is a greater use of “laissez-faire.” The current lockdown strategy is a bleak choice of (allegedly) fewer short term deaths against a much larger long-term death toll. We must return to a business-as-normal situation as soon as possible. We need to free drugs from overbearing drug regulations and make them widely available (with appropriate dosages and warnings) everywhere at a market price without the need for a prescription. We need markets to be free so they can provide a wide choice of medications.

    The argument is not for a non-strategy; it is for allowing the markets to define the strategy. For example, the elderly might consider taking chloroquine preventively; it has a long history of being taken to prevent malaria in Africa. It is naïve to think that people can’t inform themselves and take appropriate actions for their own health benefits.

    It is also naïve to think that businesses and people won’t adapt to the perceived threat. Restaurants can seat patrons several meters apart. Waiters and cooks can wear masks and gloves. There is an infinite number of innovative ways people will adjust. Just because we cannot imagine a voluntary market solution does not mean one does not exist. South Korea is an example to emulate. Instead of an authoritarian locking down of its people, it took a much more libertarian approach to the problem and is already showing promising results.

    This market-oriented strategy is obviously not without risks, but we must move away from the current defensive 16th-century bunker mentality and consider less disastrous economic alternatives.

    1. Brenner, M. Harvey (1979). “Influence of the Social Environment on Psychology: The Historical Perspective”. In Barrett, James E. (ed.). Stress and Mental Disorder. New York: Raven Press. ISBN 978-0-89004-384-4.


    Frank Hollenbeck

    Frank Hollenbeck is a financial consultant who worked for the State Department as senior economist, Caterpillar overseas as chief economist, and Director of Research at the Banque Eduard Constant in Geneva.

    This article was originally published on FEE.org. Read the original article.