The medical industry is highly regulated by government at both the Federal and state level. The justification of the extensive regulations is to protect the public from abuse at the hands of bad doctors, pharmacists, and other medical providers as well as from drug companies selling dangerous drugs.
There are cases when health industry regulators help people, prevent suffering, and save lives. However, there are also cases when people are hurt, forced to endure unnecessary suffering, and needlessly die because of regulators. Balancing the costs and benefits can sometimes be challenging, but government regulation almost certainly creates more costs in economic, human suffering, and human life.
The primary reason for this is that regulators tend to be more risk averse than the average medical consumer (patient) and want to avoid blame for people being hurt by bad drugs or bad medical practitioners. They are also more interested in building bureaucratic empires than delivering value to patients and consumers. Patients are often willing to make riskier trade-offs than regulators because they have a personal stake in good outcomes as well as the bad outcomes. Regulators are more concerned about avoiding bad outcomes than getting good outcomes. This is because of a desire for job security. There is no credit for good things approved, no significant penalty for good things NOT approved or delayed, and suffering horrible, job threatening blame for bad things approved.
The most recent example of bad outcomes from medical regulation is the use of hydroxycloroquine to treat COVID-19.
Many physicians have successfully used hydroxycloroquine to successfully prevent and treat COVID-19. There are no clinical trials to support this, but there are no clinical trials disputing it. Given that COVID-19 is new, it would be almost impossible to have legitimate clinical trials. However, experience from treating patients successfully should be considered valid information in a fast breaking medical situation. The only negative studies were done incorrectly and retracted. A negative study at a VA hospital used excessive doses and administered them too late to do any good. Yet, the discredited studies are still used by government agencies as justification for not using hydroxycloroquine to treat COVID-19.
Nobody has documented anything except minor side effects from using hydroxycloroquine in its many decades of use. Even if it provides no benefits, it does not hurt someone who takes it. That means even a small chance that it will work on COVID-19 should encourage its use since there is no risk.
The FDA was pressured by the Trump Administration to permit use of hydroxycloroquine to treat COVID-19 and issued a temporary permit. It let that permit expire and refused to extend it citing the flawed VA study and lack of clinical trials proving its effectiveness.
Anthony Fauci at the CDC also discouraged the use of hydroxycloroquine based on the same flawed study and the FDA not approving it for COVID-19. Remember that Fauci initially told the general public that masks were not helpful in preventing the spread of COVID-19 before he changed his public stance. He said that the reason for lying about the science of using masks was to prevent the public from using them and aggravating an existing shortage of masks available for use by medical personnel. Shortages of hydroxycloroquine have been reported for people who regularly take it for chronic conditions. Perhaps he is discouraging hydroxycloroquine use for COVID-19 to protect the supply for other people being treated with it for chronic conditions. Since Fauci is a doctor of medicine rather than economics, he should stick to medical and scientific determinations. Supply and demand are something beyond his expertise.
Based on the FDA and CDC positions, the Wyoming Board of Medicine and Wyoming Pharmacy Board have prohibited the use of hydroxycloroquine for treating COVID-19. In addition, they explicitly reference the shortage of hydroxycloroquine for patients already taking it for chronic conditions as a reason for prohibiting its use for COVID-19. This shortage is documented by anecdotal evidence from a few pharmacists sending in emails. Again, we have government organizations that should be making determinations based on medical and scientific factors making decisions based on supply and demand which is outside their area of expertise and, if it isn’t illegal, should be. Any medical providers writing hydroxycloroquine prescriptions for COVID-19 and any pharmacists filling them, are subject to having their licenses revoked for unethical behavior even though it is normal and legal for prescriptions to be written for drugs to be used for purposes they were not originally approved for. The real ethical question is why are the Medical Board and Pharmacy Board coercing doctors and pharmacists to act contrary to the interests of their patients in order to protect the supply of a drug for “preferred” patients with “preferred” conditions when they don’t even have conclusive evidence of a serious supply problem.
The actions of regulators are probably costing many lives in this instance. Many doctors report reducing death rates by at least 50% by using hydroxycloroquine. Some report losing no patients when hydroxycloroquine treatment was started early enough. Of course, that will not work with people who die with COVID-19 rather than because of it which limits the effects on the CDC mortality numbers. However, it is reasonable to assume that tens of thousands of lives could have been saved by appropriate use of hydroxycloroquine as it has been used in many foreign countries.
President Trump took forceful action to secure a sufficient supply of the drug from India, the leading hydroxycloroquine producer. Thus, the supply and demand decisions should be left to the political leadership or the free market (or both working together in their own spheres) rather than in the hands of bureaucratic government regulators. India is using hydroxycloroquine successfully to prevent COVID-19 deaths and Indian companies have dramatically increased production of the drug.
Our government medical regulators have failed us once again.
It is impossible, without a thorough investigation, to conclusively determine why. However, it almost certainly has to be one of these reasons or a combination of them:
Ignorance of how markets and supply chains work.
Malevolence regarding the effects of limiting prescriptions to their approved purposes.
Bureaucratic inertia and reluctance to take any risks with approving a drug for an alternative use even during a serious outbreak of an illness.
Favoring the use of more expensive drugs currently going through the regulatory process.
Willingness to increase suffering and deaths to increase the death count attributed to the President for political purposes.
Less government and more free enterprise is a better way to allow people to protect themselves. Bureaucrats are not accountable to the people and easily run roughshod over their rights and even their lives.
Comments