More than 500,000 people have now died from COVID-19. It was the biggest killer of Americans last year despite all the preventative measures taken and despite a related increase in deaths from heart disease, the prior holder of the title of deadliest health problem (people were less likely to go to the doctor because of fear of COVID, so diagnoses were delayed and thus more died from other deadly diseases). Fear of the disease also crippled the global economy (If going out comes with a high likelihood of infection, it turns out people go out less often). Given the speed and scale of the pandemic, we might expect the FDA to take more aggressive approaches to drugs meant to prevent or treat the disease. Unfortunately, that just has not been the case. AstraZeneca’s vaccine, despite usage across Europe, the UK, and Israel, is getting panned by FDA officials because it might not be quite as effective as early studies indicate.
This example highlights a problem that has only gotten worse over time: the FDA places a much higher value on lives lost because of a problem with a drug than it does on lives lost because of diseases. People suffering from terminal illnesses cannot access drugs that have been shown to help alleviate or even cure those illnesses in clinical trials. Drug approval processes can take upwards of two years AFTER clinical trials have concluded. The time it takes to bring a drug to market has steadily risen and now stands at a staggering 14 years.
Regulation in the healthcare industry is important. Without some arbiter determining whether drugs are safe and effective, people would have a much more difficult time figuring out what might be safe. We would rely heavily on doctors to tell us what to do, but not all doctors are able to keep up with all information about all drugs, so that could cause serious problems. Having a trustworthy institution certify that drugs are doing what they are supposed to do simplifies things for everyone. This became problematic only because the FDA sets the bar for approval high enough to quash any possibility of a drug being approved that should not have been. Officials are highly risk-averse because if they approve a drug that turns out to be bad, they will look bad, but if they take a long time to approve a drug, they can blame the process.
The New York Times recently ran an article revealing extensive delays in drug inspections by the FDA in 2020 and COVID was blamed. No further questions were asked. Thousands of people will not have access to needed drugs, but it is not because of COVID. FDA employees could still travel to facilities with proper PPE, but, instead, they have simply refused to do their jobs. The Times, for its part, took the exact same view as the FDA.
We cannot blame FDA officials. Humans are inherently risk-averse and we fear the results of action far more than the risk of inaction. We just need a more intelligent system. FDA approval for provisionary use should be the norm. If people are in desperate straits, they should be able to take drugs that could save their lives before the approval process is completed. The risk of doing nothing is quite clear to someone told they have a few months to live. Rather than a gatekeeper, the FDA could serve as a certification board for drugs treating serious illnesses.