COVID-19 may be the greatest societal threat in our lifetime.
According to The Institute for Health Metrics and Evaluation, the virus will peak in Utah on April 25. As of this writing, the site projects that the state will suffer 186 COVID-19 deaths, while the nation will see 81,766 deaths by August 4.
Faced with such a dire threat, it is hard for some people to understand why we can’t find a cure immediately. After all, we have self-driving cars and ways to beat some types of cancer. What are the roadblocks to quickly finding a treatment for COVID-19?
To understand the barriers, we need to understand a little about how drugs are developed and approved for use.
Drugs are developed in stages that includes initial animal studies through increasingly precise research studies on humans, FDA approval, manufacturing and distribution. Each stage narrows its focus on how safe and how effective the drug is, and each phase involves more test subjects and money.
Thousands of potential drugs are screened every year to find just a few that are safe and effective enough to be approved. The average drug takes at least 10 years to be developed and approved. Today, companies spend nearly $1 billion before they receive approval to market a new drug.
However, drugs that have already been approved for one purpose are sometimes studied to see if they will help with different diseases. Gaining approval to repurpose a drug requires less time than developing a drug from scratch. This is the kind of solution we hope will work for COVID-19. Alternatively, drugs already approved to treat a disease can be used “off label” even without entering a clinical trial.
But doctors should have enough data to know whether a particular drug is safe and effective for off-label use. Using a drug with insufficient information about its benefits and risks on the basis of wishful thinking can be a dangerous practice.
Hydroxychloroquine (which has been approved for malaria) and favilavir (an antiviral medicine) are examples of drugs already approved for other diseases that can be used for COVID-19 — but they would have to be used without evidence that they are safe or effective for COVID-19.
Currently, there is no medication or vaccine proven to be effective against COVID-19, despite what anyone says. Without research, there is no evidence of their safety or success in treating people with coronavirus — and research takes time.
However, there are thousands of people working hard to find a treatment. According to the Milken Institute, as of April 3, there are 97 studies involving possible treatment medications and 52 potential vaccines for COVID-19.
Separately, Clinicaltrials.gov reports that, as of April 7, there are 95 drug trials at various stages of development for the treatment of coronavirus. Most of these trials will take years to complete, and only a few will be marketed. However, there are 20 international studies involving hydroxychloroquine that, hopefully, will show some effectiveness within the year.
Drugs take a long time to develop because untested or inadequately tested drugs and vaccines can cause harm. Before any drug or vaccine can be approved for COVID-19, researchers must find that potential benefits sufficiently outweigh possible risks. It is the duty of the FDA and researchers to be sure the treatment is not more harmful than the disease. That takes time — and requires patience.
Meanwhile, physical distancing is the best way to help slow the spread of COVID-19. While scientists work fiercely to create successful treatments and vaccines, and health care workers work grueling hours at high risk of contracting the disease to care for those with the virus, we can best help by following the instructions from our public health authorities and understanding why the drug development process takes time.
Lynn Webster, M.D., is vice president of scientific affairs for PRA Health Sciences in Salt Lake City. His opinions are his own and do not necessarily reflect those of PRA Health Sciences.