By Alysha Clark
You can’t scroll social media or turn on the news without being bombarded with information related to COVID-19. The world is racing to find effective treatments and vaccines for a new disease that has infected at least 16 million people and killed more than 658,000 people thus far. We still know so little about the novel coronavirus, so we daily face a tidal wave of news reports, op eds, exposés, and downright conspiracy theories about the nature and seriousness of the disease, the sincerity of the effort to combat it, and the expected timeline for when (and if) we might ever be able to go back to life as usual.
Information from the experts seems to shift daily: Hydroxychloroquine shows promise, but then seems unsafe. Some say it has helped people, but now it may only be used as part of a clinical trial. Remdesivir shows encouraging results in reducing hospitalization lengths, but it is unclear whether it reduces mortality. Vaccines take years to develop, but we may have one by early next year, or perhaps never. Then of course the whole country is fighting over when and how to reopen economies, send children back to school, and resume travel.
In this environment of medical and financial uncertainty, as the flood of information (and misinformation) and politicking creates a pressure cooker of our public discourse, how are Christians to view medical research? We can argue all day about politics and crisis management and public health, but how can we speak well about clinical trials, especially in relation to COVID-19?
Medical Research: Complications and Controversy
Medical research is a vast and complicated field. In 2019, the FDA approved 48 novel drugs. And as of mid-July, the FDA has approved 28 novel drugs this year. The clinicaltrials.gov website contains 2,734 studies related to COVID-19. (These trials include tests of a combination of drugs for treating COVID, tests to identify biomarkers, observational registry studies, behavioral studies among certain populations to manage stress, etc.) In light of the ongoing flurry of medical research, people often ask whether these drugs are safe, whether we should put chemicals into our bodies, or whether we should trust vaccines, especially a COVID vaccine that is being developed at rapid pace.
In addition, some people question the trustworthiness and intentions of the medical researchers themselves. The history of medical research is dotted with horrible cases such as the Tuskegee Syphilis Study, the theft of Henrietta Lacks’ cancer cells and researchers (such as former oncology researcher Dr. Anil Potti) falsifying their results. Likewise, numerous television shows have crafted episodes about pharmaceutical companies hiding or falsifying data to get a bad drug approved. The popular narrative now is that big pharmaceutical companies take advantage of the sick to make a profit; for example, skeptics say, the cure for cancer has already been found but scientists are keeping it under wraps so Big Pharma and hospitals can get rich. Additionally concerning is the involvement of political figures with pharmaceutical companies, with politicians either receiving money from pharmaceutical lobby groups or holding stock in pharmaceutical companies.
Many of the listed concerns are valid, but they do not reflect the field of medical research as a whole. The skepticism of modernity that once caused us to question the value of faith has now led us to doubt the effectiveness of the very scientific method that encourages skepticism in the first place. The average person is unfamiliar with the inner workings of medical research, particularly clinical trials. This unfamiliarity is unfortunate because research has had a positive effect on the length and quality of life across the globe. Because I am a Christian who works in medical research, I would like to give you a peek behind the curtain to see its inner workings.
What Really Goes on in Medical Trials
First, know that medical research is one of the most highly regulated industries in the world. Because of tragic events like the inhumane Nazi experiments during World War II and deceptive research on poor and disadvantaged people in the 20th century, the field of human subjects research is bound by numerous guiding principles and strict laws. All individuals and organizations conducting human subjects research must comply with the Nuremburg Code, the Code of Federal Regulations and the International Conference on Harmonization’s Guidelines for Good Clinical Practice (ICH GCP). All participants in any study must provide written informed consent without coercion, and they can withdraw that consent at any time. Additional guidelines dictate proper conduct for vulnerable populations such as children, prisoners and (in the United States) people for whom English is not their first language.
Two fundamental principles guide any clinical trial:
- The proposed benefit of the treatment must outweigh the risks.
- The proposed treatment must be at least clinically non-inferior any other current approved treatment.
For example, in the first case, the side effects of a drug cannot be worse than the original condition the drug is designed to treat. In the second, researchers cannot develop a drug that is inferior to a drug already on the market. They may want to demonstrate that a generic formulation of a painkiller works just as well as the name brand, or they may want to claim that one brand of a painkiller works faster, lasts longer, or has fewer side effects than another. Contrary to the scientific experiments conducted during World War II, we cannot perform exploratory research that intentionally injures a participant (whether physically or psychologically) to test the limits of the body; all research must pose a potential benefit to the individual participant and to society as a whole. The goal of medical research is to improve health.
The two pillars of clinical trials research are safety and efficacy. Scientists conduct clinical trials to ensure the agents we put into our body (whether naturally occurring or synthetic) are safe and that they actually work. To confirm safety and efficacy, any new drug, or new combination of drugs, must undergo multiple phases of research before researchers can submit the agents for FDA approval.
- Phase I trials usually involve administering a drug to 20-100 volunteers for the purpose of determining the safety of the drug, including the maximum safe dose that can be given without causing harm.
- Phase II trials employ 100-500 volunteers to test the effectiveness of the drug.
- Phase III trials can test thousands of patients to further measure efficacy. Side effects are collected during all phases of drug testing, but they are especially emphasized in this phase.
If a drug passes the first three phases of testing, researchers submit their findings to the FDA for approval. If the FDA approves the investigational agent (which can take over a year of review), researchers conduct Phase IV trials after the drug is available on the market to determine long-term effects of drug exposure and the medication’s use in a wide population. The entire research process for any one drug can take up to 15 years and $1 billion to go from initial discovery in the lab to the market. For every one treatment the FDA approves, up to 10,000 potential investigational agents fail this process.
Medical Research Is About Improving Lives
What does all of this information mean for the average Christian?
Just as in any other industry, recognize there are people in the pharmaceutical industry who may try to take advantage of the system or break the rules. Some individuals may be motivated more by profit than by altruism. Others may attempt to use their company’s prestige to gain favors or influence lawmakers to benefit them. Every industry has politics and companies can be protective of their patents to the detriment of working with other organizations to discover the best solutions for curing disease.
But most people I’ve met want to make people’s lives better. In my time working with oncologists, nurses, study coordinators, pharmaceutical company employees and contract research organization employees, this desire to improve lives is a common thread running through these universities, hospitals and businesses.
As a Christian, I believe in clinical trials research because I see the goal of medical research is to counteract the effects of the fall (Genesis 3:19). Because of our disobedience and rebellion against God in our father Adam, the world no longer works the way it should. Our bodies fail, we get sick and we die. Medical research helps us find ways to heal sickness and make our lives better. And while God has given us many good things in creation that naturally treat disease, he has also given us the ability to work with the creation, cultivating it to bring out its possibilities and create even better treatments that heal or prevent illness (Genesis 1:28; 2:15).
Medical research is immensely difficult. Few people see the considerable number of hours and dollars spent trying to do the good work of bringing healing to creation. Yet medical research is also rewarding, and Christians can encourage participating in and funding research to help ministering to both the healthy and the ill.
Takeaways for the Present Situation
In any time, but especially now as scientists are conducting seemingly countless trials related to COVID-19, it is important for Christians to emphasize science literacy:
- Understand the steps of the scientific method. First, we ask a question. Then, after performing preliminary background research and form a hypothesis. We test the hypothesis with an experiment. Then we analyze the data and draw conclusions. The results may confirm the hypothesis, reject the hypothesis, or be inconclusive. We then use these results to serve as the background research to do more testing and repeat the process. This process is why it sometimes seems like the science is constantly changing. One trial may indicate a drug is safe or effective, but when the method is duplicated in another setting or with another population, that may not be the case. We always test and re-test and expand the sample to verify results.
- When possible, read studies in medical journals rather than opinion pieces or even news reports. There is certainly a hierarchy in the news media regarding reliability and accuracy. But even when reading trusted news sources, seeking out the original study reported in a medical journal is always best. News outlets necessarily condense information for readability and thus may miss important nuances about the data or even misreport the conclusions of a study (intentionally or not).
- Exercise caution. Check the source. Claims of miracle drugs that seem too good to be true are probably not true. Because we live in a fallen world, we must face the reality that some people lie to benefit their wallets or position. It is okay to have a healthy dose of skepticism—Christians are to be shrewd as serpents after all (Matthew 10:16). But be careful to not let cynicism lead to conspiracy theorizing. Read a variety of good sources with reputable authors who are experts in their fields.