The search for a COVID-19 vaccine is at a pivotal point in numerous pharmaceutical companies and laboratories globally. Many clinical trials are underway, determining the safety and efficacy of potential treatments in this fight. However, Donald Trump claims to have found the cure…
After testing positive for the virus, Trump stated that contracting COVID-19 was a ‘blessing from God’ and the treatment he received is our cure. For 3 days, Trump was admitted to the Walter Reed National Military Medical Centre where he was administered an antibody treatment, REGN-COV2, which is not currently approved by the Food and Drug Administration (FDA). It is unclear what ‘cured’ the president as he was actually given an antibody cocktail, so claiming that Regeneron (the drug) is the answer to this pandemic could be incorrect.
Since the beginning of the pandemic, Trump has raved about several drugs that could help tackle the outbreak. In March, he claimed hydroxychloroquine, an anti-malarial drug, was our answer and later stated the use of this drug in combination with azithromycin could be ‘one of the biggest game-changers in the history of medicine’. These claims resulted in the death of a US citizen after a couple took chloroquine phosphate, a chemical used to clean fish tanks, which is often found in anti-malaria drugs.
A MESSAGE FROM THE PRESIDENT! pic.twitter.com/uhLIcknAjT
— Donald J. Trump (@realDonaldTrump) October 7, 2020
For now, COVID-19 health guidance hasn’t changed: there is no cure.
A US president receiving a non-approved drug is a very unique scenario. Before any drug reaches the market, it must undergo rigorous testing and be approved by multiple bodies, such as the FDA. Clinical trials are a key for the development of a drug, allowing scientists to determine the dosage, side effects and effectiveness. There are 3 main phases of a clinical trial, with each phase increasing the number of volunteers and altering the demographics.
Phase 1 trials are the smallest of the three phases, involving a handful of healthy volunteers, to identify the safety of the drug. Phase 2 trials often consist of 100 people including individuals with the disease. The main aim of this phase is to establish effectiveness. Finally, phase 3 trials are conducted with thousands of volunteers. Some clinical trials may also have an earlier phase (phase 0) or a subsequent phase 4 trial.
Completion of a clinical trial is not the final stage. The drug must then be approved by the FDA and undergo more regulatory stages, such as quality control. Once a drug has been licensed to market, the FDA will monitor the drug for up to 2 years noting any additional side effects (and benefits). A drug can be recalled at any moment and depending on the urgency, it can be off shelves within hours.