Almost exactly a year ago, on 23 October 2019, CapeRay’s senior management team held an online pre-submission meeting with representatives of the Food and Drug Administration (FDA). Our purpose was to seek the FDA’s guidance on an appropriate pathway to secure regulatory approval for Aceso, our novel system that incorporates dual-modality imaging for early detection of breast cancer. Less than two months later, on 17 December 2019, radiation oncologist Dr Stephen Hahn (seen right, © University of Texas) was appointed Commissioner of the FDA by President Donald Trump.
Hahn could not have foreseen the challenges that lay ahead for him and the American people – the deadly coronavirus, subsequently known as COVID-19. As the medical community scrambled to find therapeutic agents to treat the disease, the FDA was called upon to adjudicate on the safety and efficacy of certain drugs. During a declared state of emergency, the FDA has the authority to apply an emergency use authorization (EUA) for a drug that has not yet undergone extensive clinical testing.
Under pressure from the White House, on 28 March 2020, Hahn granted EUA for hydroxychloroquine, an older drug used to treat malaria. Given the lack of scientific evidence, the biomedical community lost trust in him and, three months later when the clinical data showed the drug did more harm than good, the EUA was rescinded. Hahn courted controversy again in late August when he issued an EUA for convalescent plasma which is made from the blood of patients who have recovered from COVID-19. To date, this treatment has not yet proven successful.
Hahn’s greatest challenge has been to set stringent protocols for the approval of a vaccine for COVID-19. Yesterday, Dr Holden Thorp, editor of Science, stated: “The pressure put on Hahn by the scientific community played a big role in stiffening his spine.” He has incurred the wrath of Trump by insisting that an EUA for a vaccine will only be issued once testing has been completed, which will occur after the election on 3 November.
In South Africa, scientists have also had to endure the interference of politicians during the COVID-19 pandemic. Dr Glenda Gray (seen right), president of the country’s Medical Research Council, felt compelled to speak out during the strict lockdown in mid-May, stating that some of the regulations were irrational and unscientific. She was chastised by government officials and threatened with “investigation” but, to its credit, the academic community rallied to her defence, standing up for science.