The UK, US, and Japan have all approved different drugs to assist with COVID-19. The fact that each medical community esteemed a different drug would provide the safest and most efficacious treatment for COVID-19 has raised red flags.
The medical community is now debating in the world's most prestigious medical journals how it can do better. Common themes are improvements in the emergency drug approval and pharmacovigilance consulting processes.
Mobilize Rapid Evidence-Based Trials
The quick approval process has shone the spotlight on pharmacovigilance in data collection and analytics. A tradeoff between evidence-based science and rapid drug approvals is not necessary, argue Harvard Medical School doctors in The New England Journal of Medicine.
Thousands of patients with coronavirus were submitted to hospitals daily with key study data such as the need for a ventilator, days in intensive care, and mortality rates known within days or weeks.
One such rapid study was conducted on 96,000 COVID-19 patients given hydroxychloroquine or chloroquine and reported in the Lancet. However the study, showing decreased survival rates, has since been retracted due to the unreliability of the data.
Employ Advanced Pharmacovigilance Data Management
Had these emergency trials used advanced pharmacovigilance systems to ensure the reliability of evidence—by applying software, artificial intelligence, and big data, for example—they could have lowered the risk of data errors.
Quantify Qualitative Risks
The reliability of drug manufacturer data is also at issue. The amount of qualitative data used in the FDA approval process increases in emergency drug approvals. UCLA researchers have sought to quantify data such as availability of alternative treatments, the seriousness of the illness, and other treatment options. For the coronavirus, other qualitative factors such as the rate of spread of the disease and the ability to prevent spread were likely considered. When quantifying such factors, the researchers produced higher significance levels than the FDA's 2.5 percent threshold for the probability of approving non-efficacious drugs.
Create Transparency in Emergency Drug Approvals
Increased transparency in the drug approval process could have avoided hasty emergency drug approvals, argue Yale and Harvard law and medical professors in Health Care Policy and Law. They state that although hydroxychloroquine and chloroquine have been found to eliminate replication of the coronavirus, no evidence existed of this at the time of the emergency approval.
All these studies point to the need to implement more rigorous pharmacovigilance standards. Drug approval agencies and drug manufacturers must ask themselves if they can do better in assuring the safety and efficacy of drugs when providing emergency approvals.
For information about how drugs get approval, reach out to a pharmacovigilance consulting company.