What happens when politics and science mix? Scary stuff. Dr. Henry Miller examines the considerable downside of releasing any COVID vaccine prior to the completion of Phase 3 trials. The founding director of the FDA's Office of Biotechnology, Dr. Miller argues that precise science, not the date of an election, is critical at this time.
For everything, there is a time and place. Emergency Use Authorizations by the FDA were necessary for COVID-19's recent past; they are not necessary and will be harmful when applied to a COVID-19 vaccine.
This week marks the 37th anniversary of the approval of human insulin – the first biotech drug ever. Almost as revolutionary as the drug was its five-month approval by the FDA, which was two years less than average. Dr. Henry Miller celebrates the dawn of biotechnology. He should know. At that time he was in charge of the FDA team that reviewed it.
Due to the opaque nature of the pharmaceutical industry’s disclosures, a study published in JAMA Internal Medicine sought to quantify a standard amount companies spent on the research and development of cancer drugs. Do these R&D costs justify such high prices and revenues?