UChicago Doctor and Researchers Challenge FDA and Drugmakers on Cancer Drug Dosing
A community of researchers, doctors, and patients, including University of Chicago Medicine professor Dr. Mark Ratain and Northwestern University economist Chuck Manski, are advocating for more studies on optimal cancer drug dosages. They argue that current FDA-approved protocols for drugs like nivolumab (Opdivo) and pembrolizumab (Keytruda) may involve higher doses or longer durations than necessary, leading to severe side effects and significant costs. Manski, a cancer patient himself, opted to discontinue his nivolumab treatment early due to adverse effects and a lack of clear justification for the year-long protocol. Evidence from countries like India suggests that significantly lower doses of these immunotherapies can be effective, and European clinicians are also exploring reduced dosages. However, pharmaceutical companies, hospitals, and even some doctors have financial incentives that disincentivize dose-optimization studies, as lower dosages could reduce revenue and profits. The FDA, through its P...