Ensuring Black Lives Matter in Drug Development
- PDF / 499,350 Bytes
- 2 Pages / 595.276 x 790.866 pts Page_size
- 29 Downloads / 234 Views
LETTER TO THE EDITOR
Ensuring Black Lives Matter in Drug Development William E. Fitzsimmons, Pharm.D., M.S.1,2,4 · Clara Okorie‑Awé, Ph.D., Ed.D.3 Received: 1 August 2020 / Accepted: 9 October 2020 © The Drug Information Association, Inc 2020
Recent events surrounding the Black Lives Matter movement has led many CEOs of biopharmaceutical companies to speak out against racial injustice wherever it is seen [1]. The support and action of these leaders is critical to making a difference on this issue within the pharmaceutical industry. It has long been recognized that Blacks are underrepresented in clinical trials in oncology, rheumatology, and cardiology [2, 3, 4, 5]. This is despite having a higher incidence of many diseases including diabetes, hypertension, asthma, sarcoidosis, stroke, and myeloma. We assessed the novel therapeutic drugs approved in the US so far in 2020 and identified 20 drugs where the FDA has posted their review documents. These Reviews were searched for data on race including Black or African American. Blacks comprised > 10% of the active treated population in only 5/20 (25%) of the approvals. Of the 8 oncology drugs, 7 (88%) described efficacy assessments in less than 10 Black patients, which was also less than 10% of the trial population. Representation in oncology studies is particularly important since Blacks have the highest death rates and shortest survival for most cancers and Black men have the highest cancer incidence. In some reviews, the FDA noted higher rates of adverse events or lower drug exposure in Black patients, however their ability to draw conclusions were limited as evidenced by statements such as: “The slightly higher incidence of TEAEs (treatment emergent adverse events) among black patients is likely not significant given the small numbers of black patients enrolled in the clinical studies,” or “There * William E. Fitzsimmons [email protected] 1
Department of Physiology and Biophysics, College of Medicine, University of Illinois at Chicago, Chicago, USA
2
Tutela Pharmaceuticals Inc, Vernon Hills, IL, USA
3
Diversity and Inclusion, College of Pharmacy, University of Illinois at Chicago, Chicago, USA
4
Vernon Hills, USA
were insufficient African American patients for any comparative analyses,” or “…this reviewer notes that the safety population is almost entirely white and worries that this may limit the generalizability of the results.” Although these limitations were described by the FDA reviewers, there were not Post-Marketing Commitments (PMCs) to study additional Black patients. It is paramount that we not delay the availability of innovative new therapies, but if there are inadequate representation of Blacks or other relevant groups this could be addressed in labeling so that prescribing clinicians are aware and also in Phase 4 commitments to help ensure that these data are collected post-approval. Generating these data are important since it is known that there are examples of pharmacogenetic (e.g. CYP3A5 metabolism, G6PD deficiency) and pharmacodyn
Data Loading...
