Racial under-representation in clinical trials: Consequence, myth, and proposition

The historical under-representation of Blacks in clinical trials is well-documented. The ethical ramifications of racial under-representation in clinical trials are exacerbated by the epidemiologic and clinical consequences. For example, persistent under-representation undermines generalizability and challenges inferences regarding treatment safety and efficacy for minority races. The potential for such consequences warrants greater racial diversity in clinical trials. However, investigators have assumed that recruiting Blacks for clinical trials is hampered by unwillingness to participate. Recent reports indicate that the perception of unwillingness may be unjustified. An often overlooked aspect is that conventional recruitment strategies may be ineffective for recruiting racial minorities. Public health professionals from all disciplines have the collective capacity to improve racial diversity in clinical trials primarily because of access to minority communities. Public health professionals could facilitate an effort to encourage collaboration between trial centers and community health clinics in predominantly minority settings

Health Care Policy Issues as a Result of the Genetic Revolution: Implications for Public Health

The genetic revolution has spawned 4 distinct issues of universal importance to health care policy and society: genetic privacy, regulation and standardization of genetic tests, gene patenting, and education. Adequate policy advancements for these 4 areas are lacking. Stringent controls must be placed on individual health records to prevent their misuse. Genetic testing within the clinical setting should undergo thorough evaluation before it is implemented. Regulations are needed to prevent the monopolization of DNA sequences. Society and health care professionals must be educated about the scope of genetic testing because current trends indicate that genetic and molecular assessments are destined to become a routine component of health care

Cytogenetically defined myelodysplasia after melphalan-based autotransplantation for multiple myeloma linked to poor hematopoietic stem-cell mobilization: the Arkansas experience in more than 3000 patients treated since 1989

Myelodysplastic syndrome (MDS) is a well-recognized complication of chemotherapy for multiple myeloma (MM). Serial bone marrow metaphase examinations were performed for MM restaging in 3077 patients undergoing high-dose therapy (HDT). MDS-associated cytogenetic abnormalities (MDS-CAs) were observed in 105 of 2418 patients in whom cytogenetic data were available after HDT. MDS-CAs occurred transiently in 72 patients and on 3 successive occasions (persistent MDS-CAs) in 33 patients, for 10-year estimates of 4% and 2%, respectively; only 21 patients developed overt clinical MDS and 5, acute myeloblastic leukemia (AML). MDS-CA development was linked to lower CD34 yield at collection, longer time interval from MM diagnosis to HDT, older age, and lower platelet recovery after HDT; persistent MDS-CAs were predicted by CD34 yield of less than 3 × 106/kg and need for more than 2 apheresis procedures. Applying a tertile frequency distribution over time to all 105 patients with MDS-CAs, its detection early after HDT was associated with longer time interval from diagnosis and low pre-HDT platelet count (likely resulting from pre-HDT damage), whereas late-onset MDS-CAs were noted among patients treated with Total Therapy 2 and Total Therapy 3 that applied post-HDT consolidation chemotherapy (suggesting possible post-HDT damage). While the risk of MDS-CAs was low and clinical MDS occurred infrequently, monitoring after post-HDT consolidation chemotherapy appears warranted