Huge exposé this morning in Stat (which relies heavily on data collected by ProPublica) about the dearth of black patients in clinical trials for breakthrough drugs. As the length of the piece suggests, it’s a complex issue with many variables in play. The authors start off with multiple myeloma: one out of every five people diagnosed with the disease in the U.S. is black.
Recently, there was a clinical trial for a multiple myeloma-fighting drug called Ninlaro, produced by Takeda Pharmaceutical. It can be taken in pill form, allowing patients to avoid the discomfort and pain of injections or IV treatments. “Yet of the 722 participants in the trial, only 13 — or 1.8 percent — were black,” Stat reports. Black Americans make up 13.4% of the U.S. population.
Stat also points out that that this might reflect “the reluctance of the FDA to force drug makers to enroll more minority patients, and the failure of most manufacturers to do so voluntarily….” There is stark underrepresentation of African-Americans in clinical trials for cancer drugs “even when the type of cancer disproportionately affects them.”
Some pharmaceutical companies respond that part of the problem has to do with circumstances beyond the drug companies’ control. They include an historic mistrust of the health care system that many blacks harbor because they had been unknowing participants in medical experiments in the past. Also, a concerted effort by pharma companies to increase minority participation to meet any standards that the FDA might impose could result in fewer trials and higher drug costs.
Still, as Stat reports: “Not enrolling in clinical trials is just one of many ways that African-Americans trail white Americans in the quality of their health care. From diagnosis to death, they often experience inferior care and worse outcomes. Because some black Americans can’t afford the health insurance mandated under the Affordable Care Act, they remain less likely to have coverage than non-Hispanic white Americans.”