This story was co-published with Stat.
It’s a promising new drug for, one of the most savage blood cancers. Called Ninlaro ( ), it can be taken as a pill, sparing patients painful injections or cumbersome IV treatments. In a video sponsored by the manufacturer, Takeda Pharmaceutical, one patient even hailed Ninlaro as “my savior.”
The U.S. Food and Drug Administrationafter patients in a clinical trial gained an average of 6 months without their cancer spreading. That trial, though, had a major shortcoming: its racial composition. One out of five people diagnosed with multiple myeloma in the United States is black, and African Americans are more than twice as likely as white Americans to be diagnosed with the blood cancer.
Yet, of the 722 participants in the trial, only 13 – or 1.8% – were black.
The scarcity of black patients in Ninlaro’s testing left unanswered the vital question of whether the drug would work equally well for them. “Meaningful differences may exist” in how multiple myeloma affects black patients, what symptoms they experience, and how they respond to medications, FDA scientistsin a 2017 journal article.
The racial disparity in the Ninlaro study isn’t unusual. Reflecting the reluctance of the FDA to force drugmakers to enroll more minority patients, and the failure of most manufacturers to do so voluntarily, stark underrepresentation of blacks is widespread in clinical trials for cancer drugs, even when the type of cancer disproportionately affects them. A ProPublica analysis ofrecently made public by the FDA found that in trials for 24 of the 31 cancer drugs approved since 2015, fewer than 5% of the patients were black. African Americans make up 13.4% of the U.S. population.
As a result, desperately ill black patients who have exhausted other treatment options aren’t getting early access to experimental drugs that could extend their life spans or improve their quality of life. While unapproved treatments also carry a risk of setbacks or side effects, new cancer drugs have dramatically shifted outcomes for some patients.
Recently approved lung cancer treatments are “revolutionary,” said, associate director for research at UC Davis Comprehensive Cancer Center. Even in the first phase of clinical testing, which is aimed at making sure a drug is safe, 20% of cancer patients now see their tumors shrink or disappear, up from 5% in the early 1990s, Dr. Kelly said.
, research head at Maryland Oncology Hematology, has spent 7 years recruiting patients for about 30 cancer and blood disease trials a year. He said he’s often seen minorities, including African Americans, miss out on trials because of financial hurdles, logistical challenges, and their lingering distrust of the medical community because of a history of being victimized by medical experimentation.
“They’re potentially losing out on life-extending opportunities because it’s one more option they no longer have,” Dr. Ali said. “Especially when patients are in advanced stages of cancer, treatments are like stepping-stones: When one stops working, you move on to the next.”
Not joining a trial can mean “you’ve lost life expectancy,” he said.