Patients who can’t afford to travel long distances to a trial, take time off work, or find child care are at a disadvantage. They are usually reimbursed for travel and food costs, but drugmakers are careful not to pay too much because they do not want to appear to be enticing patients to join when it isn’t in their medical interests, said Laurie Halloran, founder and CEO of a consulting firm for the drug industry.
While the experimental drug used in a study is free, any approved treatments that are part of the trial typically need to be covered by a patient’s own insurance, according to Dr. Ali.
He recalled one black patient who was eligible for a study that entailed taking an already approved drug in combination with a new treatment. The approved drug cost $10,000 a month and the patient’s insurance charged 20% as his copay, Dr. Ali recalled. The patient decided that joining the trial would be too expensive. He instead underwent chemotherapy, which was cheaper, but he didn’t tolerate it well. The patient is now considering hospice, Dr. Ali said.
Criteria for admission to clinical trials have become more stringent over the years, Mass. General’s Dr. Jackson said, and patients of color increasingly are excluded. They are more likely than white people are to have other conditions such as stroke, hypertension, and diabetes, which could complicate research results. Trials often want to enroll “the healthiest sick people they can find” and preclude patients with other conditions. “The wall basically gets taller and taller,” he said.
Aredia Taylor didn’t qualify for a clinical trial on other grounds. A former U.S. Department of Agriculture supervisor for food-safety inspections, she was diagnosed with multiple myeloma in 2014 and had undergone a gamut of treatment including various chemotherapy drugs and a stem cell transplant.
While the transplant drove her cancer into remission, she still needs to take Revlimid (lenalidomide) – a standard treatment – daily to keep the cancer at bay. The drug has given her side effects that she describes as devastating to her daily life, including diarrhea, muscle spasms, and an inability to concentrate. She said she wants to stop taking Revlimid and would be willing to try an experimental treatment.
Ms. Taylor, 58, said she saw pamphlets at her doctor’s office encouraging patients to ask about clinical trials, so she asked her oncologist, Larry Anderson, MD, at the University of Texas Southwestern Medical Center in Dallas, whether she should join a study. He told her that she “wasn’t a fit,” she said. Dr. Anderson told ProPublica that most trials are seeking patients with either newly diagnosed or relapsed multiple myeloma, and since Ms. Taylor is currently in remission, she wouldn’t be accepted.
Ms. Taylor was disappointed. Knowing that blacks like herself are especially susceptible to multiple myeloma, she’d like to be a part of developing more effective treatments.
“I want to pay it forward and be a blessing to somebody else,” she said. “I want to be one of the people that they try to do a clinical trial for, so they find a way to a cure.”
Spurred by Congress, the FDA began in January 2015 to regularly publish a “Drug Trials Snapshot” for every new drug approved, delineating the demographic breakdown for clinical trial participants by sex, race and age subgroups. ProPublica’s analysis focused on participants in trials for the 31 cancer drugs approved since then, comparing their demographics with data from the National Cancer Institute on the incidence of various cancers by race.
Eighteen of those drugs targeted cancers that are at least as likely to afflict black Americans as white Americans. On average, only 4.1% of patients in those trials were black. Trials for four multiple myeloma drugs, including Ninlaro, averaged 5% black participation.
An FDA study over a longer time period corroborated ProPublica’s findings. In a 2017 article in the journal Blood coauthored by Richard Pazdur, the FDA’s cancer chief, the agency reported that black patients on average made up 4.5% of participants in trials for multiple myeloma drugs since 2003. Higher enrollment of minorities in myeloma trials would have “multiple benefits,” the FDA scientists noted. Not only would “underserved populations” gain access to new therapies, but additional data could help researchers identify subtypes of the blood cancer and develop targeted treatments.
A similar pattern emerges for treatments of non–small cell lung cancer. It occurs in 56 out of 100,000 black Americans, versus 49 out of 100,000 white Americans. Yet ProPublica found that in trials for two recently approved drugs for a type of non–small cell lung cancer driven by a mutation in what is known as the ALK gene, less than 2% of participants were black.
Those drugs, Takeda’s Alunbrig (brigatinib) and Genentech’s Alecensa (alectinib), are approved for patients whose lung cancer has spread to other parts of the body. In trials, both drugs were able to shrink tumors, including lesions in the brain. Patients taking Alecensa lived without the disease progressing for an average of 25.7 months, more than double the 10.4 months for patients on another treatment.
“We believe that we must consider differences across all populations to deliver on the promise of personalized health care,” said Meghan Cox, a Genentech spokeswoman, adding that the drugmaker is “continuing to study patient response to Alecensa across populations in the postmarketing setting.”
Similarly, prostate cancer affects 178 out of every 100,000 African Americans, more than for any other race in the United States, compared with 106 out of every 100,000 white Americans. Black Americans are twice as likely as white Americans to die from prostate cancer.
Yet during 2009-2015, in seven trials conducted for five new prostate cancer therapies, only 3% of participants were black, according to a study conducted by Daniel Spratt, MD, vice chair of research in the department of radiation oncology at the University of Michigan, Ann Arbor. More recently, 11 times as many white as black participants, or 66% – compared with 6% – joined trials for Johnson & Johnson’s new prostate cancer treatment, Erleada (apalutamide).