The FDA approved Erleada in February after trials showed patients on the drug lived an average of 2 years longer without their cancer spreading into other organs than if they were taking a placebo. In a J&J press release, physicians hailed Erleada’s “impressive clinical benefits” for prostate cancer patients.
J&J is “confident in the efficacy and safety data that have supported the approval” of Erleada, J&J spokeswoman Satu Glawe said.
Like Genentech, J&J and Takeda said they track drugs after approval to see if any racial differences emerge. For example, after another J&J drug for prostate cancer, Zytiga (abiraterone), went on the market in 2011, the company ran a new study of 100 patients, 50 black and 50 white.
“We were aware of the low number of African American men” in the preapproval drug studies of Zytiga, Ms. Glawe said. The postmarketing study was intended “to ensure the medication was also providing clinical benefit to these patients.” In fact, it showed that black men responded better than white men did to the drug.
The FDA is able to look for signs that an approved drug isn’t helping a specific population through a surveillance system launched in 2016, called the Sentinel Initiative, which provides access to medical claims and other data on 200 million Americans obtained from insurers and other health providers, said the FDA’s Dr. Sherman.
Still, postmarketing surveillance doesn’t compensate for lack of diversity in clinical trials. Minorities still miss out on experimental treatments – and, if they take a drug once it’s approved, may suffer unanticipated side effects.
Leaving analysis of a drug’s effect on minorities until it’s already on the market is “a hubristic assumption, unnecessarily arrogant,” Dr. Jackson said. Drugs should “work for the individuals who are the most vulnerable,” he said. “That necessarily includes racial and ethnic minorities.”
Like African Americans, Native Americans rarely enroll in clinical trials. Among the drug trials analyzed by ProPublica, 64.5% did not report any Native American participants, even for types of cancer that Native Americans get at similar rates as other races. (It’s possible that some Native Americans were enrolled but lumped into a generic “other” category.)
Native Americans are at higher risk of colorectal cancer than are white or Asian Americans. Yet the drugmaker Taiho Oncology didn’t report a single Native American among the 800 participants in its trials for the colorectal cancer treatment Lonsurf (trifluridine and tipiracil). Taiho didn’t respond to requests for comment.