At her 33rd appearance as Subject 16019 in a clinical trial of an experimental drug she hoped would fix “this little problem with my memory,” Sandra Brannon sank into a medical exam room’s recliner and waited.
“What’s the date again?” Sandra asked me. I had escorted her to a wing at Bellevue Hospital Center in Manhattan, where the NYU Langone Medical Center was among 210 institutions worldwide conducting the trial. As a family friend, I was standing in for Sandra’s only child and chief caregiver, who had business elsewhere that morning.
“November 18th,” I answered.
I’d responded to the same question from Sandra four times during our 27-minute subway ride to a stop a few blocks from Bellevue.
“Right. Got it.” Sandra scribbled my reply on her cheat sheet as a nurse bounded through the door to prep her for her monthly intravenous infusion of solanezumab, which Eli Lilly developed to target mild cognitive impairment caused by Alzheimer’s.
“How was your commute here?” the nurse began.
Sandra had been diagnosed with Alzheimer’s in 2011. She was now 69. Sandra’s mother had died of the incurable degenerative disease at 83, about seven years after she was diagnosed.
“Any changes in your health since the last time we saw you?” the nurse continued, probing Sandra. “You know what today is?”
Sandra cheerfully wiggled and snapped her fingers. She let out a blip of laughter and grinned. “The third of May?” She hesitated, looked at the nurse’s raised eyebrows and realized she’d gotten it wrong. “No. Ummm — oh, yes, it’s November 18th. Friday.”
“You looked at your pad, huh?” the nurse said, smiling and gently patting Sandra’s hand. She pushed two plastic cups of water toward her: “You’re dehydrated, and we can’t get the needle into your vein easily when you’re dehydrated. Drink this.”
That cheat sheet of scribbled notes and details had become Sandra’s brace and comfort during visits to that wing at Bellevue — ground zero in her quest for anything to slow her dementia.
As a black woman, she had assumed a critical role in that trial, and not just because of her own plight: Blacks are diagnosed with Alzheimer’s twice as often as whites, and Latinos 1½ times as often. Yet during those many visits to that wing, Sandra always seemed to be the only black patient present.
“From the beginning of this,” Monica Montgomery, Sandra’s daughter, told me, “I’d see lots of little white ladies lovingly leading their girlfriends into the office and asking questions: ‘I hear you have a clinical trial for Alzheimer’s? We want to get in that.’ But hardly ever — if ever — did I see others of us, black people, there signing up for the same thing.”
When Eli Lilly reported preliminary results of the trial in December, the data told a similar story: 83 percent of the 2,129 trial participants were white, 1.6 percent black.
I’d met Sandra and Monica more than 20 years earlier at Emmanuel Baptist Church in Brooklyn. At the time, Monica was active in the church’s teen group, Sandra was a trustee, and I did double duty as a choir member and newsletter editor.
At the start of our surrogate kinship, Sandra was an assistant principal at a high school. She’d gone into education after being a graphic designer at the New York Times and CBS News.
Before her Alzheimer’s started progressing, Sandra was a voluble and vibrant person who could command a room, weighing in on any discussion and — perhaps to liven things up — peppering the conversation with cuss words.
Monica was living in Washington when she first noticed Sandra’s lapses. Sandra had driven from New York to visit her, but on her way back she called Monica to ask which highway she was supposed to take.
Over time, Sandra started repeating herself and misplacing things. “She was having these small accidents,” Monica said. “Bumping a street sign with her car. Losing her keys, wallet. It was scary, nerve-racking.
“And I instantly knew what it was.”
Years earlier, Monica had seen her grandmother’s decline. “I knew this thing ran in families,” Monica said. “I felt this disappointment and dread, and rugged resignation.”
An African American internist diagnosed Sandra with Alzheimer’s. Monica assumed that she would be knowledgeable about the disproportionately high numbers of black Alzheimer’s patients and therefore be fairly aggressive about treatment. But she offered few tangible suggestions, recommending instead that Sandra do crossword puzzles and that the family hope for the best. After Monica’s repeated requests, the doctor finally prescribed Aricept, a treatment for symptoms of mild to moderate Alzheimer’s.
At that point Monica, now an arts activist and museum curator who had lectured internationally and been an adjunct professor at Harvard University, decided to move back to her mother’s Brooklyn apartment.
Monica researched Alzheimer’s and searched for physicians lauded for their work on the disease. She conferred with a close friend, a geriatric social worker, about how to move forward. In the fall of 2013, Monica chose to have her mother treated by a neurologist at the NYU Langone’s Pearl I. Barlow Center for Memory Evaluation and Treatment, largely because she knew about the Eli Lilly drug trial and wanted to get Sandra in it.
“Actually getting her into the trial was an uphill battle,” Monica said, one that required letters from Sandra’s diagnosing physician to NYU Medical Center’s Center for Cognitive Neurology, which was administering the trial drug.
In the fall of 2014, Sandra joined 2,128 NYU patients in that testing of solanezumab. Sandra was notified in fall 2015 that she was being infused with solanezumab, not the trial’s placebo drug.
Her optimism spiked.
In 1994, the National Institutes of Health mandated that participants’ enrollment in NIH-approved clinical trials reflect the nation’s racial makeup and gender breakdown.
Whites accounted for 61.6 percent of the U.S. population in July 2015, according to the most recent census data. That figure will dip to 44 percent by 2060, if current trends hold. By 2020, more than half of the nation’s children are projected to be people of color, the Census Bureau says.
According to a 2013 NIH report, minorities accounted for 36.5 percent of the 17.6 million participants in NIH-registered clinical trials of drugs and other medical interventions in fiscal 2012.
But researchers in the Empact Consortium, which provides training to medical professionals and community organizations to increase minority participation in clinical trials, estimate the share of minority participants in NIH-registered clinical trials to be less than 10 percent.
Given the nation’s changing demographics, it’s neither good health policy nor good business to be developing drugs and possible cures that are tested in only a subset of the population, said Willie Deese, a former executive vice president at Merck, the pharmaceutical company
Months after retiring last year, he earmarked part of a $1 million gift to the North Carolina Agricultural and Technical State University in Greensboro — a historically black college and Deese’s alma mater — for its Center for Outreach in Alzheimer’s, Aging and Community Health. In addition to collecting and studying the DNA of black patients with Alzheimer’s, the center provides support services for such patients and their caregivers, and educates blacks about scientific research.
Deese, who is African American and whose mother has Alzheimer’s, said there’s a growing recognition within the black community that its members can’t be absent from clinical trials and expect medicine to work as well for them as it does for other populations.
“We have to be included,” he said. “Enlightened companies are ensuring that that’s taking place today.”
Still, as clinicians and researcher studies find more minorities expressing interest in clinical trials, there are some looming questions and challenges: How can medicine and the culture surrounding trials be demystified? Should trials continue to exclude, as they generally do, people with co-morbidities — especially given the disproportionate percentage of minorities with more than one illness?
Meanwhile, experts say that private physicians must do more to change the racial makeup of trials by referring more minority patients to trials. Experts say such referrals may be more common at university-run medical centers, where staff members know about on-campus research and help funnel patients to those researchers. Unfortunately, not every doctor has that access or will make the effort.
In November 2016, Eli Lilly reported that solanezumab had no effect on people with mild Alzheimer’s symptoms and began winding down the trial. Monica forwarded the emails from the NYU researchers to me. She and her mother were crushed by the drug’s failings. Monica tried not to show her mother the fullness of her disappointment and anger, afraid it would rub off.
They decided that Sandra’s 34th appointment at Bellevue would be her last.
Monica requested all of her mother’s files, the stuff in the black vinyl binder that nurses annotated during Sandra’s monthly visits. For being a trial volunteer, Sandra had gotten a $40 stipend per visit and extra-vigilant checks of her weight, blood pressure, cholesterol and assorted physiological markers. Monica wanted those notations.
“I want a written report of their findings and her progress, if she made any,” she told me. “I just want more insight into my mom’s health.”
Today, Sandra is no longer avidly reading the New York Times. She does walk to a senior citizen center several afternoons a week, on her own, but only if Monica lists the landmarks along the way for her, a new kind of crutch. So far, that has kept Sandra from getting lost.
For 14 consecutive days in March, Sandra phoned the doorman of her apartment building for instructions on using the elevator that she had ridden for four decades.
“She just stands in front of it at times, totally bewildered,” Monica said.
Monica and Sandra’s home health aide decided that Sandra should no longer light the stove. She has grudgingly surrendered her driver’s license and the keys to her Toyota. Except for sporadic engagement with a handful of friends, she is more isolated than ever.
Yet when I talked to her after the clinical trial ended, Sandra sounded pretty chipper, all things considered. She once told me that she veers toward joy, no matter what life throws at her.
“Thank you,” she told me, “for being my balm in Gilead.” An emotion I cannot name rears up in me. My eyes tear. “You’re my jewel and joy,” I said. “Let’s get our nails done and go to lunch soon.”
“Absolutely,” she said. “And you never know: The drug they were giving me might kick in.”
Gray (firstname.lastname@example.org) is a freelance writer, editor and journalism lecturer who covers health, criminal justice and education. This article was excerpted from Health Affairs and can be read in full at healthaffairs.org.