PUMPING IRONY: Trials and Tribulations

Elderly Americans who volunteer for drug trials seldom make the cut. That makes it more difficult for researchers to know just how their new product will work for folks who often need it the most.

Many paper people around a stethoscope

One of the more ironic features of our Medical-Pharmaceutical Complex is the inability of drug companies to recruit elderly volunteers when testing treatments ostensibly designed to cure their maladies. It’s not that I would ever offer my pharma-phobic self as a guinea pig for some clinical trial, but I’d like to think there are among us here in Geezerville more courageous public-spirited denizens than myself.

It’s a pretty rare occurrence, though, if a new study out of City of Hope is any indication. Mina Sedrak, MD, and his team released the results of their analysis last week showing that seniors — who account for more than two-thirds of all U.S. cancer diagnoses — make up less than 25 percent of participants in clinical cancer trials. “There is currently no incentive to establish real-world effectiveness among older adults,” Sedrak says. “Older adults need a seat at the table.”

His conclusions only reinforce those of earlier studies describing the challenges Big Pharma faces when trying to include older adults in these trials. Issues that include overly stringent eligibility requirements and concerns about comorbidities as well as transportation challenges, caregiver burdens — and, yes, ageism — often combine to shut out even the willing elderly.

It’s a trend that has continued during COVID-19 drug trials, half of which will exclude older adults, according to a recent report. How researchers will use their results to evaluate the efficacy and safety of their products when marketed to a broader demographic is anyone’s guess, says University of Texas clinician Ethan Ludmir, MD. “It is important we have a trial population that reflects the real-world population,” Ludmir tells STAT News. “We don’t know if an 18-year-old and a 55-year-old will tolerate [a] treatment differently or respond to it differently.”

So, I was a little surprised the other day to read about Judy Stokes. A 69-year-old health writer in Sacramento, Stokes stepped up to volunteer for Moderna’s clinical trial for a COVID-19 vaccine after hearing that her 29-year-old son, Ian Haydon, had rolled up his sleeve in Seattle. And the company actually picked her.

“I felt proud and fascinated, that he had sought this out, and learned about it, and then made the decision that he was going to do it,” Stokes tells Alexandra Sifferlin in Elemental. “There was maybe a little trepidation, but not a lot, because Ian works in this field and knows what he’s doing.”

She was, however, a bit shocked to learn she’d been accepted. She’s not just older than most participants, but she figured her high blood pressure and heart disease would disqualify her. It did not. “They welcomed me with my diverse problems, issues, and age,” she notes. “They really wanted a whole diverse set of people to test phase 3.”

Parts of the lengthy interviews left her “a little woozy,” Stokes admits, as nurses combed through her extensive health history, but they clearly presented the risks involved and she completed the application process excited about the trial. Eighteen months and two doses of the experimental vaccine (or placebo) later, she remains convinced she’s done the right thing.

“I’ve really felt that the whole time that we’ve been in lockdown and quarantine, that time has been spent just living passively in one’s home and avoiding things and being fearful,” she explains. “And, when the trial came up, I felt like, well, this is one thing I can do that’s positive, that’s a step forward and not a reason to recoil away from something. It felt good to be doing something.”

My hat’s off to Stokes and any other senior bold enough to throw themselves into the Big Pharma vortex for the sake of public health. In fact, it’s kind of a refreshing antidote to the prevailing cynicism — to which I must plead guilty — surrounding COVID-19 research. Some people really do care enough about finding a cure to the virus that they’d put their own bodies on the line. I wish I could say I was one of them.

is an Experience Life deputy editor who explores the joys and challenges of aging well.

Leave a Comment

Subscribe to our Newsletters

Newsletter Signup
Weekly Newsletter
Special Promotions