The pharmaceutical industry has rapidly adapted to promoting prescription drugs to young people on TikTok, Instagram, and other social media platforms, yet it can’t be troubled to include adolescents and young adults in clinical trials for these products. The industry needs to address this hypocrisy.
Children, adolescents, and young adults are physically different from adults. It seems obvious, but the industry has not yet caught up to this fact. In a clinical trial of tofacitinib (Xeljanz), a drug approved for people living with forms of inflammatory bowel disease, the participants range in age from 18 to 65 years. For adalimumab (Humira), a similar drug, the mean age of clinical trial participants was around 40 years.
Given that 25% of people with inflammatory bowel disease are diagnosed with it before age 16, more adolescents and young adults need to be included in clinical research to fully understand the effects — and side effects — of these and other drugs. It is unfair for companies or clinicians to claim that safety and efficacy are, as one medical professional told me, “likely the same” in adolescents and young adults as they are in adults. Assumptions cannot be made about serious chemical compounds without being tested in clinical trials.
When I was six years old, I was diagnosed with ulcerative colitis, an inflammatory bowel disease that would later cause me to lose my colon. I have personally experienced serious side effects from the medications I’ve taken, some of which were not included on the prescription drug label, and a case report has even been written about an adverse reaction I had to a drug.
Through my own experiences and my work with young adult patients through Generation Patient, I’ve learned that the side effects of some prescription medications are often worse than the symptoms of the diseases they are treating. Little information is available about age stratification in non-cancer clinical trials. In the FDA’s Adverse Event Reporting System, the ages of 18 through 64 are lumped together. The body of an 18-year-old is far different than that of a 60-year-old. A better age delineation would include 18 to 26 years as a distinct category.
Research is not complete unless it includes people of all ages. If a drug is being indicated for “adults,” then all adults — including young adults — must be adequately represented in the research. This is a prime year for doing this, because the Prescription Drug User Fee Act is up for reauthorization in 2022. This act lets the FDA collect fees from companies that produce certain drugs and biological products for humans. Discussions underpinning the reauthorization offer a prime opportunity to advocate for advances in comparative effectiveness, post-market surveillance, clinical trial inclusion criteria, and greater representation of adolescents and young adults in trials.
Contract research organizations such as IQVIA have created white papers on adolescent and young adult patients, but without greater action from the pharmaceutical industry, these documents are meaningless. Including more adolescent and young adult participants in clinical trials shouldn’t be hard. Reaching adolescents and young adult patients to recruit them for trials may be one of the easiest demographics to get in front of because of their widespread use of social media. To be sure, it will take resources and partnering with young adult communities to gain trust and reduce the burdens of clinical trials to encourage their participation.
Biopharmaceutical companies and contract research organizations could partner with media organizations targeted toward younger people to aid in recruitment. The FDA should also require more stringent reporting criteria on age, in addition to other factors. Furthermore, the FDA has an opportunity to promote the value of including adolescents and young adults within clinical trials during the upcoming discussions about user fee agreements.
Adolescents and young adults, many of whom live with chronic conditions, cannot wait for another five years for user fee agreement reauthorization talks, because we are missing out on an opportunity to understand and promote the likely differing safety, efficacy, and information for the next generation of lifelong patients. The options are vast but the urgency must be recognized as more and more of us are being diagnosed with these conditions at younger ages.
Sneha Dave is the executive director of Generation Patient, an industry-independent nonprofit organization focused on connecting and empowering adolescents and young adults with chronic and rare conditions.