Medical research might have an age bias

In treatment trials, seniors often are underrepresented

Life After 50

March 23, 2003|By Korky Vann | Korky Vann,Special to the Sun

Older people are significantly underrepresented in clinical trials even though they represent the majority of those who receive drugs and treatment for medical conditions, says a brief recently released by the International Lon-gevity Center-USA, a nonprofit organization in Manhattan.

"People aged 65 and over are woefully underrepresented or even excluded from clinical trials which evaluate the safety and efficacy of drugs and treatments," said Dr. Robert N. Butler, president of the longevity center and co-author of notes in the preface of the brief. "This can result in adverse reactions, inappropriate dosages or treatments, and in the misperception that older people cannot tolerate or benefit from new drugs and procedures."

Clinical trials help determine whether new drugs or treatments are safe and effective. They can be used to answer specific questions about vaccines, develop new therapies or new ways of using known treatments. According to the National Institutes of Health, clinical trials are the fastest, safest way to find treatments that work. A high representation of children with cancer in clinical trials, for example, has resulted in high cure rates for pediatric cancers.

While the National Institutes of Health Revitalization Act of 1994 requires women and minorities to be better represented in NIH-funded research, there are no formal requirements or regulations to ensure older people are represented.

The International Longevity Center brief highlights two studies that focused on cancer and heart disease, both leading causes of death in older people. The cancer study, done in 1999, found that although 63 percent of all cancer patients are 65 and older, only 25 percent of cancer clinical trial enrollees were in that age group.

The second study looked at clinical trials for heart disease between 1996 and 2000. Researchers found that only 9 percent of patients enrolled in trials studying treatments for acute heart conditions were 75 and over -- but almost 40 percent of people who suffer heart attacks are in that age group. Overall, say researchers, 40 percent of clinical trials between 1991 and 2000 explicitly excluded people over 75 from participating.

Experts say there are a number of reasons older people have been underrepresented in clinical trials. Physicians, patients and family members may mistakenly believe that seniors are less likely to tolerate or benefit from aggressive treatment, or assume that they are less interested in medical research.

Dr. Christine de la Paz disagrees.

"We do not have difficulty recruiting older participants; in fact, quite the opposite," says de la Paz, manager of the recruitment and retention core for clinical trials done at the Claude Pepper Center on Aging at the University of Connecticut Health Center. "We find older individuals often have more free time to come in for screenings and visits than younger participants and are very health-conscious."

Trials at the center focus on problems and illnesses associated with aging, including osteoporosis, heart disease and stroke. All study participants are 60 or older.

"Many volunteer for altruistic reasons. They want to feel that they are doing something useful to help others," says de la Paz. "Also, they are very interested in learning more about medical conditions and health. As participants, they get free study-related tests, exams and blood work. And an additional benefit is the social component. Participating in a study becomes an important part of their routine."

To increase the number of seniors in research studies, the International Longevity Center recommends that physicians be trained in geriatrics to help dispel myths among medical students about older people; that older people-advocacy groups work for balanced age representation in research trials; and that legislation be enacted to require inclusion of seniors in clinical trials.

In the meantime, seniors interested in volunteering for medical studies can ask their doctors, check the National Insti-tutes of Health's Web site at www.clinicaltrials.gov or contact local research centers.

Korky Vann wrote this piece for the Hartford Courant, a Tribune Publishing newspaper.

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