NurseWeek: Body and Soul: Volunteer patients submit to clinical experiments, for health’s sake

Body and soul
Volunteer patients submit to clinical experiments, for health’s sake
By José Alaniz
August 28, 2000

Although the public may not always perceive altruism as a motivation of participants in clinical trials, it does emerge in a surprising number of cases in which people submit to new medical procedures.

Photo: Photospin


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What would it take for you to give your body to science? Not as a cadaver, mind you – but as the living, warm-blooded, breathing, pain-feeling organism that carries you where you want to go, that flips the pages of this magazine, that right now focuses on this word.

Would you hand over your body to someone to test a drug for, say, $1 million? Would you submit to medical procedures, the repercussions of which are not fully known – that’s why they’re trying them out on you – for a vacation in Hawaii? How about six months, or 15 years, under observation for a chance to make new friends?

Or how about this: You do it for nothing.

About 160,000 women chose to do just that as part of the Women’s Health Initiative program, a massive 15-year, $700 million study of women’s well-being sponsored by the National Institutes of Health.

The postmenopausal women, between the ages of 50 and 79, have agreed to show up at 40 sites across the country and take part in studies, which include clinical trials investigating hormone replacement therapy, dietary modification and calcium/vitamin D supplementation.

"The research indicates women do this for altruistic reasons," said Jill Spivak, site director for the Women’s Health Initiative clinical trial at UCLA. "Many of them think of it as their legacy, something they’re leaving for their daughters and granddaughters. Future generations of women will have answers about whether or not to take hormones or calcium in their later years, thanks to this study, and they’re very proud of that."

The program’s organizers would like to shed new light on the major causes of death, disability and frailty in postmenopausal women, thereby reducing coronary heart disease, breast and colorectal cancer, and osteoporotic fractures through prevention and intervention strategies and identifying risk factors.

In the process, the 4,000 participants at UCLA get to have some fun and socialize with each other, Spivak said. Organized events include raffles, lecture series and free concerts.

"We also meet to motivate each other," said Sonja Langridge, 58, a homemaker in Pacific Palisades, Calif., and fourth-year participant in the dietary modification study. "I have to record what I eat, and stick to a strict fat limit. I have lost some weight, which I needed to lose."

Even in the face of unexpected setbacks, the women in the study remain committed to their ideals, said Pam Cate, NP, RN, lead nurse practitioner for the UCLA study.

"There was a scare for the hormone study participants when the media reported that hormone replacement therapy might cause breast cancer," Cate said. "But they went back and remembered why they began this, that they were doing it not because it benefits them, but future generations. And not one of them quit the study."

While participants in this study and other clinical trials come from diverse socioeconomic backgrounds, all benefit from regular health care visits. Some have detected breast cancer as a result of their participation.

In other cases, volunteering for a study may be the participant’s only chance to receive health care, said Sharon Sedgely, NP, RN, study coordinator at Denver’s Downtown Women’s Health Care, a private clinic that performs gynecological studies for pharmaceutical companies.

"We do have some regulars, who do more than one study if they qualify, for the financial rewards and free medicine," Sedgely said. "But some also do it for altruistic reasons. They hope there will be better drugs for women someday, and this is how they can help."

In a world where it might cost a pharmaceutical company as much as $300 million and up to 10 years of studies to clear a drug for sale, the government has strict guidelines and safeguards to protect people who choose to participate in clinical trials.

These safeguards are largely based on Nuremberg War Crimes standards, which various governments drafted for judging those who had performed ghastly medical procedures on concentration camp prisoners during World War II. The Nuremberg code formed the basis of what would become the U.S. policy on clinical trials on humans, codified in the government’s 1979 Belmont Report.

The document spells out basic rules and procedures, as well as participants’ rights during a clinical trial, which, as The Economist recently put it, is "a tidy-sounding term for the messy notion of human experimentation."

"We shy away from that term," Spivak said. "So do the participants." No one used the phrase in recruiting efforts for volunteers, she added.