Fifty years ago this month, a band of researchers fanned out through the neighborhoods of Framingham, urging residents to sign up for a study designed to track ordinary people to try to detect early signs of heart disease – then, as now, the No. 1 killer of Americans.
One of the 5,209 who agreed was Ida Leach, now 83.
With her late husband, Henry, Ida Leach worked at the Dennison Manufacturing Co., making labels and crepe paper. The young couple eagerly agreed to undergo two hours of free medical testing every couple of years, and years later enrolled their kids and their spouses, too – an act that would prove life-saving.
Today, thanks to the Leaches and about 10,500 other volunteers, the Framingham researchers have published more than 1,000 scientific papers on heart disease, and spent $ 43 million.
Along the way, they’ve discovered most of what we now take for granted about heart disease – that cigarettes increase the risk (1960), that high cholesterol and blood pressure do, too (1961), that exercise lowers risk while obesity raises it (1967), that homocysteine (an amino acid) in the blood raises it (1990).
Those findings, like those from major studies of cancer and other diseases, are of inestimable benefit to society. But as the Leaches discovered, the personal benefits of becoming a human guinea pig can be enormous, too.
Twelve years ago, their son-in-law, Kenneth Kaczmarowski, of South Milwaukee, was in town for a regular family visit-cum-checkup, more than 15 years after he first accepted the Leaches’ suggestion that he, too, enter the study.
“I was a thick-headed Pollack,” says Kaczmarowski, now 57. “I kept saying nothing was really wrong.”
But the vigilant Framingham team, alarmed by his test results, thought otherwise and urged him to get help, fast. He did: a septuple coronary bypass that saved his life.
Over the last half-century, hundreds of thousands of people – some healthy, some deathly ill – have volunteered for studies that have changed medical treatment.
Over the last 40 years, for instance, 50,000 women with breast cancer have participated in groundbreaking trials run by Dr. Bernard Fisher of Pittsburgh, scientific director of a study of how various treatment combinations affect survival.
Among other things, Fisher’s studies showed that for most women with breast cancer, survival was the same whether a woman had a mastectomy, a lumpectomy (removal of just the cancerous lump) or a lumpectomy plus radiation, a finding that has spared countless from losing a breast. Nowadays, however, women usually have radiation plus lumpectomy because that reduces the chance for a local recurrence.
Fisher’s studies have revolutionized treatment in other ways, too. They’ve shown the efficacy of chemotherapy and the hormone tamoxifen, and demonstrated that many women with early cancer benefit from systemic (whole body) treatment with chemotherapy, tamoxifen or both, in addition to surgery and radiation.
Volunteers with heart disease have also helped change medical history, says Dr. Patrice Desvigne-Nickens, director of the heart research program at the National Heart, Lung and Blood Institute, sponsor of the Framingham study.
Over the years, she says, key studies have shown that for many people with severe heart disease, bypass surgery is more effective than drug treatment; that clot-busting drugs (TPA and streptokinase) can open arteries and save the lives of people who have just had heart attacks; that lowering cholesterol, too, can be life-saving.
In many such research projects, people volunteer out of altruism, hoping the knowledge gained from testing a new cancer drug for cancer or tracking symptoms of a disease will help other people.
But many say they reap personal benefits as well, a fact researchers hope will lure more people into trials.
Sometimes, as in the Framingham study, all you have to do is agree to undergo free, thorough checkups every few years. The risks in this kind of “observational” trial are few, chiefly a little time lost from work and perhaps babysitting costs.
There is, of course, a potential risk to confidentiality because so many researchers pore over each blood test or chest X-ray. But researchers take pains to guard the privacy of medical records.
“We do not release them to anyone for any reason under any circumstances without a signed release each time,” says Dr. Daniel Levy, director of the Framingham study.
“Usually, there isn’t a name linked to the data. There may be a number, but that’s not given to insurance companies,” adds Dr. JoAnn Manson, an endocrinologist at Brigham and Women’s Hospital. She is a principal investigator in the Women’s Health Initiative, an ongoing, nationwide study to determine the health consequences of hormone replacement therapy, low fat diet, and vitamin D and calcium supplements in older women.
Perhaps the greatest risk in joining an observational trial is actually a benefit: You may get bad news sooner than you otherwise would, because you’re watched so closely. Levy, for instance, recently discovered breast cancer in a woman who was there for a routine visit for the heart study.
With interventional, as opposed to observational, studies, the risks and benefits of volunteering are slightly different. These studies involve patients who already have a disease or are at high risk for it. Often, they’re divided into two or more groups randomly, then given different drugs or other treatments. Typically, neither the patients nor their doctors are told who is in which group.
Many people hesitate to join such a trial, fearing that they’ll be among the group that gets a placebo, or dummy drug, in place of a real treatment.
In many cancer studies, however, “this isn’t much of an issue,” says Mary McCabe, head of the office of clinical research promotion at the National Cancer Institute. That’s because patients usually get either the new treatment or the best available standard care.
And while people often assume a new treatment is better, nobody really knows, which is precisely why the study is needed.
As a volunteer, you have the right be fully informed about the study and to drop out at any time, notes McCabe of NCI, though you should discuss this with your doctor.
If you’re pregnant, of course, the pros and cons of joining an interventional study get trickier, but if your doctor suggests it, it’s worth considering.
The bottom line is that you should never feel coerced into joining a study, says Manson of the Brigham. But if you’re comfortable with it, the benefits – to you, as well as society at large – often outweigh the risks.
After 50 years in the Framingham study, Ida Leach needs no convincing: “There are no disadvantages, as far as I can see.”
Information on studies
Although some studies are not recruiting new volunteers, many others are.
The Framingham Heart Study, for instance, is still seeking minority volunteers for a waiting list. (Telephone 508-935-3438)
The National Cancer Institute has numerous ongoing studies. For more information call 1-800-4-CANCER or search the web at http://cancertrials.nci.nih.gov.
You can also check the bulletin board sections of newspapers and listen for ads recruiting volunteers on radio and TV, or call major teaching hospitals for information about participating in research studies in your area.