We trust the Centers for Disease Control to save us from the things we fear most: invisible germs that can sicken or kill. But by failing to tell poor Los Angeles parents their infants would be guinea pigs for an unapproved vaccine, the CDC has severely damaged that trust and impaired its ability to protect all the nation's citizens.
In 1991, the threat came in the form of a measles epidemic that was wreaking havoc on impoverished African-American and Latino communities. Researchers decided to test whether the experimental Edmonston Zagreb or E-Z vaccine could be used to immunize children too young for regular measles shots. What they failed to do was tell parents that they might get an unlicensed vaccine not yet approved by the Food and Drug Administration for use in the United States.
Nearly 1,500 mostly black and Latino 6- and 9-month-olds were enrolled in the study, and 900 received the vaccine before the experiment was called off. The reason? High doses of E-Z were linked to increased infant death rates in Guinea Bissau and Senegal. A Haitian study confirmed the connection. The World Health Organization said high doses of E-Z were not safe. Unsuspecting parents had signed consent forms that never told them their babies could be in danger.
The Los Angeles County health department and Kaiser Permanente of California co-sponsored the study under the CDC's auspices. The CDC knew of the vaccine's experimental status and approved the incomplete consent forms anyway.
A 22-month-old child who received a low dose of E-Z in the study died, but authorities attribute his death to a bacterial infection. Medical journals have reported that high doses of the vaccine can cause immune system suppression, leaving infants vulnerable to infections other than measles. Officials say they are monitoring the other children from the study, and none have been hurt by the vaccine so far.
Sadly, the same cannot be said for the CDC's credibility.
"A mistake was made," says CDC director David Satcher. "It's a terrible error," he continues, and "It's going to hurt _ hurt in research and hurt in treatment.
"Every little mistake like that seeds the concerns of people," he said. "We need to move to a new level of assurance so people can really trust what we're doing."
Both the African-American and Latino communities have well-documented foundations for distrust.
Latinos can point to largely unregulated maquiladoras assembly plants, situated just inside the Mexican border, that have polluted the earth and water in border areas since the 1960s. When neighboring Latino communities saw hepatitis infections skyrocket and babies being born without brains, both the U.S. and Mexican governments were reluctant to conclude that the pollution levels they allowed caused the health problems. The pollution continues to flow.
The African-American community's misgivings date all the way back to 1932. In the infamous, 40-year Tuskeegee Experiment in Alabama, black men were denied treatment for syphilis when penicillin first became available so researchers could watch the disease run its course. The men were poor and uneducated. They were promised free health care, meals and burials. They were never told they had syphilis or that they were part of an experiment. It took the government until 1973 to admit it watched while their bones, heart and nerve tissues disintegrated.
Satcher says Tuskeegee was different. Explaining that difference will be difficult in communities where as recently as 1995, a third of African-Americans surveyed said acquired immune deficiency syndrome is a plot to exterminate blacks and gays. Explaining the difference to 1,800 parents spending sleepless nights watching and waiting for some mysterious illness to claim their children will be hard. Convincing poor parents to bring their children in for immunizations again or seek necessary health care now will be a formidable task, and trying to get some poor minorities to participate in future experiments will be nearly impossible. With the L.A. Experiments, like the Tuskeegee Experiment, irreparable damage has been done.
In the California case, a National Institutes of Health investigation found researchers violated informed consent regulations. Although a review by the Office for Protection from Research Risks, part of the Department of Health and Human Services, concluded that the study was scientifically justified, it also said that the CDC and Kaiser were wrong for not informing parents of the experimental vaccine.
To the public mind, the CDC looks like an accomplice in a danger zone where it was supposed to act as police officer. To restore some trust they should cooperate fully with investigators and open their practices to well-deserved public scrutiny. Kaiser Permanente and the government agencies involved should offer to provide the victimized families with outside medical care or money to hire doctors of their choice. It may not heal the rifts of suspicion and fear, but it may make the researchers' apologies ring a little less hollow.
Beth Glenn is the 1996 Robert Pittman Scholar of the University of North Carolina at Chapel Hill.