New Data Clouds Debate Over DPT Vaccine : Health: A panel of medical experts says that on rare occasions, the shots may trigger serious side effects, but benefits still outweigh the risks.
For 25 years, Dr. Jeanette Wilkins, a pediatrician at County-USC Medical Center, has pored over medical studies and articles while attempting to answer one question:
Can the DPT vaccine cause severe injury or even death in children?
She has concluded that the shots can, in rare cases, cause an allergic reaction that a child may not recover from and that may result in permanent brain damage.
Wilkins’ findings mesh with the fears of thousands of parents and the suspicions of a few other medical experts who believe the diphtheria-pertussis-tetanus vaccine--which is required for American children before they enter school--may carry dangerous side effects in isolated instances.
Their views clash dramatically with prevailing medical opinion that death or permanent injury, like brain damage, from DPT shots is a myth.
Last month, the safety question was further clouded when a government-appointed panel of medical experts partly agreed with Wilkins’ and the parents’ position. The experts said the shots can, on rare occasions, cause acute allergic reactions--including shock, seizures and death--but they found little evidence to link the vaccine to brain damage. The panel also said it could not explain how and why the reactions occur.
The consensus that the vaccine can cause severe reactions has led many critics to demand that more be done to eliminate even the slightest chance of injury. Parent groups and some medical experts suggest the government begin research to:
* Understand the causes of the adverse side effects.
* Clarify whether brain damage can occur.
* Determine which children may be most at risk.
* Explore whether a different formulation of the DPT vaccine might be safer.
Although the immunization’s value still clearly outweighs the risk of side effects, Wilkins predicts that safety questions will continue to plague the vaccine until more is done to prevent serious side effects: “I am for prudent use of vaccination. But that requires an understanding of why the reaction occurs.”
Since anecdotal reports of side effects began to accumulate more than a decade ago, the DPT vaccine has been steeped in controversy. Each shot combines elements to protect against all three diseases, each of which has serious repercussions if contracted by a young child or infant.
About 4,000 cases of pertussis, a serious respiratory disorder popularly known as whooping cough, are reported in the United States each year. Tetanus, a sometimes-fatal infection that can cause intense pain and muscle spasms, is more rare. Only a dozen cases have been reported nationwide this year. And only one case of diphtheria, which can cause high fever and obstructed breathing, has been reported in 1991.
The diseases were epidemic and produced many fatalities before the practice of vaccination became widespread in the early 1950s.
Officials fear that a weakening in efforts to immunize children might lead to outbreaks of all three diseases. Despite federal regulations requiring vaccination of children before they enter school, many remain unimmunized because of lack of access to medical care. Although some parents may avoid having their children vaccinated out of fear of side effects, that number is thought to be small.
Parents and some physicians have cited incidents in which the DPT shots have caused such consequences as inconsolable crying for up to 48 hours; seizures; fever; encephalitis, a brain inflammation; a shock-like condition that includes rapid loss of consciousness; permanent brain damage; learning disabilities and death.
The side effects are thought to be linked to the pertussis component. The shots are given at 2, 4 and 6 months, with booster shots at 18 months and again between ages 4 and 6.
Parent groups, including the Virginia-based Dissatisfied Parents Together, lobbied throughout the 1980s for a re-examination of the vaccine and have filed lawsuits--with mixed results--against manufacturers for injuries reportedly suffered by their children.
Medical experts have long agreed that, in some children, the shots can cause redness, sore muscles, inconsolable crying and a temporary shock-like state. Further, the U.S. Centers for Disease Control has said children with a history of seizure disorders or a previous reaction to a vaccination should not receive a DPT shot. But repeated medical studies have failed to find evidence that the shots cause permanent injury, like brain damage, learning disabilities or death.
Government and medical experts had hoped that the panel, convened by the Institute of Medicine, would alleviate public fears once and for all.
Indeed, one panel member called the findings “very reassuring.” The panel found two cases of a life-threatening allergic reaction per 100,000 injections and concluded that the benefits of the vaccine far outweigh the risks.
But others have not interpreted the committee’s findings so optimistically. According to Wilkins, the findings also suggest:
* Studies should be implemented to determine the cause of the allergic reactions and how they might be prevented.
* The government should move quickly to examine the merits of a DPT vaccine that has been submitted to the Food and Drug Administration for approval. The new vaccine is similar to one that has been used in Japan for many years and reportedly has been linked to fewer side effects.
“I was pleased the panel had done away with the idea that (these reactions are) a ‘myth,’ ” says Wilkins. “But it’s a hollow victory. The risk of the vaccine is something that needs to be attended to.”
Jeff Schwartz, a spokesman for Dissatisfied Parents Together, also says the panel’s findings call for continued investigation.
“We think (the panel) should have acknowledged that there are some children who will have some long-lasting effects. What we’ve been saying is that some children do suffer long-term brain damage, seizures and death as a consequence of the vaccine. Although that may be a relatively small percentage, it’s still significant enough for us to do everything we can to prevent it.”
The parents’ groups disagree with the panel’s finding of only four deaths linked to the vaccine over several decades of use; they say the number is higher. And because the panel failed to conclusively link the vaccine to permanent brain damage, Schwartz says, “the report is susceptible to misunderstanding” that such damage can never occur.
Whether the vaccine can cause permanent brain damage is unresolved, according to panel member Richard Johnston, a professor of pediatrics at the University of Pennsylvania. But, he says, the panel could find no evidence that the vaccine directly caused such brain damage.
“What has, in part, gotten this vaccine a bad rap is that children can have these local reactions, a fever or a convulsion,” Johnston says. Coincidentally, he says, on some occasions an infant may suffer an unrelated neurological injury or infection that does cause permanent brain damage.
Or, symptoms of a neurological or physical disorder present at birth only become evident after two, three or four months. Because these symptoms appear around the time the DPT vaccine is administered, parents conclude that the shot caused the injury.
Parents, however, continue to ask how such “coincidences” can be summarily dismissed.
Stephanie and Richard Smullen had noticed that their son, Steven, cried, became lethargic and suffered large, raised welts after his first two DPT shots. Within hours of his third shot, he began having seizures. His mental development began to deteriorate, and he is permanently brain-damaged.
No other explanation for his brain damage has been found, says Stephanie Smullen.
“It had to be that shot,” she says. “I saw Steve change in one day.”
The Hacienda Heights family sued the manufacturer of the vaccine and won an out-of-court settlement six years ago.
Parent group spokesman Schwartz says even extremely low risks of serious injury should motivate health officials to explore alternatives and look for safer approaches to vaccination:
“Since Dissatisfied Parents Together is comprised of people who have suffered the loss or injury to a child, we feel one injury would be too many. And we know there are many more than one.”