When Vaccines Do Harm to Kids

Thousands of parents have described injuries in their kids that they believe are linked to shots. But the research community maintains the claims have no scientific merit.

The safety and efficacy of the 12 million doses of vaccines approved by the federal government, mandated in states and administered to American children every year will receive unrelenting scrutiny in Washington as long as Republican Rep. Dan Burton of Indiana has anything to say about it. “I stated at the Aug. 3 hearing [published as Vaccines — Finding the Balance Between Public Safety and Personal Choice] that as long as I remain chairman of the Government Reform Committee, we are going to continue looking into vaccine issues, and I will keep my word,” Burton tells Insight.
       On Dec. 9, 1993, the congressman’s daughter, Danielle Burton Sarkine, took her 5-week-old daughter, Alex, to her pediatrician for a dose of the hepatitis B vaccine. The infant responded to the shot with high-pitched screams and was inconsolable. She still was crying hours later when her parents put her into her crib for the night. Checking on her when the cries at last subsided, they found a parent’s worst nightmare: Alex had stopped breathing. Danielle began CPR immediately and the baby gasped her first breath just as paramedics arrived. Alex spent an intense three-and-a-half weeks in the hospital but went home with a clean bill of health.
       Not so for her little brother, Christian. On June 1, 1998, this happy 14-month-old received nine vaccines in one day. His mother says his entire disposition changed overnight. By the next day, he was screaming. Within a week and a half the baby had begun slamming his head on the floor, slapping himself and banging his head against a wall. Soon he was diagnosed with mild to moderate autism, a condition that is manageable but chronic. Since his immunizations, Christian’s life has been a series of therapy sessions for speech and developmental disorders.
       Coincidence? Among the pieces of the puzzle publicized by Insight:

Rates of autism have skyrocketed. However, public-health officials say better diagnostics account for the 273 percent increase in cases reported in California during the last 11 years.

An average of 13,000 reports of neurological and autoimmune trauma following on the heels of vaccination, especially the hepatitis B inoculation, have been filed annually since 1990 with the Vaccine Adverse Event Reporting System, a voluntary program, at the Food and Drug Administration, or FDA. Yet many public-health officials interviewed for this article claim the reported events are coincidental, reveal no patterns and are not worth investigating.

Since the 1930s, when children often received just one vaccination, many immunizations have contained a 49.6 percent mercury preservative called thimerosal. Most children today receive 33 doses of 10 vaccines by age 5, generally receiving several vaccines per visit on their immunization schedules. Reports surfaced in 1999 that infants being vaccinated using multi-dose vials, such as hepatitis B and MMR (measles, mumps and rubella), with thimerosal can receive 62.5 micrograms of mercury per visit. This is 100 times the exposure federal Environmental Protection Guidelines consider safe for the average-sized infant, as mercury is known to cause neurotoxicity and brain damage that mirrors the symptoms of autism. The Centers for Disease Control and Prevention, or CDC, is encouraging the development of thimerosal-free doses and has withdrawn its recommendation that infants receive the thimerosal-containing hepatitis B vaccine at birth. However, the CDC maintains that mercury in vaccines never has caused an adverse reaction and is not pulling thimerosal-containing vaccines off the shelves.

Oral polio vaccines contain live viruses that can cause polio and are being replaced with a killed-virus version. The DTP (diphtheria, tetanus and pertussis) inoculation, acknowledged within the federal government to be the source of brain damage in some cases, still is on the market; a modified version, the DTaP, is said to be safer and is commonly used. The MMR vaccine has been a suspected cause of autism for more than a decade. The rotavirus inoculation, a vaccine against usually mild diarrhea, was recalled last year after it was found to cause bowel blockage and collapse in infants.

       According to Charles Prober of Stanford University, an American Academy of Pediatrics spokesman on immunizations, “Each of the individual vaccines has some recognized side effects with varying degrees of frequency” but scientifically documented severe reactions are “very rare. And autism has not been shown to be caused by vaccines in any sort of credible study. Measles shots are given at 15 to 18 months of age — and autism typically appears about the same time. The same [temporal association] is true for many of the other autoimmune and chronic neurologic disorders.” He adds, “Anything that is reasonably plausible in terms of how vaccines interact with immune and neurologic systems are vigorously explored. Vaccine developers, governmental organizations and manufacturers have a vested interest in understanding them.”
       Nonetheless, after comparing stories with other parents around the country, Sarkine and her father began to wonder whether government-mandated vaccines had become a severe children’s health problem. Sarkine has become an activist for autism awareness and parental consent in vaccinations. She’s the Indiana representative for Unlocking Autism, an organization founded in 1998 by two mothers whose children suffered experiences similar to those of Christian and Alex.
       Burton’s committee held several hearings in 1999 to examine claims by health-care consumers and advocacy groups that vaccines have caused thousands of injuries and deaths, claims which government health agencies and vaccine manufacturers largely have discounted. They point out that many theories implicating vaccines as injurious are founded on anecdotal evidence, not solid scientific research.
       But Burton wouldn’t be dissuaded by FDA and CDC denials, saying in last year’s hearings, “We as a government can no longer keep our heads buried in the sand like an ostrich, pretending there is no problem.” The hearings provided a platform for parents whose skepticism about vaccines has continued to grow in the face of government and industry insistence that they are perfectly safe.
       One parent who caught Burton’s attention is Rick Rollens, former secretary of the California Senate and father of a 9-year-old boy whose autism he believes was triggered by vaccinations. With other concerned parents he founded the M.I.N.D. Institute to conduct research into the incidence, causes and treatments of autism and other neurodevelopmental disorders. Their initial study found a 273 percent increase in cases of severe autism in California during the last 11 years. Other neurodevelopmental disabilities such as mental retardation also increased — but only at a population-adjusted rate. Through the late 1970s, only 100 to 200 new cases of autism were reported each year. In 1998, new cases reported to the public-school system were 1,425. That number jumped another 36 percent to 1,944 in 1999.
       Perhaps it’s coincidence that each upsurge in autism has followed the introduction and mandate of a new vaccine in the state, Rollens observes. But he’s raising millions of dollars to find out. “Vaccines contain numerous active agents such as live viruses, bacterial agents, preservatives and toxic chemicals, including formaldehyde and mercury, as well as human, animal and plant RNA. Not a single safety study has ever been done on the short-term or long-term effects of the interaction of this potent cocktail of numerous multiply active agents on the developing brain and immune systems of our children,” Rollens testified before Congress. “I must ask the public-health community: Where is the science?”
       In April, Burton’s committee will hear more testimony on the possible link between autism and immunizations. “From my family’s experience and from our hearings, I know how devastating this is to the entire family,” he tells Insight.
       But even vaccine naysayers do not insist that childhood inoculations are all bad — or even mostly bad. Their strictest critics acknowledge that vaccinations may be the most successful public-health triumph in American history. The CDC statistics make this clear. The worst year for diphtheria, for instance, was an incidence of 206,939 cases in 1921, its worst pre-vaccine year. In 1998, thanks to inoculation, only one case was reported. More than 21,000 cases of polio were reported in 1952, but in 1998 none was seen. Measles hit more than 894,134 people in 1951, its worst year. Vaccinations cut the caseload to 100 in 1998.
       But if some kids are vulnerable to harm from vaccines and their adverse reactions can be prevented, parents need to know. “As much as parents value the public-health successes, they don’t want to see their injured children written off as statistically insignificant,” says Barbara Loe Fisher, who founded the nation’s most comprehensive vaccine consumer-advocacy organization, the National Vaccine Information Center, in Vienna, Va., after her son suffered brain damage following a DPT shot in the early 1980s. “They want to be taken seriously. They want to know how vaccines interact with their children’s immune and neurological systems so that appropriate treatments can be developed. They want other parents to have the full information on what factors contribute to risks of adverse reactions so that they can weigh the costs and benefits for themselves and make informed decisions on which vaccinations to use and when.”
       “I only have two grandchildren, and both of them had adverse events,” says Burton. “In my family, that is statistically significant.” The congressman’s daughter adds, “The only person that has stood by me on this has been Dad. The manufacturer is not going to step up to the plate. I don’t know if the FDA and the CDC are ever going to. I constantly get calls from people with autism — from people just dying to speak with him.”
       Fisher sees 1999 as a turning point in the battle to secure more research into the safety and efficacy of vaccines and to have informed-consent provisions taken seriously. In the NVIC’s end-of-the-year report, she said she saw an upswing in “public recognition that the vaccine safety and informed-consent issue is a serious one, with a significant medical, legislative, social and political history behind it.”
       The NVIC report says the sea change in public perception began in January 1999 when ABC’s 20/20 ran an investigative report on the hepatitis B vaccine publicizing interviews with health-care workers who were experiencing arthritis, muscle and nerve damage and vision and memory loss after receiving the shot. By the next month the debate had begun to spread through articles in Insight and other print media. “The media are beginning to realize this is not a black-and-white issue. It’s not about being pro-vaccine or antivaccine,” says Fisher. “It’s not about using every vaccine according to government standards or recommendations or using no vaccines. It’s about having information and being able to make informed choices. It’s also about reforming the mass-vaccination system to make it safer.”
       In addition to the national congressional hearings, debate in many state legislatures was intense as parent groups battled pharmaceutical lobbyists to alert lawmakers to widespread concern and to push through legislation allowing parents to choose not to vaccinate their children.
       But is anyone among the vaccine manufacturers acknowledging these concerns or investing in research to make vaccines safer? “No,” says Fisher. “I think because they have such a tremendous investment in future vaccines, they are very reluctant to admit that they’ve got problems with current vaccines.” A 1995 study by research firm Frost & Sullivan projected that the worldwide vaccine market would skyrocket from $2.9 billion to $7 billion by 2001. At least 200 more vaccines are in development, including mandatory shots to protect 12-year-olds against sexually transmitted diseases (see chart, p. 19). Unlike the situations with almost any other medical product, pharmaceutical companies can pursue vaccine development and licensure nearly risk-free, thanks to indemnity assured them by Congress in 1986 when it established the Vaccine Injury Compensation Program. Within the guidelines of this program, parents who believe their children have been injured by vaccines can’t sue the manufacturers directly. The General Accounting Office reported last month that families whose children have been injured by vaccines have experienced undue difficulty obtaining assistance from the compensation fund.
       Parents need to know their options, says Burton. “Parents certainly need to have more information about their rights and about vaccines themselves,” he says. He recommends that parents get a copy of the package insert of every vaccine their child is to receive before setting up a vaccination appointment and that they prepare questions for their pediatricians. Because some people believe risks for adverse reactions to vaccines to be higher when a child’s immune system is weak, Burton adds, “The health of the child should take precedence over the convenience of keeping a child on shot schedule. A child with the sniffles or other illness should not be vaccinated.”
       Burton says he has heard reports that some schools have refused to enroll unvaccinated children even when their families have received exemptions allowed by their states. “Families need to be informed of their exemption rights prior to vaccination and their decision should be respected by the medical community and school officials.”
       Leading vaccine developer and public-health proponent Neal Halsey’s response to Insight’s initial vaccine investigation reflects the sentiments of many leading officials (see “Ounce of Prevention, Pound of Misery?”, March 22, 1999). “Bad things happen to people all the time. It’s unfortunate that we don’t know the causes of many of those.” Consulted for this article about whether the growing controversies about vaccines have changed his views, he reiterates: “Just because something bad happened after a vaccine does not mean that the vaccine caused the problem.” Halsey heads the Institute for Vaccine Safety at Johns Hopkins University, which receives research-grant support from government sources including the FDA and the World Health Organization and educational-grant support from vaccine manufacturers such as Merck & Co., SmithKline Beecham, North American Vaccine and Pasteur Mirieux Connaught.
       “Until we do independent scientific studies, allowing subspecialties like immunology, cell biology and molecular biology to come in and evaluate the precise effects of these vaccines on the human body, we’re not going to have the answers to the questions we’re asking,” says Fisher. “I think this year has been important because there has been recognition that vaccines do cause significant side effects. And there’s beginning to be recognition in Congress that we’ve got to fund studies.”
       Indeed, Burton says, “I anticipate a series of hearings looking at varying issues regarding vaccine policy development, vaccine research and, where necessary, vaccines themselves.”

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