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New Law Limits Actions Over Vaccine PreservativeVaccines have made front-page news recently, from headlines about who should receive a smallpox shot to stories about better prevention of anthrax to analyses of the connection between autism and the mercury-based vaccine preservative thimerosal. This last issue, which has been the subject of various scientific studies as well as heated political debate, was treated in the Homeland Security Bill, passed by Congress and signed by President Bush in November. One of its provisions limits the ability of claimants to sue vaccine makers whose products contain the thimerosal preservative. Some charge that the mercury levels in thimerosal-containing vaccines are a cause of autism, though no research thus far has shown this to be the case. Parents of affected children still may be able to seek monetary compensation through the Vaccine Injury Compensation Program (VICP), a fund created in the 1980s to address the rise in lawsuits against vaccine manufacturers. But passage of the thimerosal legislation has raised questions and concerns among policymakers and the public. From Preservative to PariahThe mercury compound thimerosal has been used since the 1930s in biomedical products. In recent years, pressure has mounted to remove the mercury from vaccines as the scientific community has become more aware of the potential neurological impact of mercury derivatives and as the number of vaccinations children receive has increased.
The removal of this compound from vaccines is not without cost: multidose preparations may be reformulated as single-dose vials, and substitute preservatives tend to be more expensive. Perhaps even more costly are the pending lawsuits against vaccine manufacturers, which some observers believe were spurred by the 1999 joint recommendation. A Federal "No Fault" SystemThe VICP was created with the passage of the National Childhood Vaccine Injury Act of 1986 and became functional in 1988. The impetus for the creation of the VICP was the rise in lawsuits filed in civil court against manufacturers of childhood vaccines and the need to stem the mounting cost of the tort system. Between 1979 and 1997, more than 1,000 suits were filed against manufacturers of diphtheria-tetanus-pertussis vaccines, reaching a peak of 255 suits in the year the act was passed. Public health officials were concerned that parents would stop vaccinating their children and vaccine manufacturers would cease production.In order to receive compensation, a claimant has to prove that an injury in the VICP vaccine injury table (www. hrsa.gov/osp/vicp/table.htm) occurred and that the vaccine caused the condition, or that the vaccine aggravated a pre-existing condition. Public Pressure for AnswersAdvocacy groups have played an important role in bringing the thimerosal-autism debate to the fore. According to Marie McCormick, a professor of pediatrics at HMS and the Sumner and Esther Feldberg professor and chair of the Department of Maternal and Child Health at the HPSH, these groups have brought "appropriate attention to what they see is an adverse event." McCormick chairs the Immunization Safety Review Committee for the Institute of Medicine, which has examined the issue of thimerosal as well as ways to provide parents and others with information in a timely and effective manner. She suggests the public look to established professional websites for up-to-date information, and for those who lack trust in the information provided by federal agencies, websites of independent professional organizations such as the AAP and the National Network for Immunization Information are available.Neal Halsey, professor of international health and director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health, says that public pressure brought by the autism interest groups has "done a service to families of children with autism by bringing to public attention the need for more research" to understand this disorder. "Unfortunately," he said, "autism has been inappropriately blamed on poor parenting, and some of the pain and anger over this misunderstanding has contributed to the response to concerns raised by some about vaccines. More research would help us understand the cause of this disorder and how to prevent and treat it." Homeland Security and ThimerosalHalsey believes that the manner in which the thimerosal provision was included in the Homeland Security Bill created anger and mistrust among the public. "My position has always been that if the scientific studies in progress reveal evidence of an increased risk of learning disorders among children who received high doses of thimerosal in early infancy, then some compensation should be made through the VICP," he said. "This program was designed to compensate families when injuries occur from vaccines and avoid driving vaccine companies out of business because of potential liability issues."There is some indication that a few of the provisions in the Homeland Security Bill, including the thimerosal clause, may be modified in early 2003 to address the concerns of critics and the public. But given the history of the preservative and the lack of clear answers about its effect on young children, the issue is likely to attract continued interest over the coming year. --Erica Seiguer, a fourth-year MD-PhD student at HMS Websites of Interest |
