Pharmacy & Therapeutics - September 2008 - (Page 543)

HEALTH CARE AND LAW sets of claims on behalf of 4,800 parents who allege that vaccines caused their children to become autistic.6 Decisions are not expected until next year. If the decisions favor the claimants, the implications for childhood vaccination in the U.S. could be considerable. of new technologies, particularly genomics. However, although research can uncover new clinical possibilities, success in actually producing vaccines and distributing them to large populations depends as much on social, economic, and political factors as on the underlying science. Vaccines will not reach large numbers of people without mechanisms to fund their development, which can cost hundreds of millions of dollars, systems to distribute them widely and equitably to those in need, and arrangements to reimburse for their cost. The panelists also agreed that the public must gain a better understanding of the value of this medical technology. Information on risks and benefits should be widely disseminated and clearly presented to counter inaccurate statements about vaccine risks, which exist in abundance on the Internet. In particular, many parents might not appreciate the severity of childhood illnesses, such as polio, that have become distant memories because of vaccination. In other words, they might not be viewing vaccine risks in the context of full vaccine benefits. To pave the way for the future of vaccines, the panelists saw key roles for many different players. For instance, the federal government should maintain and expand assistance programs for those unable to afford vaccines. The pharmaceutical industry should continue to invest in research and development, even if the payoffs are decades away. Organizations such as the Bill and Melinda Gates Foundation and the Global Alliance for Vaccines and Immunization (GAVI) should maintain and expand their role in funding mechanisms to distribute vaccines, especially in the developing world. Clinicians should remain abreast of medical developments so that they can accurately counsel patients, and parents of patients, on vaccination decisions. All of these roles are essential to the continued success of this primary public health tool. creased funding for research into possible vaccine risks, and fair compensation for documented vaccine injuries. The public and the medical community must understand that vaccination benefits the health of entire populations, not just the individuals receiving them. Vaccines can save countless more lives in the future, but components of the entire health care system must be part of the effort to realize this goal. Mandates as a Policy Response To encourage widespread vaccination, all states mandate that children receive recommended inoculations as a condition of attending school. However, all of these mandates contain exceptions.7 Children in every state can avoid vaccination based on clinical contraindications, such as allergies and religious objections. About half of all states also permit people to decline vaccination if they oppose the practice on broader philosophical grounds. Research has found higher rates of unvaccinated children in these states along with higher rates of measles and pertussis, which are vaccine-preventable diseases.8,9 This finding suggests that increasing rates of vaccine declination are, in fact, jeopardizing herd immunity in some communities. While public health officials cringe at these trends, solutions are not readily apparent. Stricter mandates for vaccination raise complex legal, ethical, and policy implications.10 Americans cherish their autonomy, and efforts by government to supersede individual health care choices tend to be viewed with suspicion. As vaccine opponents become increasingly vocal, the subject is taking on increasing emotional intensity. Merck encountered substantial opposition when it launched a vigorous lobbying campaign for state mandates of its vaccine (Gardasil) against virus strains that can cause cervical cancer.7 As new vaccines are developed, public resistance seems certain to continue to rise. Will this reluctance to receive vaccinations jeopardize hard-fought gains against infectious diseases? Where will it leave the role of vaccines as an essential public health tool? References 1. Wakefield AJ, Murch SH, Anthony A, et al. Ileal–lymphoid–nodular hyperplasia, nonspecific colitis, and per vasive developmental disorder in children. Lancet 1998; 351:637–641. 2. Murch S, Anthony A, Casson D, et al. Retraction of an interpretation. Lancet 2004;363(9411):750. 3. Anderson RM. The concept of herd immunity and the design of communitybased immunization programmes. Vaccine 1992;10(13):928–935. 4. Nichol KL, Hauge M. Influenza vaccination of healthcare workers. Infect Control Hosp Epidemiol 1997;18(3):189–194. 5. Harris G. Deal in autism case fuels debate on vaccine. The New York Times, March 8, 2008. 6. Harris G. Court hears more claims of vaccine–autism link. The New York Times, May 13, 2008. 7. Charo AR. Politics, parents, and prophylaxis: Mandating HPV vaccination in the United States. N Engl J Med 2007;356: 1905–1908. 8. Fiekin DR, Lezotte DC, Hamman RF, et al. Individual and community risks of measles and pertussis associated with personal exemptions to immunization. JAMA 2000;284(24):3145–3150. 9. Saad B, Omer SB, Pan, WKY, et al. Nonmedical exemptions to school immunization requirements: Secular trends and association of state policies with pertussis incidence. JAMA 2006;296(14):1757–1763. 10. Field RI, Caplan AL. A proposed ethical framework for vaccine mandates: Competing values and the case of HPV. Kennedy Inst Ethics J 2008;18(2):111–124. 11. Symposium participants: Alan R. Hinman, MD, MPH, Senior Public Health Scientist, Task Force for Child Survival and Development, Emory University and The Carter Center; Paul A. Offit, MD, Chief, Division of Infectious Diseases, and Director, Vaccine Education Center, Children’s Hospital of Philadelphia; Stanley Plotkin, MD, Emeritus Professor, University of Pennsylvania, and Executive Advisor to Sanofi Pasteur; and Thomas Vernon, MD, retired Vice President for Policy, Public Health, and Medical Affairs, Merck & Co. Moderator: Arthur L. Caplan, PhD, Emmanuel and Robert Hart Professor of Bioethics; Chair, Depar tment of Medical Ethics; and Director, Center for Bioethics, University of Pennsylvania. I The Challenge for Policy The Experts Weigh In At a symposium held at University of the Sciences in Philadelphia in May 2008, vaccine experts explored these questions from a range of perspectives, and they reached some interesting conclusions.11 Major medical advances in developing vaccines against a range of conditions lie on the horizon. They represent the fruits The challenge for lawmakers will be to implement policies that harness the skills of all key players to promote vaccine use and development. Mandates will be one tool, but they must be approached cautiously to minimize the fierce opposition that has become increasingly evident. Other elements of this effort should include public and clinician education, in- Vol. 33 No. 9 • September 2008 • P&T® 543

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Pharmacy & Therapeutics - September 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Effect of Prescription Copays on Adherence and Treatment Failure with Oral Antidiabetic Medications Vaccine Declinations Present New Challenges for Public Health Universal Health Care in America Digestive Disease Week and American Diabetes Association Pharmaceutical Approval Update

Pharmacy & Therapeutics - September 2008

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