With the return of Ebola to center stage in world health and the much heralded and anticipated start of vaccine trials for this disease in West Africa, it is easy to forget old diseases and debates. Vaccinations created by man, not by natural disease processes, have historically engendered controversy. According to Link (2005, p. 38), "vaccines are counterintuitive. What sense does it make to inject a well baby with a potent, biologically active vaccine that contains elements of the very disease it is supposed to prevent?"
Over the past seventeen years, since the publication of the Wakefield et al. 1998 retracted Lancet article asserting a link between measles, mumps, and rubella vaccines and childhood autism, fear of making well babies sick, rather than protecting them, have swelled among certain groups. Some of the fears are founded in well-grounded research and concerns about special populations and faulty vaccine preparation. Other fears are based on theories that big Pharma is conspiring to make money by killing our children. Unfortunately, what has remained in some parents’ minds is not the fact that the physician falsified data and was discredited, but the notion that all vaccinations are bad, including those that have withstood the test of time.
Due lack of immunization in other countries, porous borders, global travel, and parental refusals to vaccinate their children in this country, diseases we once thought we vanquished with vaccines are making a comeback, often in tragic ways. We are now seeing a resurgence of:
Despite the fact that public concerns about vaccinations were addressed at great length by the 2013 IOM Report, The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies, we still battle avoidable pediatric illnesses that can cause severe sequelae and even death. By way of review, here was the charge of the IOM committee:
1. Review scientific findings and stakeholder concerns related to the safety of the recommended childhood immunization schedule.
2. Identify potential research approaches, methodologies, and study designs that could inform this question, including an assessment of the potential strengths and limitations of each approach, methodology and design, as well as the financial and ethical feasibility of doing them.
3. Issue a report summarizing their findings (IOM, 2013, p. S-3).
The report was guided by four research questions:
1. How do child health outcomes compare between those who receive no vaccinations and those who receive the full currently recommended immunization schedule?
2. How do child health outcomes compare between (a) those who receive the full currently recommended immunization schedule; and (b) those who omit specific vaccines?
3. For children who receive the currently recommended immunization schedule, do short- or long-term health outcomes differ for those who receive fewer immunizations
per visit (e.g., when immunizations are spread out over multiple occasions), or for those who receive their immunizations at later ages but still within the recommended ranges?
4. Do potentially susceptible subpopulations—for example, children from families with a history of allergies or autoimmune diseases—who may experience adverse health
consequences in association with immunization with immunization with the currently recommended immunization schedule exist? (IOM, 2013, p. S-5).
The report did not just give a cursory nod to concerns about safety. The committee painstakingly reviewed extant methodologies that could potentially provide more and better information. This is important because when someone doesn't like the findings of a study, it is easy to attack a weak or inappropriate research methodology. Much like a foundation of a house, if the way the research is conducted is flawed, then the results will automatically be subject to suspicions—as they should be.
Randomized controlled trials or RCTs, the gold standard for clinical research, were addressed first. This approach was rejected because the subjects would be between the ages of 6 and 10. They would also be assigned randomly to treatment or no treatment arm, which means those who wanted their children to have immunizations would be just as likely to be in the "wrong" arm as those who did not want their children to have immunizations. The committee concluded "The risks to participants’ health, the cost and time involved, and the ethical challenges all make the conduct of an RCT unsuitable for addressing the research questions, at least until further work with secondary data has been conducted." (IOM, 2013, S-6).
Prospective Observational Studies require large numbers of participants and controls for confounding variables. To be useful, a study of this nature would require matching each subject on demographic, medical, and other variables. "Since less than 1% of the US population refuses all vaccinations making meaningful numbers in the non-vaccinated group percent of the U.S. population refuses all immunizations, the detection of enough unvaccinated children would be prohibitively time-consuming and difficult." (IOM, 2013, p. S-7). It would also be prohibitively expensive, taking health care dollars away from other opportunities for research or direct care.
Animal Models are not human models. While in the past, I sometimes referred to my now adult son as a "little monkey," at no time did I ever believe he had the same genetic material as one. Any research conducted on animals for the purposes outlined above would require a leap of faith beyond the scope of most scientists. The committee politely reported, "Given the committee’s recognition of the complexity of the immunization schedule, the importance of family history, the role of individual immunologic factors, and the complex interaction of the immunization schedule with the health care system, the committee determined that it was more appropriate to focus future research efforts on human research." (IOM, 2013, S-7)
Secondary Analyses with Existing Data was determined to be "the most feasible approach to studying the safety of the childhood immunization schedule." The committee recommended using the large data bases of participating managed care organizations connected through the Vaccine Safety Datalink (VSD). According to the CDC, "The VSD was established in 1990 to monitor immunization safety and address the gaps in scientific knowledge about rare and serious events following immunization." This is a feasible, affordable, population-based approach utilizing an existing data base that would otherwise be costly to establish. The drawback is, of course, that children who do not receive immunizations are not in the VSD, so research cannot include any adverse health effects that occur due to lack of vaccination.
Literature review: The committee found no evidence in extant literature that the current immunization schedule was unsafe, nor did they find links to a myriad of diseases that have been blamed on vaccinations.
Recommendations from this report can be boiled down to the following:
• More research is needed;
• More attention needs to be paid to concerns of parents when conducting research;
• Research should be conducted on the level of confidence in the immunization schedule;
• There is a need for improved communication between health care professionals and parents;
• Standardized definitions are needed to conduct research and improve communication;
• Studies on immunizations and child safety and health outcomes should be a priority for the Department of Health and Human Services (HHS);
• The HHS should not start any RCTs of childhood vaccinations; and,
• The HHS should fund research utilizing the VSD.
As a health care manager, nurse, mother, and grandmother, here are some of my thoughts and reactions to this report:
• We need to remember that herd immunity, also known as community immunity conferred by most of the population having vaccinations is not the same as a closed colony. In the second instance, no one new comes in and no one leaves the protective bubble. This is not a realistic approach to thinking about immunizations. We are an open society, with global connections. Disease does not respect national borders or state boundaries.
• Vaccines are not new. Nor are parent advocates. Lady Mary Wortley Montagu visited Turkey in 1717 and wrote letters home about the women healers who vaccinated children against smallpox using nutshells full of the infectious material. She asserted she would not leave the country without having her son "engrafted" and vowed to take the treatment to England. She also swore to fight physicians if needed to bring the innovation to her beloved country.
• Using disease for warfare is not new, either. An eye witness account of pustule covered bodies being tossed over the walls of the city of Caffa gave rise to a theory that the Black Plague spread through Europe as a result of biological warfare. The author concluded that it really only gave bubonic plague to the city, not all of Europe. Still, it was an effective weapon.
• We should be very concerned about ensuring the next generation is protected as much as possible against biological warfare from something as easy to prevent as measles, mumps, polio, pertussis, and influenza.
What does this mean for health care managers?
Some readers may be scratching their heads and saying, “Aside from ensuring my employees have their flu shot, this is not my job.” I disagree. Anywhere a health care manager is responsible for the health of a population, such as in accountable care organizations which are “organized groups of physicians, hospitals or other providers jointly accountable for caring for a defined patient population” (Lake, Stewart, Ginsburg, 2011), she is responsible for the healthcare provided by those physicians. Likewise, as the proportion of physicians employed by hospitals continue to rise, the buck for the quality of the healthcare delivered stops with the CEO and the Board of Trustees. I haven’t even mentioned HEDIS measures and organizations like health care insurance companies, ambulatory care centers, public health clinics, or urgent care centers, where health care managers are employed. Health care organizations with large data bases have the ability to implement the recommendations from the IOM report. They also have the ability to use better health literacy approaches to improve communication between health care providers and families. Where there is good team work, there is no disconnect between health care managers and health care providers. This, too, is the responsibility of health care managers. The bottom line is health care managers are responsible for the health of populations and for ensuring vaccinations are provided for a healthier populations today and for future generations.
Sharon B. Buchbinder, RN, PhD
Sharon Buchbinder is Professor and Program Coordinator for the MS in Healthcare Management at Stevenson University in the Graduate and Professional School and former chair of the Association of University Programs in Health Administration (AUPHA). She is also the author of three books from Jones & Bartlett: Introduction to Health Care Management, Cases in Health Care Management, and Career Opportunities in Health Care Management.
Here are some references if you are interested in this topic:
Centers for Disease Control and Prevention (CDC). (2013a). Glossary: Community immunity.
Centers for Disease Control and Prevention (CDC). (2013b). Pertussis.
Centers for Disease Control and Prevention (CDC). (2013d). Vaccine Safety Datalink (VSD).
Centers for Disease Control and Prevention (CDC). (2015). Weekly US map: Influenza summary updated. http://www.cdc.gov/flu/weekly/usmap.htm
Centers for Disease Control and Prevention (CDC). (2015). Measles cases and outbreaks. http://www.cdc.gov/measles/cases-outbreaks.html
Dornhelm, R. (Producer). (2015, January 14). Worst pertussis outbreak in 70 years, but what can state health officials do? California Healthline [Audio podcast]. http://www.californiahealthline.org/insight/2015/worst-outbreak-of-pertussis-in-70-years-but-what-can-state-health-officials-do
Global Polio Eradication. (21 January 2015). Data and monitoring: Polio this week. http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
Halsall, P. (1998, July). Modern History Sourcebook: Lady Mary Wortley Montagu (1689-1762): Smallpox Vaccination in Turkey. http://legacy.fordham.edu/halsall/mod/montagu-smallpox.asp
Institute of Medicine (IOM) Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedules. (16 January 2013). The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. http://iom.edu/Reports/2013/The-Childhood-Immunization-Schedule-and-Safety.aspx
Lake, T.K., Stewart, K.A., & Ginsburg, P.B. (2011 January). Lessons from the field: Making accountable care organizations real. NIHCR Research Brief No. 2. http://hschange.com/CONTENT/1179/?words=accountable%20care%20organanizations
Leonard, K. (22 January 2015). Ebola vaccine trials to begin in West Africa. http://www.usnews.com/news/articles/2015/01/22/ebola-vaccine-drug-trials-to-begin-in-west-africa
Stern, A.M. & Markel, H. (2005). The history of vaccines and immunization: Familiar patterns, new challenges. Health Affairs, 24:3 pp. 611-621. doi: 10.1377/hlthaff.24.3.611
Link, K. (2005). Vaccine Controversy: The History, Use, and Safety of Vaccinations. Westport, CT: Praeger.
O’Malley, A.S., Bond, A.M., & Berenson, R.A. (2011, August). Rising hospital employment of physicians: Better quality, higher cost? Center for Studying Health System Change, Issue Brief No. 136. http://hschange.com/CONTENT/1230/?words=physician%20employment#ib4
RETRACTED: Wakefield, A.J., Murch, S.H., Anthony, A., Linnell, J., Casson, D.M., Malik, M., Berelowitz, M., Dhillon, A.P., Thomson, M.A., Harvey, P., Valentine, A., Davies, S.E., & Walker-Smith, J.A. (1998, February). Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. The Lancet 28:351 (9103) pp. 637-641 DOI: 10.1016/S0140-6736(97)11096-0)
Southern Illinois School of Medicine. (2012, October 30). Overview of Potential Agents of Biological Terrorism. http://www.siumed.edu/medicine/id/bioterrorism.htm
Wheelis, M. Biological warfare at the 1346 siege of Caffa. (2002, September). Emerg Infect Dis [serial online] http://wwwnc.cdc.gov/eid/article/8/9/01-0536_article