Are you up to date with your vaccines? What about your family, are they? Vaccination time can be confusing, not just for the patient. Here is a view from nurse, educator, mom Sharon Buchbinder on vaccinations and safety in the new IOM (Institute of Medicine) expert report.

The IOM Report on The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies

       Available at http://www.iom.edu/Reports/2013/The-Childhood-Immunization-Schedule-and-Safety.aspx

By Sharon Buchbinder, RN, PhD

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 fifteen 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.

In reading this new IOM [ Institute of Medicine ] report, I wore several hats: Registered Nurse, PhD in Public Health, health care manager and educator, mother, great aunt, and, most recently, grandmother. My “bias” as a scientist and health care professional is well balanced by my family concerns.

As the mother of a child who could not tolerate the pertussis vaccine (high fevers), thirty years ago I fought with pediatricians who thought I was a raving lunatic. As the great aunt and grandmother of three preemies, I raced to obtain my Tdap (Tetanus, diptheria, and pertussis) vaccination to protect our newborn family members. It is all about balance.

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. As a researcher and educator, I chose to focus on this part of the report to give the reader insight into the difficulties intrinsic in proving or disproving immunization beliefs.

Methodologies

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 I have, on occasion, in the past, 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

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.

Reactions

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. But, still, it was effective as a 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 and rubella.

The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies provides a balanced, thoughtful, and well-referenced report (with an understandable glossary!) on the current state of immunizations in the United States. The committee provided ethical, feasible, and cost-effective recommendations for actions that can be commenced immediately. The committee also provided insight into types of research that should not be conducted. As a Registered Nurse with a PhD in Public Health, a health care manager and educator, mother, great aunt, and, grandmother, my concerns were addressed. Were yours?

References

• 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). (2013c). Pertussis prevention.
• Centers for Disease Control and Prevention (CDC). (2013d). Vaccine Safety Datalink (VSD).
• Halsall, P. (1998, July). Modern History Sourcebook: Lady Mary Wortley Montagu (1689-1762): Smallpox Vaccination in Turkey.
• Link, K. (2005). Vaccine Controversy : The History, Use, and Safety of Vaccinations. Westport, CT: Praeger.
• 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 Lancet28:351 (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.
• Wheelis, M. Biological warfare at the 1346 siege of Caffa. (2002, September). Emerg Infect Dis [serial online]

 

 

Meet Sharon Buchbinder, RN, PhD

Dr. Sharon Buchbinder, RN, PhD worked in healthcare as an Intravenous Therapist from 1973 to 1980, where she was greeted by patients with “Not again!” each time she entered their rooms. Practitioner, researcher, and teacher, this multi-published author is currently Professor and Program Coordinator for the MS in Healthcare Management Program at Stevenson University. When not attempting to make students, colleagues, and babies laugh, she can be found writing. More information about her non-fiction and fiction publications can be found at http://www.amazon.com/Sharon-Bell-Buchbinder/e/B001IODIE2

If you’re interested in learning more about her award-winning fiction and chatting with authors, stop by her blog at http://www.sharonbuchbinder.com/blog/

You may also be interested in…

Nurses Lead Healthcare: a Science rEvolution article :  http://sciencerevolution.org/2012/01/13/nurses-lead-healthcare-no-handmaidens-of-doctors-here/

Some Other Child, by Sharon Buchbinder – a novel about family, love, and a public health issue : http://www.amazon.com/Some-Other-Child-ebook/dp/B009JX31KK

Vector, by Jennifer J.Brown – a novel about coming of age during the HIV epidemic in NYC : http://www.amazon.com/Vector-Modern-Story-Jennifer-Brown/dp/0983821135