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Fighting Windmills in California

F Edward Yazbak MD

 

The story of Don Quixote charging windmills under the delusion that they were giants is well-known. Just as memorable were the melody and lyrics of “The Impossible Dream”.  

In the early 1990’s, a renowned pediatrician realizing that susceptible adults in the United States were uninterested in the recently introduced Hepatitis B vaccine, decided that the best way to control Hepatitis B infection was to vaccinate all newborns in the nursery, whether they needed to be vaccinated or not. Clearly he was fighting a windmill because acute and chronic hepatitis B infections are still occurring in large numbers among immigrants, adults choosing risky behaviors and prison inmates who were still adamantly refusing to be vaccinated.    

More recently, laws were introduced in California to educate doubting parents and abolish personal belief and religious exemptions in order to further improve pediatric vaccination rates and prevent outbreaks of communicable diseases.  

It may be wise for the California Legislature to stop tilting at such windmill and to concentrate on the state’s devastating autism epidemic.

*****

California Assembly Bill 2109 was signed by Governor Brown and filed with the California Secretary of State on September 30, 2012. At the time, existing law exempted a child from vaccination requirements if the parent or guardian filed with the governing authority a letter or affidavit stating that the immunization was contrary to his or her beliefs.

AB -2109 authored by Assembly Man Richard Pan MD, MPH required that as of January 1, 2014, the parents’ affidavit be accompanied by:

a) A signed attestation from a health care practitioner that the risks of communicable diseases and the risks and benefits of the recommended vaccinations had been fully explained to the parents or guardian and…

b) A signed statement by the parent or guardian that indeed he or she had indeed received said information.  https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201120120AB2109

Although AB-2109 effectively reduced the number of KG Personal Belief Exemptions (PBE), it did little towards actually preventing outbreaks of communicable diseases.

In February 2015, the CDC reported:

“As of February 11, a total of 125 measles cases with rash occurring during December 28, 2014–February 8, 2015, had been confirmed in U.S. residents connected with this outbreak. Of these, 110 patients were California residents. Thirty-nine (35%) of the California patients visited one or both of the two Disney theme parks during December 17–20, where they are thought to have been exposed to measles, 37 have an unknown exposure source (34%), and 34 (31%) are secondary cases. Among the 34 secondary cases, 26 were household or close contacts, and eight were exposed in a community setting. Five (5%) of the California patients reported being in one or both of the two Disney theme parks during their exposure period outside of December 17–20, but their source of infection is unknown. In addition, 15 cases linked to the two Disney theme parks have been reported in seven other states: Arizona (seven), Colorado (one), Nebraska (one), Oregon (one), Utah (three), and Washington (two), as well as linked cases reported in two neighboring countries, Mexico (one) and Canada (10).

Among the 110 California patients, 49 (45%) were unvaccinated; five (5%) had 1 dose of measles-containing vaccine, seven (6%) had 2 doses, one (1%) had 3 doses, 47 (43%) had unknown or undocumented vaccination status, and one (1%) had immunoglobulin G seropositivity documented, which indicates prior vaccination or measles infection at an undetermined time. Twelve of the unvaccinated patients were infants too young to be vaccinated. Among the 37 remaining vaccine-eligible patients, 28 (67%) were intentionally unvaccinated because of personal beliefs, and one was on an alternative plan for vaccination. Among the 28 intentionally unvaccinated patients, 18 were children (aged <18 years), and 10 were adults. Patients range in age from 6 weeks to 70 years; the median age is 22 years. Among the 84 patients with known hospitalization status, 17 (20%) were hospitalized.

The source of the initial Disney theme park exposure has not been identified. Specimens from 30 California patients were genotyped; all were measles genotype B3, which has caused a large outbreak recently in the Philippines, but has also been detected in at least 14 countries and at least six U.S. states in the last 6 months.”

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6406a5.htm

The “28 intentionally unvaccinated because of personal beliefs” individuals in a state of almost 39 million inhabitants immediately became an attractive “Windmill” to now CA State Senator Richard Pan MD to realize his dream to abolish once and for all pediatric “philosophical and religious exemptions.” 

On February 4, 2015, surrounded by mothers carrying their infants, Senators Ben Allen and Richard Pan announced to the world that they would be introducing “Legislation to End California’s Vaccine Exemption Loophole.”

http://sd26.senate.ca.gov/news/2015-02-04-senators-richard-pan-and-ben-allen-introduce-legislation-end-california-s-vaccine

At the announcement, Dr. Pan stated: “As a pediatrician, I’ve been worried about the anti-vaccination trend for a long time. I’ve personally witnessed the suffering caused by these preventable diseases and I am very grateful to the many parents that are now speaking up and letting us know that our current laws don’t protect their kids.”

In spite of significant opposition, Dr. Pan feverishly lobbied for “SB-277” until it was passed by the Senate 25 to 10. The bill was approved by Governor Brown and filed with the Secretary of State on June 30, 2015. https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520160SB277

TIME Magazine called Dr. Pan a Hero who had authored a “landmark legislation to abolish non-medical exemptions to legally required vaccines for school students, thereby restoring community immunity from preventable contagions.” There were even unconfirmed reports that Dr. Pan often hummed “The Impossible Dream” driving to work in Sacramento’s famously challenging traffic.  http://www.dot.ca.gov/hq/roadinfo/Hourly

In addition to practicing Pediatrics and witnessing the suffering caused by preventable diseases around the State Capital, Dr. Pan chaired “ the Senate Budget and Fiscal Review Subcommittee on Health and Human Services, the Committee on Public Employment and Retirement and the Senate Select Committees on Children with Special Needs and on Asian Pacific Islander Affairs” and that he also served on the Senate Committees on Agriculture; Business, Professions, and Economic Development; and Education” and accomplished all that in record time. 

http://sd06.senate.ca.gov/biography

***

On April 12, 2017, Dr. Pan victoriously “hailed new data by the California Department of Public Health (CDPH) demonstrating that, in its first year of implementation, Senate Bill 277 is raising school vaccine rates to levels not seen in a decade and a half…”

Dr. Pan added: “I am pleased that this first year of the implementation of SB277 has resulted in the significant rise of the vaccination rate of this year’s Kindergarten class” and “This success is a first step toward reducing the number of unimmunized people putting our families at-risk for preventable diseases, thereby restoring community immunity throughout our state in the coming years.”

http://sd06.senate.ca.gov/news/2017-04-12-dr-richard-pan-vaccinate-california-respond-new-state-data-showing-kindergarten

The same report also mentioned that “The results posted today by CDPH in their annual immunization assessment, show that the proportion of kindergarten students who received the required vaccines dramatically rose from 93 percent during the 2015-16 school year, to 96 percent during the 2016-17 school year, a rate above the 94 percent needed to prevent measles transmission.”

Without mentioning measles by name, Dr. Pan appeared to suggest that the 2014-2015 measles outbreak in California was somehow related to philosophical exemptions and poor pediatric vaccination rates among KG students necessitating the introduction and adoption of SB277.

Once more he had jousted against another windmill!  

*****

On May 16, 2017, an “Original Research” report was published in “Annals of Internal Medicine.It was titled “Missed Opportunities for Measles, Mumps, Rubella Vaccination Among Departing U.S. Adult Travelers Receiving Pretravel Health Consultations” and authored by Emily P. Hyle, MD, MSc; Sowmya R. Rao, PhD; Emily S. Jentes, PhD, MPH; Amy Parker Fiebelkorn, MSN, MPH; Stefan H.F. Hagmann, MD, MSc; Allison Taylor Walker, PhD, MPH; Rochelle P. Walensky, MD, MPH; Edward T. Ryan, MD; Regina C. LaRocque, MD, MPH.

“Among the five most widely cited medical journals in the world” Annals of Internal Medicine, the Journal of the American College of Physicians,  “sets the standard for evidence-based, practice-relevant information.” https://store.acponline.org/ebizatpro/Default.aspx?TabID=251&productId=4897

The authors of the “Original Research” report, all attached to distinguished hospitals and universities, clearly stated that: “Measles outbreaks continue to occur in the United States and are mostly due to infections in returning travelers" and not to foreign visitors or a magic percentage of California or US children.

According to the report, “40 810 adult travelers were included; providers considered 6612 (16%) to be eligible for MMR vaccine at the time of pretravel consultation. Of the MMR-eligible, 3477 (53%) were not vaccinated at the visit; of these, 1689 (48%) were not vaccinated because of traveler refusal, 966 (28%) because of provider decision, and 822 (24%) because of health systems barriers. Most MMR-eligible travelers who were not vaccinated were evaluated in the South (2262 travelers [65%]) or at nonacademic centers (1777 travelers [51%]). Nonvaccination due to traveler refusal was most frequent in the South (1432 travelers [63%]) and in nonacademic centers (1178 travelers [66%]).”

The authors concluded that: Of U.S. adult travelers who presented for pretravel consultation at GTEN sites, 16% met criteria for MMR vaccination according to the provider's assessment, but fewer than half of these travelers were vaccinated. An increase in MMR vaccination of eligible U.S. adult travelers could reduce the likelihood of importation and transmission of measles virus.

[The Global TravEpiNet (GTEN) includes 24 sites of a CDC-funded consortium]

The study was funded by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Steve and Deborah Gorlin MGH Research Scholars Award.

http://annals.org/aim/article/2626466/missed-opportunities-measles-mumps-rubella-vaccination-among-departing-u-s

***

By tradition, an “Original Research” publication is almost invariably accompanied by a related editorial. The editorial published on May 16, 2017 was titled “Why Aren't International Travelers Vaccinated for Measles?” and authored by Lori K. Handy, MD, MSCE and Paul A. Offit, MD.

Dr Handy is Assistant Professor of Pediatrics, Sidney Kimmel Medical College, Thomas Jefferson University. Her area of expertise is Infectious Diseases and Vaccines. 

Dr. Offit is Professor of Pediatrics, Division of Infectious Diseases, Children’s Hospital of Philadelphia and Maurice R. Hilleman Professor of Vaccinology, Perelman School of Medicine, University of Pennsylvania. He is also the Director of the Vaccine Education Center at CHOP.

In their Editorial, Drs. Handy and Offit reported that: “Before a vaccine against measles was introduced, 500 000 cases occurred each year in the United States, resulting in 500 deaths, 48 000 hospitalizations, and 1000 cases of permanent brain damage from encephalitis (1). Endemic measles was eliminated from the United States in 2000 (2), but sporadic outbreaks have occurred since then because of importation of the virus from other countries. These cases occur in travelers as well as their contacts in the United States, many of whom are unvaccinated themselves (3). In 2014, the United States had the largest single outbreak of measles (667 cases) in more than 20 years because of infected travelers returning from abroad combined with the low vaccination rate of certain U.S. populations (4). This outbreak was linked to travel to the Philippines, which was in the midst of a measles epidemic. In 2015, a multistate outbreak associated with Disneyland likely was the result of a park visitor who had traveled overseas; 188 cases were reported that year (5). Importations remain the source of measles transmission in the United States, and persons visiting travel clinics present an opportunity to reduce or eliminate these cases.”

http://annals.org/aim/article/2627899/why-aren-t-international-travelers-vaccinated-measles

It is very clear that Drs. Handy and Offit were also discussing unvaccinated US travelers who go to countries where they are exposed to measles and then return to the United States where they expose friends and relatives.

The listed Reference # 4 related to the largest single measles outbreak of 667 cases deserves discussion in some detail. That report was published in the New England Journal of Medicine on October 6, 2016. https://www.ncbi.nlm.nih.gov/pubmed/27705270

According to the authors, the outbreak of measles originated from two unvaccinated Amish men in whom measles was incubating at the time of their return to the United States from the Philippines.  

The reported and most interesting findings of the study were that:

From March 24, 2014, through July 23, 2014, a total of 383 outbreak-related cases of measles were reported in nine counties in Ohio. The median age of case patients was 15 years (range, <1 to 53); a total of 178 of the case patients (46%) were female, and 340 (89%) were unvaccinated.

Transmission took place primarily within households (68% of cases).

The virus strain was genotype D9, which was circulating in the Philippines at the time.

Measles-mumps-rubella (MMR) vaccination coverage with at least a single dose was estimated to be 14% in affected Amish households and more than 88% in the general (non-Amish) Ohio community.

The spread of measles was limited almost exclusively to the Amish community (99% of case patients) and only affected about 1% of the estimated 32,630 Amish persons in the settlement.

***

Drs. Handy and Offit stated:

“Although these results may not be representative of all travelers, individuals who visit travel clinics presumably are highly motivated to seek protection from infectious diseases while abroad. Therefore, it is surprising that the MMR vaccination rates at these visits were not higher.

Vaccine eligibility in this study population was based on self-reported disease and immunization history, which is less strict than the criteria of the Advisory Committee on Immunization Practices. Although these more lenient standards may have influenced one's perception of whether vaccination was needed—or not—previous studies estimated that measles seroprevalence is greater than 75%—and likely closer to 90%—in agreement with the authors' findings (8).

Many departing U.S. travelers attend travel clinics or visit their own physician to take appropriate precautions before leaving the country. Conversely, many others are not motivated to visit a travel clinic or are logistically unable to do so; travelers overall may have even lower immunization rates.

Because these data are from surveys, information is incomplete regarding the reason for traveler refusal, the drivers of provider decisions, and the measures taken to encourage vaccination.

The study included sites at both academic and nonacademic institutions in various regions of the country. Variability by clinic is one factor that may be addressed to try to standardize care among clinics. Travelers did have the opportunity to report why they refused the MMR vaccine, and most stated they did so because they were “not concerned about illness.”

Exotic infections, such as malaria and yellow fever, preoccupy travelers; measles should be just as feared, and vaccination should be strongly encouraged.

Because of the low incidence of measles in the United States, few persons understand the severity of the disease for themselves, the contagiousness of the virus, or the implications for society at large on their return.

Providers must play a role in helping travelers understand the seriousness of this infection.”

***

Hyle et al clearly stated that “An increase in MMR vaccination of eligible U.S. adult travelers could reduce the likelihood of importation and transmission of measles virus.”

They clearly were not talking about KG vaccination rates.

The related Editorial by Handy and Offit should make reasonable people wonder whether Dr. Pan’s elation was justified and whether indeed a 1 or 2% increase in vaccination rates in Kindergarten was going to actually prevent infectious disease outbreaks and as Dr. Pan promised “restore community immunity throughout our state in the coming years.”

Concerning the earlier mentioned California Department of Public Health statement “that the proportion of kindergarten students who received the required vaccines dramatically rose from 93 percent during the 2015-16 school year, to 96 percent during the 2016-17 school year, a rate above the 94 percent needed to prevent measles transmission.”, it seems strange that the good people at the CDPH really believed that a 93% MMR vaccination rate was dismal and a 94% vaccination rate in KG was totally effective in preventing measles transmission statewide.

It was also interesting to note that the California measles outbreak of less than 150 cases was more intensely used by Dr. Pan as an argument in favor of abolishing philosophical and religious exemptions than the recent whooping cough California epidemics.   

In 2010, California experienced the highest number of pertussis cases in >60 years, with >9000 cases, 809 hospitalizations, and 10 deaths. https://www.ncbi.nlm.nih.gov/pubmed/22819634

More recently, the CDC reported that “During January 1–November 26, 2014, a total of 9,935 cases of pertussis with onset in 2014 were reported to CDPH, for a statewide incidence of 26.0 cases per 100,000.” Referring to the relatively ineffective whooping cough vaccine presently in use, the CDC authors had added: “As long as currently available acellular pertussis vaccines are in use, it is likely that the "new normal" will be higher disease incidence throughout pertussis cycles.” https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6348a2.htm

Interestingly, California’s leading calamity appeared to have been somewhat ignored during the fierce discussion of SB277.  According to the Sacramento Bee, July 18, 2016, published in Dr. Pan’s own backyard: “More than 97,000 California public school students have been diagnosed as autistic, a number that has risen seven-fold since 2001, according to the latest special education data from the California Department of Education.

The figure represent a jump of about 6,500, or 7 percent, from 2014-15 to 2015-16.

The increase was especially sharp among kindergartners, where autism cases grew by 17 percent last year. More than one of every 65 kindergartners in California public schools is classified as autistic.”

In 10 years, “the number of autistic students statewide has risen by between 5,000 and 7,000 every year, state figures show.

In the four-county Sacramento region, the number of autistic students rose by about 660, or 12 percent, to roughly 6,400 from 2014-15 to 2015-16.”

According to the included graph, California public school students diagnosed with autism increased from about 14,000 cases in 2001 to about 97,000 cases in 2016. http://www.sacbee.com/site-services/databases/article90300877.html

During the same 15 years, the population of California increased from 34.5 to 39.25 million.

https://www.statista.com/statistics/206097/resident-population-in-california/

The societal cost of autism in California was estimated to reach $40 billion in 2015.

http://californiahealthline.org/news/high-cost-of-autism-to-california/


*****

Like everywhere else, there are a multitude of serious issues confronting California.

The relatively small number of pediatric vaccination exemptions does not appear to be the state’s gravest challenge

Maybe Senator Pan can forget the windmills and concentrate on discovering what is really causing California’s Mega-Epidemic of Autism.


F. Edward Yazbak MD, FAAP                   May 30, 2017

 

 

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