HPV Vaccine Is Being Ignored

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Medical News & Perspectives .....p1502 Global Health...... p1506 News From the Food and Drug Why the “No-Brainer” HPV Vaccine Diet Quality Declines Despite Increase Administration...... p1507 Is Being Ignored in Healthy Food Consumption Device Approved for Some Patients Gut Bacteria Combined With Poor Diet With Atrial Fibrillation The JAMA Forum...... p1504 May Promote Childhood Malnutrition New Chantix Warnings Of Mouse and Measles Report Outlines Investment Strategies for “ResQCPR” Could Help Prevent Cardiac Targeting NTDs Arrest Deaths Fifty Breakthroughs for Sustainable First Biosimilar Product Approved Global Development

Medical News & Perspectives Why the “No-Brainer” HPV Vaccine Is Being Ignored

Rita Rubin, MA

odney Willoughby, MD, a pediatric come infected at least once during their life used for routine immunization (Petrosky E infectious disease specialist at the (http://1.usa.gov/1NZJvwU). Moreover, per- et al. MMWR Morb Mortal Wkly Rep. 2015; R Medical College of Wisconsin, can’t sistent infection with certain strains causes 64[11]:300-304). help thinking about the future—a future in virtually all cervical cancers as well as about Human papillomavirus types 16 and 18, which thousands of men and women de- two-thirds of vulvar and penile cancers, associated with cervical cancer, are also as- velopprecancerousorcancerouslesionsthat three-fourths of vaginal and oropharyngeal sociated with penile and oropharyngeal can- could have been prevented had they been cancers, and about 9 in 10 anal cancers cer. Although the HPV vaccines are pre- vaccinated against the human papillomavi- (http://1.usa.gov/1CjY7nN). sumed to protect against those 2 cancers as rus (HPV) as 11- or 12-year-olds. Human papillomavirus vaccines can’t well as cervical cancer, clinical trials have not “The family practitioners and pediatri- prevent infection after the fact, which is why yet been conducted to demonstrate effi- cians do a really bad job in promoting HPV theACIPrecommendsimmunizationforpre- cacy against these cancers (http://1.usa.gov vaccination for a variety of reasons,” said teens before they become sexually active. /18tjZiY). Such studies would be prohibi- Willoughby,a member of the Advisory Com- The ACIP has recommended routine vacci- tively long and expensive, Willoughby said, mittee on Immunization Practices’ (ACIP) nation of girls aged 11 or 12 years since 2006, because researchers have nothing compa- working group on the HPV vaccine and the when Gardasil, the first approved HPV vac- rable to the Pap smear to detect precancer- American Academy of Pediatrics’ Commit- cine, became available (http://1.usa.gov ous penile or oropharyngeal lesions. tee on Infectious Diseases. “We recognize /1DoEGKj). The committee issued the same Despite the preventive benefits and that we are falling down on the job. This is recommendation for boys in 2011 (http://1 documented efficacy in protecting against actually a real emergency.” .usa.gov/1G97qVc). cervical cancer, HPV vaccination rates re- Research has shown that most parents Gardasil, Merck’s quadrivalent vaccine main far below 2 other recommended pre- would immunize their children if their pe- approved for males and females, protects teen vaccines—the one for Tdap (against diatrician or family practitioner recom- against 2 HPV types (16 and 18) that cause tetanus, diphtheria, and pertussis) and the mended the HPV vaccine as part of the stan- 70% of cervical cancers as well as 2 other meningococcal conjugate vaccine (Elam- dard package of vaccines for adolescents HPV types (6 and 11) responsible for EvansLDetal.MMWRMorbMortalWklyRep. (Holman DM et al. JAMA Pediatr. 2014; 90% of genital warts cases. Cervarix, 2014;63[29]:625-633). In 2013, 86% of US 168[1]:76-82, and Rickert VI et al. Vaccine. GlaxoSmithKline’s bivalent vaccine teens aged 13 to 17 years had received Tdap 2015;33[5]:642-647). But studies also have approved only for girls, protects against the and 77.8% had received the meningococcal found that parents, like physicians, some- same 2 cancer-causing types of HPV (http: vaccine. But only 57.3% of girls and 34.6% times delay immunization because they //bit.ly/1wPTsYd). In December, the Food of boys had received at least 1 of the 3 rec- think their child is years away from becom- and Drug Administration approved the ommended doses of HPV vaccine, and only ing sexually active and contracting HPV. In 9-valent HPV vaccine (9vHPV), Gardasil 9, 37.6% of girls had received all 3 doses (http: addition, the HPV vaccine requires 3 trips to which protects against HPV types in the //kff.org/womens-health-policy/fact-sheet the physician’s office, which might prove original quadrivalent vaccine and an addi- /the-hpv-vaccine-access-and-use-in/). daunting to busy families. tional 5 HPV types that cause cervical These vaccination rates fall far short of The urgency for vaccination is under- cancers (http://1.usa.gov/1LiJp4E). ACIP the Healthy People 2020 initiative’s target scored by the fact that HPV is the most com- recently updated its HPV vaccine recom- goal to have 80% of 13- to 15-year-old girls mon sexually transmitted infection, and mendations to include 9vHPV as one of the and boys fully immunized with all 3 HPV most sexually active men and women be- three recommended vaccines that can be doses (http://1.usa.gov/1MFXTH7).

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“Manypeople,likeme,thoughtthatavac- ter for HPV Research at Indiana University– has disproved that notion. For example, an cinetopreventcancerwouldbeano-brainer,” Purdue University Indianapolis. He echoed analysis of a large, longitudinal insurance da- Anne Schuchat, MD, director of the National Feemster, saying, “It [the HPV vaccine] is tabase of girls aged 12 to 18 years found that CenterforImmunizationandRespiratoryDis- typically brought up last and discussed in a HPV vaccination was not associated with in- eases at the Centers for Disease Control and way like it’s almost a different species of vac- creases in sexually transmitted infections, Prevention, said in an interview. cine, which reinforces [the notion] that “suggestingthatvaccinationisunlikelytopro- Thelowimmunizationratesindicatethat there’s something weird about it,”he said. “It mote unsafe sexual activity” (Jena AB et al. has not been the case, Schuchat said. “I do unfortunately reveals the social stigma that’s JAMAInternMed.doi:10.1001/jamainternmed think providers think they’re recommending so pervasive around sex and sexually trans- .2014.7886 [published online February 9, thevaccine,butthewaythey’retalkingabout mitted diseases.” 2015]). itisoftendifferentandmayraisequestionsin- Pediatriciansalsoassumeparentswillbe Increasingly, parents seem to be less fo- stead of reassure,” she said. In a recent edi- reluctant to discuss or consider vaccination cused on a possible link between the HPV torial, Schuchat noted that if teenagers were because HPV is sexually transmitted. Physi- vaccine and increased sexual activity. Zimet offered and accepted HPV vaccination every cians hesitate to bring it up because they still and his colleagues have shown that sexual time they received another vaccine, first- expect a negative reaction, said William promiscuity ranked lowest among parents’ dose coverage for HPV would exceed 90% Schaffner,MD,professorofpreventivemedi- reasons for not having vaccinated their son (Schuchat A. N Engl J Med. 2015;372[8]:775- cine and infectious diseases at Vanderbilt (Donahue KL. Vaccine. 2014;32[31]:3883- 776). However, she wrote, “research sug- University. As a result, instead of giving par- 3885). In the study,they surveyed a national geststhatparentshearmixedmessagesabout ents a chance to ask questions, they’ll say, sample of parents of 11- to 17-year-old boys HPV vaccination; pediatricians communi- “we can wait until next year,” said Debbie who had not received the HPV vaccine. catelessurgencyandgiveweakerrecommen- Saslow, PhD, director of breast and gyneco- Among 9 possible reasons for nonvaccina- dations for this vaccine.” logic cancer at the American Cancer Soci- tion, only 8.5% of the parents said they Thelackofstatemandatesalsomayhelp ety. “They’re afraid that the parent is going thoughttheshotwouldmakeiteasierfortheir explainthelowerHPVimmunizationrates.All to ask about sex,” she said. son to have sex. Some 15% said they consid- but 4 states require Tdap and 22 states and Parents and physicians might worry ered the HPV vaccine potentially danger- Washington, DC, require the meningococcal that adolescents will view immunization ous,and17.7%saidtheyfeltthevaccinecould vaccine for all middle school–aged children against HPV as a greenlight for unsafe sexual have adverse effects. But a whopping 60.9% (2 other states require the meningococcal activity, Emory epidemiologist Robert A. said their doctor or health care provider had vaccine only for boarding school students), Bednarczyk,PhD,wroteinarecentcommen- not recommended the vaccine. according to the Immunization Action Coali- tary (Bednarczyk RA. JAMA Intern Med. doi: A recent study involving parents or tion (http://bit.ly/1CnGROp and http://bit 10.1001/jamainternmed.2014.7894 [pub- guardians of 11- to 17-year-old girls who had .ly/1Cm9XMv). But only Washington, DC; lished online February 9, 2015]). But research not been vaccinated and their physicians Virginia;andRhodeIslandhavelawsrequiring theHPVvaccineformiddleschoolchildren,ac- HPV Vaccination Rates of Adolescent Girls Aged 13-17 Years by State: 2013 cordingtothecoalition(http://bit.ly/19s1MU1).

What’s Sex Have to Do With It? WA b VT ME Physicians’ hesitancy to recommend the MT ND OR MN NH MA HPV vaccine dates back to its introduction, ID SD WI NY WY MI RI said pediatrician Julie Morita, MD, acting CT NE IA PA NV OH NJ commissioner of the Chicago Department of ILa IN CA UT CO DE WV VA Public Health. “Right after it was recom- KS MO KY MD mended by the ACIP…there was this imme- NC DC TN diate backlash about it being this STD [sexu- AZ NMa OK AR SCa a ally transmitted disease] vaccine. Providers MS AL GA LA TX had this discomfort,” Morita said. AK Pediatricians tend to regard the HPV FL vaccine as a different breed from the other HI

preteen vaccines because the virus is sexu- 2013 US average = 37.6% ally transmitted, and some of them aren’t comfortable talking about sexual health, said Estimated vaccine coverage for girls aged 13-17 y pediatrician Kristen Feemster, MD, a fac- <30% (10 states) 30%-37.6% (17 states + DC) 37.7%-44.9% (16 states) ≥45% (7 states) ulty member at PolicyLab at the Children’s Share of girls aged 13-17 y who had received all 3 doses of the HPV vaccine series. Hospital of Philadelphia and an infectious aStatistically significant P( <.05) increase from 2012. disease specialist. bStatistically significant P( <.05) decrease from 2012. Data Source: Centers for Disease Control and Prevention. National, state, and local area vaccination Such attitudes could in part explain low coverage among adolescents aged 13-17 years: United States, 2013. vaccination rates, suggests psychologist Source: The HPV vaccine: access and use in the US. The Henry J. Kaiser Family Foundation; February 26, 2015. Gregory Zimet, PhD, co-director of the Cen-

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similarly found that one of the most com- European Medicines Agency last year ap- agreement with a prescriber or if the girl had mon reasons parents reported for nonvac- proved that regimen for quadrivalent and bi- aprescription.Onlyafewstatesallowedphar- cination was the lack of physician recom- valentHPVvaccinesforadolescents9to13or maciststoadministerHPVvaccinesto12-year- mendation (Perkins RB. Pediatrics. 2014; 14 years old (http://bit.ly/1MEA7LK and http: old girls with no prior approval. 134[3]:e666-e674). The study also revealed //bit.ly/1GdDt6p). And in February, Canada’s that some providers delayed recommend- National Advisory Committee on Immuniza- Less Is More ingthevaccineforgirlsperceivedtobeatlow tion began recommending 2 doses, 6 to 12 It may seem counterintuitive, but perhaps risk for sexual activity. months apart, for children aged 9 to 14 years the best way to raise HPV immunization “If you ask physicians, they’ll say they (http://bit.ly/1CktDAw). rates is to focus less, not more, attention on recommend it. That doesn’t really capture In the United States, the ACIP wanted to the vaccine, experts suggested. what’s going on. We hear providers essen- wait until the Food and Drug Administra- That’s the objective of the “Less Is More” tially talking parents out of vaccinating,” tion approved Gardasil 9 before it consid- campaign developed by Morita and Rachel Zimet said in an interview. ered an across-the-board reduction in the Caskey,MD, MaPP,assistant professor of pe- Although social stigma and discomfort number of doses needed, Schuchat said. Af- diatrics and general internal medicine at the surrounding STDs and sexual health may de- ter the December approval, Merck began University of Illinois College of Medicine. As ter productive conversations between physi- shipping Gardasil 9 in February,and the ACIP its name suggests, the campaign aims to per- ciansandparentsabouttheHPVvaccine,even has added the vaccine to its recommenda- suade physicians to stop overexplaining the whenframedasacancervaccine,it“isaharder tions for routine vaccination of 11- and 12- HPV vaccine and instead treat it in the same sell for some pediatricians and some parents year-old boys and girls, according to com- informative and casual manner that they do becausetheconsequencesare20yearsdown pany spokeswoman Pamela Eisele. other adolescent and childhood vaccines the road,” Willoughby acknowledged. Merck is now conducting a study of al- (http://bit.ly/1CnTEAn). ternative schedules and timing for adminis- Launched in 2012, Less Is More encour- Maybe 2 Is Enough tering the vaccine, Schuchat said. “I think ages physicians to allow parents to initiate The HPV vaccine is unique among the 3 pre- that over the next year and a half, there the conversation. The campaign has reached teen vaccines in that it requires 3 doses— should be new data about whether poten- out to Chicago providers in presentations at administered over a period of 6 months— tially 2 doses in some age groups would be severalvenuesaroundthecity,coveringsuch instead of a single dose. okay with the 9-valent,” she said. topics as the need to strongly recommend Other countries are addressing poten- MakingHPVvaccinationavailableinven- the HPV vaccine and information about its tialadherenceissuesthatmightcontributeto ues other than the physician’s office would safety and effectiveness. low immunization rates by moving toward a help accelerate uptake, the President’s Can- “I feel the vast majority of our practi- 2-dose regimen for younger teens and pre- cer Panel wrote in its 2012-2013 annual re- tioners now get it,” Morita said, adding that teens. In 2014, the World Health Organiza- port (http://1.usa.gov/1bqAspO). Pharma- the Less Is More message is spreading to tion (WHO) changed its HPV vaccination cies are a particularly promising location, but their peers around the country. recommendations to a 2-dose schedule, at in 2012, pharmacists in more than a third of Vaccine advocates hope the word least 6 months apart, if the first dose is ad- states were not permitted to administer HPV spreads quickly, boosting HPV immuniza- ministered before age 15 years (WHO Re- vaccineto12-year-oldgirls,accordingtothere- tion rates among preteens and teens. “Ev- port. Vaccine. doi:10.1016/j.vaccine.2014.12 port. In more than half the states, pharma- ery year we don’t turn things around, more .002 [published online December 12, 2014]). cistswereallowedtodoso—dependingonthe people are unprotected and more HPV in- Based on the WHO recommendation, the state—if they entered into a supervision fections will occur,” Schuchat said.

The JAMA Forum Of Mouse and Measles

Joshua M. Sharfstein, MD

ickey Mouse Gets the is certainly attention-grabbing news. Most clusters of under- Measles,” reported one of the reporting and commentary, in turn, immunization in 5 “Mwebsite (http://bit.ly has focused on the role of declining vacci- areas of northern /1zyoQZn). “Space Mountain with a Side of nation rates. This concern is especially California (http://bit Measles,” proclaimed a news blog (http: acute in specific communities, including .ly/1EDFQSn) . //reut.rs/1z8fMqh), which could not resist Orange County, California, where the Beyond the set- adding that Measles was “not the name of theme park is located, and where some ting, there has not an eighth ‘Snow White’ dwarf.” private schools have immunization rates been much discus- That a major measles outbreak began as low as 60% (http://lat.ms/1zEniOV). A sion of the signifi- Joshua M. Sharfstein, MD

at the home of beloved cartoon characters recent Kaiser study in Pediatrics found cance of Disneyland Maximilian Franz/The Daily Record

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