Green Mtn
location: Observing the Progressive madness with considerably less amusement.
listening to: Grandchildren, the best reason for saving the future.
registered: 2004.04.03
posts: 2617
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FYI UpdateEditorial
Mandatory HPV VaccinationPublic Health vs Private Wealth
Lawrence O. Gostin, JD, LLD; Catherine D. DeAngelis, MD, MPH
JAMA. 2007;297:1921-1923. By any measure, genital human papillomavirus (HPV) infection and HPV-associated cervical
cancer are significant national and global public health concerns. An estimated 11 000 newly
diagnosed cases of cervical cancer occur annually in the United States, resulting in 3700
deaths.1 Globally, an estimated 493 000 new cervical cancer cases occur each year, with
274 000 deaths; more than 80% of cervical cancer deaths worldwide occur in developing
countries.2 Human papillomavirus is the most common sexually transmitted infection in the United
States, with an estimated 6.2 million individuals newly infected annually.3 Data from the
National Health and Nutrition Examination Survey revealed a 26.8% overall HPV prevalence
among US girls and women, with increasing prevalence each year for ages 14 to 24 years
(44.8% for ages 20-24 years) followed by a gradual decline in prevalence through age 59 years
(19.6% for ages 50-59 years).4 Although infection with high-risk HPV types is necessary for
the development of cervical cancer (detected in 99% of cervical cancers),5 high-risk types 16
and 18 have a relatively low prevalence (3.4% of all HPV infections),4 and not all women who
are infected with high-risk HPV types will develop cervical cancer. Approximately 90% of
women with new HPV infections clear the infection within 2 years.6 In June 2006, the US Food and Drug Administration (FDA) licensed a prophylactic quadrivalent
HPV vaccine against types 6, 11, 16, and 18 for use among girls and women aged 9 to 26
years.7 The FDA approval is conditional on manufacturer assurances concerning ongoing
safety and efficacy studies.8 The Centers for Disease Control and Prevention Advisory
Committee on Immunization Practices (ACIP) recommends routine vaccination of girls aged 11
to 12 years with 3 doses of quadrivalent HPV vaccine; the vaccination series can be started as
young as age 9 years.9 ACIP also recommends "catch-up" vaccination for unvaccinated girls
and women aged 13 to 26 years.9 Clinical trials among 16- to 26-year-olds show that the quadrivalent HPV vaccine is almost
100% effective in preventing infection and disease associated with HPV types included in the
vaccine.10 Studies show that the vaccine is safe and immunogenic for girls aged 9 to 15 years
for at least a short term, but efficacy among this age group has not been evaluated. For those
older than 15 years, the vaccine provides protection for at least 5 years, and follow-up studies
are under way to determine the duration of protection.9 A bivalent vaccine against HPV types
16 and 18 also has been shown to be highly immunogenic and safe for up to 4.5 years,
although it is not yet licensed.11 Earlier this year, Texas (by executive order) and Virginia made quadrivalent HPV vaccine
mandatory for girls entering sixth grade. However, the Texas legislature recently voted to
overturn the governor's order and Virginia granted parents generous "opt-out" provisions.12
Nearly 20 additional states are considering similar legislation,13 and some medical experts in
Europe are calling for mandatory HPV vaccination.14 Routine use of the quadrivalent HPV
vaccine undoubtedly is beneficial to the public's health, as it is likely to reduce the incidence of
cervical cancers. However, the rush to make HPV vaccination mandatory in school-aged girls
presents ethical concerns and is likely to be counterproductive. The ACIP recommendation supports making quadrivalent vaccination the standard of clinical
care. However, it is important to emphasize that the vaccine is supported by limited efficacy
and safety data. Clinical trials have thus far involved a relatively small population (<12 000
participants) for a limited period of follow-up (5 years). The vaccine has not been evaluated for
efficacy among younger girls (aged 9 to 15 years). Yet, if the vaccine were required nationwide,
it would be administered to some 2 million girls and young women, most of them between 11
and 12 years old and some as young as 9 years old. The longer-term effectiveness and safety
of the vaccine still need to be evaluated among a large population, and particularly among
younger girls. Given that the overall prevalence of HPV types associated with cervical cancer is relatively low
(3.4%)4 and that the long-term effects are unknown, it is unwise to require a young girl with a
very low lifetime risk of cervical cancer to be vaccinated without her assent and her parent's
consent. Consider the information a clinician can honestly provide to a 12-year-old girl to
obtain her assent: "The 3 injections will probably protect you from an infection that you can
only get from sexual contact, but research has not shown how long the protection will last or
whether it might have rare bad effects on your health." Although many clinicians who have
spent most of their professional lives caring for children and adolescents would probably
recommend the vaccine, they would be troubled if the patient and her family felt pressured or
coerced. Making the HPV vaccine mandatory contributes to long-standing parental concerns about the
safety of school-based vaccinations.15 The use of compulsion, therefore, could have the
unintended consequence of heightening parental and public apprehensions about childhood
vaccinations. It also does not help to offer generous religious and conscientious exemptions
for HPV vaccination because legislators may extend these to other childhood vaccinations,
which would be detrimental to the public's health.16 >>> Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. >> Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. >> Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. > Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. > Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. >>> Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. >> Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. >> Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. > Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. > Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. >>> Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. >> Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. >> Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. > Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. > Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. The ACIP probably recommended routine vaccination for girls only because the data are
limited to that sex. However, if compulsory powers were justified on classic public health
grounds, the same arguments could and should apply to vaccination of boys. While less is
known about HPV prevalence in men, some studies have shown that men can have at least as
high a prevalence of HPV infection as women,19 and they are just as likely to transmit the
infection to their partners. Issues of fairness arise if young girls are compelled to submit to a
new vaccine as a condition of receiving publicly funded education, when boys are not. There is also the question of cost—who will pay for the mandated HPV vaccine and what other
public health services would society have to forgo because of the cost? The estimated cost of
quadrivalent HPV vaccine is $360 for a 3-course series, making it among the most expensive
of all vaccines.17 Cost-effectiveness studies of HPV vaccination have had variable results,
depending on assumptions about effectiveness and safety.20 Some pediatricians and other
physicians are not offering the most costly vaccines because they cannot afford to purchase
them, and they cannot be certain about full reimbursement.21-22 Policy makers also have not
answered the question of who will pay: consumers, insurers, or federal, state, or local
government (ie, taxpayers). If consumers or insurers were to pay, poor and uninsured persons
would be unable to afford the vaccine, which would exacerbate health disparities. If the
government were to pay, it would have to find the funds from its general revenues, perhaps
reducing public health spending for other programs. Years from now, when additional data and experience better inform clinicians and policy
makers about the risks and benefits, states might consider requiring HPV vaccination as a
condition of school entry. But for now, it is preferable to take a deliberative approach and view
routine, voluntary HPV vaccination as part of a comprehensive package for preventing sexually
transmitted infections and cervical cancer. A systematic approach to prevention would include
promoting reduced sexual activity and safer forms of sex, cervical cancer screening (eg,
Papanicolaou tests and HPV testing), and education about HPV and cervical cancer among
schoolchildren, health care professionals, and the general public. Interventions are particularly
important among African American and Hispanic women, who have disproportionate burdens
of cervical cancer.23 These important concerns about mandatory HPV vaccination are not motivated by morals, as
there are no data to suggest that an appropriately conducted public health program
encourages sexual activity. Rather, maintaining the public's trust is vital—both for HPV
vaccination in particular and for school-based vaccination programs more generally.24
Legislation to make HPV vaccine mandatory has undermined public confidence and created a
backlash among parents. There is nothing more important to the success of public health
policies than to ensure community acceptability. In the absence of an immediate risk of serious
harm, it is preferable to adopt voluntary measures, making state compulsion a last resort.25
AUTHOR INFORMATION
Corresponding Author: Catherine D. DeAngelis, MD, MPH, JAMA, 515 N State St, Chicago, IL
60610 ([email protected]). ). ). Financial Disclosures: None reported. Editorials represent the opinions of the authors and JAMA and not those of the American
Medical Association. Author Affiliations: Georgetown Law Center, Washington, DC (Dr Gostin). Dr DeAngelis is
Editor in Chief, JAMA.
REFERENCES
1. Saraiya M, Ahmed F, Krishnan S, et al. Cervical cancer incidence in a pre-vaccine era in the
United States, 1998-2002. Obstet Gynecol. 2007;109:360-370. FREE FULL
TEXT 2. Parkin DM. The global health burden of infection-associated cancers in the year 2002. Int J
Cancer. 2006;118:3030-3044.
FULL TEXT |
ISI | PUBMED 3. Weinstock H, Berman S, Cates W Jr. Sexually transmitted diseases in American youth:
incidence and prevalence estimates, 2000. Perspect Sex Reprod Health. 2004;36:6-10.
FULL TEXT |
ISI | PUBMED 4. Dunne EF, Unger ER, Sternberg M, et al. Prevalence of HPV infection among females in the
United States. JAMA. 2007;297:813-819. FREE FULL TEXT 5. Walboomers JM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of
invasive cervical cancer worldwide. J Pathol. 1999;189:12-19.
FULL TEXT |
ISI | PUBMED 6. Ho GY, Bierman R, Beardsley L, et al. Natural history of cervicovaginal papillomavirus
infection in young women. N Engl J Med. 1998;338:423-428. FREE FULL TEXT 7. US Food and Drug Administration. FDA licenses new vaccine for prevention of cervical
cancer and other diseases in females caused by human papillomavirus [press release]. June 8,
2006. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html. Accessed March 28,
2007.8. US Food and Drug Administration. Product approval information: licensing action. June 8,
2006. http://www.fda.gov/cber/approvltr/hpvmer060806L.htm. Accessed March 28, 2007.9. Advisory Committee on Immunization Practices. Quadrivalent human papillomavirus
vaccine. MMWR Morb Mortal Wkly Rep. 2007;56:1-24.
PUBMED 10. US Food and Drug Administration. Gardasil. http://www.fda.gov/cber/label/
hpvmer060806LB.pdf. Accessed March 28, 2007.11. Harper DM, Franco EL, Wheeler CM, et al. Sustained efficacy up to 4.5 years of a bivalent L1
virus-like particle vaccine against human papillomavirus type 16 and 18: follow-up from a
randomized control trial. Lancet. 2006;367:1247-1255.
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ISI | PUBMED 12. Saul S, Pollack A. Furor on rush to require cervical cancer vaccine. New York Times.
February 17, 2007:A1.13. National Conference of State Legislatures. HPV Vaccine: Introduced Legislation. 2007.
http://www.ncsl.org/programs/health/HPVvaccine.htm#hpvlegis. Accessed March 28, 2007.14. Should HPV vaccination be mandatory for all adolescents? Lancet. 2006;368:1212.
PUBMED 15. Colgrove J. State of Immunity: The Politics of Vaccination in Twentieth Century America.
Berkeley: University of California Press; 2006.16. Salmon DA, Teret SP, MacIntyre CR, et al. Compulsory vaccination and conscientious or
philosophical exemptions: past, present, and future. Lancet. 2006;367:436-442.
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ISI | PUBMED 17. Gardner A. Drugmaker assists in pushing for mandate for HPV vaccination. Washington
Post. February 11, 2007:C5.18. Pollack A, Saul S. Lobbying for vaccine to be halted. New York Times. February 21, 2007.
http://query.nytimes.com/gst/
fullpage.html?sec=health&res=9403E6D6123EF932A15751C0A9619C8B63&n=Top%2fReferen
ce%2fTimes%20Topics%2fPeople%2fS%2fSaul%2c%20Stephanie. Accessed April 10, 2007.19. Dunne EF, Nielson CM, Stone KM, et al. Prevalence of HPV infection among men: a
systematic review of the literature. J Infect Dis. 2006;194:1044-1057.
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ISI | PUBMED 20. Elbasha E, Dasbach EJ, Insinga RP. Model for assessing human papillomavirus vaccination.
Emerg Infect Dis. 2007;13:28-41.
ISI | PUBMED 21. Davis MM, Zimmerman JL, Wheeler JRC, et al. Childhood vaccine purchase costs in the
public sector: past trends, future expectations. Am J Public Health. 2002;92:1982-1987.
FREE FULL TEXT 22. Pollack A. Rising costs make doctors balk at giving vaccines. New York Times. March 24,
2007:C1.23. Ries LAG, Eisner MP, Kosary CL, et al. SEER Cancer Statistics Review, 1973-1999, National
Cancer Institute. http://seer.cancer.gov/csr/1973_1999/cervix.pdf. Accessed March 28, 2007.24. Verweij M, Dawson A. Ethical principles for collective immunisation programmes. Vaccine.
2004;22:3122-3126. FULL TEXT
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SchoolrequirementsFINAL.pdf.
RELATED ARTICLE
This Week in JAMA
JAMA. 2007;297:1853.
FULL TEXT THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES In This Issue: Clinical Diagnosis and Management
Stange
Ann Fam Med 2007;5:290-291.
FULL TEXT
JAMA's Contributing Writers
DeAngelis and Fontanarosa
JAMA 2007;297:2139-2140.
FULL TEXT
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“Restriction of free thought and free speech is the most dangerous of all subversions.” Wm O. Douglas
“Restriction of free thought and free speech is the most dangerous of all subversions.” Wm O. Douglas
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Green Mtn
(view)
FYI UpdateEditorial
Mandatory HPV VaccinationPublic Health vs Private Wealth
Lawrence O. Gostin, JD, LLD; Catherine D. DeAngelis, MD, MPH
JAMA. 2007;297:1921-1923. By any measure, genital human papillomavirus (HPV) infection and HPV-associated cervical
cancer are significant national and global public health concerns. An estimated 11 000 newly
diagnosed cases of cervical cancer occur annually in the United States, resulting in 3700
deaths.1 Globally, an estimated 493 000 new cervical cancer cases occur each year, with
274 000 deaths; more than 80% of cervical cancer deaths worldwide occur in developing
countries.2 Human papillomavirus is the most common sexually transmitted infection in the United
States, with an estimated 6.2 million individuals newly infected annually.3 Data from the
National Health and Nutrition Examination Survey revealed a 26.8% overall HPV prevalence
among US girls and women, with increasing prevalence each year for ages 14 to 24 years
(44.8% for ages 20-24 years) followed by a gradual decline in prevalence through age 59 years
(19.6% for ages 50-59 years).4 Although infection with high-risk HPV types is necessary for
the development of cervical cancer (detected in 99% of cervical cancers),5 high-risk types 16
and 18 have a relatively low prevalence (3.4% of all HPV infections),4 and not all women who
are infected with high-risk HPV types will develop cervical cancer. Approximately 90% of
women with new HPV infections clear the infection within 2 years.6 In June 2006, the US Food and Drug Administration (FDA) licensed a prophylactic quadrivalent
HPV vaccine against types 6, 11, 16, and 18 for use among girls and women aged 9 to 26
years.7 The FDA approval is conditional on manufacturer assurances concerning ongoing
safety and efficacy studies.8 The Centers for Disease Control and Prevention Advisory
Committee on Immunization Practices (ACIP) recommends routine vaccination of girls aged 11
to 12 years with 3 doses of quadrivalent HPV vaccine; the vaccination series can be started as
young as age 9 years.9 ACIP also recommends "catch-up" vaccination for unvaccinated girls
and women aged 13 to 26 years.9 Clinical trials among 16- to 26-year-olds show that the quadrivalent HPV vaccine is almost
100% effective in preventing infection and disease associated with HPV types included in the
vaccine.10 Studies show that the vaccine is safe and immunogenic for girls aged 9 to 15 years
for at least a short term, but efficacy among this age group has not been evaluated. For those
older than 15 years, the vaccine provides protection for at least 5 years, and follow-up studies
are under way to determine the duration of protection.9 A bivalent vaccine against HPV types
16 and 18 also has been shown to be highly immunogenic and safe for up to 4.5 years,
although it is not yet licensed.11 Earlier this year, Texas (by executive order) and Virginia made quadrivalent HPV vaccine
mandatory for girls entering sixth grade. However, the Texas legislature recently voted to
overturn the governor's order and Virginia granted parents generous "opt-out" provisions.12
Nearly 20 additional states are considering similar legislation,13 and some medical experts in
Europe are calling for mandatory HPV vaccination.14 Routine use of the quadrivalent HPV
vaccine undoubtedly is beneficial to the public's health, as it is likely to reduce the incidence of
cervical cancers. However, the rush to make HPV vaccination mandatory in school-aged girls
presents ethical concerns and is likely to be counterproductive. The ACIP recommendation supports making quadrivalent vaccination the standard of clinical
care. However, it is important to emphasize that the vaccine is supported by limited efficacy
and safety data. Clinical trials have thus far involved a relatively small population (<12 000
participants) for a limited period of follow-up (5 years). The vaccine has not been evaluated for
efficacy among younger girls (aged 9 to 15 years). Yet, if the vaccine were required nationwide,
it would be administered to some 2 million girls and young women, most of them between 11
and 12 years old and some as young as 9 years old. The longer-term effectiveness and safety
of the vaccine still need to be evaluated among a large population, and particularly among
younger girls. Given that the overall prevalence of HPV types associated with cervical cancer is relatively low
(3.4%)4 and that the long-term effects are unknown, it is unwise to require a young girl with a
very low lifetime risk of cervical cancer to be vaccinated without her assent and her parent's
consent. Consider the information a clinician can honestly provide to a 12-year-old girl to
obtain her assent: "The 3 injections will probably protect you from an infection that you can
only get from sexual contact, but research has not shown how long the protection will last or
whether it might have rare bad effects on your health." Although many clinicians who have
spent most of their professional lives caring for children and adolescents would probably
recommend the vaccine, they would be troubled if the patient and her family felt pressured or
coerced. Making the HPV vaccine mandatory contributes to long-standing parental concerns about the
safety of school-based vaccinations.15 The use of compulsion, therefore, could have the
unintended consequence of heightening parental and public apprehensions about childhood
vaccinations. It also does not help to offer generous religious and conscientious exemptions
for HPV vaccination because legislators may extend these to other childhood vaccinations,
which would be detrimental to the public's health.16 >>> Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. >> Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. >> Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. > Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. > Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. Another important consideration is how vaccine recipients would be compensated if
they
incurred serious adverse effects in the future as a result of a vaccine that the state required. By
making the vaccine mandatory, the state would probably complicate tort claims, with some
courts holding that the manufacturer had no (or reduced) responsibility for consumer harms.
Ethically, if the state mandates an intervention, it should also provide a compensation system,
for example, through the no-fault National Vaccine Injury Compensation Program. As with
other vaccines, issues of legal liability and fair compensation must be considered carefully. >>> Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. >> Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. >> Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. > Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. > Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. Public health authorities, pediatricians, and infectious disease specialists, rather than
political
bodies, should drive mandatory vaccination decisions and policies. The Centers for Disease
Control and Prevention recommend routine use of HPV vaccinations, but that is not equivalent
to mandatory use. Merck, the manufacturer of the HPV quadrivalent vaccine, lobbied
legislatures to make the vaccine mandatory17 before withdrawing its campaign when it
became controversial.18 Since the manufacturer stands to profit from widespread vaccine
administration, it is inappropriate for the company to finance efforts to persuade states and
public officials to make HPV vaccinations mandatory, particularly so soon after the product was
licensed. Private wealth should never trump public health. >>> Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. >> Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. >> Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. > Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. > Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. Human papillomavirus is not a highly infectious airborne disease, which is the
paradigm for
the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of
HPV in schools, as is the case, for example, with measles. The HPV vaccine does not create
herd immunity, although it would probably reduce the prevalence of HPV infections. The
primary justification for HPV vaccination is to protect women from long-term risks, rather than
to prevent immediate harm to others. This may not be a definitive argument against universal
use of HPV vaccine because states already mandate vaccination against another disease
(hepatitis B) that can be transmitted sexually (among other routes of exposure). But because
the HPV vaccine is not immediately necessary to prevent harm to others, it does suggest that
compulsory measures need to be more carefully thought through. The ACIP probably recommended routine vaccination for girls only because the data are
limited to that sex. However, if compulsory powers were justified on classic public health
grounds, the same arguments could and should apply to vaccination of boys. While less is
known about HPV prevalence in men, some studies have shown that men can have at least as
high a prevalence of HPV infection as women,19 and they are just as likely to transmit the
infection to their partners. Issues of fairness arise if young girls are compelled to submit to a
new vaccine as a condition of receiving publicly funded education, when boys are not. There is also the question of cost—who will pay for the mandated HPV vaccine and what other
public health services would society have to forgo because of the cost? The estimated cost of
quadrivalent HPV vaccine is $360 for a 3-course series, making it among the most expensive
of all vaccines.17 Cost-effectiveness studies of HPV vaccination have had variable results,
depending on assumptions about effectiveness and safety.20 Some pediatricians and other
physicians are not offering the most costly vaccines because they cannot afford to purchase
them, and they cannot be certain about full reimbursement.21-22 Policy makers also have not
answered the question of who will pay: consumers, insurers, or federal, state, or local
government (ie, taxpayers). If consumers or insurers were to pay, poor and uninsured persons
would be unable to afford the vaccine, which would exacerbate health disparities. If the
government were to pay, it would have to find the funds from its general revenues, perhaps
reducing public health spending for other programs. Years from now, when additional data and experience better inform clinicians and policy
makers about the risks and benefits, states might consider requiring HPV vaccination as a
condition of school entry. But for now, it is preferable to take a deliberative approach and view
routine, voluntary HPV vaccination as part of a comprehensive package for preventing sexually
transmitted infections and cervical cancer. A systematic approach to prevention would include
promoting reduced sexual activity and safer forms of sex, cervical cancer screening (eg,
Papanicolaou tests and HPV testing), and education about HPV and cervical cancer among
schoolchildren, health care professionals, and the general public. Interventions are particularly
important among African American and Hispanic women, who have disproportionate burdens
of cervical cancer.23 These important concerns about mandatory HPV vaccination are not motivated by morals, as
there are no data to suggest that an appropriately conducted public health program
encourages sexual activity. Rather, maintaining the public's trust is vital—both for HPV
vaccination in particular and for school-based vaccination programs more generally.24
Legislation to make HPV vaccine mandatory has undermined public confidence and created a
backlash among parents. There is nothing more important to the success of public health
policies than to ensure community acceptability. In the absence of an immediate risk of serious
harm, it is preferable to adopt voluntary measures, making state compulsion a last resort.25
AUTHOR INFORMATION
Corresponding Author: Catherine D. DeAngelis, MD, MPH, JAMA, 515 N State St, Chicago, IL
60610 ([email protected]). ). ). Financial Disclosures: None reported. Editorials represent the opinions of the authors and JAMA and not those of the American
Medical Association. Author Affiliations: Georgetown Law Center, Washington, DC (Dr Gostin). Dr DeAngelis is
Editor in Chief, JAMA.
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“Restriction of free thought and free speech is the most dangerous of all subversions.” Wm O. Douglas
“Restriction of free thought and free speech is the most dangerous of all subversions.” Wm O. Douglas
