From: "Saved by Windows Internet Explorer 8" Subject: JAMA -- The Risks and Benefits of HPV Vaccination, August 19, 2009, Haug 302 (7): 795 Date: Mon, 14 Dec 2009 07:21:14 -0800 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0049_01CA7C8E.04F33B50" X-MimeOLE: Produced By Microsoft MimeOLE V6.1.7600.16385 This is a multi-part message in MIME format. ------=_NextPart_000_0049_01CA7C8E.04F33B50 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://jama.ama-assn.org/cgi/content/full/302/7/795?home JAMA -- The Risks and Benefits of HPV Vaccination, = August 19, 2009, Haug 302 (7): 795

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3D" 3D" Vol. 302 No. 7, = August 19,=20 2009 3D" 3D"
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The = Risks and=20 Benefits of HPV Vaccination

Charlotte=20 Haug, MD, PhD, MSc

JAMA. 2009;302(7):795-796.=20

When do = physicians know=20 enough about the beneficial effects of a new = medical=20 intervention to start recommending or using it? = When is=20 the available information about harmful adverse = effects=20 sufficient to conclude that the risks outweigh the = potential=20 benefits? If in doubt, should physicians err on the = side=20 of caution or on the side of hope? These = questions are at=20 the core of all medical decision making. It is a=20 complicated process because medical knowledge is=20 typically incomplete and ambiguous. It is = especially=20 complex to make decisions about whether to use = drugs that=20 may prevent disease in the future, particularly = when=20 these drugs are given to otherwise healthy individuals. = Vaccines are examples of such drugs, and the human=20 papillomavirus (HPV) vaccine is a case in = point.=20

zur Hausen, winner of the Nobel Prize in Physiology or=20 Medicine in 2008, discovered that oncogenic HPV = causes=20 cervical cancer.1-4=20 His discovery led to characterization of the natural=20 history of HPV infection, an understanding of = mechanisms=20 of HPV-induced carcinogenesis, and eventually to = the=20 development of prophylactic vaccines against HPV=20 infection.

The theory behind the vaccine is sound: If HPV infection = can=20 be prevented, cancer will not occur. But in practice = the=20 issue is more complex. First, there are more than = 100=20 different types of HPV and at least 15 of them = are=20 oncogenic. The current vaccines target only 2 = oncogenic=20 strains: HPV-16 and HPV-18. Second, the = relationship=20 between infection at a young age and development = of=20 cancer 20 to 40 years later is not known. HPV is the = most=20 prevalent sexually transmitted infection, with an=20 estimated 79% infection rate over a = lifetime5-6=20 The virus does not appear to be very harmful = because=20 almost all HPV infections are cleared by the = immune=20 system.7-8=20 In a few women, infection persists and some women = may=20 develop precancerous cervical lesions and = eventually=20 cervical cancer. It is currently impossible to predict = in=20 which women this will occur and why. Likewise, it is = impossible=20 to predict exactly what effect vaccination of young = girls=20 and women will have on the incidence of cervical = cancer=20 20 to 40 years from now. The true effect of the = vaccine=20 can be determined only through clinical trials = and=20 long-term follow-up.

The first HPV vaccine was licensed for use in the United=20 States in June 2006,9=20 and the Advisory Committee on Immunization Practices=20 recommended routine vaccination of girls aged 11 to 12 = years later that same month.10=20 However, the first phase 3 trials of the HPV = vaccine with=20 clinically relevant end points=97cervical = intraepithelial=20 neoplasias grades 2 and 3 (CIN 2/3)=97were not = reported=20 until May 2007.11=20 Previously only reduction in the prevalence of = persistent=20 infection and CIN from the 2 virus strains = included in=20 the vaccine had been reported. The results were=20 promising, but serious questions regarding the overall=20 effectiveness of the vaccine for protection against=20 cervical cancer remained to be answered, and more = long-term studies were called for.12=20 However, no longer-term results from such studies = have=20 been published since then.

So how should a parent, physician, politician, or anyone=20 else decide whether it is a good thing to give = young=20 girls a vaccine that partly prevents infection = caused by=20 a sexually transmitted disease (HPV infection), = an=20 infection that in a few cases will cause cancer = 20 to 40=20 years from now? Two articles in this issue of=20 JAMA13-14=20 present important data that may influence, and = probably=20 already have influenced, such decisions about HPV = vaccination.=20

The report by Rothman and Rothman13=20 demonstrates how the vaccine manufacturer funded=20 educational programs sponsored by professional = medical=20 associations in the United States. The article = illustrates=20 how the Society of Gynecologic Oncology, the American=20 Society for Colposcopy and Cervical Pathology, = and=20 American College Health Association helped market = the=20 vaccine and influenced decisions about vaccine = policy=20 with the help of ready-made presentations, slide = sets,=20 e-mails, and letters. It is of course reasonable = for=20 professional medical associations to promote medical=20 interventions they believe in. But did these = associations=20 provide members with unbiased educational = material and=20 balanced recommendations? Did they ensure that = marketing=20 strategies did not compromise clinical = recommendations?=20 These educational programs strongly promoting HPV = vaccination began in 2006, more than a year before = the=20 trials with clinically important end points were = published.=20 How could anyone be so certain about the effect of the = vaccine? This matters because the voices of = experts such=20 as the professional medical associations are = especially=20 important with a complex issue such as this. =

In another article, Slade and colleagues14=20 from the US Centers for Disease Control and = Prevention=20 and the US Food and Drug Administration describe = the=20 adverse events that occurred 2.5 years following = the=20 receipt of quadrivalent HPV vaccine that were = reported=20 through the US Vaccine Adverse Events Reporting = System=20 (VAERS). Even though most of the reported adverse = events=20 were not serious, there were some reports of=20 hypersensitivity reactions including anaphylaxis, = Guillain-Barr=E9 syndrome, transverse myelitis,=20 pancreatitis, and venous thromboembolic events. = VAERS is=20 a passive, voluntary reporting system, and the = authors=20 call attention to its limitations. They point out = that=20 only systematic, prospective, controlled studies will = be=20 able to distinguish the true harmful effects of the = HPV=20 vaccine. These limitations work both ways: it is = also=20 difficult to conclude that a serious event is not = caused=20 by the vaccine.

Whether a risk is worth taking depends not only on the=20 absolute risk, but on the relationship between = the=20 potential risk and the potential benefit. If the=20 potential benefits are substantial, most = individuals=20 would be willing to accept the risks. But the net = benefit=20 of the HPV vaccine to a woman is uncertain. Even = if=20 persistently infected with HPV, a woman most likely = will=20 not develop cancer if she is regularly = screened.15=20 So rationally she should be willing to accept = only a=20 small risk of harmful effects from the = vaccine.=20

When weighing evidence about risks and benefits, it is = also=20 appropriate to ask who takes the risk, and who gets = the=20 benefit. Patients and the public logically expect = that=20 only medical and scientific evidence is put on = the=20 balance. If other matters weigh in, such as = profit for a=20 company or financial or professional gains for = physicians=20 or groups of physicians, the balance is easily = skewed.=20 The balance will also tilt if the adverse events = are not=20 calculated correctly.


AUTHOR=20 INFORMATION=20
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Corresponding = Author:=20 Charlotte Haug, MD, PhD, MSc, The Journal of = the=20 Norwegian Medical Association, Akersgata 2, Oslo = 0107,=20 Norway (charlotte.haug{at}legeforeningen.no ).

Financial Disclosures: None reported.

Editorials represent the opinions of the authors and = JAMA=20 and not those of the American Medical = Association.=20

Author=20 Affiliation: The Journal of the Norwegian Medical=20 Association, Oslo, Norway.


REFERENCES=20
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1.=20 zur Hausen H. Human papillomaviruses and their possible role = in=20 squamous cell carcinomas. Curr Top Microbiol Immunol. = 1977;78:1-30. PUBMED
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2.=20 Tsunokawa Y, Takebe N, Nozawa S; et al. Presence of human=20 papillomavirus type-16 and type-18 DNA sequences and their=20 expression in cervical cancers and cell lines from Japanese=20 patients. Int J Cancer. 1986;37(4):499-503. WEB = OF=20 SCIENCE | PUBMED
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3.=20 zur Hausen H. Papillomaviruses and cancer: from basic = studies to=20 clinical application. Nat Rev Cancer. = 2002;2(5):342-350. FULL = TEXT | WEB = OF=20 SCIENCE | PUBMED
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4.=20 Nobelf=F6rsamlingen 2008: the discoveries of human papilloma = viruses=20 that cause cervical cancer and of human immunodeficiency = virus. http://nobelprize.org/nobel_prizes/medicine/laureates/2008/adv.pdf= .=20 Accessed July 16, 2009.
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5.=20 Woodman CB, Collins SI, Young LS. The natural history of = cervical=20 HPV infection: unresolved issues. Nat Rev Cancer.=20 2007;7(1):11-22. FULL = TEXT | WEB = OF=20 SCIENCE | PUBMED
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6.=20 Woodman CB, Collins S, Winter H; et al. Natural history of = cervical=20 human papillomavirus infection in young women: a = longitudinal cohort=20 study. Lancet. 2001;357(9271):1831-1836. FULL = TEXT | WEB = OF=20 SCIENCE | PUBMED
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7.=20 Syrj=E4nen K, Hakama M, Saarikoski S; et al. Prevalence, = incidence,=20 and estimated life-time risk of cervical human = papillomavirus=20 infections in a nonselected Finnish female population. = Sex Transm=20 Dis. 1990;17(1):15-19. WEB = OF=20 SCIENCE | PUBMED
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8.=20 Human papillomavirus (HPV) natural history. http://www.asccp.org/hpv_= history.shtml.=20 Accessed July 16, 2009.
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9.=20 FDA. June 8, 2006 approval letter: human papillomavirus = quadrivalent=20 (types 6, 11, 16, 18) vaccine, recombinant. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/Appr= ovedProducts/ucm111283.htm.=20 Accessed July 24, 2009.
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10.=20 Markowitz LE, Dunne EF, Saraiya M; et al, Advisory Committee = on=20 Immunization Practices (ACIP). Quadrivalent human = papillomavirus=20 vaccine: recommendations of the Advisory Committee on = Immunization=20 Practices (ACIP). MMWR Recomm Rep. = 2007;56(RR-2):1-24. PUBMED
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11.=20 FUTURE II Study Group. Quadrivalent vaccine against human=20 papillomavirus to prevent high-grade cervical lesions. N = Engl J=20 Med. 2007;356(19):1915-1927.=20 FREE FULL=20 TEXT
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12.=20 Sawaya GF, Smith-McCune K. HPV vaccination: more answers, = more=20 questions. N Engl J Med. 2007;356(19):1991-1993. FREE FULL=20 TEXT
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13.=20 Rothman SM, Rothman DJ. Marketing HPV vaccine: implications = for=20 adolescent health and medical professionalism. JAMA.=20 2009;302(7):781-786. FREE FULL=20 TEXT
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14.=20 Slade BA, Leidel L, Vellozzi C; et al. Postlicensure safety=20 surveillance for quadrivalent human papillomavirus = recombinant=20 vaccine. JAMA. 2009;302(7):750-757. FREE FULL=20 TEXT
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15.=20 Sawaya GF, Brown AD, Washington AE, Garber AM. Current = approaches to=20 cervical-cancer screening. N Engl J Med.=20 2001;344(21):1603-1607. = FREE FULL=20 TEXT
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= CiteULike   =20 Connotea    = Del.icio.us   =20 Digg   =20 Reddit   = =20 Technorati   =20 Twitter     What's = this?

RELATED=20 ARTICLES=20
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Postlicensure Safety Surveillance for = Quadrivalent Human=20 Papillomavirus Recombinant Vaccine
Barbara A. = Slade,=20 Laura Leidel, Claudia Vellozzi, Emily Jane Woo, Wei Hua, = Andrea=20 Sutherland, Hector S. Izurieta, Robert Ball, Nancy Miller, = M. Miles=20 Braun, Lauri E. Markowitz, and John Iskander =
JAMA.=20 2009;302(7):750-757.
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ABSTRACT= =20 | FULL=20 TEXT  =20


THIS ARTICLE HAS = BEEN CITED=20 BY OTHER ARTICLES=20
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Cost effectiveness analysis of including boys in = a human=20 papillomavirus vaccination programme in the United=20 States
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Quadrivalent HPV Vaccine: Postlicensure Safety = Data and=20 Marketing Controversies
JWatch Women's = Health=20 2009;2009:1-1.
FULL= =20 TEXT  =20



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.JAMAHome #cover-image2 A { POSITION: absolute; WIDTH: 184px; BACKGROUND: = url(/images/jamaclassics_homepagebtn.gif) 0px 0px; HEIGHT: 41px } .JAMAHome #cover-image2 A:hover { BACKGROUND-POSITION: 0px -41px } * HTML .JAMAHome #cover-image2 { TOP: 287px; RIGHT: 170px } .JAMAHome #cover-image3 { BORDER-BOTTOM: #9db6c7 1px solid; POSITION: absolute; BORDER-LEFT: = #9db6c7 1px solid; WIDTH: 184px; BACKGROUND: = url(/images/podcast_icon.gif) 0px 0px; HEIGHT: 40px; MARGIN-LEFT: 40px; = BORDER-TOP: #9db6c7 1px solid; TOP: 287px; RIGHT: 10px; BORDER-RIGHT: = #9db6c7 1px solid } .JAMAHome #cover-image3 A { POSITION: absolute; WIDTH: 184px; BACKGROUND: = url(/images/podcast_icon.gif) 0px 0px; HEIGHT: 40px } * HTML .JAMAHome #cover-image3 { TOP: 287px; RIGHT: 170px } .JAMAHome #podcast-text { BORDER-BOTTOM: medium none; POSITION: absolute; BORDER-LEFT: medium = none; WIDTH: 184px; HEIGHT: 100px; MARGIN-LEFT: 40px; FONT-SIZE: 10px; = BORDER-TOP: medium none; TOP: 340px; RIGHT: 10px; BORDER-RIGHT: 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