Our Bodies, Our Blog

Panel de la FDA recomienda vacuna contra el cáncer cervicouterino; Joven de Florida se opone a Gardasil como vía a la ciudadanía

By Kiki Zeldes |

Publicado por Christine / del orginial en inglés Sept 15, 2009:

OBOS is committed to expanding our audience and in this spirit we’ve asked former board member Moises Russo to translate into Spanish several of our blog entries. We hope to translate more entries in the coming year.

En OBOS estamos comprometidos a expandir nuestra audiencia de lector@s  y en este espíritu le hemos solicitado a Moisés Russo, ex-miembro de la Junta de OBOS, que traduzca al español varios de los blogs que tenemos en la página electrónica. Esperamos continuar con dichas traducciones durante este año.

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Una segunda vacuna diseñada para proteger contra el cáncer cervicouterino estará disponible pronto en Estados Unidos.

La semana pasada, un panel de la de Food and Drug Administración (FDA) dio su aprobación a la vacuna Cervarix de GlaxoSmithKline PLC*, esencialmente recomendando que la FDA apruebe la vacuna para el uso en mujeres de 10 a 25 años de edad. La recomendación no es obligatoria; la FDA puede rechazar la decisión, pero ésta generalmente acepta la opinión de paneles externos de expertos.

La vacuna protege contra dos tipos de virus papiloma humano (VPH), asociados al 70% de los cánceres cervicouterinos.

Escribiendo en el Wall Street Journal, Jennifer Corbett Dooren resumió las preocupaciones con respecto a la seguridad que la FDA levantó acerca de Cervarix, incluyendo “una mayor tasa de abortos entre las mujeres que recibieron Cervarix”. La FDA refirió además “no se puede excluir un ‘pequeño efecto’ sobre los embarazos”. (La vacuna no está aprobada para su uso en mujeres embarazadas).

GlaxoSmithKline intentó por primera vez conseguir la aprobación el año 2007, pero la FDA solicitó más información luego de que algunos reportes sugirieron una tasa más alta de abortos en mujeres embarazadas. Dooren escribe:

La agencia dijo que se requeriría de un estudio de seguridad post- marketing para monitorizar los resultados de embarazos en mujeres que pudiesen recibir Cervarix, junto con otras potenciales preocupaciones sobre su seguridad incluyendo el desarrollo de enfermedades autoinmunes como Artritis Reumatoide y Esclerosis Múltiple. En su revisión del año 2007 de Cervarix, la FDA indicó que tenía preocupaciones sobre un “desequilibrio” en posibles desordenes autoinmunes visto en algunos estudios clínicos. Sin embargo, la agencia ha dicho que revisiones adicionales de los datos realizadas por sus propios equipos y por un reumatólogo externo concluyeron que las diferencias no eran estadísticamente significativas.

Oficiales de Glaxo dijeron que estaban planeando un estudio de post-marketing que enrolaría a 100.000 mujeres en los EEUU, el cual incluiría un registro de embarazos. La compañía también se encuentra realizando otro estudio de post-marketing de grandes proporciones en Finlandia.

Gardasil, la popular vacuna contra el VPH fabricada por Merck y & CO. Fue aprobada por la FDA el 2006. Uno de los principales investigadores para la vacuna recientemente ha comenzado a denunciar preocupaciones con respecto a sus riesgos, beneficios y agresivas estrategias de marketing – principalmente que la protección puede no durar más allá de los 5 años, por lo que las niñas que sean vacunadas a una edad temprana pudiesen en el futuro aún encontrarse en riesgo.

El mes pasado, Rachel apuntó a una editorial del Journal de la Asociación Médica Americana sobre los riesgos y beneficios de la vacunación contra el VPH y analizó un comentario en la misma edición de JAMA (sólo resumen) sobre el marketing de Gardasil. Describiendo los hallazgos de los autores, Rachel escribió: “ La táctica de la compañía fue fomentar que todas las mujeres dentro de un cierto grupo de edad se vacunaran como una medida para evitar el cáncer, en vez de trabajar con oficiales de la salud pública para enfocarse en aquellas niñas que tienen un riesgo más elevado”.

Los Centros para el Control y Prevención de las Enfermedades (CDC por sus siglas en inglés) recomienda la vacuna para niñas de 11 y 12 años, y niñas y mujeres entre las edades de 13 y 26 años que aún no hayan sido vacunadas. Esa recomendación sin embargo se convierte en un mandato para las mujeres inmigrantes entre 11 y 26 años que buscan la ciudadanía Estadounidense. Gardasil fue agregada a la lista de vacunas requeridas el año 2008.

Simona Davis, una niña de 17 años en Florida que nació en el Reino Unido está buscando la ciudadanía Estadounidense pero se rehúsa a vacunarse. El noticiario ABC News tiene un reportaje completo sobre su rechazo a la vacuna. Davis, que es una cristiana devota que dice no tener intención de iniciar relaciones sexuales en el futuro cercano (menciona su promesa de virginidad como una prueba), está buscando una exención por razones morales y religiosas. Los Servicios de Ciudadanía e Inmigración de los EEUU han rechazado su solicitud.

“La decisión de incluir el VPH como una vacuna requerida fue hecha por el CDC”, ha dicho la vocera de los Servicios de Ciudadanía e Inmigración de los EEUU Chris Rhatigan a ABC News. “Nosotros seguimos la ley….La objeción a una exención debiese ser a todas las vacunas, no solamente a Gardasil”.

Un vocero del CDC ha dicho que se espera que el CDC publique nuevos criterios dentro de aproximadamente un mes para determinar que vacunas debiesen ser recomendadas a inmigrantes a los EEUU.

FDA Panel Recommends Cervical Cancer Vaccine; Florida Teen Objects to Gardasil as Path to Citizenship

By Christine Cupaiuolo |

A second vaccine designed to protect against cervical cancer may soon be available in the United States. A Food and Drug Administration panel last week gave its approval to GlaxoSmithKline PLC’s Cervarix vaccine, essentially recommending that the FDA approve the vaccine for use in females 10 to 25 years old. The recommendation is not binding; the FDA can reject the decision, but it generally accepts the opinions made by an outside panel of experts. The vaccine protects against two strains of human papilloma virus (HPV) that are associated with 70 percent of cervical cancers. Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act NowWriting in the Wall Street Journal, Jennifer Corbett Dooren summarized the safety concerns the FDA raised about Cervarix, including “a higher rate of miscarriages among females who received Cervarix.” The FDA also “couldn’t rule out a ‘small effect’ on pregnancies.” (The vaccine is not approved for use in pregnant women.) GlaxoSmithKline first sought approval in 2007, but the FDA asked for more information after reports suggested a higher miscarriage rate in pregnant women. Dooren writes: The agency said it would require a post-marketing safety study to monitor the outcome of pregnancies … More

Commentary on the Marketing of Gardasil

By Rachel Walden |

A commentary in the current issue of the journal JAMA [abstract only] addresses Merck’s marketing of its HPV vaccine, Gardasil, and describes several ethical and public health-related problems with the company’s approach. The authors observe that the vaccine was “promoted primarily to ‘guard’ not against HPV viruses or sexually transmitted diseases but against cervical cancer,” and provides an interesting critique of the broad approach vaccine-maker Merck used. The company’s tactic was to encourage all girls within a certain age group to be vaccinated as a cancer avoidance measure, rather than to work with public health officials to target those girls at the highest risk: Marketing this HPV vaccine as an anticancer vaccine appears to have enabled its manufacturer to circumvent possible parental and public unease with an antidote to sexually transmitted diseases. But in doing so, the company bypassed public health officials who would have spearheaded a risk-sensitive vaccination campaign. So too, this manufacturer understandably wanted as many adolescents as possible to be vaccinated. But the pursuit of this goal was neither cost-effective nor equitable. It meant rather than concentrating on populations in geographic areas with excess cervical cancer mortality, including African Americans in the South, Latinos along the Texas-Mexico … More

Double Dose: Gay Marriage Legal in CT; Ad Council Introduces First Campaign on Gay/Lesbian Issues; CCR Sues Over Required Ultrasound in Oklahoma; South Dakota Abortion Ban 2.0; One-Year Update on Gardasil

By Christine Cupaiuolo |

Gay Marriage Legal in California, Massachusetts and now Connecticut: The Connecticut Supreme Court on Friday struck down the state’s civil union law with a 4-3 ruling that same-sex couples have a constitutional right to marry. From The New York Times: The ruling, which cannot be appealed and is to take effect on Oct. 28, held that a state law limiting marriage to heterosexual couples, and a civil union law intended to provide all the rights and privileges of marriage to same-sex couples, violated the constitutional guarantees of equal protection under the law. Striking at the heart of discriminatory traditions in America, the court — in language that often rose above the legal landscape into realms of social justice for a new century — recalled that laws in the not-so-distant past barred interracial marriages, excluded women from occupations and official duties, and relegated blacks to separate but supposedly equal public facilities. Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act NowView the full ruling here (PDF). Opponents spoke of steps to enact a constitional ban on same-sex marriage, but on Friday night the plaintiffs in the original court case filed four years ago and … More

Gardasil and Fear-Mongering

By Rachel Walden |

Combine girls, vaccines, and sex, and you apparently get a recipe for sensationalism and poor reporting. CNN yesterday featured a piece, “Should parents worry about HPV vaccine?” which notes that “Gardasil has been the subject of 7,802 ‘adverse event’ reports from the time the Food and Drug Administration approved its use two years ago.” What the article doesn’t explain is how the Vaccine Adverse Event Reporting System (VAERS) system works. Reports to VAERS can be submitted by anyone, and are not verified or definitively linked to the vaccine without further investigation. This understanding was not demonstrated by the piece, which simply conceded, “The company said in a statement that an adverse event report ‘does not mean that a causal relationship between an event and vaccination has been established — just that the event occurred after vaccination.’” Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act NowThis phrasing makes it seem as though it’s just the company (that stands to make money) that believes that reports don’t indicate a causal relationship – it seems designed to make the average reader believe that this characterization is just the vaccine maker protecting its financial interests. While … More

Heading to the Beach? Dry Off With Gardasil!

By Christine Cupaiuolo |

Ed Silverman at Pharmalot makes my day: What better way to advertise to other beachgoers that you’re free of a sexually transmitted disease than to wrap yourself in this nicely designed terry velour towel, which measures 30 inches by 60 inches. Catch a wave and then use the towel to make clear to that attractive person nearby that genital warts or HPV won’t be a problem. Truly, this is a new way to advertise the advantages the vaccine has to offer. Frisky teenagers will love them! Check out a larger image here. Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act NowAnd if this is your idea of a must-have summer item, you’ll be pleased to learn that there are five bidding days left for a lot of six terry velour towels. Looks like someone doesn’t want their swag.

Gardasil: What’s All the Noise About?

By Christine Cupaiuolo |

Writing in The Nation, Karen Houppert provides the most comprehensive overview I’ve seen of the controversy surrounding making Gardasil mandatory for middle-school age girls. Gardasil, as we’ve discussed before, is is the only FDA-approved HPV vaccine. Houppert outlines who’s for it, who’s against it and all the reasons why it’s become such a huge issue. Today, as thirty-one state legislatures consider mandating the vaccine for middle school girls, skepticism about the wisdom of embarking on this swift and widespread inoculation program has bubbled up from critics who span the political spectrum. These strange bedfellows include Christian conservatives and their abstinence-only ilk, who have long argued that safe sex encourages profligate sex; a slew of Big Pharma critics, who see how Merck (which stands to make $4 billion a year on the vaccine by most estimates) is angling to corner this huge new vaccine market; the growing antivaccine movement, which objects to all such school-entry requirements; the parental-rights folks with a libertarian strain, who bridle at any mandates regarding their children’s health; and a smattering of women’s health advocates, who worry that the pace of the vaccine’s introduction is jeopardizing its ultimate success. Like what you’re reading? Our Bodies Ourselves needs … More

A Guide to Cervical Cancer Screening & HPV Vaccines

By Rachel Walden |

Human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States. According to the Centers for Disease Control and Prevention (CDC), “nearly all sexually-active men and women will get at least one type of HPV at some point in their lives.” But the virus usually clears on its own, without causing any damage — and often without showing any symptoms. The HPV vaccine can prevent infection, but it’s not for everyone. We’ll tell you what you need to know about the virus and the vaccine. Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act NowWhat are the risks from HPV? In both men and women, HPV infection can lead to warts or cancer in the person’s genitals, mouth, or throat. There are more than 150 types of HPV, but two (types 16 and 18) are thought to cause almost two-thirds of all cervical cancer cases, and close to half of all vaginal, vulvar, and penile cancers. What are the current recommendations for cervical cancer screening? The U.S. Preventive Services Task Force (USPSTF) recommends that women who have a cervix have a Pap test (which looks for pre-cancerous cells to … More

Study: No Link Between HPV Vaccine and Girls’ Sexual Activity

By Rachel Walden |

In 2006, when the FDA approved the first HPV vaccine for girls and women ages 9 to 26, one of the concerns opponents expressed was that it might make young girls think it’s OK to have sex. That’s because the HPV vaccine protects against a virus that is contracted during sexual contact; specifically, four strains of the human papillomavirus, or HPV, which can cause cervical cancer and some vaginal, vulvar, penile and throat cancers. In Nashville, where I live, one religious leader claimed, “What we are encouraging is abstinence and sexual purity. If they have a relationship with the Lord, they will recognize that they don’t need that vaccine.” Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act NowOthers made claims along the same lines — that girls who “come from good homes” don’t need the vaccine, or that it would otherwise somehow promote promiscuity. We’ve heard a lot less of this rhetoric lately, now that the novelty of the vaccine has worn off and the initial controversy has subsided. It always seemed like a bit of a ridiculous objection, since girls who become sexually active are probably not weighing the risk of … More

Ending Cervical Cancer Requires Ending Disparities in Access to Pap Tests and HPV Vaccines

By Christine Cupaiuolo |

Every year in the United States alone, more than 12,000 women are diagnosed and more than 4,000 women die of cervical cancer, a preventable disease that disproportionately affects women of color. January is Cervical Cancer Awareness Month, and the National Latina Institute for Reproductive Health (NLIRH) is launching “¡Acábalo Ya! Working Together to End Cervical Cancer.” The campaign is aimed at educating Latinas about this disease and how to protect their health; raising the profile of cervical cancer prevention as a national reproductive justice and women’s health priority; and advocating for greater access to the tools and care needed to prevent, detect, and eventually end cervical cancer. The NLIRH is hosting a blog carnival this week on the topic: What will it take to end cervical cancer? Read more on Why Cervical Cancer is a LGBT Issue by Verónica Bayetti-Flores, NLIRH policy research specialist; Cervical Cancer Awareness Month: Trans Men and Genderqueer/Gender Nonconforming People by the National Center for Transgender Equality; Screen More Women for Cervical Cancer – Not the Same Women More Often! by Kate Ryan, program coordinator, National Women’s Health Network; and Thank YOU Affordable Care Act for Helping Cervixes Stay Healthy by Keely Monroe, program coordinator, National Women’s Health Network. Like what you’re … More