Gardasil is "Mostly" Safe, But Is It Effective?

Here in Virginia, health officials are pushing the vaccine that protects against HPV. As the Washington Post reports, the Commonwealth wants Gardasil administered to every girl entering the 6th grade. Parents here can opt out simply by refusing to give their girls the shot.

But fears of adverse affects still abound. This month, a study in the Journal of the American Medical Association showed that in the 2.5 years between June 2006 and December 2008, there were

12,424 reports of side effects, or 54 reports per 100,000 doses given. That included 32 reports of death, or 1 per 1 million girls vaccinated, though it’s unclear whether the vaccine or something else was to blame.

An NPR report also stated that we’re not sure how many of those deaths were due to preexisting conditions in the teen girls, such as blood clots:

All of these people had a known risk factor for having blood clots. Most commonly was that they were on some sort of estrogen birth control. But obesity, traveling, immobility and some of these people had genetic risk factors for getting – for having blood clots, as well.

So…we’re blaming the girls for their deaths? For their previously unknown medical conditions? Not only are we as yet uncertain of Gardasil’s safety, we also have no clue about its efficacy, especially long-term.

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These adverse effects were reported by physicians to the Vaccine Adverse Events Reporting System (VAERS). JAMA notes that this is a voluntary, passive reporting system, so the data is limited.

They point out that only systematic, prospective, controlled studies will be able to distinguish the true harmful effects of the HPV vaccine. These limitations work both ways: it is also difficult to conclude that a serious event is not caused by the vaccine.

After some of these adverse effects, the FDA recently ordered that the manufacturer of Gardasil, Merck, must now add a few more warnings to its labeling, including:

fainting, tonic-clonic (jerking) movements, and “seizure-like” reactions.

Dr. Charlotte Haug, writing an editorial for JAMA this month, points out a few other problems with HPV vaccines overall.

  • There are over 100 different types of HPV. Yes, HPV is the most common STD, at an estimated 79% over a lifetime. Most of these go undiagnosed and many clear up from our own immunity. Women get annual Pap smears to check for precancerous cells associated with cervical cancer. Nearly all cases of cervical cancer (and some cases of penile cancer) are caused by HPV.
  • Gardasil and other HPV vaccines operate under the theory that if the STD spread can be prevented, so can cervical cancer.
  • There are over 11,000 cases of cervical cancer diagnosed each year and 4,070 deaths.
  • Gardasil only protects against two types of HPV, responsible for about 60% of cervical cancer cases. Approximately 15 of the 100 types of HPV are cancer-causing.
  • Before Gardasil was approved by the FDA, drugmaker Merck tested about 2,500 with the vaccine and followed up one month and again 3 years later to check the incidence of cervical cancer and HPV infection. The girls and women tested were between 16 and 23 years old and with a lifetime history of sexual partners bewteen 0-4. Gardasil was 100% effective against cervical disease and had a maximum efficacy of 34% when it came to “lesions”.
  • HPV vaccines are recommended for girls as young as 9 and has only been tested on a few hundred 11- and 12year-olds. And we’re not sure about long-term efficacy, as Dr. Haug states in her editorial:

In a few women, [HPV] infection persists and some women may develop precancerous cervical lesions and eventually cervical cancer. It is currently impossible to predict in which women this will occur and why. Likewise, it is impossible to predict exactly what effect vaccination of young girls and women will have on the incidence of cervical cancer 20 to 40 years from now. The true effect of the vaccine can be determined only through clinical trials and long-term follow-up.

It’s on the Recommended Immunization Schedule for girls aged 7-18, and drugmaker Merck is hoping that the FDA will soon approve it for boys. After all, we’ve already got parents circumcising boys over the fear of penile cancer. Why not add a vaccine to the mix?

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Image: Wikimedia Commons

Comments

  1. I am still doubtful of the effectiveness of Gardasil verses safe sex practices and routine Pap smears.

  2. What I really don’t get about Gardasil is that there is strong indication that it only lasts about 3-5 years but the push is to give it to *MIDDLE SCHOOLERS*????? The average age for girls to lose their virginity in the U.S. is 17.3 and nearly half of girls are still virgins on their 18th birthdays. So the shot will wear off right about the midway part of high school, just when the average girl would actually start to need protection against HPV.

    Real smart idea…

  3. The language of this article is alarmist – no one in the study is “blaming the women” for having adverse reactions – they were stating that pre-existing health problems like blood clots made it difficult to determine whether the vaccine was the root cause of the complications.

    We also have slightly more than “no clue” about it’s effectiveness at preventing HPV, even if that doesn’t necessarily translate into solid data regarding it’s ability to prevent the cancers linked to HPV. HPV has other complications besides cervical cancer (sterility and death are on the list) so it’s worth preventing the infection even if it turns out that doing so doesn’t protect from the cancer.

    17.3 may be the national average age at which student have sex, but it’s not the average for Virginia, where this program is being considered and it varies widely from the average depending on social grouping criteria (race, economic status). It’s naive to suggest that since the average is 17.3, middle school is “too soon.”

    Gardasil _is_ a safe-sex practice, and the risks associated with it are lower than the risk of contracting an STD _despite_ using a condom.

  4. Rosemary Mathis says:

    My 13 year old daughter was injured by Gardasil and completely disabled for the past year. Merck got it right when they used the slogan “One Less” for Gardasil. Because of Gardasil, my daughter was “One Less”. She was “One Less Student”, “One Less Active Child”, “One Less in every aspect of her life”. Take it from a mother who has spent the past year sitting by my child’s beside wondering if she would die in her sleep. INVESTIGATE BEFORE YOU VACCINATE. DO NOT trust your doctor to make this decision. If you want to understand Merck’s role in the medical community, investigate some of their former wonderdrugs such as VIOXX and then marvel at how many people died from it before it was pulled off the market. The CDC AND FDA need to do their job and get this off the market before more children are harmed. The public is not aware of VAERS and the #’s are grossly understated. I have had to tell my child’s doctors about VAERS and make them file reports or she would not be one of the current statistics in VAERS. Even then, her information has not been entered correctly so I know that VAERS is not what it should be.Please do not let this happen to your child.

  5. Crosius: You seem to like commenting on my vaccine blogs. You are clearly pro-; I am obviously not.

    Merck tested Gardasil for effectiveness against cervical disease after 3 years. Because HPV doesn’t immediately cause cervical disease or cancer (hence annual Paps), that is a poor indication of whether it works. Plus, Gardasil didn’t protect well against “lesions” (genital warts). Did you read that list above? Those aren’t my facts; those are the facts in the Journal of the American Medical Association.

    Read the comment following yours and you might understand the cause for alarm.
    And because we haven’t tested the HPV vaccine long-term, we DON’T have a clue about long-term efficacy. Will women need a shot again in their 20s? Their 30s?
    And if it only protects against 2 of the cancer-causing forms of HPV and 2 that cause warts (of the hundred), I’d say that’s hardly a cause for celebration.

    Ask the parents of the girls with adverse effects and see how they feel about the protection Gardasil has given their girls.
    It’s not alarmist to be skeptical.

  6. Allison Wolff says:

    A friend told me about his professor’s daughter who, soon after receiving the Gardisil vaccine, came down with a debilatating disease and, soon after, died. There is a website about her death and the possible link to the vaccine http://jenjensfamily.blogspot.com/.

  7. For every story that tells of someone dying from the vaccine, there is going to be another story that tells of someone dying from cervical cancer. Like this story:

    http://www.mydeathspace.com/article/2006/11/09/China_Stogner_%2823%29_died_of_cervical_cancer

    and this one:

    http://www.celebitchy.com/42471/jade_goody_died_of_cervical_cancer/

    I am twenty-two. I grew up in Nashville, TN where the majority of my friends had sex before their 18th birthday. A large amount of people had sex in middle school. I know someone with cervical cancer who did not get the vaccine. I have yet to ask her whether or not she wishes she got it, but I think I know what her answer would be.

    I understand the point behind preaching safe sex instead of pushing the Gardasil shot, but the truth is, kids are not going to listen. They never have and probably never will. Before the age of 25, kids do not understand the consequences of their actions- death and cancer are only something talked about in a far away place, away from their reality. The same reason college kids binge drink, chain smoke, and snort cocaine- they cannot grasp long-term effects of their actions. So how can we expect preaching safe sex will change their ways?

    Getting the Gardasil shot is a risk. As it says above, 1 per 1 million girls vaccinated died from the vaccination. But, it is a greater risk to not get the vaccine. 3, 924 women die every year from cervical cancer (http://www.cdc.gov/cancer/cervical/statistics/). There are 3,301,112,087 women in the world. That means 1 in every 84,117 women die from cervical cancer.

    If you are a virgin or have protected sex, then by all means, don’t get the vaccine. If you personally know someone who has died or had serious side effects from the vaccine, then I don’t blame you for not getting it- I wouldn’t either. But if you have children from the ages of 15-25, I guarantee you a lot of them are not virgins and are not having safe sex. Try talking to them, sure. But if you feel that doesn’t work, get the vaccine.

  8. just so everyone knows even in practicing “safe sex” you can still contract HPV. HPV is a SKIN transmitted virus and since condoms don’t cover all skin during sexual contact you still have a very high chance of getting the virus…herpes works the same. I know quite a few people infected with hpv and herpes. I am 21 and got vaccinated a year ago and would recommend people DO get vaccinated. yes people can die from an allergic reaction to the vaccine but that happens with any vaccine so stop complaining some protection is better than nothing.

  9. i have gotten the shot about a few years ago, around the age of 16, thinking it would be one less thing i would have to worry about. i am currently 18 now and sexually active. i went to the doctor thinking i should start getting regular check-ups since now im sexually active, i got the test results back two weeks later, saying that i tested positive for HPV. i thought i would be protected against HPV.. i had no side effects or allergic reactions when i received the shot. i am beyond upset and just going to move on with my life getting routine check-ups. i am scheduled to get another series of shots ASAP. is this actually going to work? or is it going to do the same thing and just be useless? i dont know what to believe…

  10. Godofredo Arauzo says:

    CARTA ABIERTA AL MINISTRO DE SALUD DE PERÜ
    Huancayo Perú 7 de Enero del 2011

    Señor Ministro de Salud de Perú
    Lima
    ASUNTO: SOLICITO MORATORIA DE LA VACUNA CONTRA EL PVH POR NO ESTAR COMPROBADO MÉDICA NI CIENTÍFICAMENTE QUE PREVIENE EL CARCINOMA DEL CUELLO UTERINO; RECIÉN SE COMPROBARÁ ENTRE EL 2025-2030.
    De mi mayor consideración:
    Me dirijo a Ud.. para hacer de conocimiento que EsSalud de Huancayo, La Libertad, Arequipa, Sabogal, Rebagliati y Almenara han iniciado la vacunación contra el papiloma virus humano (PVH) dice en su propaganda porque es el que causa el carcinoma del cuello uterino (CCU). Existen varios factores sospechosos que favorecen la aparición del CCU entre ellos el PVH; pero este virus no reúne el postulado de Koch para considerarlo como agente etiológico del CCU, como EsSalud y los fabricantes están promocionando en forma masiva. Esta vacuna está elaborada a partir de un virus de laboratorio; no tienen ningún estudio de toxicidad, se ha investigado en 11,000 y en solamente 5 años. Dicen que investigaron por métodos indirectos, hacer por métodos directos no era realista ni ético (Harper 2008). La vacuna fue autorizada por la FDA para su comercialización en sólo 6 meses y en España en 9 meses, cuando este plazo dura 3 años; antes de la autorización del Gardasil se probó en solamente 1,200 mujeres, se niegan las compañías que venden las vacunas a proporcionar datos sobre los dineros invertidos en la propaganda (Medicina Sistemática 11-2010). La vacuna fue autorizada para ser utilizada sólo en jóvenes que no habían iniciado sus relaciones sexuales pero están vacunando a mujeres de hasta los 45.años;. existen evidencias que sí se vacunan a mujeres infectadas con el PVH, se incrementaría el CCU en un 44.6 % ( Jara M 2010); el ensayo clínico fase II no ha sido publicado (Laurel AC 2009); la vacunación no está justificada, es un gran negocio (Red Científica 2009) y existe una descarada campaña publicitaria exagerando el riesgo (Cam-Men 2009); en España por investigaciones han determinado que prevenir un carcinoma del cuello uterino originado por el PVH, costaría 8 millones de euros lo que estadísticamente es inaceptable. Además la World Association for Cancer Research (WACR) dice a la letra que médica ni científicamente está demostrado que sea eficaz y en Europa se han formado dos asociaciones uno de cerca de15,000 investigadores de primera línea que se dedican al cáncer y otra asociación de familiares afectadas por la vacuna quienes solicitan una moratoria, hasta que se determine su eficacia, que será recién el 2025-2030. En USA se ha formado un grupo “ La verdad sobre el gardasil”de madres que piden que prohiban la mal llamada vacuna contra el carcinoma del cuello uterino a la que acusan de haber arruinado la vida de sus hijas e incluso en algunos casos de haberlas asesinado. La vacuna contra el PVH ni es eficaz, ni segura, ni previenen el cáncer del cuello uterino (http://isabeldelafuente.ning.com/forum/topics/ineficacia-y-peligrosidad-de?xg_source=activity). .
    Según VAERS (siglas en inglés), Sistema de Reporte de Reacciones Adversas Provocadas por las Vacunas del gobierno de estados unidos, hasta la fecha solamente en USA se han producido 81 muertes y más de 20,000 reacciones adversas; de ellas entre el 6 % al 10 % eran graves y sólo se reportan el 1 % al 10%; extrapolando estoa datos entonces se han producido cerca de 200,000 reacciones adversas y 810 muertes ( VAERS Report 2009) En la India se suspendió la vacunación porque ocasionó 6 muertes (Dempeus 2010); después de la vacunación se presentaron dos muertes en Austria y uno en Alemania (Supositorio 2010); en Valencia una niña tuvo convulsiones después de la vacuna y actualmente permanece en silla de ruedas; otra adolescente de16 años después de vacunarse parece una persona de 50 años (Serra MJ 2009); en USA en Febrero del 2009 se presentaron 638 efectos adversos graves: 544 convulsiones, 34 trombosis, 9 paros cardíacos y 51 alopecias (Lleida 2009); después de la inyección se produjeron 28 abortos (GineBlog 2009); 35 niñas sufrieron reacciones graves, dos siguen hospitalizadas (elPeriodico.Com 2009); en Balear una niña sufrió 14 convulsiones por día después de la vacunación (diariodemallorca.es 2009); científicos de España, Alemania y Canadá exigen la moratoria de la vacuna hasta obtener pruebas sólidas de la seguridad y eficiencia (Lajornada 2009); su eficacia se determinará recién el 2025-2030 (cherada 2010); las vacunaciones son injustificadas y son un gran negocio ( Red Científica 2009) y el costo es elevado $ 1000 las 3 dosis.
    El Dr. Bernat Soria Ministro de Sanidad de España expresa: “faltan estudios, sobran evidencias de sus efectos adversos y agota el presupuesto de salud pública”; el Dr. Carlos Alberto Dardet Catedrático de Salud Pública de la Universidad de Alicante, España y Director del Journal of Epidemiología and Community Health asegura que la vacuna contra el PVH es: Fraude?, Estafa?, Robo?; es el marketing del miedo; el investigador Juan Servas dice que es una tomadura de pelo a la salud de las mujeres.:
    La industria farmacéutica introdujo medicamentos dañinos a la salud: el etilestilbestrol que se usó entre las décadas del 40 al 70 en mujeres, especialmente embarazadas; se prohibió su uso porque se comprobó que originaba el carcinoma de células claras en la vagina de las mujeres y alteraciones morfológicas en el árbol genitourinario; los estrógenos que favorecía el carcinoma de mama; gracias a la investigación de la Women Health Iniciative (WHI) se suspendió su uso; la thalidomina, el edulcorante aspartamo y últimamente el uso masivo y obligatorio innecesario de la vacuna contra la gripe A en complicidad con la OMS (Forcades 2009). Entre el 2000-2003 la casi totalidad de las compañías farmacéuticas de USA pasaron por los tribunales acusados de prácticas fraudulentas y obligadas a pagar más de 2.2 billones de dólares; 4 de ellas reconocieron su responsabilidad por actuaciones criminales (http://www.scribd.com/doc/20359792/CRIMENES-FARMACEUTICOS-TERESA-FORCADES) .
    Por las razones invocadas solicito a su despacho, Señor Ministro, emitir una resolución declarando moratoria de la vacuna contra el papiloma virus humano, hasta que se determine su eficacia que será recién entre el 2025-2030; nuestras compatriotas no sean conejillo de indias de las transnacionales y el estado no dilapide sus magros recursos en una vacuna incierta, en etapa de experimentación y no comprobado su eficacia médica ni científica.
    Atentamente
    Dr. Godofredo Arauzo
    Email: godo_ara@hotmail.com
    Tel : 05164252052

  11. Godofredo says:

    EL ENIGMÁTICO PAPILOMA VIRUS HUMANO

    Se han identificado 200 tipos de papiloma virus humano, existe una psicosis mundial del PVH por la propaganda para introducir la vacuna; la prevalencia de la infección por el PVH en 1970 era del 1%; en 1985 3 %, actualmente por métodos de alta sensibilidad 85%: en las embarazadas del primer trimestre 40%, tercer trimestre 60%, en el puerperio 17 % y cerca del l0 % en mujeres sin contacto sexual; la mayoría son latentes o subclínicas; una minoría son clínicas observadas directamente: las verrugas o condilomas o el condiloma plano o invertido del cuello uterino; está muy difundido en la naturaleza, infecta a los animales domésticos y silvestres; se transmite también al nacer; se ha detectado en el líquido amniótico, guantes de goma, pinzas de biopsias, espéculos, ropa interior, toallas, en el piso, asiento de los servicios higiénicos, las uñas, gimnasios, vestuarios de las piscinas; se halla en la parte más externa de la piel (Harper 2010) y otros; se los considera como comensales de la persona; aproximadamente el 50% tienen afinidad por la piel y mucosas del ano, parte final del árbol genital y parte superior de los aparatos digestivo y respiratorio; el 80% de las mujeres se infectaran durante su vida; existen PVH de bajo riesgo que son la mayoría que ocasionan lesiones benignas y PVH de alto riesgo sospechosas de ser un cofactor más en la aparición del carcinoma del cuello uterino; la infección por los PVH 1 y 2 se inicia en la infancia y en la niñez produciendo verrugas que desaparecen espontáneamente y los localizados en otros lugares en forma latente o subclínica son diagnosticados con técnicas muy sofisticadas, viven en el medio ambiente por poso tiempo; la vía sexual no es la única vía de contaminación; aparece en los órganos genitales de la mujer cuando inicia sus relaciones sexuales. Es caprichoso y ubicuo; aparece y desaparece del organismo de la persona; la incidencia más alta se halla en las mujeres de 20 a 26 años; con la edad desaparecen; pueden persistir durante toda la vida sin ocasionar ningún trastorno; para desarrollar la infección requiere microtraumas, como sucede durante el acto sexual por choque entre el cuello y el pene; en el 80% de la mujeres que tiene PVH en su cuello uterino desaparecen antes de los doce meses, por acción de su sistema inmunológico; en el resto 20% permanecen estacionarios o progresan a displasia y sólo el 1% puede progresar a carcinoma del cuello uterino después de 30 a 40 años: Por progresar sólo el 1% al cáncer del cuello uterino nos hace pensar que en la aparición del proceso maligno del cuello uterino intervienen también otros cofactores el primero y fundamental es el acto sexual. Mix en 130, 000 monjas no halló ningún carcinoma del cuello uterino, seguido de: tabaco, alcohol, herpes virus simple 2, edad de inicio del coito, número de parejas, cofactor hombre, factores económicos, más frecuente en mujeres de baja condición económica, multiparidad, circuncisión, alteraciones del sistema inmunológico, anticoncepción hormonal, medio ambiente y otros.
    En 1974 zur Hausen postuló la hipótesis que el PVH fuera el agente que ocasionara el cáncer del cuello uterino y que otros investigadores divulgaron la misma idea; pero el PVH no reúne los postulados de Koch, que como dogma se acepta en el mundo científico médico, para considerarlo como el causante del cáncer del cuello uterino..El PVH se halla en otras lesiones, no solamente en el cáncer del cuello uterino (CCU), el PVH no se halla en el 100% de todos los carcinomas del cuello uterino, sólo ser ha encontrado su presencia por métodos inmunológicos en el 90%, la determinación del PVH por inmunolgía se interpreta que el PVH está presente o que es un residuo
    inmunológico cómo queda una cicatriz después de la curación de una herida; no se ha hallado el virus natural o nativo y todavía no se ha reproducido el tumor maligno del cuello uterino al inyectarse PVH en los animales de laboratorio
    La presencia del PVH no es suficiente para el desarrollo del tumor maligno del cuello uterino, se requiere la compañía de varios cofactores exógenos y endógenos
    Nuestros conocimientos de las relaciones del PVH con los cofactores aun son deficientes y el papel que juegan los cofactores en la aparición de la patología maligna del cuello uterino son nebulosos. Científicamente se asegura que el PVH no produce el carcinoma del cuello uterino y la vacuna no previene el PVH menos previene el carcinoma del cuello uterino; la infección por el PVH no son contagiosas, infecciosas ni epidémicas: cómo tampoco es, el carcinoma del cuello uterino. Las investigaciones deben profundizarse en el PVH y los otros cofactores.
    Dr. Godofredo Arauzo
    Huancayo PERÜ
    E mail: godo.ara@gmail.com

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  1. […] according to CBS. The rate of serious adverse events on par with the death rate of cervical cancer. Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical […]

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