Check Up: So far, very little flu

CDC Director Gerberding Gives Green Light to G...
CDC Director Gerberding Gives Green Light to Gardasil then Goes to Work for Merck (g1a2d0049c1) (Photo credit: watchingfrogsboil)

Check Up: So far, very little flu

The U.S. Centers for Disease Control and Prevention has confirmed what you already guessed: This has been a remarkably mild flu season.
The influenza virus likes cold weather, so infections normally occur from October through March. But technically, the flu season doesn’t start until labs that test respiratory swabs from sick people find the virus in more than 10 percent of the samples.
This season, that threshold wasn’t reached until the week ended Feb. 11, making this the kindest flu spell in 29 years.
Pennsylvania, for example, had only 80 confirmed cases in all of January – barely more than one achy, feverish, nauseated citizen per county.
What’s going on?
No one really knows.
“With flu, everything is unpredictable,” said immunologist Scott Hensley, a flu expert at the Wistar Institute in Philadelphia. “I don’t think we’re out of the woods; it could just be a delayed season.”
Then again, maybe the flu has been as scarce as snow because snow has been scarce.
“Flu is more easily transmitted in colder temperatures. This has been a mild winter,” Hensley said.
Another theory is that the population has high levels of immunity to the influenza strains now circulating, which include the one that caused the 2009 “swine flu” pandemic. Because the strains have been so stable, people have had time to develop antibodies against them. Vaccination has also boosted immunity.
Although Hensley subscribes to this theory, he adds a caveat: “If that’s true . . . the virus will start mutating” to evade human defenses. “A novel strain might emerge in the next couple of months.”
While there’s no room for complacency, let us celebrate the signs, monitored by the CDC, that the flu has given the nation a respite:
One person per 100,000 has been hospitalized with the flu since October. That’s a 95 percent drop from last season’s rate of 22 people per 100,000.
Only 1 percent to 2 percent of visits to doctors since October have been for flulike illness. The usual rate is 3 percent to 8 percent.
This flu season, there have been three flu-related deaths among children, compared with 122 pediatric deaths last season – and 348 during the 2009 pandemic.
– Marie McCullough

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Juan Gervas y Vacuna HPV

También en:

Todo ello recogido en:

Ver también la petición de una moratoria para la vacuna contra el VPH
en España:

Es importante:

He añadido comentarios varios actualizados, de artículos y estudios
publicados en 2010 y 2011.

Juan Gérvas. 

Where The Boys Are: Merck, Gardasil And HPV

Pharmalot by Ed Silverman

where-the-boys-are1In the midst of ongoing controversy over HPV vaccines, the Advisory Committee on Immunization Practices, which advises the US Centers for Disease Control and Prevention, voted unanimously to recommend routine use of Merck’s Gardasil in boys as young as 11 years old. The vaccine fights human papillomavirus, which causes genital warts and oral, penile and anal cancers in men and cervical cancers in women.
Two years ago, Gardasil was first approved for in males between ages 9 and 26 to combat two HPV strains that can cause genital warts, so the new recommendation greatly expands the population, although the ACIP previously suggested vaccination was suitable for boys. As for females, the Merck vaccine was originally approved in 2006 to protect against four HPV strains that can lead to cervical and other cancers in girls and women in the same age range.
The move comes just weeks after Gardasil took center stage in the Republican presidential primary campaign. Texas Governor and GOP candidate Rick Perry backpedaled on a 2007 decision to mandate Gardasil for school-age girls, and his ties to Merck at the time became campaign fodder. Later, rival candidate Michele Bachmann claimed Gardasil causes brain damage (see here and here).
The ruckus reflected concerns over side effects, long-term benefits and views of social conservatives, who fear vaccination will give teenagers a green light to premarital sex. This last issue was debated in California over the past several months, where a bill was introduced that removed parental consent for vaccinating children 12 and older against sexually transmitted diseases. Earlier this month, California Governor Jerry Brown signed it into law, but not before the debate raised charges that Merck engaged in the sort of surreptitious lobbying that was conducted when Gardasil was approved in 2006 (back story).
This is the second bit of good news that Merck has received this week about Gardasil. Early-stage research found evidence of a link between HPV infection and heart disease in women who have no other risk factors. The study appeared in the Journal of the American College of Cardiology (see here).
Last year, Gardasil sales slowed considerably, from $1.4 billion in 2008 to $988 million, although for the first half of this year, revenue climbed about 10 percent, to $490 million, from a year earlier. Besides controversy, cost has also been a factor – Gardasil costs about $360 for a three-course dose. The drugmaker will welcome the increased sales that come with the ACIP recommendation, given that 13,000 jobs are in the process of being eliminated. In fact, Merck employees in numerous locations this week are being notified of pending layoffs.

Ante la incorporación de la vacuna HPV como obligatoria en Argentina

Juan GérvasImage via Wikipedia

Ante la incorporación de la vacuna HPV como obligatoria en Argentina
Gérvas J. La incierta prevención del cáncer de cuello de útero con la vacuna contra el virus del papiloma humano. Rev Port Clín Geral. 2007;23: 547-55
Gérvas, J. Prevention of cervical cancer by the HPV vaccine is not definitive. Rev. Port Clin Geral. 2007; 23: 547-55.
Juan Gérvas
Médico de Canencia de la Sierra, Garganta de los Montes y El Cuadrón (Madrid) España
Equipo CESCA, Madrid, España
Abstract with Eleven Questions & Answers into Spanish and English.
English translation by Juan Gérvas (“nogracias” Spain, and Joana Ramos, (www.healthyskepticism.og )
En 2007 se ha comercializado de la vacuna contra el virus del papiloma humano, con la que se propone vacunar a niñas de 11 y 12 años para la prevención primaria del cáncer de cuello de útero, dada la fuerte asociación entre el cáncer y algunos tipos oncogénicos del virus. La vacuna ha sido rápidamente incluida en los calendarios vacunales de la mayoría de los países desarrollados. En este texto se revisa el fundamento científico de dicha decisión. Son puntos clave: la ausencia de cambios en la epidemiología de la infección, la estabilidad o disminución del la incidencia y mortalidad del cáncer de cuello de útero, la falta de correlación entre respuesta inmunitaria serológica y la inmunidad natural, el impacto de la vacuna en la ecología del virus, las evaluaciones coste-efectividad que dependen de la duración desconocida de la inmunización, la dependencia excesiva de la investigación financiada por la industria farmacéutica, y la necesidad de mantener la citología de cribado. Se precisaría más tiempo e información antes de introducir la vacunación en el calendario vacunal.
Palabras clave: Vacunas, Virus del papiloma humano, Evaluación.
Sales of the vaccine against human papilloma virus began in 2007, promoted for administration in girls 11 -12 years old, as preventative measure against cervical cancer, due to the strong link between this cancer with the presence of certain oncogenic strains of the papilloma virus. The vaccine was quickly included in the official immunization programs in many developed countries. In this paper I review the scientific basis for that decision. Critical questions for review are: the absence of changes in the epidemiology of the infection; stability or reduction in the incidence and mortality from cervical cancer; lack of correlation between levels of serologic immune response and natural immunity; the effect of the vaccine on virus ecology; evaluation of the cost-effectiveness of immunization in the face of lack of definitive information about the length of its effectiveness; pharmaceutical industry sponsorship of most of the HPV vaccine research; and the need to maintain screening with Papanicolau exams. More time and information are needed before including this vaccine in the official immunization program.
Key words: Vaccines, Human papilloma virus, Evaluation.
Once preguntas básicas (sin respuesta concluyente)
Eleven basic questions (with no definitive answer)
Con un ímpetu frenético, sin parangón en el campo vacunal, la vacuna contra el virus del papiloma humano se ha incluido en los calendarios vacunales de casi todos los países europeos, Alemania, Austria, Bélgica, Dinamarca, España, Grecia, Holanda, Italia, Luxemburgo, Reino Unido, Suecia y Suiza (1) y en otros desarrollados como Australia, Canadá y EEUU.
With a speed never before seen in the field of immunization, the HPV vacccine has been added to the vaccination schedules of almost all the European countries, including Germany, Austria, Belgium, Denmark, Spain, Greece, the Netherlands, Italy, Luxemburg, the UK, and Switzerland (1) and in other developed nations like Australia, Canada, and the USA.
¿Indica la unanimidad lógica y certeza científica? No. La prevención es campo aparte, como se deduce de otros casos; por ejemplo, respecto al cribado de la displasia del desarrollo de caderas en el recién nacido (2-4).
Does this mean that there is complete agreement and solid scientific basis for this action? No.
The field of preventive medicine is a whole different matter as we can learn from other cases; for example, with respect to screening of newborns for hip displasia (2-4).
En el caso de la vacuna contra el virus del papiloma humano existen dudas razonables acerca de la racionalidad de la decisión de su inclusión en el calendario vacunal. Al menos hay once preguntas básicas sin respuesta concluyente, que hacen dudar de la oportunidad de la aprobación del nuevo calendario:
Reasonable doubts exist about the rationale for the decision to include the HPV vaccine in the immunization schedules. At the very least, there are eleven basic unresolved questions, which raise doubts about the appropriateness of its inclusion in the new [vaccination] schedule.
¿Hay cambios recientes en lo que respecta a la infección por virus del papiloma humano? No. De hecho, desconocemos su historia natural. Es la enfermedad de transmisión sexual más frecuente y la más benigna (el 90% de las infecciones curan espontáneamente) (5). Seguimos sin saber porqué algunas infecciones son persistentes y cancerígenas (al cabo de 20-30 años provocan cáncer de cuello de útero).
Have there been any recent changes in our understanding of the papilloma virus infection? No.
In fact we do not know its natural history. It is the most common sexually transmitted disease, but most cases are benign (90% clear spontaneously) (5). We still don’t know why some infections become chronic and cause cancer (it takes about 20-30 years for [the infection] to transform into cervical cancer).
2. ¿Hay cambios en los países desarrollados de la epidemiología del cáncer de cuello de útero que lo justifiquen? Por ejemplo, en España la incidencia se mantiene estable y baja, así como la mortalidad (respectivamente, de 7,11 y de 2,4 casos por 100.000 mujeres y año) (6). En EEUU disminuye, y cada año hay unos 11.100 nuevos casos y unas 3.700 muertes por cáncer de cuello de útero (5).
Are there known changes in the epidemiology of cervical cancer in developed countries that would justify vacciantion? No.
In most developed countries mortality is stable or decreasing.
No. In Spain, for example, the incidence has remained stable to low, as has the monthly rate (some 7. 11 cases and 2.4 deaths yearly per 100,000 women, respectively) (6). In the USA, there has been a decrease, and there are about 11,100 new cases and about 3700 deaths from cervical cancer annually (5).
3. ¿La inmunidad natural, ¿conlleva la presencia de anticuerpos en sangre? No. La cifra de anticuerpos en sangre es muy baja o inexistente (en la mitad de los casos) en las mujeres inmunes naturalmente. La infección no conlleva viremia (la replicación vírica se produce en la superficie epitelial, muy lejos de la células presentadoras de antígeno y de los macrófagos) (7). Desconocemos en detalle la respuesta inmunológica normal, pero es muy efectiva. Además, no se ve afectada por la re-exposición debida a la actividad sexual continuada.
Is natural immunity correlated with levels of antibodies in the blood? No.
In most cases, the quantity of blood antibodies is very low to nonexistent (in half of all cases) among women with natural immunity. Infection does not correlate with viremia (viral replication occurs on the epithelial surface, very far from the antigen-presenting cells and from the macrophages) (7). Viral replication is a cellular phenomenon. We do not understand very well the normal immune response, but it is very effective. Furthermore, it does not seem to be affected by re-exposure resulting from ongoing sexual activity.
4. La vacuna, y re-vacuna, provoca la presencia en sangre de anticuerpos, en dosis de hasta veinte veces las máximas normales, pero ¿existe relación demostrada entre el nivel de anticuerpos y la eficacia de la vacuna? No. No hay correlación inmunológica demostrada. Ignoramos el mecanismo de acción de la vacuna. Se supone que los anticuerpos en sangre ayudan a eliminar los virus en la superficie epitelial, pero no sabemos cómo (5, 8). La inmunidad natural es celular, no serológica.
Vaccination, and re-vaccination, boost the presence of antibodies in the blood, up to twenty times the normal maximum counts, but is there any relationship shown between the antibody levels and the effectiveness of the vaccine? No.
There is no immunological correlation shown at all. The vaccine’s mode of action is unknown. It is theorized that antibodies in blood might help in getting rid of the infection, but we don’t know how (5,8). Natural immunity is cellular, not serological.
5. Si la vacuna elimina los virus, puede tener un doble efecto beneficioso y perjudicial? Por ejemplo, la vacuna disminuye las infecciones persistentes y las lesiones pre-malignas causadas por los virus contra los que se vacuna (beneficioso). Pero si eliminase otros virus del papiloma humano no sabríamos cómo valorarlo. Por ejemplo, la co-infección con los tipos 6 y 11 (bajo riesgo oncológico) disminuye naturalmente la posibilidad de ser infectado por el tipo 16 (alto riesgo oncológico) (9). En general se acepta que la vacuna evita la presencia o actividad de los virus contra los que vacuna. Por ello cambia la “ecología” del cuello uterino y alrededores, y hay datos (10) que sugieren un efecto de “nicho vacío”, que permite la proliferación de otros virus de alto riesgo oncológico, o la transformación de los de bajo riesgo.
If the vaccine eliminates the viruses, is it possible that it might have two effects, both beneficial and harmful? Yes.
For example, the vaccine might reduce chronic infections and pre-malignant lesions caused by the viruses which the vaccine acts against (helpful). But if this eliminated other human papilloma viruses, we wouldn’t know how to assess such a change. For example, co-infection with types 6 and 11 (low cancer risk) naturally decreases the probability of infection by type 16 (high cancer risk) (9). It is generally accepted that the vaccination blocks the appearance or activation of the viruses that it targets. Because of these changes occur in the “ecology” of the uterine cervix and surrounding areas, and there are data (10) to support the existence of an “empty niche” effect, that permits the proliferation of other high cancer risk viruses, or that permits the transformation of low-risk viruses into high-risk ones.
6. ¿Se ha demostrado su efectividad? No; no se tienen datos sobre su resultado en la práctica clínica diaria, ni siquiera ensayos clínicos con resultados en salud en las niñas en que se propone la vacunación. Se tienen datos de eficacia de casi el 100% (resultados de ensayos clínicos para los que cumplen todas las condiciones ideales, muy diferentes de la clínica diaria), para lesiones asociadas a los virus contra los que se vacuna, en mujeres de 16 a 26 años, generalmente blancas, sanas, de países desarrollados y educadas (10-14). Cuando se tiene en cuenta “la intención de tratar” (se incluyen todos los pacientes participantes en los ensayos, aunque no hayan cumplido las condiciones ideales) la eficacia baja al 50% (10-14), y si se incluyen las lesiones no asociadas a los virus contra los que se vacuna, la eficacia baja hasta el 17% (11).
Has the vaccine been shown to be effective? No.
There are no clinical data about its effectiveness, nor have there been clinical trials showing health outcomes for girls in the age group being targeted for vaccination. There is data showing almost 100% effectiveness (results from clinical trials conducted under the most ideal conditions, quite different from real-life clinical practice) for lesions associated with the viruses that the vaccine targets, in women ages 16 to 26, who were mostly white, healthy, well educated and living in developed countries (10-14). When “intention to treat” is taken into account (if all patients who participated in the trials are included, even if not meeting ideal inclusion criteria), the vaccine’s effectiveness decreases to 50% (10-14). And if all those patients whose cervical lesions are not associated with the viruses targeted by the vaccine are included then the rate of effectiveness of the vaccine falls to 17% (11).
7. ¿Se sabe cuánto dura la inmunidad? No, no se sabe. Lo máximo demostrado son cinco años. Si la inmunidad decae, se podría precisar de una re-vacunación cada cierto tiempo. Además del gasto y complicaciones que ello implica, no sabemos si al ceder la inmunidad artificial se debilitaría la inmunidad natural y habría infecciones oncogénicas más graves y agresivas (algo parecido sucede con la vacunación contra la varicela) (7,12).
Do we know how long immunity [from the vaccine] will last? No.
So far, it has been shown to work for five years. If immunity would decrease, then re-vaccination would be necessary after a certain length of time. Besides the expense and logistical complications this would entail, we do not know if inducing artificial immunity would inhibit natural immunity, resulting in serious and more aggressive oncogenic infections. (something similar to what has happened with small pox vaccination) (7,12).
8. ¿Se ha determinado el coste-efectividad de la vacuna? Sí. Pero se asumen condiciones no demostradas. Especialmente respecto a la efectividad y respecto a la duración de la vacuna. De hecho, en condiciones muy probables, si la inmunidad provocada por la vacuna dura menos de treinta años, y si la efectividad es del 70%, en Canadá, el coste-efectividad es nulo. Es decir, habría que vacunar a infinitas niñas para evitar un caso de cáncer de cuello de útero (15).
Has the vaccine’s cost-effectivenes been determined? Yes.
But some unproven assumptions have been made about its effectiveness and duration of immunity it offers. In fact, under ordinary conditions, if the period of immunity from the vaccine lasts less than 30 years, and if its rate of effectiveness is 70%, in the case of Canada, then it is not cost-effective at all. In other words, it would be necessary to vaccinate all girls in order to prevent one case of cervical cancer (15).
9. ¿Sirve en mujeres que ya han iniciado la actividad sexual? No. Las mujeres se contagian al comienzo de la actividad sexual. La eficacia (ensayos clínicos, condiciones ideales) es muy baja en mujeres que ya han iniciado la actividad sexual, de alrededor del 17% (10,16). Es una vacuna profiláctica (que evita el contagio), no terapéutica (que elimine el virus de las células epiteliales) (5, 10).
Is the vaccine effective for women who are already sexually active? No.
Women get the infection when they become sexually active. Clinical trials done under ideal conditions show that the vaccine has very low efficacy in sexually active women, about 17% (10,16). The vaccine is prophylactic (blocks transmission), not therapeutic (which would eliminate virus in the epithelial cells) (5, 10).
10. ¿Hay ensayos clínicos y estudios independientes, no financiados o promovidos por la industria farmacéutica? No, o son irrelevantes. El grueso de la investigación sobre la vacuna contra el virus del papiloma humano ha dependido, depende y dependerá de la industria que fabrica dichas vacunas (10). Se ignora porqué los gobiernos de los países desarrollados han renunciado a tener un papel activo en el conjunto de la salud sexual, y se reservan sólo el papel pasivo de “pagador” de la vacuna.
Are there clinical trials and independent research that have not been financed or sponsored by the pharmaceutical industry? No, or if so, they are irrelevant.
The bulk of the research on the HPV vaccine has been, is, and will continue to be dependent on the manufacturers of the vaccine. It is unclear why the governments of wealthy countries have declined to take an active role in this area of sexual health services, and instead have assumed merely a passive role as “payor” for the vaccine (10).
11. ¿Se precisa mantener el programa actual de detección precoz del cáncer de cuello de útero? Sí. Los actuales programas de cribaje con la citología (Papanicolau) tienen graves problemas de cobertura y fundamento científico, pero la vacuna no los evita, pues combate sólo dos de los quince virus oncogénicos. No sabemos en qué forma se modificará la sensibilidad y especificidad del cribaje (5,7).
Is it still necessary to continue the current early dectection programs for cervical cancer? Yes.
Current screening programs to detect cervical cancer by cytology (Pap smears) have serious problems in terms of patient access as well as scientific basis, the vaccine doesn’t replace them, as the vaccine only acts against 2 of the 15 oncogenic viruses. We do not know how the specificity and sensibility of screening tests should be modified (5,7).
Bibliography Calendario de vacunación. Europa. Consultado el 13 de octubre de 2007.
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Starfield B, Hyde J, Gérvas J, Heath I. The concept of prevention: a good idea gone astray? J Epidemiol Community Health. 2008 [in press].
Gérvas J, Starfield B, Heath I. Caution in clinical prevention. Lancet. 2008 [in press].
Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chessm H, Unger E for the ACIP. Quatrivalent human papilloma virus vaccine. MMWR. 2007;56(RR02): 1-24.
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Joura EA, Leodoter S, Hernández-Ávila M, Wheeler CM, Pérez G, Loutsky LA et al. Efficacy or quadrivalent prophylactic human papillomavirus (types 6, 11,16, and 18) L1 virus-like-particle vaccine against high-grade vulvar, and vaginal lesions: a combined analysis of three randomised clinical trials. Lancet. 2007;369:1693-702.
Rambout L, Hopkins L, Hutton B, Fergusson D. Prophylactic vaccination against human papillomavirus infection and disease in women: a systematic review of randomized controlled trials. CMAJ. 2007;177:469-79.
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Fuente: Gervas, J. (2008, June 8). June08. Retrieved Sep. 21, 2008, from

Investigate Gardasil Vaccine Risks NOW!

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