HPV vaccine

(Difference between revisions)Routine pap smears are an inexpensive and easy way to detect cervical cancer early so that it can be treated.MayoClinic.com:  Pap smear: Screening test for cervical cancer: Understand the importance of the Pap smear, including how it's done, what it means when it's abnormal and why it needs to be part of your regular health checkups. [http://www.mayoclinic.com/health/pap-smear/HQ01177]Routine pap smears are an inexpensive and easy way to detect cervical cancer early so that it can be treated.MayoClinic.com:  Pap smear: Screening test for cervical cancer: Understand the importance of the Pap smear, including how it's done, what it means when it's abnormal and why it needs to be part of your regular health checkups. [http://www.mayoclinic.com/health/pap-smear/HQ01177]A new study looking at the prevalence of human papillomavirus (HPV) infections in girls and women before and after the introduction of the HPV vaccine shows a significant reduction in vaccine-type HPV in U.S. teens. The study, published in [the June issue of] The Journal of Infectious Diseases  reveals that since the vaccine was introduced in 2006, vaccine-type HPV prevalence decreased 56 percent among female teenagers 14-19 years of age. http://www.cdc.gov/media/releases/2013/p0619-hpv-vaccinations.html

The HPV vaccine exists as 2 products, Gardasil (marketed by Merck and protecting against types 6, 11, 16 and 18 of the human papillomavirus) and Cervarix (marketed by GlaxoSmithKline and protecting against types 16 and 18 only).

Genital warts are most commonly associated with HPV–6 and HPV–11. HPV types 16 and 18 together are found in about 70 percent of cervical cancers. [1]

Only about 3% of women are infected by these four types of HPV (Types 6, 11, 16, 18) targeted by the vaccine.[2] The vaccine is very expensive and has been associated with severe adverse reactions, including paralysis.[3]

The HPV vaccine does not protect against other sexually transmitted diseases (e.g., chlamydia, herpes, hepatitis, trichomoniasis, gonorrhea, syphilis, HIV, AIDS, etc.), and the vaccine is not recommended for use in pregnant women or girls.[4]

"Gardasil had three times the number of Emergency Room visits [than associated with the meningitis vaccine] - more than 5,000. Reports of side effects were up to 30 times higher with Gardasil."[5]

In a remarkable move, a researcher for the HPV vaccine declared, "Public Should Receive More Complete Warnings":[6]

Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the vaccine to prevent cervical cancer. ... It’s highly unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved. Dr. Harper joins a number of consumer watchdogs, vaccine safety advocates, and parents who question the vaccine’s risk-versus-benefit profile. She says data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond five years. if (window.showTocToggle) { var tocShowText = "show"; var tocHideText = "hide"; showTocToggle(); }

As of May 1, 2009, there have been 13,758 adverse reactions occurring after administration of the HPV vaccine, including 39 deaths, reported to the CDC since the FDA approval on June 8 2006.[7] Of the the 39 deaths, 26 were confirmed; the CDC claims that none of these were caused by the vaccine. [8]

In addition to the above referenced injuries and deaths, many girls who receive the HPV vaccine say that it is the most painful of all injections they get, and that the vaccine itself burns, unlike the "other shots [that] tend to hurt only at the moment of the needle stick, and not after the vaccine plunges in." Many girls have passed out from the pain.[9]

The FDA approved this HPV vaccine without reviewing any epidemiological studies, and after monitoring for only a brief period elevated antibody levels in recipients of the vaccine.[10] No tests were done, for example, to see if the vaccine causes cancer or birth defects in rats, though such tests would be easy for the FDA to require, if it weren't for the possibility that it might cause disapproval of the vaccine.[11]

The long-term consequences of the HPV vaccine are not known. Children in the 9-year-old age group have been monitored for only 18 months, and there have been no studies of possible longer-term risks of the vaccine, such as infertility, cancer, or autism.

The HPV vaccine is being promoted as protection against cervical cancer, but Merck itself does not ensure protection in its package insert.[12] Rather, this claim is based on research showing that 70% of cervical cancer cases also have prevalence of these four strains of HPV.[13] Cervical cancer has already been quickly declining in the United States without the vaccine.

Merck sells Gardasil for $360 ($120 per shot in a three-shot series). Adding administrative costs, the overall cost to the public is $400-500 per child vaccinated. Doing the math, the cost of vaccinating 100 children will be at least $40,000, but only 3 out of that 100 will ever be exposed to the HPV types targeted by the vaccine.[2]

The average age of diagnosis of cervical cancer is 48 years old. Accordingly, the effective cost is $13,000 per child to possibly protect her against a cancer over 30 years in the future. But the vaccine is not known to be effective for more than five years; most new vaccines are not effective any longer than that.

An effective means of protection against the same disease is freely available, and it is abstinence. The National Cancer Institute notes that "The surest way to eliminate risk for genital HPV infection is to refrain from any genital contact with another individual." [14]

Routine pap smears are an inexpensive and easy way to detect cervical cancer early so that it can be treated.[15]

A new study looking at the prevalence of human papillomavirus (HPV) infections in girls and women before and after the introduction of the HPV vaccine shows a significant reduction in vaccine-type HPV in U.S. teens. The study, published in [the June issue of] The Journal of Infectious Diseases reveals that since the vaccine was introduced in 2006, vaccine-type HPV prevalence decreased 56 percent among female teenagers 14-19 years of age. [16]

The Association of American Physicians and Surgeons, the Texas Medical Association and the American Academy of Pediatrics have not supported making this vaccine mandatory.

Dr. Jon Abramson, a member of the CDC's Advisory Committee on Immunization Practices, said to the Washington Times that "I told Merck my personal opinion that it shouldn't be mandated. And they heard it from other committee members."[17]

Parents can best decide whether to give this unproven vaccine to their own children, most of whom are never likely to benefit from it.

Merck has succeeded in having its HPV Vaccine added to the "list of required vaccinations for immigrants applying to become citizens," thereby forcing immigrants to pay for and receive this vaccine.[18]

? National Cancer Institute: Human Papillomaviruses and Cancer: Questions and Answers [1]? 2.0 2.1 This was confirmed by a study published February 28, 2007 in the Journal of the American Medical Association, JAMA 297(8):813-819, February 28, 2007. "HPV vaccine types 6 and 11 (low-risk types) and 16 and 18 (high-risk types) were detected in 3.4% of female participants ...."[2]? 12-year-old paralyzed? http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf? http://www.cbsnews.com/stories/2009/02/06/eveningnews/main4781658.shtml?source=RSSattr=HOME_4781658? http://www.cbsnews.com/stories/2009/08/19/cbsnews_investigates/main5253431.shtml? CDC: Reports of Adverse Events Following Gardasil® Vaccination [3]? CDC: Reports of Adverse Events Following Gardasil® Vaccination [4]? MSNBC: Some girls fainting after receiving HPV vaccine Gardasil gaining reputation as most painful of childhood shots, experts say [5]? http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm? http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf? http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf? http://www.cancer.gov/cancertopics/factsheet/Risk/HPV? National Cancer Institute: Human Papillomaviruses and Cancer: Questions and Answers [6]? MayoClinic.com: Pap smear: Screening test for cervical cancer: Understand the importance of the Pap smear, including how it's done, what it means when it's abnormal and why it needs to be part of your regular health checkups. [7]? http://www.cdc.gov/media/releases/2013/p0619-hpv-vaccinations.html? http://www.wnd.com/?pageId=40432? http://thinkprogress.org/2008/09/15/immigrant-gardasil/

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U.S. FDA delays approval of GSK bird flu vaccine

LONDON, March 25 (Reuters) - U.S. regulators have delayed approval of an H5N1 bird flu vaccine from GlaxoSmithKline , designed to be used in a pandemic.

The vaccine had been backed by an expert panel in November but GSK said on Monday the Food and Drug Administration (FDA) had informed it that additional review time was needed before approval.

Britain's biggest drugmaker said the delay was "due to an administrative matter that has recently been rectified", adding the company and the FDA were working to complete to review in a timely manner.

(Reporting by Ben Hirschler; editing Keith Weir)

((ben.hirschler@thomsonreuters.com; +44 20 7542 5082; Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net))

Keywords: GLAXOSMITHKLINE BIRDFLU/

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UPDATE 1-U.S. FDA delays approval of GSK bird flu vaccine

* GSK says U.S. delay not related to narcolepsy controversy

* Similar vaccine linked to sleeping disorder in Europe

(Adds comment from GSK spokesman, background)

LONDON, March 25 (Reuters) - U.S. regulators have delayed approval of an H5N1 bird flu vaccine from GlaxoSmithKline , designed to be used in a pandemic.

A spokesman for Britain's biggest drugmaker said the delay was not related to recent controversy over links between a similar flu vaccine made by the company and narcolepsy.

Rather, the U.S. Food and Drug Administration (FDA) decided it needed more time to assess the product "due to an administrative matter that has recently been rectified", GSK said in a statement on Monday.

"GSK and the FDA are actively working together to complete the review in a timely manner," it added.

There is growing evidence of a link between GSK's earlier H1N1 flu vaccine, Pandemrix, and an increase in narcolepsy cases among children who received it in Europe - a fact which has raised questions as to whether the FDA should approve the similar H5N1 product.

Both vaccines contain AS03, a new adjuvant, or booster, that turbo-charges the body's immune response to a vaccine.

A 14-member panel of advisers to the FDA voted unanimously in November to recommend the H5N1 vaccine to protect against bird flu. The panel considered early studies from Europe showing an increase in the number of narcolepsy cases but concluded that the potential benefit of the vaccine outweighed the risk.

Since then, however, new data, including study results from Britain, suggest the scale and strength of the narcolepsy link to Pandemrix during the 2009-10 H1N1 swine flu pandemic could be greater than first thought.

Officials at the FDA were not immediately available to comment on the case.

(Reporting by Ben Hirschler; editing Keith Weir)

((ben.hirschler@thomsonreuters.com)(+44 20 7542 5082)(Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net))

Keywords: GLAXOSMITHKLINE BIRDFLU/

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Novartis meningitis vaccine wins EU approval

European regulators have approved the first vaccine against meningitis B, made by Swiss drugmaker Novartis.

Novartis said Tuesday that the European Commission approved Bexsero for use in patients ages 2 months and older, and the company will make the vaccine available as soon as possible.

Meningitis mainly affects infants and children. The disease can be fatal or can leave patients with lifelong consequences such as brain damage or impaired hearing.

There are five types of bacterial meningitis, and while vaccines exist to protect against four, none has previously been licensed for type B meningitis. In Europe, type B is the most common, causing 3,000 to 5,000 cases every year.

Novartis said a vaccination is the best defense against the rare disease, since its symptoms often resemble the flu, and it can be easily misdiagnosed.

The European Medicines Agency had said in November that it recommended the vaccine's approval. Novartis also is seeking to test the vaccine in the United States.

Its shares closed at $65.64 on Friday.

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What The Daily Beast’s Absurd Vaccine Truther Screed Tells Us About Journalism

Pictured: The Daily Beast's approach to covering vaccination.

I’m not going to link to the execrable anti-vaccine screed published on The Daily Beast today. I’m not even going to link to the thoughtful, well-written counterpoint they published by a infectious disease specialist. To do either would reward a transparent attempt to gin up a pageview-inducing “controversy.” Moreover, it would treat the two pieces as if they were two sides of an argument, as opposed to medical fact and conspiratorial lunacy.

If you must read something on the topic, here‘s how many people die of influenza in the United States and here‘s an explanation of why vaccine panics aren’t worth taking seriously.

What’s particularly galling about The Daily Beast‘s vaccine “debate” is that it treats science criticism like punditry. Political writing is plagued by a consensus of bores, commentators who all have opinions within the same narrow band of “acceptable” views. The online journalism revolution opened this up a bit, but not nearly enough. Hence, as a matter of inclination, I’m reflectively skeptical about claims that editors should refuse to publish authors with certain political opinions simply because they’re “out of the mainstream.” More often than not, such arguments serve more to defend staid political views from challenge than anything else.

Science journalism has, if anything, the opposite problem. The basic task of a science journalist is to explain complicated scientific findings to people who don’t have the time or the expertise to learn it from primary sources. Increasingly, science journalists are acting as science critics as well as science expositors, but that doesn’t undermine the need to fully understand and embrace scientific methodology (if anything, it intensifies it). Science journalism, sadly, often fails in both of these roles. This generally happens when writers lack the time or background knowledge necessary to properly digest and explain the research in question.

That last problem is particularly pronounced because people have a tendency to accept science as fact. Setting aside (wrongly) politicized disciplines like climate science for the moment, people without scientific expertise reading write-ups of research findings are reasonably likely to accept them as fact. So science journalism needs to correct its flaws by more gatekeeping, not (as in politics) less. Editors should work to make sure that only people who are fair and knowledgeable observers of scientists’ work are in a position to explain easily-misinterpreted research to the public.

By setting up vaccination as an issue up for debate in the same way that political questions are, the Beast articles can leave a reader who isn’t aware of the overwhelming scientific consensus might simply throw up their hands (as happens in the climate debate) and say “who knows whose research is right?” But that’s not how it is. People who conclude that there’s a real case that the flu vaccine might do more harm than good are less likely to get flu vaccines, for them or their family. That makes people more likely to get sick and, possibly, die. There isn’t any real debate about this among epidemiologists. This should be settled.

Science journalism isn’t like political writing: it really could benefit from tighter editorial control on the sorts of views expressed. Judging by today, I wouldn’t look to The Daily Beast to point the way forward.

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The Dangerous Consequences Of Right-Wing Scaremongering Around The HPV Vaccine

CBS News reports that cancers related to human papillomavirus (HPV) has been on the rise over the last two years, largely because not enough people are getting vaccinated against HPV. Even though fewer numbers of Americans have been dying from cancer over the last two decades, a annual joint report by the Centers for Disease Control (CDC) and the National Cancer Institute finds that HPV-related cancers have ballooned:

The new report found increases in rates for HPV-associated oropharyngeal cancer (throat cancer) among white men and women, in addition to rises in anal cancer rates among white and black men and women.

Alcohol and smoking can also lead to these cancers, however, HPV accounts for about 70 percent of the cancers in this area, [Dr. Michael B. Prsytowsky] said.[...]

“We need to get adolescent children — both boys and girls — vaccinated before they’re sexually active,” Prsytowsky said. “Parents need to understand the vaccine is safe and effective and prevents disease down the road.”

The report found that less than half of girls ages 13 to 17 got at least one dose of the recommended HPV vaccine. The government’s Healthy People 2020 campaign aims to have 80 percent of eligible girls vaccinated by the next decade.

While Obamacare provides support for wellness initiatives and eliminates co-pays for HPV screenings, such provisions are useless if Americans buy into the widely-debunked conservative hysteria that the HPV vaccine is unsafe. 2012 GOP presidential contender Rep. Michele Bachmann (R-MN) went as far as to claim that the vaccine causes “mental retardation” in girls, and other Republicans have falsely asserted that it somehow leads to sexual promiscuity.

Conversely, medical professionals urge Americans to safeguard their health by receiving their recommended vaccinations. “We must face these hurdles head on, without distraction, and without delay, by expanding access to proven strategies to prevent and control cancer,” Dr. John R. Seffrin, the chief executive officer of the American Cancer Society explained in response to the rising rates of HPV-related diseases.

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