- The product information of the four-type (6,11,16,18) human papillomavirus (HPV) vaccine Gardasil® has been updated to include the clinical efficacy and safety information of the vaccine for women up to 45 years of age.*,1

In a clinical study which included 3,819† women between 24 and 45 years of age, among those who were not infected with the relevant virus type at vaccination‡ and who received all three doses of the vaccine (3,351 women§, Gardasil® prevented 90.5%** of HPV 6-, 11-, 16-, or 18-related persistent infection, cervical lesions (CIN††) of any grade, adenocarcinoma in situ (AIS), cervical cancer, vulvar and vaginal lesions and genital warts.1,2

Gardasil® was generally well tolerated and demonstrated a good safety profile with fever as well as redness, swelling and pain at the injection site as the most commonly reported side effects.1,2

“Vaccination recommendations or campaigns from health authorities will continue to focus on adolescent girls. However, women may remain at risk of HPV infection and developing related diseases during their adult life. Women should be aware of the efficacy and safety of Gardasil® up to 45 years. They should make an informed decision about individual vaccination following discussion with their doctors taking into account their personal and HPV disease histories“, says Professor Xavier Bosch from the Catalan Institute of Oncology in Barcelona, Spain.

All women should continue regular screening for early detection of cervical cancer whether they have been vaccinated or not. Gardasil® is a preventive vaccine and can therefore not treat preexisting infections or disease. The vaccine cannot protect against all HPV types.

Gardasil® is the only HPV vaccine to have clinical efficacy and safety for women up to 45 years added to its product information. Gardasil® is a four-type (6,11,16,18) HPV vaccine. In addition to unsurpassed and sustained cervical cancer protection, Gardasil® can protect from cervical, vulvar and vaginal pre-cancer, and from genital warts caused by HPV types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases.1,3,4,5

©2012 An Inconvenient Woman. All Rights Reserved.

In twin votes likely to add considerable force to U.S. marketing efforts for HPV vaccines, an FDA expert panel has voted to back GlaxoSmithKline’s long delayed application to market its HPV vaccine Cervarix to women and soon after supported Merck’s application to extend the use of Gardasil to males. Glaxo shares gain 0.5 pct, Merck shares gain 1.9 pct.

Glaxo had originally tried and failed to gain FDA approval for Cervarix back in 2007 but was thwarted by the agency’s desire to see more information on potential side effects, particularly a heightened risk of miscarriage. Since that time the pharma giant has gained approvals in more than 100 countries, while biding its time with the FDA. And while the panel concluded that the link between Cervarix and miscarriages is tenuous, the experts suggested a warning to prevent pregnant women from getting the vaccine. The panel vote makes it all but certain that Glaxo will gain final marketing approval from the FDA, opening the door to the world’s biggest drug market and finally offering Merck some competition for Gardasil. Glaxo’s shares were buoyed by the news.

Food and Drug Administration advisers, in an 11-1 vote, said Cervarix appeared safe despite miscarriages reported around the time of vaccination and a small number of autoimmune problems such as rheumatoid arthritis and lupus. Panelists urged monitoring for those issues after approval to see if there was any link to the vaccine.Merck, meanwhile, is seeking an FDA approval to use its HPV vaccine to guard against genital warts in boys and men. The panel gave Merck its support, but there was widespread agreement that the use of an HPV vaccine for males 9 to 26 offered little protection against cancer, as HPV-related penile and anal cancer cases are extremely rare. The FDA has indicated that any final approval on Gardasil’s use in males will require post-marketing safety studies.

Check out full story in  the Los Angeles Times
Read  Reuters Report

©2012 An Inconvenient Woman. All Rights Reserved.

Fresh controversies are heating up over the marketing of products to prevent cervical cancer

The U.S. Food & Drug Administration is gearing up to make critical decisions about two controversial vaccines. On Sept. 9 an FDA advisory committee will consider whether Merck (MRK)’s Gardasil, given to girls to prevent cancer-causing human papilloma virus (HPV), should be approved for use in boys, who can be HPV carriers. The same panel will also advise the agency on whether it should allow a new HPV vaccine, GlaxoSmithKline (GSK)’s Cervarix, to enter the U.S. market. The FDA doesn’t have to follow its panels’ recommendations, but it usually does.

Sales of Gardasil to prevent cervical cancer hit a respectable $1.4 billion last year, but they are already starting to slump, and fresh controversies could pour more cold water on this whole class of vaccines. Ever since Gardasil was approved in 2006, health-care watchdogs have griped that Merck has been overselling the vaccine’s cancer-beating power without having a full understanding of potential long-term risks. On Aug. 19, Columbia University professors Sheila M. and David J. Rothman published an article in the Journal of the American Medical Assn. blasting the company for paying grants to medical organizations that are strong advocates for vaccination. “Telling every mom she needs to get her daughters vaccinated to protect them from cancer is creating a market out of thin air,” David Rothman says. “They’re already protected” through regular pap smears, he adds.

Such criticisms mark a stark turnabout for a product once hailed as a breakthrough. Cervical cancer is a scourge: 11,000 cases are expected to be diagnosed this year, and 4,000 women will probably die of the disease, says the National Cancer Institute. The vaccine could prevent more than 70% of such cases. But from Day One, Merck has been lambasted for tactics such as lobbying lawmakers to make vaccination mandatory. After a strong start in the first two years, Gardasil sales fell 5% in 2008 and second-quarter sales are down 18% from a year earlier.

Dr. Richard M. Haupt, who heads the Gardasil research program for Merck, defends the company’s marketing. “Our goal is to act in the best interest of public health,” he says, noting that many organizations have spent money to promote the cause. Should boys be vaccinated? Merck has given the FDA data showing Gardasil prevents 90% of HPV symptoms in men, but since related male cancers are rare, the main justification is to protect their partners from cervical cancer. (Gathering data is also dicey because even if there were a drop-off in cases after widespread male vaccination, Merck could never prove its vaccine deserved more of the credit than, say, improved screening.)

Glaxo, for its part, doesn’t plan to market Cervarix to boys because it doesn’t think the strategy would be worth the expense. The Centers for Disease Control estimates that vaccinating males would cost the health-care system at least twice as much per year of added life as it costs to vaccinate females.

As for payments to medical organizations, Glaxo, Merck, and their beneficiaries say their disclosures are adequate. Two recipients, the American College of Obstetricians & Gynecologists and the Society of Gynecologic Oncologists, say they put the money to many uses beyond endorsing a specific vaccine. Meanwhile, Merck’s Haupt says the scandals are drawing attention away from what could be a public health boon. “I vaccinated both my daughters,” says the father of four. And if Gardasil is approved for boys, he says, “I plan to vaccinate both my sons.”

Arlene Weintraub is a senior writer for BusinessWeek‘s Science & Technology department and published this article in Businessweek, online August 27th, 2009.

©2012 An Inconvenient Woman. All Rights Reserved.

Less then a month after a JAMA article critized Merck for aggressively marking Gardasil, Merck is planning a big-time advertising push on Gardasil, hoping to revive flagging sales of the human papillomavirus vaccine. As Advertising Age reports, the drugmaker i’s plotting its campaign for the big back-to-school shopping season.

Besides ramping up ad spending, Merck is participating in vaccine-day events with doctors’ offices and clinics, providing posters, direct-mail pieces, and pocket cards. “Resources were made available several months ago to support execution during the back-to-school time frame,” a Merck spokeswoman told AdAge.

During Merck’s recent earnings call, EVP Ken Frazier touted the Gardasil push, saying he expected “sequential growth” in the vaccine’s sales “as we leverage the back-to-school season.” Second-quarter sales amounted to $268 million, down 28 percent from the same period last year and 18 percent from two years ago.

But–and this is a big ‘but’–Frazier also said during that call that the 13-to-18-year-old market for Gardasil has already peaked. So despite the back-to-school campaign, Merck is looking outside that age group for any real growth in the vaccine. Frazier said the company is “firmly committed to achieving greater vaccination rates in the 19-to-26 age group.” And it’s still hoping for new indications–for boys and for women up to age 45–from the FDA.

See Full  AdAge article

©2012 An Inconvenient Woman. All Rights Reserved.

This week has shown that a large number of reports stating that Gardasil is proving unsafe. News stations around the world have reported that Gardasil the HPV vaccine has been found to cause adverse reactions. The adverse reactions range from mild, such as headaches, nausea and fainting, to the more severe such as seizures, blood clots, Guillian Barre Syndrome and even death.

Christina England, The American Chronicle

This week has shown that a large number of reports stating that Gardasil is proving unsafe. News stations around the world have reported that Gardasil the HPV vaccine has been found to cause adverse reactions. The adverse reactions range from mild, such as headaches, nausea and fainting, to the more severe such as seizures, blood clots, Guillian Barre Syndrome and even death. This information has come to light since the publication of the
JAMA papers on the 19th August 2009, showing the results of the VAERS Vaccine Adverse Event Reporting System. The Gardasil data published was collected from June 1, 2006 through December 31, 2008.

Merck has only recently changed packaging showing acknowledgement that this vaccine causes fainting and seizures in some children.

Information Pertaining to Labeling Revision for Gardasil

“On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil, a vaccine to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. In the new label, information pertaining to syncope (fainting) is now also included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity. The addition of syncope to the Warnings and Precautions section emphasizes that healthcare providers and consumers should be alert that fainting may occur following vaccination with Gardasil, sometimes resulting in falling and injuries. To prevent falls and injuries all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes following vaccination.”

Cynthia Janak a USA journalist has been writing and proving this vaccine is unsafe for the last few years. Her website Only the Truth gives tribute to the many girls who have lost their life after taking Gardasil shots. This site points out and lists the adverse reactions, showing pictures of beautiful young woman now no longer with us, other pages have stories of girls suffering every day from the adverse reactions to this vaccine. There is up to date news and views on Gardasil.

News stories have been hitting America for three years about the dangers of this vaccine. Stories like this one 2007 Did Gardasil Vaccine Cause a 12-yr-old Girl’s Paralysis and Girl Dies after HPV Jab – CDC Blame Birth Control Pill

Merck says however, Merck Says FDA And CDC Reaffirm Safety Profile Of Gardasil – Update

“Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks.”

Confusing that because if Merck were so convinced that their vaccine was safe why have they recently changed the labelling?

Diane Harper who worked on the Gardasil trials has reservations. Harper told CNN she has concerns about the safety of the HPV vaccine for pre-adolescents, noting that a small number of girls have died or suffered neurological damage after receiving the shot.

However, despite the controversy surrounding this vaccine, with much information proving it to be unsafe, it appears not only is still being offered to teenage girls across the USA and the world today but is a mandatory vaccine for immigrants wanting to come into the USA. In a sickening story in a letter passed to me a grandmother who has been raising her grandchild and was trying to escape to the USA from domestic violence was refused entry because she refused after researching Gardasil. to let her grandchild have it. The letter also shows 140 immigration rights, women´s rights, public health, medical, and reproductive justice organizations including an attorney have joined a coalition in NYS.The letter to the CDC was written as the author felt the vaccine activists might want to know the names of political organizations opposing the US immigration regulation that requires immigrants receive the Gardasil shot.

So why is it that USA citizens in many states have the option to choose whether they or their children have the HPV vaccine but immigrants can not? In order to become a permanent, legal resident of the U.S, immigrants now must receive a vaccine that is not required of U.S. citizens. This is like saying these people are less important or more likely to be infected. This surely is wrong.

For The complete article go to: http://www.americanchronicle.com/articles/view/115767

Christina England is a  UK journalist studying for an HND in journa and a member of ICAP International Coalition of Advocates for the People
i.c.a.p.org

©2012 An Inconvenient Woman. All Rights Reserved.

In the wake of new safety data on Merck’s human papillomavirus vaccine, both FDA and the Centers for Disease Control and Prevention have issued a statement supporting the product. “Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks,” the agencies said, calling the vaccine an “important cervical cancer prevention tool.”

Earlier this week the Journal of the American Medical Association published an analysis of safety data that found the most common serious side effect was fainting, though some more severe adverse event occurred in Gardasil patients, including more than two dozen deaths. But the FDA and CDC say there’s no evidence the deaths or other severe effects were actually caused by the shot, and the agencies emphasize that they have reviewed the same safety data repeatedly.

In response to the government support, Merck sought to reassure parents, encouraging them to “look to the CDC and FDA, and to the advice of their own physicians” to help them decide whether to have their children vaccinated. ”We hope that the many parents who may have been frightened this week by misleading reports understand that Merck people are parents, too,” Dr. Richard Haupt, who heads up the Gardasil program, said in a statement. “Our own children are vaccinated with Gardasil.”

- see the FDA/CDC statement
- read the release from Merck
- get the story in the Wall Street Journal

©2012 An Inconvenient Woman. All Rights Reserved.

The latest issue of JAMA delivered a mixed blessing to Merck’s Gardasil. In a headliner study published by the Journal of the American Medical Association, the side effects of the human papillomavirus shot were deemed reasonable. Serious adverse events cropped in up those who got the vaccine–including some 32 deaths and two cases of Lou Gehrig’s disease–but there’s no evidence the shot actually caused them. The most common complications were fainting and clot risk.

Overall, there were 54 adverse event reports for every 100,000 doses, and some 6 percent of those were serious. “We feel confident recommending people get the vaccine; the benefits still outweigh the risks,” Dr. Barbara A. Slade, lead author and a medical officer with the Centers for Disease Control and Prevention, told the New York Times. The company sent out a release touting the news: “We are pleased that the study published by JAMA today further reinforces the safety profile of Gardasil,” Merck’s Richard Haupt said in a statement.

That’s the good stuff. The not-so-good: JAMA asks in an editorial whether any level of risk is appropriate in the case of HPV vaccination. “I wouldn’t accept much risk of side effects at all in an 11-year-old girl, because if she gets screened when she’s older, she’ll never get cervical cancer,” the editorial’s author, Dr. Charlotte Haug, told the Times.

And another JAMA study dropped a bombshell: Merck gave money to three medical societies to fund their promotion of Gardasil.

Researchers from Columbia University said the American College Health Association, the American Society for Colposcopy and Cervical Pathology and the Society of Gynecologic Oncologists used Merck funding on educational materials and lectures that offered lopsided information about the vaccine’s risks and benefits. “I think what happened here was that marketing and medical education got blurred,” co-author Sheila Rothman told the Washington Post.

“This shows how [Merck was] able to influence physicians,” Diane Harper of the University of Missouri, who helped test the vaccine, told the paper.

Merck, however, says that the $750,000 it gave to those three groups was intended to help them develop “independent” information for their membership. “[O]ur activities with these societies were done in an appropriate and independent manner,” Haupt said. The groups themselves say the funding didn’t affect the content of their materials or programs.

Read the Merck release

- check out the NYT story

- See Washington Post Article:

- read the news from FirstWord

-  find the AP story

©2012 An Inconvenient Woman. All Rights Reserved.

Ещё одна прививка, ещё одна ложь!

Сейчас, когда в нашей стране начата массивная пропаганда и внедрение в практику вакцинации наших девочек, девушек, молодых женщин – будущих матерей России – против рака шейки матки вакциной «Гардасил», якобы безопасной и имеющей 100-процентную гарантию защиты от рака, стоит узнать об её истинной безопасности и эффективности из информации, поступающей из стран, где уже в течение нескольких лет эта вакцинация проводится.
Прочитав статью английской журналистки Кристины Энгланд (и краткие выдержки из других её статей, касающихся вакцинации против рака шейки матки), Вы узнаете, что вакцина против рака шейки матки и ОПАСНА, и НЕЭФФЕКТИВНА! Она даёт тяжёлые побочные реакции, в том числе повреждение головного мозга, а в некоторых случаях – смерть. И никто не знает, какие болезни разовьются у привитых в отдалённые сроки.

Решайте сами, стоит ли подвергать такому риску своих дочерей!

Институт Роберта Коха в Германии ставит под сомнение эффективность HPV-вакцин против рака шейки матки. (Germany`s Robert Koch Institute is Questioning the effectiveness of the HPV vaccines)

31 мая 2009 год

Кристина Энгланд (Christina England)

Источник http://www.americanchronicle.com/articles/view/104266

Перевод И. М. Сазоновой

Во всём мире возникают опасения относительно эффективности и безопасности HPV-вакцин (далее русская аббревиатура ВПЧ-вакцина. Примечание переводчика). Пока многие из наших правительств отказываются прислушиваться к общественности и игнорируют всё большее число детей, которые имеют побочные реакции на вакцины Гардасил (Gardasil) и Церварикс (Cervarix), в Германии эти проблемы, наконец, рассматриваются и тщательно изучаются.

Институт Роберта Коха в Германии, который даёт рекомендации по государственному финансированию вакцин, пересматривает свою программу вакцинации после того, как 13 экспертов призвали к переоценке программы ВПЧ-вакцинации и к тому, чтобы положить конец «вводящей в заблуждение информации» об эффективности прививки.

Несколько недель назад Scotland on Sunday сообщила, что, по словам пресс-секретаря института Роберта Коха, их комитет по вакцинации изучает сложившуюся ситуацию. Она добавила: «Из-за общественного обсуждения, некоторых новых отчётов и новых заявлений от 13 профессоров, комиссия в течение ближайших нескольких недель опубликует заявление»

Шотландия серьёзно изучает свою политику вакцинации в отношении вакцины Церварикс из-за важных сообщений, написанных немецкими учёными  (German Scientists) такими, как Сандра H-Шевалье Батик (Sandra H Chevalier-Batik reports)

«Шотландская многомиллионная (в фунтах стерлингов) программа вакцинации против рака шейки матки была вчера вечером подвергнута сомнению после предупреждения старших экспертов в области общественного здравоохранения о том, что она может быть не столь эффективной, как ожидалось первоначально. Правительственные советники Германии пересматривают свои программы после сказанного ведущими учёными, что прививка не оправдывает ожиданий в предотвращении заболевания раком шейки матки

Теперь критики говорят, что шотландские советники по здравоохранению, которые дали разрешение на программу иммунизации за £ 64 млн. с участием тысяч школьниц, должны были бы рассмотреть доказательства полезности.

В последние несколько недель специалисты и заинтересованные матери из США, Великобритании и Голландии собрались вместе и решили написать этим 13-ти учёным, чтобы они описали свои опасения. Каждый из этих заинтересованных лиц имеет контакт с жертвами этих вакцин и они вооружены новыми доказательствами, которые они решили послать по электронной почте непосредственно этим учёным. Они разработали документы, которые отправили этим учёным, подкрепив их своими доказательствами и статистическими данными, свидетельствующими о том, что опасения учёных действительно оправданы. Эти документы были направлены 700 специалистам по всему миру. Профессионалы, которые получили их, являются представителями разных профессий, включая медицинских работников, учёных, представителей власти, журналистов и многих других. Они представлены на веб-сайтах по всему миру. Прошлой ночью Синтия Дженэк (Cynthia Janak), одна из авторов этого документа из США направила письмо другим авторам, в котором написала:

«Я только что получила письмо от онколога, и он согласился с тем, что безопасность вакцины, в действительности, не была доказана.

Профессионалы в целом сказали, что документы были хорошо представлены, и очень хорошо написаны».

Profitable Harm является одним из многих сайтов, на котором сейчас есть копии этих документов.

Чтобы понять, как ВПЧ-вакцины и другие вакцины вызывают повреждения головного мозга, слушайте программу радио в понедельник 1 июня 2009 6-7 PM MST и тогда Вы услышите ответ на вопрос «Вакцины вызывают повреждения головного мозга?» Настройтесь на KRFC FM 88.9 и слушайте аудио программы, где д-р Эндрю Мулден (Dr Andrew Moulden) лидер канадской группы активистов будет объяснять предмет неврологического повреждения от вакцины у Лесли Бота (Leslie Botha) из Holy Hormones, Honey.

На передаче будут Синтия Дженэк, журналистка, которая разместила список жертв Гардасила и Церварикса на своём веб-сайте Only The Truth, и которая пишет для Renew America, а также врач Dr Judi Gurstung

По словам д-ра Мулдена, микрососудистые повреждения от вакцинации вызывают аутизм, СДВГ (ADHD – синдром дефицита внимания и гиперактивности. Примечание переводчика), внезапную младенческую смерть (СВДС или SIDS).

Правительства всех стран и все, кто осмелился заявить, что вакцины безопасны, должны прислушиваться к тому, что он говорит, потому что этот человек действительно является очень сильным. В только что выпущенной статье под названием «Вакцины, применяемые у детей, вызывают повреждение головного мозга» (Vaccines used in children causing brain damage), он объяснил, каким образом с использованием фотографий до и после вакцинации может доказать, что 100% детей имеют повреждения головного мозга от MMR (вакцина против кори, краснухи и паротита. Примечание переводчика).

Эти данные были использованы в деле Бен Зеллера (Ben Zeller). Бен Зеллер говорит, что его сын Бен был нормальным 11-месячным ребёнком, когда ему сделали прививку вакциной MMR.

Через несколько дней у него случился приступ. Приступ был настолько серьёзным, что он оставил Бена с тяжёлым поражением мозга.

Г-н Зеллер всегда полагал, что приступ Бена был реакцией на MMR. Бен был здоровым и счастливым ребёнком во всём, а после вакцины он остался с тяжёлым повреждением головного мозга.

Д-р Мулден сказал: «У нас есть тысячи дел, и мы можем показать, что все вакцины вызывают точно такие же проблемы,

©2012 An Inconvenient Woman. All Rights Reserved.

Merck (MRK) is expected to report Q2 earnings Tuesday, July 21, before market open, with a conference call scheduled for 8:30 am ET.

Guidance

Analysts are looking for EPS of 77c on revenue of $5.84B. The consensus range is 75c-79c for EPS, and $5.70B-$5.98B for revenue, according to First Call. On April 21, Merck reaffirmed its FY09 EPS guidance of $3.15-$3.30 versus a consensus of $3.25.

Analyst Views

Possible positive drivers for Merck this quarter might be seen in its Singulair and Januvia sales. Weighing on this quarters earnings will be the loss of patent protection on Fosamex and slower Gardasil sales. Sales of cholesterol drugs Vytorin and Zetia, co-marketed by Schering-Plough (SGP), might also be disappointing especially in a weak economy with cheaper alternatives.

In late June, UBS mentioned Merck cautiously, citing May as another weak month for Merck’s U.S. vaccines franchise.

On July 9, Natixis downgraded Merck to Hold from Buy.

©2012 An Inconvenient Woman. All Rights Reserved.

In a July 9th story, ‘WHO clears Glaxo’s Cervarix for developing world’ Reuters reported that  GlaxoSmithKline’s (GSK.L) cervical cancer vaccine Cervarix has won a green light from the World Health Organisation (WHO) for use in developing countries, although how the shot will be paid for has yet to be resolved.

WHO “prequalification” —  a key hurdle for gaining wider use of Glaxo’s HPV vaccine Cervarix, an necessary endorsement for UN agencies and the non-profit GAVI Alliance to purchase the vaccine, and Glaxo said on Thursday it hoped the move would help speed access to Cervarix globally.

And Glaxo quickly followed up, saying that the company plans to explore new financing mechanisms that would ensure broad availability. “We’re exploring a variety of distribution partnerships to ensure Cervarix will protect women and girls around the globe,” Jean Stephenne, head of vaccines, tells Reuters.

WHO had already approved Gardasil and the Global Alliance for Vaccines and Immunization, a broad umbrella group of international health organizations, has made access to cervical cancer vaccines a top priority. Dan Thomas, a GAVI spokesman stated “We’re very eager to offer women in developing countries these vaccines because without early screening, they are arguably more vulnerable to cervical cancer.”

It’s likely that Glaxo will work out discount prices for global health agencies and nonprofits, a common avenue for Big Pharma companies selling expensive therapies in poor countries.

For full Reuters story Click here: http://www.reuters.com/article/rbssHealthcareNews/idUSL948126520090709

For AP Coverage, ‘WHO approves cervical cancer vaccine Cervarix’ Click Here:

http://www.google.com/hostednews/ap/article/ALeqM5gLW3aCaSxKeKddyL_g7p2uerLjkgD99AT25G0

©2012 An Inconvenient Woman. All Rights Reserved.