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.

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.

Reported by David Jolly

With the purchase, Merck is expanding its franchise in cardiovascular, respiratory and oncology drugs and shoring up its research pipeline, in particular with a Schering-Plough product called TRA, a promising drug designed to prevent blood  clotting.

In addition, Merck will benefit from the worldwide reach of Schering- Plough, which generates about 70 percent of its sales outside the United States, including more than $2 billion in annual revenue from emerging markets.

The companies said in a joint statement that the merged company would keep the name Merck and that the deal had been unanimously approved by their boards. Richard Clark, Merck’s chairman and chief executive, will lead the combined company.

The deal is the second major pharmaceutical deal this year after Pfizer, the world’s biggest drug maker, agreed in January to pay $68 billion for Wyeth. And Roche, the Swiss pharmaceutical company, is pursuing a full acquisition of the California biotechnology company Genentech, in which it already owns a majority stake.

Merck is among the drug makers that face the hardest time in the next decade because of patent expirations, said Richard Purkiss, a drug sector analyst at Atlantic Securities in London. Most pressingly, it faces the expiration in 2012 of the patent on Singulair, the asthma drug that is its top-selling product.

In contrast, “Schering- Plough doesn’t have much exposure to patent expiries in the same time frame,” he said. “This is really about combining to protect earnings.”

Shares of Schering- Plough rose more than 8 percent Friday amid speculation that the company had been pursuing a deal with either Merck or Johnson & Johnson, with which it jointly produces the arthritis drug Remicade.

Under the terms of the agreement announced Monday, Schering-Plough shareholders will receive 0.5767 share of the combined company and $10.50 in cash for each share of Schering-Plough. Each Merck share will automatically become a share of the combined company. Based on Merck’s closing stock price Friday, the deal values Schering-Plough at $23.61 ar share, or $41.1 billion, a premium to Schering-Plough shareholders of about 34 percent.

The 44 percent of the deal that is being paid in cash will include $9.8 billion from existing cash balances and $8.5 billion from financing provided by JPMorgan Chase.

Merck shareholders will own about 68 percent of the merged company, and Schering-Plough shareholders will own the rest. Merck said it expected the deal to contribute “modestly” to its earnings in the first year and “significantly”  thereafter.

“We are creating a strong, global health care leader built for sustainable growth and success,” Clark said in the statement. “The combined company will benefit from a formidable research and development pipeline, a significantly broader portfolio of medicines and an expanded presence in key international markets, particularly in high-growth emerging markets. The efficiencies we gain will allow us to invest in strategic opportunities, while creating meaningful value for  shareholders.”

The transaction will be structured as a “reverse merger” in which Schering-Plough, renamed Merck, will continue as the surviving public company.

Merck said it expected annual cost savings of about $3.5 billion after 2011. The savings “are expected to come from all areas across the combined company and from the full integration of the Merck/Schering-Plough Pharmaceuticals cholesterol joint venture,” it said, and are in addition to previously announced cost-cutting measures at the two companies.

David Moskowitz, an analyst at Caris & Co. in New York, suggested that the companies might have to raise the offer price above $23.61.

“I think it should be at least $12 billion to $15 billion higher,” he told Reuters, as investors might not be happy until the price reaches “the high $20s or $30″ a share.

©2012 An Inconvenient Woman. All Rights Reserved.

Consumers can only  hope. Of course if  MERCK corporate lawyers figure out that such an open source platform may lead to a clear chain of custody of the type of information they would rather not have readily available during a trial environment, we will see who prevails, the scientist or the lawyers

Reported by Kevin Davies

March 3, 2009 | SAN FRANCISCO – Merck scientists and executives Stephen Friend and Eric Schadt unveiled their plans for Sage, an open-access platform for sharing and disseminating complex data representing disease biology, in a major announcement at CHI’s Molecular Medicine Tri-Conference last week.*

In a joint presentation, Friend, Merck senior vice president and former oncology chief, and Schadt, an outstanding researcher based at Merck’s Seattle subsidiary Rosetta Inpharmatics, reviewed the successes and outstanding challenges that prompted them, with Merck’s blessing (in the form of money and resources) to entertain a bold new approach to improving the expense, time and productivity of drug development.

The benefits of analyzing complex bionetworks are very good, said Schadt, but “more expensive than any one company can afford.” The vision of Sage was “to create open access, integrative bionetworks, evolved by contributor scientists, to accelerate the elimination of human disease.” An all-star advisory team includes Nobelist Leland Hartwell, Sir David Lane (A*STAR Singapore), Navigenics co-founder Dietrich Stephan, Merck research chief Peter Kim, Yale’s Rick Lifton, and John Wilbanks (Science Commons).

“We need massive amounts of information appropriately integrated to build models that are predictive,” said Schadt. “Scientists across the globe involved in different areas of research need to be actively engaged in accessing these networks and contributing information back.”

The transition from a linear to a network mindset would require the generation of coherent datasets, the development of predictive models to design novel therapeutic approaches, and the leveraging of social networks and other means to foster a contributor network. “Watching the trends of public data access, we anticipate a transition of disease biology into the precompetitive space,” said Schadt. Friend added, “The concept of making disease biology a pre-competitive space is… something that we feel in the long run has an opportunity [to succeed].”

Schadt said Merck’s leadership had recognized an opportunity where donating some of its data into the public domain, forming an open access platform that will emerge from an incubator phase, would provide a potentially significant long-term understanding of disease biology.

As for why scientists should include their own data, Friend said, “picture chemistry, picture physics. The people who were originally trying to mix compounds didn’t get very far until they found molecular structures… This is the analogy for what’s going to happen in biology.” New representations of disease allow for data to be shared and layered.

The hardest part in making Sage successful may not be the technology, Friend concluded. “It’s either going to be … our institutions … that have a certain culture about what we do with data. Or it’s going to be the clinicians,” who aren’t used to presenting clinical data using defined standards.

Decade of Discovery

Over the past decade, Friend said Merck has introduced numerous bold technologies that have been successful to a degree. Widescale RNA expression profiling in tumors (in conjunction with the Netherlands Cancer Institute) led directly to the development of Mammaprint and Oncotype diagnostic tests for breast cancer metastases. But such measurements are confounded by multiple variables, making it impossible to infer causality.

Merck also championed whole-genome RNA interference (RNAi) screening. “Often we use it to choose what drug should be combined with what standard of care, and what patient is likely to respond to what therapy,” said Friend, such as identifying gene networks that influence the activity of cisplatin. But heterogeneity of samples made it almost impossible to put the results into context. “It’s like looking at a single frame in “Slumdog Millionaire” and going, Ah, that’s what that movie was about,” he said.

A third initiative, beginning around 2002, was to merge databases of clinical information and genetic information. Merck forged collaborations with European and Chinese cancer institutes, as well as the Moffitt Cancer Center, which enables Merck researchers to direct patient selection in clinical trials based on molecular signatures in the database. But Friend said that the volume of disease data amounted to “a clinical/genomic Tower of Babel” problem.

More recently, Merck has been riding the success of Schadt’s team in Seattle, which has taken major steps to harness the explosion of data and analyze biological networks to predict the physiological state of the system. “Drug companies were betting the farm on seeing things correlated with disease and beautiful patterns of expression and then developing drugs, without having any real idea of the casual nature of those patterns,” said Schadt. The key was to leverage DNA information and environmental effects. “To be competitive in the future and to impact human health, we must become masters of information,” Schadt said, displaying a picture of Aria, the all-seeing master computer from the film Eagle Eye.

Ed’S NOTE: Eric Schadt will keynote the 2009 Bio-IT World Expo on Tuesday, April 28.

*CHI’s Molecular Medicine Tri-Conference. San Francisco, February 23-26, 2009.

©2012 An Inconvenient Woman. All Rights Reserved.

WASHINGTON–(BUSINESS WIRE)–The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious side effects. NVIC will also be calling on the newly elected President and members of Congress to remove the nation’s vaccine safety monitoring system from the Department of Health and Human Services (DHHS) and place it in a separate entity reporting directly to Congress to restore trust in the nation’s public health laws based on federal mass vaccination policies.

The CDC and FDA are alleging that the vast majority – if not all – of the approximately 9,000 HPV vaccine adverse events, including 27 deaths, reported to the federal Vaccine Adverse Event Reporting System (VAERS) are not causally related to the Gardasil vaccine based on internal analysis, including review of medical records of girls and women vaccinated in HMO’s participating in the federal Vaccine Safety Datalink (VSD) Project and other closed government operated databases.

“Transparency in government is essential to trust in government and replication is the hallmark of good science,” said NVIC co-founder and president Barbara Loe Fisher. “Parents of young girls and women cut down in their prime – some of them paralyzed or dead within hours or days of getting Gardasil vaccine – deserve better answers than a whitewashing of this vaccine’s very serious side effects. Until there is an independent confirmation of these unverified findings by individuals and companies without financial ties to the government or industry, it is not credible.”

* In June 2006 NVIC questioned the quality and quantity of Merck’s pre-licensure Gardasil vaccine safety data in girls under age 16 and, in 2007, issued three reports analyzing serious Gardasil adverse events reported to VAERS;

* In 2007, Merck lobbied in many states for Gardasil vaccine mandates but failed in most;

* During 2008, about 20 percent of all vaccine adverse event reports to VAERS were related to Gardasil even though it is not a mandated vaccine like most others;

* Last week, reports that Merck’s Gardasil sales are falling dramatically and are not offsetting similar declining sales of other drugs associated with safety concerns prompted Merck to lower profit projections and layoff employees.

NVIC (www.nvic.org) was founded in 1982 and worked with Congress on the 1986 National Childhood Vaccine Injury Act. The non-profit watchdog group advocates for safer vaccine policies and the legal right for Americans to make informed, voluntary decisions about vaccination.

©2012 An Inconvenient Woman. All Rights Reserved.

Gardasil® Deaths, Gardasil® Side Effects, Gardasil® Paralysis -

Is the HPV Vaccine Given to Prevent Cervical Cancer Causing More Medical Problems?

A vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems.

Gardasil® has been the subject of 7,802 “adverse event” reports from the time the Food and Drug Administration approved its use two years ago, according to the Centers for Disease Control and Prevention.

Girls and women have blamed the vaccine for causing ailments from nausea to paralysis — even death. Fifteen deaths were reported to the FDA, and 10 were confirmed, but the CDC says none of the 10 were linked to the vaccine. The CDC says it continues to study the reports of illness.

Gardasil prevents the spread of human papillomavirus, known as HPV — a sexually transmitted virus that can cause cervical cancer in a relatively small number of girls and women.

The vaccine’s manufacturer, Merck & Co. Inc., says it has distributed more than 26 million Gardasil® vaccines worldwide, including nearly 16 million in the United States. It estimates that 8 million girls and women have received the vaccine in the United States since June 2006. V

Two girls allege in court that the vaccine made them sick.

One — Jesalee Parsons of Broken Bow, Oklahoma — got the shot at age 13.

Jesalee’s lawyer, Michael McLaren, said she got the shot on February 27, 2007 and soon developed a fever and felt pain. The next day, he said, Jesalee felt pain in her chest and abdomen.

Her mother, Laura Parsons, said Jesalee spent weeks in the hospital and underwent two surgeries after developing pancreatitis. She says the federal government should have studied the drug more before approving its use.

“I just feel let down by the government,” Parsons said.

Merck says it could be a coincidence that the girls got sick after receiving the vaccine.

The company said in a statement that an adverse event report “does not mean that a causal relationship between an event and vaccination has been established — just that the event occurred after vaccination.”

Merck said it would continue to evaluate reports of adverse reactions. It said it “updates product labels with new safety information as appropriate.”

Watch more on complications linked to Gardasil »

For Full Article and more video go to:

http://www.cnn.com/2008/HEALTH/conditions/07/07/cervical.cancer.vaccine/

A sincere thank you to major media outlets, CNN, the Washington Post and the New York Times, for following and reporting the Gardasil® adverse events and asking probing questions about the safety and effectiveness of this aggressively-marketed Merck product.

©2012 An Inconvenient Woman. All Rights Reserved.

Addressing Questions About Gardasil

On this page:

• What is Gardasil?
• Why is Gardasil needed?
• Is Gardasil safe?
• Why have questions been raised about the vaccine’s safety?
• Should these reports worry me?
• What non-serious problems have been reported?
• What are FDA and CDC doing about the concerns?
• How is Gardasil’s safety being monitored?

Recently, questions have been raised about the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts, and some vulvar and vaginal cancers.

What is Gardasil?

Gardasil is a vaccine for use in girls and women 9 through 26 years of age. It is approved for preventing cancer of the cervix, vulva and vagina, and for preventing genital warts caused by the types of HPV contained in the vaccine.

These four HPV types (6, 11, 16, and 18) cause about 70% of cervical cancers and about 90% of genital warts. They are also known to cause some vulvar and vaginal cancers. (Percentages related to these conditions are not well defined.)

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Why is Gardasil needed?

Gardasil may benefit the health of millions of people. Each year, more than 12,000 American women are diagnosed with cervical cancer, and almost 4,000 women die from this disease. In addition, about 6.2 million Americans become infected with genital HPV each year. Worldwide, cervical cancer is the second most common cancer in women, with 233,000 deaths per year.

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Is Gardasil safe?

Based on ongoing assessments of vaccine safety information, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to find that Gardasil is a safe and effective vaccine.

Studies involving approximately 21,000 girls and women in the United States and worldwide were conducted to evaluate the safety and effectiveness of Gardasil before the vaccine was approved by FDA. Approximately half of the study participants received Gardasil, and the other half received a control.

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Why have questions been raised about the vaccine’s safety?

There have been reports of serious adverse events in girls and women that have received the vaccine. These include death and Guillain-Barre Syndrome (GBS), a rare neurological disorder that causes muscle weakness.

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Should these reports worry me?

Based on the review and assessment of vaccine safety information available, FDA and CDC continue to find that the benefits of Gardasil outweigh the risks.

Twenty deaths had been reported to the FDA- and CDC-administered Vaccine Adverse Event Reporting System (VAERS) as of June 30, 2008, in women that received Gardasil.

However, no common pattern to these deaths has been detected that would suggest they were caused by the vaccine. In cases where autopsy, death certificate, and medical records were available, the cause of death was explained by factors other than the vaccine.

Given the large number of vaccine doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in a large population during the time period following vaccinations.

The manufacturer, Merck and Co., has distributed more than 16 million doses of Gardasil nationwide. As of June 30, there were 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events.

Also, FDA routinely reviews manufacturing information, and has not identified any issues affecting the safety, purity, and potency of Gardasil.

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What non-serious problems have been reported?

• Syncope (Fainting)
• Pain at the injection site
• Headache
• Nausea
• Fever

Fainting, which may sometimes cause serious injuries from falling, is common after injections and vaccinations, especially in adolescents. FDA and CDC have reminded health care professionals that women receiving Gardasil should be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall. The vaccine’s prescribing information includes this as well.

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What are FDA and CDC doing about the concerns?

FDA and CDC take all concerns about vaccine safety seriously, and, as they do with all licensed vaccines, will continue to closely monitor Gardasil’s safety.

Because available information indicates that Gardasil continues to be safe and effective, and that its benefits continue to outweigh its risks:

• CDC has not changed its recommendations for use of Gardasil.
• FDA has not made any changes to the Warnings or Precautions sections in the vaccine’s prescribing information related to safety.

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How is Gardasil’s safety being monitored?

• FDA and CDC closely monitor the safety of all vaccines through VAERS, which receives unconfirmed reports of possible side effects following the use of vaccines licensed in the United States.
• Each batch (known as a “lot”) of Gardasil is manufactured and tested for quality control according to the requirements of its FDA license. FDA verifies this, as it does with other vaccines, by performing a lot-by-lot batch review process.
• FDA’s review assures the appropriateness of manufacturing processes and confirmation of testing results. It also includes regular unannounced on-site inspections.
• No batch may be released for distribution until it has successfully completed all testing and review requirements.
• FDA analyzes possible side effects associated with individual lots to look for any unusual patterns.

CDC also has other systems in place to monitor the safety of all licensed vaccines.

This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

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For More Information

CDC and FDA Information on Gardasil’s Safety

www.fda.gov/cber/safety/gardasil071408.htm

Vaccine Adverse Event Reporting System (VAERS) Web site

www.vaers.hhs.gov

FDA Press Release (Sept. 12, 2008):

Approval of Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers

www.fda.gov/bbs/topics/NEWS/2008/NEW01885.html

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Date Posted: September 29, 2008

©2012 An Inconvenient Woman. All Rights Reserved.

“In television advertisements, a cast of hip people in their 20s — artists, writers and professionals — describe why they got the shots, in the language of liberation, such as, “I chose to get vaccinated because my dreams don’t include cervical cancer.” The advertisements direct viewers to gardasil.com, which includes patients’ stories, buddy icons and downloads for holding an event at sororities.

Girls of any age who have had one dose of the vaccine can ask for text-message “reminders” from Merck to get the next two shots. The offers come with another reminder: “I understand that the information I provide will be used by Merck or those working on behalf of Merck for market research purposes.”

For such efforts, Merck last May swept the 2008 Pharmaceutical Advertising and Marketing Excellence awards, and Gardasil was named Brand of the Year by Pharmaceutical Executive magazine.

The marketing helped make Gardasil one of Merck’s best sellers, with a projected sales of $1.4 billion to $1.6 billion outside Europe this year, and more from sales in Europe, where Merck sells the vaccine through a joint venture with Sanofi Aventis.

Aggressive pharmaceutical advertising is nothing new, but the campaign was a revolution for a vaccine. Vaccines were traditionally the orphans of the pharmaceutical world because they were cheap and not particularly profitable. But the two for cervical cancer are the latest in a wave of high-priced vaccines that have come to market since 2001, opening a lucrative new field.”

Excerpted from:: THE EVIDENCE GAP; Drug Makers’ Push Leads to Cancer Vaccines’ Rise

August 20, 2008 – By ELISABETH ROSENTHAL (NYT) – Front Page –

… DRUG MAKERS’ BIG PUSH A marketing campaign in the United States and Europe by Merck has made Gardasil, its cervical cancer vaccine, a best seller. Cervarix, a similar vaccine from GlaxoSmithKline, has also proved popular, and profitable.

Read the full article and send the link out to anyone who cares about the health issues of women and girls!

Inconvenient Women do not get angry…We get ACTIVE!!

The marketeer/lobbyist/legislator ‘hook-up’ only works if no one is looking. Make sure your representatives know you are watching them and are holding them accountable for the health and wellfare of the nations’ women and girls.

©2012 An Inconvenient Woman. All Rights Reserved.

The following article was written by Deborah Kotz, senior writer for U.S. News & World Report, who covers everything women care about when it comes to their health.

About a month after being vaccinated against the cervical cancer-causing HPV virus, 13-year-old Jenny Tetlock missed the lowest hurdle in gym class, the first hint of the degenerative muscle disease that, 15 months later, has left the previously healthy teenager nearly completely paralyzed. Did the vaccine, Gardasil, cause her condition? Her father, Philip Tetlock, a psychology professor at UC-Berkeley’s Haas School of Business, has embarked on an odyssey to find out whether the vaccine or random coincidence is to blame.

As father and scientist, Tetlock has contacted top medical experts, posted pleas on discussion boards looking for other teens who’ve experienced neurological problems post-vaccination and has been desperately trying to get the government to open an investigation into his daughter’s case. “The weakening process is gradual so it may take months for parents to notice what is going on,” he writes me in an E-mail. He started a blog a few weeks ago that shows photos of his sweet-faced teen and reveals his anger and frustration in the form of a box counting the days that he has yet to get a response from the government’s Clinical Immunization Safety Assessment Network. As of today, it’s 28.

He’s not the only one to raise an alarm. The conservative public watchdog group Judicial Watch has been periodically obtaining adverse event reports on Gardasil from the Food and Drug Administration. I received the group’s latest warning this week: of 10 deaths linked to Gardasil since September 2007 and 140 reports so far this year of serious effects such as miscarriage and Guillain-Barré syndrome, a nervous system disease that causes weakness and tingling in the arms and legs. (But these reports filed by patients or doctors with the government’s vaccine adverse event reporting system may or may not reflect true vaccine risks. Some problems may be missed or underreported, while others, including sudden deaths, may have nothing to do with the vaccine itself.)

Judicial Watch opposes efforts in many states to make the vaccine mandatory for all girls ages 11 and 12. Those efforts have raised concerns among religious groups that protecting against the sexually transmitted virus will encourage promiscuity among teen girls. The FDA insists there’s no medical reason to be worried. “We’re monitoring the safety of the HPV vaccine very carefully, and the only adverse event that causes some concern is syncope or fainting after the vaccine,” says Robert Ball, director of the FDA’s office of biostatistics and division of epidemiology at the center for biologics evaluation and research. Higher rates of Guillain-Barré have been associated with the swine flu vaccine and possibly with the meningitis vaccine Menactra, but it is no more common in those who get Gardasil than in those who don’t, says Ball. The same goes for other side effects like spontaneous miscarriage.

What’s more, the FDA has not documented any other cases of vaccine-related peripheral motor neuropathy—what Jenny has—either in the adverse event reports filed by doctors and patients or in the manufacturer’s clinical trial data. Merck, the vaccine’s manufacturer, has dismissed the possibility that Jenny’s condition was caused by Gardasil. “We’re aware of this case and based on the facts that we’ve received, the information doesn’t suggest that this event was causally associated with vaccination,” says Merck spokesperson Kelley Dougherty.

Tetlock, though, wonders if Jenny carries genes that predisposed her to problems with the Gardasil vaccine. At age 10, Jenny developed a rare skin disease called pityriasis lichenoides that’s thought to be triggered by an overactive immune system, and her grandmother died of a nervous system disease. Could it be that certain genetic tendencies make some people more likely to develop severe reactions from vaccines? I ask Ball. “That’s an important question,” he responds. “We just don’t know.” It’s certainly going to be a topic of future research, he adds. The Centers for Disease Control and Prevention is starting to look at whether those who developed Guillain-Barré after being vaccinated share a common set of genes. So Tetlock could find out someday if his hunches are correct.

At this moment, he and his wife, Barbara Mellers, also a professor at Berkeley, are focused on being with their daughter as she struggles to breathe on her own. “Jenny endures terrible suffering each day,” Tetlock tells me via E-mail. “She must watch her capacity to control her own body gradually ebb away—and each day her hopes of ever having a normal human life recede ever further into memory. The disease is cruel beyond belief.”

As a parent, I’ve wrestled with whether or when to get my 12-year-old daughter vaccinated against HPV. As much as vaccines are vital in protecting against life-threatening infectious diseases, they do, indeed, have the potential to cause harm—however rare that may be. Evidence is mounting that the mercury-based vaccine preservative thimerosal could trigger autism in certain susceptible kids, as my colleague Bernadine Healy previously reported. We don’t know yet whether Jenny’s illness is linked to Gardasil, though it’s certainly plausible given the timing of symptoms several weeks after vaccination, which is when vaccine-related neurological problems typically occur. I’m not sure whether Jenny’s case has changed my opinion about the value of Gardasil. But it certainly has given me pause.

You can contact Deborah Kotz at onwomen@usnews.com. She’s often tapping out “Oprah-esque” confessions about how the latest news relates to her personally—whether it’s on breast cancer, contraception or easing work-family stress. She’d love to hear your confessions too

©2012 An Inconvenient Woman. All Rights Reserved.