Spam

Nyheter og klipp fra utlandet

Warning, Gardasil may cause increased risk of cervical cancer
http://www.examiner.com/vaccines-in-national/warning-gardasil-may-cause-increased-risk-of-cervical-cancer
According to Information the manufacturer of this vaccine presented to the FDA prior to approval, if a person has already been exposed to HPV 16 or 18 prior to injection Gardasil increases the risk of precancerous lesions, or worse, by 44.6%. (See VRBPAC Background document, bottom of page 13) This documentation was presented on the 18th of May 2006.
Webmasters kommentar: Merck sier selv at man må ha vært smittet med HPV 16 eller 18 OG ha gjennomgått en infeksjon. Infeksjoner kan være helt symptomfri.

Gardasil Tied to 16 Additional Deaths
http://www.newsinferno.com/pharmaceuticals/gardasil-tied-to-16-additional-deaths/

We have long been writing about the many issues—medical and political—linked to Gardasil. Now, Judicial Watch announced that it just discovered that US Food and Drug Administration (FDA) records detail 16 new deaths tied to the controversial medication.

Approved in 2006, Gardasil prevents four strains of HPV. As of June 2009, 15 million girls had received Gardasil vaccines and some also reported suffering from adverse reactions that have included dizziness, numbness, and blood clots, among other dangerous, and sometimes even deadly, reactions. Gardasil prevents four strains of HPV, two of which cause 70 percent of all cervical cancers. The other two HPV strains are responsible for about 90 percent of genital warts.

According to existing records, 3,589 adverse reactions have been tied to Gardasil between May 2009 and September 2010, including 213 cases resulting in permanent disability, said Judicial Watch, a public interest group that investigates and prosecutes government corruption.

Judicial Watch just announced that it received the new documents from FDA under the provisions of the Freedom of Information Act (FOIA). The documents detail reports of adverse reactions to Gardasil, including 16 new deaths, which includes four suicides, between May 2009 and September 2010. The FDA also produced 789 “serious” reports, with 213 cases resulting in permanent disability and 25 resulting in a diagnosis of Guillian Barre Syndrome.

Judicial Watch provided the excerpts of the following adverse reports:

• A 19-year-old girl with no medical history except occasional bronchitis received Gardasil and in 53 days, had “Headache, Nausea, dizziness, chilling, tiredness, shortness of breath, complained of chest plain, severe cramps.” She experienced an Acute Cardiac Arrhythmia. Attempts to resuscitate her resulted in a sternal fracture, but were unsuccessful and the patient died. — V. 356938


• A 13-year-old girl was vaccinated on July 17th, 2009. Ten days later, she developed a fever and was treated; however, “the patient did not recover and was admitted to the hospital on [August 8th] … She developed dyspnoea and went into a coma…she expired [that day] at around 9:00 pm. The cause of death was determined as ‘death due to viral fever.’ … This event occurred after 23 days of receiving first dose of Gardasil. — V. 380081


• Thirteen days after vaccination, a 10-year-old girl developed “progressive loss of strength in lower and upper extremities almost totally…. Nerve conduction studies [showed Guillain Barre Syndrome].” Case was “considered to be immediately life-threatening.” — V. 339375


• One mother of a 13-year old girl who died 37 days after receiving the vaccination noted in a report: “I first declined getting her the vaccination but her doctor ensured me that it was safe…” After her daughter complained of a severe headache, no feeling in her foot, and a tingling feeling in her leg, a doctor’s appointment was set for October 23, 2009. “My daughter never made it to Oct[ober] 23rd, which is also her birthday,” the mother noted. “She passed on Oct[ober] 17th, I found her cold, unresponsive in her room at 7am….”

“To say Gardasil has a suspect safety record is a big understatement. These reports are troubling and show that the FDA and other public health authorities may be asleep at the switch,” said Judicial Watch President Tom Fitton. “In the meantime, the public relations push for Gardasil by Merck and politicians on Capitol Hill continues. No one should require this vaccine for young children.”


In 2008, Judicial Watch launched a comprehensive investigation of Gardasil’s safety record. All previous FDA documents uncovered by Judicial Watch, as well as a Judicial Watch special report, entitled “Examining the FDA’s HPV Vaccine Records: Detailing the Approval Process, Side-Effects, Safety Concerns & Marketing Practices of a Large Scale Health Experiment,” are available at www.JudicialWatch.org.
NewsInferno.com disclaimer: This article: Gardasil Tied to 16 Additional Deaths was posted on Wednesday, September 29th, 2010 at 8:16 am at NewsInferno.com and is filed under Pharmaceuticals.

HPV4 not associated with autoimmune conditions
Webmaster gjør oppmerksom på at dette studiet er finansiert av Merck.
Deltakerne i studiet er kvinner som har hatt råd til å betale for helseforsikring. Personer som har mottatt vaksine, men ikke har hatt råd til å betale for helseforsikring er utelatt fra studiet. Årsaken er antakelig at den sistnevnte gruppen ikke har en enkelt tilgjengelig sykehistorie.


http://www.abstractsonline.com/plan/ViewAbstract.aspx?mID=2583&sKey=900fe526-6d88-4b11-864f-0b5ca269731f&cKey=9a094646-2031-4c7d-8839-46d9016a67a5&mKey={93AEED6A-54D4-4EF6-99BD-A9B3CE9FACD9}

http://www.infectiousdiseasenews.com/article/68429.aspx#submitComment

BOSTON — The quadrivalent human papillomavirus vaccine did not raise the risk for developing autoimmune conditions, according to data presented here at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy.

In a study sponsored by Merck and conducted on behalf of the Gardasil Safety Team, researchers investigated the safety of the quadrivalent HPV vaccine (HPV4; Gardasil, Merck). The researchers honed in on identifying 16 prespecified rheumatologic, endocrine and neurologic or ophthalmologic autoimmune conditions.

During the post-licensure, observational study, the researchers monitored girls and women in managed care organizations who received at least one dose of HPV4 between August 2006 and March 2008. Follow-up lasted for 6 months after administration of each dose.

The researchers found 11 conditions among a random sample of girls and women who had at least a 12-month health care plan before HPV4 vaccination. Clinicians reviewed medical records to verify diagnosis and determine time of disease onset. Incidence rates for each condition were also established for vaccinated and unvaccinated participants during case identification and review.

The researchers included the medical records of 189,629 girls and women in their surveillance of autoimmune conditions. Of these, 1,014 were deemed potential new cases of condition onset, and 719 had records available for review.

Results indicated that the proportion of new onset autoimmune cases was 31% for rheumatologic conditions, 40% for endocrine conditions and 32% for ophthalmologic or neurologic conditions. The researchers noted no trends in condition onset and vaccination timing, dose sequencing or age. – by Melissa Foster

Leslie Carol Botha exposes HPV vaccines’ fraudulent claims

Gardasil, Silgard and Cervarix may turn out to be the biggest medical hoax of the century should the information revealed on a recent KRFC radio broadcast be proven true. If indeed, the information presented during last Monday evening’s broadcast is accurate, HPV vaccines are nothing more than a worldwide exercise in profiteering.

Leslie Carol Botha regularly hosts a radio show based out of Fort Collins, Colorado called, “Holy Hormones, Honey — the Greatest Story Never Told.” She has been a health educator and broadcast journalist for 30 years.

On August 2, her guests were prominent cancer pathologist, Dr. Sin Hang Lee, and Norma Erickson, Vaccines Examiner for Examiner.com.

Ms. Botha has spent a great deal of time over the last few years investigating HPV vaccines and their effect on young women and children around the world. Even so, the information presented during this show shocked her beyond belief.

Leslie started her broadcast with a brief recap of facts that have already come to light during the ongoing HPV vaccine controversy. They are as follows:

Cervical cancer is not a major health issue for women under good gynecological care.
HPV vaccines may protect against four strains of high-risk HPV but the duration of effectiveness is not clear; best estimates to date are from 4 to 6 years
HPV vaccination does not eliminate the need for traditional cervical cancer screening
Prior exposure to vaccine-relevant strains of HPV can increase the risk of cancer by 44.6% if injected with Gardasil and 32.5% if injected with Cervarix
HPV is not transmitted solely via sexual contact, there are multiple other ways to have been exposed
There are already 278 reports to VAERS of abnormal pap smears post-vaccination
Following the recap, Norma Erickson explained the circumstances surrounding her original contact with Dr. Lee, including a couple of statements from his original 2007 petition to the FDA for reclassification of his HPV test kit that brought the value of HPV vaccinations into question. These statements were:

HPV does not cause cervical cancer, it is the persistant infection, not the virus, that determines the risk
93% of women initially infected with a particular strain of HPV will not show the same strain four menstrual cycles later
Norma also stated that during one of her initial conversations with Dr. Lee, that he had disclosed the fact that the original studies to determine HPV type prevalence had been done with self-collected specimens by women in Costa Rica, a country with one of the highest cervical cancer rates in the world. These were the statistics used to market HPV vaccines to an American population where women have a 14 times greater chance of dying of digestive cancer than they do of cervical cancer.

Dr. Sin Hang Lee on women’s healthcare (PR photo)Enter, Dr. Sin Hang Lee, prominent cancer pathologist and HPV testing expert. Dr. Lee and his associates actually developed one of the most sensitive HPV test kit available. This test kit, which could be used in nearly any medical facility around the world can not only identify if HPV is present, it will accurately determine which of the 100+ strains of HPV are exhibited.

Because of a 20 year old error in FDA classification, this test cannot be currently marketed as the virology test it is. In order to market this test kit, the inventors must perform clinical trials, at a cost of hundreds of thousands of dollars, to prove it can accurately detect cancer — something it was not developed for, nor is it intended to do.

Following is a brief summary of the critical information Dr. Lee wants women the world over to know and understand:

Most cervical cancer deaths in the United States, and developed countries, are people who are not under regular OB/GYN care.
The National Cancer Institute has no data on which HPV genotypes are prevalent in the United States.
A CDC study showed that HPV types 16 and 18, the two HPV vaccine-relevant strains, are NOT the prevalent types in American women.
Three published papers on HPV prevalence in the U.S., indicated that types 62, 84 and 52 are the most prevalent. These are all classified as high-risk strains, none of which are targeted in either approved HPV vaccine.
If a person has prior exposure to vaccine-relevant HPV prior to injection, the vaccine provides no benefit, but does provide potential risks.
If a woman is infected with HPV-16 in January, HPV-18 in July, and HPV-31 in December, her cancer risk is zero. Even though these are all high risk types, they are considered transient. It takes repeated infection by the same type to perhaps pose a risk of cervical cancer.
Even when a woman has persistant infection by the same type, if her lifestyle is healthy (she does not smoke, does not take oral contraceptives, does not have multiple sexual partners, does not have a compromised immune system) her risk of cervical cancer is still minimal.
HPV is not necessarily a sexually transmittable virus–you can get it other ways.
American women currently spend $10 billion on unnecessary colposcopies (cervical biopsies) every year, primarily because the currently used HPV tests frequently display false positive results.
A study conducted by Harvard Medical School estimated that 95% of cervical biopsies in the United States are not necessary.
If a young woman is considering taking an HPV vaccine, it is critical that she know if she has been exposed to HPV, and if so, what genotype.
Nothing has been proven to be more effective at controlling cervical cancer than pap smear technology.
So why do HPV vaccine manufacturers, the CDC, and the National Cancer Institute tell physicians not to screen for HPV exposure prior to vaccination? Unfortunately for young women and children around the world, the answer appears to be abundantly clear.

*****************************************************

Nytt fra FDA: Nå ønsker de også å vaksinere gutter.
For Immediate Release: Oct. 16, 2009
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys
The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.

Each year, about 2 out of every 1,000 men in the United States are newly diagnosed with genital warts.

Gardasil currently is approved for use in girls and women ages 9 through 26 for the prevention of cervical, vulvar and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types 6 and 11.

HPV is the most common sexually transmitted infection in the United States and most genital warts are caused by HPV infection.

“This vaccine is the first preventive therapy against genital warts in boys and men ages 9 through 26, and, as a result, fewer men will need to undergo treatment for genital warts,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Gardasil’s effectiveness was studied in a randomized trial of 4,055 males ages 16 through 26 years old. The results showed that in men who were not infected by HPV types 6 and 11 at the start of the study, Gardasil was nearly 90 percent effective in preventing genital warts caused by infection with HPV types 6 and 11.

Studies were conducted to measure the immune response to the vaccine in boys ages 9 through 15. The results showed that the immune response was as good as that found in the 16 through 26 years age group, indicating that the vaccine should have similar effectiveness.

The manufacturer will conduct postmarketing studies to obtain additional information on the safety and effectiveness of Gardasil in boys and men.

Gardasil is given as three injections over a 6-month period. Headache, fever and pain at the injection site, itching, redness, swelling and bruising, were the most common side effects observed.

Gardasil is manufactured by Merck and Company Inc. of Whitehouse Station, N.J.

LINK TIL FIN PRESENTASJON OM HPV, VAKSINEN OG STATISTIKKER.

Presentasjonen er på engelsk, og er i tillegg noe rask. Anbefales likevel!   (Krever Adobe.)

http://www.thinktwice.com/HPV9.swf

INNRAPPORTERING AV DØDSFALL I USA

As of June 1, 2009, there have been 43 U.S. reports of death among females who have received the vaccine. Twenty six of these reports have been confirmed, 9 are still under investigation, and 8 remain unconfirmed due to no identifiable patient information in the report such as a name and contact information to confirm the report. Confirmed reports are those that scientists have followed up on and have verified the claim. In the 26 reports confirmed, there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine.

More information is available at:

http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-oct08/12-3-hpv.pdf

GARDASIL CANCER VACCINE PROBED FOR LINK TO 18 DEATHS

Posted: 3:44 am
July 6, 2008

http://www.nypost.com/seven/07062008/news/nationalnews/feds_warning_shot_118716.htm

GARDASIL – a new cervical-cancer vaccine heavily marketed to young girls in ubiquitous ads on TV and in movie theaters – is under investigation for possible links to paralysis, seizures, and 18 deaths.

Federal health officials have logged 8,000 “adverse events” in girls and women injected with the Merck & Co. vaccine introduced two years ago, more than 500 of them from New York.

And lawyers last month filed the first two claims on behalf of girls with ailments blamed on Gardasil under a federal program to compensate victims of vaccine-caused illness, The Post has learned.

Both girls got the injections at their middle schools.

One is Jesalee Parsons, now 15, of Oklahoma, who began vomiting the day she got a Gardasil shot and developed pancreatitis, her claim says.

“It makes me mad because they’re saying how great it is, but they never mention how many people have been hurt by it,” Jesalee told The Post.

Healthy all her life, her family says, Jesalee has been hospitalized on and off for more than a year. She restricts her diet, takes pain pills and misses many school days.

“I’m pretty sick all the time,” she said.

The other claim was filed for Jessica Vega of Nevada, who came down with Guillain-Barré Syndrome, an immune-system disorder, at age 14 – a week after her second Gardasil shot.

Thirty others have reported the syndrome after getting the vaccine.

JESSICA’S mom, Rhonda Vega, says the girl’s lower legs and arms were paralyzed, but she’s learned to walk again. “Protecting girls against cervical cancer is a fabulous thing, but if this is what’s going to happen, they need to research it more,” she said.

In Florida, the mother of 13-year-old Brittany LeClaire said her daughter suffered headaches and lethargy after a Gardasil shot last Aug. 13. On Sept. 2, Brittany’s left leg became paralyzed. After months on a walker, she limps.

Her pediatrician “highly recommended” the vaccination, mom Christina Bell said. “He told me it was a cancer preventative. I thought it was the right thing to do. You see it advertised on TV every 15 minutes.”

Brittany’s case is one of six being prepared for filing by Boston vaccine lawyer Kevin Conway. He said other cases include “paralysis, seizures and brain damage.”

Gardasil was licensed by the Food and Drug Administration in June 2006 for females ages 9 to 26. Sold worldwide, it’s been given to more than 8 million US girls and women, Merck says.

The vaccine is aimed at warding off strains of the human papillomavirus, or HPV, which can lead to cancer. The vaccinations cost a total $360.

Securities and Exchange Commission documents show Merck made $1.5 billion in Gardasil sales last year.

ONE doctor who helped conduct clinical trials on Gardasil told The Post the vaccine has been aggressively marketed to girls too young to need it.

“There’s a huge push for giving this to girls 11 and 12 years of age,” said Dr. Diane Harper of Dartmouth Medical School. “There’s no hurry. You can give it to someone who is 20, 25 or 30 and still have the same level of protection.”

The Vaccine Adverse Event Reporting System, run by the FDA and the Centers for Disease Control and Prevention, has collected thousands of reports of health problems after Gardasil shots.

The fatalities include:

* A 17-year-old New York girl who collapsed and died on Feb. 22 this year, two days after the last of three Gardasil injections. An autopsy could not pinpoint the cause, but doctors suspect a heart-rhythm disorder.

* An 11-year-old who suffered a heart attack in May 2007, three days after a Gardasil shot. The nurse who reported it said a doctor blamed it on “an anaphylactic [severe allergic] reaction to Gardasil.” The feds could not confirm the case.

* A 12-year-old girl with no prior medical problems who died in her sleep on Oct. 6, 2007, three weeks after a Gardasil shot.

DR. John Iskander, the CDC’s acting director for immunization safety, said a review of 10 confirmed deaths found no common thread. Officials “concluded to the degree of certainty possible” that Gardasil wasn’t to blame.

“It’s tragic that young, apparently healthy people, do die,” Iskander said.

But he added that doctors hold special meetings weekly to review new cases, and compare them to prior ones.

Fainting is the main symptom linked to Gardasil, he said.

Merck spokeswoman Kelley Dougherty said the company “actively monitors” reports of side effects.

“An event report does not mean that a causal relationship between an event and vaccination has been established – just that the event occurred after vaccination,” she said.

A Post analysis of adverse- event reports filed through April 30 found that about 20 percent followed injections of Gardasil, plus up to seven other vaccines at the same time – including shots to prevent flu, chicken pox, hepatitis and tetanus. Almost 6,300 cases involved Gardasil alone.

Under a federal law passed in the late 1980s, victims of vaccines may file a claim under the Vaccine Injury Compensation Program, but cannot sue the pharmaceutical.

Last year, the government added HPV to a list of vaccines, including polio, hepatitis and measles, granted immunity from suit.

If victims prove a vaccine likely caused injuries, the program pays a maximum $250,000 for death. The average payment for injury has been $1 million.

susan.edelman@nypost.com

For de som er ekstra stø i engelsk, kan det anbefales å ta en titt på denne rapporten:

http://www.whale.to/vaccine/JWReportFDAhpvVaccineRecords.pdf