The National Vaccine Information Center warned state officials to investigate the safety of a cancer vaccine as Texas became the first state to make the HPV vaccine mandatory for school-age girls (this webpage begins with 2008 articles at top;scroll down) Death Toll & Adverse Reactions (such as Nerve Disorder Guillain-Barre syndrome) Linked to Gardasil Vaccine Rise, HPV Vaccine Researcher Urges Caution...  updated 21 November 2009 (October 09 article added, 1/10)...

 [To view all previous updates on the HPV Vaccine situation found on this website,

please click here .]

9 January 2008

HPV VACCINE RESEARCHER CRITICIZES DRUG MARKETING AS "PUBLIC HEALTH EXPERIMENT". Diane M. Harper, the researcher who has spent 20 years studying human papillomavirus (HPV) and did the bulk of the work that was used to develop a vaccine for several strains of the virus, has warned that mandating the vaccine for girls under the age of 18 may actually backfire, causing cervical cancer rates to go up.

Twenty-six states are considering some form of mandatory HPV vaccination for school-age girls. Harper [director, Dartmouth Medical School's Gynecologic Cancer Prevention Research Group, Norris Cotton Cancer Center, New Hampshire] warned that there have been no tests of the vaccine's effectiveness on girls under the age of 15.

The drug may not be effective on younger girls, and it may have unforeseen side effects or interactions with other vaccines given at that age. Nonetheless, the CDC Advisory Committee on Immunization Practices has recommended it for ages 9-26. "Giving it to 11-year-olds is a great big public health experiment," Harper said.

"To mandate now is simply to Merck's benefit, and only to Merck's benefit." But with the way the drug is being marketed, Harper is concerned that vaccinated women may decide that they are immune, and forego their yearly Pap smear testing.

Harper also warned that the vaccine is ineffective if given to someone who is already infected -- and because HPV is spread by skin-to-skin contact, a person does not have to be sexually active to contract it. For this reason, Harper suggests giving the vaccine only to those who test negative for the targeted HPV strains.

The HPV test is conducted by vaginal swab, which Harper says is inappropriate for children.

Finally, Harper warned that not enough research has been done to know how long the vaccine lasts, or at what age a booster may be needed. This means that even if the vaccine is effective in young girls, it may have worn off by the age at which they are most susceptible to cervical cancer. BTW, the vaccine also does NOT protect women from the other HPV strains associated with cervical cancer, nor does it protect against any other types of STDs. It also does not affect ovulation; thus, pregnancy is always possible... [9January08, David Gutierrez, newstarget.com]


16 January 2008

VA HOUSE STALLS USE OF HPV VACCINE FOR SCHOOLGIRLS. A year after becoming the only state to mandate that schoolgirls receive a vaccine for the sexually transmitted virus that can cause cervical cancer, Virginia lawmakers 15Jan08 took a step to delay the requirement for one year, until 2010.

Lawmakers who support the delay said it would allow more time to study the vaccine's effects on young girls and for competing vaccinations (Cervarix) to reach the market.

More than a dozen states opted instead for laws that either provided more funding for the vaccination or required schools to distribute educational materials about it.

"It is one thing to endorse the use of a vaccine against cervical cancer, but altogether another to require children to get it," said Robert A. Smith, director of cancer screening for the American Cancer Society.

The legislation faces opposition in the Senate, where Democrats have a new one-seat majority. [16Jan08, Richmond, AP, D. Potter, http://washingtontimes.com/article/20080116/METRO/308830924/1004]

28 January 2008

TWO EUROPEAN DEATHS MAY BE ASSOCIATED WITH HPV VACCINE. Two women have died shortly after receiving the new vaccine for human papilloma virus (HPV) that is being used in massive vaccination programmes in Europe. The European Medicines Agency (EMEA) did not disclose the women's names, but has reported that the deaths occurred in Austria and Germany.

The agency, which acts as the European Union drug overseer, maintains that "benefits of Gardasil continue to outweigh its risks and that no changes to its product information are necessary." An estimated 1.5 million women have already been vaccinated with the drug in Europe, the agency said.

"No causal relationship has been established between the deaths of the young women and the administration of Gardasil," the EMEA statement said.

The drug that will be distributed in mandatory public health programmes in Britain has been implicated in the deaths of three women in the US. Marketed by the pharmaceutical giant Merck Frosst, Gardasil is a vaccine against some strains of HPV, the sexually transmitted infection that is known to cause most cases of cervical cancer.

Gardasil's approval by the US Food and Drug Administration was based on the testing of only a few thousand patients, only a small portion of whom (1200) were young girls, aged 9-13 years. This age, group, however, is now being specifically targeted for mandatory vaccination programmes, including one by the province of Ontario.

The group Judicial Watch reported last year on the deaths of three US women related to the vaccine. One physician's assistant reported that a female patient "died of a blood clot three hours after getting the Gardasil vaccine." Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting.

In the US, the company dropped its lobbying efforts to have the drug used in nation-wide immunization programmes after opposition grew from medical groups.

Side effects published by Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after receiving the vaccine. Other more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures.

The US National Vaccine Information Center (NVIC) warned last year that "Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials."

NVIC president Barbara Loe Fisher said in February 2007, "Merck's pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls."

Related coverage:

Judicial Watch Uncovers Three Deaths Relating to HPV Vaccine
http://www.lifesite.net/ldn/2007/may/07052501.html

Merck Drug Company Drops Campaign for Mandatory HPV Vaccine
http://www.lifesite.net/ldn/2007/feb/07022109.html

Support for HPV Vaccine Gardasil Helps Planned Parenthood Says LDI President
http://www.lifesite.net/ldn/2007/oct/07101807.html
[28Jan08, Hilary White, LifeSiteNews.com]

February 2008

VIRGINIA IGNORES HPV VACCINE CONCERNS. Despite new fears over the safety of the HPV vaccine, a Virginia senate committee voted 10-5 yesterday to kill a bill that would have postponed the state's vaccination mandate.

The vote came just hours after Arizona news agencies broke the story that the HPV vaccine Gardasil may be linked to the paralysis of a 12-year-old girl.

Virginia now has the dubious distinction of being the only state in America to require sixth-grade girls to be immunized against the sexually transmitted human papillomavirus (HPV).

Sixteen other states backed away from mandating after a grassroots outcry from concerned parents whose role in the process was to be short-circuited. The legislation from Virginia Delegate Bob Marshall (R) simply asked the state to delay its mandate until researchers are able to collect data on the drug's long-term effects. Unfortunately, Virginia has stubbornly chosen to put corporate profit ahead of women's health and parental authority.

FRC, which welcomed the development of the vaccine but opposes school mandates, has released a pamphlet by Moira Gaul, MPH, called, "Gardasil: What Every Parent Should Know about the HPV Vaccine." Gardasil: What Every Parent Should Know About the HPV Vaccine
http://www.frc.org/get.cfm?i=BC07E02&f=WA08B34

JUNE - AUGUST 2008

Pros and Cons of HVP Vaccine Gardasil

Judicial Watch Uncovers New FDA Records Detailing Ten New Deaths & 140 “Serious” Adverse Events Related to Gardasil Since September 2007 (8,864 total Adverse Events)

HPV Vaccine Blamed for Teen's Paralysis; CDC Denies Connection

HPV Vaccine May Be Linked to Pancreatitis

NEJM: Health and Economic Implications of HPV Vaccination / HPV Vaccine: More Experts Urge Caution

PROS & CONS OF THE HVP VACCINE - GARDASIL
by Marci Black

The American Cancer Society (2008) estimates that “in 2008, 11,070 women in the United States will be diagnosed with cervical cancer, and 3,870 women will die from this disease.”  One of the leading causes of cervical cancer is the human pappillomavirus infection (HPV). 
 
According to Medical News Today (2007), The New England Journal of Medicine reports that “approximately one million cases of genital warts occur each year in the United States.”  
Genital warts are a highly contagious sexually transmitted disease caused by HPV types 6, 11, 30, 42, 43, 44, 45, 51, 52 and 54. “HPV types 6 and 11 cause 90% of genital warts.” (Medical News Today, 2007).  Also known as papillillomas, genital warts are benign (non-cancerous) tumors.
 
Human paillomavirus (HPV) infects the skin and mucous membranes of humans.  There are currently over 130 HPV types or strains, 30-40 which are transmitted through sexual contact.  According to Medical News Today (2007), “In the United States, approximately 20 million people are infected with HPV, and approximately 80% of females will have acquired HPV by age 50.”  Not all women with HPV get cervical cancer or genital warts. 
 
There is no cure for HPV but the abnormal cell growth caused by HPV can be treated.   There are also now vaccines that can prevent certain types of HPV.

Gardasil is a newly FDA approved vaccine to prevent infection from some types of HPV.   The American Cancer Society (2008) “recommends that the vaccine be given to females aged 11 to 12 (and as early as age 9 years if the doctor recommends it)” prior to becoming sexually active.   The ACS (2008) also states that after a girl becomes sexually active, or reaches the age of 21, whichever occurs first, annual Pap tests are required, in addition to the HPV vaccination, because Gardasil does not protect against all cancer-causing types of HPV.  
 
Gardasil was introduced in the United States in June 2006 to prevent infection with HPV types 16, 18, 6 and 11.  “HPV types 16 and 18 cause approximately 70% of cervical cancers.  HPV types 6 and 11 cause 90% of genital warts.”  (Medical News Today, 2007).  The Gardasil vaccination is given in 3 intramuscular injections, over 6 months, to girls ages 9 to 26.  The vaccination is recommended at an early age, prior to sexual contact and possible exposure to HPV.   
 
Certainly with a new vaccination on the American market brings with it much controversy.  Judicial Watch is a public interest group in Washington that has obtained data about Gardasil from the Federal Drug Administration through a Freedom of Information Act request. Concerns, based upon information obtained through the FDA, include that “there has not been a chance to study long term side effects from the vaccine,” approving the vaccination for “girls as young as nine years old, despite the fact that the youngest girls participating in the clinical trials were 11 - 12 years old,” and that state and local governments are proposing “requiring the vaccine for school girls entering the 6th grade.”  (Judicial Watch, 2008). 
 
There have been many adverse reactions reported in the short two years that Gardasil has been on the U.S. market. 

“On June 10, 2008, Judicial Watch received a compact disk from the FDA with a new total of 8,864 Vaccine Adverse Event Reporting System (VAERS) records.” (Judicial Watch, 2008).   According to this disk, 140 cases of 'serious' and 'life-threatening' adverse events have been  reported to the FDA since January 2008."  

The number of deaths reported in relation to the HPV vaccination is at least 18.  

The FDA records detail the death of a 20 year old female, with no medical history reported, who died four days after receiving a vaccination dose of Gardasil.  An autopsy was performed and the cause of death is unknown. 

Judicial Watch also reveals information in the FDA reports to include a 23 year old female who experienced anaphylactic shock, brief loss of consciousness and respiratory distress, two minutes after receiving her first dose of Gardasil. 

Several other reports within the FDA data include foaming at the mouth, seizures and paralysis immediately following injections of Gardasil. 

Similar to Vioxx, also manufactured by Merck Co., there is great concern of “serious adverse effects of the product may not become apparent until years after the product has been approved and widely used.”  (Association of American Physicians and Surgeons, Inc, 2007).
 
According to the Wall Street Journal (2008), Judicial Watch has obtained data from the Food and Drug Administration claiming that “Eighteen women who had received the vaccine while pregnant experienced complications ranging from miscarriages to fetal abnormalities.   Sixteen of those complications resulted in miscarriages.” 

The Wall Street Journal (2008), goes on to state that the drug manufacturer, Merck Co., reported five cases of birth defects among women who had received the vaccination 30 days prior to conception.   Merck “says it determined that they didn’t find any pattern and were unlikely to be connected to the vaccine.”  (The Wall Street Journal, 2008). 
Subsequently, Merck also indicates that Gardasil’s label clearly states that the vaccination is “not recommended for use in pregnant women” due to the fact that it had not been studied extensively enough in a large population of pregnant women.    (The Wall Street Journal, 2008).
 
One of the biggest controversial issues sparked by the vaccine Gardasil is the proposal by the drug manufacturer, Merck, for law makers to mandate schools to require all girls entering the 6th grade to receive the HPV vaccination.  Several states are considering mandating the vaccine.  Virginia has already passed a bill into law which goes into effect October 1, 2008, requiring 6th grade girls to receive the vaccination.   This debate obviously brings up many religious and civil rights issues.  
 
Being the mother of a 16 year old daughter, I have a vested interest in obtaining information concerning the pros and cons of the HPV vaccination.  While there appears to be some congenital defects with the vaccination being given at or near conception, I feel a pregnancy test should be mandated prior to administering any dose of Gardasil (similar to the Depo Provero injection).  I am reluctant to have my daughter receive the vaccine due to it being so new on the market and the many adverse reactions reported in just two years.  Also, since not all females with HVP get cervical cancer or genital warts, and inasmuch as Gardasil does not protect against all cancer-causing types of HPV, thus requiring annual Pap tests anyway, I feel it safe to wait to determine the long-term effects of Gardasil before administering the vaccine to my daughter.
 
References

American Cancer Society, Inc.  (2008).  What is cancer of the Cervix? 
     Received 8-03-2008 from
     http://www.cancer.org/docroot/CRI/CRI_2_1x.asp?dt=8

Carreyrou, John (2007).  FDA Data on Gardasil May Fuel Controversy.  The Wall
     Street Journal.    Received 8-03-2008 from    
     http://online.wsj.com/public/articles/SB117997026351112898

Judicial Watch (2007).  Judicial Watch Investigates Side-Effects of HPV Vaccine. 
     Received 8-03-2008 from http://www.judicialwatch.org/gardasil

Medical News Today (2007).  New England Journal of Medicine Publishes New Data
     on GARDASIL, Merck’s Cervical Cancer Vaccine.  Received 8-03-2008 from
     http://www.medicalnewstoday.com/articles/70808.php

Orient, Jane M. M.D., F.A.C.P., (February 2007).  “Hands Off Our Kids” Coalition
     News Conference.  Association of American Physicians and Surgeons, Inc.
     Received 8-4-2008 from  
     http://www.aapsonline.org/vaccines/jmostatement.php 
[Marci Black, Columbus State Community College, 2008]
 

DEATH TOLL LINKED TO GARDASIL VACCINE RISES: Complications include shock, 'foaming at mouth,' convulsions, coma. "Anaphylactic shock," "foaming at mouth," "grand mal convulsion," "coma" and "now paralyzed" are a few of the startling descriptions included in a new federal report describing the complications from Merck & Co.'s Gardasil medication for sexually transmitted human papillomavirus – which has been proposed as mandatory for all schoolgirls.

The document was obtained from the U.S. Food and Drug Administration by Judicial Watch, a Washington group that investigates and prosecutes government corruption, and it has details of 10 deaths just since September.

"Given all the questions about Gardasil, the best public health policy would be to re-evaluate its safety and to prohibit its distribution to minors. In the least, governments should rethink any efforts to mandate or promote this vaccine for children,” said Judicial Watch President Tom Fitton.

The organization's work uncovered reports of about one death each month since last fall, bringing the total death toll from the drug to at least 18 and as many as 20.

There also were 140 "serious" reports of complications including about three dozen classified as life-threatening, 10 spontaneous abortions and half a dozen cases of Guillain-Barre Syndrome.

The document reveals the case of an 18-year-old woman who got the Gardasil vaccine, was found unconscious that evening, and died. Another woman, age 19, got the drug and the next morning was found dead in her bed.

The new documents also reveal a total of 8,864 Vaccine Adverse Event Reporting System records, up from a total of 3,461 that had been reported in a document just last fall.

WND previously has reported how Merck was lobbying state lawmakers to require the vaccination, but said it would quit the campaign after its activities were unveiled.

WND also reported when a key researcher into human papillomavirus, which is targeted by Gardasil, reported it needed more testing, and how even the Centers for Disease Control suggested the vaccine should not be mandatory.

That, however, has not diverted the building campaign to have legislatures adopt mandatory vaccination plans.

Judicial Watch said one of the reports, VAERS ID: 310262-1 (D), had this to say:

"Information has been received…concerning a 20-year-old female with no medical history reported, who on 01-APR-2008 was vaccinated with a dose of Gardasil….The patient died four days after…patient sought unspecified medical attention. An autopsy was performed which ruled out suicide and anything suspicious."

Another report said, "Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a dose of Gardasil. Subsequently, the patient experienced a coma and is now paralyzed. At the time of this report, the patient's outcome was unknown. VAERS ID: 303188-1"

The target of the vaccine is cervical cancer, since studies show that those who have HPV have a higher chance of later developing cervical cancer. However, opponents note that such cancers develop most often in older women, while the plan is to require girls as young as 11 or 12 years old to be inoculated. They cite the lack of evidence that the vaccine would have an impact later in life.

A Judicial Watch report said, "Even though Gardasil will not be fully tested for safety until 2009, physicians are already pushing it as a routine, harmless vaccine. Merck's aggressive advertisement campaign tells young girls that their lives could be 'one less' affected by cervical cancer and that, 'It's your turn to help guard against cervical cancer.'"

The report also estimated it will cost as much as $2 billion to buy vaccinations for the nation's poorest girls.

"This vaccine will be more expensive than all other childhood vaccines put together," concluded John Schiller, a National Cancer Institute investigator.

Judicial Watch earlier uncovered reports such as this:

"Initial and follow-up information has been received from a physician concerning an 'otherwise healthy' 13 year old female who was vaccinated with her first and second doses of Gardasil. Subsequently, the patient experienced … paralysis from the chest down, lesions of the optic nerve…At the time of the report, the patient had not recovered."

Officials with the Abstinence Clearinghouse noted in a position paper that groups including the Texas Medical Association, the American Academy of Pediatrics, the Association of American Physicians and Surgeons, and the American Academy of Environmental Medicine have come out publicly against mandatory vaccination.

"The reasoning of these medical associations is clear. They are not opposed to medical progress, and certainly support all efforts to combat life-threatening diseases. The problem, as these organizations see it, lies in the fact that the drug only went through three and a half years of testing, leaving the medical community somewhat in the dark as to what serious adverse effects might result in the long term," the group said at the time.

"Along with the potential of serious adverse effects is the question of efficacy. There is evidence that after approximately four years, the vaccine's potency significantly declines. The long-term value of the vaccine has yet to be determined; if it wears off within six years, will girls and women need to repeat the battery of injections they originally received?" the organization wondered.

Michigan was the first state to introduce a plan to require the vaccine to be given to young girls, but the proposal failed. Ohio also considered a failed plan in 2006.

In 2007 Merck's aggressive lobbying campaign and contributions to Women in Government resulted in proposals in at least 39 states to institutionalize such vaccinations.
[June 30, 2008, WorldNetDaily, http://www.worldnetdaily.com/index.php?fa=PAGE.view&pageId=68454]




Judicial Watch Special Report: Examining The FDA's HPV Vaccine Records: Executive Summary
(See full report at:

http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf)


In May 2007, Judicial Watch submitted a request to the FDA under the Freedom of Information Act for all records concerning Merck's new anti-HPV vaccine, Gardasil.

After Judicial Watch filed a lawsuit in October 2007 to compel record production, the FDA finally released four sets of documents, the last in June 2008. These records detail the development and expedited approval of Gardasil.

The documents include patent and licensing memoranda, test reports for the vaccine, and the final briefing document on Gardasil submitted to the FDA in April 2006, one month before the vaccine was approved.

The FDA also produced 8,864 VAERS reports.

Judicial Watch uncovered a transcript of Merck's May 18, 2006, meeting with the Vaccines and Related Biological Products Advisory Committee (VRBPAC), at which the vaccine received a unanimous vote of approval.Analysis of the records shows:

. Gardasil is a prophylactic, preventative vaccine and will not treat pre-existing HPV infection. It is not a cancer vaccine or cure.

. Gardasil is marketed as a vaccine that prevents cancer, but it " . . . has not been evaluated for the potential to cause carcinogenicity or genotoxicity."

. Gardasil is not 100% effective against all HPVs. It is designed to protect against only four strains of HPV, even though there are over thirty strains including at least fifteen that can cause cancer.

. While Gardasil is the most expensive vaccine ever to be recommended by the FDA, its long-term effectiveness is unknown and could be as brief as only two to three years.

. During testing, an aluminum-containing placebo was used. Aluminum can cause permanent cell damage and is a reactive placebo, unlike most standard saline placebos. This means that tests of Gardasil may not have given an accurate picture of safety levels.

. Although some states are considering making it mandatory for young girls to get the Gardasil vaccine, it has only been tested with one other vaccine commonly given to children. There are ten commonly administered adolescent vaccines.

. Gardasil is still in the testing stages, and will not be fully evaluated for safety until September 2009.
VAERS reports show that as many as eighteen people have died after receiving Gardasil.

See full report:
http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf

 JUDICIAL WATCH UNCOVERS FDA RECORDS Detailing Ten New Deaths & 140 “Serious” Adverse Events Related to Gardasil Since September 2007 --  (8,864 Total Adverse Events since HPV Vaccine Released in 2006)
Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released a report based on new documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. [http://www.judicialwatch.org/news/2008/jun/judicial-watch-uncovers-new-fda-records-detailing-ten-new-deaths-140-serious-adverse-e; ProLife America Daily News, 12Aug 08]
Judicial Watch Uncovers New FDA Records Detailing Ten New Deaths & 140 “Serious”
Adverse Events Related to Gardasil: Watchdog Publishes New Special Report Examining 8,864 Adverse Event Reports Detailing Safety Concerns

Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released a report based on new documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. The adverse reactions include 10 deaths [http://www.judicialwatch.org/documents/2008/VAERS_Deaths.pdf]  since September, 2007. (The total number of death reports is at least 18 and as many as 20.) The FDA also produced 140 “serious” reports (27 of which were categorized as “life threatening”), 10 spontaneous abortions and six cases of Guillain-Barre Syndrome – all since January 2008. Adverse reports excerpts include:

    * Information has been received...concerning a 20 year old female with no medical history reported, who on 01-APR-2008 was vaccinated with a dose of Gardasil....The patient died four days after...patient sought unspecified medical attention. An autopsy was performed which ruled out suicide and anything suspicious. The cause of death is currently unknown. VAERS ID: 310262-1 (D)
    * Information has been received…concerning a 23-year-old female…who on 31-JAN-2008 was vaccinated with her 1st dose of Gardasil...the patient experienced anaphylactic shock 2 minutes after vaccination characterized by a brief loss of consciousness...respiratory arrest, eyes rolled upwards, blurred vision and greyish skin tone...Anaphylactic shock was considered to be immediately life-threatening. VAERS ID: 304739-1 (S)
    * Cold sweat, Fall, Foaming at mouth, Grand mal convulsion, Immediate post-injection reaction....Pt [patient, 14-year-old female] received vaccine, took 6 steps, fell to the ground unconscious and had a 60 sec grand mal seizure then regained consciousness. [Blood pressure] after seizure 60/40 pale clammy skin. [Patient] had bit her tongue and had foam around her mouth. VAERS ID: 305259-1 (S)
    * Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a dose of Gardasil. Subsequently, the patient experienced a coma and is now paralyzed. At the time of this report, the patient's outcome was unknown. VAERS ID: 303188-1

“Given all the questions about Gardasil, the best public health policy would be to reevaluate its safety and to prohibit its distribution to minors. In the least, governments should rethink any efforts to mandate or promote this vaccine for children,” stated Judicial Watch President Tom Fitton.

Judicial Watch had previously obtained 3,461 reports relating to Gardasil. On June 10, 2008, Judicial Watch received a compact disk from the FDA with a new total of 8,864 Vaccine Adverse Event Reporting System (VAERS) records. These documents and the new Judicial Watch 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.

    * Special Report - Appendices - June 30, 2008 - http://www.judicialwatch.org/documents/2008/TABS.pdf
[Press Office 202-646-5188, Washington, DC; prolifeamerica.com]

 
JUly 11, 2008
HPV VACCINE BLAMED FOR TEEN'S PARALYSIS; CDC DENIES CONNECTION. Gardasil certainly made headlines in 2006 when the Food and Drug Administration approved it as a vaccine against four strains of the human papillomavirus, or HPV, which can cause cervical cancer.

HPV can be transmitted sexually, so many parents decided to give the vaccination to their teenaged daughters.

Now, Gardasil is making headlines again. This time, the drug’s manufacturer is under scrutiny as the vaccine’s recipients are complaining of ill side effects.

There have been more than 7,800 complaints about Gardasil since the Food and Drug Administration approved it two years ago, according to the Centers for Disease Control and Prevention.

Complaints have included nausea, blood clots, genital warts, paralysis and even death.

The CDC said the deaths are not linked to Gardasil.

Merck is standing by its product, insisting it is safe.

“I think of all the vaccines out there, this has been thoroughly tested prior to release,” said Dr. Manny Alvarez, managing health editor of FOXNews.com. “This is a vaccine that helps protect women from a very deadly disease. Therefore the benefits fully outweigh any side effect that has been found so far.

"However, I do believe that with any medication, constant surveillance of complications need to be monitored aggressively and in extreme cases, like this one, thorough investigations are necessary.”

The family of one teenager – who is only going by the name of Jenny – told CBS News Monday that their daughter was healthy until 15 months ago when she received the third installment of the vaccine.

Jenny’s parents said it was soon after that final shot that Jenny began to experience signs of degenerative muscle disease, and she is now almost completely paralyzed.

“There may be a link. But, there is no medical consensus on whether this hypothesis is stronger than other possible explanations,” said the parents of Jenny, 13, who lives in Northern California.

“Based on the facts we’ve received, the information does not suggest that this event was casually associated with vaccination.”

Since the drug was approved, eight million females have received the vaccination.

Alvarez also noted that vaccines respond differently to the each individual’s immune system.
[http://www.foxnews.com/story/0,2933,377688,00.html Friday, July 11, 2008]
 

CANCER VACCINE MAY BE LINKED TO PANCREATITIS. Gardasil, the cervical cancer vaccine, which is being advised for all young women, may be causing pancreatitis, a painful, debilitating disease that can be fatal. Australian sources reported that three women developed pancreatitis shortly after receiving the vaccine.
Gardasil protects women from strains of the HPV (human papillomavirus) that cause 70 percent of all cervical cancer. But numerous cases of young women being stricken with various potentially deadly complications have arisen all over the world. Eighteen deaths have been reported as well as 8,000 adverse reactions which include paralysis and seizures. Australia alone reported over 1,000 suspected reactions to the vaccine, although most were not life-threatening and included headaches, dizziness and vomiting. Acute pancreatitis is characterized by sudden, severe abdominal pain. Pancreatic enzymes burn and irritate the pancreas, then leak out into the abdominal cavity. Complications can include heart, respiratory or kidney failure, all of which can be fatal. Dr. Amitabha Das, writing in the Medical Journal of Australia, said, “We suggest that pancreatitis be considered in cases of abdominal pain following HPV vaccination.” [26Aug08, NewsMax.com Health Alerts]
 

 August 2008

HPV VACCINES: MORE EXPERTS URGE CAUTION. Authors of two articles appearing in the New England Journal of Medicine are questioning the trend of large-scale vaccinations with HPV vaccines based on unproven effectiveness and value for the public health dollar. Charlotte J. Haug, MD, PhD, points out that prior trials left unanswered questions concerning the effect of the vaccine on patients’ natural immunity against HPV, whether or not cancer rates will actually decrease, and how long the vaccine will remain effective against the particular oncogenic strains of HPV it targets. She concludes, “With so many essential questions still unanswered, there is good reason to be cautious about introducing large-scale vaccination programs. Instead, we should concentrate on finding more solid answers through research rather than base consequential and costly decisions on yet unproven assumptions.”

(Sources -- see these abstracts/articles below: “Health and Economic Implications of HPV Vaccination in the United States,” NEJM, 08-21-08, http://content.nejm.org/cgi/content/full/359/8/821; “Human Papillomavirus Vaccination — Reasons for Caution,” NEJM, 08-21-08, http://content.nejm.org/cgi/content/full/359/8/861; abstinence.net, 21Aug08)

"Health and Economic Implications of HPV Vaccination in the United States"
NEJM, Volume 359:821-832, Number 8, August 21, 2008, Jane J. Kim, Ph.D., and Sue J. Goldie, M.D., M.P.H.
ABSTRACT

Background The cost-effectiveness of prophylactic vaccination against human papillomavirus types 16 (HPV-16) and 18 (HPV-18) is an important consideration for guidelines for immunization in the United States.

Results On the assumption that the vaccine provided lifelong immunity, the cost-effectiveness ratio of vaccination of 12-year-old girls was $43,600 per quality-adjusted life-year (QALY) gained, as compared with the current screening practice. Under baseline assumptions, the cost-effectiveness ratio for extending a temporary catch-up program for girls to 18 years of age was $97,300 per QALY; the cost of extending vaccination of girls and women to the age of 21 years was $120,400 per QALY, and the cost for extension to the age of 26 years was $152,700 per QALY. The results were sensitive to the duration of vaccine-induced immunity; if immunity waned after 10 years, the cost of vaccination of preadolescent girls exceeded $140,000 per QALY, and catch-up strategies were less cost-effective than screening alone. The cost-effectiveness ratios for vaccination strategies were more favorable if the benefits of averting other health conditions were included or if screening was delayed and performed at less frequent intervals and with more sensitive tests; they were less favorable if vaccinated girls were preferentially screened more frequently in adulthood.

Conclusions The cost-effectiveness of HPV vaccination will depend on the duration of vaccine immunity and will be optimized by achieving high coverage in preadolescent girls, targeting initial catch-up efforts to women up to 18 or 21 years of age, and revising screening policies.

In the United States, cervical cancer developed in an estimated 11,150 women and caused death in 3600 women in 2007.1 Infection with high-risk "oncogenic" types of human papillomavirus (HPV) is the cause of 100% of cervical cancers, 90% of anal cancers, 40% of vulvar and vaginal cancers, at least 12% of oropharyngeal cancers, and 3% of oral cancers.2
Worldwide, HPV types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cases of cervical cancer.3,4...

The impact of HPV vaccination on the rate of cervical cancer will not be observable for decades; thus, decisions regarding a vaccination policy will inevitably rely on studies reporting intermediate outcomes. Estimating the magnitude of the benefit of vaccination is further complicated when one considers the extensive secondary-prevention program in the United States. This program, which involves the use of cytology-based screening, is recommended annually or biennially, starting 3 years after the first sexual intercourse and no later than 21 years of age.13,14,15  HPV DNA testing is recommended as a triage test for equivocal results of cytologic analysis and in combination with cytologic tests for primary screening in women 30 years of age or older.16

Before long-term data become available, mathematical models used in a decision-analytic framework that synthesize the best available data while ensuring consistency with epidemiologic observations can project outcomes beyond those reported in clinical trials, provide insight into key drivers of cost-effectiveness, and be revised as new information emerges. Extending previous studies of HPV vaccination,17,18,19,20,21,22 we evaluated the cost-effectiveness of vaccinating 12-year-old girls and of temporary catch-up programs. We considered the dynamics of HPV transmission, the duration of vaccine efficacy, the potential benefits of preventing noncervical HPV-related conditions, the anticipated changes in screening practice, and potential disparities in access to care.

Effect of Waning Immunity, Vaccine Cross-Protection, and Type Replacement

If vaccine-induced immunity lasted only 10 years, the vaccination of preadolescent girls provided only 2% marginal improvement in the reduction in the risk of cervical cancer as compared with screening alone, and it cost $144,100 per QALY, whereas catch-up programs were more costly and less effective than screening alone (Table 3). With a completely efficacious vaccine booster at 10 years, the cost of vaccination of preadolescent girls was $83,300 per QALY, although catch-up strategies exceeded $125,000 per QALY. There were marginal improvements in cost-effectiveness when cross-protective effects were included against other high-risk types of HPV.8 Furthermore, in a separate analysis, with a 5% increase in the baseline risk of infection with high-risk types of HPV other than HPV-16 and HPV-18, the cost per QALY of vaccination of preadolescent girls increased from $43,600 to $53,000.
[http://content.nejm.org/cgi/content/full/359/8/821]

 
"Human Papillomavirus Vaccination — Reasons for Caution"
Charlotte J. Haug, M.D., Ph.D.
Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer. Several strains of human papillomavirus (HPV) can cause cervical cancer, and two vaccines directed against the currently most important oncogenic strains (i.e., the HPV-16 and HPV-18 serotypes) have been developed. That is the good news. The bad news is that the overall effect of the vaccines on cervical cancer remains unknown. As Kim and Goldie1 point out in this issue of the Journal, the real impact of HPV vaccination on cervical cancer will not be observable for decades.

Although it was licensed for use in the United States in June 2006, the first phase 3 trials of the HPV vaccine with clinically relevant end points — cervical intraepithelial neoplasia grades 2 and 3 (CIN 2/3) — were not reported until May 2007, first in the Journal2 and 1 month later in the Lancet.3,4

The vaccine was highly successful in reducing the incidence of precancerous cervical lesions caused by HPV-16 and HPV-18, but a number of critical questions remained unanswered.5,6

For instance, will the vaccine ultimately prevent not only cervical lesions, but also cervical cancer and death? How long will protection conferred by the vaccine last? Since most HPV infections are easily cleared by the immune system, how will vaccination affect natural immunity against HPV, and with what implications? How will the vaccine affect preadolescent girls, given that the only trials conducted in this cohort have been on the immune response? The studies with clinical end points (i.e., CIN 2/3) involved 16- to 24-year-old women. How will vaccination affect screening practices? Since the vaccines protect against only two of the oncogenic strains of HPV, women must continue to be screened for cervical lesions. Vaccinated women may feel protected from cervical cancer and may be less likely than unvaccinated women to pursue screening. How will the vaccine affect other oncogenic strains of HPV? If HPV-16 and HPV-18 are effectively suppressed, will there be selective pressure on the remaining strains of HPV? Other strains may emerge as significant oncogenic serotypes.

Resolving the first essential questions will require decades of observation of large numbers of women. The last question may be answered sooner. Published reports of trials show an increasing trend of precancerous cervical lesions caused by HPV serotypes other than HPV-16 and HPV-18.2,4,6 The results were not statistically significant, however, possibly because there were too few clinically relevant end points in the observation periods reported. If randomized, controlled trials involving vaccinated and unvaccinated women continue for a few more years, we will most likely be able to tell whether this is a true trend. If so, there is reason for serious concern.

By the summer of 2007, there were definitely promising results with regard to the effectiveness of the HPV vaccine in the prevention of precancerous lesions (i.e., CIN 2/3) caused by the HPV-16 and HPV-18 serotypes. However, serious questions regarding the overall effectiveness of the vaccine in the protection against cervical cancer remained to be answered, and more long-term studies were called for before large-scale vaccination programs could be recommended.5,6 Unfortunately, no longer-term results from such studies have been published since then.

In the meantime, there has been pressure on policymakers worldwide to introduce the HPV vaccine in national or statewide vaccination programs. How can policymakers make rational choices about the introduction of medical interventions that might do good in the future, but for which evidence is insufficient, especially since we will not know for many years whether the intervention will work or — in the worst case — do harm? One way to provide decision support is to develop mathematical models of the natural history of the disease in question, introduce various intervention strategies, and use cost-effectiveness analysis to estimate the costs and health benefits associated with each clinical intervention. The results are typically expressed in terms of the amount we will have to pay for the extra health benefit of the treatment — that is, in dollars per life-year or quality-adjusted life-year (QALY) saved. Cost-effectiveness analyses are tools for decision making under conditions of uncertainty. These analyses do not in themselves provide evidence that medical interventions are effective. In this issue of the Journal, Kim and Goldie present a model of HPV vaccination, and they use a cost-effectiveness analysis to make projections of the possible health and economic implications of the use of the vaccine.1

To evaluate the quality of a cost-effectiveness analysis, it is essential to appraise the model's input variables, the uncertainties, and the choices the researchers have made. To set up such an analysis of a preventive medical intervention — in this case, a vaccine given to healthy 12-year-old girls — that might have an effect on the incidence of cervical cancer decades from now is extremely complex. The analysis has to model the natural history of HPV infection in this cohort of girls over their lifetime, the effect of the vaccine over all those years (whether it is the same effect or one that is waning), the effect on other HPV strains, the effect of the vaccine on the natural immunity against HPV infections, the sexual behavior of the girls and women and their partners, and finally, women's cervical-cancer screening practices.

The model presented by Kim and Goldie is well done and ambitious, and it includes most of these factors. They conclude that under certain assumptions, vaccinating 12-year-old girls is associated with an incremental cost-effectiveness ratio of $43,600 per QALY gained, whereas adding a catch-up program for older girls and women is not cost-effective. However, their base-case assumptions are quite optimistic. They presume lifelong protection of the vaccine (i.e., no need for a booster dose), that the vaccine has the same effect on preadolescent girls as on older women, that no replacement with other oncogenic strains of HPV takes place, that vaccinated women continue to attend screening programs, and that natural immunity against HPV is unaffected. Whether these assumptions are reasonable is exactly what needs to be tested in trials and follow-up studies. If the authors' baseline assumptions are not correct, vaccination becomes less favorable and even less effective than screening alone. For example, as shown in the article, if the protection of the vaccine wanes after 10 years, vaccination is much less cost-effective and screening is more effective than catch-up programs.

With so many essential questions still unanswered, there is good reason to be cautious about introducing large-scale vaccination programs. Instead, we should concentrate on finding more solid answers through research rather than base consequential and costly decisions on yet unproven assumptions.
No potential conflict of interest relevant to this article was reported. http://content.nejm.org/cgi/content/full/359/8/861
[August 21, 2008, NEJM, Volume 359:861-862, Number 8; http://content.nejm.org/cgi/content/full/359/8/861]
 

NOVEMBER 2008

  
GARDASIL LINKED TO 78 OUTBREAKS OF GENITAL WARTS. Judicial Watch, a non-profit watch dog group, has recorded 9,748 adverse events connected with the HPV vaccine Gardasil, including 78 outbreaks of genital warts and 21 deaths, not including the 10 babies miscarried by women who received the Gardasil vaccine. Naturalnews.com, 11-11-08; EF 14Nov08]

DECEMBER 2008

GARDASIL LINKED TO OUTBREAK OF GENITAL WARTS IN FIJI SCHOOLCHILDREN

Three months following the approval of Gardasil for Fijiian students and in the midst of mass vaccinations there, three primary school girls have had “reacted negatively” to the vaccine.

Prior negative reactions reported to the FDA have included fainting, paralysis, miscarriage, seizures, and ten deaths. Matelita Ragogo writes in the Fiji Times, ““Effectively, Cabinet approved a vaccine which is still being tested so no one can be sure of its effectiveness or long-term side effects. Our children are guinea pigs for a money-making, I mean, drug-making, machine.”

(Source: “Gardasil Vaccination Results in Three Outbreaks of Genital Warts in Fiji School Children,” LifeSiteNews.com, 11-18-08, http://www.lifesitenews.com/ldn/2008/nov/08111803.html; 3Nov08, abstinence.net)

MARKETING GARDASIL TO MALES

In a November press release, the maker of the HPV vaccine Gardasil announced that recent testing in males will “open the door” to seeking approval in the US to market the drug to boys as well as girls.

There is, however, no data showing that such vaccinations prevent penile, anal, or head and neck cancers in males, or that they prevent transmission of the HPV virus to females.

(Source: “Study: HPV vaccine prevents genital warts in males,” AP, 11-13-08, http://news.yahoo.com/s/ap/20081113/ap_on_he_me/med_hpv_vaccine; 13Nov08 abstinence.net)
 

2009

[While this particular article is taken from a blog, the information is noteworthy and documented; visit the link http://www.prolifeblogs.com/articles/archives/2009/04/gardasil_moms_i.php for numerous links in the text]

Gardasil Moms: If one of those 32 dead girls or women was your daughter...

ATTENTION: GARDASIL VACCINE RECIPIENTS (the one that was supposed to protect girls and women from the HPV virus and the cervical cancer it causes):

    Reports of adverse events after getting a vaccine can be submitted to VAERS by fax at 1-877-721-0366, online at https://secure.vaers.org/VaersDataEntryintro.htm, or by mail to Vaccine Adverse Event Reporting System, P.O. Box 1100, Rockville, MD 20849-1100.

Also from that CDC website:

    As of December 31, 2008, there have been 32 U.S. reports of death among females who have received the vaccine.

32. And I was berated by some Prolifeblogs.com readers in August 2008 for posting that 25 women had died because of Gardasil since March 2007, so we re-reviewed the data and modified that post to "as many as 18 or 19 women died."

So now, 9 months later, it's up 14 more deaths to 32 in the U.S. Sadly, this isn't going to be end of it. This is between 1% and, at best, 10% of the estimated cases of adverse effects.

That means there could be as many as 320 to 3,200 women dead from this Gardasil vaccine in the past 2 years alone.

The CDC and the FDA are standing by their "fast-tracking" approval of Gardasil three years ago. Read the following links for more scrutinizing information on the dangers to our young girls and women and the underreporting of those dangers:

"An Analysis by the National Vaccine Information Center of Gardasil & Menactra Adverse Event Reports to the Vaccine Adverse Events Reporting System (VAERS), February 2009

Reuters news report, "NVIC Vaccine Risk Report Reveals More Serious Reaction Reports After Gardasil," which quotes extensively from the NVIC PDF document just cited above:

    Using the MedAlerts database, compiling data for VAERS through November 30, 2008, NVIC found that compared to Menactra, Gardasil is associated with at least twice as many Emergency Room visit reports (5,021), four times as many Death reports (29); five times as many "Did Not Recover" reports (2,017) and seven times as many "Disabled" reports (261). There have been 34 reports of thrombosis, 27 reports of lupus, 23 reports of blood clots, 16 reports of stroke, and 11 reports of vasculitis following Gardasil vaccine given alone without any other vaccines. There are three to six times more fainting or syncope reports after Gardasil vaccination than after Menactra and there have been 544 reports of seizures following Gardasil and 158 after Menactra (73 Menactra-associated seizures involved co-administration with Gardasil).

    Rechallenge reports to VAERS involve cases where there was a worsening of symptoms after repeated vaccination. There were 275 Rechallenge reports after Gardasil compared to eight after Menactra (7 Menactra-associated Rechallenge reports involved co-administration with Gardasil). In the entire VAERS database for all vaccine adverse event reports, there are 467 rechallenge reports, of which nearly 60 percent are for Gardasil.

    A 15-year old gymnast, cheerleader and honor roll student in Kansas has been diagnosed with Gardasil vaccine-related brain inflammation after receiving three Gardasil shots. Her first symptoms included muscle and joint weakness and pain, numbness and tingling in her hands and feet, severe headaches excessive fatigue, rash, dizziness, and loss of concentration after the first shot. After the second and third shots she began losing her hair and developed seizures, bouts of paralysis, mini-strokes, partial loss of vision, and severe chest pain, memory and speech loss.

    A 21-year old Maryland artist, athlete and honor roll college student died suddenly without explanation in June 2008 after her third Gardasil shot. She is one of the 29 Gardasil death reports in VAERS.

"Most health officials believe that adverse reactions to medications are vastly underreported, as they are optional. Safety experts estimate that only between 1% and 10% of adverse effects are reported. Therefore the actual number of adverse events occurring after vaccination with Gardasil is likely to be much higher."

When will people stop protecting another something (in addition to abortion) that's dangerous to their daughters and has been since Day One? The rabid defense of a vaccine that enables girls to continue and expand upon sexual promiscuity and thus increase their risk of exposure to the resulting STD that is HPV, is nothing short of irresponsible and unconscionable parenting by parents and insane "governing" by the FDA and CDC.

Please don't comment if all you have to say is how few these cases are compared to the millions of vaccines given. We can read too and we have read those statistics. The point is, there are supposed to be no such massively adverse effects at all, if the FDA and the CDC do their jobs correctly.

The point is, from March 2007 through August 2008, as many as 18 U.S. women died after taking the Gardasil vaccine, and in the next 4 months after that, 14 more have been reported as dying after Gardasil was administered, according to the CDC itself.

If one of those 32 dead girls or women was your daughter, would you still really give a damn that millions more took it without incident?

[NEW ADDITION TO THIS POST at 10:38 PM, APRIL 22, 2009]

NEW ADDITIONAL INFORMATION:

This was posted in the combox by one of our readers, Melody:

    "I am grateful to you for posting this information. Last week, I was informed that a friend of the family (a very healthy teenage girl) had died suddenly as a result of this vaccine. The family was on the phone notifying everyone they knew with young girls to consider the potential fatal consequences. You are right...It matters a great deal when that one child is your beloved. I also find it difficult to believe that there are no serious incidents other than death with this vaccine. Are there only two possible consequences of the vaccine: Perfect health or death? Not likely. Chances are that there exists a range of ill-effects that haven't been reported or correctly identified with the vaccine."

Melody, read further into that NVIC document, http://www.nvic.org/Downloads/NVICGardasilvsMenactraVAERSReportFeb-2009u.aspx . There are numerous "serious incidents other than death with this vaccine."

[By Annie B. on April 22, 2009 9:43 AM; http://www.prolifeblogs.com/articles/archives/2009/04/gardasil_moms_i.php]

 May 2009

Gardasil Vaccine Linked to GUILLAIN-BARRE Syndrome Nerve Disorder

A new study from the University of Medicine and Dentistry of New Jersey,Newark, shows an increased risk of this rare nerve disorder in females for up to six weeks after receiving the HPV vaccine.

 Girls and women who receive the Gardasil vaccine to prevent cervical cancer may be at increased risk of this rare but serious disorder of the nervous system in the first few weeks after getting their shots, researchers report.

"There is clear evidence from our database of an increased incidence of Guillain-Barre syndrome in the first six weeks, especially the first two weeks, after vaccination,” says Nizar Souayah, MD, of the University of Medicine and Dentistry of New Jersey in Newark.
[http://www.webmd.com/cancer/cervical-cancer/news/20090430/gardasil-linked-to-nerve-disorder
News Source; ALL Pro-Life Today, 1May09; posted 6May09, abstinence.net]
 

THE DANGERS OF GARDASIL
Listen to this cervical cancer survivor explain why she doesn’t recommend the HPV vaccine to prevent the disease that almost took her life.

Go to: http://www.youtube.com/watch?v=msoyRYSoSJk

SINGAPORE CAUTIOUS ABOUT MASS VACCINATIONS

Balaji Sadasivan, a surgeon and former health minister, has expressed concern about any government recommendation of Gardasil for girls based on the possible long-term effects of the HPV vaccine.

"We do not know if the vaccine will confer long-term immunity or would immunity wane after some years," he said in a speech to the Asian Oncology Summit.

"We do not know if other types of HPV will become dominant after we contain the current strains of HPV." He also said that a mass vaccination effort might imply a condoning of teen sexual activity.

(Posted 6May09, http://www.zimbio.com/Gardasil/articles/165/Singapore+urges+caution+cervical+cancer+shots)
[Posted 6May09, abstinence.net]

AUGUST 2009

HPV VACCINE RESEARCHER URGES CAUTION

Dr. Diane Harper, consultant to Merck and heavily involved in the approval process for the vaccine Gardasil, is now questioning the vaccine’s risk-versus-benefit profile. Since the drug has not been shown to be effective for more than five years, she explains, it may not actually provide the hoped-for cancer-preventive effect. Also, parents should receive more complete warnings regarding the “small but real” risks from serious side effects, many of which are more serious than cervical cancer itself.

[ http://www.cbsnews.com/stories/2009/08/19/cbsnews_investigates/main5253431.shtml; Abstinence Clearinghouse, 25Aug09]

For more on Gardasil, see JAMA article (free full text) “The Risks and Benefits of HPV Vaccination,” by Charlotte Haug MD, PhD, MSc

From the abstract: “Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain.

"Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally she should be willing to accept only a small risk of harmful effects from the vaccine.
When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit. Patients and the public logically expect that only medical and scientific evidence is put on the balance.

"If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups of physicians, the balance is easily skewed. The balance will also tilt if the adverse events are not calculated correctly.”

[ http://jama.ama-assn.org/cgi/content/full/302/7/795?home ]

SEPTEMBER 2009

NOTE re: GARDASIL REQUIRED FOR US CITIZENSHIP

Note on Previous Gardasil story: We have received inquiries concerning last week’s news story about the US requirement that young women applying for citizenship receive a Gardasil vaccination. For more information, go to the US Citizenship and Immigration Services website at http://www.uscis.gov/files/nativedocuments/Jan_stakeholder_27Jan09.pdf.

In related coverage, ABC News quotes Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York City: "I am most definitely surprised and I would love to know how it ever became policy. I wonder if the drug company could have had any influence." "It's a voluntary vaccine,” he continued, “and for the U.S. government to make it a mandatory decision to come to this country is crazy. It has no public health value that has been shown."

(Source: http://abcnews.go.com/Health/ReproductiveHealth/gardasil-vaccine-roadblock-citizenship/story?id=8542051)
[www.abstinence.net, 29 Sept 09]

14 Year Old British Girl Dies after HPV Vaccination

[NOTE: Cervarix, an alternative HPV vaccine available in England, has not yet been approved in the USA]

Natalie Morton, a 14-year-old girl who attended the Blue Coat Church of England School in Coventry, died today, hours after being given Cervarix - the controversial cervical cancer vaccine manufactured for the UK market by Glaxo SmithKline.

Natalie was injected with the vaccine as part of the UK National Health Service's (NHS) immunization program directed at teenage girls with the purpose of protecting them against [some] strains of the human papillomavirus (HPV), which is a sexually transmitted disease.

The NHS started the HPV vaccination program in April last year (2008) and has recorded 2,137 reports of adverse effects following the injection.

Health officials said today they are not sure whether Natalie had an extreme reaction to a standard vaccine, or whether the particular dose she was given was from a "rogue contaminated batch."

Either situation raises serious questions about the safety of the vaccine.

Dr. Caron Grainger, director for public health at Coventry city council, said an autopsy will be conducted to investigate if the vaccine played a role in Natalie's death.

"No link can be made between the death and the vaccine until all the facts are known and a post-mortem takes place," Grainger told the UK Daily Mail.

Mike Attwood, a spokesman for Coventry Primary Care Trust said: "An urgent investigation has been launched and while we wait for the results from the post mortem all vaccinations using the drug have been temporarily stopped."

The National Vaccine Information Centre (NVC), a private vaccine-safety group based in the US, reported that from 2006 as many as 11,900 girls and young women had reported adverse events after receiving the Gardasil vaccine, which is manufactured by Merck Pharmaceutical for use in the US and Canada.

These adverse events included such mild reactions as pain, fever, nausea, dizziness and itching, to serious effects such as Bells Palsy, Guillain-Barre Syndrome, and seizures. The number of deaths associated with the Gardasil vaccine by the NVC is between 32 and 45 in the US alone.

Related LSN articles:
Deaths Associated with HPV Vaccine Start Rolling In, Over 3500 Adverse Affects Reported
http://www.lifesitenews.com/ldn/2007/sep/07092004.html

Controversial HPV Vaccine Causing One Death Per Month: FDA Report
http://www.lifesitenews.com/ldn/2008/jul/08070316.html
[29Sept09, Coventry, UK, T.M. Baklinski, www.LifeSiteNews.com]

14-Year-Old British Girl Dies after HPV Vaccination
http://www.lifesitenews.com/ldn/2009/sep/09092914.html
News Source
Health officials said today they are not sure whether Natalie Morton had an extreme reaction to a standard vaccine, or whether the particular dose she was given was from a "rogue contaminated batch." Either situation raises serious questions about the safety of the vaccine.

OCTOBER 2009

The Gardasil vaccine has made millions for Merck, but it will prevent very few cases of cervical cancer.  And it has caused tens of thousands of prepubescent girls to suffer side effects.
SWM
 
Merck Researcher Admits:
Gardasil Guards Against Almost Nothing

by Joan Robinson and Steven W. Mosher

On the morning of 2 October 2009, one of us (Joan) joined an audience of mostly health professionals and listened as Dr. Diane Harper, the leading international developer of the HPV vaccines, gave a sales pitch for Gardasil.  Gardasil, as you may know, is the new vaccine that is supposed to confer protection against four strains of the sexually transmitted Human Papillomavirus (HPV).

Dr. Harper came to the 4th International Public Conference on Vaccination to prove to us the real benefits of Gardasil. Sadly, her own presentation left me (Joan) and others filled with doubts.  By her own admission, Gardasil has the doctors surrounding me glaring at a poor promise of efficacy as a vaccine married to a high risk of life-threatening side effects.

Gardasil, Dr. Harper explained, is promoted by Merck, the pharmaceutical manufacturer, as a “safe and effective” prevention measure against cervical cancer. The theory behind the vaccine is that, as HPV may cause cervical cancer, conferring a greater immunity of some strains of HPV might reduce the incidence of this form of cancer.  In pursuit of this goal, tens of millions of American girls have been vaccinated to date.

As I sat scribbling down Merck’s claims, I wondered why such mass vaccination campaigns were necessary.  After all, as Dr. Harper explained, 70% of HPV infections resolve themselves without treatment in one year.  After two years, this rate climbs to 90%.  Of the remaining 10% of HPV infections, only half coincide with the development of cervical cancer.

Dr. Harper further undercut the case for mass vaccination campaigns in the U.S. when she pointed out that “4 out of 5 women with cervical cancer are in developing countries.” (Harper serves as a consultant to the World Health Organization (WHO) for HPV vaccination in the developing world.) Indeed, she surprised her audience by stating that the incidence of cervical cancer in the U.S. is so low that “if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the US.”

If this is the case, I thought, then why vaccinate at all?  From the murmurs of the doctors in the audience, it was apparent that the same thought had occurred to them.

In the U.S. the cervical cancer rate is 8 per 100,000 women.1 Moreover, it is one of the most treatable forms of cancer.  The current death rate from cervical cancer is between 1.6 to 3.7 deaths per 100,000 cases of the disease.2 The American Cancer Society (ACS) notes that “between 1955 and 1992, the cervical cancer death rate declined by 74%” and adds that “the death rate from cervical cancer continues to decline by nearly 4% each year.”3

At this point, I began to wriggle around in my seat, uncomfortably wondering, is the vaccine really effective? Using data from trials funded by Merck, Dr. Harper cheerfully continued to demolish the case for the vaccine that she was ostensibly there to promote.  She informed us that “with the use of Gardasil, there will be no decrease in cervical cancer until at least 70% of the population is vaccinated, and in that case, the decrease will be very minimal. The highest amount of minimal decrease will appear in 60 years.”

It is hard to imagine a less compelling case for Gardasil.  First of all, it is highly unlikely that 70% or more of the female population will continue to get routine Gardasil shots and boosters, along with annual PAP smears.  And even if it did, according to Dr. Harper, “after 60 years, the vaccination will [only] have prevented 70% of incidences” of cervical cancer.

But rates of death from cervical cancer are already declining. Let’s do the math. If the 4% annual decline in cervical cancer death continues, in 60 years there will have been a 91.4% decline in cervical cancer death just from current cancer monitoring and treatment. Comparing this rate of decline to Gardasil’s projected “very minimal” reduction in the rate of cervical cancer of only 70 % of incidences in 60 years, it is hard to resist the conclusion that Gardasil does almost nothing for the health of American women.

Despite these dismal projections, Gardasil continues to be widely and aggressively promoted among pre-teen girls. The CDC reports that, by 1 June 2009, over 26 million doses of Gardasil have been distributed in the U.S.4 With hopes of soon tapping the adolescent male demographic, Merck, the pharmaceutical manufacturer of the vaccine, and certain Merck-funded U.S. medical organizations are targeting girls between the ages of 9 and 13.5 As CBS news reports, “Gardasil, launched in 2006 for girls and young women, quickly became one of Merck's top-selling vaccines, thanks to aggressive marketing and attempts to get states to require girls to get the vaccine as a requirement for school attendance.”6

Just as I began, in my own mind, to question ethics of mass vaccinations of prepubescent girls, Dr. Harper dropped another bombshell.  “There have been no efficacy trials in girls under 15 years,” she told us.

Merck did study a small group of girls under 16 who had been vaccinated, but did not follow them long enough to conclude sufficient presence of effective HPV antibodies.

If I wasn’t skeptical enough already, I really started scratching my head when Dr. Harper explained, “if you vaccinate a child, she won’t keep immunity in puberty and you do nothing to prevent cervical cancer.” But it turned out that she wasn’t arguing for postponing Gardasil vaccination until later puberty, as I first thought.  Rather, Dr. Harper only emphasized to the doctors in the audience the need for Gardasil booster shots, because it is still unknown how long the vaccine immunity lasts.  More booster shots mean more money for Merck, obviously.  

I left Dr. Harper’s lecture convinced that Gardasil did little to stop cervical cancer, and determined to answer another question that she had largely ducked:  Is this vaccine safe?

Here’s what my research turned up.  To date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse effects include Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.7

Dr. Harper, who seems to specialize in dropping bombshells, dropped another in an interview with ABC News when she admitted that “The rate of serious adverse events is greater than the incidence rate of cervical cancer.”8 This being the case, one might want to take one’s chances with cancer, especially because the side effects of the vaccine are immediate, while the possibility of developing cancer is years in the future.

In the clinical studies alone, 23 girls died after receiving either Gardasil or the Aluminum control injection. 15 of the 13,686 girls who received Gardasil died, while 8 died among the 11,004 who received the Aluminum shot. There was only one death among the group that had a saline placebo. What this means is that 1 out of every 912 girls in the Gardasil clinical studies died. (9, see page 8.) The cervical cancer death rate is 1 out of every 40,000 women per year.10

The numbers of deaths and adverse effects are undoubtedly underestimates.  Dr. Harper’s comments to ABC News concur with the National Vaccine Information Center’s claim that “though nearly 70 percent of all Gardasil reaction reports were filed by Merck, a whopping 89 percent of the reports Merck did file were so incomplete there was not enough information for health officials to do a proper follow-up and review.”11 On average, less than 10 percent—perhaps even less than 1 percent—of serious vaccine adverse events are ever reported, according to the American Journal of Public Health.12

Given the severity and frequency of Gardasil adverse reactions, I definitely wasn’t the only one in Dr. Harper’s audience who winced when she dismissed most Gardasil side effects as “easily just needle phobia.”  

Due to the young age of the trial participants and the short duration of the studies, the effects of Gardasil on female fecundity have not been studied. I did discover, in my post-conference reading, that Polysorbate 80, an ingredient in the vaccine (13, see page 12), has been observed in a European clinical study to cause infertility in rats.14  Is this an additional concern?  Time will tell.

I do not wish to give the impression that Dr. Harper presented, even inadvertently, a consistently negative view of her own vaccine.  She did tout certain “real benefits,” chief among them that “the vaccine will reduce the number of follow-up tests after abnormal PAP smears,” and thereby reduce the “relationship tension,” “stress and anxiety” of abnormal or false HPV positive results.

To me, however, this seems a rather slim promise, especially when weighed against the deaths and side effects caused by the Gardasil campaign.  Should millions of girls in the United States, many as young as 9, be put at risk, so that sexually active adults can have less “relationship tension” about false positive Hepatitis results? Is the current rate of death, sterility and serious immune dysfunction from Gardasil worth the potential that in 60 years a minimal amount of a cervical disease (that is already decreasing on its own) may perhaps be reduced?

But what I really wanted to know is why Merck is so eagerly marketing such a dangerous and ineffective vaccine? Aren’t there other ways they could make a profit? While Merck’s behavior is probably adequately explained by the profit motive, what about those in the Health and Human Services bureaucracy who apparently see Gardasil as medicine’s gift to women?  What motivates them?

I (Steve) think that they see Gardasil as what one might call a “wedge” drug.  For them, the success of this public vaccination campaign has less to do with stopping cervical cancer, than it does with opening the door to other vaccination campaigns for other sexually transmitted diseases, and perhaps even including pregnancy itself. 

For if they can overcome the objections of parents and religious organizations to vaccinating pre-pubescent—and not sexually active—girls against one form of STD, then it will make it easier for them to embark on similar programs in the future.

After all, the proponents of sexual liberation are determined not to let mere disease—or even death—stand in the way of their pleasures. They believe that there must be technological solutions to the diseases that have arisen from their relentless promotion of promiscuity. 

After all, the alternative is too horrible to contemplate:  They might have to learn to control their appetites. 

And they might have to teach abstinence.
[2009 Oct 14     Vol. 12 / No. 31, Steven Mosher is the President of the Population Research Institute. Joan Robinson is an Assistant Editor at the Population Research Institute. NOTE: Footnotes were hyperlinked to various sources in the original emailed article.]

30 OCTOBER 2009

HPV Vaccines have Attracted Much Media Attention over the last month. Amid ongoing controversy, several landmark decisions were made:

Food and Drug Administration (FDA) approval of Cervarix: The FDA approved a second HPV vaccine for the prevention of cervical cancer and precancerous cervical lesions in females aged 10 to 25 years.1 Cervarix, a bivalent vaccine made by GlaxoSmithKline, targets HPV types 16 and 18. Infections with these two types of HPV are reported to be responsible for about 70% of cervical cancer.1 Although Cervarix has been approved for use in the US only very recently, it has been widely used throughout the world for several years.2

FDA approval for use of Gardasil in boys and men: The FDA approved Gardasil to be used in males aged 9 to 26 years specifically to prevent genital warts caused by HPV types 6 and 11.3 Gardasil, a quadrivalent HPV vaccine targeting HPV types 6, 11, 16, and 18, was approved for use in females in June 2006 to prevent cervical cancer, precancerous cervical lesions, and genital warts.3 However, the Gardasil study that included males and was evaluated by the FDA did not show that Gardasil significantly reduces HPV-associated cancers, like penile or oral cancer, in men.4 Future studies with more male participants may be necessary to determine if Gardasil does, in fact, have an effect on HPV-associated cancers in men.

Advisory Committee on Immunization Practices (ACIP) decision concerning Cervarix: The ACIP is an advisory committee that provides immunization recommendations to the CDC. During its October 21-22, 2009 meeting, the ACIP voted to add Cervarix to the list of HPV vaccines recommended for females aged 10-25 years. The ACIP did not state a preference for either Gardasil or Cervarix, despite significant differences between the two vaccines. Cervarix only targets two types of HPV, while Gardasil targets 4 types of HPV, including the two types that are responsible for about 90% of genital warts.5,6 In response to questions about why they did not state a preference for one of the two vaccines, the ACIP indicated that they thought Americans would benefit by having two HPV vaccines available in the marketplace.5

ACIP decision regarding the use of Gardasil in males: The ACIP granted a "permissive statement" for the use of Gardasil in males aged 9-26 years.5,7 The permissive statement communicates that the committee believes it is acceptable to immunize males with Gardasil, but that they do not recommend that all boys and men get the vaccine routinely. A recently published report that cast doubt on the cost effectiveness of vaccinating males appeared to be one reason that the committee did not recommend routine vaccination of boys and young men7,8; however, the committee did recommend that the cost of the vaccine be covered through a federal immunization program for Medicaid-eligible and certain other low income boys who choose to receive it.5

In summary, during October 2009, the FDA approved the use of the bivalent HPV vaccine Cervarix in females aged 10 to 25 years and the quadrivalent HPV vaccine Gardasil in males aged 9 to 26 years. The ACIP recommended that Cervarix be included on the list of HPV vaccines recommended for routine use in girls and young women, and that Gardasil be permitted, but not recommended routinely, for males aged 9 to 26 years.

Finally, while the Medical Institute supports the continued development and widespread use of vaccines against HPV and other STIs, we promote risk avoidance as the best strategy to prevent sexually transmitted infections and their consequences. Sexual abstinence outside of a lifelong, faithful relationship is the optimal approach for maintaining the highest level of physical and emotional health.

References:

1. U.S. Food and Drug Administration. FDA Approves New Vaccine for Prevention of Cervical Cancer. Press release, October 16, 2009. Department of Health and Human Services, Food and Drug Administration: Silver Spring, MD. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187048.htm. Accessed 2009 October 27.
2. GlaxoSmithKline. FDA Approves Cervarix, GlaxoSmithKline's Cervical Cancer Vaccine. Press release, October 16, 2009. GlaxoSmithKline: Middlesex, U.K. Available at: http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10112.htm. Accessed 2009 October 27.
3. U.S. Food and Drug Administration. FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys. Press release, October 16, 2009. Department of Health and Human Services, Food and Drug Administration: Silver Spring, MD. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm. Accessed 2009 October 27.
4. Palefsky J, Giuliano AR. Efficacy of the quadrivalent HPV vaccine against HPV 6/11/16/18-related genital infection in young men. EUROGIN. Nice, France, 12-15 Nov, 2008. Available at: www.eurogin.com/2008/EUROGIN2008_LastMinuteAbstracts.pdf. 2009.
5. Associated Press. Panel Backs Vaccine as Cervical Cancer Alternative. New York Times, October 21, 2009. Available at: http://www.nytimes.com/aponline/2009/10/21/health/AP-US-MED-Cervical-Vaccine.html?_r=1. Accessed 2009 October 27.
6. Villa LL, et al. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like vaccine in young women: a randomized double-blind placebo-controlled mutlicentre phase II efficacy trial. Lancet Oncol. 2005;6(5):271-8.
7. Lowes R. HPV vaccine fails to get nod for routine use in boys. Medscape Medical News, October 21, 2009. Available at: http://www.medscape.com/viewarticle/711125. Accessed 2009 October 27.
8. Kim JJ, Goldie SJ. Cost effectiveness analysis of including boys in a human papillomavirus vaccination programme in the United States. BMJ 2009;339:b3884.

More Questions Arise About HPV Vaccine
Gardasil, the vaccine given to girls to prevent a sexually transmitted disease that can cause cervical cancer, is continuing to be questioned on its safety and efficacy.
http://www.onenewsnow.com/Culture/Default.aspx?id=728652
PharmFacts E-News Update -- 26 Oct 2009


MERCK RESEARCHER ADMITS: GARDASIL GUARDS AGAINST ALMOST NOTHING

On the morning of 2 October 2009, one of us (Joan) joined an audience of mostly health professionals and listened as Dr. Diane Harper, the leading international developer of the Human Papillomavirus (HPV) vaccines, gave a sales pitch for Gardasil. Gardasil, as you may know, is the new vaccine that is supposed to confer protection against four strains of the sexually transmitted HPV.

Dr. Harper came to the 4th International Public Conference on Vaccination to prove to us the real benefits of Gardasil. Sadly, her own presentation left me (Joan) and others filled with doubts. By her own admission, Gardasil has the doctors surrounding me glaring at a poor promise of efficacy as a vaccine married to a high risk of life-threatening side effects.

Gardasil, Dr. Harper explained, is promoted by Merck, the pharmaceutical manufacturer, as a “safe and effective” prevention measure against cervical cancer. The theory behind the vaccine is that, as HPV may cause cervical cancer, conferring a greater immunity [to] some strains of HPV might reduce the incidence of this form of cancer. In pursuit of this goal, tens of millions of American girls have been vaccinated to date.

As I sat scribbling down Merck’s claims, I wondered why such mass vaccination campaigns were necessary.

After all, as Dr. Harper explained, 70% of HPV infections resolve themselves without treatment in one year. After two years, this rate climbs to 90%. Of the remaining 10% of HPV infections, only half coincide with the development of cervical cancer.

Dr. Harper further undercut the case for mass vaccination campaigns in the U.S. when she pointed out that “4 out of 5 women with cervical cancer are in developing countries.” (Harper serves as a consultant to the World Health Organization [WHO] for HPV vaccination in the developing world.)

Indeed, she surprised her audience by stating that the incidence of cervical cancer in the U.S. is so low that “if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the U.S.”

If this is the case, I thought, then why vaccinate at all? From the murmurs of the doctors in the audience, it was apparent that the same thought had occurred to them.

In the U.S., the cervical cancer rate is 8 per 100,000 women. Moreover, it is one of the most treatable forms of cancer. The current death rate from cervical cancer is between 1.6 to 3.7 deaths per 100,000 women. 

The American Cancer Society (ACS) notes that “between 1955 and 1992, the cervical cancer death rate declined by 74%” and adds that “the death rate from cervical cancer continues to decline by nearly 4% each year.”

At this point, I began to wriggle around in my seat, uncomfortably wondering, is the vaccine really effective? Using data from trials funded by Merck, Dr. Harper cheerfully continued to demolish the case for the vaccine that she was ostensibly there to promote.

She informed us that “with the use of Gardasil, there will be no decrease in cervical cancer until at least 70% of the population is vaccinated, and in that case, the decrease will be very minimal. The highest amount of minimal decrease will appear in 60 years.”

It is hard to imagine a less compelling case for Gardasil. First of all, it is highly unlikely that 70% or more of the female population will continue to get routine Gardasil shots and boosters, along with annual PAP smears. And even if it did, according to Dr. Harper, “after 60 years, the vaccination will [only] have prevented 70% of incidences” of cervical cancer.

But rates of death from cervical cancer are already declining.

Let’s do the math.

If the 4% annual decline in cervical cancer death continues, in 60 years there will have been a 91.4% decline in cervical cancer death just from current cancer monitoring and treatment.

Comparing this rate of decline to Gardasil’s projected “very minimal” reduction in the rate of cervical cancer of only 70 % of incidences in 60 years, it is hard to resist the conclusion that Gardasil does almost nothing for the health of American women.

Despite these dismal projections, Gardasil continues to be widely and aggressively promoted among pre-teen girls. 

The CDC reports that, by 1 June 2009, over 26 million doses of Gardasil have been distributed in the U.S. With hopes of soon tapping the adolescent male demographic, Merck, the pharmaceutical manufacturer of the vaccine, and certain Merck-funded U.S. medical organizations are targeting girls between the ages of  9 and 13. As CBS News reports, “Gardasil, launched in 2006 for girls and young women, quickly became one of Merck's top-selling vaccines, thanks to aggressive marketing and attempts to get states to require girls to get the vaccine as a requirement for school attendance.”

Just as I began, in my own mind, to question ethics of mass vaccinations of prepubescent girls, Dr. Harper dropped another bombshell. “There have been no efficacy trials in girls under 15 years,” she told us.

Merck did study a small group of girls under 16 who had been vaccinated, but did not follow them long enough to conclude sufficient presence of effective HPV antibodies.

If I wasn’t skeptical enough already, I really started scratching my head when Dr. Harper explained, “if you vaccinate a child, she won’t keep immunity in puberty and you do nothing to prevent cervical cancer.”

But it turned out that she wasn’t arguing for postponing Gardasil vaccination until later puberty, as I first thought.

Rather, Dr. Harper only emphasized to the doctors in the audience the need for Gardasil booster shots, because it is still unknown how long the vaccine immunity lasts.

More booster shots mean more money for Merck, obviously.

I left Dr. Harper’s lecture convinced that Gardasil did little to stop cervical cancer, and determined to answer another question that she had largely ducked: Is this vaccine safe?

Here’s what my research turned up. To date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse effects include Guillain-Barre syndrome, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.

Dr. Harper, who seems to specialize in dropping bombshells, dropped another in an interview with ABC News when she admitted, “The rate of serious adverse events is greater than the incidence rate of cervical cancer.” 

This being the case, one might want to take one’s chances with cancer, especially because the side effects of the vaccine are immediate, while the possibility of developing cancer is years in the future.

In the clinical studies alone, 23 girls died after receiving either Gardasil or the aluminum control injection. 15 of the 13,686 girls who received Gardasil died, while 8 died among the 11,004 who received the aluminum shot. There was only one death among the group that had a saline placebo. What this means is that 1 of every 912 who received Gardasil in the study died (see page 8 of Merck’s prescribing information). 

The cervical cancer death rate is 1 of every 40,000 women per year. 

The numbers of deaths and adverse effects are undoubtedly underestimates. Dr. Harper’s comments to ABC News concur with the National Vaccine Information Center’s claim that “though nearly 70 percent of all Gardasil reaction reports were filed by Merck, a whopping 89 percent of the reports Merck did file were so incomplete there was not enough information for health officials to do a proper follow-up and review.” On average, less than 10 percent—perhaps even less than 1 percent—of serious vaccine adverse events are ever reported, according to the American Journal of Public Health.

Given the severity and frequency of Gardasil adverse reactions, I definitely wasn’t the only one in Dr. Harper’s audience who winced when she dismissed most Gardasil side effects as “easily just needle phobia.”

Due to the young age of the trial participants and the short duration of the studies, the effects of Gardasil on female fecundity have not been studied. I did discover, in my post-conference reading, that Polysorbate 80 (sometimes referred to as “Tween 80”), an ingredient in the vaccine (see page 14 of Merck’s prescribing information)  has been observed in a European clinical study to cause infertility in rats. Is this an additional concern? Time will tell.

I do not wish to give the impression that Dr. Harper presented, even inadvertently, a consistently negative view of her own vaccine. She did tout certain “real benefits,” chief among them that “the vaccine will reduce the number of follow-up tests after abnormal PAP smears,” and thereby reduce the “relationship tension,” “stress and anxiety” of abnormal or false HPV positive results.

To me, however, this seems a rather slim promise, especially when weighed against the deaths and side effects caused by the Gardasil campaign. Should millions of girls in the United States, many as young as 9, be put at risk, so that sexually active adults can have less “relationship tension” about false positive HPV results?

Is the current rate of death, sterility and serious immune dysfunction from Gardasil worth the potential that, in 60 years, a minimal amount of a cervical disease (that is already decreasing on its own) may perhaps be reduced?

But what I really wanted to know is why Merck is so eagerly marketing such a dangerous and ineffective vaccine? Aren’t there other ways they could make a profit?

While Merck’s behavior is probably adequately explained by the profit motive, what about those in the Health and Human Services bureaucracy who apparently see Gardasil as medicine’s gift to women?

What motivates them?

I (Steve) think that they see Gardasil as what one might call a “wedge” drug. For them, the success of this public vaccination campaign has less to do with stopping cervical cancer than it does with opening the door to other vaccination campaigns for other sexually transmitted diseases, and perhaps even including pregnancy itself.

For if they can overcome the objections of parents and religious organizations to vaccinating prepubescent—and not sexually active—girls against one form of STD, then it will make it easier for them to embark on similar programs in the future.

After all, the proponents of sexual liberation are determined not to let mere disease—or even death—stand in the way of their pleasures. They believe that there must be technological solutions to the diseases that have arisen from their relentless promotion of promiscuity. After all, the alternative is too horrible to contemplate: They might have to learn to control their appetites. And they might have to teach abstinence. 

Joan Robinson is assistant editor for the Population Research Institute. [By Joan Robinson and Steven Mosher; 26Oct09, ALL Pro-Life Today]

NOVEMBER 2009

CDC Reverses Gardasil Vaccine Requirement for Immigrants

By Matt Anderson and Kathleen Gilbert

WASHINGTON, D.C., November 20, 2009 (LifeSiteNews.com) - The U.S. Center for Disease Control announced Friday that starting December 14 it will no longer require female immigrants, ages 11 to 26 seeking permanent resident status, to receive the controversial human papilloma virus (HPV) vaccine Gardasil before entering the United States.

Simone Davis, a 17 year-old British immigrant to the United States, has been seeking citizenship status but was blocked in her search by the requirement for Gardasil. Davis, who is a devout Christian, believes that pre-marital sex is wrong and did not see the necessity for her to receive the vaccine that guards against cervical cancer and other STD's since she has pledged to remain abstinent until marriage.

"I am only 17 years old and planning to go to college and not have sex anytime soon," she told ABC News. "There is no chance of getting cervical cancer, so there's no point in getting the shot."

Davis, who was facing deportation, was also concerned with negative effects attributed to the vaccine.

Since its release in 2006, the vaccine has been linked to 47 deaths.

In 2008, the FDA documented 6,723 "adverse events" related to Gardasil; 1,061 were considered "serious," and 142 considered "life threatening" according to the FDA's Vaccine Adverse Event Reporting System (VAERS.) The reported side effects included Guilliane-Barré Syndrome, lupus, seizures, paralysis, blood clots and brain inflammation, among others.

According to a report by the Associated Press, the HPV vaccine was required by the CDC starting July of 2008.

However, soon after the announcement many immigrant, health, and woman's advocacy groups challenged the requirement arguing that since U.S. citizens are not obligated to get the vaccine, immigrants shouldn't be forced to either.

On November 13, though, the CDC announced that the HPV vaccine did not meet the criteria for being a required vaccine for immigrants. According to the CDC, to be required, a vaccine "must be age-appropriate for the immigrant applicant, … protect against a disease that has the potential to cause an outbreak, and … protect against a disease that has been eliminated or is in the process of being eliminated in the United States."

Christine Pearson of the CDC told LSN in an e-mail, "These criteria were not developed specifically with HPV in mind but were developed after concerns were raised about whether HPV was necessary as part of the immigration process."

Although 90% fo HPV infections resolve themselves without treatment after two years, Gardasil is administered as a preventative against cervical cancer, since HPV may be connected to the later development of cervical cancer. 

Yet Dr. Diane Harper, a Merck Pharmaceutical researcher who helped develop Gardasil, admitted  that girls were more likely to suffer adverse affects from Gardasil than develop cervical cancer, and that Gardasil was ultimately expected to effect a "very minimal" reduction of the U.S. cervical cancer rate. 

The CDC announcement comes only weeks after the Alliance Defense Fund filed a brief with U.S. immigration services on behalf of Simone Davis. In September, Simone was denied a waiver that would have allowed her to opt out of the vaccination requirement on the grounds it violated her religious convictions. On October 22, ADF filed the brief seeking to overturn the immigration service's denial.

In the brief, ADF said "Because HPV is passed through sexual activity, receiving the HPV vaccine for protection in case Simone has sex would be the same thing as giving her a condom to put in her purse 'just in case.' It violates her commitment to remain pure until marriage, a commitment she made as part of her Christian faith"

In response to the CDC announcement, ADF Senior Legal Counsel Joel Oster told LSN, "We are pleased that the path has now been cleared for the government to grant Simone citizenship without forcing her to violate her religious beliefs."

"The government should not be forcing applicants for citizenship to violate their sincerely held religious beliefs in order to become a citizen, especially when the same requirement is not placed on natural-born citizens.  We are glad that the government has stopped this double-standard"

For more information on Gardasil please visit: http://www.nvic.org/

--------------------------------------------------------------------------------

 CERVARIX  (GlaxoSmithKline)

PFLI PharmAid Center, www.pfli.org


PharmFacts E-News Update -- 1 Jul 2008

NB: GSK announced yesterday that their HPV vaccine, Cervarix, will be delayed in the US until sometime in late 2009 due to less than stellar results submitted to the FDA...

www.google.com/news/url?sa=t&ct=us/0-0&fp=486aa268c1550cc7&ei=TnJqSJupMIfsyATvnJjHAw&

url=http%3A//online.wsj.com/article/SB121484151326916113.html%3Fmod%3Dgooglenews_wsj&

cid=1224229756&usg=AFQjCNG82std0P5cNCHVdx7gG2XXK_ascg
 

ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com

FYI

***Though approved for marketing by the FDA in May 2006, Merck's HPV vaccine, Gardasil, is still in the testing stages, and will not be fully evaluated for safety until September 2009.

Gardasil gained FDA approval under a fast track process--within 6 months of testing. Fast-track approval is a process reserved for life-saving products with the potential to fill an unmet medical need, such as, new cancer treatments or AIDS drugs.

A special report issued by Judicial Watch, "Examining the FDA's HPV Vaccine Records: Detailing the Approval Process, Side-Effects, Safety Concerns and Marketing Practices of a Large-Scale Public Health Experiment" is (June 30, 2008) shows that aggressive lobbying by Merck--rather than medical need backed by scientific data--led the FDA to approve Gardasil before adequate testing for safety had been completed.

The report is a MUST READ for every parent considering vaccinating a daughter with Merck's papillomavirus (HPV) vaccine, Gardasil. The report should be required reading for every public health official and policy maker.
http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf

Thousands of documents were obtained by Judicial Watch after filing a lawsuit against the FDA.  The documents include Merck's patent and drug information submitted to the
FDA, transcripts and briefing material from approval meetings, and reports documenting health, safety, and efficacy test results, as well as Vaccine Adverse Event Reporting System (VAERS) documents.

VAERS reports provide details about 8,864 cases of adverse effects experienced by girls and women after receiving the Gardasil vaccine. 

Since January 2008, the FDA identified 140  as "serious" reports (27 were categorized as "life threatening"), 10 spontaneous abortions and 6 cases of Guillain-Barre Syndrome .  VAERS reports show that at least eighteen people have died after receiving Gardasil. 

See adverse effect reports submitted to VAERS: http://www.judicialwatch.org/gardasil

Adverse report excerpts include:

    * Information has been received...concerning a 20 year old female with no medical history reported, who on 01-APR-2008 was vaccinated with a dose of Gardasil....The patient died four days after...patient sought unspecified medical attention. An autopsy was performed which ruled out suicide and anything suspicious. The cause of death is currently unknown. VAERS ID: 310262-1 (D)

    * Information has been received.concerning a 23-year-old female.who on 31-JAN-2008 was vaccinated with her 1st dose of Gardasil...the patient experienced anaphylactic shock 2 minutes after vaccination characterized by a brief loss of consciousness...respiratory arrest, eyes rolled upwards, blurred vision and greyish skin tone...Anaphylactic shock was considered to be immediately life-threatening. VAERS ID: 304739-1 (S)

    * Cold sweat, Fall, Foaming at mouth, Grand mal convulsion, Immediate post-injection reaction....Pt [patient, 14-year-old female] received vaccine, took 6 steps, fell to the ground unconscious and had a 60 sec grand mal seizure then regained consciousness. [Blood pressure] after seizure 60/40 pale clammy skin. [Patient] had bit her tongue and had foam around her mouth. VAERS ID: 305259-1 (S)

    * Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a dose of Gardasil. Subsequently, the patient experienced a coma and is now paralyzed. At the time of this report, the patient's outcome was unknown. VAERS ID: 303188-1

Most health officials believe that adverse reactions to medications are vastly underreported, as they are optional.

Safety experts estimate that only between 1% and 10% of adverse effects are reported.

Therefore the actual number of adverse events occurring after vaccination with Gardasil is likely to be much higher.

Based on the reports submitted to the VAERS database, Gardasil is demonstrably a risk-laden vaccine.

Even without Gardasil, cervical cancer deaths have decreased drastically in the past several decades. The American Cancer Society estimates that deaths from cervical cancer declined 74% between 1955 and 1992, and that the rate continues to decrease by about 4% each year.

Since condoms are indisputably a safe, non-invasive, cost-effect method for protecting boys and girls / men and women against ALL sexually transmitted diseases -- Why are we exposing American girls and young women to a public health experiment whose benefits are unclear while its risks include death ?

Below is the Executive Summary of Judicial Watch's special report.

Contact: Vera Hassner Sharav

212-595-8974

Food and Drug Administration (FDA) approval of Cervarix: The FDA approved a second HPV vaccine for the prevention of cervical cancer and precancerous cervical lesions in females aged 10 to 25 years.1 Cervarix, a bivalent vaccine made by GlaxoSmithKline, targets HPV types 16 and 18. Infections with these two types of HPV are reported to be responsible for about 70% of cervical cancer.1 Although Cervarix has been approved for use in the US only very recently, it has been widely used throughout the world for several years.2 [OCTOBER 2009]