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

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

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

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

©2012 An Inconvenient Woman. All Rights Reserved.

Merck’s HPV vaccine, Gardasil, was approved by the FDA and endorsed by the Center for Disease Control (CDC)  in June of 2006. According to the Merck marketing literature, the $360, three shot-series of Gardasil, administered over six months, protects against two HPV strains that cause nearly 70 percent of cervical cancer cases and also prevents two other strains linked to 90 percent of genital warts cases. The nationwide rollout of Gardasil  was accompanied by an award-winning marketing blitzkrieg that helped raise the profile of HPV through a large-scale communications campaign, highlighted by the “Tell Someone” TV adds shown on channels with high-teen viewer-ship. Additionally, Merck waged an extensive lobbying campaign in State-houses, Congress, city councils and regulatory agencies.  Merck & Company carpet bombed the halls of power with cash, goods, services and favors to be named later. The ‘Charm and Cash Offensive’ yielded early victories amongst Federal regulators and ‘soft target’ states.

By early 2007, Wall Street analysts predicted Gardasil would generate $2 billion to $4 billion that year even without the sought-after State mandates. The State mandates offered legal cover and protected Merck shareholders from future vaccine liability losses. Based on projected Gardasil sales, the 2006 Merck Annual Report promised shareholders excellent market share and increased dividends. Good news indeed, for shareholders battered by the losses Merck endured after it pulled Vioxx off the market in 2004 (Vioxx, an FDA-approved anti-inflammatory drug for osteoarthritis and acute pain that was used by 2 million people, was linked to increased risk of heart attack and stroke.)

Things were finally“looking’ good in the Merck neighborhood”…until the public  started to question why politicians were moving so quickly to Mandate the very expensive, newly released, HPV vaccine for school girls.

Critics pointed out that this vaccine is not to prevent childhood disease like mumps, measles or chicken pox…contagious  diseases that can move through schools quickly, effecting large numbers of children. Gardasil is a vaccine for a  sexually transmitted virus, that if left undetected by regular PAP screening, could lead to cervical cancer in a woman’s later years. Gardasil ‘protects’ girls from cervical cancer, the most easily detected and treatable of all the cancers that affect women.

Once a major killer in the U.S., cervical cancer has been nearly wiped out since the creation of the Pap test, which detects precancerous lesions and early cancer, and is credited with a 74 percent drop in cervical cancer deaths since 1955.

The CDC says most cervical cancer diagnoses in the U.S. are in women who either have never had a Pap test or have not had a Pap test in the previous five years. Those inoculated with Gardasil still will have to have regular Pap tests for the disease, which is hard to detect because it does not usually cause pain.

Cervical cancer does have high mortality rates in low-income regions of U.S. and poor nations where health care coverage is not routine. Cervical cancer is the fifth most common cancer among women worldwide, according to the World Health Organization, and kills about 230,000 women a year, most in developing countries. Because of these figures, public health officials still back use of the vaccine.( Note: When Merck is making it’s pitch for the need for Gardasil, they always quote the World HPV infection rates and Cervical cancer deaths, not the cervical cancer numbers for the United States.)

“The vaccine is not nearly as effective as vaccines for mumps or measles, but it is an important step forward in public health,” said Dr. John Swartzberg, director of public health policy at the University of California at Berkeley. “The vaccine will decrease the two most common strains of HPV that cause cancer, and we’ll be left with strains that have far less potential to cause cancer. In this case, the benefits outweigh the risks.”

That sounds like a great justification for childhood inoculation
until you start thinking about everything we just don’t know yet…

As with any new drug, there are potential risks that short-term studies used for federal approval don’t detect. Dr. Clayton Young, an obstetrician-gynecologist in Texas, is concerned that Gardasil will actually strengthen cancer-causing strains of HPV.

“My concern is that we are pushing ourselves into something worse than we already have,” Dr. Young said. “Vaccinating for only two strains may lead to an increase in infection with other and possibly more aggressive strains.”

Gardasil is effective against two of 10 carcinogenic HPV strains. In the United States, those two strains dominate the current statistics, estimated to have caused 6,800 new cervical cancer cases in 2006, while the other eight strains combined affected 2,900 women.

In answer to the issue of Gardasil possibly producing  more aggressive HPV strains, Dr. Haupt, executive director of medical affairs in Merck’s vaccine division, has said, “The probability of additional cancer-causing HPV strains leading to as many cervical cancer cases as today is minute.” Despite Merck’s doubt, the company is studying the additional cancer-causing HPV types in Scandinavian countries, where national cancer registries allow drug companies to track people with the disease. “It is an important issue to us,” Dr. Haupt said. “But we think the two types of HPV that Gardasil work for are unique, and if other types become more common, they will not cause cancer at the same rate and won’t over time.”

What about Merck’s early lobbying push for State mandated Gardasil shots for school girls?

State mandated Gardasil shots for preteen girls to protect them from the viruses that causes cervical cancer, are targeting the wrong age group.

Middle-school girls inoculated with the HPV vaccine will be no older than eighteen when they pass Gardasil’s five-year window of proven effectiveness  — more than a decade before the typical cancer patient contracts the sexually transmitted human papillomavirus (HPV). Merck & Co. has repeatedly refused to respond to requests for its HPV incubation statistics, stating that it is still studying the longevity of Gardasil.

Infectious disease specialists and cancer pathologists say the incubation period for HPV becoming cancer is 10 to 15 years — meaning the average cervical cancer patient, who is 47, contracted the virus in her 30s and would not be protected by Gardasil taken as a teen.

“It is a delicate balancing act,” said Debbie Saslow, director of breast and cervical cancer control at the American Cancer Society. “If the vaccine is given at too young an age, it may wear off. Yet if it is given too late, it won’t work”

Lets Look At The Numbers

In July of 2007, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, endorsed the Gardasil inoculation for girls 11 to 12 and Merck lobbyists persuaded  lawmakers and regulators to start the fast-track push for  mandatory HPV vaccination legislation.

Dr. Joseph Bocchini, chairman of the committee on infectious disease of the American Academy of Pediatrics, says HPV can take up to 20 years to cause cervical cancer. “It can occur more rapidly, but very commonly, it is a 20-year period before it leads to cancer,” said Dr. Bocchini, whose group has endorsed HPV vaccinations on 11- and 12-year-olds but has withheld support for its mandated use.

Even when applying a longer 20-year incubation period, requiring Gardasil for sixth-grade girls, as nearly all the current and proposed legislation does, would not prevent the overwhelming majority of cervical cancer cases in the U.S.

American Cancer Society numbers show that from 2000 to 2003, more than 70 percent of cervical cancer patients were older than 40 — still outside Gardasil’s five-year protection window if given to sixth-graders.

Merck is working on a booster shot to extend Gardasil’s five years of protection. “We are aware of some evidence of immune memory. But if a booster shot is necessary, it would likely be another dose of Gardasil,” Dr. Haupt said.

Vaccine boosters vary in longevity. A ‘hepatitis B’ booster is required every 10 years, while others can provide lifelong immunity. None of the current or proposed HPV vaccine legislation addresses the potential for booster inoculations that could fall outside the enforcement mechanism — rules that bar students from school unless they have the required shots.

According to the CDC, seventy percent of females are sexually active by age 18. “The point in vaccinating kids 9 to 12 is not to reduce number of cases found in that age group, but to vaccinate prior to beginning sexual activity,” said CDC spokesman Curtis Allen. “The benefits of the vaccine decrease as women age because they are more likely to have already been infected by one of the HPV strains.”

But based on cancer statistics, cervical cancer incubation periods, and the five-year life-span of Gardasil, state lawmakers — who have billed the inoculations as a cure to cervical cancer — would have a much greater effect on cervical cancer rates by mandating its use later. Cervical cancer rates are less than one per 100,000 women until age 20 and then begin to pick up in the late 20s and early 30s. Thus, women who likely contracted HPV in their early 20s could be protected by Gardasil taken at 17 or 18.

In April 2006,  Lancet, a British medical journal published a study that concluded the GlaxoSmithKline HPV vaccine, Cervarix, is effective for 4½ years. Cervarix is not yet licensed for use in the United States, but is in wide use throughout Europe. So the targeted age group is a problematic for the EU legislators proposing mandatory HPV vaccination polices as well.

What is the probability of a school girl in America contracting cervical cancer later in her life?

Dr. Mona Saraiya, a medical epidemiologist in the Division of Cancer Prevention and Control at the CDC, says nearly all sexually active woman are exposed to HPV.

“However, only a few will get an infection that stays and won’t go away, and only a portion of those will get a precancerous lesion. At that point, only a few will eventually develop cervical cancer,” Dr. Saraiya said.

Fewer than one-hundredth of 1 percent of the 108 million U.S. women older than 18 (0.009 percent) get cervical cancer and even fewer die from it. There were an estimated 9,700 new cervical cancer cases and 3,700 fatalities in 2006, according to the American Cancer Society.

But the fact that very few U.S. women are affected by cervical cancer, hasn’t stopped the rush by lawmakers to push mandatory HPV vaccines for school girls.

“The number one problem with the vaccine is that it has not been tested adequately on the group that is recommended to get it,” said Dr. Joseph DeSoto, a fellow in the American Institute of Chemists and a physician-scientist at the National Institutes of Health.

According to Merck’s clinical study documents on Gardasil, 20,541 women ages 16 to 26 participated in four studies. The documents show some data is available on 9-year-old girls related to immune responses to the vaccine but not whether it prevents cancer.

Because most 9-year-old girls are not sexually active, it is not possible to test the effectiveness of Gardasil against cervical cancer, Dr. Haupt said. Instead, the clinical trials measured antibody responses against HPV as a proxy for cervical cancer.

Merck conducted two clinical trials that involved 1,121 girls ages 9 to 15, according to Merck’s labeling documents for Gardasil.

“The clinical trials tested younger girls, but they only looked at immune response to the vaccine, not whether it prevented cervical cancer,” Dr. Young said. “It has not been studied long enough to know that it prevents cervical cancer.”

Will Gardasil be a Mandated Vaccine For ALL American School Girls?

Well before FDA regulators approved the HPV vaccine, Gardasil,  in mid-2006, Merck’s lobbyists had started “Education Programs” aimed at State Representatives, Governors, and special interest groups to instigate a rapid deployment plan to mandate the Gardasil vaccine  for school girls around the country. In early 2007,  reacting to a furor from some parents, advocacy groups, public health experts, and after several public relation disasters precipitated by inept politicians like Texas Governor Rick Perry, ‘ham-handed’ Executive Order mandating the Gadasil shot for every school girl in Texas, Merck said that it would stop lobbying state legislatures to require the use of its new cervical cancer vaccine. The speed with which legislatures and other Government officials moved to require use of the vaccine before school entry has galvanized critics. Some say making a vaccine mandatory would pre-empt parental choice; others contend that protection from a sexually transmitted virus would encourage promiscuity. These voices were joined by others worried about the influence of pharmaceutical companies over our “Representative” Government. Many of the legislators who have sponsored some of the state laws to make the vaccine mandatory, are members of  Women in Government. WIG is a non-profit organization that is heavily subsidized  by Merck.

Merck representatives are quoted as publicly stating the company would stop lobbying specifically for state mandates, many of which would require girls to be vaccinated before they entered sixth grade. Merck made the decision to stop lobbying legislators  after realizing that their campaign had fueled objections across the country that could undermine adoption of the vaccine.

Dr. Richard M. Haupt, executive director for medical affairs in Merck’s vaccine division, said the company had acted after hearing from public health officials and medical organizations that its campaign was counterproductive. “They believe the timing for the school requirements is not right,” Dr. Haupt said, adding: ”Our goal is to prevent cervical cancer. Our goal is to reach as many females as possible. Right now, school requirements and Merck’s involvement in that are being viewed as a distraction to that goal.”

But Dr. Haupt said that Merck would continue to provide health officials and legislators with education about the vaccine and would continue to lobby for more financing for vaccines in general. Public Interest groups continue in their attempts to track the  money and staff resources Merck had expended in its efforts to require use of the cervical cancer vaccine.

Dr. Larry K. Pickering, executive secretary of the Advisory Committee on Immunization Practices, the federal panel that originally recommended the vaccine’s use, applauded Merck’s decision to stop lobbying. ”They finally are going to stop doing that, which all of us will be happy about,” he said. Dr. Pickering, who works at the Centers for Disease Control and Prevention, said that while the vaccine was useful, more data on its safety, effectiveness and cost was needed. Objections to the vaccine could undermine its use. ”I think it has been somewhat counterproductive. Anything that takes away from the process of getting vaccine into people is deleterious to the whole process.”

Merck Put A Noble Spin to Getting Caught Handing Out Cash For Legislative Favors

“Merck’s goal is to support efforts to implement policies that ensure that Gardasil is used to achieve what it was designed to do: help reduce the burden of cervical cancer — the second-leading cancer among women around the world — and other HPV-related diseases for as many people as possible, and as quickly as possible,” Merck’s Dr. Haupt said about its lobbying efforts.

If you are concerned about the possibility of legistlation concerning mandatory HPV vaccines for school girls keep your eye on your representatives.

The current Merck position on lobbying is all about “For Now”.
Merck has only been delayed, not deterred.

©2012 An Inconvenient Woman. All Rights Reserved.

The Germans call it Schweinegrippe, the French talk about la Grippe A. The World Health Organization now calls it “influenza A(H1N1),” and so do government officials in many countries, but not the Dutch, who are sticking with “Mexican Flu.” The Mexican ministry of health, meanwhile, often calls it simply la epidemia.

Martin Enserink of the Science Insider recounts how political correctness is effecting the ever evolving nomenclature of the influenza virus. A few months after the world woke up to the threat of an influenza pandemic, a Babylonian confusion has arisen about what the virus—and the pandemic, if it happens—should be called. And some virologists say WHO’s new name, A(H1N1) may be politically correct but isn’t very clear and is not going to stick.

The U.S. team that first officially reported two cases of the new virus on 21 April called it “swine influenza A (H1N1)” simply because its genes matched those of viruses previously found in pigs. WHO adopted that name as well; during a 27 April teleconference with reporters, WHO influenza expert Keiji Fukuda used the words “swine flu” 22 times, and when asked the next day by a German reporter whether that name was appropriate, Fukuda said “the virus that is identified is a swine influenza virus,” and “we do not have any plans to try to introduce any new names for this disease.”

In the Morbidity and Mortality Weekly Report, researchers from the U.S. Centers for Disease Control and Prevention came up with several creative alternatives, including, on 29 April, “swine-origin influenza A (H1N1) virus,” S-OIV for short. The same name also appears in a paper that was published online May 7, 2009 by The New England Journal of Medicine. But in the 6 May issue of MMWR, CDC coined the name “novel influenza A (H1N1) virus,” this time without an acronym. “It’s clearly a name that is evolving fast,” says Derek Smith, who studies flu virus evolution at the University of Cambridge in the United Kingdom.

WHO’s new name resembles the strict conventions used to distinguish individual virus isolates in the scientific literature. In that system, A/duck/Vietnam/43/2007 (H5N1) is the 43rd A(H5N1) virus isolated in Vietnam in 2007, and it came from a duck. (The species name is sometimes left out for human isolates.) But A(H1N1) alone makes less sense, says virologist Albert Osterhaus of Erasmus Medical Center in Rotterdam, the Netherlands. One of the three subtypes that make up seasonal influenza every year is also an A(H1N1), and so is the virus that caused the 1918–19 pandemic, widely known as the “Spanish flu.” “It’s unfortunate, because it creates confusion,” says Smith.

Nobody is in charge of naming pandemics either. The “Spanish flu” didn’t originate in Spain; it got its name because that country, not involved in World War I, didn’t keep reports about the disease out of the press, thus creating the mistaken impression that it was very hard hit. The 1957–58 pandemic, first seen in China and caused by an H2N2 strain, came to be popularly known as the “Asian flu.” The pandemic of 1968–69, an H3N2 strain, went down in history as the “Hong Kong flu,” because that’s where the first known outbreak occurred.

Calling the new outbreak the “Mexican flu” fits nicely with that tradition, says Osterhaus, who believes that it will be the popular name for the pandemic no matter what public health officials say. That’s also why the Dutch Outbreak Management team, an expert group of which he is a member, continues using the term “Mexican flu,” as does the Dutch government. (Their insistence has triggered a fiery letter from the Mexican embassy in The Hague.) Thompson says there’s “ongoing discussions” at WHO about other potential names. Ideas abound: Some have suggested talking about the “North American flu” in an effort to continue the geographic tradition without singling out any country.

Jon Cohen of the Science Insider has compiled  this chronology of the H1N1 pandemic. This record will updated regularly as news breaks and past events come to light. This information and all hyperlinks have been provided by the Science Insider. If you use or refer to any if this information in your own research, please cite the Science Insider and include track back links. The Science Insider is a great publication and deserves our respect and support.

Influenza A Virus H1N1 Strain, Swine Flu Outbreak – Day by Day

©2012 An Inconvenient Woman. All Rights Reserved.

JayaJan Pharmaceutical Research in India was one of the companies with which Merck had a contract to test Gardasil. Like most of the industry, Merck increasingly outsources its clinical trials to Contract Research Organizations (CROs) in areas of the world where trial subjects are plentiful, operating costs are low, and regulations lax.

Some $285 million worth of clinical trials are outsourced to CROs in India, according to biopeer.com.  These CROs are a booming $15 billion industry whose revenues are rising at 15 percent a year.

“CROs are known for their speed and efficiency; they can complete a clinical trial in two-thirds the time a drug company can, shaving months off the process and offering $120 million to $150 million in increased revenue per drug.” Sam Bidwell an executive with Quintiles a U.S.-based CRO told Nature. “Of the top 30 best-selling drugs, we’ve touched every one.”

Critics point out that CROs can come with built-in problems. Conflicts of interest can arise when CROs are paid royalties only after a drug is approved rather than being paid a set fee that is independent of how safe or effective the drug turns out to be. Problems can also arise because CROs know that favorable findings mean that research into a test drug will continue, and they may also believe that results that please the hiring corporation can lead to future contracts. “Companies know that the farther the compound moves through the research cycle, the more money they can raise,” Nature reported.

Merck spokesperson Amy Rose refused say how many trials Merck contracted to CROs or what percentage of the Gardasil subjects these contractors recruited in the Third World. She also refused to specify how, or even if, the company oversees CROs.

Many consumers assume that the FDA carefully monitors CROs. But the agency hobbled by under-funding, politicization, and dependence on industry fees has few resources to assess foreign trials and relies on drug companies.

In the case of the JayaJan Pharmaceutical Research Gardasil cervical cancer vaccine clinical trials, the FDA was forced to rely on the veracity of one of the largest pharmaceutical companies in the world, Merck & Co, Inc.

In the past, Merck & Co, who refers to itself as a global pharmaceutical research company, has allegedly falsified, suppressed, or misrepresented the results of clinical trials to make some of its products seem more safe than they really are.

Merck supports the Fast Food Nation by promoting drugs that treat ailments associated with bad eating habits. Drugs prescribed for high cholesterol, hypertension, and heart failure are among Merck’s most profitable product lines. Merck employed 59,800 people worldwide in 2007, and reported $24.2 billion in sales. In October 2008, the New York Times reported that Merck announced plans to cut 7,200 jobs, or 12 percent of its workforce. The layoffs are not in response to the financial crisis, but rather the result of falling drug and vaccine sales. As their patents expire, large pharmaceutical companies are faced with skyrocketing competition from cheap generics. The job cuts are expected to save the company up to $4.2 billion in operating costs over the next four years, though they will need to spend up to $2 billion in reorganization and severance costs.

Cost cutting did not extend to Merck’s ongoing political lobbying to secure state mandated HPV vaccination programs. If a vaccine is mandated by a State or Federal agency, a victim of an adverse vaccine event CAN NOT sue Merck directly. The injured individual or their surviving kin must go through Vaccine Court that has a set limit on damages. Totally sweet for Big Pharma who has been known to rush a product to market, and totally sucks for the citizens who trusted the governments Drug safety oversight process to protect them and their children.

According to opensecrets.com, during the 2008 election cycle, Merck & Co’s political action committee gave $572,499 to federal candidates. Fifty-one percent went to Democrats, 49 percent went to Republicans. Of course additional money was spent through PACs, Committees, and plain brown wrapper. How much money, to whom, to what apparent result, is a topic for a future Blog.

Green America has reported that Merck has repeatedly violated water pollution regulations and has fought against measures meant to improve water quality near its manufacturing facilities.  I don’t know how the FDA Honcho’s feel about Merck recent history in the “Good Corporate Citizen” department, but personally, I would be inclined to check for my ring, watch and wallet, if I ever bumped into a Merck exec prowling the halls of ant Local, State or Federal office.

©2012 An Inconvenient Woman. All Rights Reserved.

Old school journalism would have described the Reuters story titled ‘Allergic Reactions to Gardasil Uncommon’, as “having legs”. The ‘Next-Gen’ journalist would describe the story as ‘going viral’.

The implied “No-Worries Mate” message was carried in Newspapers, Blogs and Journals across the Commonwealth and though out the US and EU. As I read the various accounts, I tracked the story back to the original published study, I wanted to know how many study participants, followed over what period of time, at what location, and who designed and funded the study and why.

The study was conducted in Australia, in 2007 and reported in The British Medical Journal in Dec 2008. Sharon Choo of the Royal Children’s Hospital in Melbourne reported that during 2007 more than 380,000 doses of the vaccine had been administered in schools in Victoria and South Australia under the Australian immunization program. Choo and colleagues noted some components of Merck’s treatment — such as aluminum salts and yeast — have been associated with allergic reactions. In the British Medical Journal article, published in late 2008, she and her colleges are quoted as saying,  “Our clinical recommendation is that females with suspected hypersensitivity to the quadrivalent vaccine should be evaluated before receiving more doses, and any challenges with the same vaccine should be carried out in a supervised setting.”

In the British Medical Journal Article, Dr Sharon Choo and her Australian colleagues described the results of clinical evaluation, skin tests, and vaccine challenge in schoolgirls with suspected hypersensitivity to 4vHPV. “Thirty-five schoolgirls with suspected hypersensitivity reactions including urticaria (hives), generalised rash, angioedema (swelling of subcutaneous tissues) and anaphylaxis were reported to specialised immunisation services and 25 agreed to be referred to paediatric allergy centres for further evaluation.”

A detailed account of the reactions was noted including previous doses of the vaccine, time and severity of reaction, and previous clinical history. Skin prick tests of the quadrivalent and bivalent HPV vaccines were carried out, and vaccine challenges were administered intramuscularly. The schoolgirls were followed-up by telephone one week after the subsequent dose and any adverse events were recorded.

The researchers report that 19 girls had skin testing of the quadrivalent vaccine and all were negative. Seventeen of the 18 girls subsequently challenged with the quadrivalent vaccine tolerated further doses. One reported limited urticaria (hives) four hours after the vaccine was given.

Choo and associates reported that only three of the 25 evaluated schoolgirls had probable hypersensitivity to the quadrivalent vaccine, and conclude that true hypersensitivity is uncommon. They point out that suspected hypersensitivity reactions such as hives are often “idiosyncratic” and do not increase the risk of adverse reactions in subsequent vaccinations.

Immunisation specialist Dr Jim Buttery, who works at the Royal Children’s Hospital, declared Gardasil safe but said all adverse effect reports are taken seriously. The authors recommend that girls with suspected hypersensitivity to the quadrivalent vaccine should be evaluated before receiving more doses, and call for research into the mechanisms of hypersensitivity to the vaccine.

What is my take away?

OK, I’ve read the British Medical Journal article several times, as well as all the spin-off articles I could track and I have reached a conclusion and still have several questions.

My conclusion is that Doctor Choo and her colleagues were on the right track in 2007. Young women and girls need to be tested for hypersensitivity before being vaccinated with Gardasil.

Just reading the ‘FDA-approved product sheet Merck provides for Gardasil gets you there. The Gardasil product sheet clearly states:

“WHO SHOULD NOT RECEIVE GARDASIL?
Anyone who:
Is allergic to any of the ingredients in the vaccine. A list of ingredients can be found at the end of this leaflet.”

The only way to know if a girl is allergic to Gardasil’s chemical amalgam would be to test her BEFORE the shot.

Based on the number of adverse reactions being reported around the world, it is time to step back and add a pre-vaccination safety procedure.

Merck has injected a sense of urgency around the HPV vaccine, that is simply not justified based the ‘developed’ world’s experience with Cervical cancer. In the developed world cervical cancer is rare, detectable and treatable inexpensively with current technology. The only rational for the red-hot hurry is Merck’s shareholders. In the undeveloped world, were cervical cancer is still a very real danger to women, Gardasil is too costly to deploy. It makes far more sense to find ways to get affordable cervical cancer screening and treatment to women in the developing countries, than spend Billions in the developed world chasing down, the possibility of a cancer that is already under control.

In my opinion, Dr Choo had the right question, but didn’t pursue it long enough.

With all due respect to Doctor Choo and colleagues, when did a “Study of 25 Australian girls” that indicated 3-girls with suspected hypersensitivity to the vaccine out of the hundreds of thousands of does administered become a “Study”? If this were consumer survey, 25 would be considered an insignificant sampling, considering some 380,000 doses of the vaccine had been administered in schools in Victoria and South Australia at the time of the “Vaccine Hypersensitivity Study”.

Professor Ian Frazer at University of Queensland is a co-developer of the cervical cancer vaccine. Australia was one of the first countries to roll out a national cervical cancer immunization campaign using Gardasil. According to published government statistics, 700 new cases of cervical cancer are reported each year in Australia, and in 2005 cervical cancer led to the deaths of 216 women The Australia government has strongly supported the National immunization program, and has given every indication that they fully intend to administer the HPV Vaccine to all females aged 12 to 26 in the country.

As of second quarter 2009, approximately 4.7 million doses of Gardasil have been distributed in Australia.  According to official Australian government reports, there have been 1,304 suspected adverse events following vaccination with Gardasil. Australian health officials have used the following talking points to describe the Gardasil-related adverse events. American readers will recognize them — we have heard them all before.

• With this number of people receiving the vaccine, even if all are healthy and young, some serious events can be expected within days or hours of vaccination by chance alone and unrelated to vaccination.

• No vaccine is completely without side effects, and so adverse events following immunization are carefully monitored in Australia and regularly reviewed by expert advisory groups.

• A significant volume of reporting of adverse events is often seen shortly after the introduction of a new, widely used vaccine because of the higher degree of vigilance and lack of familiarity with the new product. Many of the reported events (such as headache, feeling dizzy or unwell) may be equally common in people of the same age who have not received the vaccine.

• An April 1, 2009 government report stated that of the 1,304 suspected adverse reactions reported in Australia following vaccination with Gardasil, the great majority have been mild and common problems such as soreness, swelling, or redness at the injection site. Most of the adverse reactions that have been reported are well recognized and listed in the Gardasil Product Information.

What Non-Government Sources Are Reporting

The unofficial reports differ drastically from the reassuring tone of the Australian Health Officials.

In a December 2007 article in the Heraldsun.com.au, (Herald and Weekly Times) Natali Tkacruk Sikora reported that, “ Almost 500 girls have had adverse reactions such as seizures, rashes and paralysis after taking cervical cancer vaccine Gardasil in Australia since it was released in April.”

The article went on to report that as of November 30, 2007, “there had been 496 adverse reaction reports to the Therapeutic Goods Association (Australian equivalent to the FDA Vaccine Adverse Event Reporting System) with the HPV vaccine as the sole suspected cause.” Tkacruk Sikora reported that in the U.S. more than 2220 reports were lodged with VAERS in past 12-month period, including controversial reports of more than seven deaths.

In response to the Herald Sun article, University of Queensland Professor and Gardasil co-creator, Ian Frazer, the Australian Health Department and vaccine manufacturer CSL, dismissed allegations of associated deaths in the US, claiming the women died of unrelated causes. Professor Frazer, a leading immunologist and former Australian of the Year, blamed anti-immunization groups for exaggerating data as a scare tactic against inoculation. (I guess now would be a bad time to bring up Merck’s award winning ‘Scare tactics commercials’ touting the clear and immediate danger of cervical cancer…a cancer that is detectable, treatable and who’s rate of incidence and death has been steady falling for the past 50 years; ever since the invention of and wide spread deployment of the PAP test and minimally invasive cervical cancer treatments.) The article quoted “unnamed leading experts” who defended the benefits of Gardasil and dismissed controversial reports of overseas deaths as unrelated and fictitious. Apparently the “unnamed leading experts” have no problem with obfuscation. I hate to rain all over Doctor Frazer’s patent royalty checks, but healthy, vibrant, American girls have died after receiving the Gardasil vaccine. American girls have suffered critical illness post Gardasil injection. Girls and young women around the world are suffering adverse events after being injected with the HPV-vaccine.

Right now the only common denominator to the injury and death of these young women is the injection of the HPV vaccine, Gardasil. If Professor Ian Frazer, the Australian Health Department and vaccine manufacturer CSL, and the un-named leading experts have proof that the HPV vaccine, Gardasil is not the causative factor, than share it with the parents of the girls who have already been effected and educate the parents of the girls you want to vaccinate.

The injection of Garasil should require a signed informed consent form, a complete medical work-up to determine predisposition to genetic disease, a current assessment of the girls immune system and to quote Choo’s recommendation from the BMJ; “Our clinical recommendation is that females with suspected hypersensitivity to the quadrivalent vaccine should be evaluated before receiving more doses, and any challenges with the same vaccine should be carried out in a supervised setting.”

Until that series of prudent medical protocol is practiced, Australian parents can expect to hear the same bureaucratic babble as the parents in the other Commonwealth counties, America, and the EU.

The Therapeutic Goods Association (TGA) while refusing to reveal detailed results said, “Gardasil was monitored by the US FDA and Centres for Disease Control, and in Australia by the Adverse Drug Reaction Advisory Committee, the Australian Technical Advisory Group on Immunization and the National Immunization Committee.”

The TGA’s Dr Rohan Hammett said: “All . . . advised that current rates of adverse reactions are consistent with those expected with any vaccine.”

…and that statement my dear reader is a topic for another Blog.

Source:

British Medical Journal / Research paper: Human papillomavirus vaccine hypersensitivity reactions: retrospective cohort study in Australia BMJ Online
HPV vaccine (GARDASIL) Advice from the Australian Therapeutic Goods Administration 05.05.09-

©2012 An Inconvenient Woman. All Rights Reserved.

A Canadian doctor, Dr. Andrew Moulden says he conclusively proved seven years ago that vaccines cause micro-vascular strokes. Dr Moulden has a 21 year record of award-winning medical study and practice starting at Nipissing University, but he has been unable to get the attention of the College of Physicians or politicians to investigate his findings, which have been corroborated by other doctors.

How vaccines cause micro-vascular strokes

Dr. Moulden says the shots cause our body’s own immune systems to hyper-react as large white blood cells naturally rush to attack the foreign particles injected into our bloodstream. The white blood cells are too big to enter, so they surround tiny capillaries where the foreign particles land, clog and collapse the capillaries.

This cuts off pathways for the smaller red blood cells to carry oxygen to the organs near those capillaries that contain the foreign particles. When the particles float near the brain, this lack of blood supply can lead to autism, SIDS and many other diagnosed illnesses in both children and adults.

Our immune systems will continue fighting the particles leading to long-term or chronic illness. Different organs are affected depending on where the particles are, which leads to different symptoms and ‘disease’ names, but the basic causes are the same and before this discovery were unknown.

The main cause of the problem is the additives in the vaccines. The purpose of the additives is to generate a faster response from white blood cells. This works perfectly – white blood cells rush to the site of the introduced foreign matter – and that is the source of the problem. The white blood cells block the capillaries and also collapse them, trying to destroy the foreign matter.

A History of Ignoring a Medical Breakthrough

In 2001, he took his work to the College of Physicians and Surgeons of Ontario. They refused to review his work. He took it to Canadian Members of Parliament including Gurbax Singh Mali (Liberal, Bramalea-Gore) and Michael Ignatieff (Liberal, Etobicoke). They refused to respond. He wrote to U.S. Senator Charles Grassley. Grassley refused to respond. He took it to many established medical bodies. They also did not respond.

Taking His Work to The Public

Dr. Andrew Moulden has developed a website, http://brainguardmd.com/ that asked the question, “What do we do when Medical science catches up to public health practices?”

Additionally he produced the DVD — “Tolerance Lost” This 3 DVD series proves, in medical physiology and clinical sciences, with new and old diagnostic technologies, that ALL vaccinations cause immediate and delayed, acute and chronic, permanent and transient, disease and disorders that cut across all organ systems.Tissue damages are a result of impaired blood flow and blood ‘sludging” in the microscopic vessels throughout the circulatory system. Autism, ADHD, Sudden infant death, Gardasil, Gulf war syndrome, specific learning disabilities, seizures and more.

Below are three YouTube videos from the “Tolerance Lost” DVD

Tolerance Lost Video 1

Tolerance Lost Video part 2

Tolerance Lost Video Part 3

©2012 An Inconvenient Woman. All Rights Reserved.

By Cynthia A. Janak

NEWS RELEASE
FOR IMMEDIATE RELEASE
CONTACT: Leslie Botha
970-231-2008
leslie@HolyHormones.com

Neurological Vaccine Damage Explained by Dr. Andrew Moulden

Pathological processes have been clinically silent — until now
May 26, 2009, Fort Collins, CO. Canadian physician, Dr. Andrew Moulden BA, MA, MD, PhD, and leader of the Canadian Action Party will join radio talk show host, Leslie Botha, safe vaccine advocate and researcher, Cynthia Janak and Dr. Judi Gerstung on Holy Hormones Honey the Greatest Story Never Told! on community radio, KRFC FM 88.9, Monday, June 1 from 6 to 7 pm MST. The show will be audio streamed via the KRFC web site.

For the past seven months, the popular talk show has focused on the dangers of Gardasil, Childhood Immunizations and the Anthrax vaccine that has been linked to the Gulf War syndrome. The hosts have interviewed parents, and medical experts as they strive to share information about the dangerous and toxic adjuvants that are used in the vaccine serums as preservatives and additives. After months of research and combing FDA, CDC and myriads of pharmaceutical documents, Janak and Botha discussed the link between vaccines with toxic compounds, and neurological damage. In February, on a show titled: “Gardasil Girls Give the Silent Faces of Autism a Voice,” and with documentation in hand, they announced that the Gardasil vaccine and childhood immunizations were responsible for brain damage.

On June 1, Dr. Andrew Moulden, whose expertise is in neurobehavioral assessments of acquired brain and behavioral disorders, will be addressing how vaccines cause micro-strokes that result in neurological damage to those with adverse vaccine reactions. Dr. Moulden has chosen to devote his career to neurobehavioral and neurocognitive assessments and research based upon his PhD and Masters training rather than practicing clinical medicine. For the past several years Dr. Moulden has devoted his work to deciphering neurobehavioral sequelae associated with immune system hyper stimulation, neurodevelopmental disorders, “and ultimately to vaccinations as the common environmental trigger for several brain and behavioral disorders.”

Dr. Moulden has just released a DVD series titled: Tolerance Lost, proving “in medical physiology and clinical sciences, by using new and old diagnostic technologies, that all vaccinations cause immediate and delayed, acute and chronic, permanent and transient, disease and disorders that cut across all organ systems.” According to Moulden, damaged tissues are the result of impaired blood flow and blood “sludging” in the microscopic vessels of the circulatory system. Autism, ADHD, Sudden Infant Death Syndrome (SIDS), Anthrax (Gulf War Syndrome) Gardasil adverse reactions, specific learning disabilities, seizures and more are caused by the impaired blood flow — specifically to the brain.

Dr. Moulden stresses that “all vaccinations are causing the same neurological damages as wild polio and other ‘vaccine preventable pathogens did in the past — albeit in an attenuated form. It is not the germs/toxins that are causing damage; it is the body’s non-specific response to foreign substances entering it. All vaccinations are ‘foreign substances.’ Repeat vaccinations serially aggravate the underlying mechanisms of injury.”

Now, with Dr. Moulden’s expertise, lay people and practitioners will now be able to see the neurological damages, in real time, or retrospectively, in most that have been injured or who have died — whether or not they recognized at the time that injury/death was vaccine induced. The range of impairment -common to all vaccinations — is from clinically silent to terminal, (life ending) with the entire gamut of neurocogntive, neuropscyhiatric, and neuroimmunological derailments existing along a continuum of harm and end organ diagnostic labels…. including the proverbial “cause of death unknown.”

The June 1 radio show will be a groundbreaking event because the question, “do vaccines cause brain damage?” will finally be answered.

© Cynthia A. Janak

Cynthia Janak is a freelance journalist, mother of three, foster mother of one, grandmother of five, business owner, Chamber of Commerce member. Her expertise is as an administrative professional. Her specialties are adoptee and genealogy research and research journalism. Hobbies: Writing prose, crocheting, Conservative Studies, and rehabbing houses. You can visit her website at www.cynthiajanak.com. Her e-mail is cj1951@ameritech.net

©2012 An Inconvenient Woman. All Rights Reserved.

Cancer begins in cells, the building blocks of tissue which make up the organs.  Normally, cells grow and divide to form new cells as the body needs them. When cells grow old, they die and are replaced with new cells.   The problem comes in when abnormal cells “appear” and start multiplying.   The abnormal multiplications form masses resulting in growth or tumors.

In the case of cervical cancer, abnormal cells found in pap smear screenings do not necessarily mean “cancer”.    Abnormal cells can lead to cancer.  However they do not define cancer of the cervix.

The National Cancer Institute estimates that  Cervical cancer, in the lining of the cervix, will affect about 11,270 women in the U.S. each year. Cervical cancer occurs at an average age of 54. About 4,000 die. Worldwide, a half million get the disease and 225,000 die.

In the 1970s, herpes simplex virus (HSV) was touted as the cause of cervical cancer.  This based on population studies that showed a correlation of the disease with HSV dna.

The blame shifted to human papillomavirus (HPV) in the 1980′s.

The HPV is a group of more than 100 viruses.  About 30-40 of which are supposedly linked to cervical cancer.
Of these 30 or so, HPV-16 is said to be found in 50% of cervical cancers. HPV-18 supposedly accounts for 20%.

In 1992 molecular biologists of the University of California at Berkely, Peter Duesberg and Jody Schwartz, questioned the theory that HPV causes cervical cancer. They were concerned about the lack of consistent HPV DNA sequences and consistent HPV gene expression in tumors that were HPV-positive. They said quite possibly “carcinogens  may be primary inducers of abnormal cell proliferation rather than HPV or HSV.” And here’s the key point: “Since proliferating cells [cancer cells dividing wildly] would be more susceptible to infection than resting cells, the viruses would just be indicators rather than causes of abnormal proliferation.”

Even though the National Cancer Institute (NCI) admits that the “direct” cause of cervical cancer has not been demonstrated, they work with the theory that it has been.

Since 2003 even the FDA has been well aware that the human papillomavirus (HPV) does NOT cause cervical cancer. They acknowledged this fact in their statement March 31st 2003, “most infections by HPV are shortlived and not associated with cervical cancer. Most women who become infected with HPV are able to eradicate the virus and suffer no apparent long term consequences to their health.” Repeated transient HPV infections even when caused by high risk types of HPVs are characteristically not associated with an increased risk of developing squamous intraepithelial lesions, the precursor lesion of cervical cancer.

According to the New England Journal of Medicine, women face an increased risk of cervical cancer if their mothers took the world’s first synthetic female hormone during pregnancy. These women were known as ‘DES daughters’ because their mothers took diethylstilbestrol (DES) and labeled to have higher rates of infertility and miscarriages. DES has also been linked to a higher risk of developing a relatively uncommon type of cancer at an early age, known as clear-cell adenocarcinoma of the vagina and cervix.

Current guidelines from the American College of Obstetricians and Gynecologists suggest that most women should have annual Pap tests. The American Cancer Society guidelines suggest that screening less frequently than every year might be adequate for women who have had three negative annual tests.  CDC backs this up by warning in a 2000 weekly report (MMWR), that women who get annual pap smears may receive no benefit over women who are tested less frequently.  They even say it may in fact be causing harm since frequently tested women may also be at increased risk of unnecessary treatment and anxiety.

“Many times, especially for low-grade abnormalities, there’s a lot of false positives (results which appear positive, but are in fact negative), and women may be biopsied and receive other treatment because of the Pap test result,” Dr. Mona Saraiya from the CDC told Reuters Health. “These symptoms might have gone away if we’d left (the women) alone,” she added. “”There needs to be more research to show what actual harmful morbidity is associated with an abnormal Pap.”

The [CDC] researchers concluded that “Women who were screened annually rather than less frequently might have worse health outcomes if low-grade results of undetermined clinical importance lead to further testing and unnecessary patient morbidity and anxiety”.  Thus the reason for recommending pap screenings once every three years only.

Dr. Nancy Lee is the Associate Director for Science, within the Division of Cancer Prevention and Control of the National Centers for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia.  She testified before the House Committee March 16, 1999 that the incidence rate for all U.S. women is about 8 per 100,000 and that cervical cancer rates have [already] been dropping for several years. The cervical cancer death rate declined 45 percent between the periods 1972-74 and 1992-94 and the overall incidence of the disease has decreased steadily from 14.2 per 100,000 in 1973 to 7.4 per 100,000 in 1995.  According to the American Cancer Society, “Between 1955 and 1992 the number of cervical cancer death in the united states dropped by 74%”

Most young adults who have been sexually involved and exposed to HPV naturally clear the virus from their body, thus going on to live normal healthy lives.  Deaths associated with cervical cancer are very low on the totem pole of leading cancer killers for women with lung cancer at 68,000 deaths annually, breast cancer at 42,000 deaths, colorectal cancer at 29,000 deaths, ovarian cancer at 14,000 deaths, skin cancer at 9,600 deaths, and uterine cancer at 6,500 cancer deaths.  Pap smears potentially prevent nearly 100% deaths caused by cervical cancer.

One can only ask why Merck and CDC are pushing for a vaccine when the war against cervical canc already a success story.

Source:

The New England Journal of Medicine – June 22, 2000 – Vol. 342, No. 25
Testimony on Cervical Cancer by Nancy C. Lee, M.D.  http://www.hhs.gov/asl/testify/t990316b.html
CDC Morbidity and Mortality Weekly Report 2000;49:1001-1003
http://vaers.hhs.gov VAERS (vaccine adverse events reporting system) 2006 database
Daily Press.com, Kimball Payne, Feb.11, 2007
JAMA Vol. 297 No. 8 February 28, 2007

International statistics for cervical cancer: World Health Organization

Anti-Cervical Cancer Vaccine — A Medical Break Through?
National Cancer Institute

©2012 An Inconvenient Woman. All Rights Reserved.

HPV vaccines were a hot topic during the 25th International Papillomavirus Conference, held May 8-14 in Malmö, Sweden. In the weeks leading up to the big event, Glaxo’s PR machine has been touting new Cervarix vs. Gardasil head-to-head study, saying Cervarix prompted a stronger immune response. The ever-marketing Merck has been promoting its own ‘new’ study data, which claims Gardasil offers protection from certain HPV strains for up to 9.5 years. Originally, the Merck marketing blitzkrieg claimed Gardasil’s protective shield lasted for five years. Based on another study, which they did not site in the press release, Merck is now claiming their HPV-vaccine, Gardasil cut down on abnormal Pap tests and cervical procedures. It should be noted that GlaxoSmithKline were platinum sponsors of the International Papillomavirus Conference, and Merck was an exhibitor.

Well the big boys huffed and they puffed, but neither Merck nor Glaxo posited the big issue —can trial data make a big difference in revenues for either company?

Merck’s U.S. sales of Gardasil are falling off, sharply, plummeting 33 percent in the first quarter, and Glaxo’s Cervarix has not yet won FDA approval for sales in the US.

Thanks to a Fast Track approval from FDA and an endorsement from the CDC, not to mention aggressive lobbying and a wildly successful, but predatory marketing campaign, Merck has the sole HPV shot available in the U.S. to date. It’s fully entrenched in the market. However, during the past year, Merck has seen a trending decline in the sales of its HPV vaccine, Gardasil. Parental backlash to State mandated Gardasil vaccination policies, has slowed down the lobbying juggernaut that marked Merck’s 2006 Gardasil vaccine introduction. An increasing number of adverse effects, including death, have been reported, raising safety concerns. In the final count, the decline in Gardasil sales can be attributed to Merck’s award-winning “One Less” marketing program. It was wildly successful in attracting huge numbers of early adapters. Caring mom’s flocked to their family doctors for the Gardasil shot, wanting to protect their girls from cervical cancer. As the majority of early adapter girls and young women complete their three-shot series, the pool of unvaccinated females shrinks. To grow that market Merck has been positioning Gardasil for wider distribution the new target market is older women and boys.

Even with the long-delayed FDA approval, Glaxo will have to fight very hard indeed to crave out significant market share for it’s HPV-vaccine, Cervarix. Glaxo is dealing with efficacy issues in the U.K. The Scotsman reports that an influential German public-health organization is reviewing both Cervarix and Gardasil HPV-vaccination policy after 13 researchers claimed that governments might have bought into “overly optimistic” assumptions about how effective HPV-vaccination really is against cervical cancer. The Robert Koch Institute says it will issue a report in two weeks. Additionally, HPV-vaccine critics in Scotland are calling for government to review its $97 million commitment to its HPV-vaccination program.

Research sources:

25th International Papillomavirus Conference Proceeds

The Scotsman

FiercePharma Newsletter

Merck Press Release

©2012 An Inconvenient Woman. All Rights Reserved.

The safety of the HPV vaccine was studied in 5 clinical trials before it was licensed. There were over 21,000 girls and women ages 9 through 26 in these clinical trials.

Since it was licensed, CDC and FDA have been closely monitoring the safety of the HPV vaccine. There are 3 systems used to monitor the safety of vaccines after they are licensed and being used in the U.S.  These systems can monitor side effects already known to be caused by vaccines as well as detect rare side effects that were not identified during a vaccine’s clinical trials. The 3 systems are:

• The Vaccine Adverse Event Reporting System (VAERS)--a useful early warning public health system that helps CDC and FDA detect possible side effects or adverse events following vaccination.




• The Vaccine Safety Datalink (VSD) Project–a project between CDC and 8 health care organizations to study patterns in reports detected by VAERS and determine if a vaccine is causing a side effect.




• The Clinical Immunization Safety Assessment (CISA) Network–a project between 6 academic centers in the U.S. which conduct research on adverse events that might be caused by vaccines.

Reports to VAERS Following HPV Vaccination

As of December 31, 2008, more than 23 million doses of Gardasil were distributed in the United States.

As of December 31, 2008, there were 11,916 VAERS reports of adverse events following Gardasil vaccination in the United States. Of these reports, 94% were reports of events considered to be non-serious, and 6% were reports of events considered to be serious.

Based on all of the information we have today, CDC continues to recommend Gardasil vaccination for the prevention of 4 types of HPV. As with all approved vaccines, CDC and FDA will continue to closely monitor the safety of Gardasil.  Any problems detected with this vaccine will be reported to health officials, healthcare providers, and the public, and needed action will be taken to ensure the public’s health and safety.

Non-serious adverse event reports

VAERS defines non-serious adverse events as those other than hospitalization, death, permanent disability, and life-threatening illness.

The vast majority (94%) of the adverse events reports following Gardasil have been non-serious. Reports of non-serious adverse events after Gardasil vaccination have included fainting, pain and swelling at the injection site (the arm), headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be easily prevented by closely observing the vaccinated person for 15 minutes after vaccination.

Serious adverse event reports

VAERS defines serious adverse events as adverse events that involve hospitalization, death, permanent disability, and life-threatening illness. As with all VAERS reports, serious events may or may not have been caused by the vaccine.

All serious reports (6%) for Gardasil have been carefully analyzed by medical experts. Experts have not found a common medical pattern to the reports of serious adverse events reported for Gardasil that would suggest that they were caused by the vaccine. The following is a summary of selected serious adverse event reports that were submitted to VAERS between June 8, 2006 and December 31, 2008.

Guillain-Barré Syndrome (GBS)

Guillain-Barré Syndrome (GBS) has been reported after vaccination with Gardasil. GBS is a rare disorder that causes muscle weakness. It occurs in 1-2 out of every 100,000 people in their teens.* A number of infections can cause GBS. There has been no indication that Gardasil increases the rate of GBS in girls and women above the rate expected in the general population, whether or not they were vaccinated.

Blood Clots

Rarely, people have reported blood clots after getting Gardasil. These clots have occurred in the heart, lungs, and legs. Most of these people had a risk of getting blood clots, such as taking oral contraceptives (the birth control pill).

Deaths

As of December 31, 2008, there have been 32 U.S. reports of death among females who have received the vaccine. There was no common pattern to the deaths that would suggest that they were caused by the vaccine.

More information is available at:

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

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.

Page last modified: April 10, 2009
Content source: Immunization Safety Office

* Editorial Note to Immunization Safety Office: The actual reference source did not say teens it referred to ‘people’

“About 1 or 2 people out of 100,000 develop Guillain-Barré Syndrome (GBS) each year1.
1.Shy ME (2008). Guillain-Barré syndrome section of Peripheral neuropathies. In L Goldman, D Ausiello, eds., Cecil Textbook of Medicine, 23rd ed., pp. 2802–2816. Philadelphia: Saunders Elsevier.

©2012 An Inconvenient Woman. All Rights Reserved.