The Gardasil Story: Continued Controversy And Crippling Consequences!
By Susan Brinkmann, For The Bulletin
SUNDAY, OCTOBER 25, 2009
Dr. Diane Harper, lead researcher in the development of two human papilloma virus vaccines, Gardasil and Cervarix, said the controversial drugs will do little to reduce cervical cancer rates and, even though they’re being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15.
Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, made these remarks during an address at the 4th International Public Conference on Vaccination which took place in Reston, Virginia on Oct. 2-4. Although her talk was intended to promote the vaccine, participants said they came away convinced the vaccine should not be received.
“I came away from the talk with the perception that the risk of adverse side effects is so much greater than the risk of cervical cancer, I couldn’t help but question why we need the vaccine at all,” said Joan Robinson, Assistant Editor at the Population Research Institute.
Dr. Harper began her remarks by explaining that 70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer, which leaves little need for the vaccine.
She went on to surprise the audience by stating that the incidence of cervical cancer in the U.S. is already so low that “even if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the US.”
There will be no decrease in cervical cancer until at least 70 percent of the population is vaccinated, and even then, the decrease will be minimal.
Apparently, conventional treatment and preventative measures are already cutting the cervical cancer rate by four percent a year. At this rate, in 60 years, there will be a 91.4 percent decline just with current treatment. Even if 70 percent of women get the shot and required boosters over the same time period, which is highly unlikely, Harper says Gardasil still could not claim to do as much as traditional care is already doing.
Dr. Harper, who also serves as a consultant to the World Health Organization, further undercut the case for mass vaccination by saying that “four out of five women with cervical cancer are in developing countries.”
Ms. Robinson said she could not help but wonder, “If this is the case, then why vaccinate at all? But from the murmurs of the doctors in the audience, it was apparent that the same thought was occurring to them.”
However, at this point, Dr. Harper dropped an even bigger bombshell on the audience when she announced that, “There have been no efficacy trials in girls under 15 years.”
Merck, the manufacturer of Gardasil, studied only 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.
This is not the first time Dr. Harper revealed the fact that Merck never tested Gardasil for safety in young girls. During a 2007 interview with KPC News.com, she said giving the vaccine to girls as young as 11 years-old “is a great big public health experiment.”
At the time, which was at the height of Merck’s controversial drive to have the vaccine mandated in schools, Dr. Harper remained steadfastly opposed to the idea and said she had been trying for months to convince major television and print media about her concerns, “but no one will print it.”
“It is silly to mandate vaccination of 11 to 12 year old girls,” she said at the time. “There also is not enough evidence gathered on side effects to know that safety is not an issue.”
When asked why she was speaking out, she said: “I want to be able to sleep with myself when I go to bed at night.”
Since the drug’s introduction in 2006, the public has been learning many of these facts the hard way.
To date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.
Dr. Harper also participated in the research on Glaxo-Smith-Kline’s version of the drug, Cervarix, currently in use in the UK but not yet approved here. Since the government began administering the vaccine to school-aged girls last year, more than 2,000 patients reported some kind of adverse reaction including nausea, dizziness, blurred vision, convulsions, seizures and hyperventilation. Several reported multiple reactions, with 4,602 suspected side-effects recorded in total. The most tragic case involved a 14 year-old girl who dropped dead in the corridor of her school an hour after receiving the vaccination.
The outspoken researcher also weighed in last month on a report published in the Journal of the American Medical Association that raised questions about the safety of the vaccine, saying bluntly: "The rate of serious adverse events is greater than the incidence rate of cervical cancer."
Ms. Robinson said she respects Dr. Harper’s candor. “I think she’s a scientist, a researcher, and she’s genuine enough a scientist to be open about the risks. I respect that in her.”
However, she failed to make the case for Gardasil. “For me, it was hard to resist the conclusion that Gardasil does almost nothing for the health of American women.”
1.-Vaccines are big business : http://www.generationrescue.org/vaccines.html
-As this recent Wall Street Journal article reported, Merck stands to generate as much as $2 billion in revenues per year for their new Gardasil vaccine for girls targeting Cervical cancer.
For a company beaten down by the Vioxx scandal, Gardasil’s success is a very important initiative, which according to the article has caused the company to push the vaccine out the door using questionable marketing techniques while legitimate concerns about safety and efficacy still exist. (A January 2008 story that made headlines across Europe reported on the deaths of two teenage girls immediately after getting the Gardasil vaccine -- we couldn’t find any U.S. media outlets that covered the story.)--
-Vaccine manufacturers are no different from other corporations: they want to sell more of whatever it is they make. Unfortunately, there is a revolving door between the policy-makers who determine the vaccine schedule and the pharmaceutical companies who make vaccines, as our own Congressional Committee on Government Reform reported in this document titled Conflicts of Interest in Vaccine Policy Making.—
It's been months since dancer and former gymnast Nicole Goodman of Pocasset has been able to do a forward jazz slide or a kick ball change move.
The 18-year-old fell ill weeks after receiving her third Gardasil shot, and she blames the vaccine for the human Papillomavirus for putting her in a wheelchair.
The hpv/cervical cancer connection
At least 70 percent of sexually active people will get HPV at some time in their lives. Most people who become infected will have no symptoms and will clear the infection on their own.
- According to the Centers for Disease Control and Prevention, there are 6.2 million new infections each year.
- Particular strains of HPV cause 70 to 90 percent of all cervical cancer.
- More than 11,000 new cases of invasive cervical cancer are diagnosed each year in the U.S., and more than 4,000 deaths from the disease will result.
- Early detection is crucial; the five-year survival rate for invasive cervical cancer is 92 percent.
- The best method for detecting cervical cancer - one that reduced the death rate 74 percent from 1955 to 1992 - is the Pap test.
"I was a normal teenager. I did everything," says the Bourne High School graduate. She played softball and basketball in community leagues and took lessons in lyric and jazz dance.
But weeks after receiving the third shot of the Gardasil vaccine, Goodman found herself in a downhill health slide. A charley-horse-type pain in her right leg led to spasms and tremors. She experienced fainting episodes, an irregular heartbeat and nausea so severe that she lost 15 pounds in one month and had to go on intravenous fluids.
Her left leg and foot are now stuck in a sort of permanent spasm, and Goodman says she developed a red rash on her upper body around the same time.
"So many girls have that rash," she says.
Goodman is referring to the "Gardasil Girls," an informal nickname for girls and young women who believe they have been injured by the Merck vaccine that was approved in 2006 and has been heavily marketed as a preventative for cervical cancer.
Their numbers include Rachel Whiting, 17, of Orleans and Madeline Wunder, 17, of Brewster, both students at Nauset Regional High School who experienced autoimmune-type disorders shortly after receiving Gardasil injections.
They says their side effects include digestive problems, rashes and severe muscle pain, among other ailments. "It's just a nightmare," says Rachel's mother, Kim Whiting. She brought her daughter to Boston last week for a bone marrow biopsy and other tests to find out why Rachel's lymph nodes are so inflamed.
"She's in pain every day," Donna Wunder says of her daughter, Madeline, a competitive figure skater.
Wunder is convinced that Gardasil caused her daughter's symptoms, and she says she wishes she'd never approved the shots.
"I got sold the whole bill of goods that this is wonderful," she says. Wunder says Madeline had to drop out of a major skating competition this month because she can no longer land jumps or handle a four-minute routine.
As concerns over the safety of the vaccine that has been given to millions of American girls and women heat up, Merck, the Centers for Disease Control and Prevention, and the Food and Drug Administration say the vaccine - given in three separate shots - is safe and effective, with side effects including pain at the injection site and risk of fainting.
"We are confident in the safety profile of Gardasil," says Merck spokeswoman Jennifer Allen. "The benefits outweigh the risks."
A study that appeared in August in the Journal of the American Medical Association found that injections of Gardasil in the general population had resulted in a greater risk of blood clots and fainting than appeared in the clinical trials. It said the overall risk of other side effects was comparable to other vaccines.
But parents, vaccine safety advocates and even a doctor who worked on Gardasil trials as a paid consultant for Merck are questioning whether the risk of a widespread vaccination campaign is worth the benefit of hoped-for protection against cervical cancer, which in the U.S. is a rare killer of women.
The Centers for Disease Control recommends the HPV vaccine for girls starting at age 11 and says doctors may give it to girls as young as 9.
Gardasil vaccinates girls and women against four types of HPV, including two types that cause about 70 percent of cervical cancer and two types that cause about 90 percent of genital warts.
It's an expensive vaccine. A series of three shots costs $360, not counting administrative and office fees. Insurance usually covers the cost.
The problem is there's no proof that Gardasil is effective after five years, so there's no point in vaccinating such young girls, says Dr. Diane Harper of the University of Missouri in Kansas City. She was hired by Merck as a consultant to design phases 2 and 3 of Merck's clinical trials.
"There will be zero change in cervical cancer (rates)," Harper says. "This whole concept of targeting 11- to 12-year-olds is a myth."
She's also concerned that women who receive the vaccine will get a false sense of security and forgo regular Pap smear tests, which detect most cases of cervical cancer.
The $30 Pap test is credited with cutting the cervical cancer death rate in the United States by 74 percent from 1955 to 1992. Currently, about 4,000 women are expected to die of cervical cancer in this country in 2009, and the New England Journal of Medicine says at least half of those deaths are among women who have never or seldom had a Pap smear.
Still a major killer in developing nations, cervical cancer no longer appears on the top 10 list of fatal malignancies among American women.
"Getting the vaccine in the U.S. is not going to make one less cervical cancer victim," Harper says, referring to Merck's advertising campaign slogan. "That is entirely marketing."
By this summer, there were more than 15,000 reports of Gardasil vaccine reactions, including more than 3,000 injuries and 48 deaths, says Barbara Loe Fisher of the National Vaccine Information Center, a vaccination watchdog group.
She says a study by her organization shows that Gardasil has resulted in more adverse reactions - such as stroke, blood clots, cardiac arrest, seizures, fainting and lupus - than occur after Menactra vaccinations against meningitis.
And Gardasil reactions may be underreported, Fisher says. She says doctors don't always take patient reports of Gardasil reactions seriously, and that's a problem, because reporting to the federal Vaccine Adverse Event Reporting System is done on a volunteer basis.
While doctors are required by the National Childhood Vaccine Injury Act to report potential adverse reactions, the act lacks teeth, Fisher says.
"Many doctors write off Gardasil-related hospitalizations, injuries and death as just a coincidence and do not report. Labeling bad things that happen after vaccination as a 'coincidence' minimizes the risks of vaccination," Fisher wrote in a report on the reporting system's Web site.
The three young Cape women who say they were injured by the Gardasil vaccine have struggled to get the medical community to take them seriously. Two of the young women responded to a Cape Cod Times online question about people's experiences with the Gardasil vaccine, and one of the families put the reporter in touch with Wunder's mother.
The teams of physicians who treated Madeline Wunder at Children's Hospital agreed that something catastrophic must have happened to cause the extreme nausea that put her on acid blockers, the muscle pain that at one time required morphine, and the "roaming paralysis" that sometimes cramps her hands into claws and numbs her feet, Donna Wunder says.
Doctors asked if it could have been a fall on the ice, she says. "They didn't want to hear about the shot."
Finally, in April, a rheumatologist at Children's Hospital wrote that Madeline most likely was suffering from post viral fatigue syndrome. Without explaining, he wrote that "it was possible" but "not very likely" that her Feb. 9 Gardasil and Menactra immunizations triggered the symptoms.
There is some evidence that having those two shots together increases the risk of side effects, Fisher says.
Rachel Whiting's pediatrician didn't think her second Gardasil shot in January had anything to do with her fevers, joint pains and debilitating hives, her mother, Kim Whiting says, and has not reported the possible adverse reaction. But a second Children's Hospital rheumatologist told her she would report it to VAERS if no one else has, Whiting says.
Despite Goodman's severe physical limitations, she says most of her physicians do not consider Gardasil a possible culprit.
Doctors at Children's Hospital told her she has a "conversion disorder," in which stress causes physiological symptoms, Goodman says. She says her ailments have been getting worse for months, ever since she got her third Gardasil shot.
Seated at home in a hospital bed with the words "love," "live" and "laughter" pasted to the blue bedroom wall above, Goodman says she had migraine-type headaches after the first two shots but didn't consider them possible side effects.
Shortly after the final shot she experienced a flurry of symptoms - including a fainting episode after driving her car - that eventually disabled her. "I haven't walked in six months," Goodman says.
She pulls up a pants leg and points to her left leg, which looks as if it's about to launch the former gymnast and cheerleader into a midair jump.
Her calf is knotted and her left foot is stuck in an arched position. Meanwhile, her right leg reverberates with periodic tremors.
A physician at a pain clinic at St. Anne's Hospital in Fall River said her muscle tone was so low it almost looked as though she had been born with cerebral palsy, Goodman says. She says he advised her to pursue the Gardasil connection but didn't tell her how.
The constellation of symptoms described by the three Cape teens and their families is typical of complaints reviewed by the NVIC, Fisher says. Many of the afflicted are athletes like Wunder and Goodman.
"You have to take it very seriously," she says. "These are high-functioning girls."
Fisher says it's possible that the young women's bodies are getting caught in an inflammatory process that affects their brains and immune systems.
"Why is it the healthy girls?" Fisher asks. "We don't know."
Autoimmune disorders are known to occur in teenage girls and young women, but there is nothing to suggest they are caused by the Gardasil vaccine, Allen says. "We encourage people to report adverse effects in any way they can."
Harper, in the meantime, suggests the vaccine be reserved for women 18 and over who carefully weigh risks and benefits.
Although the vaccine is approved only for women up to age 26, Harper says data indicate it will work just as well for women who already have had abnormal Pap smears.
"Gardasil is not safe for everyone. It's safe for most people," she says.
Gardasil came on the market with much fanfare, and the word "mandate" was used in many discussions. But plans to vaccinate all sixth-grade girls in Texas, for example, were dropped after parents balked at a gubernatorial executive order, Fisher says. Virginia and the District of Columbia mandate the HPV vaccine for schoolgirls, she says, but parents can "opt out" of the provision.
Although plans for large-scale HPV vaccine largely have died down, Merck is still taking jabs for heavy-handed marketing of the new vaccine.
The pharmaceutical company paid doctors several thousand dollars per talk to chat up the vaccine to fellow physicians, Harper says. She says Merck provided the physicians with slides that didn't mention adverse reactions.
"Merck controls the information flow entirely," Harper says.
A JAMA editorial took the drug manufacturer to task for playing up the risk of cervical cancer to adolescents and downplaying the sexual transmission of HPV.
"The subpopulations most at risk were practically ignored," according to Drs. Sheila and David Rothman, authors of the editorial.
For a while it seemed as if parents couldn't get away from magazine ads and TV commercials urging them to make their daughters "one less" cervical cancer statistic with the Gardasil vaccine, Wunder says.
You felt "you're a terrible mother if you don't do this," she says.
All three families interviewed for the story say their daughters' doctors championed the vaccine without mentioning the possibility of severe reactions.
Get ready for more marketing, Harper says. The FDA has approved GlaxoSmithKline's new HPV vaccine for women, Cervavix, as well as Merck's new vaccine to protect boys against genital warts.
"Merck is going to come out gangbusters promoting that," she says.
Since men transmit the HPV to women, the male vaccine is seen as a public health triumph by some.
Kim Whiting says she doesn't want to see other girls or boys go through what her daughter Rachel is experiencing.
"She is so sick. She has a bag of pills she has to take throughout the day. They still don't work. I told the pediatrician, 'I can't believe you're still giving it.'"
Well it turns out that WebMD is coming out with the information that Merck’s financial golden goose that was to recoup the money lost on the Vioxx lawsuits is being linked to Guillain Barre Syndrome.Gardasil is also being linked to seizures, paralysis, fainting and in some cases death. Investigative journalist Sharyl Attkisson has been doing several investigations into vaccines including gardasil. Her most recent piece (February 6th of this year) can be found HERE.
We are all familiar with the “One Less” television spots. Well I found a website that also professes the “one less” message. This site is about young ladies who received at least one dose of Gardasil vaccine. These are the young women who have been adversely effected by the vaccines. The site can be viewed HERE. The one less this site speaks of is one less adverse reaction, one less Gardasil vaccine and one less death.
The following came directly from the FDA adverse website concerning the Gardasil vaccine. The piece can be found HERE.
“Gardasil Adverse Events Include Deaths, Seizures, Judicial Watch Says
There have been 3,461 reports of adverse events, including a maximum of 11 deaths, in patients receiving Merck’s cervical cancer vaccine Gardasil, public interest group Judicial Watch said.
Since May, the group has found documents detailing 1,824 reports of adverse reactions to Gardasil (quadrivalent human papillomavirus [Types 6, 11, 16, 18] recombinant vaccine), including eight deaths. Before May, Judicial Watch had obtained 1,637 adverse event reports. The group received the data from the FDA through a Freedom of Information Act (FOIA) request.
Of the 1,824 adverse events reported between May 10 and Sept. 7, 347 were serious reactions including paralysis, Bell’s palsy, Guillain-Barre syndrome and seizures, according to the group.
Thirty-three out of 77 pregnant women who received the vaccine experienced side effects, including spontaneous abortion and fetal abnormalities, Judicial Watch added.
“In light of this information, it is disturbing that state and local governments might mandate in any way this vaccine for young girls,” Judicial Watch President Tom Fitton said.”
This article is from October of 2007. Most of us within the autism community know that most doctors do not report adverse reactions to VAERS (vaccine adverse event reporting system). It is well known that only roughly 10% of adverse reactions are reported. Based on this information back in 2007 there were 1,637 adverse events reported. IF that represents 10% then there are a total of 16,000 events. Keeping in mind this is 2007 that the 1,637 quoted in the article is from. So the question bears asking: If there were that many reported and suspected reactions to this vaccine then why is it 18 months later that this vaccine is still on the market?
For more accurate and recent numbers (11,916 by December 2008) please go HERE. Keep in mind that approximately only 10% of all adverse reactions even get reported at all and the number is more like 119,160 adverse events. So again the question bears to be asked: If there are that many reported adverse reactions then why not error on the side of caution and remove the vaccine from use until independent testing can be done?
Even the Wall Street Journal; formerly a huge proponent of the drug cartels and vaccines in general has THIS to say about the Gardasil vaccine.
For my daughter I too will choose “one less”. One less disabling effect, one less seizure, one less diagnosis of paralysis, one less diagnosis of GBS, and one less DEATH!! Merck and all the drug cartels can take their products whether they be vaccines or medications and shove them where the sun never shines. I choose for myself and my children to be ONE LESS victim of their poisons and unfeeling disregard for human life. The drug cartels have had their “bite at the apple” in the form of childhood vaccinations and I refuse to give them another shot at it. I shall never trust them again AND they will always be my enemy for what they have done in the past and what they are continuing to practice to this day.
Records Document 6,723 Adverse Reactions in 2008, Including 1,061 Considered "Serious" and 142 Considered "Life Threatening"
Press Office 202-646-5172, ext 305
Washington, DC -- June 22, 2009
Judicial Watch, the public interest group that investigates and prosecutes government corruption, announced today that it has obtained records from the Food and Drug Administration (FDA) documenting 28 deaths in 2008 associated with Gardasil, the vaccination for human papillomavirus (HPV), up from 19 deaths in 2007. The total number of Gardasil-related deaths is 47 since the vaccine was approved in 2006. Overall, the FDA documented 6,723 "adverse events" related to Gardasil in 2008, of which 1,061 were considered "serious," and 142 considered "life threatening."
The following are several "adverse events" documented by the FDA’s Vaccine Adverse Event Reporting System (VAERS):
- "15 months from the completion of the GARDASIL HPV vaccination, I had full blown cervical cancer. My oncologist would like to do a hysterectomy at this time, but [as I have] always wanted children, I have chosen to wait . . . I have two of the [strains] that the shot is suppose to prevent . . . I now have cervical cancer and I am left wondering what role the GARDASIL HPV vaccination played in the hasty onset." (ID: 319836)
- "After receiving her second dose of GARDASIL … she could crawl but … needed to use crutches or a wheel chair ... She was experienced problems breathing and had ‘super migraines' that never went away … She had swelling in her face, jaw and wrists. The patient was diagnosed with GUILLAIN-BARRE syndrome, myelin sheath degeneration and peripheral neuropathy. Patient was hospitalized twice … patient has not recovered from symptoms." (ID: 318052)
- A 19-year-old girl with no medical history immediately experienced side effects after receiving the Gardasil vaccine. Within eleven days her symptoms included "Aggression, Arthralgia, Complex partial seizures, Confusional state, Convulsion, Crying, Dizziness, Epilepsy, Fatigue, Feeling abnormal, Grand mal convulsion, Immediate post-injection reaction, Irritability, Myalgia, Nausea, Pain, Postictal state, Somnolence, Syncope, Tremor, and Unresponsive to stimuli." (ID: 320598)
- "Two weeks after the third dose, the patient developed a complication. She was taken to the hospital by ambulance but passed away during the transport from an unknown cause…Upon arrival in ER unresponsive, pupils fixed and dilated, no cardiac activity. Resuscitation unsuccessful and patient expired." (ID: 314769)
The FDA VAERS reports show that since last June, 235 cases detailed permanent disability. There were also 29 new cases of Guillain-Barre Syndrome, and 147 cases of "spontaneous abortions," or miscarriages, when the vaccine was given to pregnant women.
Moreover, 62 girls developed warts after receiving the vaccine. This development is of particular concern because Gardasil, which is designed to prevent two strains of genital warts, is not supposed to react with other HPV strains. However, not only did previously healthy women experience genital warts after the vaccination, but 21 girls developed warts on other areas, most commonly the face, hands and feet, and in one case, "all over her body." (ID: 330671)
Of the 47 reported deaths, 41 occurred within a month of receiving the vaccine and of those 17 were within two weeks or receiving the vaccine. In most of the deaths the cause is still unknown.
"The FDA is supposed to be a guardian of public health, and yet the agency continues to turn a blind eye to what seems to be an extremely serious public health problem. The public relations push for Gardasil by Merck, politicians and public health officials needs to pause so that these adverse reactions can be further studied," said Judicial Watch President Tom Fitton. "The already serious problems associated with Gardasil seem to be getting worse. No One Should Require This Vaccine For Young Children."
The FDA Adverse Event Reports On The HPV Vaccine Read Like A Catalog Of Horrors. Any state or local government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports."
On June 8, 2006, the Food and Drug Administration (FDA) approved the drug Gardasil. Gardasil is a vaccine against certain types of human papillomavirus (HPV) which is the primary cause of cervical cancer in women.
- Several state and local governments have proposed requiring the vaccine for school girls entering the 6th grade.
- Gardasil is approved for girls as young as nine years old, despite the fact that the youngest girls participating in clinical trials were 11-12 years old.
- A recent study, published in the New England Journal of Medicine, also questioned the general effectiveness of Gardasil. Additionally, there has not been a chance to study long term side effects of the vaccine.
Judicial Watch, concerned about the rush to market and mandate a drug with possible serious adverse effects, filed its first Freedom of Information Act (FOIA) request on May 9, 2007, and received 1,637 adverse event reports on May 15, 2007. These reports are submitted to the Vaccine Adverse Event Reporting System (VAERS) and used by the FDA to monitor the safety of vaccines.
On August 20, 2007 Judicial Watch filed a request for updated adverse event reports and received 1,824 reports on September, 13 2007. Judicial Watch then filed a complaint against the FDA on October 3, 2007 for failing to fully respond to the May 9, 2007 FOIA request.
Judicial Watch has posted links to the adverse event reports below and continues to monitor VAERS reports submitted to the FDA in relation to Gardasil.
- Examining the FDA's HPV Vaccine Records - Appendices - June 30, 2008
- Vaccine Adverse Effects Report System (VAERS) serious effects report from May 1, 2008 to May 15, 2009 - May 15, 2009
- Vaccine Adverse Effects Report System (VAERS) serious effects report from January 1, 2008 to June 10, 2008 - June 30, 2008
- Vaccine Adverse Effects Report System (VAERS) reports on Guillane-Barre Syndrome, spontaneous abortions, and all life-threatening cases from 2008 - June 30, 2008
- Vaccine Adverse Effects Report System (VAERS) cumulative Gardasil adverse effects report (Warning, this is a very large file) - June 30, 2008
- Merck's application to the FDA to patent the Gardasil vaccine - February 22, 2008
- Merck's report to the FDA giving the details of Gardasil and its clinical test results - February 22, 2008
- A transcript of the Vaccines and Related Biological Products Advisory Committee's meeting to discuss Gardasil - February 22, 2008
- Document from the FDA giving a determination of Regulatory Review Period for Purposes of Patent Extension for Gardasil - February 22, 2008
- Complaint for Injunctive and Declaratory Relief - October 3, 2007
- New FDA Records Obtained by Judicial Watch Indicate 28 Deaths Related to Gardasil in 2008 - June 22, 2009
- Judicial Watch Uncovers New FDA Records Detailing Ten New Deaths & 140 "Serious" Adverse Events Related to Gardasil - June 5, 2009
- Judicial Watch Uncovers New FDA Records Detailing Ten New Deaths & 140 “Serious” Adverse Events Related to Gardasil - June 30, 2008
- Judicial Watch Uncovers New FDA Records Detailing Deaths in 1,824 Adverse Reaction Reports Related to HPV Vaccine - October 4, 2007
- Judicial Watch Uncovers Three Deaths Relating to HPV - May 3, 2007
News Stories, Reports and Informational Links
- New England Journal of Medicine
- Guide to State Legislation About Mandatory HPV Vaccination
Date Published: Wednesday, February 4th, 2009
Despite Merck & Co.’s claims that Gardasil is safe, stories abound over devastating reactions to the three-shot inoculations that claim to prevent some—not all—types of the human Papillomavirus (HPV).
For instance, after just one injection a 13-year-old girl was diagnosed with Acute Pancreatitis, spent nearly 100 days in the hospital, and underwent two surgeries to remove Pseudocysts. Her family filed a petition for vaccine compensation seeking damages from the government.
A group of Australian researchers found young women there who received the drug were five to 20 times likelier to suffer rare and severe allergic reactions. In the U.S., a 20-year-old woman suffered a stroke after receiving a second Gardasil injection. Two women overseas died after receiving their Gardasil injections and those deaths followed the deaths of three other young women who died in the U.S. days after Gardasil was administered.
A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Another 13-year-old began showing signs of a degenerative muscle disease after her third Gardasil injection; she is almost completely paralyzed.
Now, the Rocky Mountain News is reporting about a 16-year-old girl who is sick all the time with constant exhaustion and nausea; hair falling out in clumps, ongoing episodes of passing out, numbness, and paralysis; dangerously low blood pressure; and severe back spasms that cause her to stop breathing. The family is convinced the reactions are a result of Gardasil vaccinations, which in her case, were given with a meningitis vaccine.
Although industry claims the Gardasil-meningitis combination is safe, and although the combination is routinely administered, Rocky Mountain News points out that Gardasil has never been clinically tested in this combination.
As a matter-of-fact, the meningitis vaccine was not available when clinical testing for Gardasil was first being conducted, so the U.S. Food and Drug Administration (FDA) agreed to test it after licensure was granted said Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health. Those clinical results remain pending.
Worse, says Rocky Mountain News, according to the National Vaccine Information Center, Gardasil reactions increase when given with the meningitis vaccine. Also, Halsey reported that general guidelines allow for two or three inactivated vaccines—and Gardasil and the meningitis vaccinations fall into this category—to be administered conjunctively without an expectation of increased adverse events.
Merck and Co.’s Gardasil was licensed in 2006 by the FDA and both the Centers for Disease Control and Prevention (CDC) and Merck say it is safe; however, as of late summer, the federal Vaccine Adverse Event Reporting System (VAERS) logged 10,326 reports of reactions to Gardasil, according to the CDC, including reports of Guillain-Barre syndrome, a rare disorder that causes muscle weakness, blood clots, and death.
Gardasil accounted for about 20 percent of reactions reported to VAERS in 2007-2008 according to Barbara Loe Fisher, co- founder and president of the National Vaccine Information Center. “To say that … 10,000 reports of reactions, injuries, 30 deaths is all a coincidence is simply not scientifically responsible,” Fisher told the Rocky Mountain News. “You have perfectly healthy girls go in and get this shot and then suffer a pattern, a very clear pattern of injury, and some of them are dying. This is not acceptable.” Side effects reported involve brain inflammation; immune system dysfunction; tingling and numbness in the hands, feet and legs; severe headaches; strokes; joint pain; muscle weakness; seizures; and memory loss Fisher said.
The Vue Weekly points out that many believe over-immunization is a major contributor to the rise in autoimmune disease and parents are often pressured to immunize. But, in the case of Gardasil, perhaps avoiding the vaccine might not be so irresponsible given that, as The Vue pointed out, “the research was done by those who stand to gain magnificently” and the drug has been the focus of “an extensive public relations campaign” but “has been subjected to little independent scientific review.”
Of note, the Vue points out that the Nobel Prize Committee—which awarded the 2008 Nobel Prize in Medicine to German scientist Harald zur Hauser for his work linking HPV to cervical cancer—is facing investigation over bribery allegations for taking payments from the drug company that own the patents and collects royalties on both—U.S. and overseas—HPV vaccines.
Also, said the Vue, an FDA document stated that, “identifying and typing HPV infection does not bear a direct relationship to stratification of the risk for cervical cancer. Most acute infections caused by HPV are self-limiting. It is the persistent HPV infection that may act as a tumor promoter in cancer induction … most infections are short-lived and not associated with cervical cancer.” Perhaps the vaccine is not so critical after-all.