Judicial Watch reports on the Gardasil public health experiment
August 25th, 2008
Based on records obtained under a May 2007 Freedom of Information Act (FOIA) request, Judicial Watch has summarized the approval process, side effects, safety concerns, and marketing practices related to the human papillomavirus (HPV) vaccine Gardasil. It calls these a “large-scale public health experiment.”
One of the most startling findings is 78 cases of outbreaks of warts following the vaccine in women already infected without knowing it. Besides genital warts, some patients experienced massive outbreaks on the face, hands, or feet, sometimes caused by strains not included in the vaccine.
Additionally, the vaccine could increase the incidence of CIN 2/3 (cervical endothelial neoplasia in moderate stage) in women who had persistent infection with “vaccine-relevant” HPV strains at baseline. A chart in a report of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) showed an efficacy rate of –44.6% (that’s a minus sign) in subjects already exposed to “relevant HPV types.”
On June 25, 2008, the FDA denied Merck’s application to expand marketing of Gardasil to women aged 27 through 45. The FDA refused Judicial Watch’s request for a copy of the letter to Merck, stating that it may be available under FOIA.
Merck also failed to win approval to expand the vaccine to more strains and has reportedly dropped plans to do so.
Most tests with Gardasil were done against an adjuvant-containing “placebo,” rather than a nonreactive saline base, possibly making the vaccine seem safer than it actually is.
In its report to the FDA, Merck noted that “it is not known whether Gardasil can cause fetal harm when administered to a pregnant woman.” It reported that 27% of pregnant women experienced an adverse reaction upon receiving the vaccine, and the Vaccine Adverse Event Reporting System (VAERS) contains 45 cases of spontaneous abortion following Gardasil.
A pre-condition for fast-tracking Gardasil was a requirement for a safety surveillance study, which will not be complete until June, 2009. Nonetheless, intensive marketing continues.
A total of 8,864 VAERS reports have been filed, including 38 of Guillain-Barre syndrome and 18 deaths, 11 occurring within one week of receiving the vaccine. Association, of course, does not prove causality.
Mandating HPV vaccine is a matter of the public good vs. private rights, states Alexandra M. Stewart, J.D., who worked under contract from Merck with the George Washington University Medical Center to study Medicaid coverage for HPV vaccine. The intimate mode of transmission is “a distinction without a meaningful difference”; therefore, legal precedents justifying mandates should apply to Gardasil, she writes (N Engl J Med 2007;356:1998-1999).
In an article that appeared in MedScape on July 26, and was quickly taken off the website, Diane Harper, M.D., a principal chief investigator in clinical HPV trials, was quoted as saying, “The side effects that have been reported are real and they cannot be brushed aside.” She suggested that physicians not vaccinate patients with personal or family histories of the more serious complications, which have included neurologic disorders, thromboembolism, and autoimmune conditions.
“The cause of recent complications remains a mystery and it is difficult to know whether they are linked to vaccines,” the article stated.
Two physicians, a cardiologist and a rheumatologist, say they regret their decision to immunize their 17-year-old daughter and will not encourage his younger daughters to receive the vaccine. After being vaccinated, their eldest went from being a healthy athlete to a chronically ill patient. He worries that other girls may be struggling with immune damage, feeling achy and unwell, but going undiagnosed and unreported.
Gynecologist Christiane Northrup, M.D., appearing on the Oprah Winfrey Show, told viewers that she wouldn’t advocate vaccinating her daughters, and that medical dollars were better spent elsewhere.
The FDA and CDC issued a joint statement reassuring the public and physicians of the vaccine’s safety.
MedScape was accused of “germ theory denialism” (apparently for suggesting that it might be fruitful to investigate how most patients successfully fight off HPV) and “antivaccination myths.” It was also criticized for having the “chutzpah” to run a poll on how physicians were reacting to the reports about adverse events and the FDA/CDC advisory, and the poll has apparently been pulled also.
Additional information:
Another point of view
http://www.cogforlife.org/gardasilfacts.htm
Gardasil
By Peg Luksik, PhD
Important Questions and Answers
April 18, 2007
Introduction
Gardasil is a vaccine for 4 types of HPV developed by Merck. It is currently being marketed to parents as a way to “protect your daughter’s future from cervical cancer and genital warts”. In fact, on the Merck web site for Gardasil, the vaccine is headlined as “the only cervical cancer vaccine.” (Appendix A, p 1)
Does Gardasil actually “protect your daughter’s future from cervical cancer and genital warts”?
No, it doesn’t.
Why not?
Gardasil offers SOME protection against SOME of the Types of HPV that have been linked to cervical cancer.
There are over 40 Types of HPV, and 15 of them have been linked to cervical cancer and/or genital warts. Gardasil has been developed to vaccinate against the 4 Types that have the highest correlation with cancer and genital warts.
However, unlike the smallpox vaccine, for example, Gardasil does not grant full immunity to those 4 Types of HPV. Additionally, in the studies offered to the FDA in Merck’s application for approval, data indicated that Gardasil MAY INCREASE your daughter’s risk of developing cervical disease if she already had one of the relevant strains of HPV at the time of vaccination (Appendix E, p13 & 25).
Gardasil offers no protection against the other 11 strains of HPV that have been linked to cervical cancer. Those strains currently account for 30% (Appendix A, p6, Appendix B, p8) of the diagnosed cervical cancer cases. The continuing potential risk for the non-vaccine strains has led the FDA to require that Merck conduct further studies to determine whether the long-term effect of Gardasil will be nothing more than a shifting in the dominant cancer-linked HPV strains (Appendix C, p1 & 7).
How does Gardasil work?
Like other vaccines, Gardasil stimulates the body to produce antibodies to protect the person from getting the virus when they are exposed to it. There must be enough antibodies in the blood to protect against infection when an exposure happens. The antibodies remain in the blood for some period of time, and the protection remains in effect as long as enough antibodies are there. Some protections last for a lifetime, so the vaccine does not need to be repeated. Others require periodic booster shots to ensure that enough antibodies remain in the blood to protect against infection. The level of antibodies can be measured through a blood test. It is reported as a Titer count.
To determine the duration of effectiveness of a vaccine, one needs to know what Titer count is necessary to ensure protection against the disease, and how long that Titer count will be maintained through a vaccination.
What Titer count is needed to protect my daughter against HPV?
Merck doesn’t know.
Its testing data indicates that Gardasil elevates the Titer count for the 4 Types of HPV targeted. It also indicates the Titer count drops after 7 months and continues dropping until 24 months post-vaccination. The studies only report Titer count levels for 36 months. Merck states that because so few subjects were tested, and therefore too few disease cases developed, they were unable to establish the minimum antibody levels necessary to protect against clinical disease caused by the 4 Types of HPV Gardsil targets. (Appendix D, p5)
How long will Gardasil’s protection last?
Merck doesn’t know (Appendix D, p5).
Does that mean that a little girl vaccinated as a 9-year-old could lose all protection before she becomes 14?
Merck doesn’t know.
How can Merck “not know”?
Data for this information comes from the testing done to develop a vaccine. The drug company conducts studies on patients, with some of them receiving the vaccine and some of them receiving a placebo (saline solution or sugar cubes). The subjects are then studied over time to observe the differences between the two groups in both the effectiveness of the drug and any side effects in may produce in someone taking it.
In the case of Gardasil, there have been not enough subjects, nor enough disease cases, nor enough time to know the answers to these questions (Appendix D, p5).
How many subjects were there?
It varied by age.
Generally, Merck conducted their studies on women from the ages of 16 to 23. Merck reported that they conducted 4 placebo-controlled studies that evaluated 20,541 women, with about half receiving the “placebo”. The women were followed for 4.0 years in the first study, 3.0 years in the second, 2.4 years in the third, and 2.0 years in the fourth study.
Then how was Gardasil approved for little girls under 16 years of age?
Results were based on small testing populations in 2 studies. Study #016 included only 506 girls from 10 to 15 years of age (Appendix E, p19).
In Study 018, Merck reported the following numbers of subjects to the FDA (Appendix E, p20):
9 year-old girls – # evaluated: 67
10 year-old girls - # evaluated: 131
11 year-old girls - # evaluated: 165
12 year-old girls - # evaluated: 142
13 year-old girls - # evaluated: 165
14 year-old girls - # evaluated: 150
15 year-old girls - # evaluated: 109
Merck reports that the total number of children from 9 to 15 years of age who were tested was 1,121 (Appendix D, p7).
The company states that the effectiveness of Gardasil on this population is “inferred” (Appendix D, p7).
“Inferred?”
Yes.
Merck is lobbying to mandate the administration of a vaccine to little girls that they only “INFER” will be effective?
Yes.
What are the side effects?
Unclear, but some indications are troubling.
Why?
Because an accurate determination of side effects is determined in clinical trials by comparing the group that received the vaccine to a placebo group of equal size who received no medication in their injections.
Wasn’t that done?
No.
Wasn’t there a placebo group?
Yes, but it did not receive only a saline injection. In all but 10% of the subjects, the “placebo” group received the same aluminum-containing base as the Gardasil group (Appendix D, p11). Merck received permission from the FDA to treat the aluminum-containing group as the “placebo” group when it reported comparative side effects (Appendix F, p1).
Is the aluminum-containing base safe?
Although widely used, it has never been tested for safety. There has been research from around the world dating back to at least the 1980’s questioning its links to neurological and arthritic conditions (Appendix F).
So there was no group that received a neutral placebo?
Merck reports that 320 subjects received a saline placebo, and 3470 received the aluminum-containing placebo.
Were any comparisons made?
Merck reports saline results only for injection site reactions measured for no longer than 5 days. It does not report saline results for later reactions, or systemic (not just local injection site) reactions.
In the data that IS reported, those receiving Gardasil experienced:
173% more pain
350% more swelling
203% more erythema (redness and inflammation)
517% more pruritus (itching)
than the saline group (Appendix D, pp11-12).
In the product information insert, Merck reports cases of arthritis (juvenile, rheumatoid, and reactive) and lupus among the test subjects after Gardasil treatments. They do not report the ages of those affected, nor how many doses each received.
Is there any other information available on side effects?
Yes.
The Vaccine Adverse Effects Reporting System (VAERS) is a federal data base where patients and/or health care professionals can report adverse effects from a vaccine. The VAERS is a passive reporting system, meaning that data is only received when individuals voluntarily submit it. The government therefore considers that vaccine side effects are underreported by a factor of over 90%.
The VAERS lists 82 cases of Gardasil related adverse effects between July and December 2006. These side effects included local effects such as pain, swelling, inflammation, and itching.
They also included severe headaches, dizziness, temporary loss of vision, slurred speech, fainting, seizures, muscle weakness, tingling and numbness in hands and feet and joint pain, and Guillain-Barre Syndrome (Appendix G).
What about pregnant or breastfeeding mothers?
Congenital anomalies were reported in women who became pregnant within 30 days of Gardasil injection, including pyloric stenosis and club foot (Appendix D, p9, Appendix E, p25).
Merck does not know whether vaccine antigens or antibodies are excreted in breast milk (Appendix D, p9).
Merck reports that an increase in acute respiratory illnesses (300%) in breastfeeding infants whose mothers received Gardasil within 30 days of breastfeeding (Appendix D, p10).
Why the push for mandating? Is cervical cancer a huge problem?
Merck calls cervical cancer the second leading cancer in women around the world. But in the United States, it’s 14th, accounting for less that 1% of the cancers diagnosed here, with about 10,000 diagnosed cases per year nationally. The median age of those diagnosed is 48, leading many to question how a vaccine with an unknown effectiveness duration, given to pre-teen girls, will result in a decrease in cervical cancer rates.
The American Cancer Society reports that cervical cancer rates have dropped by 70% in the past 30 years because of Pap tests, leading to early detection and successful treatment (Appendix H).
Interestingly, Merck did not test Gardasil to see if it causes cancer.
So who is pushing to mandate Gardasil?
Merck is.
The company is aggressively lobbying in every state, including employing Texas Governor Perry’s former Chief of Staff to lobby in Texas.
Why?
Some insight might be gained from The Wall Street Journal. On 2/7/07, the WSJ reported that Merck was desperate for cash. With estimates that the settlements Merck will owe for its Vioxx litigation will amount to approximately $970 million, and the expiration of some of its patents, Merck faces a huge cash flow problem.
But if Gardasil is mandated, Merck will generate sales of approximately $1 billion in the first year alone, with 5 year revenue projections of up to $4 billion (Appendix I).
NOTE: On February 21, 2007, Merck announced that it has cancelled its lobbying efforts to make Gardasil mandatory (Appendix J).
QUESTION: Why is Gardasil considered safe enough for little girls, but not for little boys until Merck conducts “further study?” Since HPV is a sexually transmitted disease, don’t both halves of the sexual partnership need to be vaccinated for a vaccine to be considered “effective” in eliminating its spread?
Appendix A: http://www.gardasil.com
Appendix B: http://ahrp.blogspot.com/2007/02/more-about-mercks-help-pay-for-viox.html
Appendix C: http://www.ahrp.org/cms/content/view/466/27/
Appendix D: Merck & Co, Inc., Whitehouse Station, NJ
Appendix E: VRBPAC Background Document, May 18, 2006 VRBPAC Meeting
Appendix F: http://www.909shot.com/PressReleases/pr62706gardasil.htm
Appendix G: http://www.909shot.com/Diseases/HPV/HPVrpt.htm
Appendix H: American Cancer Society, Cancer Facts & Figures 2005
Appendix I: http://ahrp.blogspot.com/2007/02/merck-lobbies-states-to-mandate.html
Appendix J: http://www.lifesite.net/ldn/2007/feb/07022109.html
Peg is a graduate of Clarion University of Pennsylvania, in Special Education and Elementary Education. She was awarded an Honorary Doctor of Humanities Degree by Stonehill College in Massachusetts in 1997.
2006, 180 cases of mumps (no deaths) were reported to the Minnesota Department of Health. Case-patients ranged in age from 2 months to 92 years.
From the 180 reported cases, 22 had an unknown history of mumps vaccination.
158 had a known history of mumps vaccination:
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29 with history of no vaccination (2 month old, too young to be vaccinated)
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16 with history of vaccination, but number of doses unknown
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22 with history of one dose
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87 with history of two doses
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4 with history of three doses
The numbers in black are the total reported mumps cases and the numbers in red are the reported mumps cases with known vaccine history and percent vaccinated by age groups:
In 2006, the highly vaccinated population (<24 years) had over 2 to 3 times more reported cases of mumps per population than the largely unvaccinated population (>50 years), protected by natural immunity. Contagiousness of mumps is similar to that of influenza.
Mumps vaccine may also change the normal immune response to a natural mumps infection.
"In previously vaccinated persons, the expected rise in IgM antibody may be delayed or absent; therefore, healthcare providers should consider repeating initially negative IgM serologic tests at least 1 week after onset in previously vaccinated persons."
So how dangerous was mumps when the vaccine was licensed in 1967? According to the CDC there were 25 deaths in 1968, the first year mumps became a nationally reportable disease in the U.S. http://www.cdc.gov/vaccines/pubs/pinkbook/pink-chapters.htm Chapter 11. Mumps (301KB, 10 pages)
Before 1977 mass vaccination with the mumps vaccine apparently was not a U.S. public health policy.
"...Death from mumps is exceedingly rare....vaccination of children in most instances is contraindicated because enduring immunity from infection is preferable, thus avoiding serious consequences of mumps after adolescence. Vaccination has value in selected groups of susceptible in military practice or a labor force likely to be exposed to the disease for a limited time." Personal and Community Health, nursing text on public health
Today childhood mass vaccination seems to be a quick fix that produces "vaccine" immunity. But what unforeseeable public health issues may develop when "natural" immunity in the older half of the U.S. population is gone?
Will public health policy ever change from mass vaccination (one shot fits all) back to offering vaccines to those at risk and leave the rest of the population alone (first do no harm)?
Chris
http://www.health.state.mn.us/divs/idepc/newsletters/dcn/sum06/mumps.html
During 2006, 180 cases of mumps (3.7 per 100,000) were reported to MDH. By comparison, one to six cases had been reported annually in each of the previous 5 years. A total of 22 cases were reported in Minnesota between 2001 and 2005.
A multi-state resurgence of mumps occurred in the United States in 2006. Eight Midwestern states including Minnesota, Iowa, Kansas, Illinois, Missouri, Nebraska, South Dakota, and Wisconsin reported mumps incidence rates of more than 2 per 100,000. Forty-five states and Washington D.C. reported a collective total of 6,330 mumps cases, the largest outbreak in more than 20 years. The first outbreak cases occurred in college students in eastern Iowa in December 2005; peak incidence occurred in April 2006 in Iowa and other outbreak states, including Minnesota.
In Minnesota, case-patients ranged in age from 2 months to 92 years. The highest age-specific attack rate occurred in persons 18-24 years of age (42 [23%] cases; 7.9 per 100,000). This is consistent with other outbreak states for which the overall age-specific attack rate for persons 18-24 years of age was 6.0 per 100,000, affecting primarily college students. Sixty-seven (37%) cases occurred in children <18 years of age (5.2 per 100,000); 40 (22%) occurred in adults 25-49 years of age (2.1 per 100,000); and 31 (17%) occurred in adults age >50 years of age (2.1 per 100,000). The comparable age-specific incidence rates in adults 25-49 years of age and those aged >50 years do not support the assumption that persons born before 1957 are immune to mumps due to natural infection.
IgM and IgG serologic testing, and viral culture, should all be performed on suspect mumps cases. False-positive indirect immunofluorescent antibody (IFA) results for mumps IgM antibody have been reported, particularly in persons who are infected with Epstein Barr Virus (EBV). Initial specimens for IgM and acute IgG should be drawn 4-7 days after onset of symptoms. In previously vaccinated persons, the expected rise in IgM antibody may be delayed or absent; therefore, healthcare providers should consider repeating initially negative IgM serologic tests at least 1 week after onset in previously vaccinated persons. Mumps is confirmed by viral culture of buccal swabs, throat swabs, urine, or spinal fluid specimens. Specimens for viral culture should be collected as soon as possible during the first 5 days of illness.
Requested vaccine histories of reported cases from the MDH and their reply. April 2008:
In Minnesota, 180 reported cases of mumps for 2006:
In the age groups:
< 18 years of age
· 1 case of mumps in an unvaccinated (too young)
· 3 cases with history of no vaccination
· 3 case that reports history of vaccination, but number of doses unknown
· 10 cases with history of one dose
· 48 cases with history of two doses
· 2 case with history of three doses
18-24 year olds
· 2 case with history of no vaccination
· 4 cases with unknown history of vaccination
· 5 cases with history of vaccination, but number of doses unknown
· 5 cases with history of one dose
· 25 cases with history of two doses
· 1 case with history of three doses
25-49 year olds
· 5 cases with history of no vaccination
· 8 cases with unknown history of vaccination
o 2 reported history of mumps
· 7 cases with history of vaccination, but number of doses unknown
· 5 cases with history of one dose
· 14 cases with history of two doses
· 1 case with history of three doses
> 50 year olds
· 18 cases with history of no vaccination
o 11 reported history of mumps
· 10 cases with unknown history of vaccination
o 1 reported history of mumps
· 1 case with history of vaccination, but number of doses unknown
· 2 cases with history of one doses
Of those with history of mumps: "They were all reported from their own memory or their parent's memory. We did not follow-up with clinics to verify."
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